Comphya Secures CHF 7.5M for Groundbreaking ED Device, Accelerates U.S. Trials
July 14, 2025, 3:38 pm
Location: United States, Maryland, Baltimore
Employees: 10001+
Founded date: 1996
Comphya, a trailblazing Swiss MedTech firm, closed its CHF 7.5 million Series A funding. This capital propels CaverSTIM, their groundbreaking implantable neuromodulator. CaverSTIM restores erectile function, targeting men post-prostatectomy or unresponsive to oral medications. Early clinical trials in Australia show strong safety and efficacy. Patients maintained function without additional therapies. These positive results underpin an expanded Australian study and a new U.S. pilot study at Johns Hopkins. FDA approval already secures the U.S. pathway. A pivotal U.S. clinical trial is set for 2026. This funding revolutionizes ED treatment, offering a viable alternative to painful, outdated options. The company fills a critical unmet need in men's health. New CEO Pim van Wesel leads strategic growth. A Series B round will fund the pivotal U.S. trial. Comphya's innovation offers significant hope.
Comphya’s recent Series A funding round represents a pivotal moment. The company secured CHF 7.5 million. This total includes convertible loan conversions. It adds to the CHF 4.35 million raised earlier this year. This substantial capital infusion fuels the development of CaverSTIM. CaverSTIM is an innovative implantable neuromodulator. It promises a new era in erectile dysfunction (ED) therapy. The funding accelerates critical clinical trials in both Australia and the United States. Comphya seeks to address a profound unmet medical need.
CaverSTIM specifically targets patients unresponsive to conventional ED medications. This includes a significant population: men recovering from prostate surgery. Prostatectomy often leads to erectile dysfunction. Current therapeutic options are limited. They are often painful or ineffective. Comphya’s device offers a novel, physiological approach. It aims to restore natural function. This contrasts sharply with existing problematic solutions.
Clinical progress fuels Comphya’s momentum. An ongoing first-in-human clinical trial in Australia demonstrates promising results. Patients in this study received CaverSTIM implants during robotic-assisted prostatectomy procedures. Data presented at the 2025 American Urological Association (AUA) Annual Meeting highlighted key successes. A large majority of participants maintained good erectile function postoperatively. They required no additional therapies. No infections or adverse events occurred. These early outcomes underscore CaverSTIM’s potential. The device could fill a major gap in post-prostatectomy care.
The new funding expands the Australian study. It allows recruitment of additional patients. Crucially, it initiates a U.S. pilot study. This U.S. trial commenced at Johns Hopkins. It followed a crucial FDA Investigational Device Exemption (IDE) approval. This approval was announced in January 2025. The U.S. pilot study builds on the strong Australian data. Combined insights from both regions will guide future development. These efforts lay the groundwork for a pivotal U.S. clinical trial. This large-scale trial is slated for 2026.
CaverSTIM’s technology is sophisticated. It is a neurostimulation system. It features an implantable pulse generator (IPG). The IPG contains a rechargeable battery. It houses electronics that generate electrostimulation signals. This generator connects to an array of electrodes. These electrodes are implanted in the pelvic cavity. They specifically activate and restore the nerves responsible for penile erection. The IPG itself is implanted subcutaneously in the lower abdomen. External controllers operate the device remotely. A clinician controller allows medical experts to tailor parameters for each patient. A patient controller enables individuals to activate the device. This delivers electrical stimulation directly to the cavernous nerves. The goal is to restore their natural function.
Comphya addresses a substantial market deficiency. Patients currently face stark choices. Intrapenile injections offer one option. Penile implants provide another. Both are considered painful, problematic, and outdated. They fail to restore physiological sexual function. Comphya aims to transform this landscape. The company seeks to offer improved quality of life to millions of men. Its neurostimulator system is reportedly the first implantable therapy designed to restore natural erectile function through nerve stimulation. This innovation offers significant hope where current options fall short.
Leadership changes coincide with this funding round. Pim van Wesel was appointed CEO in May 2025. Van Wesel is an industry veteran. He now guides Comphya’s clinical and strategic development. His leadership will steer the company through its next stage of growth. Comphya has garnered previous recognition. It won Venture Kick. It participated in Venture Leaders Life Sciences. The company also ranked among the TOP 100 Swiss Startups. These accolades underscore its innovative spirit and potential.
