Latest news with #KevinEisenfrats
Yahoo
07-05-2025
- Health
- Yahoo
'World's first' male contraceptive implant in trials: how it works
'World's first' male contraceptive implant in trials: how it works Men generally have two contraception methods: condoms and vasectomies. However, biotechnology company Contraline plans to change that with the 'world's first' contraceptive implant for men, Adam, now in Phase 2 of clinical trials. The contraception is a water-soluble hydrogel that is implanted in the sperm ducts, which prevents sperm from mixing with semen for at least two years. Contraline described it as 'like the IUD [intrauterine device], for men.' Here's what we know about the male contraceptive implant so far: How will the new male contraception work? The implantable contraceptive is a gel that is injected underneath the scrotum, the pouch of skin that contains the testicles. ADVERTISEMENT Advertisement It is designed to block sperm from travelling through the vas deferens — the duct transporting sperm from the testicle to the urethra — without impacting sensation or ejaculation. The hydrogel then liquifies at the end of its lifespan, so sperm can continue to flow. Contraline has shared the results of its Phase 1 clinical trial, revealing that Adam can successfully block sperm's release for 24 months. 'This is really exciting because our goal since day one has been to create a two-year-long male contraceptive — that is what the demand is for,' Contraline founder and chief executive Kevin Eisenfrats told the Guardian. 'We have the first data to show that that's possible.' How is it implanted? Adam is inserted into the scrotum through an injection, under local anaesthesia. Contraline described the procedure as 'minimally invasive' and said it should take 'less than 30 minutes.' Men generally have two contraception methods: condoms and vasectomies (PA Archive) Are there any risks? The biotechnology company reported no sperm detected in the semen of the two participants in the trial, and no serious adverse effects have been recorded. ADVERTISEMENT Advertisement However, Adam is still in the early stages of clinical trials. The results from its Phase 1 clinical trial haven't yet been published in a peer-reviewed journal, and no data shows whether the implant is effective in preventing pregnancy. 'Men would need to check at regular intervals whether Adam was still totally effective as the two-year time window came to its end,' Dr Gill Lockwood, a consultant for Fertility Family told the Standard.. ''Home done' sperm tests are not totally reliable, and, as a fertility doctor, I am aware that ' miraculous' pregnancies occur with even very low sperm counts." The long-term effects of Adam are also largely unknown. There is little data to confirm that fertility is restored after the two years. There are also concerns that the incision could cause scarring and even permanent sterilisation. When will it be out? According to Med City News, Contraline wants Adam approved by 2028, with the possibility of an Australian approval even sooner. Why are male contraception methods so limited? Adam shows promising results, but the news still begs the question of why it has taken so long to get another male contraception method on the market. ADVERTISEMENT Advertisement Dr Jeff Foster, Director of Men's Health at Manual, told the Standard that part of the reason is practical. 'Unlike female contraception, which primarily targets ovulation (a once-a-month event), a male contraceptive would need to suppress millions of sperm, which would be potentially active every time you ejaculate,' he said. 'This means it would need to be something that permanently suppresses sperm production without interrupting key functions like testosterone.' Dr Foster added that 'societal expectation' is another factor that has put the onus of contraception on people with uteruses. 'Women carry a baby and therefore there is often a historical expectation that birth control is therefore the women's responsibility,' he said. 'As a woman, would you trust a new partner who says they are taking birth control? Sadly, it is easier for a male partner to remove himself from parental responsibility than it is a woman.'
