Escala Medical receives FDA regulatory clearance

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

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.

Mickey Karram M.D. joins Escala Scientific Advisory Board

Mickey Karram M.D. joins Escala Scientific Advisory Board

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.

Escala CEO Edit Goldberg remarked,

Receiving FDA clearance for our first prolapse repair device, in addition to the recent completion of one-year follow up on our FIH clinical study, is an exciting achievement for us. Our device addresses a long overdue need in pelvic organ prolapse repair, allowing treatment at early stages and improving the quality of life of women around the world. We are also very happy to welcome Dr. Mickey Karram, an internationally renowned urogynecologist and pelvic surgeon, to our Scientific Advisory Board. These three events position us well as we introduce our device in the US market.

 

Dr. Robert Auerbach, Chairman of the Escala BOD added:

Escala’s achievements in the emerging FemTech market makes us very proud. We look forward to providing patients suffering from pelvic organ prolapse with a durable treatment that can be performed in an incisionless manner and improve their quality of life.