The company envisions a transformative solution. It seeks to bring a new standard of care to men living with erectile dysfunction. Especially those impacted by prostate cancer treatment. Preparations for the pivotal U.S. clinical trial are underway. This includes critical regulatory and operational groundwork. A forthcoming Series B round will fund the execution of this pivotal trial. Comphya’s advancements represent a significant stride in MedTech. They promise a future where men’s health challenges are met with cutting-edge, effective therapies. The focus remains clear: delivering a transformative solution.
Comphya’s recent Series A funding round represents a pivotal moment. The company secured CHF 7.5 million. This total includes convertible loan conversions. It adds to the CHF 4.35 million raised earlier this year. This substantial capital infusion fuels the development of CaverSTIM. CaverSTIM is an innovative implantable neuromodulator. It promises a new era in erectile dysfunction (ED) therapy. The funding accelerates critical clinical trials in both Australia and the United States. Comphya seeks to address a profound unmet medical need.
CaverSTIM specifically targets patients unresponsive to conventional ED medications. This includes a significant population: men recovering from prostate surgery. Prostatectomy often leads to erectile dysfunction. Current therapeutic options are limited. They are often painful or ineffective. Comphya’s device offers a novel, physiological approach. It aims to restore natural function. This contrasts sharply with existing problematic solutions.
Clinical progress fuels Comphya’s momentum. An ongoing first-in-human clinical trial in Australia demonstrates promising results. Patients in this study received CaverSTIM implants during robotic-assisted prostatectomy procedures. Data presented at the 2025 American Urological Association (AUA) Annual Meeting highlighted key successes. A large majority of participants maintained good erectile function postoperatively. They required no additional therapies. No infections or adverse events occurred. These early outcomes underscore CaverSTIM’s potential. The device could fill a major gap in post-prostatectomy care.
The new funding expands the Australian study. It allows recruitment of additional patients. Crucially, it initiates a U.S. pilot study. This U.S. trial commenced at Johns Hopkins. It followed a crucial FDA Investigational Device Exemption (IDE) approval. This approval was announced in January 2025. The U.S. pilot study builds on the strong Australian data. Combined insights from both regions will guide future development. These efforts lay the groundwork for a pivotal U.S. clinical trial. This large-scale trial is slated for 2026.
CaverSTIM’s technology is sophisticated. It is a neurostimulation system. It features an implantable pulse generator (IPG). The IPG contains a rechargeable battery. It houses electronics that generate electrostimulation signals. This generator connects to an array of electrodes. These electrodes are implanted in the pelvic cavity. They specifically activate and restore the nerves responsible for penile erection. The IPG itself is implanted subcutaneously in the lower abdomen. External controllers operate the device remotely. A clinician controller allows medical experts to tailor parameters for each patient. A patient controller enables individuals to activate the device. This delivers electrical stimulation directly to the cavernous nerves. The goal is to restore their natural function.
Comphya addresses a substantial market deficiency. Patients currently face stark choices. Intrapenile injections offer one option. Penile implants provide another. Both are considered painful, problematic, and outdated. They fail to restore physiological sexual function. Comphya aims to transform this landscape. The company seeks to offer improved quality of life to millions of men. Its neurostimulator system is reportedly the first implantable therapy designed to restore natural erectile function through nerve stimulation. This innovation offers significant hope where current options fall short.
Leadership changes coincide with this funding round. Pim van Wesel was appointed CEO in May 2025. Van Wesel is an industry veteran. He now guides Comphya’s clinical and strategic development. His leadership will steer the company through its next stage of growth. Comphya has garnered previous recognition. It won Venture Kick. It participated in Venture Leaders Life Sciences. The company also ranked among the TOP 100 Swiss Startups. These accolades underscore its innovative spirit and potential.
The company envisions a transformative solution. It seeks to bring a new standard of care to men living with erectile dysfunction. Especially those impacted by prostate cancer treatment. Preparations for the pivotal U.S. clinical trial are underway. This includes critical regulatory and operational groundwork. A forthcoming Series B round will fund the execution of this pivotal trial. Comphya’s advancements represent a significant stride in MedTech. They promise a future where men’s health challenges are met with cutting-edge, effective therapies. The focus remains clear: delivering a transformative solution.