Escala Medical receives FDA regulatory clearance

Escala Medical, a portfolio company of The Trendlines Group, announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its first pelvic organ prolapse repair device. This clearance is concurrent with the successful completion of the one-year follow up on the first-in-human (“FIH”) clinical study performed at Rambam Health Care Campus, Haifa, Israel, on 17 patients.

Pelvic Organ Prolapse (POP) is a highly prevalent debilitating condition in women’s health. It affects nearly 50% of women worldwide and occurs when one or more of the organs in the pelvis slips down from its normal position. Current repair alternatives available for women with POP are invasive, and therefore intended for women at advanced stages of prolapse. For symptomatic women at early stages of prolapse or women who are not surgical candidates, there currently is no incision-free repair solution. Escala is changing this.

Escala addresses a huge market need, offering a repair alternative that is safe and easy for the clinician to perform. In Escala’s FIH clinical study, POP repair was performed with an incision-free procedure completed in under 10 minutes.

News of  this development appeared in Bioworld, Yahoo Finance and PRNewswire