Approach to spur testosterone production instead of synthesis on the horizon – Pharmaceutical Technology

Acesis Biomeds lead candidate has the potential to provide a safer solution to treat low testosterone and hypogonadism compared to existing treatments by instructing the bodys own cells to produce testosterone naturally.Image source: Shutterstock

Low testosterone in men is a widespread clinical problem linked to obesity, high blood pressure and Type 2 diabetes. Nearly 39 percent of the worlds male population aged 45 and over have hypogonadism. But, despite this, there is a serious lack of innovation in the area with all current therapies available being based on synthetic testosterone developed in the 1930s.

Hypogonadism is widely referred to as male menopause since it mostly starts to affect men in midlife, impacting their mood, energy, fertility and can lead to osteoporosis. However, low testosterone and hypogonadism can affect younger men as well.

After the age of 30, testosterone levels decline 1-2% on average a year, depending on ethnicity and several other conditions or comorbidities, explains CEO and co-founder of Acesis Biomed, Dr Costas Karatzas in an interview with Pharmaceutical Technology.

The company is unique in its approach to treating low testosterone, without being a testosterone company and is developing a first-in-class non-steroidal oral peptide therapy designed to induce endogenous testosterone production in testosterone-deficient males.

Currently in preclinical development, Acesis lead candidate ACE-167 has the potential to provide a safer solution to treat low testosterone and hypogonadism compared to existing treatments by instructing the bodys own cells to produce testosterone naturally. This will be in contrast to synthetic testosterone AKA Testosterone Replacement Therapy (TRT) or anabolic steroids which can have serious side-effects and a high potential for abuse as performance-enhancing drugs.

Many symptoms associated with low testosterone have been grouped under a depression disorder. So, many people who suffer from hypogonadism are given antidepressants which makes some issues worse their libido never comes back and their ability to perform is even worse.

In March 2019, the FDA approved Clarus Therapeutics TRT capsule to treat men with certain forms of hypogonadism. This marked the first and only FDA-approved oral soft gel for TRT, but as Karatzas says, it is still based on 70-year-old chemistry. As with other TRTs on the market, it is also indicated only for the age group of 40 to 65 years, thus excluding younger and older men. For ages 65 and above, the agency posits that the testosterone lowering process is part of normal ageing.

Acesis Biomeds lead candidate ACE-167, is an orally administered non-steroidal treatment that instructs the testis to produce its own testosterone. The testosterone (T) peptide modulator is being developed under the expertise of Dr Vassilios Papadopoulous, dean of the University of Southern Californias School of Pharmacy and co-founder of Acesis. He received millions in funding from multiple sources to support the research that led to the understanding of the mechanism underlying steroidogenesis, its regulation and the identification of a novel molecular therapeutic target of T restoration.

Karatzas says since the companys asset is not a steroid like testosterone, it does not come with the side-effects seen with widely used TRTs which includeenlarged breasts, high blood pressure, bone growth problems and acne. Its a peptide, which when taken orally, is designed to instruct the testes to make testosterone at the normal physiological levels.

Cholesterol transportation to the mitochondrial membrane is the limiting factor of how much steroid the testes will make, Karatzas says. There is a protein complex that affects how cholesterol is transported into the mitochondria, and, Dr Papadopoulos discovered a negative regulator of these proteins that transport cholesterol, he explains. The companys intellectual property deals with the peptides that can remove that negative regulator and allow cholesterol to move into the mitochondria to control the maximal amount of steroid being produced.

TRTs currently on the market involve administering testosterone to the body via gel, injection, patch or, as mentioned more recently, a pill.

Their administration can be almost as problematic as the TRTs themselves. Injections can require patients to go and visit their doctor every two weeks or six months. In the weeks running up to the next shot, men can suffer under the effects of waning testosterone levels. Furthermore, they run the risk of being addictive and abused, requiring recipients to be closely monitored.

Over the past few years, there has been a huge rise in off-label use, misuse and abuse of testosterone which is often touted to men for the improvement of things related to desirable facets of male masculinity energy, hair growth, sexual performance and muscle gains.

Steroids, differentiated only from TRT by being illegal, medically unsupervised and usually administered at much higher doses, were popularised by bodybuilders in the 80s and 90s. They soon became attractive to young men who wanted more muscular physiques.

When abused or taken in heavy doses, not only can it become highly addictive, but can also shut down organic testosterone production in the body leading to reduced testicle size and infertility. It also comes with an increased risk of blood clots and heart attack and can lead to paranoia and aggression.

Patches and gels, meanwhile, can cause cross-contamination to partners and children. An oral treatment that encourages the body to make its own testosterone could be a gamechanger. Karatzas says ACE-167 is not conducive to abuse or cross-contamination because of that unique protein to protein interaction.

There are nine therapies for the treatment of low testosterone and hypogonadism in preclinical development or Phase I trials including Acesis, but the firm is the only one developing an oral treatment that encourages the bodys own testosterone production rather than administering a synthetic hormone.

Based on our preclinical data so far, there is no excessive increase in testosterone. The limit of how much testosterone you make is personalised and depends on your own machinery.

Karatzas says that experts and pharma companies have only recently realised the central role that testosterone plays as the protagonist of many comorbidities. Aside from hypogonadism, low testosterone levels in blood have, in recent years, been found to also be an independent predictor of a number of cardiovascular risk factors. That includes metabolic syndromes at large obesity, abnormal cholesterol levels, high blood pressure and hypertension all of which can lead to Type 2 diabetes and heart disease.

The prevalence of hypogonadism appears to be in almost 50% in individuals with Type 2 diabetes and obesity. In terms of the development space for hypogonadism, Karatzas says the market is anywhere between $3-4 billion per year for the FDA-approved indication in the 40-65 years age group. But, there will be more demand if the regulatory agencies allow use outside that age threshold, and there is potential for other comorbidities as well, he adds.

Acesis current clinical development plan is to show the safety and early efficacy of ACE-167 in individuals with hypogonadism in that 40-65-year-old age group, where there is already a path to approval. A Phase I trial is expected to commence in the next two years.

After this, Acesis will evaluate the peptide in a number of secondary markets including obesity, pre-diabetes, Type 2 diabetes and the reversible condition non-alcoholic fatty liver disease (NAFLD). The company also plans to collaborate with foundations for patients with Klinefelters syndrome a condition where an extra X chromosome is present in addition to the XY resulting in low testosterone. Boys with Kleinfelter are put on TRT but they often face the problem of infertility, and Acesis approach can help enable sexual maturity.

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Approach to spur testosterone production instead of synthesis on the horizon - Pharmaceutical Technology

Testosterone Replacement Therapy Market: Introducing New Industry Dynamics Through SWOT Analysis 2020-2026 NeighborWebSJ – NeighborWebSJ

The Latest Updated market research study on Global Testosterone Replacement Therapy Market with data Tables, charts, Premium insights & Graphs is available now to provide complete guidance of the Market. The report highlights the growing trends, top market players, current & future market scenario analysis, and growth drivers evaluated by Industry Experts and Professionals. With an all-round approach for data accumulation, the market scenarios comprise major players, cost, and pricing operating in the specific geographies. Statistical surveying used are SWOT analysis, PESTLE analysis, predictive analysis, and real-time analytics. Graphs are clearly used to support the data format for a clear understanding of facts and figures.

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Kevin Holland Calls Out Conor McGregor Over Weight Gain – Heavy.com

Getty ImagesUFC star Conor McGregor.

Conor McGregor showed off his bulky new look this week and Kevin Holland isnt too sure that the UFC stars gains are all-natural.

Holland is never scared to make a joke or speak his mind and took to Instagram with a message about McGregors new look.

Conor vitro Belfort McGregor, Holland wrote, appearing to reference former UFC champ Vitor Belfort, who has been known for using testosterone replacement therapy.

Holland used the same photo McGregor posted earlier in the week, hinting his gains were from eating at his restaurant, The Black Forge.

Before a feed at The Black Forge. After a feed at The Black Forge,McGregor wrote in a tweet. Quality Irish produce. All across the board. Unmatched!

McGregor is coming off a broken leg suffered while fighting Dustin Poirier at UFC 264 and has been on the mend, obviously putting in work. He mentioned previously on social media that he was tipping the scales around 190 pounds a big shift for McGregor who has fought as low as 145 pounds in his career.

Holland is a meme master and also poked fun at McGregor following his loss to Poirier with an edited interview of his interview with Joe Rogan.

In case you missed [Conor McGregors] first words after the fight he was really letting go after the fight, Holland wrote.

After catching some heat from the McGregor army he apologized in the comments.

Dam I forgot the Conor fans would murder me. I sorry, Holland wrote.

Whether theres a belt on the line or not, a McGregor fight brings the eyeballs and cash. And while the Irishman could sit back on his piles of cash, hes still hungry to get in the octagon.

Hes chomping at the bit to get back in there and compete again, White said of McGregor. Its going to be a while before he can put some torque on that leg. April, for him to start training again in April is probably about right.

White said theres no question about McGregors commitment and he wants to get back to winning fights. Hes won just one fight since 2018, which came against Donald Cerrone.

He obviously still has the desire to compete, White said. You dont ever hear Conor going, You know what, man? I just dont have the desire for this anymore. You now what I mean? Yes, hes obviously very rich, and hes training like Rocky in Rocky III, but he still has the desire to compete and the desire to fight, and well see what happens.

There are a few routes McGregor could go with his next fight and his longtime head coach John Kavanagh noted some of those during Mondays The MMA Hour.

Ill be honest, the Nate Diaz trilogy is very, very tempting, Kavanagh said. Its a fight that gives me nightmares. The man doesnt stop coming forward, whether its three rounds or five rounds, but its an intriguing fight. So that one is definitely very interesting. But also the Tony Ferguson one it never happened. It was talked about a lot. And Tony still has, I believe, a lot to offer the game. Hes a very unorthodox striker, grappler. I think the buildup would be fun for the fans. So any of those kind of legacy guys.

