K9-ICT: A Novel Urethral Valve Treatment for Canine Urinary Incontinence

Project Summary / Abstract Venarum Medical, LLC (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 ICT-K9 is intended to control the flow of urine in order to reduce urine leakage and other complications of UI. The ICT-K9 consists of a Nitinol stent scaffold embedded in a biocompatible polymer with a completely integrated polymeric inner valve comprised of a flexible leaflet-like membrane; it is placed in the mid to proximal urethra and is designed to significantly reduce urine leakage by restoring the ability to retain urine and void at similar urinary bladder pressures that are seen in continent dogs. Canine UI is a condition characterized by inappropriate or “involuntary” passage of urine. Clinical signs and sequelae of UI include urine leakage, unwanted urination in the house, skin irritation, and discomfort. The most common non-neurogenic cause of canine UI 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 pets in the U.S. None of the current treatment options for UI—medical management, urethral bulking agents, and surgical correction—are reliably efficacious and all carry risks. The Venarum Team intends to leverage its expertise in implantable valve technology, veterinary medicine and polymer science to bring the ICT-K9 device from concept to market. The Company has extensive experience with polymer-coated Nitinol stent technology through the development of a prosthetic venous valve device and is well positioned to apply its design and manufacturing knowledge to meet the challenge of canine UI. Effective treatment of UI requires an understanding of the interplay between intra-abdominal pressure, urinary bladder pressure, urethral pressure, sphincter competency, and the feedback and reflexes involved in the voiding mechanism. Venarum has demonstrated with a preliminary urethral valve design that the implant can feasibly prevent indiscriminate fluid leakage and permit fluid passage within a desired range of pressures approximating those in continent dogs. Refinement of the valve design, fabrication process, and implantation characteristics would enhance control of valve performance across a variety of canine UI patients. Under Phase I, Venarum proposes to (1) iterate on the urethral implant design and choose a leading prototype, (2) perform a cadaveric implantation study and leverage data gained to refine its bench top simulation model, and (3) perform “first-in-dog” in-vivo implantations to evaluate device safety in a small number of dogs that have exhausted all other treatment options for their UI. Venarum intends to identify opportunities to publish its findings and experience when appropriate. Concurrent to the proposed Specific Aims, Venarum will engage the veterinary community and canine UI experts in order to build interest in the ICT-K9 technology and identify an efficient path to commercialization. The U.S. pet population is desperate for an effective treatment of UI.Project Narrative Canine urinary incontinence (UI), most commonly caused by urethral sphincter mechanism incompetence (USMI), affects millions of dogs in the United States. Signs associated with UI such as urine dribbling, house soiling, and skin irritation can profoundly and negatively impact the quality of life of canine pets and their owners. Venarum’s proposed implantable urethral valve system controls urine flow, which could enable a treatment option for canine UI that does not exist today and may contribute to an improvement in technical and medical knowledge of UI management.