Periodic Reporting for period 1 - apyx (The first non-surgical repair for Pelvic Organ Prolapse)
Okres sprawozdawczy: 2023-10-01 do 2024-09-30
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
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
Mendit (formerly Apyx) is a FDA cleared device and commerically availabel in the USA. We are optimizing Mendit to address market needs prior to commercialization in Europe. Currently the Mendit device incorporates a stainless steel securement element and an anchor retrieval tool that can be used during the index procedure. We have optimized the design of both the securement element (“button”) and the retriever. The Key achievements include production of the redesigned, releasable, securement element (button) that may be removed without cutting the sutures holding it in place to allow the universal retriever withdraw the anchor during or after the repair procedure while the sutures are still intact. Initially the releasable button was designed to composed of stainless steel and silicon and is further optimized to compose entirely of a resorbable material.
Following the optimization of the Apyx design, we have made progress in the manufacturing process of the optimized design for both the securement element ("button") and the retriever. The redesigned releasable button has been produced and tested. It was developed to allow the universal retriever to withdraw the anchor during or after the repair procedure while the sutures remain intact. This redesigned button serves as the interim component for the biocompatible resorbable button, for which the first injected samples will be available by October 2024.
The new button was designed to meet the device's intended use while making minimal dimensional and mechanical changes that would not pose clinical or regulatory risks.
Following the optimization of the Apyx design, we have made progress in the manufacturing process of the optimized design for both the securement element ("button") and the retriever. The redesigned releasable button has been produced and tested. It was developed to allow the universal retriever to withdraw the anchor during or after the repair procedure while the sutures remain intact. This redesigned button serves as the interim component for the biocompatible resorbable button, for which the first injected samples will be available by October 2024.
The new button was designed to meet the device's intended use while making minimal dimensional and mechanical changes that would not pose clinical or regulatory risks.
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
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