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Restore Medical Solutions was one of the first companies to participate in the accelerated device development program.
Restore Medical Solutions (RMS), one of the original startups that participated in the inaugural ZeroTo510 cohort, will proceed to a full round of venture capital funding led by Innova Memphis and MB Venture Partners. ZeroTo510 is a program hosted in Memphis, Tenn. by Innova, MB Venture Partners, The Memphis Bioworks Foundation and the Seed Hatchery. The program takes submissions from small startups that have an idea for an innovative medical device, and if accepted, the startup will receive $50,000 in seed capital as well as the chance to pitch its idea to investors. If accepted to Phase II of the process, the startup receives an additional $100,000 in investment money. The name of the program refers to the 510(k) clearance pathway from the U.S. Food and Drug Administration (FDA). Financial terms of the investment in RMS were not released, but the reported multimillion-dollar deal may include additional investors, said Jan Bouten, partner at Innova and ZeroTo510 advisor. During the recent ZeroTo510 Investor Day, RMS representatives requested an initial investment of $2.5 million. The move toward venture capital funding indicates that the company, which designed a modular tray and method for reprocessing sterile surgical instruments and already has a customer base, is at a mature market-entry position. RMS is awaiting clearance for its product from the FDA, which should take about 90 days. During that time the company will not be able to sell its product, but may continue medical trials with participating hospitals. The device RMS pitched to investors and which it will be marketing upon FDA clearance is a tray system and method designed to lessen the touch points within the surgical flow of instruments being used in surgery. The intention is that this system will increase efficiency of the instrument reprocessing process that happens hundreds of times per day in a medical facility. According to the company, the system has the capability of reducing reprocessing times by 60 percent, thereby showing an increase in surgical volume that can range from two up to 25 cases per day depending on the facility. RMS argued to investors that this would translate into increased revenue and number of patients seen.
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