Comphya SA Commences Recruitment for Pilot Clinical Study in Prostatectomy Patients
05 June 2023
PRESS RELEASE
Lausanne, Switzerland, June 5th, 2023 – Comphya SA and the Australian Prostate Centre (APC) to announce the initiation of a pioneering pilot clinical trial to be conducted through the APC. The pilot clinical trial will investigate the CaverSTIM system, the first neurostimulator designed to treat erectile dysfunction (ED). The trial has already received necessary approvals from the Human Research Ethics Committees (HREC) and Therapeutic Goods Administration (TGA), making Australia part of an international clinical development program, joining the United States, France, and Brazil.
The CaverSTIM trial, spearheaded by renowned urologists Prof. Tony Costello and Dr. Philip Dundee, will assess this novel ED treatment’s safety and preliminary efficacy. The procedure involves the long-term implantation of Comphya’s innovative CaverSTIM device through robotic-assisted laparoscopic surgery, into patients who are undergoing prostatectomy.
“Our team has worked tirelessly to bring the CaverSTIM system to this stage, and we are delighted to initiate this new phase of clinical trials with the brilliant clinical team at the Australian Prostate Centre,” said Rodrigo Fraga-Silva, Ph.D., Comphya’s Chief Executive Officer.
“We are thrilled to be leading this modern initiative. This first-in-human trial of the CaverSTIM system in Australia marks a milestone in the journey towards better solutions for ED,” stated Dr. Philip Dundee, Clinical Director at the Australian Prostate Centre.
Through state-of-the-art facilities and a multidisciplinary approach, the Australian Prostate Centre, a leading institution specializing in prostate-related conditions, aims to enhance patient outcomes and quality of life while evaluating the efficacy of cutting-edge treatments. Comphya has partnered with APC to launch this groundbreaking pilot study for erectile dysfunction treatment utilizing Comphya’s novel CaverSTIM system.
About CaverSTIM
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.
Contact
Comphya SA
Rodrigo Fraga-Silva, PhD
CEO & Co-founder
Image by Drazen Zigic on Freepik