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

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 2014895
Agency Tracking Number: 2014895
Amount: $224,998.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: MD
Solicitation Number: N/A
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-01
Award End Date (Contract End Date): 2021-04-30
Small Business Information
United States
DUNS: 116999164
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 Chanya Godzich
 (858) 205-8129
Business Contact
 Chanya Godzich
Phone: (858) 205-8129
Research Institution
 Johns Hopkins University School of Medicine
 Jessica Izzi
Homewood Divisions, Room 113
Baltimore, MD 21218
United States

 () -
 Nonprofit College or University

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.

* Information listed above is at the time of submission. *

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