It might be a while before we see McGregor back in the octagon but his next fight result will dictate quite a bit about how the rest of his career goes.

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Mens Health And Fitness: How to Easily Restore Your Energy – The Southern Maryland Chronicle

Mens health and fitness are important for good living. Good health allows us to live pain-free lives while reducing the chances of contracting illnesses that can render us incapable of normal activities like work or daily errands. So, if you are a man, and you want advice on how to restore your energy, here are them.

Restoring energy is a task that many men have to deal with daily. As we mature, our bodies slowly become less efficient in the ways they use energy. And this can result in a man who is too tired by midday to function effectively at work or at home. Luckily, restoring your energy isnt so hard when you know how and what you need to do. The first thing for me is testosterone replacement therapy (TRT). Men who are looking for an easy way to restore their energy should consider TRT because it has been proven highly effective. In fact, when used properly, TRT can restore a mans physical strength almost immediately after starting treatments. If you live in Atlanta you can consider an Atlanta TRT clinic, and in fact, there are many clinics in this area that offer the therapy. You can consider it alongside your location and see which one will be the best for you.

The next thing to restoring energy and staying healthy and fit is regular exercise. If you want to restore your energy, its important that you dont let yourself get out of shape. That means making the necessary effort to stay active and healthy, even when youre tired. It doesnt take much time to go for a jog around the block or do some sit-ups and push-ups in your living room, so theres no excuse not to be doing it on a daily basis. You can also consider joining a gym or finding some other form of indoor exercise like yoga. Exercise can also help you to get rid of stress and tension, which can not only drain your energy but also lead to a number of other health problems.

The next thing you should do to help yourself restore your energy is to make sure that you eat right. That means eating a balanced and nutritious diet and reducing the amount of caffeine and sugar in your food. This can be difficult for some men because they love their sweet treats and caffeine boosts, but its important if you want to live an energetic life. Also, consider taking vitamins on a daily basis just like any other man who wants to restore his energy. For example, vitamin B can help with fatigue so adding more foods containing this vitamin will boost your overall energy levels.

Last but not least, getting enough sleep is one of the most essential things you can do for your energy levels. Most men need around eight hours of sleep per night, so try to make it a priority in your life. If youre struggling to get enough sleep, there are a few things you can do to help yourself out. For example, avoid using electronic devices before bed and establish a regular bedtime routine that will help your body prepare for sleep. Once youve gotten into the habit of getting enough sleep, youll find that your energy levels are restored, and you feel more alert and productive during the day.

Sometimes, the best way to restore your energy is to take a break. This could mean taking a short vacation, even if its just for a few days. Or it could mean taking some time away from work or daily tasks so that you can relax and recharge your batteries. If youre feeling run down or constantly exhausted, then taking a break is something to consider doing. It doesnt have to be anything too extreme, just whatever works best for you. Excessive stress will drain your energy almost as much as poor diet and exercise habits will. So make sure that you take enough time off throughout the week so that you can relax and rejuvenate.

Another thing that you can do to restore your energy is to get a massage. There are lots of different types of massage available, so if youre not sure which one is right for you then you can do some research online. For example, a Swedish, hot stone, or deep tissue massage are all good choices if you want to relax and restore your energy. Remember that even though it might be difficult to find the time in your schedule to get a massage, its something that will benefit you long term by helping you relax and recharge after a hard day at work or looking after the kids.

So there you have it, six easy ways to restore your energy. All of these tips are simple and easy to follow, so theres no excuse not to get started today. Just remember that it takes time and effort to make a change in your lifestyle, but its worth it in the long run!

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Clarus Therapeutics Announces Two Notices of Allowance for – GlobeNewswire

JATENZO (testosterone undecanoate) is the first and only FDA-approved oral softgel for testosterone replacement therapy (TRT) in adult males who have deficient testosterone due to certain medical conditions

Upon issuance, Clarus plans to list these patents in FDAs Orange Book, which would bring the total number of Orange Book-listed patents covering JATENZO (testosterone undecanoate) to seven

NORTHBROOK, Ill., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (Clarus) (Nasdaq:CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announcedthat it has received two notices of allowance from the United States Patent and Trademark Office (USPTO) for claims that cover its oral testosterone replacement product, JATENZO (testosterone undecanoate).

Patent application No. 16/656,157 entitled Oral Testosterone Ester Formulations and Methods of Treating Testosterone Deficiency Comprising Same and patent application No. 15/814,162 entitled Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same both cover Clarus approved product JATENZO (testosterone undecanoate). The U.S. patents scheduled to issue from these applications will expire in 2030 and 2026, respectively.

These recent patent allowances by the USPTO are another important milestone in protecting the commercial potential of JATENZO and the life cycle management programs we have under development for this lead asset, said Dr. Robert Dudley, Founder, President and Chief Executive Officer of Clarus. Once issued, these two new patents will be listed in FDAs Orange Book and will bring the total number of patents that protect JATENZO to seven. These new patents will further strengthen the broad and robust intellectual property portfolio for JATENZO.

About Male Hypogonadism Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the U.S. have hypogonadism, with approximately 6 million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy (TRT).

About Clarus Therapeutics Holdings, Inc.Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women including potential therapies for orphan indications. Clarus Therapeutics first commercial product is JATENZO. For more information, visit http://www.clarustherapeutics.comand http://www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

Clarus Forward-Looking StatementsCertain statements in this press release constitute forward-looking statements for purposes of the federal securities laws. The words anticipate, believe, contemplate, continue, could, estimate, expect, intends, may, might, plan, possible, potential, predict, project, should, will, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Clarus forward-looking statements in this press release include, but are not limited to, statements regarding the issuance of these patents, listing in the FDAs Orange Book and the effect of these patents on the JATENZO patent portfolio. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that Clarus has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Clarus control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with pharmaceutical development, risks associated with Clarus financial position, and those factors described under the heading Risk Factors in the prospectus filed with the Securities and Exchange Commission (the SEC) under Rule 424(b)(3) on October7, 2021, and those that are included in any of Clarus future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Clarus assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the COVID-19 pandemic and there may be additional risks that Clarus considers immaterial, or which are unknown. It is not possible to predict or identify all such risks. Clarus forward-looking statements only speak as of the date they are made, and Clarus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Clarus Investor Relations Contact:Kara Stancellkstancell@clarustherapeutics.com(847) 562-4300 x 206

About JATENZO

IndicationJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of useSafety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONSJATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTSThe most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding JATENZO at http://www.jatenzo.com.

2021 Clarus Therapeutics, Inc. All rights reserved.

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Crain’s Health Pulse is your source for actionable, exclusive and inside news on the health care industry. – Crain’s Chicago Business

IS LAB SPACE BOOM TOO SCATTERED? Locally born life sciences companies no longer have to worry about a lack of high-quality lab space forcing them to leave town as they grow, thanks to developers racing to build it during the COVID-19 pandemic. Where those companies decide to go in the Chicago area is a separate issue, and one that is shaping the next chapter of the city's evolution into a biotech and pharmaceutical research hub.

While more mature life sciences markets like Boston, Raleigh-Durham and San Diego feature centralized clusters of startups, well-established companies and lab buildings all close to academic institutions that churn out research, Chicago's growing biotech landscape thus far has been anything but concentrated. New lab space in the area has been scattered by geographically separated universities and where real estate developers want to build, fragmenting the momentum among city and suburban nodes that all show promise, but have little connective tissue.

The research that seeds many of the life sciences companies grown in Chicago, meanwhile, has historically been done closer to Northwestern in Evanston, University of Chicago in Hyde Park and the hospital systems in the Illinois Medical District on the city's Near West Side. But instead of building more lab space on or near those campuses, developers have been jockeying to create what they hope will emerge as the nucleus for local life sciences startups in places like Fulton Market or Lincoln Yards. READ MORE.

MILLS CLAN'S POTENTIAL $29 BILLION WINDFALL, AND THE FATE OF MEDLINE:As the Mills family weighs what to do with an enormous pile of cash from selling a 79% stake in Northfield-based Medline, managers are charged with steering a suddenly debt-laden medical-supply firm through an industry besieged by supply issues.

Investors dont seem too concerned. Septembers offering of more than $14 billion in junk bonds and leveraged loans to finance the deal was met withenthusiasm.The company also raised an additional $2.1 billion of commercial mortgage bonds.

In Medlines favor, the family executivesCEO Charlie, his cousin Andy Mills and their in-law, Jim Abramswill remain in their roles and the family will keep a significant stake. The Mills family is rolling $3.5 billion of their equity into the business, allowing them to retain 21% of Medline, according to bond documents seen by Bloomberg. READ MORE.

TITLE FIGHT PITS 'PHYSICIAN ASSISTANTS' AGAINST DOCTORS:Seeking greater respect for their profession, physician assistants are pushing to rebrand themselves as physician associates. Their national group, formally replaced assistant with associate in its name in May, transforming into the American Academy of Physician Associates. The group wants state legislatures and regulatory bodies to legally enshrine the name change in statutes and rules.

Rechristening the P.A. name has spiked the blood pressures of physicians, Kaiser Health News reports.

They complain that some patients will wrongly assume a physician associate is a junior doctor, much as an attorney who has not yet made partner is an associate. The head of the Chicago-based American Medical Associationwarnedthat the change will undoubtedly confuse patients and is clearly an attempt to advance their pursuit toward independent practice. The American Osteopathic Association, also based in Chicago,accusedthe P.A.s and other nonphysician clinicians of trying to obfuscate their credentials through title misappropriation.

But the P.A. group says theres no ulterior motive in altering their name.

Changing the title is really just to address that misperception that we only assist, said Jennifer Orozco, president of the Alexandria Virginia-based P.A. association and an administrator at Rush University Medical Center. It wont change what we do.

