Tyber Medical announces 510(k) FDA clearance for modified surface treatment
Tyber Medical LLC announced it has received FDA clearance for its BioTy, a modified surface treatment to use on the company’s headless screw system.
According to a company press release, Tyber Medical also has expanded its exclusive licensing agreement with Northwestern University in order to enhance the proprietary technology and intellectual property of BioTy. According to the release, BioTy is a non-scale technology that modifies the surface characteristics of medical devices for yet to be disclosed advanced indications.
Tyber Medical and Northwestern University have conducted several studies on BioTy to analyze the cellular response with the new technology. The company reportedly expects the results to indicate a significant decrease in bacterial adherence with the use of the technology compared with the use of non-surface modified implants.
Rui Ferreira, vice president of research and development at Tyber Medical, said with the new technology, the company looks to set a new standard for orthopedic implants and that the technology can be used across the market.
“With the excellent reputation of Northeastern University as a research institute, as well as Tyber Medical’s expertise in rapid device development and surface modification, the BioTy modified surface treatment technology and exclusive licensing agreement go hand in hand with Tyber Medical’s business model of providing rapid access to portfolio enhancing technologies,” Jeff Tyber, chief executive officer and president of Tyber Medical, said in the release.
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