Calm Medical Advantage

Today's permanently implanted neurostimulators for Overactive Bladder (OAB) and Neurogenic Bladder (NB) require surgical access through a ~3cm incision to reach the tibial nerve (near the ankle) or sacral nerves (lower back). These incisions typically leave visible scars.

Calm Medical utilizes Injectrode Technology, licensed from Neuronoff, Inc., to deliver a more elegant, less invasive therapy for overactive and neurogenic bladder.

Patient and Physician preferences

OAB and NB patients typically try pharmacological and non-invasive therapies before choosing a permanent implant. A permanent neuromodulation system provides confidence in long-term bladder management.

Patients prefer injectable solutions over surgery. Needle placement reduces scarring risk and has lower complication rates than sutured or glued surgical incisions. While existing FDA-cleared bladder neuromodulation therapies are well-established, they require surgical placement.

Physicians aim to provide reliable solutions with minimal complications. Wound healing issues, IPG migration, and lead migration disrupt clinic schedules—especially under the global payment models used in neuromodulation.

Figure 1: Needle placement greatly reduces scarring risk. In a clinical trial, the Injectrode was placed on the lower back, with many participants reporting injection sites became virtually invisible.

Insurance and payer preferences*

Payers prefer less invasive, lower-cost solutions.

Existing Competitive Technologies for Sacral Nerve Stimulation (SNS) requires a Trial ($6,563 ASC) before a permanent implant ($21,444 ASC). Tibial Nerve Stimulation (TibN) doesn't require a trial, but permanent implants cost similar to SNS (Outpatient $21,063 / ASC $19,463). More pricing details available here.

Our goal: Calm Medical priced at ~$6,000 (single lead) and ~$12,000 (dual lead).

Lower pricing reduces peer-review conversations and streamlines prior authorization, enabling earlier patient access.


*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.

Clinic and facility preferences

Clinics maximize facility utilization by treating more patients across available rooms. Injection procedures offer advantages over surgical cut-downs requiring sutures or glue—lower complication rates and faster case times. Complications from wound healing, IPG migration, and lead migration disrupt schedules, particularly under global payment models.


Broadening Patient access to OAB & NB Therapies

Calm Medical's Injectrode-based neuromodulation offers an elegant solution without reinventing electrical stimulation. We simply enable a better way to treat this chronic condition—earlier and at lower cost:

  • Injection instead of surgery and sutures

  • Faster recovery with immediate return to normal activities

  • Significant cost and time reduction versus surgical alternatives

  • Reliable permanent implant performance with consistent stimulation. Self-anchoring technology prevents lead migration from day one. No IPG means no migration risk and fewer follow-up complications

  • Precise nerve targeting under ultrasound/fluoroscopy guidance

  • Needle injection enables multiple physician specialties to offer treatment