ALS THERAPY SHOULD TARGET BRAIN, NORTHWESTERN STUDY SAYS: Flipping the notion that ALS starts in the spine, Northwestern Medicine scientists said in a study published Thursday that the brain is indeed a target for treating ALS, Northwestern said in a statement.

The study in the Nature journal, Gene Therapy, shows the degeneration of brain motor neurons is not merely a byproduct of the spinal motor neuron degeneration, as had been previously thought, the statement said.

We have discovered that the brain degenerates early in diseases like ALS, sends us warning signals and shows defects very early in the disease, lead study author Hande Ozdinler, an associate professor of neurology at Northwestern University Feinberg School of Medicine said in the statement. Therefore, we need to repair the brain motor neurons if we want long-term and effective treatment strategies. The brain is important in ALS.

HEALTH CARE EQUITY FIRM FORMS VETERINARY REIT: Chicago-based Thurston Group, a private-equity firm focused on investments in health care service companies, said in a statement its formed a Real Estate Investment Trust, or REIT, dedicated to serving veterinary property owners. For the National Veterinary REIT, Thurston is partnering with real estate investors, AMO Partners, which is experienced in the veterinary business, the statement said.

"Partnering with AMO is the perfect fit for National Veterinary REIT because it lets us replicate our health care REIT success in a very similar, yet underserved space: the veterinary market. We have a proven track record of bringing wealth creation tools to clinicians. AMO's experience and depth of understanding will bring the same opportunities to an entirely new group of caring yet underserved providers," Thurston Group Chairman and CEO Patrick J. Haynes III said in the statement.

Thurston has a similar REIT strategy in the dental arena, where it has over 70 properties in 12 states, the statement said.

GTCR'S CORZA MEDICAL BUYS KATENA PRODUCTS: Chicago-based private-equity firm GTCR said in a statement that its medical device portfolio company Corza Medical has acquired Katena Products, Inc., a medical device company focused on ophthalmic surgery products. The acquisition of Katena expands Corza's portfolio of surgical products and adds significant scale, product breadth and infrastructure to Corza's ophthalmic surgery segment, the statement said. Terms were not disclosed.

CLARUS SELLING SECURITIES IN PRIVATE PLACEMENT: Northbrook-based Clarus Therapeutics Holdings, which develops androgen and metabolic therapies for men and women, said in a statement that it has entered into a definitive agreement to sell securities in a private placement with a leading health care investor.

Clarus said it intends to use the net proceeds from gross proceeds of about $15 million, "to support growth initiatives for its near-term commercial objectives for its oral testosterone replacement product, Jatenzo," the statement said.

Pursuant to the terms of the securities purchase agreement, Clarus said it will issue to the investor 3,024,194 units at a price of $4.96 per unit. The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, Clarus said in the statement.

VILLAGEMD ADDS ANOTHER MICHIGAN PRACTICE: Chicago-based VillageMD said in a statement that Envision Medical Group, with 12 locations across three Michigan counties, will begin practicing as Village Medical starting Nov. 17. The practices are located in Metro Detroit. Village Medical also has two practices in Westland, Mich.

JOIN US FOR CRAIN'S HOSPITAL CEO BREAKFAST:Hear how Chicago-area hospitals have been weathering the storm and what's on the horizon at Crain's Hospital CEO Breakfast on Dec. 14.Register now for the in-person event.

PEOPLE ON THE MOVE

Mike Ferson and Michelle Werr have been promoted to the roles of managing director at HealthScape Advisors.

Ferson has extensive experience supporting health plans, systems and physician groups in solving complex strategic and operational challenges. Werr serves as a key advisor to health plans, providers and private-equity firms as they navigate the health care market, particularly in government programs.

Kimberly Bors, senior vice president and chief human resources officer at Dover Corporation has been appointed to the American Heart Associations Midwest Board of Directors for a two-year term.

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Crain's Health Pulse is your source for actionable, exclusive and inside news on the health care industry. - Crain's Chicago Business

The greater role of genetics in the cause and diagnosis of male infertility – ESHRE

A wide-ranging ESHRE Campus workshop organised by the SIGs Andrology and Reproductive Genetics looked at current and emerging approaches for the characterisation of various causes of male infertility, including tests in the genetics of idiopathic conditions, chromosomal anomalies notably Klinefelter syndrome and new molecular methods for investigation.

The apparent contribution of genetics to male infertility continues to grow. Indeed, the final presentation of a three half-day Campus meeting in September, from Antoni Riera-Escamilla, described the identification of five new candidate genes to add to seven others now implicated in the aetiology of non-obstructive azoospermia. Riera-Escamilla proposed that whole genome and exome sequencing were now a valid approach to identifying genetic factors in the cause of male infertility, particularly when idiopathic.

From the 15 presentations of this virtual Campus it was evident that genes are implicated in both the quantitative and qualitative features of male reproductive impairment. Genetic causes affecting sperm numbers are commonly chromosomal in origin, and include microdeletions in the AZF subregions of the Y chromosome, Klinefelter syndrome, and chromosome structural abnormalities. Genetic factors also play a role in the aetiology of hypothalamic-pituitary axis disturbances and ductal dysfunction, such as congenital hypogonadotrophic hypogonadism (eg, Kallmanns syndrome) and congenital absence of the vas deferens.

Of these many conditions, Ellen Goossens from the Biology of the Testis research group at the VUB Brussels described Klinefelter syndrome as the most common sex chromosome anomaly in men and the most frequent genetic cause of infertility, implicated in around 15% of all azoospermia cases. Presentations on Klinefelter syndrome occupied around one-third of this Campus meeting, and all speakers acknowledged a lack of consistency in the syndromes clinical presentation because of the wide variation in phenotype and only the moderate treatment potential from TESE, and even less from prepubertal testicular tissue banking.

What does seem clear is the syndromes classic genotype (47,XXY) and the high rate of azoospermia (~90%) in diagnosed cases. Alongside, said urologist Robert Oates from Boston Medical Center, theres a range of typical and atypical symptoms which may be indicative of the syndrome. The classic male profile is characterised as tall and thin, azoospermic with small testes, decreased muscle mass, gynecomastia and learning disabilities while an atypical profile might be short and obese, very virilised, possibly fertile and with regular muscular development. Moreover, infertility might not be the only health concern for patients with Klinefelter syndrome, with greater cardiovascular, metabolic and cerebrovascular risks all evident in the adult.

According to Lise Aksglde from Rigshospitalet in Copenhagen, these risks and other developmental problems seem greater when the additional X chromosome is paternally inherited. This, she proposed, may explain the high rate of X-linked copy number variations seen in Klinefelter, as well as evidence of impairment in the function of the androgen receptor gene. These proposals too, she explained, were based on candidate genes identified by transcriptome and methylome analysis of autosomes and sex chromosomes. Nevertheless, she said, more studies are needed to shed light on the mechanisms underlying the high phenotypic variability of Klinefelter syndrome.

Experiments in the Brussels lab of Ellen Goossens suggest that germ cell loss occurs at a very early age, suggesting that testicular tissue banking may not be a viable fertility preservation option for young men even in their adolescent years. However, testicular sperm extraction for ICSI apparently successful in around 35-50% of adult Klinefelter patients, said Goossens was similarly successful in boys at the onset of puberty, despite the fibrosis of the seminiferous tubules and germ cell loss notable around the time of puberty.

Of course, any treatment at these young ages comes with considerable personal and ethical challenges. Nathalie Rives from the University of Rouen reported from her data that fertility preservation is not accessible for most Klinefelter boys and adolescents, with parental discussion (especially about potential poor treatment outcomes) an absolute necessity. Her own data indicated that after TESE failure the majority of adult cases (81%) turned to sperm donation or adoption. She reiterated the recent recommendations of the European Academy of Andrology guidelines that testicular tissue cryopreservation or spermatogonial stem cell retrieval is not recommended in pre-pubertal and pubertal boys with Klinefelter syndrome.(1) In adults, the same guidelines recommend semen analysis and sperm cryopreservation, and in those with confirmed azoospermia TESE for ICSI.

Another classic feature of Klinefelter along with azoospermia is hypergonadotropic hypogonadism, which, as an isolated and rare congenital condition, may be helped (for the induction of spermatogenesis) by testosterone replacement therapy. Such treatment in such cases is usually lifelong, said Csilla Krausz from the University of Florence, but in around 10% of cases the condition may be reversible and thus represents a treatable form of azoospermia. Testosterone supplementation, however, said Nathalie Rives, was not recommended for boys in the recent European Academy of Andrology guidelines for Klinefelter syndrome.

Interestingly for this Campus meeting, congenital hypergonadotropic hypogonadism was until recently considered a monogenic disease, but, said Krausz, there are now 35 genes with strong/definitive clinical evidence for cHH. Screening for a genetic cause, she added, would be important for siblings and for the health of future offspring.

It was evident at this meeting that, while emerging sequencing technologies might explain cause and improve diagnosis, there was little evidence yet of their role in treatments except perhaps in the application of testing for DNA fragmentation in sperm cells. So far, however, and from a wealth of data presented, Nicols Garrido from the IVI Foundation in Valencia and Coordinator of ESHREs SIG Andrology, concluded that existing study results do not support a consistent strong relationship between abnormal DNA integrity and reproductive outcomes. He therefore was unable to recommend routine use, so echoing some of the recent (and not so recent) reviews of DNA fragmentation tests.

One of the main reasons for Garridos caution was an inconsistency in studies between populations, samples, outcomes and techniques. Notably, he explained, you measure all sperm, but use one sperm. Moreover, even in cases of high DNA fragmentation index, there is no downstream influence on treatment and the tests mainly serve to identify the cause and advise on lifestyle changes. Are the tests diagnostic or simply risk assessment tools? he asked.

Garrido added that sperm DNA fragmentation analysis is one of several proposed techniques to improve sperm selection for ICSI, but all of them, he said intracytoplasmic morphologic sperm injection (IMSI, in which sperm is viewed under very high magnification), PICSI (physiological ICSI in which selected sperm bind to droplets of hyaluronic acid), electrophoresis and birefringence have limited clinical application due to insufficient data.

