Women's Health Tech Startup Womed Showcases Clinical Trial Results of First Fertility Preserving, Intrauterine Technology Product
8.9.2021 08:15:00 EEST | Business Wire | Press release
Womed, the women's health tech company pioneering innovative treatments against challenging uterine pathologies based on a novel polymer material technology, today announced the publication in the Journal of Minimally Invasive Gynecology (JMIG) of results of the clinical trial evaluating its first product, Womed Leaf™. The clinical data demonstrated that the device is safe and effective in preventing intrauterine adhesion in women with uterine fibroids undergoing hysteroscopic myomectomy. Womed also announced that Womed Leaf™ received CE Marking.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210907005710/en/
Womed Leaf mode of action
Intrauterine adhesions (IUAs) occur after 20% to 45% of surgical interventions, when the uterine walls bind together due to abnormal scarring. IUAs are a major cause of infertility and repeated miscarriages. IUA treatment, with a recurrence rate as high as 60%, leaves women unsure and anxious about their chance to conceive.
To prevent IUA formation, ObGyns need to keep the uterine walls separated after an intrauterine intervention. They can use various kinds of gels, but these existing materials become liquid and typically flow out of the cavity too quickly to create an effective barrier. Womed Leaf™ is the first and only mechanical barrier against IUA as it is composed of a soft film that protects the entire uterine cavity for a week and is painlessly discharged naturally afterwards.
Womed LeafTM was evaluated during the first trial of Womed's clinical program, PREG1, which enrolled 23 patients who were scheduled for hysteroscopic myomectomy. Device manipulation was less than two minutes in all cases, and the procedure was described as easy by all operators. None of the study participants suffered any injuries, reactions or adverse events attributable to Womed Leaf. The device caused zero to minimal discomfort to patients and effectively prevented adhesion formation in 83% of women at six weeks.
"We have been impressed with Womed Leaf's ease of use and are now very confident in its safety profile," said Prof. Herve Fernandez, head of the Obstetrics and Gynecology Department at the Bicetre University Hospital, AP-HP, Paris, France. "A mechanical barrier that protects the cavity during the entire healing phase is very compelling compared to our current options."
"Womed Leaf™ represents a major breakthrough in helping women preserve or recover their fertility from the heartbreaking condition of IUA, and we are thrilled by its clinical results and CE Mark approval," said Gonzague Issenmann, co-founder and Executive Chairman of Womed. "We now feel confident to carry out our ambitious strategy: to leverage Womed's proprietary polymer technology and develop a portfolio of unique intrauterine drug delivery products to safely treat challenging uterine pathologies, like acute bleeding and endometriosis."
About WOMED
Womed was founded by health tech entrepreneur Gonzague Issenmann, biomedical polymer specialist Prof. Xavier Garric and reproductive specialist Dr. Stephanie Huberlant, to commercialize an invention from Garric's Polymers for Health and Biomaterials lab at the University of Montpellier, France. Womed's proprietary degradable polymer technology is designed specifically for temporary uterine implantation and controlled drug delivery.
The first product, Womed Leaf™, is a medical device to treat and prevent bonding of the uterine walls after surgical intervention, which is responsible for one in five miscarriages. Womed's pipeline of intrauterine drug delivery products include treatments for acute uterine bleeding and endometriosis.
www.womedtech.com
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210907005710/en/
Contact information
Press contact:
Gonzague Issenmann, news@womedtech.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Hisense Delivers 38% Sales Uplift in Western Europe Markets With NIQ’s AI-Powered Market Intelligence6.5.2026 06:00:00 EEST | Press release
NIQ (NYSE: NIQ), a global leader in consumer intelligence, today shared new learnings from its long-standing collaboration with Hisense, a leading global brand in home appliances and smart technologies. Using NIQ’s AI‑powered market intelligence, Hisense has accelerated international expansion, improved local market decision-making, and delivered measurable growth across more than 20 key markets and 12+ categories. The case study demonstrates how AI‑driven insights help global brands move faster, localize better, and compete more effectively in complex markets. The Challenge As Hisense expanded internationally, it faced rising complexity across global markets. Consumer preferences differed sharply across regions such as Western Europe, Eastern Europe, and Latin America, making a one‑size‑fits‑all approach ineffective. NIQ’s AI‑powered intelligence delivered the local market depth needed to guide investment, refine product positioning, and identify the features that mattered most in eac
KILL Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 05:14:00 EEST | Press release
Samsung Bioepis Co., Ltd. requests that their press release NewsItemId: 20260505353718 “Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)” be killed. The release was issued prematurely by Samsung Bioepis Co., Ltd. The news release will be updated and redistributed in the near future, incorporating further information on SB27.
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 02:00:00 EEST | Press release
Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks, maximum 18 cycles over about 51 weeks, and blood samples were collected. The preliminary pharmacokinetic evaluation indicates t
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 01:00:00 EEST | Press release
Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing significant latency and complexity. Megaport DDoS Protection removes these challenges by integrating fabric-native protection directl
IFF Reports First Quarter 2026 Results5.5.2026 23:23:00 EEST | Press release
IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks the balance of the year and gives us the confidence to reaffirm our full-year 2026 financial guidance ranges in an uncertain environment. At the same time, w
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom