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.
May 07, 2021
Medical Device Industry Veteran, Martin J. Emerson, Joins Contraline Board New Board appointment strengthens Contraline with world-class expertise in urology device development, approvals, commercial strategy, and business developmentCharlottesville, VA Contraline, Inc., a venture-backed medical device company devoted to providing men and couples with long-lasting, safe, and effective male contraception, has appointed medical device industry executive Martin Emerson to its Board of Directors.Marty joins our Board at an exciting time as we transition to a clinical-stage organization and plan to initiate our first-in-human clinical trial of ADAM, the worlds first injectable hydrogel designed to provide long-lasting, non-permanent vas-occlusion for men, says Kevin Eisenfrats, Co-Founder and Chief Executive Officer of Contraline. We are charting the path to bring a revolutionary reproductive health product like ADAM to market, and we will greatly benefit from Martys wealth of knowledge and successful experience leading numerous companies with innovative medical devices, including in urology.Mr. Emerson brings to Contraline over 30 years of medical device industry experience. From 2005-2008, he served as the CEO of American Medical Systems AMS, a publicly-traded urology and gynecology device company with sales of over 500 million later acquired by Boston Scientific for 1.6 billion. After AMS, Mr. Emerson served as the president and CEO of Galil Medical, a cryoablation device company acquired for 110M by BTG plc, and currently serves as the president and CEO of Monteris Medical. He has also held various management positions, both domestic and international, with Boston Scientific Corporation and Baxter International. Mr. Emerson currently serves on the Board of Directors for SubioMed and Tepha Medical Devices, and has previously served on other boards of both public and private medical device companies. He holds a Bachelor of Science in Accounting from Marquette University.Contraline is pioneering a new modality for men to control their fertility in a non-hormonal way and that could transform family planning around the globe, said Mr. Emerson. I look forward to working with the team to help guide the strategy of accelerating a robust clinical program to validate their innovative hydrogel technology and bringing ADAM to multiple markets to have significant impact on men, families, and society as a whole. In addition to CEO Kevin Eisenfrats and Martin Emerson, Contralines Board of Directors includes-Michael King, PhD, chemical engineering professor with more than 30 years experience in research and manufacturing related to the commercialization of new pharmaceuticals and vaccines as SVP of Science and Technology at Merck and as a consultant to the Bill Melinda Gates Foundation.-Tom Thorpe, MBA, CEO of Afton Scientific, a cGMP contract manufacturer of sterile drugs and products for use in new drug development and production.-Gurdane Bhutani, founder and managing partner at MBX Capital, an early-stage healthcare venture fund.
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.
October 26, 2020
RICHMOND, VA October 26, 2020 The Virginia Catalyst, formerly known as the Virginia Biosciences Health Research Corporation VBHRC, today announced that it has awarded 2.1 million in grants to three life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded as Round 11 of Virginia Catalysts ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth. The life sciences industry has been a catalyst for economic growth during the pandemic and is poised to accelerate Virginias recovery in a post COVID world, said Mike Grisham, CEO, Virginia Catalyst.Through programs like these grant initiatives, Virginia Catalyst and the Commonwealth of Virginia are investing in the future by driving additional capital and business opportunity through the life sciences. The funding we provide for these innovative programs helps generate significant outside capital and interest in Virginia. We are proud to announce the awardees for our eleventh round of funding as we help to finance the commercialization of Virginias innovations and investment in research infrastructure tools to facilitate bioscience research.Contraline is one of three companies to have been selected in this years round of funding. Contralines project, Clinical Translation of a Male Contraceptive Procedure will involve collaborating with UVA and VCU to prepare the companys lead product ADAM for use in humans.Nearly half of all pregnancies in the United States each year are unintended, with three-fourths of couples relying on the female partner for birth control. Currently, mens options are limited to condoms and vasectomy, creating a substantial opportunity for a novel male contraceptive to contribute to family planning and improved quality of life. Contraline, a spin-out from UVA, is a medical device company developing ADAM, the worlds first injectable hydrogel designed to provide long-lasting barrier contraception for men. The hydrogel is inserted into the vas deferens through a quick outpatient procedure, which has been shown to be safe and effective in large animal studies. The Virginia Catalyst grant will support our translational research collaborating with UVA and VCU urology departments to ready our male contraceptive ADAM for a first-in-human clinical trial in 2021. This will be the first clinical trial conducted on a non-hormonal male contraceptive device in over 20 years and we are excited to partner with Virginia Catalyst to enable it. - Kevin Eisenfrats, Co-Founder and Chief Executive Officer, Contraline, Inc.
