Investigational Device

CaverSTIM™ Neuromodulation System

A novel implantable therapy designed for men with neurogenic erectile dysfunction. CaverSTIM™ works directly on the nerves involved in erectile function, using targeted neuromodulation to help restore erectile function when medications are not enough. CaverSTIM™ is currently being evaluated in clinical studies, with a focus on men living with spinal cord injury.

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

For prostatectomy It intervenes during the critical post-surgical window when nerve recovery potential is highest.

Seamless Integration

For prostatectomy it's 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 spinal cord injury or 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

CaverSTIM™ is implanted through minimally invasive laparoscopic surgery, which may be robot-assisted. The electrodes are positioned near the pelvic nerves involved in erectile function, while the stimulator is placed under the skin. The implant is fully contained within the body, with no components passing through the skin.

02

System Activation

After few days of surgery, the clinical team activates the implanted stimulator and adjusts the stimulation settings for each patient. The system is programmed to provide targeted stimulation of the nerves involved in erectile function.

03

Ongoing Therapy

CaverSTIM™ is designed to provide both daily stimulation and on-demand use. Daily stimulation is intended to support nerve rehabilitation and help reinforce the pathways involved in erectile function, while on-demand stimulation can be activated by the patient when desired.

04

Monitoring & Adjustment

The clinical team monitors the patient's progress and, if needed, can adjust the stimulation settings to further personalize the therapy. The system can be programmed wirelessly, allowing adjustments to be made without additional procedures.

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.