Women’s health tech company Womed has obtained CE mark for its fertility-preserving intrauterine device, Womed Leaf, for the treatment and prevention of bonding of the uterine walls after surgical intervention.
Womed Leaf is the first-ever mechanical barrier against intrauterine adhesion (IUA) and is composed of a soft film that shields the complete uterine cavity for a week.
After this, the device is discharged naturally and painlessly.
Womed Leaf was analysed during the first trial of the company’s PREG1 clinical programme, which enrolled 23 subjects who were scheduled to undergo hysteroscopic myomectomy.
Results from the clinical trial showed that Womed Leaf was safe and efficient in averting IUA in women with uterine fibroids undergoing hysteroscopic myomectomy.
Furthermore, device manipulation was under two minutes in all cases with the procedure termed to be easy by all operators.
None of the subjects experienced any injuries, reactions or adverse events linked to the device.
Womed Leaf caused zero to slight discomfort for patients and efficiently averted adhesion formation in 83% of women at six weeks.
IUAs occur following 20% to 45% of surgical procedures when the uterine walls attach together because of abnormal scarring.
It is a key cause of infertility and recurrent miscarriages, being responsible for one in five miscarriages, the company noted.
To prevent the formation of IUA, obstetrician-gynaecologists need to keep the uterine walls separated following an intrauterine procedure.
IUA treatment, with a relapse rate of 60%, leaves women concerned about their chances of conceiving.
Womed co-founder and executive chairman Gonzague Issenmann said: “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.
“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.”