IlluminOss Names VP of Regulatory Affairs

East Providence, R.I.-based IlluminOss Medical, a privately held company developing minimally invasive, customized orthopedic implants for the stabilization and treatment of bone fractures, has named Frederick Tobia as vice president regulatory and clinical affairs.

Tobia brings more than 20 years of experience in regulatory, quality and clinical affairs to IlluminOss as the company is developing plans to secure U.S. regulatory approval for its proprietary Photodynamic Bone Stabilization System (PBSS).

“Fred brings to the IlluminOss team deep regulatory experience and leadership in many areas including device, orthopedics and general surgery,” said Dirk Kuyper, president and CEO of IlluminOss. “He has successfully led regulatory and clinical affairs teams through various approval processes in the United States and abroad, as well as supporting successful launch and sales strategies. He certainly will be an asset for IlluminOss as we navigate U.S. regulatory pathways for our innovative, minimally invasive fracture repair system.”

The minimally invasive PBSS enables clinicians to repair bone fractures using a light-curable polymer contained within an expandable balloon catheter, to achieve bone stabilization. The procedure is made through a small percutaneous surgical approach providing patients and clinicians with a fast, customized, method of orthopedic bone stabilization. As a commercial stage company with marketing authorization in the European Union for light to low-load bearing indications, IlluminOss has developed a growing patient case tracker and evidence of excellent outcomes. IlluminOss is seeking U.S. Food and Drug Administration approval as well as an expansion of its EU label.

“IlluminOss’ innovative technology for the stabilization and treatment of bone fractures has the potential to improve patient outcomes and provide cost savings to the health care systems in the US and abroad,” said Tobia. “I look forward to leading a dynamic team through the FDA 510(k) clearance process and lead regulatory and clinical efforts as we expand European commercialization efforts.”

Tobia most recently served as director for regulatory and clinical services at Aptiv Solutions where he managed daily operations of the company’s clinical and regulatory services groups and assisted clients in ensuring compliance with regulations in various countries where their medical devices were on the market.

He holds a bachelor of science in biology from Providence College and a certificate in public health from Harvard School of Public Health.