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This project, funded by Gebert Rüf Stiftung, is supported by the following project partners: Urology Department at CHUV; Regenosca SA
Données de projet
Numéro du projet: GRS-073/20
Subside accordé: CHF 146'000
Durée: 07.2021 - 09.2022
InnoBooster, seit 2018
Direction du projet
PhD Eva-Maria Balet, COO
Avenue de Sévelin 13C
1004 Lausanne (Schweiz)
Description du projet
In the US and Europe, around 77 000 patients undergo each year a major bladder surgery with the complete removal of the bladder and a life-long use of urostomy bags, having a huge negative impact on their quality of life. Therefore, in some non-oncological cases, the surgeons preserve the bladder and only remove the diseased bladder tissue. However, a bladder augmentation is required to guarantee well-performing urine storage. The gold standard for bladder augmentation is the use of patient’s own intestine tissue, adding an additional risk of postoperative complications mainly due to the intestine recovery and the mismatch between the bladder tissue and the intestine tissue patch.
Regenosca’s technology platform was developed at EPFL in collaboration with the CHUV and Neutromedics AG as industrial partner and allows producing engineered collagen implants suitable for surgical applications. The engineered collagen implant was successfully used in preclinical studies to reconstruct the bladder and the urethra with the surprising result of tissue regeneration at the implantation site. This engineered collagen implant may present a patientfriendly alternative to intestine patch for bladder reconstruction since it does not create additional harm to the patient’s body and provides a potential curative therapy due to functional tissue regeneration.
The aim of this project is to complete our engineered collagen implant preclinical setting asked for by regulation with the support of the department of urology at CHUV. This includes testing its biocompatibility, shelf-life assessment, and usability in order to validate it for clinical investigation.
Quelles sont les particularités de ce projet?
Regenosca's engineered collagen implant was develpped in close collaboration with urologists and fullfills all the medical requirements: off-the-shelf available, ready-to-use, and easy to suture to the bladder wall. The use of Regenosca's implant would turn the today's challenging procedure of bladder reconstruction in a less complex and shorter operation where no additional harm would be added to the patient's body. No need of harvesting intestinal tissue decreases the risk of complications and promisses a faster recovery time.
Regenosca was founded in January 2019 with the aim to bring its engineered collagen implant as a class III medical device on the market for pediatric and adult bladder reconstruction. We have successfully finalized our preclinical studies demonstrating tissue regeneration and functional outcome in several animal models. Our preclinical data convinced the University of Malaya Medical Center to approve a first-in-man safety study where the implant will be used in five patients. We are currently preparing the GMP manufacturing of our prototype that will demonstrate safety in a first-in-man study and biocompatibiliy according to regulations.
Regenosca obtained financial support from the Canton de Vaud, Venture Kick and the Gebert Rüf foundation.
The InnoBooster project allows us to perform the biocompatibility studies that are an essential part of the application dossier to Swissmedic and European authorities to apply for clinical trials in Switzerland and in Europe.
Larsson HM et al., "Fiber desnity of collagen grafts impacts rabbit urethral regeneration", Sci Rep 2018
Pinnagoda K et al,. "Engineered acellular collagen scaffold for endogenous cell guidance, a novel aproach in urethral regeneration"Acta Biomater 2016
Revue de presse
L'implant de Regenosca plus doux pour la vessie, publié 15 juin dans AGEFI
Personnes participant au projet
Dernière mise à jour de cette présentation du projet 26.04.2021