Memphis-based Restore Medical Solutions has received 510(k) clearance from the U.S. Food & Drug Administration, clearing the way for the company to begin producing and selling its RMS Modular Sterilization Tray System.

As a result, Restore has moved into around 2,500 square feet of space in the Memphis Bioworks Foundation’s office. That space will be used for assembly and distribution.

Steve Bares, executive director of the Memphis Bioworks Foundation, said getting through the FDA process in 13 months from the end of Zero to 510 provides validation for the process of collaboration between the company’s founders, the Memphis Bioworks Foundation, Zero to 510 and other people who served as advisors and mentors in the city. “We’ve built an ecosystem around them to help them become successful going forward,” Bares said. “That’s why we call it Zero to 510. They took the whole path.”

Founded in Atlanta in 2011, by Ryan Ramkhelawan and Shawn Flynn, Restore moved to Memphis in 2012 to take part in the Zero to 510 device accelerator.

Ramkhelawan said the process has been a long one for Restore.

Sometimes it didn’t work as fast as we’d like, but working fast would cause mistakes that would be costly,” Ramkhelawan said.

After receiving $50,000 in seed funding through Zero to 510, Restore received another $2.5 million in capital from Memphis-based Innova and MB Venture Partners.

Gary Stevenson, managing partner of MB Venture Partners, said the company has a strong product, and while Restore will continue to receive support from its investors, Ramkhelawan and Flynn are at the beginning of a newer process.

“Now that they’ve achieved this, they become attractive to more investors,” Stevenson said. “This is a company with young entrepreneurs who have gone from a standing start to regulatory approval.”

Flynn said what began as a two-man company will now look to assemble and distribute the RMS Modular Sterilization Tray system and create new jobs in the city. The company can now officially make purchase orders for potential customers who were waiting for the FDA clearance to be completed.

“Being a class 2 medical device, we couldn’t market or sell our product until we received FDA clearance,” Flynn said. “Without that, we couldn’t even get into sales. We rolled up our sleeves and did the work necessary to achieve clearance. This has been our focus 24/7.”

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