Daily Mail
25-04-2025
- Health
- Daily Mail
The 'IUD for men' is 100 per cent effective at blocking sperm for TWO YEARS - male contraceptive on its way
A non-hormonal male contraceptive that prevents sperm from leaving the body remains effective for at least two years, groundbreaking research suggests. The implantable contraceptive, known as Adam, is a gel that is injected underneath the scrotum. The Virginia-based company behind the product, Contraline, says this approach offers a convenient alternative to existing methods such as condoms and vasectomies. The hydrogel is designed to break down in the body after a set period of time, restoring fertility. Contraline has released findings of its study of 25 men that showed the gel successfully blocked the release of sperm for two years in the two participants who saw out the entirety of the trial. It said no serious adverse side-effects had been recorded though the results of the study do not include data on the reversibility of the implant. Founder Kevin Eisenfrats, told the Guardian: 'This is really exciting because our goal since day one has been to create a two-year-long male contraceptive – that is what the demand is for. 'And we have the first data to show that that's possible.' Researchers recruited 25 men at various points over the two year trial and injected them with the contraceptive. The implant was inserted via a minimally invasive procedure into the vas deferens, the tube that carries sperm from the testes, under local anaesthetic. Doctors then made a small incision underneath the scrotum to expose part of the vas deferens. They then injected the tube with the gel before reinserting it into the body and stitching the incision closed. All participants were monitored after the procedure and no serious adverse events were reported. All participants also experienced a drop in sperm count, indicating the contraception was effective in preventing sperm from leaving the body. Eisenfrats heralded these results as a 'great proof of the concept', with more results expected to follow. Adam is not the first experimental contraceptive that acts by blocking the function of the sperm ducts. This approach means that men can still experience ejaculation, because the fluid for this is produced in another area. Eisenfrat explained, however, that some of the other male-contraceptives currentlyon trial use materials that do not break down in the body, resulting in infertility. There are, however, concerns that such implants could cause scaring of the sperm ducts and lead to permanent sterilisation. Results from the Adam trial have not yet been published in a peer-reviewed journal and do not include real life data on whether the injection can prevent pregnancy. According to Eisenfrats, the hydrogel has been shown to break down over time in animal trials, revealing a short period of efficacy. 'The way to think about this is sort of like the IUD [intrauterine device] for men', the chief executive told The Guardian. He added that after a two-year period, men could decide whether to get another implant. The team are also reportedly working on a procedure to enable 'on-demand reversal', which would use at-home sperm tests to check whether contraceptive was still effective. For women, traditional non-hormonal intrauterine devices, also known as a copper coil or IUD, last for five to ten years, depending on the type of device used. After an IUD is removed, fertility levels are expected to return to previous levels right away. Some women opt for an intrauterine system, or IUS, which uses the release of the hormone progestogen to stop pregnancy. The hydrogel designed by Contraline does not interfere with a man's hormones. While the results of the Adam show promise, some experts have raised concerns over how reversible the gel is and have warned that sperm could find a way around the blockage, resulting in an unplanned pregnancy. Professor Richard Anderson, an expert in hormonal male contraception at the University of Edinburgh, warned that at present it remains unclear how long a single implant lasts and it is yet to be shown that it can be removed. A major hurdle to male contraceptives, expert say is that they would need to interrupt the production of millions of sperm made every day. Most of the male birth control possibilities undergoing clinical trials target testosterone, blocking the male sex hormone from producing healthy sperm cells. Doctors say, however, the testosterone-blocking action can trigger weight gain, depression and increase cholesterol. The female contraceptive pill — which contains synthetic versions of female hormones estrogen and progesterone— has been linked with similar side effects.
The Guardian
24-04-2025
- Health
- The Guardian
Non-hormonal male contraceptive implant lasts at least two years in trials
An implantable, non-hormonal male contraceptive has been shown to last for at least two years, a trial has found. The contraceptive, known as Adam, is a water-soluble hydrogel that is implanted in the sperm ducts, preventing sperm from mixing with semen. The company behind the product, Contraline, says the approach offers a reversible alternative to condoms and vasectomies, with the hydrogel designed to break down in the body after a set period of time, restoring fertility. Now Contraline has released details of its phase 1 clinical trial, revealing Adam can successfully block the release of sperm for 24 months, with no sperm detected in the semen of the two participants who have so far reached this time point in the trial. In addition, it said no serious adverse events had been recorded. 'This is really exciting, because our goal since day one has been to create a two-year-long male contraceptive – that is what the demand is for: a two-year-long, temporary or reversible male birth control. And we have the first data to show that that's possible,' said Kevin Eisenfrats, the founder and chief executive of Contraline. Eisenfrats said the 25 participants in the clinical trial were enrolled at different points in time, with more results expected to follow. 'It's great proof of concept,' he added.. Eisenfrats said the implant was inserted in a minimally invasive procedure that took about 10 minutes and used local anaesthetic, meaning the patient remained awake. Adam is not the first male contraceptive in development that acts by blocking the sperm ducts (vas defrens), although Eisenfrats said some other implants had used materials that did not break down in the body, adding there was little data to show fertility was restored after they were removed, while there were also concerns such implants could cause scarring of the vas defrens and lead to permanent sterilisation. The results from the Adam clinical trial have not yet been published in a peer-reviewed journal and do not include data on the reversibility of the implant. However, Eisenfrats said the hydrogel had a predictable lifespan and had been shown to break down over time in animal trials, with work using lower doses in men revealing a shorter period of efficacy. 'The way to think about this is sort of like the IUD [intrauterine device] for men,' said Eisenfrats, adding after a two-year period men could decide whether to get another implant. The team is working on a procedure to enable 'on-demand reversal'. Eisenfrats said sperm tests could be used by men at home to check whether the contraceptive was still effective. Contraline said it was expecting to begin a phase 2 clinical trial in Australia later this year, involving 30 to 50 participants. 1 Prof Richard Anderson, an expert in hormonal male contraception at the University of Edinburgh, welcomed the findings. 'It's impressive that this looks like something that does actually work, which is great,' he said. 'We've now got hormonal and non-hormonal methods in advanced clinical development, which is potentially a much better position than we've been in previously in terms of actually getting something on the market for men to really use.' But Anderson and Prof Jon Oatley of Washington State University said at present no data had been released showing the reversibility of the Adam implant, and it remained unclear how long a single implant actually lasted for. Anderson also said it had yet to be shown that the implant could be removed, while Oatley said the long-term ramifications of blocking the vas defrens were unknown. Oatley added that while the Adam implant could be a strong contraceptive option for men, uptake may be limited. 'Given a choice of a pill, patch, injectable, or surgery I believe that most men would choose pill or patch over surgery,' he said.
