November 01, 2023

Contraline, a clinical-stage medical device company announced the successful launch of two new sites in Australia for The ADAM Study, its First-in-Human clinical trial studying the safety of ADAM, a hydrogel-based, long-lasting, non-hormonal, and non-permanent male contraceptive. The two new sites are South Coast Urology in Wollongong, led by AProfessor Peter Chin MBBS, FRACS, and AndroUrology Centre in Brisbane, led by Professor Eric Chung MBBS, FRACS. These sites join Epworth Freemasons in Melbourne, led by Professor and Principal Investigator Nathan Lawrentschuk, PhD, MBBS, FRACS.AProf Chin has been involved in a number of urological clinical trials. He led the first trials for the UroLift device, which is now one of the leading minimally invasive treatment options for benign prostate hypertrophy BPH. Prof Chung is recognized as one of leading international experts in the field of male sexual, reproductive, and reconstructive urology, and serves as the Chair of the Male LUTS and Past Chair of the Andrology sections in the Urological Society of Australia and New Zealand USANZ.Dr. Chin performed his first two ADAM procedures on August 8th on a 29-year-old and a 30-year-old patient. Both procedures were successful with no adverse events reported on the day of the procedure and no device deficiencies.I am delighted to be part of this groundbreaking study which is trialing the first implantable male contraceptive. ADAM has the potential to be the first major advancement in male contraception since the vasectomy, which was introduced over 100 years ago.Overall, the ADAM procedure was easy to get trained on and perform. The ADAM hydrogel is simple in preparation and Contralines injector ensures the correct dose of hydrogel is implanted into the vas deferens, significantly reducing the chances of variability or failure, said Peter Chin, MBBS, FRACS, AProf of Urology at the University of Wollongong.He added, I was pleasantly surprised with how much interest there was from men to participate in the trial. We were able to perform our first ADAM implantations only 4 weeks after launching the recruitment campaign. I can see a future where many younger male patients are seeking out the ADAM procedure over existing contraceptive methods.We are excited to be expanding the ADAM Study, especially after the interest we received following the American Urological Association and European Association of Urology conferences. Peter Chin and Eric Chung bring extensive urology and andrology experience and have been involved in several successful clinical trials for urological devices. It was important for us to put ADAM in the hands of more surgeons to receive as much feedback as possible in preparation for a pivotal trial. With Drs. Chin and Chung on board, we are on track to complete enrollment of the trial by end of this year. said Alexander Pastuszak, MD, PhD, Chief Medical Officer of Contraline.