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.
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.
May 07, 2021
Medical Device Industry Veteran, Martin J. Emerson, Joins Contraline Board New Board appointment strengthens Contraline with world-class expertise in urology device development, approvals, commercial strategy, and business developmentCharlottesville, VA Contraline, Inc., a venture-backed medical device company devoted to providing men and couples with long-lasting, safe, and effective male contraception, has appointed medical device industry executive Martin Emerson to its Board of Directors.Marty joins our Board at an exciting time as we transition to a clinical-stage organization and plan to initiate our first-in-human clinical trial of ADAM, the worlds first injectable hydrogel designed to provide long-lasting, non-permanent vas-occlusion for men, says Kevin Eisenfrats, Co-Founder and Chief Executive Officer of Contraline. We are charting the path to bring a revolutionary reproductive health product like ADAM to market, and we will greatly benefit from Martys wealth of knowledge and successful experience leading numerous companies with innovative medical devices, including in urology.Mr. Emerson brings to Contraline over 30 years of medical device industry experience. From 2005-2008, he served as the CEO of American Medical Systems AMS, a publicly-traded urology and gynecology device company with sales of over 500 million later acquired by Boston Scientific for 1.6 billion. After AMS, Mr. Emerson served as the president and CEO of Galil Medical, a cryoablation device company acquired for 110M by BTG plc, and currently serves as the president and CEO of Monteris Medical. He has also held various management positions, both domestic and international, with Boston Scientific Corporation and Baxter International. Mr. Emerson currently serves on the Board of Directors for SubioMed and Tepha Medical Devices, and has previously served on other boards of both public and private medical device companies. He holds a Bachelor of Science in Accounting from Marquette University.Contraline is pioneering a new modality for men to control their fertility in a non-hormonal way and that could transform family planning around the globe, said Mr. Emerson. I look forward to working with the team to help guide the strategy of accelerating a robust clinical program to validate their innovative hydrogel technology and bringing ADAM to multiple markets to have significant impact on men, families, and society as a whole. In addition to CEO Kevin Eisenfrats and Martin Emerson, Contralines Board of Directors includes-Michael King, PhD, chemical engineering professor with more than 30 years experience in research and manufacturing related to the commercialization of new pharmaceuticals and vaccines as SVP of Science and Technology at Merck and as a consultant to the Bill Melinda Gates Foundation.-Tom Thorpe, MBA, CEO of Afton Scientific, a cGMP contract manufacturer of sterile drugs and products for use in new drug development and production.-Gurdane Bhutani, founder and managing partner at MBX Capital, an early-stage healthcare venture fund.
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.
October 26, 2020
RICHMOND, VA October 26, 2020 The Virginia Catalyst, formerly known as the Virginia Biosciences Health Research Corporation VBHRC, today announced that it has awarded 2.1 million in grants to three life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded as Round 11 of Virginia Catalysts ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth. The life sciences industry has been a catalyst for economic growth during the pandemic and is poised to accelerate Virginias recovery in a post COVID world, said Mike Grisham, CEO, Virginia Catalyst.Through programs like these grant initiatives, Virginia Catalyst and the Commonwealth of Virginia are investing in the future by driving additional capital and business opportunity through the life sciences. The funding we provide for these innovative programs helps generate significant outside capital and interest in Virginia. We are proud to announce the awardees for our eleventh round of funding as we help to finance the commercialization of Virginias innovations and investment in research infrastructure tools to facilitate bioscience research.Contraline is one of three companies to have been selected in this years round of funding. Contralines project, Clinical Translation of a Male Contraceptive Procedure will involve collaborating with UVA and VCU to prepare the companys lead product ADAM for use in humans.Nearly half of all pregnancies in the United States each year are unintended, with three-fourths of couples relying on the female partner for birth control. Currently, mens options are limited to condoms and vasectomy, creating a substantial opportunity for a novel male contraceptive to contribute to family planning and improved quality of life. Contraline, a spin-out from UVA, is a medical device company developing ADAM, the worlds first injectable hydrogel designed to provide long-lasting barrier contraception for men. The hydrogel is inserted into the vas deferens through a quick outpatient procedure, which has been shown to be safe and effective in large animal studies. The Virginia Catalyst grant will support our translational research collaborating with UVA and VCU urology departments to ready our male contraceptive ADAM for a first-in-human clinical trial in 2021. This will be the first clinical trial conducted on a non-hormonal male contraceptive device in over 20 years and we are excited to partner with Virginia Catalyst to enable it. - Kevin Eisenfrats, Co-Founder and Chief Executive Officer, Contraline, Inc.
