Escala Medical Receives FDA Regulatory Clearance

Rhea-AI Summary

Escala Medical received FDA clearance for its first pelvic organ prolapse repair device following the successful completion of a one-year follow-up on a first-in-human clinical study involving 17 patients. This device offers a safe, incision-free repair option for women with pelvic organ prolapse, a condition affecting nearly 50% of women globally. Escala's procedure takes less than 10 minutes, enhancing the quality of life for women. Notably, Dr. Mickey Karram joined the Scientific Advisory Board, further strengthening Escala's market position.

Positive

• FDA clearance obtained for a pelvic organ prolapse repair device.
• Successful completion of one-year follow-up on first-in-human clinical study.
• Incision-free procedure performed in under 10 minutes, addressing a significant market need.

Negative

• None.

First in Human Clinical Study Completed

Internationally renowned urogynecologist and pelvic surgeon, Mickey Karram M.D. joins Scientific Advisory Board 

MISGAV, Israel, April 6, 2022 /PRNewswire/ -- Escala Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTC-QX: TRNLY), 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.

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."

About Escala 
Escala Medical, a FemTech company, was founded in November 2014 at the Trendlines Group Incubator in Israel and has been continuously supported by Incentive Programs of the Israel Innovation Authority and Ministry of Economics. Escala offers a new repair alternative for women with pelvic organ prolapse at all stages. Escala's innovative system has the potential to change the pelvic organ prolapse treatment paradigm, shifting point of care from the hospital to the doctor's office.

Contact Information
Edit Goldberg, CEO Escala
edit@escalamedical.com 
Phone +972-54-4545-276

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SOURCE The Trendlines Group Ltd.

FAQ

What did Escala Medical announce on April 6, 2022?

Escala Medical announced FDA clearance for its first pelvic organ prolapse repair device.

What is the significance of the completed clinical study for Escala Medical?

The completed clinical study validated the safety and efficacy of the pelvic organ prolapse repair device.

What medical condition does Escala's new device address?

The device addresses pelvic organ prolapse, a condition affecting nearly 50% of women worldwide.

How quick is the procedure using Escala Medical's device?

The procedure takes less than 10 minutes to perform.

Who joined Escala Medical's Scientific Advisory Board?

Dr. Mickey Karram, an internationally recognized urogynecologist, joined the board.