STTR Phase I: Development of a Novel Minimally Invasive Reconstruction Device for the Treatment of Male Urethral Stricture Disease

Celeflux Llc, Severna Park MD

Investigators

Abstract

This Small Business Technology Transfer (STTR) Phase I project supports the development of a medical device that enables minimally invasive graft-based reconstruction of the urethra as a long-lasting treatment for male urethral stricture, a class of conditions causing restrictions in flow. Approximately 1% of men on Medicare are treated for stricture annually, and an estimated 1 in 5 men will get a stricture in their lifetime. A urethral stricture progressively narrows the urethra - leading to urinary urgency, frequent and painful urination, and impaired intimacy. The current state of practice has many challenges: Widely available endoscopic treatment is simple and minimally invasive but rarely curative, with high recurrence rates, and repeated endoscopic intervention worsens the stricture and turns a curable condition into a chronic disease, with devastating consequences to quality of life. Graft-based urethral reconstruction has excellent long-term outcomes but limited availability – as the complex open surgery is performed by a select group of reconstructive urologists. The proposed medical device simplifies minimally invasive graft-based urethral reconstruction to empower general urologists to deliver minimally invasive curative treatment. The proposed project focuses on demonstrating the anti-migration properties of a temporary indwelling urethral device prototype. The device is designed to deliver a graft to a urethral graft bed, and hold it in place as the graft adheres over a period of 14 days without migrating. Proof-of-concept studies of the mechanically functional prototype will be performed on the bench and in vivo, to be further advanced by integrating proprietary anti-migration features. Key milestones include the prototype's ability to meet: targeted biocompatibility/cytotoxicity benchmarks, anti-migration benchmarks using an in vitro model, and an absence of significant migration in vivo over a 14-day period. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.