Venarum Medical Receives FDA SBIR Grant Support for Development of Its Canine Urinary Incontinence Implantable Valve

FDA SBIR Support Enables Progress Towards a Prosthetic Urethral Valve

EATONTOWN, N.J.--(BUSINESS WIRE)-- Venarum Medical today announced receipt of a Phase I SBIR Grant award for development of K9-ICT: A Novel Urethral Valve Treatment for Canine Urinary Incontinence.

Under this Phase I work, Venarum proposes to develop and evaluate the feasibility of the Canine INCONTrol Urethral Valve system (K9-ICT), a novel urethral implant solution for the treatment of urinary incontinence (UI). The transurethral, catheter-delivered K9-ICT is intended to work with the normal voiding initiation mechanism to help control the flow of urine in order to reduce urine leakage and other complications of UI. The K9-ICT consists of a Nitinol stent-like scaffold embedded in a biocompatible polymer with a polymeric inner valve comprised of a flexible leaflet-like membrane; with a user-friendly catheter, it is placed in the urethra. It is designed to significantly reduce urine leakage by restoring the ability to retain urine and void at appropriate urinary bladder pressures that are seen in continent dogs.

Canine urinary incontinence (UI) is a condition characterized by involuntary passage of urine. UI can have neurogenic or non-neurogenic causes; the most common non-neurogenic cause is urethral sphincter mechanism incompetence (USMI), which is thought to be hormone-related and affects over 20% of spayed female dogs, equating to roughly 5 million otherwise healthy pets in the U.S. Hundreds more dogs receive a urethral stent for benign or malignant causes of urethral obstruction, with many left incontinent following stenting.

Venarum’s CEO/CTO, Janet Burpee, said, “None of the current treatment options for UI—medical management, urethral bulking agents, and surgical correction—are reliably efficacious and all carry risks. We are hoping to bring forward a simple user-friendly solution.”

About FDA Grant Support of this Project

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $167,648 with 63 percentage funded by FDA/HHS and $100,000 amount and 37 percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

About Venarum Medical, LLC

Venarum is a privately held medical device company that develops medical devices using its patented integrated valve manufacturing process. The Company’s two leading devices are a prosthetic venous valve and a urinary incontinence device, both of which are catheter-delivered implants. Venarum’s integrated valve process may enable commercial catheter-delivered valves with idealized flow conditions that address large unmet clinical needs.

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