Trial launches of neuromodulation therapy for erectile dysfunction after radical prostatectomy

The first patient has been implanted in a pilot study of the CaverSTIM device, an investigational implantable neuromodulation therapy for patients with erectile dysfunction (ED) following radical prostatectomy, Comphya announced in a news release.¹

CaverSTIM is designed to be implanted at the time of radical prostatectomy. The first patient in the study was implanted with the device at the Johns Hopkins University (JHU) School of Medicine in Baltimore, Maryland. In total, the study is expected to enroll 20 participants.

“The first US 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, cofounder and chief operating officer of Comphya, in the news release.¹ “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 postsurgical recovery for [patients with] prostate cancer.”

Overall, the study is assessing the safety and tolerability of long-term use of the CaverSTIM device for ED after surgical removal of the prostate. Early analyses from the study will assess patient satisfaction and effectiveness. According to Comphya, this investigational device exemption (IDE) study in the US is intended to “build on the promising results of ongoing international studies, which have demonstrated CaverSTIM’s potential as an innovative therapeutic option for [patients with] prostate cancer undergoing prostatectomy.”²

To be eligible for enrollment, patients must be aged 30 to 75 years and must have normal erectile function prior to surgery. The study is being conducted at a single site and is led by Arthur L. Burnett II, MD, MBA, FACS, and Christian Pavlovich, MD, both distinguished professors of urology at JHU School of Medicine.

Participants in the study will begin activating the device at one week post op. The device includes an “implantable pulse generator containing a rechargeable battery and electronics responsible for generating the electrostimulation signal,” according to Comphya. Activation of the device delivers electrical pulses to the cavernous nerves, potentially allowing patients to recover natural erectile function.

“Erectile dysfunction after prostate cancer surgery is both common and personally impactful,” concluded Pim van Wesel, CEO of Comphya, in the news release.¹ “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 IDE study is currently open for enrollment.

REFERENCES

1. Comphya announces first patient implanted with CaverSTIM in U.S. pilot study at Johns Hopkins University School of Medicine. News release. Comphya SA. October 1, 2025. Accessed October 8, 2025. https://www.biospace.com/press-releases/comphya-announces-first-patient-implanted-with-caverstim-in-u-s-pilot-study-at-johns-hopkins-university-school-of-medicine

2. Comphya receives FDA IDE approval to initiate U.S. clinical trial for CaverSTIM. News release. Comphya SA. January 6, 2025. Accessed October 8, 2025. https://comphya.com/news/receives-approval-caverstim/