1. Zitzmann M, Aksglaede L, Corona G,et al. European academy of andrology guidelines on Klinefelter Syndrome Endorsing Organization: European Society of Endocrinology. Andrology 2021; 9: 145-167.doi:10.1111/andr.12909.

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The greater role of genetics in the cause and diagnosis of male infertility - ESHRE

Testosterone Replacement Therapy Market Is Thriving Worldwide with AbbVie, Bayer AG, Endo Pharmaceuticals, Eli Lilly and Company Otterbein 360 -…

According to the latest report by Coherent Market Insights on global Testosterone Replacement Therapy market, with the latest insights and statistics from the biggest pharmaceutical and healthcare device manufacturers across the globe, CMI presents an extensive analysis on Testosterone Replacement Therapy market. CMI offers insights into the market data on over 5000+ drugs for more than 100 countries, which further aids the research on current and upcoming market scenario for the market. Our expert researchers and analysts for healthcare tracks the data of established players as well as new entrants in medical industry to provide an unbiased analysis for a sound and financial decision.

Over the past decade, healthcare sector has been expanding remarkably, following the advent of artificial Intelligence and the Internet of Things integrated medical devices. Advancement in technology has created impressive scope within the medical sector for diagnostics and therapeutics.

Get more Insights Analysis on this Testosterone Replacement Therapy Market@https://www.coherentmarketinsights.com/insight/request-sample/2024

The report offers extensive data sets validating key trends impacting growth in the Testosterone Replacement Therapy market. It offers insights into strategies adopted by the key players rise and address the concerns that will challenge the growth of market. With our extensive research and information about the past, current and future market scenario, the Testosterone Replacement Therapy market report will help and identify the concerns, for a smooth-sail of the small & medium as well as large enterprises.

Major Players in Testosterone Replacement Therapy Market

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With an extensive SWOT analysis, the CMIs study presents the strengths, weaknesses, growth prospects and challenges of each player. The report also includes important data including the sales strategy, pricing strategy, and marketing strategy adopted by these players in the Testosterone Replacement Therapy market

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With the pandemic plaguing maximum countries across the globe, healthcare industry is witnessing its fair share of ups and downs. The COVID-19 has placed an enormous strain on the healthcare sectors workforce, facilities and infrastructure. Despite the endless pressure, healthcare sector is growing at a moderate pace due to the improvement in infrastructure and advancement in technology, healthcare sector is delivering a healthy performance.

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Ground breaking research and market player-centric solutions for the upcoming decade according to the present market scenario

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Our analysts are experts in this field with years of experience. We atCoherent Market Insights maintain the highest level of accuracy and transparency in the report. The primary and secondary resources used in the report are taken from reliable and high authority sources to deliver 100% accurate and trusted data.

Thanks for reading this article;you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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Testosterone Replacement Therapy Market Is Thriving Worldwide with AbbVie, Bayer AG, Endo Pharmaceuticals, Eli Lilly and Company Otterbein 360 -...

Lipocine Inc. (NASDAQ: LPCN And Antres Pharma signs Exclusive Commercialization Agreement for TLANDO In The US – BP Journal

Lipocine Inc. (NASDAQ: LPCN) and Antres Pharma Inc. have signed an exclusive licensing agreement for the commercialization of TLANDO in the US. TLANDO is a testosterone replacement therapy for treating adult males with conditions associated with endogenous testosterone deficiency or absence, such as hypogonadotropic hypogonadism or primary hypogonadism.

TLANDO received provisional approval from the US FDA, as previously disclosed. The drug will be eligible for final approval once the exclusivity term given to Clarus Therapeutics, Inc. under the Hatch-Waxman Act with respect to its medicine, JATENZO, expires on March 27, 2022. The agency has confirmed that the NDA resubmission for TLANDOs final approval will be classified as a Class 1 resubmission, with a goal period of two months for FDA review.

According to agreement terms, Lipocine will receive an $11 million payment upfront, an additional $5 million licensing payment by January 2025, and another licensing payment of $5 million by January 2026. Also, the company will be entitled to sales-based milestone payments of up to $160 million based on net sales of TLANDO. Liposcine will retain TLAND rights for all ex-US jurisdictions and for non-TRT indications. On the other hand, Antres Pharma will be responsible for commercial and post-marketing roles in the US.

Liipocine CEO and President Mahesh Patel said, We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space. Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharmas capabilities, given its established marketing experience and demonstrated success in the TRT space. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet need.

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Lipocine Inc. (NASDAQ: LPCN And Antres Pharma signs Exclusive Commercialization Agreement for TLANDO In The US - BP Journal

Is Male Menopause a Real Thing That Guys Deal With? – AskMen

Ah, middle-age the self-doubt, the existential angst, the sudden awareness of just how short life is. Work, marriage, kids. Its not easy. And then comes the lack of enthusiasm, the tiredness, the brain fog and the irritability. But these are not necessarily de facto products of having made it to a certain age.

Rather they aresymptoms and you can throw in hot flushes, insomnia, mood swings and a general disinterest in sex of a still controversial idea: that, like women, men experience menopause.

This is not a definitive biological, hormonal event as it is for women the sometimes decade-long spell of similar symptoms, leading to a lack of menstruation for a year, followed by officially entering ones post-child-birthing phase of life. It likely doesnt have quite the same negative impact on well-being, on relationships and work.

Certainly not everyone in medical circles thinks its even a real thing, and scientific study of the manopause more officially, the andropause is lacking. And yet many men, and increasingly, clinicians too, concede that something sometimes happens when you hit your mid-40s or early 50s. You go off the boil.

RELATED:Turning 30? Here's How Your Bod's Going to Change

The male menopause just isnt as well recognized as the female menopause, explains Dr. Clive Morrison of Londons Centre for Mens Health. This is in part because the latter is a natural, well-documented event for every woman, but its a less distinct, drawn-out process for most men, and it doesnt affect all men either. In part its because were not really sure why it happens to men. And in part also because of culture, which still broadly has a temperance attitude to sex. The male menopause is confused with the stigma around loss of libido, even though thats only one possible symptom. But this is more about your mojo. Its about your quality of life.

It doesnt help, of course, that a lot of the many possible symptoms of andropause are products of aging too: like it or not you can start to lose muscle typically about 3-5 percent of your muscle mass every 10 years after the age of 30. You might put on weight too, or rather your body fat is redistributed, so you get a bit of a belly. This all makes correct diagnosis of the andropause tricky a situation only made worse because, as Morrison stresses, each of us has our own threshold levels for each symptom, such that a man may display all of the psychological signs and some but by no means all of the physical or bio-chemical ones.

And psychological factors may be indicative of something else depression, maybe, not the andropause. Inevitably this all makes deciding on the right course of action tricky too.

There are simple things that we know do help that, in fact, help towards better health generally. Move more at a minimum just taking good, regular, long walks. Train gently but regularly with weights. Eat a low-carb, high protein diet. Get a good eight hours sleep every night. Address the stress in your life rather than normalizing it.

But others those who may be tempted to supply a quick fix, much as HRT or Hormone Replacement Therapy has (not uncontroversially) become for menopausal women also suggest that the andropause is likewise a hormonal issue in men. Its all, they say, about a loss of testosterone, as for womenabout estrogen.

Indeed, far from the misconception of testosterone as being all about sex, its decline is also linked to muscle atrophy, reduced bone density and a susceptibility to depression; and theres an inverse correlation with obesity and mortality from heart failure the less of it you have, the more prone you are to both issues. This is why some experts dub the male menopause Testosterone Deficiency Syndrome. And why often testosterone replacement therapy is pushed.

Anecdotally, that certainly works for some men. But dont rush into this. For one, while the rapid shutdown in estrogen production has been attributed to symptoms of the female menopause, men typically see only a 2% testosterone decline per year over their thirties. Its argued that this is unlikely to have noticeable consequences.

Then there are the practical issues: regular testosterone injections this is how its typically delivered into the bloodstream dont come cheap. Prices vary but were often talking at least a few hundreds dollars per month and, obviously, those who recommend this treatment also profit from it too. Nor can you just have these as boosters to get back on track: since injecting testosterone also typically causes your natural testosterone production to gradually close down, once you start, youre committed for life. Its a crutch, not a cure.

RELATED:Heres the Healthy Heart Advice You Aorta Follow

This doesnt help when a drop in testosterone can be hard to measure conclusively healthy testosterone levels may disguise a decline from even higher ones. Current understanding also has it that subtle shifts in testosterone levels are more part of a broader package of metabolic changes in various key hormone levels prolactin, gonadotropin, DHEA and others youve likely never heard of with consequences similar to those experienced by menopausal women.

Its all very complex, sighs Morrison. Its often partners who first notice the problems the moodiness, the low libido. But then that gets misinterpreted and the man is sent off for marriage guidance when that kind of intervention isnt whats needed at all. Its the male menopause.

But understanding that, understanding the part played by testosterone which a lot of general practitioners still think of as some kind of snake oil is only recent. Thats just over the last 10 to 20 years, which unfortunately is not very long in medicine.

In other words, were still some way from grasping quite what the andropause is, what to do about it and, in some quarters, whether theres anything to do anything about. All of which is little consolation for those men who are suffering from a nasty potpourri of physical and psychological ailments that just when careers are peaking, just when theyre maybe wrangling both children and elderly parents, when retirement seems a lifetime away and time to look after themselves is almost zero comes along and really screws with their day.

But dont let that put you off. If youre not feeling right, and something inside leaves you unconvinced if its all just the normal pressures of a certain time of life, see a doctor. The manopause may sound like a joke, but it doesnt feel like it.