September 11, 2024

CHARLOTTESVILLE, Va.-- Contraline, Inc., a clinical-stage biotechnology company, proudly announces the signing of an exclusive option-to-license agreement with the Population Council for the NestoroneTestosterone Transdermal Gel NEST for male contraception. Upon exercising the option, Contraline will spearhead the global development and commercialization of NEST, positioning Contraline as the worlds preeminent biotechnology company in male contraception. Contralines pipeline now includes two revolutionary, clinical-stage, investigational male contraceptives NEST, a daily-use topical gel, and ADAM, an implantable, reversible device. NEST is an investigational short-acting, transdermal, and reversible hormonal contraceptive, developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD, part of the US National Institutes of Health. The NEST gel, containing Nestorone segesterone acetate and testosterone, is formulated for men to apply daily to their shoulders to decrease sperm production. Over 750 men have been dosed with NEST across Phase 1 and 2 clinical trials, with preliminary data suggesting NEST has the potential to be a highly effective male contraceptive with an acceptable side-effect profile.Globally, nearly 50 percent of all pregnancies are unplanned, amounting to over 120 million unintended pregnancies each year.1,2 Beyond condoms and vasectomy, men lack reliable and acceptable contraceptive options. Market research estimates that 15-17 million men in the United States would use novel male contraceptives.3,4Since founding Contraline in 2015, our vision has been to pioneer new male contraceptives and establish the industry from the ground up. With no new male contraceptives introduced since the vasectomy in 1897, our products, NEST and ADAM, have the potential to change the paradigm by providing men with reliable, reversible, and appealing options. Our goal is to offer a toolbox of choices to fit each individuals lifestyle. This partnership with the Population Council and NICHD marks a major leap forward in our mission to transform global contraceptive solutions and promote reproductive equality, said Kevin Eisenfrats, CEO and Founder of Contraline.Contraline is a leader in the male contraceptive field, making them a natural potential partner for the NEST gel, said Jim Sailer, Executive Director of the Population Council Center for Biomedical Research. Contralines goal to offer new methods of male contraception fits with our mission to provide women and men more contraceptive options.This announcement comes as NEST is completing a Phase 2b trial, enrolling over 460 couples across 17 global sites to assess safety and contraceptive efficacy pregnancy prevention.5 Upon exercising the option and an end-of-Phase 2 meeting with the FDA, Contraline will launch a Phase 3 program for NEST. This would be the first Phase 3 trial conducted in the United States for a novel male contraceptive drug product, marking a significant milestone in the field.The acceptability of NEST in the Phase 2b trial was very high, said Regine Sitruk-Ware, MD, distinguished scientist at the Population Council and co-director of the Phase 2b trial. Men in the trial were asking when the method will be available or whether they could re-enroll in the study to continue using the gel. Their female partners indicated that this method was much better than the female oral contraceptive pill.We believe NEST can be a game-changer, with the potential to offer a novel male contraceptive option that provides a comparable pregnancy prevention rate as some of the most widely used female contraceptives today. We commend the Population Council and NICHD for their 20 years of dedication to developing NEST, said Dr. Alexander Pastuszak, Chief Medical Officer of Contraline.Contraline is dedicated to transforming the contraception industry by providing men with diverse, effective, and reversible contraceptive choices that enhance reproductive freedom and responsibility.Disclaimer ADAMADAM 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, ADAM is not available for commercial use at this time and it is currently available only for investigational use in approved clinical trials.Disclaimer NESTThe NEST gel is a US. FDA-Regulated Investigational Drug Product not yet authorized by the US FDA or any other regulatory authority worldwide. It is currently available only for investigational use in approved clinical trials.About Contraline, Inc.Contraline, Inc. is a venture-backed, clinical-stage, biotechnology company focused on innovation in reproductive health. The companys mission is to develop novel male contraceptives that are safe, effective, appealing, and reversible. Visit www.contraline.comAbout the Population CouncilThe Population Council confronts critical health and development issues - from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, they work with partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Over 170 million women around the world use contraceptives developed by the Population Council. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees. Visit www.popcouncil.org.References1 httpswww.guttmacher.orgfact-sheetinduced-abortion-worldwide2 httpswww.guttmacher.orgreportadding-it-up-investing-in-sexual-reproductive-health-20193 httpswww.sciencedirect.comsciencearticlepiiS001078242400101X4 httpswww.malecontraceptive.orguploads1319131958006mciconsumerresearchstudy.pdf5 httpsclinicaltrials.govstudyNCT03452111

July 09, 2024

CHARLOTTESVILLE, VA, UNITED STATES, July 9, 2024 -- Contraline, a clinical-stage biotechnology company, has announced promising initial safety and efficacy results from its First-in-Human clinical trial. The trial, which is evaluating the safety and preliminary efficacy of Contralines ADAM, a non-permanent male contraceptive, has had its first patients demonstrate 12 months of efficacy in the study. ADAM is a water-soluble, biocompatible, and non-permanent hydrogel that is implanted into the vas deferens where it blocks sperm transport, resulting in azoospermia no sperm in the ejaculate. ADAM has the potential to be the first male contraceptive option beyond condoms single-use and vasectomy permanent.Earlier this year, Contraline completed enrollment of an open-label, multicenter trial, with 25 participants across three sites in Australia. ADAM continues to demonstrate a favorable safety profile, with no reports of treatment-related serious adverse events. All adverse events AEs have been anticipated and a majority of the AEs have been mild. Additionally, no AEs have been related to ADAM hydrogel.Contraline previously reported that within 30 days of ADAM implantation, a 99.8-100.0 reduction in the number of motile sperm was observed, demonstrating that ADAM can lower sperm concentration and motility to levels comparable to vasectomy in a short amount of time. Contraline is now reporting that patients in the study are demonstrating azoospermia 12 months after implantation, providing an initial signal for ADAM as a long-term contraceptive option.There is a significant demand from patients seeking long-lasting, reversible male contraception, a gap that ADAM may fill. Approximately 17-20 million men in the United States are actively seeking to use new forms of male contraception, and the percentage of younger men getting vasectomies has significantly increased since the overturn of Roe v. Wade, supporting the demand for safe, long-lasting alternatives. Market research studies have shown that men have the strongest preference for a one year contraceptive duration n1,500. Contralines market research confirmed these results, with 35 of men choosing 1-2 years as their primary preference for an implantable male contraceptive, followed by 6-months and 3-5 years.Prof. Nathan Lawrentschuk, Principal Investigator of the clinical trial, shared his perspective on the achievement, stating, The results of Contralines first in human clinical trial are promising. The ADAM hydrogel has a tremendous safety profile and with patients showing efficacy signals over a 12-month period, there is potential to address the longstanding need for long-lasting, safe, and reversible male contraception.Dr. Alex Pastuszak, Chief Medical Officer at Contraline, expressed his enthusiasm about the results, stating, These efficacy results support the conclusion that 12 months of efficacy is possible using the ADAM hydrogel, marking a significant milestone in the development of novel, flexible male contraceptive options.These promising First-in-Human results pave the way for further advancements in male reproductive health. Contraline is planning on conducting an Early Feasibility Study on the ADAM hydrogel, which is slated to initiate in Q1 2025.DisclaimerADAM is an investigational device and is not yet approved by the U.S. Food and Drug Administration FDA or any other regulatory authority worldwide. As such, ADAM is not available for commercial use at this time. The devices safety and effectiveness have not been established, and it is currently available only for investigational use in approved clinical trials.References1. httpswww.contraline.comnewsc4ovrhbcostzz18u299no44contraline-achieves-promising-early2.httpswww.malecontraceptive.orguploads1319131958006mciconsumerresearchstudy.pdf3. httpswww.latimes.comsciencestory2024-05-14younger-patients-sought-vasectomies-after-roe-vs-wade-overturned4. httpspubmed.ncbi.nlm.nih.gov15608042

