PolarityTE registers bone repair product with FDA

PolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA.

The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells.

In preclinical trials, OsteoTE regenerated bone with similar characteristics to natural bone, according to PolarityTE. The company also suggested that the product has shown promise in preclinical studies to be a viable alternative to bone grafts in treating long bone, craniomaxillofacial, spine, dental, hand and foot/ankle defects.

“With the registration of OsteoTE with the FDA, we remain on track to meet our goal of commercialization through a phased release starting in early 2019,” chairman & CEO Dr. Denver Lough said in prepared remarks.

“OsteoTE is the second product from our platform technology which is based on understanding how cells across the body work and how they can be deployed to regrow where needed. Through OsteoTE, we are giving providers an advanced regenerative solution that challenges current standards of care and improves patient outcomes,” he added.

The company’s first product, which was in a limited market roll-out earlier this year, is a skin regeneration product used for burn reconstruction.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW