HINGHAM, Mass., Jan. 14, 2015 /PRNewswire/ -- Phase One Medical (POM), a medical device company, today announced it has received a Phase II SBIR grant of approximately $700,00 from the National Science Foundation (NSF) to complete the development and commercialization of the company's distally valved hemodialysis catheter to be sold under the trade name Goldilocks™.
"This SBIR grant ensures that valved catheter technology, which promises to address major complications associated with hemodialysis catheters, will become available to patients who need it most," said Adrian Ravenscroft, CEO at Phase One Medical. "Improving hemodialysis outcomes while reducing costs should make this product of tremendous clinical and commercial importance as we continue to head towards a capitated payment environment."
About the Goldilocks Valved Hemodialysis Catheter: Currently, all commercially available hemodialysis catheters are open-ended; leaving lumens unprotected when not in use. "Open-ended catheters are frequently occluded with thrombus which increases the likelihood of catheter related infection," said Dr. Thomas Vesely, Medical Advisor to POM. As a result, hemodialysis technicians spend considerable time solving catheter flow issues leading to a reduction in dialysis therapy. If flow cannot be restored, the catheter must be replaced. Catheter related infection, the most severe complication, requires expensive medical treatment and may also necessitate catheter replacement. These catheter malfunctions negatively impact clinical outcomes and add significant cost to patient care.
Goldilocks™ seeks to improve catheter function and safety by integrating a positively controlled valve at the distal tip. This valve seals off the catheter lumens when not in use. With the valve closed, lock solutions stay secure and an internal flushing pathway allows cleansing and/or antimicrobial solutions to be flushed lumen to lumen without risk of systemic spillage. Upon valve actuation for treatment, fibrin sheath formation is disrupted, lumens are thrombus free, and high flow rate hemodialysis can be freely delivered. With its unique distal valve, Golidlocks™ has the potential to reduce catheter occlusion, decrease infection, lower cost of care, and ultimately, improve patient outcomes.
About Phase One Medical: Phase One Medical is a medical device company focused on the development and commercialization of Interventional Radiology and Vascular Access products. Founded as a Research and Development company in 2003, the company recently received 510(k) clearance for its first product the Symetrex™ Long Term Hemodialysis Catheter, a next generation symmetrical tip catheter, expected to be available in early 2015. For more information, visit www.phaseonemedical.com.
Goldilocks™ and the claims made herein have not been evaluated by the United States Food and Drug Administration (FDA). Goldilocks™ is not available for sale.
SOURCE Phase One Medical