June 25, 2024

DNA Diagnostics Center DDC, a global leader in consumer testing services, and part of the global network of Eurofins laboratories, announces its collaboration with Contraline, a clinical-stage medical device company specializing in reproductive health innovation, in their first of a kind clinical trial for ADAM, an investigational male contraceptive device. ADAM represents a significant advancement in male contraception. It involves injecting a proprietary hydrogel into the vas deferens, providing long-lasting and non-hormonal contraception for male patients. ADAM occludes sperm transport within the vas deferens, similar to a vasectomy, however, is designed to be non-permanent and easier to reverse. This innovative approach aims to offer men an alternative to traditional contraceptive methods such as condoms and vasectomy. Contralines ADAM Study, a First-in-Human trial conducted in Australia, has fully enrolled 25 patients into the study and is now focusing on monitoring the long-term safety and efficacy of the device.Contraline received approval from the Human Research Ethics Committee HREC to integrate DDCs SpermCheck Vasectomy into the ADAM Study protocol. SpermCheck Vasectomy is an accurate and convenient at-home test kit designed to confirm the success of vasectomy procedures by detecting the presence of sperm in semen samples. SpermCheck Vasectomy is a leading male fertility brand in the US, with over one million units sold, and is currently an investigational device in Australia.SpermCheck Vasectomy will be utilized by patients implanted with ADAMTM to monitor the effectiveness of the male contraceptive in real-time. By offering a user-friendly and accessible solution for monitoring sperm presence, SpermCheck Vasectomy enhances the convenience and reliability of ADAM as a male contraceptive option.Kevin Eisenfrats, co-founder CEO of Contraline, remarked, We are excited to integrate SpermCheck Vasectomy into the trial. Its a natural fit to combine an at-home diagnostic like SpermCheck Vasectomy with a male contraceptive like ADAM because it will offer patients the ability to know whether ADAM is working from the privacy of their own home. We are excited to be collaborating with DNA Diagnostics Center to make this happen.Both DNA Diagnostics Center and Contraline are dedicated to advancing the field of male contraception and improving reproductive health outcomes for individuals worldwide.