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Is Male Menopause a Real Thing That Guys Deal With? - AskMen

Blue Water Acquisition Corporation Announces Merger Agreement with Clarus Therapeutics, Forming A Publicly Listed Company To Address Unmet Needs Of…

NORTHBROOK, Ill. and GREENWICH, Conn., April 27, 2021 /PRNewswire/ --Clarus TherapeuticsInc. ("Clarus"), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, and Blue Water Acquisition Corp. (NASDAQ: BLUW) ("Blue Water"), a special purpose acquisition company (SPAC), todayannounced adefinitive business combination agreement that will result in Clarus becoming a publicly traded company. This transaction values Clarus at $379 million on a fully diluted basis, assuming no redemptions by Blue Water stockholders. In addition, current Clarus stakeholders will invest an additional $25 million in Clarus following the announcement of this transaction. Subject to stockholder approval and the satisfaction of customary closing conditions, the business combination transaction is expected to close in the third quarter of 2021.

Clarus Therapeutics OverviewClarus was founded by Dr. Robert Dudley, chairman, CEO and president to develop an oral testosterone replacement therapy (TRT) for appropriate men with testosterone deficiency. Dr. Dudley had previously co-invented and launched AndroGel, the most successful TRT product to date, worldwide, but was keenly aware of the need for a safe and effective oral TRT for the approximately 2,000,000 men currently on testosterone therapy in the United States. Of these men, 95% receive topical testosterone gel or weekly testosterone injections. Based on research conducted for Clarus by the Harris organization1, more than 75% of men on non-oral TRT therapies are dissatisfied with their TRT and over 80% are interested in learning about an oral alternative.

In March 2019, Clarus's mission to bring a new, state-of-the-art oral TRT to market was realized with U.S. Food and Drug Administration (FDA) approval of JATENZO (testosterone undecanoate oral capsules; CIII). Prior to JATENZO's approval, the only oral TRT product ever approved by FDA over 60 years ago was one associated with potentially serious liver toxicity a characteristic not observed in clinical studies of JATENZO up to two years in length. Clarus launched JATENZO in February 2020 as the first and only FDA-approved oral softgel for TRT in adult males who have low or no testosterone due to certain medical conditions.2,3,4 JATENZO is available in three softgel strengths so that healthcare professionals can individualize patient testosterone response and adjust dosing, as necessary. Approval of JATENZO addressed a conspicuous void in the TRT market that is currently dominated by topical gels and injections. The funds from these transactions will be invested in growth-driving initiatives for JATENZO and focused R&D to expand the company's pipeline beyond testosterone replacement. Following the close of the transaction, Dr. Dudley will continue to serve as Clarus's CEO and President. Frank Jaeger, Clarus's Chief Commercial Officer, and the architect of AndroGel 1.62%'s sales and marketing efforts that resulted in annual peak sales of over $1 billion, will continue to lead commercialization efforts for JATENZO. Mr. Jaeger has built a team with vast experience in the TRT field.

Investment Highlights

"When I established Clarus, the singular focus of our team was the development and launch of an oral TRT product to address a significant void in treatment options available to appropriate men in need of testosterone therapy. When JATENZO launched in early 2020, it represented not only the culmination of those efforts but also brought our collective vision to life," said Dudley. "Clarus is now ready to enter the public markets and build out its pipeline. The merger with Blue Water Acquisition Corp. is expected to bring fresh capital and exceptional board members to the company so that we can expand our commercialization of JATENZO in the U. S., develop new innovative products, and set a broader course for Clarus beyond men's health."

In addition to monetary value, this transaction brings with it Blue Water's deep expertise in the life sciences and pharmaceutical sectors. We believe this will serve as a complementary asset to Clarus as it expands its footprint in the industry. To this end, Kimberly Murphy, former VP, Global Vaccines Commercialization (Influenza) at GSK will join Clarus's board as Chairperson after close of the transaction.

"We are excited about the prospects for Clarus," said Joseph Hernandez, Chairman and CEO of Blue Water Acquisition Corp. "Clarus's commitment to the success of JATENZO, deep bench of expertise, proclivity for innovation, compelling financial profile and attractive growth prospects are the drivers for our decision to select Clarus as our merger partner after a thorough search. We look forward to working with the impressive team at Clarus to close our merger in a timely manner."

Key Transaction Terms & Proposed Transaction TimelineThis transaction, which has been unanimously approved by the Boards of Directors of Clarus and Blue Water is subject to approval by Clarus's stockholders, Blue Water's stockholders and other customary closing conditions. The proposed business combination is expected to be completed in the third quarter of 2021.

A more detailed description of the transaction terms and a copy of the definitive merger agreement will be included in a Current Report on Form 8-K to be filed by Blue Water with the United States Securities and Exchange Commission ("SEC"). Blue Water will file a registration statement on Form S-4 (which will contain a joint proxy statement/prospectus) with the SEC in connection with the transaction.

AdvisorsTruist Securities acted as a financial advisor and Needham & Company acted as a capital markets advisor to Clarus. Cantor Fitzgerald & Co. and Oppenheimer & Co., Inc. acted as capital markets advisors to Blue Water Acquisition Corp. Maxim Group LLC acted as financial advisor to Blue Water. Goodwin Procter served as legal counsel to Clarus. Ellenoff Grossman & Schole LLP served as legal counsel to Blue Water. Mayer Brown LLP served as legal counsel to the capital markets advisors.

About Clarus Therapeutics, Inc.Clarus is a pharmaceutical company with expertise and interest in developing androgen and metabolic therapies for men and women including potential therapies for orphan indications. Clarus's first commercial product, JATENZO, was launched in early 2020. For more information, visit http://www.clarustherapeutics.com and http://www.jatenzo.com.

About Blue Water Acquisition Corp. Blue Water Acquisition is a special purpose acquisition (SPAC) company incorporated as a Delaware corporation formed to effect a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses.

Forward-Looking StatementsCertain statements made in this press release are "forward-looking statements" within the meaning of the federal securities laws, including statements about the parties' ability to close the proposed business combination and related transactions, the anticipated benefits of the proposed business combination, and the financial condition, results of operations, earnings outlook and prospects of Blue Water and/or the proposed business combination and related transactions and may include statements for the period following the consummation of the proposed business combination and related transactions. In addition, any statements that refer to projections (financial or otherwise), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as "plan," "believe," "expect," "anticipate," "intend," "outlook," "estimate," "forecast," "project," "continue," "could," "may," "might," "possible," "potential," "predict," "should," "would" and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements are based on the current expectations of the management of Blue Water and Clarus Therapeutics, as applicable, and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Clarus Therapeutics' ability to increase sales of JATENZO, secure favorable reimbursement coverage for such sales and expand its product offerings to include a pipelineof androgen and metabolic therapies for men and women, including orphan indications; the ability to complete the proposed business combination and to obtain approval from Blue Water's stockholders or satisfy other closing conditions in the definitive merger agreement; the outcome of any legal proceedings that may be instituted against Blue Water or Clarus related to the merger agreement or the proposed transaction; the ability to maintain the listing of Blue Water's securities on a national securities exchange; the amount of any redemptions by existing holders of Blue Water's common stock; the ability to recognize the anticipated benefits of the business combination; other risks and uncertainties included under the header "Risk Factors" in the registration statement on Form S-4 to be filed by Blue Water, in the final prospectus of Blue Water for its initial public offering dated December 16, 2020 and in Blue Water's other filings with the SEC.

Additional Information Blue Water has filed today an investor presentation which describes in more detail the proposed transaction and provides a business overview of Clarus Therapeutics. The presentation is available on the U.S. Securities Exchange Commission's (the "SEC") website at http://www.sec.gov.

In connection with the proposed business combination, Blue Water is expected to file a Form S-4 with the SEC. Clarus and Blue Water Acquisition urge investors, stockholders and other interested persons to read, when available, the Form S-4, including the preliminary proxy statement/prospectus and amendments thereto and the definitive proxy statement/final prospectus, as well as other documents to be filed with the SEC in connection with the Transaction, as these materials will contain important information about Clarus Therapeutics, Blue Water, the combined public company and the business combination. Blue Water also will file other documents regarding the Transaction with the SEC. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Blue Water through the website maintained by the SEC at http://www.sec.gov.

Participants in the SolicitationBlue Water and its directors and executive officers may be deemed to be participants in the solicitation of proxies from Blue Water's stockholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the business combination will be contained in the proxy statement/prospectus when available. You may obtain free copies of these documents as described in the preceding paragraph.

Non-SolicitationThis press release does not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This press release also does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Media Contact:Russo PartnersDavid Schull12 West 27th Street, 4th FloorNew York, NY10001(858) 717-2310david.schull@russopartnersllc.com

Clarus Investor Relations Contact:Ric PetersonClarus Therapeutics, Inc.555 Skokie Blvd., Suite 340Northbrook, IL 60062(847) 562-4300rpeterson@clarustherapeutics.com

About JATENZO

IndicationJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of useSafety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONSJATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTSThe most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. You can also obtain information regarding Jatenzo at http://www.jatenzo.com.

2021 Clarus Therapeutics, Inc. All rights reserved.

1 Harris Poll conducted online survey between May 6 June 5, 20202 JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.3 US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.4 US Food & Drug Administration. NDA Approval Letter. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206089Orig1s000ltr.pdf

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SOURCE Blue Water Acquisition Corporation; Clarus Therapeutics

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Blue Water Acquisition Corporation Announces Merger Agreement with Clarus Therapeutics, Forming A Publicly Listed Company To Address Unmet Needs Of...

10 Warning Signs That You May Have Low Testosterone – News18

Sex may permeate our popular culture, but conversations about it are still associated with stigma and shame in Indian households. As a result, most individuals dealing with sexual health issues or trying to find information about sex often resort to unverified online sources or follow the unscientific advice of their friends.

To address the widespread misinformation about sex, News18.com is running this weekly sex column, titled Lets Talk Sex, every Friday. We hope to initiate conversations about sex through this column and address sexual health issues with scientific insight and nuance.

