Comphya receives approval for first long-term implantation clinical trial

Comphya SA, developer of the first neuromodulator to treat erectile dysfunction (ED), recently announced that Australian regulatory authorities (Human Research Ethics Committees (HREC) and Therapeutic Goods Administration (TGA)) have approved the pilot clinical trial for CaverSTIM. The trial is part of a clinical development program including other pilot clinical trials in United States, France and Brazil. The pilot clinical trial in Australia will assess the safety and preliminary efficacy of the CaverSTIM system. The implantation will be performed by minimally invasive robotic-assisted laparoscopic surgery at the Royal Melbourne Hospital, Victoria, Australia.

Rodrigo Fraga-Silva, CEO and co-founder of Comphya commented “I’m excited to start this new phase of clinical activities. Comphya’s team did excellent work and we’re very happy to work with the brilliant clinical team in Australia, led by Dr. Tony Costello and Dr. Philip Dundee”.

CaverSTIM is the first implantable neurostimulator to restore erectile function. This new technology is primarily intended for patients that are non-responders to oral drugs such as spinal cord injured patients or postprostatectomy patients. CaverSTIM is a neurostimulation system composed of an implantable pulse generator (IPG), containing the rechargeable battery and electronics responsible for the generation of the electrostimulation signal; and connected to two electrodes array (with several electrodes) to be implanted in the pelvic cavity and which will activate and restore the nerves responsible for penile erection.

(Press release / SK)