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Improvement and validation of the Spring System for Permanent Relief of Urinary Obstruction related to Benign Prostatic Hyperplasia (BPH)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DK124094-01
Agency Tracking Number: R44DK124094
Amount: $1,271,190.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-15
Award End Date (Contract End Date): 2021-07-31
Small Business Information
400 OYSTER POINT BLVD SUITE 417
San Francisco, CA 94080-1920
United States
DUNS: 079412969
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 NICHOLAS DAMIANO
 (917) 821-1105
 nick@zenflow.com
Business Contact
 NICHOLAS DAMIANO
Phone: (917) 821-1105
Email: nick@zenflow.com
Research Institution
N/A
Abstract

ABSTRACT
Benign Prostatic Hyperplasia (BPH) is the most common cause of obstructive lower urinary tract symptoms in
men. As the prostate progressively enlarges with age, it obstructs the flow of urine from the bladder, leading to
urinary straining, frequency, urgency, and nocturia. At Zenflow, we have developed the Spring System, which
consists of a single-wire nickel titanium (nitinol) coil implant designed to permanently relieve BPH-related urinary
obstruction, and a flexible transurethral delivery system that includes a cystoscope with built-in visualization. We
developed this solution to meet the long-standing clinical need for a safe, effective, cost-efficient, office-based
BPH therapy that provides durable symptom relief in a single procedure without side effects. The device aims to
improve upon previous technologies such as stents and the prostatic urethral lift device. Between 2014 and
2017, we developed the first-generation Spring System and successfully completed preclinical work including
cadaver and chronic animal studies, then first-in-man studies. In 2017, we were awarded a Phase II NIH SBIR
grant. This project involved development of a refined design to improve clinical safety, effectiveness, and ease
of use. The goal of this Phase II project was, in conjunction with ongoing pilot clinical trials, to prepare Zenflow
for a US pivotal IDE study. While the aims of this project were successful, clinical testing revealed opportunities
for further improvements to the Spring System, which we believe will result in an even safer and more reliable
procedure that reaches a new frontier in effectiveness, and will also expand the range of anatomical
configurations that the system can treat. These improvements fall into two categories which we offer to test under
the current grant proposal: in Specific Aim 1 we will improve the implant and delivery system to yield a more
effective procedure that can treat a broader range of patients, and in Specific Aim 2 we will improve our
proprietary single-use cystoscope to enable better visualization and allow urologists to place the implant more
accurately and confidently. Next, in Specific Aim 3 we will validate all improvements described above, we will
test the full Spring System in cadavers to demonstrate functionality of the Spring System in simulated use by a
urologist. The system will be tested on two cadavers at the end of year 1 after completing all implant and delivery
system work described in Aim 1, then two more at the end of year 2 after completing all scope developments in
Aim 2. Successful completion of both of these studies will represent completion of our Phase II work. We will
incorporate the results of the Aim 1 implant work into our US pivotal IDE study. The Aim 2 Scope improvements
will be incorporated into later clinical studies. While we developed the Spring Scope specifically to place the
Spring Implant, it could be used for deployment of implants to treat conditions such as urethral strictures or
painful bladder syndrome, delivery of drugs or energy to treat BPH-related LUTS, prostate cancer, or other
conditions. We will continue to explore these possibilities and file intellectual property on alternative applications.NARRATIVE
Benign Prostatic Hyperplasia (BPH) is the most common cause of obstructive lower urinary tract symptoms
(LUTS) in men. In the US, more than 50% of men in their 60s and 90% of octogenarians present with LUTS.
Zenflow has developed the Spring System consists of a single-wire nickel titanium coil implant designed to
permanently relieve BPH-related urinary obstruction, and a flexible transurethral delivery system that includes a
cystoscope with built-in visualization. The aim of this project is to further improve the implant and the delivery
system in order to yield a safer and more effective procedure that can treat a broader range of patients.

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

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