The column is being written by Sexologist Prof (Dr) Saransh Jain. In todays column, Dr Jain explains low testosterone or (low T), its signs, symptoms and treatment options.

Testosterone is a hormone produced in both male and female bodies. In men, its produced in the testicles and affects several different physical features and functions. Testosterone in men stimulates sex drive, sperm production, and development of muscle and bone mass. It is also responsible for hair growth, causes the voice to deepen, among other male features.

After the age of 30, testosterone levels in men can decline somewhat, but this is not a problem. But if your testosterone levels get too low, it can cause a range of symptoms and interfere with your daily life, overall wellness, and relationships.

The signs and symptoms of low testosterone are sometimes overlooked, attributed to other causes or ignored due to the condition itself.

Extra Body Weight

Its not clear if low testosterone (low T) contributes to weight gain, or if weight gain contributes to low testosterone. However, fat cells play a role in converting testosterone to estrogen, the dominant female sex hormone. Healthy eating and exercise, therefore, are must.

Loss of Muscle

While testosterone doesnt affect the function or strength of your muscles, its necessary for building muscle mass. If you find youre losing muscle volume, it may be due to lower levels of testosterone affecting new tissue growth as well as existing muscle maintenance.

Fatigue

Are you tired all the time? It might not just be about getting older or mounting stress at work. Perhaps you find it hard to get yourself motivated to exercise, or you dont feel rested after a full nights sleep. While there are many potential causes of fatigue, add low T to the list, particularly if you have other symptoms.

Osteoporosis

Although commonly associated with older women as a side effect of estrogen loss, loss of bone mass in men results from low testosterone levels. The results are the same. Bones may fracture or compress more easily because of an increasingly porous structure.

Low Sex Drive

This is a condition that many ignore, since in some cases you wont feel the absence of your libido, even though its gone. Testosterone is a key factor in triggering sex drive in men and women, when its level drops, so may your desire to have sex.

Erectile Dysfunction

Testosterone stimulates the brain to produce nitric oxidea molecule that triggers the chemical reactions necessary for an erection. Low testosterone can make it difficult for men to maintain or achieve an erection. There are other common factors that can lead to erectile dysfunction. Some include thyroid issues, smoking, stress, alcohol and tobacco consumption, high blood pressure and diabetes. However, low testosterone is another common cause for erectile dysfunction.

Low Volume of Ejaculation

Low testosterone causes a reduction in the amount of semen your body manufactures. When this occurs, the amount of semen released during orgasm may be less than the amount youre accustomed to. Again, in combination with other signs, low semen volume may indicate low testosterone production.

Hair loss

While there are hereditary factors that influence hair loss, low testosterone also contributes to it, and its the likely culprit if youre losing body and facial hair as well.

Changes in Sleep Patterns

Decreased energy, trouble sleeping, and even sleep apnea have been associated with low testosterone.

Depression and Mood Disorders

Over 50 per cent men in a study on the effects of low testosterone also showed signs of depression, and depressed men often find that testosterone replacement therapy can sometimes be more effective than antidepressants.

If you have any or all of these symptoms of low testosterone, a simple blood test can establish your T levels. Combined with your medical history, your blood test can suggest why your testosterone levels are low. The underlying cause of low testosterone can determine your treatment options.

What you eat has a major impact on testosterone as well as other hormone levels. Eating enough protein can help maintain healthy levels and aid fat loss, which is also associated with your testosterone. A diet based mainly on whole foods is best, with a healthy balance of fat, protein and carbs, which can help boost testosterone levels.

If you do experience low testosterone symptoms, your healthcare provider may order a blood test to measure your total testosterone level, luteinizing hormone (LH), blood prolactin level, and blood hemoglobin or HgB.

Testosterone Therapy (or TT) is sometimes prescribed if an individual has a testosterone deficiency. Typically, there are five different ways in which this can be done:

Skin patch: A patch is applied once every 24 hours, in the evening, which releases small amounts of the hormone into the skin.

Gels: Topical gels are spread daily onto the skin over both upper arms, shoulders, or thighs. It is important to wash your hands after applying and to cover the treated area with clothing to prevent exposing others to testosterone.

Oral therapy: Capsules are swallowed or tablets are attached to your gum or inner cheek twice a day. Testosterone is then absorbed into the bloodstream.

Pellets: These are implanted under the skin, usually around the hips or buttocks, and slowly release testosterone. They are replaced every three to six months.

Injections: Various formulations are injected every seven to 14 days. Testosterone levels can rise to high levels for a few days after the injection and then slowly come down, which can cause a roller-coaster effect, with mood and energy levels spiking before trailing off.

If you are concerned about low-T symptoms, or if youve tried therapies that didnt work, talk to your primary doctor or sexologist. Personalized care from a board-certified sexologist or male fertility expert is the healthiest way to get there.

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10 Warning Signs That You May Have Low Testosterone - News18

Sizeable Numbers to Endorse Benefits and Efficacy of Umbrella of Hormone Replacement Therapies underscores Growth in Testosterone Replacement Therapy…

ALBANY, N.Y., April 22, 2021 /PRNewswire/ -- Testosterone replacement therapy is widely used treatment for men with symptomatic hypogonadism. The benefits of testosterone replacement therapy manifest as increased energy and libido level, improved bone density and strength, improved muscle strength, and cardioprotective effects. According to The Baltimore Longitudinal Study of Aging, 20% hypogonadism is reported in men over the age of 60 years, 30% in men over 70 years, and 50% in men over 80 years.

Testosterone replacement therapy is a reasonable treatment option often used for men with low testosterone levels and symptoms of hypogonadism. When testosterone is replaced, a number of positive effects of higher testosterone levels are experienced. Thus, the positive results of such therapy has led to a substantial demand for testosterone replacement therapy for men with symptomatic hypogonadism, though there is insufficient data for long-term efficacy and safety of the therapy.

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Nonetheless, the beneficial effects of testosterone replacement therapy is rarely disputed instead widely publicized that marks bright prospects for the testosterone replacement therapy market. As such, in the near-term, from 2019 to 2027, the testosterone replacement therapy market is predicted to rise at a solid 4.4% CAGR.

Testosterone Replacement Therapy Key Findings of the Report

Keen Players seeking Regulatory Approvals for Launch of New Therapies points at Bright Future

Key players in the testosterone replacement therapy market are undertaking efforts to obtain regulatory approvals for launch of new products, integration of novel technologies, and M&As and collaborations with other companies. For example, in the recent past, the U.S. FDA provided approval for a generic testosterone gel to use for testosterone replacement therapy for men with symptomatic hypogonadism. In another example, in March 2019, an oral testosterone capsule produced by Clarus Therapeutics received approval of the U.S. FDA for the treatment of certain forms of hypogonadism.

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While North America to remain Prominent, Asia Pacific to display Stellar Growth Rate

Factors such as increasing adoption of testosterone replacement therapy and high awareness of availability of convenient treatment options makes North America prominent region in the testosterone replacement therapy market.

On the other hand, Asia Pacific is anticipated to chart an impressive growth rate in the testosterone replacement therapy market in the forthcoming years. Focus of key players to target emerging economies in the region such as India, wherein rising disposable incomes is leading to demand for treatment of unconventional health conditions is creating opportunities in the testosterone replacement therapy market of the region. Besides this, a large population base with testosterone deficiency due to several factors in various countries offers immense prospects for testosterone replacement therapy market of the region.

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Solid Marketing Programs to create Awareness Paints Strokes of Growth

Leading players in the testosterone replacement therapy market are undertaking solid marketing programs to promote their branded products, and at the same time create awareness among the general population. Companies in the testosterone replacement therapy market are promoting their products directly to consumers and physicians via journals, meetings, and events.

Testosterone Replacement Therapy Growth Drivers

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Testosterone Replacement Therapy Key Players

Explore Transparency Market Research's award-winning coverage of the global Healthcare Industry:

Continuous Renal Replacement Therapy Market: https://www.transparencymarketresearch.com/continuous-renal-replacement-therapy-market.html

Primary Immunodeficiency Market: https://www.transparencymarketresearch.com/primary-immunodeficiency-disease-market.html

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Sizeable Numbers to Endorse Benefits and Efficacy of Umbrella of Hormone Replacement Therapies underscores Growth in Testosterone Replacement Therapy...

Hormone Replacement Therapy (HRT) Market 2021 Watch Voluminous Epic Growth & Overwhelming Opportunities in Covid-19 Till 2027 | Pfizer Inc.,…

Worldwide Hormone Replacement Therapy (HRT) Market Analysis to 2027 is a specialized and in-depth study of the Hormone Replacement Therapy (HRT) Market Industry with a focus on the global market trend. The report aims to provide an overview of global Hormone Replacement Therapy (HRT) Market with detailed market segmentation by product/application and geography. The global Hormone Replacement Therapy (HRT) Market is expected to witness high growth during the forecast period. The report provides key statistics on the Market status of the players and offers key trends and opportunities in the market.

Research report has been compiled by studying the market in-depth along with drivers, opportunities, restraints & other strategies as well as new-developments that can help a reader to understand the exact situation of the market along with the factors that can limit or hamper the market growth and the report also has been updated with Impacts & effects of Coronavirus pandemic and how it has influenced consumer behavior& the growth of the Hormone Replacement Therapy (HRT) Market as well as industries.

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The COVID-19 outbreak is currently going the world over, the Hormone Replacement Therapy (HRT) Market report covers the impact of the corona-virus on top companys growth. This research report categorizes as the key players in the Recombinant Proteins market and also gives a comprehensive study of Covid-19 impact analysis of the market by regions like (Americas, Europe APAC, and EMEA).

Whats included :

Top Key Players in Hormone Replacement Therapy (HRT) Market:

Pfizer Inc.,Abbott,Novo Nordisk A/S,Novartis,Merck KGaA,Bayer AG,Eli Lilly and Company,Mylan Laboratories,F. Hoffmann-La Roche Ltd,Genentech Inc.

