Comphya SA Completes First-Phase Implantation Group of Pilot Post-Prostatectomy Trial in Melbourne, Australia.
17 December 2024
PRESS RELEASE
Lausanne, Switzerland, December 17, 2024 – Comphya SA, a pioneering medical technology company and the developer of CaverSTIM, the first implantable neuromodulator designed to treat erectile dysfunction, is pleased to announce that the 10th case implantation has been successfully completed in the clinical trial in Melbourne, Australia. This milestone marks the completion of the implantation group in the first phase of our pilot study evaluating CaverSTIM for treating erectile dysfunction in post-prostatectomy patients.
Erectile dysfunction, formally known as male impotence, is a significant burden for prostate cancer patients, greatly impacting their quality-of-life following prostatectomy surgery. Comphya’s innovative approach aims to restore erectile function through neurostimulation. The clinical trial is progressing exceptionally well, yielding highly promising results. We have observed significant improvements in erectile function post-prostatectomy, which have exceeded our expectations.
“This achievement is a key milestone in our journey to revolutionize the treatment of erectile dysfunction. Completing this first phase of the study underscores the exceptional progress driven by our dedicated team at Comphya. I would also like to extend my deepest gratitude to the esteemed investigators in Australia, led by Dr. Costello and Dr. Dundee, for their outstanding efforts and collaboration. Together, we are paving the way for a superior solution to alleviate the burden of erectile dysfunction for patients worldwide,” said Rodrigo Fraga, CEO.
Nikos Stergiopulos, Comphya’s CSO, emphasized the importance of this milestone: “The completion of the first-phase is a significant accomplishment for the development of CaverSTIM. The preliminary data demonstrate the strong potential of our device to restore erectile function in post-prostatectomy patients. The insights we have gained are scientifically profound, and I am deeply grateful for the collaborative efforts of our team and the exceptional work by our clinical partners in Australia. This innovation holds great promise to benefit prostate cancer patients.”
As we celebrate this major step forward, Comphya remains committed to advancing the clinical development of CaverSTIM to deliver superior solutions for patients undergoing prostatectomy. We look forward to sharing more updates as the trial progresses.
For more information, please visit www.comphya.com
About CaverSTIM
CaverSTIM is the first implantable neurostimulator designed to restore erectile function. This innovative technology is primarily intended for patients who are non-responders to oral medications, such as spinal cord-injured patients and post-prostatectomy patients. CaverSTIM is a neurostimulation system composed of an implantable pulse generator (IPG) containing a rechargeable battery and electronics responsible for generating the electrostimulation signal. It is connected to an array of two electrodes (with multiple individual electrodes) to be implanted in the pelvic cavity, where they will activate and restore the nerves responsible for penile erection. The IPG is implanted subcutaneously in the lower abdomen and is remotely operated by external controllers. The clinician controller allows the medical expert to adjust and tailor the system parameters to best suit each patient. The patient controller enables the patient to activate the device and deliver electrical stimulation to the cavernous nerves with the aim of restoring their function.
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, 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.
The pilot clinical trial in Melbourne, Australia, is sponsored by Comphya Australia PTY LTD, a subsidiary of Comphya SA.
For more information, visit www.comphya.com
Contact
Comphya SA
Rodrigo Fraga-Silva, PhD
CEO & co-founder
Rodrigo.Fraga@comphya.com