Investigational Device

CaverSTIM™ Neuromodulation System

A novel implantable therapy that works directly on the nerves affected during prostate cancer surgery, to help restore natural erectile function when medications aren't enough. CaverSTIM™ is currently in clinical trials at leading research centers across the world.

CaverSTIM Product
70%
Men Affected Post-Surgery
400K+
Annual Prostatectomies
Novel
Technology
2026
Pivotal Trial Planned

Key Benefits

CaverSTIM™ is designed to address nerve-related erectile challenges with precision and purpose

Targets the Root Cause

Directly supports cavernous nerve function rather than just managing symptoms.

Optimal Timing

Intervenes during the critical post-surgical window when nerve recovery potential is highest.

Seamless Integration

Engineered to integrate smoothly into existing prostate cancer surgery workflows, adding no additional procedural complexity for surgeons or care teams.

Drug-Free Approach

No daily medications, pumps, or ongoing pharmaceutical interventions required.

Understanding CaverSTIM™

Learn more about how our technology works

Comprehensive Approach to Nerve Support

CaverSTIM™ introduces a new way of addressing erectile dysfunction after prostate cancer surgery by intervening early, at the point when nerve recovery is still possible. Instead of managing symptoms years later, the device is designed for placement during the primary surgical procedure, when targeted support can have the greatest impact.

By delivering focused neuromodulation during the critical post-operative healing period, CaverSTIM™ is engineered to help maintain and restore natural pelvic nerve function, with the goal of improving long-term erectile outcomes.

The system includes three coordinated components: an implantable electrode array placed during surgery, a subcutaneous pulse generator, and a clinician-controlled external programming interface.

CaverSTIM Overview

Advanced Neuromodulation Technology

Built on proven neuromodulation principles, CaverSTIM™ uses precisely calibrated electrical stimulation to support nerve activity in the cavernous nerves—the key pathways responsible for erectile function.

The system features:

  • Biocompatible electrode arrays designed for precise nerve contact
  • Rechargeable pulse generator with customizable stimulation parameters
  • Wireless programming for clinician control and adjustment
  • Real-time monitoring capabilities for optimal therapy delivery
CaverSTIM Technology

Device Components

CaverSTIM™ consists of three integrated components designed to work together to support nerve function recovery:

CaverSTIM Device Components

Implantable Electrode Array

Placed during surgery to align with nerve pathways, no additional procedure needed.

Subcutaneous Pulse Generator

A small, rechargeable unit placed under the skin, programmed by clinicians and tailored to patient needs.

Neuromodulation Protocol

Stimulation begins shortly after surgery, aligning with critical windows for nerve recovery.

How It Works

A step-by-step look at the CaverSTIM™ treatment pathway

01

Surgical Placement

During prostate cancer surgery, the electrode array is placed adjacent to the cavernous nerve bundles as part of the normal surgical workflow. The placement integrates seamlessly into the procedure and does not require additional incisions or invasive steps beyond the standard operation.

02

System Activation

After an initial post-operative healing period, the clinical team activates the subcutaneous pulse generator. Stimulation settings are tailored to each patient, informed by surgical findings and individual nerve response.

03

Ongoing Therapy

CaverSTIM™ provides programmed neuromodulation over the course of several weeks to months, delivering consistent support during the key period of nerve healing and regeneration. The stimulation schedule is optimized to reinforce natural nerve signaling as recovery progresses.

04

Monitoring & Adjustment

Regular follow-up sessions enable clinicians to evaluate nerve recovery, track patient progress, and adjust stimulation settings as needed. The wireless programming interface allows for precise, non-invasive parameter adjustments to help optimize each patient's therapeutic response.

Clinical Evidence & Development

CaverSTIM™ is being evaluated through a multi-stage clinical development program designed to assess safety, feasibility, and potential benefit in restoring erectile nerve function after prostate cancer surgery. Our global studies follow rigorous scientific and regulatory standards to build a strong foundation for future approval.

  • First-in-human study completed in Australia, demonstrating promising early signals
  • Ongoing pilot trial at Johns Hopkins University School of Medicine
  • No safety concerns reported to date across all enrolled participants
  • FDA Investigational Device Exemption (IDE) granted for U.S. clinical evaluation
  • Pivotal trial planned for 2026 to support regulatory submission and approval

CaverSTIM™ is an investigational device and is not approved for commercial use. Safety and efficacy have not yet been established.

Clinical Research

Ready to Learn More?

Whether you're a healthcare provider, researcher, or patient seeking information about CaverSTIM™, we're here to help. Connect with our team to discuss clinical trials, research opportunities, or general inquiries.