Plymouth, MN – May 14, 2014 ‐ Mar Cor Purification, a subsidiary of Cantel Medical (NYS:CMN) announced today that it has been given 510(k) clearance (K133149) from the FDA for the BioPure HX2, a Heat Disinfectable Central Reverse Osmosis (RO) Water System for Dialysis. The BioPure HX2 is a Double Pass RO with automatic hot water disinfection with 4 different modes. Mar Cor had previously been awarded a Class 3 Device License from Health Canada in 2013 for the system, which has been available in the Canadian and international markets for over a year.
The system is designed to produce high quality water and distribution for large capacity applications up to 50 stations and/or 1000 foot loop lengths. An added feature to the design is the ability to operate either as a double pass RO or as a single RO in the event of any issues with either pass. In order to reduce the carbon footprint of the system, the system is outfitted with VFD drives and automatic adjustment of product flow and reject flow based on demand and feed water quality, conserving water and energy. The system will be manufactured in the Mar Cor ISO 13485/CMDCAS registered factory in Burlington, Ontario and conforms to various standards including but not limited to: CAN/CSA C22.2#61010‐1 Standard for Electrical Safety and IEC 61326‐1 Electrical Emissions‐ General Requirements.
John Rickert, VP Medical Sales, noted, “The BioPure HX2 is a next generation, state of the art RO and Distribution system that will meet and exceed the stringent requirements for dialysis and hemodiafiltration water treatment anywhere in the world. I am excited to bring this high technology product to the U.S. market. The system is designed to install quickly, incorporate energy recovery technologies, automatically heat disinfect the entire system, and employs sophisticated hydraulic and pneumatic controls to automatically adjust critical parameters to optimize the system operation.”
About Mar Cor Purification
Mar Cor Purification, a wholly‐owned subsidiary of Cantel Medical Corp. (NYSE:CMN), is the largest supplier of dialysis medical water systems in North America. It has service offices in 27 cities in the United States and Canada, with seven ion exchange resin regeneration plants strategically located in Atlanta, Boston, Chicago, Philadelphia, San Antonio, Montreal and Toronto. Mar Cor also provides turnkey water purification systems to high purity clients including pharmaceutical, cosmetics, semiconductor and other bacteria controlled applications. Filtration/separation products and disinfectants are provided to the same customer base in addition to a separate worldwide distributor network. Visit our website at mcpur.com, or find out more about the BioPure HX2 at mcpur.com/dialysis/biopurehx2
About Cantel Medical Corp.
Cantel Medical (NYS: CMN) is a leading global company dedicated to delivering innovative infection prevention and control products and services for patients, caregivers, and other healthcare providers which improve outcomes, enhance safety and help save lives. Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products, and specialty packaging for infectious and biological specimens. Additionally, we provide technical service for our products. Visit our website at www.cantelmedical.com
This press release contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including, without limitation, the risks detailed in Cantel’s filings and reports with the Securities and Exchange Commission. Such forward‐looking statements are only predictions, and actual events or results may differ materially from those projected or anticipated.
SOURCE: Mar Cor Purification
Vice President Marketing
Mar Cor Purification