Escala Medical raises US$4.5m for prolapse device

Escala Medical has secured US$4.5m in Series A funding to expand use of its FDA-cleared device for pelvic organ prolapse, bringing total funding to over US$8m.

Proceeds from the funding round will support commercial expansion in the US, market entry in Europe following anticipated CE mark approval in 2026, and rollout in Southeast Asia via a newly signed distribution agreement with a Singapore-based partner.

The Mendit device offers a non-surgical, office-based treatment for pelvic organ prolapse (POP) – where pelvic organs drop from their usual position – a condition affecting nearly 50 per cent of women over 40.

FDA clearance was granted in April 2023. Since then, the device has been used in over 500 procedures. Commercial launch in the US began in October 2023 and it is now approved in 48 hospitals, including several major health systems.

Dr Edit Goldberg, chief executive of Escala, said: “This funding marks an important milestone as we continue to scale our operations and bring our breakthrough technology to more women worldwide.

“We’re proud to have the support of the EIB and our private investors, and we remain committed to advancing the next generation of our Mendit device to improve outcomes and expand access to millions of women worldwide who suffer from organ prolapse.”

The round was co-financed by the European Innovation Council (EIC) Fund, following a €2.5m grant awarded to Escala in October 2023 through its Accelerator programme.

Private investors from the US and Israel also took part.

Previous backers include The Trendlines Group, UK-based Consensus Business Group (CBG), and other private investors.

Escala was founded in 2014 by pelvic surgeons Dr Roger Goldberg and Professor Douglas Scherr to address what they identified as a major treatment gap.

While nearly 50 per cent of women over 40 experience POP, only around 10 per cent undergo surgery due to risk and recovery concerns.

Goldberg said: “The device offers a minimally invasive, office-based alternative to traditional surgery, combining surgical-grade effectiveness with unmatched versatility.

“As the first truly minimally invasive, reversible anchor-based system, Mendit opens the door to treatment for the 90 per cent of women who currently go without care.”

The global POP treatment market is valued at over US$7bn, with more than 8 million women seeking care annually in the US and Europe.

Procedures are typically carried out by gynaecologists, urogynaecologists and urologists in hospitals, ambulatory surgery centres and private clinics.

Competing products include suture passers and other anchor-based systems such as EnPlace, AnchorSure and Saffron.

Goldberg said these require incisions and operating rooms, while Mendit offers incision-free, reversible repair in an office setting.