- IDE approval obtained; U.S. pilot study clinical site launched at Johns Hopkins
- Series B round in planning to support pivotal U.S. trial
- New CEO appointment signals next phase of growth and expansion
LAUSANNE, Switzerland, July 08, 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 the closing of an oversubscribed Series A financing round. Including the conversion of existing convertible loans, the round brings Comphya's total equity raised to CHF 7.5 million (~USD 8.4 million).
"We are thrilled to have the continued confidence of our investors, which enables us to accelerate our mission to bring a transformative solution to men living with erectile dysfunction following treatment for prostate cancer," said Pim van Wesel, CEO of Comphya. "With our U.S. pilot study underway and preparations beginning for a pivotal clinical trial, we're entering an important new chapter in our development."
Proceeds from the Series A will be used to:
- Launch and execute a U.S. pilot study, with the first site activated at Johns Hopkins following FDA Investigational Device Exemption (IDE) approval announced in January 2025 (https://comphya.com/news/receives-approval-caverstim/).
- Prepare for a pivotal U.S. clinical trial planned for 2026, including regulatory and operational groundwork.
- Expand Comphya's ongoing clinical trial in Australia, where early data has shown strong safety and efficacy signals by recruiting additional patients.
The funding comes on the heels of highly encouraging clinical results from the company's first-in-human study in Australia, where patients undergoing robotic-assisted prostatectomy were implanted with Comphya's CaverSTIM system. Results presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas showed that a large majority of patients maintained good erectile function postoperatively without the need for adjunctive therapies. No infections or adverse events were reported. These early outcomes underscore the potential of CaverSTIM to fill a major gap in post-prostatectomy care, an area with no effective therapeutic options today.
The U.S. pilot study, now underway at Johns Hopkins, builds on the strong early data from Australia. Combined insights from both regions will guide the design of a pivotal clinical trial in 2026, which Comphya plans to fund through a forthcoming Series B round.
The Series A round also coincides with recent leadership changes at Comphya, including the appointment of industry veteran Pim van Wesel as CEO in May 2025 to guide the company through its next stage of clinical growth and strategic execution.
Comphya's neurostimulator system is the first implantable therapy designed to restore natural erectile function by stimulating the cavernous nerves. Founded in 2017 as a spin-off from EPFLin Lausanne, the company aims to redefine the standard of care for patients who do not respond to conventional therapies.
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 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.
For more information, visit www.comphya.com
Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
Tel: +1-862-213-1398
dboateng@dkbpartners.net
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2b42d6e1-196c-4d94-8c8b-64e78d85597e