February 13, 2024

By Kevin Eisenfrats, co-founder CEO of Contraline The most common question I get as the CEO of a company working on male contraception is, Will men really use a new male contraceptive No matter how many market research studies I point to, all of which have determined the answer to be YES,1httpswww.malecontraceptive.orgimr-results.html2httpspubmed.ncbi.nlm.nih.gov15608042 its a question that often still lingers in the back of peoples minds. Men are not seen as being as attentive to their health in the same way women are. Most men dont have the dedicated care nor the conversations around sexual health that women receive from their gynecologists from a young age. Since the 1960s, women have been the main users of contraception after all, theyre the ones who bear the burden of pregnancy. What if the onus for taking contraceptives didnt have to fall on women For Valentines Day this year, we decided to find out by asking men if they are willing to take a male contraceptive, subjecting their own bodies to a new drug or procedure, to balance the playing field.From the early days of Contraline, Id receive emails from men on a weekly basis asking how soon they can get into our clinical trials. In 2018, when I realized I couldnt respond to each inquiry, we set up a simple landing pagehttpswww.contraline.comparticipate. We hoped that this landing page would help us find and quickly recruit clinical trial participants one day. Today, without any active advertising, our sign-up list has 7,032 people on it growing 133 per year who have expressed interest in being in our trials. This includes people from all 50 states, numerous countries, and across all sexually active ages. Ninety-five percent of the sign-ups are men.Shared Contraline 1200x1200images.ctfassets.net9qk6qrsprs8z1fOkF4B1uVjMpypxLnuQKu4dcc3e1dcd3c857a5951986824be748fSharedContraline1200x1200.pngBut signing up for a listserv is easy, and we wanted to know how serious are these people about trying a male contraceptive And WHY Within minutes of sending the survey, the responses started pouring in. 500 responses in the first hour alone. In 48 hours, we received 1,211 responses, representing over 17 of the entire community.We found that 85 of our survey respondents use hehim pronouns n1,033, 9.4 use sheher, and 5.6 either use theythem or prefer not to say. A vast majority of the respondents live in the U.S., with Canada, Australia, and Germany also showing solid response rates. The mean age of our respondents was 29 and the median age was 27. A majority 84 of respondents dont have children. 37 dont ever want to have kids. The fact that our early adopters skewed so heavily towards being childless was a bit surprising to us.3images.ctfassets.net9qk6qrsprs8zqtgNRN4QLxeaAyX7K3xhp595255942a61d5b207291902a69faa783.pngGetting right into it, we asked respondents how serious they were about trying a new male contraceptive within 12 months of it being commercially available and, separately, at some point in their life 1 not serious or interested at all, and 5 very serious and interested.As seen in the chart below, 97.2 of responses were a 4 or 5 when it came to using a new male contraceptive in their lifetime. 90 when asked if they would use it within 12 months of being available Overall, around 75 of respondents were a 5 about using new male contraceptive within 12 months of being available.2images.ctfassets.net9qk6qrsprs8z7EmmVWFmy0M3OVc8NwMkxqfcba8df1f2ce61d076b5d2f3a82f34842.pngTo address the why, we posed two questions 1 Select the main reasons why you would be interested in trying a new male contraceptive, and 2 Select the reasons that make you the most excited about a new male contraceptive becoming available.The main reason why people are so interested in trying a male contraceptive is that they want more control over their reproduction. This is supported by the fact that 60 of respondents partners havehad issues with their contraceptives, and 50 of respondents selected they dont like using condoms and arent interested in vasectomy. There is a clear gap in the contraceptive product landscape that needs to be filled. Existing products are not meeting the demands and people are looking for novel, effective, safe non-hormonal, and appealing ways to contracept.4images.ctfassets.net9qk6qrsprs8z29511OyybUo9GBCVnZ8JaG5c7eb55ac9717012ea984641ff93007c4.pngPerhaps more surprising were the reasons that made these predominantly male participants excited about male contraception. The top two reasons were removing burden off women as the main users of contraception 85.7 and balancing responsibility reproductive equity 77.7. These reasons surpassed more control over when I have children and easier or better than the method Im currently using. I believe that people, especially men, are recognizing that we as a society need to change the overbearing reliance on women when it comes to family planning.5images.ctfassets.net9qk6qrsprs8z2buU8OmaYmQclXgMvkcB28357d551566ea13c0784e3bd1c27e0d2e5.pngFinally, we addressed the question of whether the Dobbs decision to overturn Roe v. Wade had any impact on peoples interest in male contraception. Ive generally assumed the answer to be yes. For example, since the Dobbs decision, there has been a reported 26-35 increase in vasectomy appointments 3httpswww.nature.comarticless41443-023-00672-x. But weve never asked that question to our community, many of whom have been interested in male contraception for years. What we found was that 33 of participants said the Dobbs decision had no impact on their desire to use a new male contraceptive, and for 30.5 of respondents, it impacted them very strongly. The community was pretty evenly split between the two. While the Dobbs decision may have brought the topic of reproductive health to the forefront of many peoples minds, the trend of men wanting to take more responsibility for family planning started well before 2022. 6images.ctfassets.net9qk6qrsprs8z6iC28bM6rkcNsOe1KaEU9n115cc3cf9f1859d90c78176243d542456.pngI hope that this survey demonstrates that there are men who want to take control over their reproduction and balance the contraceptive playing field. In fact, we estimate its as many as 17 million men who are willing to step up in the United States alone. I can imagine a few years from now its Valentines Day, and a boyfriend says to his girlfriend, Honey, let ME take care of the birth control. Whats more romantic than that We invite you to follow our journey at Contraline as we and our incredible community continue to pave the way forward for male contraception.