Associated Press
15-04-2025
- Business
- Associated Press
Contraline Secures 15th Issued Patent, Reinforcing IP Leadership in Male Contraception
CHARLOTTESVILLE, VA, UNITED STATES, April 15, 2025 / / -- Contraline, Inc., the leading innovator in male contraception, today announced the issuance of its 15th U.S. patent, further advancing the company's mission to develop a new standard of care in reproductive health. This milestone reflects Contraline's continued investment in building one of the most comprehensive intellectual property portfolios in the field of male contraception. With this milestone, Contraline's global patent portfolio, including those owned and licensed, has grown to 15 issued patents and more than 50 pending applications across the United States, Europe, Australia, Canada, and Asia. Contraline's flagship product is the ADAM™ hydrogel, a biocompatible hydrogel implanted in the vas deferens designed to block sperm transport. The IP portfolio spans the entire innovation lifecycle of hydrogel-based vas-occlusive contraception, from novel biomaterials and precision delivery systems to advanced imaging and minimally-invasive reversal techniques. 'This milestone underscores our commitment to leading innovation in male contraception,' said Kevin Eisenfrats, Co-Founder and CEO of Contraline. 'Our goal has always been to deliver the best possible experience for patients and physicians. Every new patent represents years of R&D and our belief that the ADAM™ hydrogel can redefine the landscape of birth control for men.' Contraline's issued and pending patents protect multiple critical components of its technology platform: Hydrogel Compositions Contraline has multiple issued patents that protect a range of hydrogel systems with tunable pore sizes and chemical and mechanical properties designed for safe, effective, and reversible sperm occlusion. These patents include, but are not limited to, two-component hydrogel compositions, which can be mixed in situ to rapidly form a stable, occlusive implant within the vas deferens. Delivery Systems Multiple patents cover proprietary injection devices featuring precision-controlled drive mechanisms, methods of delivery, and kit configurations that ensure consistent, in-office administration of the ADAM™ hydrogel. Reversal Methods Patents that cover a range of techniques for restoring fertility, including external stimuli that degrade or dissolve the hydrogel implant in situ. Contraline's patent estate includes issued patents across Europe, Canada, Australia, and Japan, with pending applications in all major international markets. While Contraline's core focus is male contraception, its underlying hydrogel platform could support broader applications—including reversible occlusion of other anatomical lumens, such as the fallopian tubes, and use in therapeutic drug delivery or vascular modulation. With 15 issued patents and a rapidly expanding pipeline of pending claims, Contraline has established itself as a clear IP leader in biomaterials-based contraception. About Contraline, Inc. Contraline, Inc. is a venture-backed, clinical-stage, biotechnology company focused on innovation in reproductive health. The company's mission is to develop novel male contraceptives that are safe, effective, appealing, and reversible. Visit Disclaimer ADAM™ The ADAM™ device is an investigational device and is not yet authorized by the U.S. Food and Drug Administration (FDA) or any other regulatory authority worldwide. As such, the ADAM™ device is not available for commercial use at this time and it is currently available only for investigational use in approved clinical trials. Kevin Eisenfrats Contraline, Inc. email us here Visit us on social media: LinkedIn Instagram Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
