Hemotek Medical Inc. Receives a $2.9M Government Start-up Grant
HEALDSBURG, CA —
Medical device start-up firm Hemotek Medical Incorporated has been awarded a 3-year, $2.9M Small Business Innovation Research (SBIR) award from the National Institutes of Health (specialty area, Diabetes, Digestive and Kidney Diseases), Hemotek CEO Charles Ventura announced today. Hemotek CSO Patrick J. Rousche, Ph.D. is the Principal Investigator. This Phase IIB SBIR award will fund essential product development and clinical evaluation of Hemotek’s patented V-Needle. The V-Needle was invented by the company as an inexpensive and easy-to-use solution to the critical problem of Venous Needle Dislodgement (VND). VND is a clinical term describing the dislodgement of access needles returning a patient’s blood to his/her body after it has passed through a hemodialysis machine. VND is a significant, potentially life-threatening complication that can occur at any time during any hemodialysis session.
Close to 55,000,000 sessions of hemodialysis are performed each year in the United States by nearly 500,000 dialysis patients. According to published medical studies, in any given week, more than 200 hemodialysis patients may suffer an incidence of VND when the needle slips out during the dialysis session and the machine continues to pump blood. An estimated two (2) VND patients may bleed to death every week as a direct result of unchecked needle dislodgement. Others will survive but will require hospitalization (sometimes in the ICU) for an average of 4 days at a typical cost of $150,000 per patient. The solution for VND is simple and affordable: The revolutionary V-Needle, invented by Hemotek Medical Incorporated’s founders, Patrick J. Rousche, Ph.D., Chuck Ventura, B.S. and Peter Tek, D.O. in conjunction with design engineer Richard A. Scribner of Scribner Designs, Shingle Springs, CA. The V-Needle incorporates a proprietary safety mechanism within a standard hemodialysis needle.
The beauty of the VNeedle lies in its simplicity. A cost-effective, single-use, easy-to-implement, engineered mechanism that defuses the constant threat of VND during hemodialysis whether in the clinic or at home. Unlike any competing technique, the V-Needle both detects VND and works to automatically shut off the dialysis machine to avoid potentially damaging blood loss. The product will provide peace of mind, will save lives and will protect Hemodialysis providers and systems manufacturers against significant financial losses. The safety of the V-Needle will be particularly welcomed by those patients who choose to do home hemodialysis. The V-Needle is anticipated to be an FDA Class II medical device requiring a fairly routine (and less expensive) premarket notification filing (a 510(k)) for FDA approval.
Hemotek Medical has laboratory facilities in Healdsburg, CA. For more information visit www.hemotekmedical.com
Email contact is CEO Charles Ventura: chuck@hemotekmedical.com