World first medical device implantation to restore erectile function - Media Release

A world first implantation of a high-tech, battery-powered device to restore erectile function, has taken place at the Royal Melbourne Hospital (RMH) leading a global trial. CaverSTIM is the first implantable ‘neurostimulator’ for erectile dysfunction treatment, designed for patients that are non-responders to oral drugs, including spinal cord-injured patients and post-prostatectomy patients.

Consulting Urologist at the RMH and Clinical Director at the Australian Prostate Centre (APC), Dr Phil Dundee conducted the successful operation on August 3rd. The first-in-human clinical safety trial for the ground-breaking treatment is a collaboration between the APC, the RMH and Swiss MedTech company Comphya SA.

CaverSTIM is a ‘neurostimulation’ system composed of an implantable pulse generator (IPG), containing rechargeable battery and electronics for the generation of an electrostimulation signal; implanted in the pelvic cavity to activate and restore the nerves responsible for penile erection. The IPG once surgically inserted in the lower abdomen, 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 and evoke a penile erection.

“It's truly exciting to be part of such innovation particularly when we know this treatment has the potential to be life-changing for millions of patients world-wide,” said Dr. Phil Dundee.

“Our collaboration with Comphya exemplifies our shared commitment to delivering cutting-edge healthcare solutions like the CaverSTIM device."

“At the Australian Prostate Centre we see first-hand the ongoing difficulties patients face post prostatectomy,” said prostate cancer care specialist nurse Helen Crowe AM, who has led patient recruitment, counselling, and post-rehabilitation for the trial.

“We are thrilled to be involved in trialing a solution which offers real hope to these patients.”

"As we initiate this clinical trial, we celebrate the culmination of our team's steadfast dedication and hard work in developing our unique CaverSTIM system," said Rodrigo Fraga-Silva, CEO and Co-founder of Comphya SA.

BACKGROUND

Australian Prostate Centre

The Australian Prostate Centre is a distinguished non-profit organisation based in Melbourne, Australia. With an unwavering commitment to excellence, the Centre is dedicated to delivering the highest quality healthcare services to prostate cancer patients. Recognising the unique challenges and needs faced by individuals who have undergone prostate surgery, the Centre's exceptional team of medical professionals, researchers, and support staff are driven by a shared mission to provide comprehensive care, innovative treatments, and unwavering support throughout each patient's journey. The APC focus is on empowering patients with the necessary resources and expertise to achieve optimal health and well-being. In addition, through vital research and collaborations with leading institutions, the Centre actively advances the field of prostate healthcare.

The Royal Melbourne Hospital

The Royal Melbourne Hospital is a renowned centre of medical excellence in Melbourne, Australia. With a rich history and a commitment to exceptional care, the RMH leads in patient care, research, and education. Through cutting-edge technology, compassionate staff, and community engagement, RMH sets the standard for quality, safety, and accessibility in healthcare, making a lasting impact on countless lives.

Comphya SA

Comphya is a medical device company based in 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.

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