Memphis Medical Device Company Achieves FDA and Canadian Regulatory Milestones

Restore Medical Solutions Announces FDA 510(k) Clearance and ISO 13485 Certification With CMDCAS

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Restore Medical Solutions
These clearances allow us to market our products domestically and internationally, and they show that our product is safe, effective and meets regulatory requirements in both the United States and Canada.

Memphis, TN (PRWEB) September 12, 2013

Restore Medical Solutions Inc., a leader in the development of innovative packaging systems for optimized surgical instrument reprocessing, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s novel Modular Sterilization Tray System.

Restore™ is also pleased to announce that it has successfully completed the certification process for internationally recognized medical device specific quality management standards ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS). Certification was conducted by BSI Group, one of the world′s leading certification bodies.

Achieving these certification milestones demonstrate Restore’s commitment to providing the highest quality products to its customers and brings Restore™ one step closer to solidifying its global market presence.

“These clearances allow us to market our products domestically and internationally, and they show that our product is safe, effective and meets regulatory requirements in both the United States and Canada,” said Ryan Ramkhelawan, Restore™ Chief Executive Officer.

Founded in Atlanta and now headquartered in Memphis, Restore Medical Solutions specializes in increasing efficiency and productivity in the estimated 6,000 hospitals and 5,000 surgery centers in the United States that utilize and reprocess re-usable surgical instrumentation. The company's patent-pending technology, its Modular Sterilization Tray System, has shown up to a 60 percent improvement in efficiency on surgical instrument reprocessing times. In addition, it provides reduced potential for surgical site infections, increased instrument/asset accountability, decreased breakage due to poor care and handling, reduction of disposable wraps and accessories, and standardization of terminal sterilization packaging, which will reduce poor outcomes associated with processing variability.

“Our product allows hospitals to clean and re-sterilize surgical instruments more efficiently, saving time and money," said Shawn Flynn, President. "More importantly, it improves the sterilization process, reducing the chances that a patient will be infected by contaminated instruments.”

The sterilization system was developed utilizing both Ramkhelawan’s and Flynn’s experience in process improvement and sterile processing in the one of the largest Level-1 trauma centers in the southeastern United States.

Restore Medical Solutions was a member of the inaugural ZeroTo510 Medical Device Accelerator in 2012, a program offered by Memphis Bioworks Foundation. The goal of ZeroTo510 is to help medical device entrepreneurs navigate the start-up process, refine their business models and achieve the Food and Drug Administration’s 510(k) pre-market notification filing. Results of the first program were outstanding, with Restore™ closing on a $2.5 million series A round of funding, co-led by Innova Memphis and MB Venture Partners.

About Restore™ Medical Solutions

Restore Medical Solutions is a medical device company focusing on products and techniques that promote efficiency and productivity within healthcare. Formed in Atlanta in 2011, the company moved to Memphis, TN in 2012 to participate in the inaugural class of the Memphis Bioworks ZeroTo510 Medical Device Accelerator program. Upon completion of the three-month accelerator, Restore™ secured venture capital funding and advanced their initial product concept to full development of the company's primary product line. To date, Restore™ has filed patents for their products, technology and methodology, obtained FDA clearance and ISO 13485 certification with CMDCAS, verified their product claims through independent laboratory testing, secured assembly/distribution space and its website is (http://www.restore-med.com).

About Innova Memphis

Founded in 2007 by the Memphis Bioworks Foundation, Innova is a pre-seed, seed and early-stage investor. Our mission is to enable and create high-growth, Tennessee-based companies and jobs in the healthcare and technology fields by providing seed capital and experienced hands-on mentorship and leadership. ([http://www.innovamemphis.com)

About MB Venture Partners

MB Venture Partners is a Memphis-based venture capital firm that provides capital and strategic direction to life sciences start-ups. The firm invests in medical device and biotechnology companies at all stages. Since inception in 2001, the firm has invested in 40 start-ups. (http://www.mbventures.com)


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