Description du projet
There are a wide variety of thermal treatment possibilities, one of them being radio frequency (RF) waves to introduce heat locally. For cutaneous Leishmaniasis (CL), a skin disease found in over 98 countries, such a treatment has been around for over 20 years. By reverse-engineering the only RF device widely used on the CL treatment market, we’ve built a prototype with the same functional principle. Through research and testing, shortcomings in the original device were rectified. By introducing a non-contact measurement method, we decrease the side-effects of the treatment while at the same time improving its controllability. Our unique selling proposition is a high-quality RF-treatment thanks to integrated temperature measurement at an affordable price. Benefiting from the partnership with the Drugs for Neglected Diseases initiative (DNDi), we plan to establish an initial business in the CL treatment market, where drug treatment with severe side effects has been prevalent. Valued at 31 million USD, it is a niche, yet global market still in its introduction phase. By lowering the cost of the device and improving patient safety the accessibility of the treatment method creates an alternative to drug treatment and improves the quality of life for millions of patients.
A Minimum Viable Product (MVP) has been developed based on detailed market research and customer needs. Our innovative solution can deliver 300 applications per battery charge, with a ±1°C accuracy in temperature adjustment.
A patent application has been lodged to safeguard our unique method of temperature delivery and control. Alongside this, an exhaustive industrialization roadmap is in place, ensuring alignment with essential technical and regulatory stipulations.
Our next strides involve identifying suitable manufacturing and regulatory partners. Upon finalizing our product's development, we anticipate securing regulatory approval through an FDA 510(k) submission, leveraging a predicate device.
We've initiated dialogue with an NGO active in the Americas and a medical procurement firm serving the African continent. These potential partnerships could serve as invaluable distributors and customers, expanding our reach.
In addition to the generous funding from the Gebert Rüf First Ventures program, we've been awarded the BRIDGE grant and have embarked on our seed financing round.
Personnes participant au projet
Dernière mise à jour de cette présentation du projet 03.08.2023