PORTEFEUILLE

In the US and Europe, around 171 000 patients undergo each year a urinary tract reconstruction including urethral reconstruction due to urethral stricture or hypospadias and urinary diversion in the case of complete bladder removal. The gold standard for urinary tract reconstruction is the use of patient’s own tissue grafts. In the case of urethral stricture inner mouth tissue is used for reconstruction causing complications such as pain, restricted mouth opening, scar formation, and loss of sensation. The harvesting of intestinal tissue for the creation of a urinary diversion in metabolic disorders, intestinal obstruction, stone formation, and in rare cases cancer.
The use of patient’s own tissue grafts causes additional discomfort to the patient. A healthy organ is harmed during tissue harvesting, thus, increasing the level of pain, the risk of complications, and the recovery time after operation. Complications may occur at the harvesting site as well as at the implantation site where a tissue-mismatch is created. The intestinal tissue placed within the urinary tract retains its native function of secreting or reabsorbing salt and water causing a multitude of metabolic disorders. The use of patient’s own tissue patches results in longer operation times, might necessitate the presence of specialized surgeons for tissue harvesting and longer hospital stays. Additionally, it creates a challenge for the surgeons. The tissue quality and the available quantities vary from one patient to the other
Regenosca’s technology platform was developed at EPFL in collaboration with the CHUV and Neutromedics AG as industrial partner and allows producing bioengineered collagen implants suitable for surgical applications. The bioengineered collagen implants were successfully used in preclinical studies to reconstruct the bladder and the urethra with the surprising result of tissue regeneration at the implantation site. This bioengineered collagen implant may present a patient friendly alternative to patient’s own tissue patches for urinary tract 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 bioengineered collagen implant preclinical setting asked for by regulation with the support of the department of urology at CHUV. This includes testing its biocompatibility following ISO-10993, and its usability in order to validate it for clinical investigations.

Regenosca was founded in January 2019 with the aim to bring its bioengineered collagen implant as a class III medical device on the market for urinary tract reconstruction. We have successfully finalized our preclinical studies demonstrating tissue regeneration and functional outcome in several animal models and translated the research prototype to a GMP-grade prototype. The GMP-grade prototype is used for a first-in-man study conducted at the University of Malaya Medical Center (NCT05463991) and for biocompatibility studies according to regulation. The first two urethral stricture patients were successfully operated in August 2022. Intraoperatively both urologists operating had no concerns with the handling and the suturing of the implant. Catheters were removed 3-5 weeks post-surgery and no leakage was observed at the implantation site. The implant was well accepted by the patient’s body. No rejection of the implant was observed post-surgery. Since 6 months now, the patients are voiding without any complications and pain.
Regenosca obtained financial support from the Canton de Vaud, Venture Kick, private investors, and the Gebert Rüf foundation.
We have successfully completed the first phase of the InnoBooster project and met the objectives of a biological risk assessment report, surgeons’ usability testing of the GMP-grade prototype, confirmed sterility of the prototype as well no in vitro cytotoxicity. Further testing with certified service providers is ongoing.