Comphya SA

Comphya Announces Publication of CaverSTIM First-in-Man Clinical Study in BJUI and Scientific Review in Nature Urology

Peer-reviewed publications validate the scientific foundation and early clinical potential of CaverSTIM™ in restoring erectile function

LAUSANNE, Switzerland, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Comphya SA, a clinical-stage MedTech company pioneering the first implantable neurostimulation therapy for erectile dysfunction (ED) unresponsive to oral medication, today announced the publication of two peer-reviewed articles highlighting the scientific foundation and early clinical experience of CaverSTIM™, its implantable cavernous nerve neurostimulator designed to preserve and restore erectile function.

A first-in-man pilot clinical study evaluating CaverSTIM™ during nerve-sparing robotic radical prostatectomy has been published in BJU International (BJUI). In addition, a comprehensive scientific review outlining the principles and rationale for using implantable neurostimulation to manage post-prostatectomy erectile dysfunction has been published in Nature Urology Review.

BJUI Study Demonstrates Feasibility, Safety, and Encouraging Early Outcomes

The BJUI publication, led by Philip Dundee, MD, and Anthony Costello, MD, reports outcomes from a prospective first-in-man study in which ten preoperatively potent men undergoing robotic radical prostatectomy received the CaverSTIM™ implant.

The study met its primary objectives of evaluating safety and tolerability, with no device explantations, no device-related infections, and no pain reported during stimulation. Only mild, transient discomfort was reported in two patients, and the implantation procedure added approximately 45 minutes to the cancer surgery.

Importantly, early functional outcomes were encouraging. Nine of the ten implanted patients regained postoperative potency, with many resuming unaided sexual intercourse. Erectile function was assessed using validated IIEF-15 questionnaires and nocturnal RigiScan monitoring, both of which demonstrated recovery of erectile activity over time.

“These publications reflect a major step forward for CaverSTIM™ and for Comphya,” said Pim van Wesel, CEO of Comphya. “Seeing our technology validated in a first-in-man clinical study reinforces our confidence that neuromodulation can meaningfully improve quality-of-life outcomes for men undergoing prostate cancer surgery. This progress is an important milestone as we work toward making erectile function rehabilitation a realistic expectation rather than an exception.”

You can find the full article here:
https://bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.70066

Nature Review Describes Implantable Neurostimulation as a Restorative Approach to Erectile Dysfunction

The Nature Urol. review, led by Arthur Burnett, MD, places implantable cavernous nerve neurostimulation within the broader context of erectile dysfunction biology and treatment, highlighting its potential role as a nerve-protective and restorative therapy.

The authors describe how electrical neurostimulation may address fundamental limitations of existing ED treatments by targeting the neural pathways responsible for erection, rather than compensating for their loss. Early human and preclinical data, including studies using CaverSTIM™, are cited as evidence supporting the feasibility of this approach.

“The strength of this technology lies in its alignment with our understanding of erectile neurophysiology,” said Rodrigo Fraga, PhD, COO of Comphya and co-author. “We are grateful to Dr. Burnett, and the other co-authors for advancing this work, which we believe will represent a cornerstone for the field of neurostimulation and erectile dysfunction management. By stimulating the cavernous nerves at a time when injury is predictable, we may be able to promote neural rehabilitation and facilitate functional recovery rather than accepting postoperative erectile dysfunction as inevitable. While larger controlled trials are required, the early data strongly support continued clinical investigation.”

You can find the full article here: https://www.nature.com/articles/s41585-025-01116-5

Building on these findings, Comphya plans to initiate a larger controlled clinical study after completion of the pilot studies, designed to further evaluate the safety, tolerability, and effectiveness of CaverSTIM™ in rehabilitating erectile function following radical prostatectomy. In parallel, additional clinical evaluation is ongoing to explore the technology’s application in other neurogenic causes of erectile dysfunction, including spinal cord injury.

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. A programmed daily stimulation routine, generally imperceptible, begins at the crucial time for nerve function recovery.

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

Investor & Media Contact:
Daniel Kontoh-Boateng
DKB Partners
dboateng@dkbpartners.net
+1-862-213-1398