In a recently published article in the International Journal of Gynecology & Obstetrics (IJGO), FEMSelect announced positive results for their EnPlace system. The research was presented during the 2023 International Urogynecology Association 48th Annual Meeting in The Hague, Netherlands. FEMSelect’s EnPlace system offers a new, minimally invasive technique for addressing pelvic organ prolapse without the need for extensive surgery or mesh.
The study titled The EnPlace® sacrospinous ligament fixation—A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results, focused on the safety and efficacy of the EnPlace system, a device cleared by the FDA for apical pelvic organ prolapse repair.
The study covered 123 consecutive female patients, aged between 42 to 84, who suffered from stage III and IV apical pelvic organ prolapse. These participants underwent a transvaginal sacrospinous ligament (SSL) fixation by EnPlace. The results were striking:
- Of the 91 patients with uterine prolapse, 83 (or 91.2%) experienced no recurrence during the six-month follow-up.
- Of the 32 patients with preoperative vault prolapse, 30 (or 93.6%) also experienced no recurrence.
Dr. Ronen Gold from the LIS Women’s Center Tel Aviv, Israel, who co-authored the study, presented these findings.
Karla Loken, DO, FACOOG, chief medical officer of FEMSelect, commented on the results, saying, “EnPlace is proven as safe and effective in women affected by pelvic organ prolapse, and it is ideal for those seeking a minimally invasive procedure.”
Professor Menahem Neuman, head of urogynecology at Raphael Hospital and Ben Gurion University, Beer Sheba, Israel, also emphasized the potential benefits. “These positive results demonstrate that EnPlace can be considered for patients needing apical pelvic organ prolapse repair,” he stated.
Furthermore, the study indicated that the EnPlace approach is especially beneficial for patients with other health concerns, such as contraindications to general anesthesia or high probabilities of adhesions in the abdominal cavity or pelvis.
FEMSelect raised $9M Series B funding co-led by New Age Ventures and TriVentures last fall. Other participants in the round included Robin Hood Ventures, Mid Atlantic Bio Angels (MABA), MEDA Angels, Keiretsu Forum Mid-Atlantic, RAD BioMed, Keiretsu Capital and Transpacific Venture Partners.