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.