In a first-in-human pilot of 10 preoperatively potent men undergoing nerve‑sparing robotic radical prostatectomy, Comphya’s implantable cavernous nerve neurostimulator (CaverSTIM) was implanted without device explants, device‑related infections, or pain during stimulation; two patients reported mild, transient discomfort. The procedure added roughly 45 minutes to the surgery. Nine of 10 patients regained postoperative potency, with recovery corroborated by IIEF‑15 and nocturnal RigiScan assessments.
The core development is two peer‑reviewed publications: a BJUI paper reporting feasibility, safety, and early outcomes from the pilot implantation during prostatectomy, and a Nature Reviews Urology article laying out the rationale for implantable neurostimulation as a restorative approach to post‑prostatectomy erectile dysfunction. Together, they move CaverSTIM from concept to early clinical signal and set the stage for a controlled study in the post‑prostatectomy setting, with parallel exploration in other neurogenic ED populations such as spinal cord injury.
Strategically, Comphya is positioning neuromodulation as an intraoperative rehabilitation tool rather than a downstream symptomatic therapy. By implanting at the moment of predictable nerve insult, the company aims to protect and retrain the cavernous nerves, potentially shortening time to potency and reducing the need for injections or later penile prosthesis. That approach departs from the prevailing ED playbook of pharmacologic compensation and salvage surgery, and aligns with a broader neuromodulation trend in pelvic health where sacral and tibial nerve stimulation have already validated the category. The challenge is evidentiary: a 10‑patient, single‑arm study can demonstrate procedural feasibility and early signal, but regulatory and payer decisions will hinge on controlled data, durability, and clinically meaningful functional recovery.
For sites, this is an OR‑integrated device that adds setup time, surgical steps for pelvic electrode placement, subcutaneous IPG placement, and postoperative programming. Adoption will concentrate in high‑volume robotic prostatectomy centers with established perioperative pathways and sexual medicine follow‑up, and will require coordination across urologic oncology, andrology, and device clinics. Trials will need rigorous management of surgeon- and center‑level variability in nerve‑sparing technique, standardized potency definitions, and longitudinal patient‑reported outcomes, while handling privacy sensitivities around sexual function data. CROs with implantable device experience and robust PRO operations will be advantaged. For sponsors and payers, the economic case will depend on whether earlier potency recovery translates into fewer salvage interventions and reduced long‑term ED care; coverage could be complicated by quality‑of‑life benefit framing unless tied to post‑prostatectomy outcomes.
Regulatory path is likely a first‑of‑kind, Class III PMA in the U.S., with emphasis on safety over extended follow‑up (infection, lead migration, revisions), durability of effect at 12–24 months, device longevity, MRI compatibility, and cybersecurity of external controllers. Trial design questions include immediate versus delayed implantation, background rehabilitation protocols, objective measures beyond PROs, and feasibility of sham controls. Patient selection will probably focus on pre‑op potent, bilateral nerve‑sparing cases, excluding complete nerve transection, with stratification by age and comorbidities.
Next, watch for the size, control strategy, and endpoints in the planned controlled study, along with surgeon learning‑curve data and real‑world programming adherence. Signals in spinal cord injury could broaden the addressable market but will involve different pathways and endpoints. The principal risks remain scale‑up beyond a single‑center pilot, durability of efficacy, and payer alignment in an area historically under‑reimbursed. If Comphya can deliver multicenter, controlled data showing faster and higher potency recovery without adding postoperative morbidity, it could redefine ED rehabilitation as part of the prostatectomy bundle rather than a salvage afterthought.
