PORTEFEUILLE

Regenosca's TissueSpan technology creates unique bio-implants designed to promote seamless tissue healing. While not living tissue, TissueSpan implants are engineered to actively attract and organize the patient’s own cells upon implantation, triggering the body’s natural regenerative processes.
Although there are numerous potential applications, Regenosca’s initial target market is urology, with urethral stricture (narrowing of the urethra) as the first clinical indication. Urethral stricture affects up to one million patients annually in the US. The current gold-standard treatment involves open surgery and harvesting the patient's own inner mouth tissue for grafting. However, simpler endoscopic treatments have failure rates of up to 80%. Regenosca has already conducted human trials, demonstrating perfect regrowth of the patient’s own tissue..
The objective of this project was to assess the biocompatibility of TissueSpan implants, including sterility and endotoxin testing in accordance with ISO 10993, and to gather customer feedback on their suitability for clinical applications. Further objectives included transforming a research process into a GMP-compliant manufacturing process, enabling the production of clinical-grade implants for a First-in-Human study, and demonstrating the platform potential by collecting data on bladder repair using TissueSpan implants.

With the support of the Gebert Rüf Stiftung, we successfully produced clinical-grade TissueSpan implants, which were used in a First-in-Human study and for preclinical testing in accordance with regulatory standards. A total of five urethral stricture patients underwent surgery, with TissueSpan implants used as an alternative to the patient's own inner mouth tissue, thereby reducing pain and surgery time.
The Innobooster project was executed in collaboration with the Urology Department at CHUV, who are eager to explore the use of TissueSpan implants for bladder reconstruction. Together with Regenosca’s team, they conducted a bladder implantation study in pigs to assess the capacity of TissueSpan implants to regenerate bladder tissue. A publication detailing the promising results is currently in preparation.
Regenosca continues to pave the way toward first market approval, aiming to make TissueSpan available to more surgeons and patients.
In addition to the financial support from the Gebert Rüf Foundation, Regenosca received funding from Innosuisse, the Canton of Vaud, and successfully closed a pre-seed round raising CHF 1 million.