January 04, 2024

This story was featured in Wiredhttpswww.wired.comstorymale-contraceptive-contraline-vasalgel-hydrogel, Stathttpswww.statnews.com20240104male-birth-control-injectable-gel-non-hormonal, NY Posthttpsnypost.com20240105lifestyleiud-for-men-shows-positive-results-on-par-with-vasectomy-in-early-trials, Daily Mailhttpswww.dailymail.co.ukhealtharticle-12930619iud-men-available-2025.html, and CENhttpscen.acs.orgpharmaceuticalsdrug-developmentContraceptive-candidate-acts-blocking-sperm102web202401. Contralines ADAM breaks new ground as a non-hormonal male contraceptive to release in-human clinical data, paving the way to reproductive equality. This marks the first major development in male contraception since the vasectomy.January 4, 2024, Charlottesville, VA and Melbourne, AustraliaContraline, a venture-backed, medical device company pioneering the field of male contraception, is pleased to announce positive interim results from its First-in-Human trial. The trial is for the companys flagship product, ADAM, a male contraceptive that is long-lasting, non-hormonal, and non-permanent.ADAM is a patented, biocompatible, and injectable hydrogel that is implanted into the vas deferens via a minimally-invasive procedure, where it blocks sperm transport. While there have been over 50 years of research into the development of vas-occlusive contraceptives, no product has achieved regulatory approval or commercial launch to date. ADAM is the first vas-occlusive product designed to be inert, non-permanent, and reversible. These results mark a significant leap forward in the development of a non-hormonal male contraceptive to enter human clinical trials, demonstrating both safety and efficacy of ADAM.Conducted across three centers in Melbourne, Brisbane, and Wollongong, Australia, the trial has successfully implanted 23 patients. All procedures were conducted by one of the studys investigators and had a 100 successful implantation rate, measured by the surgeons ability to exteriorize and cannulate the vas deferens, and implant the ADAM hydrogel into the vasal lumen using Contralines proprietary injector. ADAM procedures, lasting 20 minutes on average, were able to be performed under local or general anesthesia.Healthy males 25-65 years old with normal semen parameters, suitable for a vasectomy, wereenrolled into the trial. The trial has generated substantial interest, with over 1,500 men signing up to participate in the study. The enrolled patients ranged from 28-52 years old, most are in relationships, and about 50 have children. Participants were placed into two cohorts, each receiving varying amounts of hydrogel to gather comprehensive safety and efficacy data across several injection volumes.Within 30 days of implantation, ADAM showcased a 99.8-100.0 reduction in the number ofmotile sperm, demonstrating that ADAM is able to lower sperm concentration and motility tolevels comparable to vasectomy, the most effective contraceptive, in a short amount of time.There have been no reports of serious or severe adverse events. All adverse events reportedhave been anticipated and predominantly mild. Contralines Data Safety Monitoring Board,chaired by Dr. Larry Lipshultz, Professor of Urology at Baylor College of Medicine, concludedthat the safety of ADAM is excellent and the study should continue in its current form without modification.I am pleased with the early results we are seeing from the trial it is exciting to see the preliminary outcomes showing ADAM is safe and effective. The level of participant interest we are seeing shows that there is a major need for this type of contraception, and I am excited to continue working with Contraline in the development of the device. said Dr. Peter Chin, Urologist and Associate Professor at the University of Wollongong, and an investigator in the Study.We are thrilled to share these positive results which we believe take us one step closer to transforming the contraceptive landscape. This trial and the data presented are a clear indication that ADAM is safe, effective, easy to use, and in-demand. The fact that we are seeing such dramatic reduction in sperm counts and motility, without compromising on safety, suggests that it is possible to achieve similar levels of efficacy as long-acting female contraceptives like IUDs. Ultimately, Id like to make ADAM become a no brainer for men when it comes to considering their options for contraception, said Kevin Eisenfrats, Co-Founder and CEO of Contraline.Patients enrolled in the First-in-Human trial will continue to be monitored with regular follow-ups with the physician and semen analyses, contributing to valuable insights into the long-term effects of the implant. Contraline is currently preparing for an IDE Investigational Device Exemption submission in 2024, with subsequent plans for initiation of a US registration trial.Eisenfrats concluded, This milestone would not have been possible without our courageous patients and study investigators. Because of their contributions, we are one step closer to providing men with an appealing way to control their reproduction.

