Phase IIB: Exploratory Clinical trials for The V Needle

Hemodialysis (HD) is generally perceived as a safe, benign, procedure. But if venous needle dislodgement (VND) occurs during dialysis and the machine fails to detect it, within minutes the blood loss can be catastrophic, and even fatal. It is estimated that 400 dialysis patients suffer a dislodgement episode every week in the US. [3] In a Phase I/Phase II SBIR partnership with our clinical and medical device partners, Hemotek Medical Inc. has designed, developed, manufactured and characterized the V-Needle, the world’s first and only, inexpensive, needle-integrated, single-use AV fistula set that will protect patients from the dangers of bleed-out during needle dislodgement. The revolutionary V Needle looks and feels like a standard butterfly needle traditionally used for hemodialysis but includes a unique “skin-sensing” spring-loaded footplate element that can both immediately detect when a needle has dislodged and quickly occlude flow through the needle, dramatically limiting blood loss during dislodgment and initiating a life-saving critical automatic shut-off routine for the hemodialysis machine pump. It fills a currently unmet clinical need of efficiently protecting patients from the dangers of VND. The FDA has stipulated that a 510(k) application for the Hemotek V Needle must include human clinical trial data to validate the novel VND claims. In this Phase IIB project Hemotek proposes to partner with an industry-leading dialysis clinical trial provider and a leading worldwide needle manufacturer to perform the requested trial in-center. Results from the multi-site in-center trial proposed here will be used to attract strategic investors to inform and support more difficult, in-home/nocturnal clinical trials at a later date. The project aims are. Aim #1: Manufacture and Verification of Clinical Samples Aim #2: Clinical Study I: First-in-Man Feasibility Trial Aim #3: Clinical Study II: Confirmatory Clinical Trial (25 patients) Innovation: Hemotek’s 510(k)-approved V-Needle will be one of the most innovative disposable devices in the dialysis market place. Health Relevance: Automated shut off of HD machines during a VND occurrence using the V-Needle is expected to reduce the frequency of significant and serious events related to patient injury or death. Commercial Relevance: By partnering with world hemodialysis leaders, Hemotek ensures that the V-Needle will have maximum visibility for eventual commercialization.PROJECT NARRATIVE A grave danger faced by every dialysis patient is venous needle dislodgement (VND), the inadvertent removal of the needle returning blood into the body after filtration by the dialysis machine. Hemotek has invented a novel safety needle that can help protect patients from bleed out during dislodgement. In this Phase II B SBIR project, Hemotek proposes to run a series of clinical trials to determine the safety and efficacy of the V- Needle in dialysis patients.