Pilot study evaluates safety and tolerability of implantable neuromodulation therapy for erectile dysfunction following radical prostatectomy
LAUSANNE, Switzerland, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Comphya SA, a clinical-stage MedTech company pioneering the first implantable neurostimulation therapy for erectile dysfunction (ED) unresponsive to medication, today announced that the first patient has been implanted with its CaverSTIM therapy in a U.S. pilot study at Johns Hopkins University School of Medicine. The study will enroll twenty (20) participants and is designed to evaluate the safety and tolerability of CaverSTIMTM long-term use, with early insights into patient satisfaction and effectiveness.
The single-site study, titled "Safety and tolerability of a novel implantable neurostimulator for the treatment of erectile dysfunction following radical prostatectomy," is led by Arthur Burnett, MD, MBA, and Christian Pavlovich, MD, both distinguished professors of Urology at Johns Hopkins University School of Medicine. The study is being conducted under an FDA-approved Investigational Device Exemption (IDE), announced by Comphya at the beginning of 2025. The study is enrolling men aged 30 to 75 years who are undergoing robotic-assisted radical prostatectomy for localized prostate cancer. Eligible participants must have normal erectile function prior to surgery. This population represents men aiming to preserve their sexual function following prostatectomy, a critical need, as recovery of erectile function after surgery is achieved in only a minority of patients and typically requires months to years.
"The first U.S. implantation of CaverSTIM marks a major step in our clinical development and a meaningful milestone for men facing the long-term impact of prostate cancer surgery," said Rodrigo Fraga-Silva, PhD, Co-Founder and Chief Operating Officer of Comphya. "We're now moving from promising early trials to broader validation in a market where the need is clear and the impact can be life-changing. We're grateful to the investigators leading this study for their close collaboration and shared commitment to advancing post-surgical recovery for prostate cancer patients."
CaverSTIM is the world's first implantable neuromodulation system in clinical development designed specifically to support erectile function after prostate cancer surgery. Radical prostatectomy, the gold-standard treatment for localized prostate cancer, often damages the nerves involved in erection, leaving up to an estimated 70% of men with erectile dysfunction. Implanted during the procedure, CaverSTIM targets those cavernous nerves and delivers subsensory electrical stimulation starting one week post-op. The system is designed to support penile recovery and promote nerve regeneration in the critical window after surgery, aiming to restore natural function without medications or additional procedures.
"Erectile dysfunction after prostate cancer surgery is both common and personally impactful," said Pim van Wesel, Chief Executive Officer of Comphya. "Our goal is to support erectile function right at the source-the nerve pathways affected during surgery-by implanting CaverSTIM at the time of radical prostatectomy. We believe this restorative approach can improve recovery in ways that go beyond clinical measures and genuinely impact men's health, their relationships, and overall quality of life."
The study is now enrolling patients undergoing radical prostatectomy who meet eligibility criteria. Men undergoing radical prostatectomy who wish to learn about emerging recovery approaches for ED may speak with their healthcare provider or consult verified clinical resources.
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 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 SA is a clinical-stage medical technology company based in Lausanne, Switzerland, developing CaverSTIM, the first implantable neurostimulator in clinical development designed to support natural sexual function by stimulating the cavernous nerves. The technology is intended for patients with nerve damage-related erectile dysfunction who are unlikely to respond to oral medications and currently have limited treatment options, excluding those with complete nerve damage. Comphya's mission is to improve men's well-being by addressing nerve-related erectile challenges with innovative urology technology.
For more information, visit www.comphya.com
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