April 26, 2023

CHARLOTTESVILLE, Va.-- Contraline, a clinical-stage medical device company, announced the acceptance of abstracts detailing the initial results from the companys first in human clinical trial of ADAM, a hydrogel-based, long-lasting, non-hormonal, and non-permanent male contraceptive. The abstracts were written and submitted by investigators leading the study, and were accepted for presentation at the two largest, annual international urology meetings, the European Association of Urology EAU and the American Urological Association AUA. Contralines first-in-human clinical trial, The ADAM Study, began implanting its first patients in September 2022 and is being led by principal investigator Nathan Lawrentschuk, PhD, MBBS, FRACS, Professor of Urology at The Royal Melbourne Hospital and Epworth Hospital, and co-investigator Paul Anderson, MBBS, FRACS.The ADAM System consists of a patented hydrogel, which is implanted into the vas deferens of patients via a minimally invasive procedure, and a delivery device that automates the delivery of the hydrogel. ADAM is the first hydrogel designed to occlude sperm passage through the vas deferens for a predefined period, degrading without intervention and thus offering a non-permanent contraceptive option for men, in contrast to vasectomy, which is considered permanent.The podium presentations by Nathan Lawrentschuk at AUA and Paul Anderson at EAU highlight the early research findings on the ADAM System. The first-in-human clinical trial is focused on defining the safety of the ADAM System, while evaluating the preliminary efficacy in inducing azoospermia in study participants.The early findings of The ADAM Study support an excellent safety profile for the ADAM System, with most adverse events being minor and related to the procedure, which is similar to a no-scalpel vasectomy, rather than as a result of the implant no patients to date have experienced any serious adverse events. The preliminary efficacy data have demonstrated that azoospermia has been induced in all men implanted with ADAM. These initial data are very exciting and we are eager to continue enrolling patients into the study. This study enables us to optimize the dose of ADAM while continually improving the implantation procedure, opening to the door to conduct a pivotal trial, said Nathan Lawrentschuk.Even the early data from The ADAM Study support the vas-occlusive hydrogel being a potential game changer in reproductive medicine, with men and couples being able to take even more control over family planning than ever before, said Alexander Pastuszak, MD, PhD, Chief Medical Officer of Contraline.Contraline is currently expanding the number of sites for its first in human study in Australia, with the eventual goal of opening a larger study in the United States.

November 11, 2022

CHARLOTTESVILLE, Va.-- Contraline today announced the first hydrogel-based male contraceptive implants were performed in humans in a clinical trial. These procedures represent a significant milestone for the development of the companys flagship product, ADAM, a male contraceptive that is long-lasting, non-hormonal, and non-permanent. Four men were implanted with ADAM at Epworth Freemasons Hospital in Melbourne, Australia, led by principal investigator Nathan Lawrentschuk, Professor of Urology at Royal Melbourne Hospital and Epworth Hospital, and co-investigator Paul Anderson. The procedures were performed using a minimally invasive, no-scalpel approach, with ADAM being injected using a patent-pending delivery device.ADAM is the first hydrogel designed to occlude sperm flow through the vas deferens for a predefined period of time, eventually degrading and thus offering a non-permanent contraceptive option, in contrast to vasectomy, which is considered permanent. The procedure marks the first patient implanted in The ADAM Study, which is being conducted under Human Research Ethics Committee approval. The ADAM Study is assessing the safety of the ADAM Hydrogel, while monitoring the semen parameters of the study subjects over three years. This is an incredibly exciting milestone for the field of urology and reproductive health, said Nathan Lawrentschuk, Director of Urology at The Royal Melbourne Hospital Department of Urology and founding Director of the EJ Whitten Prostate Cancer Research Centre at Epworth Hospital. The implantation procedures went extremely well, and the patients were all discharged quickly after the surgeries.The first-in-human male contraceptive implant is a major clinical milestone that opens up new possibilities for men who wish to take contraception into their own hands, said Kevin Eisenfrats, Co-Founder and CEO of Contraline. The patient demand for the ADAM Study has been tremendous, with the entire trial oversubscribing within 3 weeks of opening enrollment. We are looking forward to advancing ADAM through clinical development and bringing this product to market to transform how people think about contraception.The study was supported by Contraline in addition to the Male Contraceptive Initiative. Recently, Contraline closed on an additional 7.2M in funding led by GV for a total of 17.9M raised to date. Rhia Ventures, ShangBay Capital, Amboy Street Ventures, MBX Capital, Graphene Ventures, and Metaplanet Holdings also contributed to the round.Contraline has the potential to fundamentally change the market for contraception, said Cathy Friedman, Executive Venture Partner at GV. We look forward to working with the team as they continue developing a long-acting, reversible male contraceptive that empowers more people with more choices over family planning.Contraline is continuing the study in Australia with the eventual goal of opening a second study with a larger group of patients in the United States.

