HINGHAM, Mass.--(BUSINESS WIRE)--Phase One Medical, L.L.C. announced today that Pelham Plastics, a medical device manufacturer located in Pelham, NH, has been contracted to produce the company’s new Reversus™ Hemodialysis Catheter.
Intended to provide long-term vascular access for hemodialysis treatment, the Reversus™ is designed to offer high flow rates, low recirculation and no loss of performance upon reversal of the hemodialysis lines. It is estimated that reversing the lines is necessary in 20% to 30% of catheter based hemodialysis treatments making equal line function critical to achieving optimal dialysis results. Additionally, the Reversus™ utilizes advanced fluid dynamics that balance and stabilize the distal tip during flow, showing tremendous promise to minimize the complication of wall suction so often associated with chronic catheter use.
The company expects the Reversus™ Hemodialysis Catheter to receive FDA clearance early 2013 and will initiate a commercial launch shortly thereafter. Phase One Medical has created a successful track record of developing and licensing endovascular devices. The launch of the Reversus™ will be the company’s first commercial product launch. According to the company, this is a significant milestone as Phase One Medical transitions from an R&D only company to one that develops and commercializes innovative medical devices.
“We are excited to be working with Pelham Plastics to scale-up production of our hemodialysis catheter,” said Don Woods, partner Phase One Medical. “We have worked with Pelham before and it was an easy choice to go back. They offer highly trained and experienced manufacturing engineers who have historically provided high quality and reliable products at a competitive price. This also aligns with our commitment to select and work with US based manufacturing partners.”
“We are pleased to be working with Phase One Medical again,” said John Mackey, President of Pelham Plastics. “We specialize in manufacturing innovative high end medical devices like the Reversus™ Hemodialysis Catheter. We look forward to supporting Phase One Medical as they prepare to commercialize this exciting technology.”
About Phase One Medical
Phase One Medical is a privately held medical device research and development company focused on early stage development and small part design and manufacture. The company has made the strategic decision to commercialize devices developed in house.
The company is currently focused on development of chronic hemodialysis catheters that will improve product performance and most importantly begin to reduce the high rates of complications and cost associated with catheter use. Catheters are an essential vascular access option for a large percent of the worldwide hemodialysis population. Approximately 2 million patients worldwide receive hemodialysis three times a week. Hemodialysis requires access to a patient’s vascular system. It’s estimated that up to 30% of those patients receive their vascular access through the use of chronic hemodialysis catheters. Phase One Medical is committed to developing catheter based technology that will deliver device solutions to clinical problems associated with catheter use.
The Reversus™ Hemodialysis Catheter has not been evaluated by the United States Food and Drug Administration (FDA) and is not for sale or approved for commercialization.