Cantel Medical and OsteoSymbionics Announce FDA 510(k) Clearance of ClearShield™ Implant Using Novel REVOX® Sterilization Process
LITTLE FALLS, N.J. and CLEVELAND, May 28, 2014 -- Cantel Medical Corp. (NYSE: CMN) and OsteoSymbionics, a leading designer and manufacturer of innovative, patient-specific craniofacial implants, are pleased to announce FDA (U.S. Food and Drug Administration) 510(k) clearance of OsteoSymbionics' signature ClearShield™ product made from Polymethyl methacrylate (PMMA). ClearShield™ is the first Class II medical device cleared by the FDA utilizing REVOX® Sterilization Solutions' room temperature peracetic acid/hydrogen peroxide (PAA) vacuum vapor sterilization process. ClearShield™ implants are used in patients who have suffered trauma to the skull, restoring the protective and cosmetic features of the individual's own bone.
Dorothy Baunach, CEO of OsteoSymbionics says, "REVOX® is the perfect solution for the sterile processing of our ClearShield™ craniofacial implants. More and more hospitals are discontinuing on-site use of ethylene oxide (EtO) sterilization and we needed a solution that would offer fast contract service turnaround and potential for processing at our manufacturing site as well. After much research into sterile processing options we discovered REVOX®, with the right technology and all the resources we needed to help our small, but well-respected company, work toward this ideal solution."
Jorgen Hansen, COO of Cantel Medical comments, "We are pleased that REVOX® Sterilization Solutions is able to facilitate the use of this innovative and critically important device. With increasing sophistication of medical, diagnostic, drug delivery, and implantable devices, REVOX is a timely alternative for manufacturers such as OsteoSymbionics. This 510(k) clearance underscores the safety and efficacy of the REVOX sterilization process and more broadly, our new product and market expansion capabilities within Cantel."
OsteoSymbionics is dedicated to the design, development and fabrication of the highest quality patient-specific craniofacial implants for patients with severe cranial and facial damage. The company's hard-tissue implants are used by top surgeons at America's leading hospitals and abroad. More than 850 patients have benefitted from ClearShield™ (PMMA) and PK-Shield™ implants made from Polyether ether ketone (PEEK). OsteoSymbionics also makes a silicone product, STT™, designed to correct temporal hollowing.
Using state-of-the-art digital technology and custom software, our biomedical engineering experts work closely with classically trained sculptors and artisans to create implants that precisely match both the surgeon's plan and the patient's needs. Cases requiring implants above average in size or difficulty of design are a specialty.
OsteoSymbionics is an awarded supplier of its Craniomaxillofacial (CMF) products to Novation, a premiere group purchasing organization serving more than 60,000 members.
Founded and located in Cleveland, Ohio, OsteoSymbionics is active in the region's vibrant community of businesses focused on bioscience technologies and health care services and products. The company is housed within the multi-tenant facility of the Manufacturing Advocacy and Growth Network (MAGNET).
For more information about OsteoSymbionics and its products, please call 877-881-6899 or visit our website at www.osteosymbionics.com
About REVOX® Sterilization Solutions
Collaboratively developed and marketed by Cantel subsidiaries Medivators and Mar Cor Purification, REVOX Sterilization Solutions offers the first commercially available room temperature vapor sterilization process. With full contract validation and sterilization services as well as on-site processing potential with multiple chamber configurations, REVOX Sterilization Solutions is positioned to foster increased innovation and production efficiencies for manufacturers of advanced devices.
For more information, please visit our website at revoxsterilization.com.
About Cantel Medical Corp.
Cantel Medical (NYSE: 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. For further information, visit the Cantel 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 Cantel Medical Corp.