Comphya receives approval for first pilot clinical trial in Australia
02 March 2023
Lausanne, Switzerland, March 2nd, 2023. Comphya SA, developer of the first neuromodulator to treat erectile dysfunction (ED), announced today that Australian regulatory authorities (Human Research Ethics Committees (HREC) and Therapeutic Goods Administration (TGA)) have approved the pilot clinical trial for CaverSTIM in patients undergoing prostatectomy.
This will be the first long-term implantation clinical trial of CaverSTIM, and 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.
“We are pleased to have completed all preparations and will soon initiate this first-in-human trial to assess efficacy of Comphya’s unique solution”, stated Fiona Joseph (Head of Clinical Affairs).
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 post-prostatectomy 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. The IPG is implanted subcutaneously in the lower abdomen and it is remotely operated by external controllers. The clinician controller allows the medical expert to adjust and tailor the system parameters to best fit each patient; and the patient controller, allows the patient to activate the device on-demand to evoke penile erection for the treatment.
About Comphya SA
Comphya is a medical device company based in Lausanne, Switzerland, developing CaverSTIM, the first implantable device to restore erectile function in patients non-responsive to oral drugs. Today, these patients resort to intrapenile injections or penile implants, which are the only available yet painful, problematic and outdated therapies. Comphya’s patented solution offers a unique and superior treatment for erectile dysfunction. The company’s goal is to offer physiological sexual function and quality of life to large parts of the male population in great need.
For more information, visit www.comphya.com.
Rodrigo Fraga-Silva, PhD
CEO & Co-founder