MARKET SEGMENTATIONThe global Hormone replacement therapy market is segmented on the basis of product, route of administration, type of disease and geography. Based on product, the market is segmented as estrogen replacement therapy, human growth hormone (HGH) replacement therapy, thyroid replacement therapy, testosterone replacement therapy, other hormone replacement therapy. On the basis of route of administration, the global hormone replacement therapy market is segmented into oral, parenteral and transdermal. The type of disease segment is further segmented into menopause, hypothyroidism, male hypogonadism, growth hormone deficiency, others.

The report offers key drivers that propel the growth in the global Hormone Replacement Therapy (HRT) Market. These insights help market players in devising strategies to gain market presence. The research also outlined the restraints of the market. Insights on opportunities are mentioned to assist market players in taking further steps by determining the potential in untapped regions.

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Elite HRT Releases New Website With Information on Hormone Replacement Therapy – Business Wire

LOS ANGELES--(BUSINESS WIRE)--The physicians at Elite HRT have collaborated on a new website to serve as a one-stop destination for information regarding Hormone Replacement Therapy. This stylish web destination contains numerous articles regarding the potential benefits and detractions involved in various HRT treatments like Human Growth Hormone Therapy (HGH), Testosterone Replacement Therapy (TRT), and Nutraceutical Injections. Elite HRT understands that HRT needs from person to person vary greatly, and hope that this new web design can arm anyone with the information they need to make the right decisions for them.

Elite HRT has worked as on-site and online consultants since 2013, offering medical expertise on innovative new anti-aging and wellness practices. Their treatments are focused on patients goals and individual desires, meaning that no two approaches are exactly the same. To this end they strive to inform their patients as much as possible, equipping them with the knowledge and awareness of all possible hormone therapies so they might know which one is best for them. This information is both cited and sourced to allow patients to do their own research, and to provide transparency so users can understand the science behind these treatments.

Prominently featured on this striking new website are dedicated pages to highlight the different available treatments, so users can compare and contrast each one. These pages focus on HGH injections, Nutraceutical injections, Sermorelin, Testosterone injections, and other low testosterone treatments, highlighting the benefits and potential detractors of each one. Each of these pages is distinct, offering specific nutrients seen in the Nutraceutical treatments and the most prevalent symptoms of low testosterone; this is because each hormone therapy is wholly unique, and taking a one size fits all approach did a disservice to the merits of each individual practice. Elite HRT is pleased with the results, and believe they reflect the diversity of available options.

Online consultations and telemedicine also enable these treatments to be available in rural communities and can help reduce costs by not requiring the use of a dedicated physicians office. As hormone therapies are typically seen as elective and not covered by health insurance plans, Elite HRT works to make these treatments as accessible as possible, including their price. Users can also make use of a local physician for providing physical information and medical history, as part of evaluating the proper treatments for that person.

Elite HRT is proud to offer a one-of-a-kind destination for Hormone Replacement Therapies and all their permutations, so curious users can learn about HGH, TRT, and more from the same destination. With a thorough commitment to providing transparently sourced information and acknowledging the medical professionals who compiled this information, Elite HRT strives to provide information and consultations of the highest quality.

About Elite HRT:

Elite HRT is a telemedicine firm led by a network of physicians specializing in hormone replacement therapies. With unique approaches to HRT, TRT, HGH, and more, Elite HRT works to tailor solutions uniquely created for specific patients, all at affordable rates. Those wanting to learn more and contact Elite HRT can visit https://www.elitehrt.com/ and submit a contact request form with background information today.

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Elite HRT Releases New Website With Information on Hormone Replacement Therapy - Business Wire

TO YOUR GOOD HEALTH: You’re never too old for HPV infection – mycouriertribune.com

DEAR DR. ROACH: I read your recent column stating that the HPV vaccine is recommended up to age 45. Are people older than 45 years no longer susceptible to HPV? Asking for a 52-year-old friend (who thinks hes Wolverine). C.F.

ANSWER: The comic character Wolverine has a mutant healing ability (thats how he was able to survive having his bones replaced with adamantium), so he has nothing to worry about.

However, non-mutants do have to worry about HPV, which can come from any kind of skin-to-skin contact with a person who has HPV. Having the virus often means having warts, but sometimes people can have contagious HPV without having any visible lesion.

Its been estimated that 90% of people with HPV dont know they have it. People of any age are susceptible to HPV. Most people have been exposed by age 45, which is why the recommendations are the way they are now, but vaccination might make sense in some situations.

The clearest example is someone who has had very few sexual partners and is about to become more sexually active (for example, a person recently divorced or widowed).

Although the vaccine is not indicated by the Food and Drug Administration in this situation and the person is likely going to have to pay out of pocket, it might still be worth it to get the vaccine to reduce the risk of acquiring a new sexually transmitted HPV infection. I received several letters from people who acquired new genital warts in just this situation who were upset that their doctor did not offer the vaccine.

If people have already been exposed to HPV, the vaccine will not harm them. In fact, there is some anecdotal evidence that the vaccine might help people with difficult-to-treat warts by boosting the immune system specifically for HPV.

DEAR DR. ROACH: Im a 79-yearold male in relatively good health. During the past year, I have lost underarm hair. What could be the cause? And is there a connection with the inability to get aroused? A.F.

ANSWER: I would be concerned about low testosterone. Androgens, particularly testosterone, are responsible for growth and maintenance of body hair. Loss of body hair, especially pubic and axillary hair, is not common with low testosterone levels unless the testosterone was very low for a long period of time, usually over a year.

Other symptoms of low testosterone include loss of muscle mass, lower energy levels, decreased libido and depression. Not all men will get all symptoms, but having more than one symptom is suggestive of low testosterone, especially in men who have difficulty getting an erection. Your doctor should check your testosterone.

Ideally, the sample should be drawn while fasting between 8 and 10 a.m. when levels are normally highest, and should take into account the age of the person being tested. Testosterone replacement is appropriate for men with symptoms of low testosterone and clear evidence by laboratory of a repeatedly low level.

Testosterone replacement is safe for most men, but is generally not given to men with a history of prostate or breast cancer. Testosterone should be given with caution to men with obstructive sleep apnea and men with symptomatic prostate enlargement. The data so far suggest that testosterone replacement in deficient men does not increase risk of prostate cancer.

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TO YOUR GOOD HEALTH: You're never too old for HPV infection - mycouriertribune.com

Testosterone Replacement Therapy Market Segmented by Application, Growth, Trends, Regions & Forecast to 2027 | Endo Pharmaceuticals, Inc., Eli…

The Report Titled on Testosterone Replacement Therapy Market which provides COVID19 Impact analysis on Market Size (Production, Capacity, Value, Values & Consumption), Regional and Country-Level Market Size, Segmentation Market Growth, Market Share, Competitive Landscape, Sales Analysis, Impact of Domestic and Market Players. Testosterone Replacement Therapy Market detailed study of historical and present/future market data. Economic growth, GDP (Gross Domestic Product), and inflation are some of the elements included in this report to offer crystal clear picture of the Testosterone Replacement Therapy industry at global level.

Testosterone Replacement Therapy Market competitive landscapes provides details by topmost manufactures like (AbbVie, Inc., Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International plc, Pfizer, Inc., Acerus Pharmaceuticals Corporation, and Perrigo Company plc.), including Capacity, Production, Price, Revenue, Cost, Gross, Gross Margin, Growth Rate, Import, Export, Market Share and Technological Developments.

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Market Segmentation & Coverage:

This research report categorizes the Testosterone Replacement Therapy to forecast the revenues and analyze the trends in each of the following sub-markets:

By Active Ingredient TypeTestosteroneMethyl TestosteroneTestosterone UndecanoateTestosterone EnanthateTestosterone CypionateBy Route of AdministrationInjectablesParenteral

Based on Geography, the Testosterone Replacement Therapy Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.

We, at Coherent Market Insights, understand the economic impact on various sectors and markets. Using our holistic market research methodology, we are focused on aiding your business sustain and grow during COVID-19 pandemics. With deep expertise across various industries-no matter how large or small- and with a team of highly experienced and dedicated analysts, Coherent Market Insights will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

The Testosterone Replacement Therapy Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window:

Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

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The report provides insights on the following pointers:

Market Penetration: Provides comprehensive information on the market offered by the key players

Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets

Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments

Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players

Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as:

What is the market size and forecast of the Global Testosterone Replacement Therapy Market?

What are the inhibiting factors and impact of COVID-19 shaping the Global Testosterone Replacement Therapy Market during the forecast period?

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What is the competitive strategic window for opportunities in the Global Testosterone Replacement Therapy Market?

What are the technology trends and regulatory frameworks in the Global Testosterone Replacement Therapy Market?

What are the modes and strategic moves considered suitable for entering the Global Testosterone Replacement Therapy Market?

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Therapeutic Vaccines Market: Rise in the prevalence of various chronic diseases to drive the market – BioSpace

Global Therapeutic Vaccines Market: Overview

The global market for therapeutic vaccines is witnessing a phase of significant growth. Thanks to the efficiency of these vaccines, an upsurge in their demand is likely to continue over the next few years.

Therapeutic vaccines trigger and build up the immune response of the body so that it can act against the disease and are administered for the treatment of specific medical conditions. With ongoing advancements, these vaccines have expanded the periphery of chronic disease therapeutics, which consequently, is likely to add to the growth of this market over the forthcoming years.

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The lengthy approval period, on the other hand, may distract this market from rising steadily in the near future. However, with an ever-expanding body of evidence about the efficiency of therapeutic vaccines, there is ample to look forward to in the worldwide market for therapeutic vaccines space.

This research study on the global therapeutic vaccines attempts to present a detailed assessment of this market on the basis of its existing status and past performance. The key trends and the growth opportunities in this market have also been examined thoroughly in this research report to identify the markets future status.