February 24, 2022

CHARLOTTESVILLE, Va.-- Contraline, Inc., a clinical-stage medical device company, today announced that its ADAM System, the worlds first investigational hydrogel implant designed to provide non-hormonal, long-lasting and non-permanent contraception for men, was awarded Best Innovation, at the 2022 Womens Health Innovation Series Reproductive Health Innovation Summit, held in Boston on February 15-16, 2022. Contraline was selected as the winning company among 9 other finalists 65 total applicants developing technologies that promote increased reproductive access, choice, and research to support womens health around the world. Currently, there are no long-lasting, reversible male contraceptives available, and ADAM has the potential to be a first-of-its-kind product that revolutionizes how couples think about contraception and family planning, said Kevin Eisenfrats, Co-Founder and Chief Executive Officer of Contraline. Almost half of all pregnancies in the U.S. are unintended even with the numerous options available to women. Furthermore, according to the Male Contraceptive Initiative, one in four men who have had intercourse has led to an unintended pregnancy. We believe that providing more contraceptive options for men is crucial to reduce the rate of unintended pregnancies and reduce burden for women. Its an honor that the top experts and investors in reproductive health recognized Contralines innovation as the top award at the summit and share our vision for making reproductive equality a reality.Contraline recently announced approval of a first-in-human clinical trial to evaluate the safety of ADAM. In the trial, the ADAM Hydrogel is injected into a trial participants vas deferens through a quick and minimally invasive outpatient procedure, where it is designed to block flow of sperm. Contraline received ethics approval to conduct the study in Melbourne, Australia. This trial is believed to be the first clinical trial studying a non-hormonal male contraceptive device in over 20 years.

October 25, 2021

Contraline, Inc., a venture-backed medical device company devoted to providing men and couples with long-lasting, safe, and effective male contraception, has closed 10.7 million in its Series A financing. The financing round was led by MBX Capital, a venture capital firm that invests in early-stage healthcare and life sciences companies. Additional investors in Contraline include Rhia Ventures, ShangBay Capital, Founders Fund, Metaplanet Holdings, Graphene Ventures, Smith Ventures, Jaffray Woodriff, and Jason Calacanis. This infusion of capital will support the initiation of a first-in-human trial of ADAM, the worlds first hydrogel implant designed to provide long-lasting, non-permanent contraception for men. The ADAM hydrogel is injected into the vas deferens through a quick and minimally invasive outpatient procedure, where its designed to block the flow of sperm. Contraline has received ethics approval from the Human Research Ethics Committee based in Melbourne, Australia to conduct the study. The clinical trial will be conducted by renown urologists at two hospitals in Melbourne. This trial on ADAM is believed to be the first clinical trial on a non-hormonal male contraceptive device in over 20 years.The Contraline team has designed a novel hydrogel and insertion procedure that has great potential to achieve the safety, durability, and efficacy required for a world-changing new male contraceptive. Currently, there are no long-lasting, non-permanent male contraceptives available, and ADAM has the potential to be a first of its kind product that revolutionizes how we think about contraception, said Gurdane Bhutani, co-founder and managing partner of MBX Capital.As Contraline initiates its first-in-human clinical trial, leading urologist and entrepreneur Alexander W. Pastuszak, MD, PhD, is joining as Acting Chief Medical Officer. Dr. Pastuszak is an Assistant Professor of Urology at The University of Utah School of Medicine where he has specialized in the treatment of male infertility and sexual dysfunction. Dr. Pastuszak has published over 130 peer-reviewed articles, with several focused on vasectomy and vasectomy reversal, and runs an NIH-funded laboratory investigating the genetics of mens health conditions. He also serves as Chief Clinical Officer of Vault Health, a hyper growth company accelerating better health outcomes through faster diagnosis, innovative clinical research, and digital-first care delivery. Dr. Pastuszak developed the Vas Reverse iOS app to educate and guide patients seeking vasectomy reversal and founded Woven Health, a company focused on empowering medical professionals to deliver higher quality, more efficient, and more accountable patient care.Nearly half of all pregnancies in the United States each year are unintended, with three-fourths of couples relying on women for birth control. Mens options are limited to temporary methods like condoms or withdrawal, or vasectomy, a permanent method. There is great need for a new appealing male contraceptive to contribute to family planning and improved quality of life, said Dr. Pastuszak. I believe that Contralines product ADAM could be a game changer for men who want more control over their fertility as well as couples who struggle with their reliance on female contraception.We have completed preclinical RD and manufacturing of the ADAM System to be used in humans, and we now have the financing, ethics approval, and team in place to transition ADAM into clinical trials, said Kevin Eisenfrats, Co-Founder and Chief Executive Officer of Contraline. Its been over 60 years since the hormonal female pill was launched, with few innovations for either men or women. This trial will launch the next generation of non-hormonal male contraceptives, increasing choice for men and achieving public health impact.

