The first non-surgical repair for Pelvic Organ Prolapse

Project Information

apyx

Grant agreement ID: 190143220

DOI

10.3030/190143220

Project closed

EC signature date 20 November 2023

Start date 1 October 2023

End date 30 September 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 5 067 216,25

EU contribution

€ 2 500 000,00

Coordinated by

ESCALA MEDICAL LTD
Israel

Periodic Reporting for period 2 - apyx (The first non-surgical repair for Pelvic Organ Prolapse)

Reporting period: 2024-10-01 to 2025-09-30

Summary of the context and overall objectives of the project

Pelvic organ prolapse (POP) is a prevalent medical condition affecting women worldwide. POP occurs when pelvic organs (bladder, uterus, vagina or rectum) descend from their normal position, causing a range of symptoms including urinary incontinence, bowel dysfunction, and pelvic pain. This condition significantly impacts women's quality of life, affecting physical, psychological, and social well-being.
Escala's Mendit device represents a paradigm shift in POP treatment. It is an innovative, incision-free repair solution designed to address the unique challenges of treating POP.
Key features of the Mendit device:
o Incision-free repair method replacing the repair surgery offered to 10% of the patients at advanced stages of the condition
o Minimally invasive procedure that can be performed under local anesthesia in the doctor’s office
o Quick recovery time
o Cost-effective compared to traditional surgical options

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Mendit (formerly Apyx) is a FDA cleared device that allows women to restore pelvic floor function and regain their quality of life immediately. EIC project allowed the development, validation, and clinical testing of the design leading to a successful chance at commercial uptake in EU. Apart from this, the project allowed Escala Medical to:
1. Build strong visibility and engagement with stakeholders (via communication and dissemination activities).
2. Secure robust intellectual property protection, now including an allowed European patent that underpins regulatory and commercial expansion.
3. Deliver commercial traction and investor confidence, with rapid U.S. adoption and financial runway secured until 2027.
4. Advanced regulatory pathways with FDA clearances and CE marks on track for Q1 2026.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Escala's Impact Strategy
1. Impact Objective

Escala aims to significantly improve the health and quality of life of women suffering from POP while generating competitive financial returns. The Mendit device is positioned to transform lives in developed as well as underserved communities where surgical options are limited or unavailable.
2. Key Impact Areas
o Increasing access to POP treatment
o Improving quality of life for women with POP
o Reducing social stigma associated with POP
o Empowering healthcare providers
3. Impact Targets for 2025-2030
o Treat thousands of women with POP using the Mendit device
o Establish partnerships with providers and distributors in target markets
o Train local healthcare providers on using the Mendit device
o Reduce average treatment costs for POP by over 50% compared to surgical options
o Substantially increase the availability of an incision-free prolapse repair option to populations in need
o Achieve a high patient satisfaction rate
4. Strategy to Achieve Impact
o Market Expansion: Leverage the established distribution agreement with the Singapore-based distributor to expand access in South East Asia. Establish distribution agreement with Europen distributors to commercialize the optimized Mendit device once CE mark is receievd. These strategic partnerships will help Escala navigate local regulatory and reimbursement environments and establish a presence in key markets.
o Pricing: Develop a tiered pricing strategy and model to ensure affordability in different markets. This approach recognizes the varying economic conditions and aims to make the Mendit device accessible to a broader range of patients.
o Awareness and Education: Partner with local NGOs and women's health organizations to raise awareness about POP and available treatments. This will help address the stigma associated with POP and encourage more women to seek treatment.
o Healthcare Provider Training: Implement training programs for local healthcare providers on using the Mendit device. This will build local capacity and ensure the sustainable delivery of POP treatment in target communities.
o Research: Conduct market research to quantify quality of life improvements and cost savings associated with the use of the Mendit device. This data will be crucial in demonstrating the device's value to healthcare systems and potential partners.
5. Measuring and Reporting Impact
Escala is committed to rigorous impact measurement and transparent reporting:
o Track the number of procedures performed, broken down by country and demographic data
o Conduct patient surveys to assess quality of life improvements and satisfaction
o Monitor training program participation and skills development of local providers and distribution partners
o Calculate cost savings compared to traditional surgical options
o Publish impact reports detailing progress towards targets and showcasing patient case studies

6. Balancing Impact and Financial Returns
Escala's strategy is designed to create both significant social impact and competitive financial returns. By addressing the large unmet need for POP treatment, Escala aims to:
o Expand its addressable market
o Build strong brand loyalty in target markets
o Create long-term value for all stakeholders
The company believes that by improving women's health outcomes, it can create a large and sustainable market that delivers both social impact and financial success

Apyx Device