A pioneering business lured to Memphis by a tech startup program has won government approval to market its product.
Restore Medical Solutions of Memphis said Thursday the U.S. Food and Drug Administration has cleared its surgical-tool cleaning system for use by doctors..
“These clearances allow us to market our products domestically and internationally,” said Ryan Ramkhelawan, chief executive officer of Restore. “They show that our product is safe, effective and meets regulatory requirements in both the United States and Canada.”
The early-stage startup won 510(k) clearance from the FDA for a modular sterilization tray system that was perfected during a 90-day boot camp program based at the Memphis Bioworks Foundation in 2012. Originally founded in Atlanta, the company relocated to Memphis to participate in the ZeroTo510 accelerator program.
Restore received $2.5 million in early funding from Innova Memphis and MB Venture Partners, making it the most successful startup to graduate from the program. Innova is an arm of Bioworks, the agency established in 2001 to develop a tech industry. MB is a venture capital fund started in Memphis the same year by AutoZone Inc. founder J.R. “Pitt” Hyde and investment banker Gary Stevenson.
The FDA clearance is significant because it allows the company to move forward in promoting and selling its product across the country. The international certifications will further enhance the product’s image and make it more attractive in global markets.
“Our product allows hospitals to clean and resterilize surgical instruments more efficiently, saving time and money,” said Shawn Flynn, president of Restore. “More importantly, it improves the sterilization process, reducing the chances that a patient will be infected by contaminated instruments.”
The company also has completed the certification process for internationally recognized medical device quality management standards as well and for the Canadian Medical Device Conformity Assessment System.
Restore has three full-time employees, but now that the FDA clearance is in hand, the company expects to boost its staff in the coming months.