November 18, 2020

Durham, NC and Charlottesville, VA Male Contraceptive Initiative MCI, a 501c3 non-profit, has partnered with the medical device company Contraline, Inc. to provide a 1 million Program Related Investment PRI to support a first-in-human clinical trial for the companys novel vas-occlusive contraceptive device, ADAM. This is the first PRI from Male Contraceptive Initiative and is representative of the organizations continued evolution. We are very excited about adding program related investments to our portfolio as a means of accelerating male contraceptive product development through a team science approach. Returns on these investments will go directly back into supporting research efforts to continue driving the field of non-hormonal male contraception forward, said MCI Executive Director Heather Vahdat. Contraline is a particularly exciting investment opportunity as they are the first US-based company to bring a novel non-hormonal male contraceptive to the clinical stage it shows that we are moving closer and closer to realizing a more robust portfolio of contraceptive options that includes more methods for men, Ms. Vahdat added. Contraline has developed ADAM, the worlds first injectable hydrogel designed to provide long-lasting barrier contraception for men. ADAM is designed to be inserted into the vas deferens through a quick and minimally invasive outpatient procedure using local anesthesia, where the hydrogel blocks the flow of sperm without affecting sensation or ejaculation. ADAM may be the first set-and-forget male contraceptive method, similar to intrauterine devices IUDs for women. MCIs investment in Contraline will be used to establish proof-of-concept of safety and feasibility of the ADAM device and procedure through a human clinical trial. This is an important first step prior to conducting a larger efficacy study required for gaining regulatory approval and widespread consumer access to the procedure. We have been excited about Contralines technology since 2018, when we provided them with a grant to validate their benchtop and preclinical studies. Given the success of their science to date, we are pleased to expand our collaboration as Contraline continues advancing their male contraceptive towards the clinic, said MCI Research Director Dr. Logan Nickels. We are grateful to MCI for their dedication to supporting innovation in male contraception and for recognizing the transformative potential of ADAM, said Kevin Eisenfrats, Contraline co-founder and chief executive officer. At Contraline, we are dedicated to developing new options for men who desire to take control of their fertility and we look forward to having our lead product, ADAM, enter the clinic soon. With over 5 million invested in product development, MCI seeks to advance male contraceptive research projects to market in order to achieve its organizational vision of Reproductive Autonomy for All. MCIs mission is, To empower men, and couples, to fully contribute to family planning goals by providing them the resources they need for reproductive autonomy. -------------------------------------------------- About Male Contraceptive Initiative Male Contraceptive Initiatives vision is Reproduction Autonomy for All, and works to accomplish this by bringing new male contraceptives to market. The non-profit accomplishes this through direct funding, technical support, research, and advocacy. They believe that couples deserve options and that they offer the biggest potential impact by focusing on male contraceptives. Its time men are given more opportunities to contribute toward family planning. About Contraline Contraline is a venture-backed medical device company devoted to providing men and couples with long-lasting, safe, and effective contraception. The company is developing ADAMTM, a non-hormonal male contraceptive that uses proprietary advancements in hydrogel technology for occlusion of the vas deferens. The company was founded in 2015 by Kevin Eisenfrats and Dr. John Herr, and is headquartered in Charlottesville, Virginia. To learn more, visit httpwww.contraline.com.