Memphis Startup Restore Medical Becomes First To 510 (K) Out Of Zero To 510 Accelerator

Restore Medical Solutions, Memphis startup, 510KThe ZeroTo510 startup accelerator in Memphis Tennessee is the first cohort-based medical device startup accelerator in the country. The joint venture between Start Co and Memphis Bioworks puts medical device companies through an accelerator program and helps shape scientists and engineers into startup founders.

The other, important goal for ZeroTo510 is getting these medical device startups to the 510(k) approval from the FDA. This approval is a quicker path to market roughly based on the idea that your product is expanding on an idea or improving an idea previously approved by the FDA. In short a typical FDA approval for a new device can take anywhere from 3-10 years while a 510 (k) approval can shorten that time down to 1-3 years.

All of the companies selected for the first two completed cohorts at ZeroTo510 (summer 2012 and summer 2013) werelooking to get that approval and get their product to market.

Marston-1We’ve covered Restore Medical almost from the point when founders Shawn Flynn and Ryan Ramkhelawan made the move from Atlanta to Memphis for the accelerator at the beginning of summer 2012. At that time both founders told Nibletz that they liked Bioworks and the cohesiveness of the Memphis startup community, despite the fact that Atlanta is a much larger city.

Restore Medical has developed a system that more thoroughly, cleanly, cheaply and greenly sterilizes surgical instruments. The way surgical instruments are currently sterilized is time consuming. Not only that, but if one instrument is found to be unsterile the entire batch of instruments for a particular surgery needs to go through the process again. This can take hours at a time, so the OR teams must make a decision on whether to wake up the patient or to keep the patient under anesthesia which can be costly for the doctors and the patients not to mention dangerous.

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

Restore Medical Solutions announced on Thursday that they had received their FDA 510(k) clearance. The company is also pleased to announced 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.

“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 Ramkhelawan.

Restore Medical Solutions is moving into a larger 2500 square foot space  in the Memphis Bioworks complex which will allow them space for assembly and distribution.

You can find out more about Restore Medical Solutions here.

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