# Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid

> **NIH NIH SB1** · BIOCIRCUIT TECHNOLOGIES, INC. · 2023 · $1,887,020

## Abstract

Project Summary
This SBIR Commercialization Readiness Pilot project will prepare and achieve the commercial launch of Bio-
Circuit Technologies’ Nerve Tape® device for sutureless nerve repair.
Nerve injuries are common and result in paralysis, sensory loss, and chronic pain. In current repair techniques,
the ends of a cut nerve are microsutured back together under high magnification by a specialized surgeon.
Microsuture repair techniques are technically challenging and time intensive, and repair quality is not consistent.
Nerve Tape was developed as a simple and easy-to-use alternative to microsuture repair. Nerve Tape consists of
flexible columns of microscale Nitinol hooks embedded in a biologic wrap. The device easily wraps to align and
hold together the two ends of a severed nerve. The microhooks are designed for safe, shallow penetration into
outer connective tissue layers of the nerve, evenly distributing tension for a firm hold. Nerve Tape is easily and
quickly applied, reliably and safely aligning nerve ends for high-quality repairs.
To achieve initial commercialization launch of the Nerve Tape product, BioCircuit must complete several key
steps. A strategic switch in the 510(k) cleared device to a new biologic material supplier requires some verification
and validation testing steps to be repeated. This testing will support a new regulatory submission to gain
clearance for the updated device. Prior to production of devices for clinical use, a formal design transfer process
must be completed. This process includes ensuring all vendors and suppliers are certified and/or qualified, and
all supplier agreements are in place. Tooling for fabricating the full range of device sizes must also be built and
qualified. Manufacturing processes that were previously developed and refined must now be transferred to a
certified contract manufacturer, and all production processes must to be qualified to meet product specifications.
After completing the design transfer process and documenting this process in BioCircuit’s Quality Management
System, production runs will build enough devices to support an initial commercial launch phase. To prepare
for successful commercial launch, market research and analytics will guide plans for initial launch and
subsequent growth. Clinical affairs activities will include plans for gathering evidence to support key claims and
preparations for a clinical registry as part of a broader evidence strategy. A strategically limited “soft launch” will
be conducted at select accounts to establish and optimize commercial procedures, obtain clinical feedback, and
position Nerve Tape for market penetration following full launch. Due to its simple, efficient, and reliable usage,
Nerve Tape will be an attractive tool for surgeons and could expand future treatment strategies for nerve repair.

## Key facts

- **NIH application ID:** 10698977
- **Project number:** 1SB1NS137879-01A1
- **Recipient organization:** BIOCIRCUIT TECHNOLOGIES, INC.
- **Principal Investigator:** Isaac Perry Clements
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,887,020
- **Award type:** 1
- **Project period:** 2023-09-22 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10698977

## Citation

> US National Institutes of Health, RePORTER application 10698977, Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid (1SB1NS137879-01A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10698977. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*