# Preclinical proof of concept validation of a novel endoscopic treatment for urethral stricture disease

> **NIH NIH R41** · CELEFLUX LLC · 2020 · $298,531

## Abstract

PROJECT SUMMARY/ABSTRACT
CeleFlux is developing a medical device which enables urologists to provide long-lasting, minimally invasive
urethral reconstruction to treat male urethral stricture - via endoscopic delivery of a temporary tissue graft
implant. Urethral stricture disease progressively narrows the urethral lumen, similar to a band of scar tissue. This
results in painful and frequent urination and dramatically reduced quality of life.
Current treatment options are suboptimal, requiring a choice between (1) minimally invasive (endoscopic)
intervention associated with high recurrence rates; or (2) highly effective but long, complex open reconstructive
surgery. The latter requires a specialized skill set, and consequently availability of urethral reconstruction is
limited. General urologists typically cannot offer definitive treatment to men with recurrent stricture. Repeated
endoscopic intervention worsens the stricture and turns a curable condition into a chronic disease. We aim to
change that by bridging the gap between the two approaches.
CeleFlux is commercializing a technology empowering general urologists to deliver curative treatment for bulbar
urethral stricture, approaching the efficacy of open reconstruction. Our medical device innovation simplifies a
procedure to reconstruct the urethra with a tissue graft endoscopically. The graft is delivered to the target site via
a temporary implant which is removed 14 days later. The result is a urethra widened by a healthy graft, durably
alleviating the symptoms of urethral stricture. The clinical need, user requirements, and product-market fit were
validated through extensive customer discovery with general (target users) and reconstructive urologists (disease
state experts).
Key hurdles include achieving engraftment with our device, and safe removal of the temporary implant. In this
proposal, we will evaluate and address these in a large animal model. We aim to demonstrate that a graft delivered
endoscopically via our temporary implant is comparable to a graft delivered via open surgery (the gold standard).
We also aim to demonstrate that the temporary implant can be removed 14 days later without disruption to the
adhered graft. The resulting outcomes will illustrate the feasibility of our innovation, drive future
commercialization-focused activities, and support our goal to shift the current clinical paradigm for men with
recurrent bulbar urethral stricture disease - away from chronic management and toward durable reconstruction.

## Key facts

- **NIH application ID:** 10080497
- **Project number:** 1R41DK125209-01A1
- **Recipient organization:** CELEFLUX LLC
- **Principal Investigator:** Chanya Godzich
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $298,531
- **Award type:** 1
- **Project period:** 2020-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080497

## Citation

> US National Institutes of Health, RePORTER application 10080497, Preclinical proof of concept validation of a novel endoscopic treatment for urethral stricture disease (1R41DK125209-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10080497. Licensed CC0.

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