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Global Therapeutic Vaccines Market: Trends and Opportunities

The global market for therapeutic vaccines is heavily influenced by the significant rise in the prevalence of various chronic diseases, such as cancer, HIV, and cardiovascular diseases. The alarming increase in the need for efficient treatment has shifted the focus towards therapeutic vaccines across the world. A number of pharmaceutical companies have begun the research to develop novel vaccines for several diseases, such as breast cancer, lung cancer, Alzheimer. Although these developments are still in pipeline and are yet to be commercialized; they point towards a thriving future of the worldwide market for therapeutic vaccines.

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As of now, several multinational drugmakers have taken an active lead in the production therapeutic vaccines, opening new growth avenues for this market. Among the pioneers, is Provenge, the first FDA-approved immunotherapy drug, developed for prostate cancer treatment. Since the approval of this drug in 2010, there is no looking back for this market. A number of vaccines have been developed and are in the pipeline since then, exhibit lucrative potential for the market.

On the other hand, together with huge research and development investments and lengthy approval processes, the developers of therapeutic vaccines have to deal with non-existent reimbursement policies for these vaccines too, which acts as a massive drawback for this market. However, in the view of the immense potential presented by therapeutic vaccines, the regulatory bodies across the world are trying to accelerate the policy formulation processes, which if implemented, will reflect positively on the global market for therapeutic vaccines in the near future.

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Global Therapeutic Vaccines Market: Geographical Analysis

North America, Europe, Asia Pacific, and the Rest of the World are considered as the prominent geographical segments of the worldwide market for therapeutic vaccines. With the presence of an advanced medical and healthcare infrastructure, North America has surfaced as the leading contributor to this market. The augment in the funding for the increase in research and development activities is likely to boost this regional market further, ensuring its lead over the forthcoming years.

Europe and Asia Pacific are also witnessing a robust rise in the demand for therapeutic vaccines on account of the growing prevalence of various diseases. Europe, which currently stands at the second position, is likely to gain significantly from the technological advancements of the products in the near future. Asia pacific, on the other hand, is expected to benefit from the rising awareness among consumers pertaining to therapeutic vaccines and their advantages over the years to come.

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Companies mentioned in this report

The global market for therapeutic vaccines demonstrates a highly competitive and fragmented structure. Merck and GlaxoSmithKline have emerged as the leading participants in this market, thanks to their strong pipeline of therapeutic vaccines. These companies are likely to outperform their competitors over next few years, states the research report. Sanofi-Pasteur, Cytos Biotechnology AG, Intellect Neurosciences, Agenus Inc., Celtic Pharma, Novartis, Bavarian Nordic, Dendreon Corp., Pfizer, and Transgene are some of the other important players operating in this market.

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TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

ContactMr. Rohit BhiseyTransparency Market ResearchState Tower,90 State Street,Suite 700,Albany NY - 12207United StatesUSA - Canada Toll Free: 866-552-3453Email: sales@transparencymarketresearch.comWebsite: https://www.transparencymarketresearch.com/

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Therapeutic Vaccines Market: Rise in the prevalence of various chronic diseases to drive the market - BioSpace

Health World Houston’s Memorial Green Emerges as a Center of Fitness, Spas and Beauty Retreats – PaperCity Magazine

Whether youve hit Houstons Memorial Green mixed-use development for a scrumptious Aai berry bowl at Clean Juice or a mini-trampoline workout at Mtiv Fitness, its impossible to wander the upscale center and not notice an atmosphere that embraces health and wellness. Midway is all about creating true live, work and play centers from CITYCENTRE to GreenStreet to Century Square.

But in the heart of the coveted Memorial district, Memorial Green is almost taking that to a new level, emerging as a haven for those who want to balance living well and healthy living.

From both planning and the influence of the wellness-conscious neighborhood it calls home, Memorial Green has become a magnet for medi spas, retreats, fitness and health studios, as well as topnotch beauty specialists. Walking along the outdoor sunlit central fountain or the cool, private hallways of its enclosed second and third floors, visitors can find an service for almost any health or beauty need. From the trendiest nail art to hangover recovery IV treatments to a new testosterone lease on a healthy sex life, its all there.

So lets get our virtual steps in as we stroll along Memorial Greens avenue of beauty and wellness centers. Consider this your guide to one of Houstons healthiest meccas:

The latest addition to the Memorial Green health and beauty oasis, this luxury IV spa specializes in IV vitamin drips and boosters. The benefit of Thrive drips is they allow the body to rehydrate quickly while allowing you to absorb 100 percent of the nutrients in each drip formula.

Registered nurses, all with clinical experience, administer the therapeutic treatment at Thrive Drip Spa. The nurses can also assess clients needs, whether reparative or preventative, and aid them in selecting the optimum drip from among 12 different customized formulas and three booster shots.

From a Hydrate Drip pick-me-up to a Beauty Drip containing a high dose of Vitamin C and Glutathionethe for glowing skin to a Party Drip hangover recovery rewinder to a Fit Drip formulated for athletes and those in training, these treatments are designed to allow one to rehydrate and revitalize in comfort and style.

The Memorial Green spa will also offer the latest biohacking technology for muscle-building and body sculpting, EMSculpt NEO. The non-invasive procedure targets HIFEM (High-Intensity Focused Electromagnetic energy) and RF (Radio Frequency) waves along selected areas to reportedly burn up to 30 percent fat and build 25 percent muscle.

For those with busy lives (which is pretty much everyone these days), many of these treatments take less than 45 minutes. Yet each minute can feel like a glorious refuge for recharging and healing.

A very different kind of neighborhood fitness studio has recently bloomed at Memorial Green. Mtiv Fitness is ready to make wellness waves beyond the Memorial area. Though independently owned, Mtiv Memorial is part of a newly launched community of eight, women-owned studios around Texas and the West.

The chic fitness retreat offers a wide range and level of classes seven days a week at convenient times including Barre, cycle, stretch and toning, along with unique physical fitness outlets. These include low-impact, high-intensity mini trampoline classes and hybrid hours melding the best of cycling and Barre. Knowledgeable and passionate instructors lead regulars on their own individual health and fitness journeys.

As the only USDA certified organic juice bar brand in North America, the juicer franchise fits right into Memorial Greens healthy vibe. Going beyond the menu of an ordinary juice bar, Clean Juice features green and grain bowls, wraps, toast treats, Aai bowls, protein smoothies and a garden of juice mixtures. So whether youre thirsty for your daily cold pressed pick-me-up or hungry for a hearty and healthy meal, Clean Juice offers a plethora of nutritious delights.

In our masking and unmasking world, the eyes really have become the windows to our hearts and souls, and these lash artists know exactly how to frame and highlight those windows. Yes, Lash Lounge beauty stylists are masters at lash extensions. But they also are experienced in the craft of lash fills, eyebrow threading, lash and brow tinting.

Situated in a private, quiet spot on Memorial Greens bright upper floor, this retreat emphasizes the lounge in its name with comfortable styling beds, private retreat rooms and boutique styled decor.

Be it tummy, hips, chin, love handles or even arms, we all have those problem spots where we wish we could do a bit of fat trimming without breaking a sweat. Or the skin. Luckily, DaVinci specializes in the hottest non-surgical procedure for fat reduction in those body areas.

Its all about CoolSculpting. Utilizing the science of Cryolipolysis, DaVincis CoolSculpting treatments freeze fat cells without damaging the skin or surrounding tissue. The CoolSculpting practice has become one of the most popular non-surgical fat reduction treatments in America.

The DaVinci difference comes in that these experts only do CoolSculpting. So they offer concentrated expertise and individualized treatments, from the first consultation to reaching the end goal.

Set sail for a paradise of feet, hand and spirit pampering in this resort-atmosphere day spa. Bask in a full manicure and pedicure menu, but know this Isle is also home to grand indulgences. These include facials, waxing and sunless tanning applications. Private alcoves await those who desire the ultimate serenity, while colorful Isle suites make for the perfect party or bridal shower celebration spot.

Men face unique health challenges at different stages of life, and this true Mens Health center supports that life journey. Especially when it comes to mens sexual wellness, with a focus on diagnosing and treating low testosterone. Low T becomes more common as men age and can sometimes lead to low libido, mood swings, fatigue and loss of muscle mass.

Once Low T is diagnosed, the Mens Health medical team consults with its patients on possible testosterone replacement therapy treatments and plans. If low testosterone has also led to weight gain, the clinic can create an individualized program combining medically supervised weight loss with testosterone replacement therapy.

The stylist to so many Texas society royals, celebrities and glitterati that hes become a one-name star of beauty himself, Ceron has elevated the lux hair studio to constellation levels in Houston and Dallas. Of course, the Memorial Green location offers womens and mens haircuts and styling.

It all adheres to Cerons Reshape the Ordinary vision, but Memorial Green hair studio visitors also can expect the richest color and keratin treat(ments) from Cerons all-star stylist team. For the grandest of galas or just an intimate night out, this is the place to make an appointment for special event styling and makeup services.

After all, being healthy and living your best life means having great hair, too.

For much more on Memorial Green, Midway and all its developments, check out its new, reimagined District website.

Excerpt from:
Health World Houston's Memorial Green Emerges as a Center of Fitness, Spas and Beauty Retreats - PaperCity Magazine

New Research: Testosterone Replacement Therapy Market 2026 Industry Specifications and Outlook 2021| Endo International, AbbVie, Eli lilly, Pfizer,…

Global Testosterone Replacement Therapy Industry: with growing significant CAGR during 2021-2026

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Analysis of Global Testosterone Replacement Therapy Market By Type: GelsInjectionsPatchesOthers

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In this report, Leading players of the global Testosterone Replacement Therapy Market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Testosterone Replacement Therapy Market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Testosterone Replacement Therapy Market. It also provides useful recommendations for new as well as established players of the global Testosterone Replacement Therapy Market.

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New Research: Testosterone Replacement Therapy Market 2026 Industry Specifications and Outlook 2021| Endo International, AbbVie, Eli lilly, Pfizer,...