Hope for Women: Womed Unveils First Fertility Restoration Device Proven Effective in Randomized Clinical Trial
March 7, 2024Womed Leaf® reduces severe and moderate intrauterine adhesions, the primary mechanical cause for female infertility
MONTPELLIER, France–(BUSINESS WIRE)–#femtech–Womed, the women’s health company pioneering innovative, safe and effective treatments to free women from uterine pathologies, today announced that the results of the PREG2 clinical trial demonstrated Womed Leaf® is effective in the management of severe and moderate intrauterine adhesions (IUAs), the primary mechanical cause for female infertility. No device indicated for IUA prevention has been shown to be effective in this specific patient group. The PREG2 trial results were presented today by Prof. Jean-Louis Benifla, head of the ObGyn department at Lariboisière Hospital – APHP, Paris, France, during the Choix des Armes conference in Marseille, France.
IUA, which refers to the pathological binding of the uterine walls, is caused by poor scarring of the uterus after procedures such as dilation and curettage or fibroid removal, and can occur in 20% to 45% of those procedures. IUAs are a major cause of infertility, recurrent miscarriages and pain. IUA treatment, called adhesiolysis, consists of surgically cutting the adhesion, but the very high recurrence rate leaves women unsure and anxious about their chance to conceive.
Womed Leaf® is the first and only mechanical barrier to protect against IUA. It is composed of a soft film made from Womed’s proprietary polymer, which is inserted like an IUD at the end of the uterine procedure, expands into the entire cavity to prevent the direct contact of the uterine walls against each other for a week, and is naturally discharged afterwards.
PREG2 is an international, randomized clinical trial designed to measure Womed Leaf’s effectiveness. 160 women with severe or moderate IUA were randomly assigned to receive a Womed Leaf or not after adhesiolysis surgery. At the six week follow up visit, women who received Womed Leaf were 2.4 times more likely to have no adhesion than those in the control group. All other efficacy endpoints were also statistically favorable to Womed Leaf. From a safety perspective, there were no serious adverse events and no device related adverse events. Post-operative pain and discomfort from vaginal discharge were low and equally reported by patients in both groups. The details of the PREG2 trial will soon be published in a peer-reviewed journal.
“The results of this landmark study, rigorously conducted in several hospitals around the world, are great news for our patients,” said Prof. Herve Fernandez, Bicetre University Hospital – APHP, Paris, France and principal investigator of the study. “Womed Leaf, which protects the cavity during the healing phase, is breaking new ground and becomes, to the best of our knowledge, the first technology to achieve a proof of efficacy in this highly complex population.”
“Womed has achieved an unprecedented feat and we are very proud to be the first team to offer a solution to women with scarred uterus in their exhausting journey to become pregnant,” said Gonzague Issenmann, co-founder and CEO of Womed. “Womed Leaf, which is already registered in Europe and Brazil, will be marketed through commercial partners.”
About PREG2
PREG2 is a multi-center, double-blind, randomized, controlled, stratified, two-arm superiority clinical trial conducted in 16 centers in 7 countries. 160 patients scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate IUA were randomized after surgery to either have a Womed Leaf film inserted (treatment group) or not (control group). The reduction in IUA severity at six week follow up was significantly higher in the treatment compared to the control group (mean AFS score reduction 5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). Similarly, the responder rate was significantly higher in the treatment arm compared to controls (51% vs 29% OR 2.72 [CI 1.353 – 5.447]; p=0.0052). The absence of adhesions at follow up was significantly higher in the treatment group (41% vs 24% OR 2.44 [CI 1.161 – 5.116]; p=0.0189). None of the reported adverse events were considered related to the device. Post operative pain and discomfort from vaginal discharge was equivalent in both groups (17% vs 27% and 10% vs 10% respectively, in the treatment and control groups).
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, which occurs in particular in one in five women treated for miscarriage. Womed’s pipeline of intrauterine drug delivery products include treatments for fibroids, endometriosis and acute uterine bleeding.
Contacts
Press: Gonzague Issenmann, [email protected]