EAST PROVIDENCE, R.I.--(BUSINESS WIRE)--IlluminOss Medical, a privately held, commercial stage medical device company pioneering the development of minimally invasive, customized orthopedic implants for the stabilization and treatment of bone fractures, today announced the appointment of Frederick Tobia as vice president regulatory and clinical affairs. He brings more than twenty years experience in regulatory, quality and clinical affairs to IlluminOss as the company is developing plans to secure US regulatory approval for the company’s 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 US and abroad, as well as supporting successful launch and sales strategies. He certainly will be an asset for IlluminOss as we navigate US 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 revolutionary 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 EU for light to low-load bearing indications, IlluminOss has developed a growing patient case tracker and evidence of excellent outcomes. IlluminOss is seeking US FDA 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.”
Mr. 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.
About IlluminOss Medical
IlluminOss Medical is a privately-held, commercial stage medical device company focused on designing, developing and marketing orthopedic fracture repair products that leverage its proprietary bone stabilization technology, Photodynamic Bone Stabilization System (PBSS). This minimally invasive technology allows for fracture fixation through patient specific intramedullary implants. The PBSS System utilizes a light-curable polymer, contained within an expandable balloon catheter, to achieve bone stabilization. The revolutionary procedure is made through a small percutaneous surgical approach providing patients and clinicians with a fast, patient-customized, method of orthopedic bone stabilization. The company currently markets its products in international countries under a CE Mark for approved clinical applications through both a direct sales force and distribution networks. Founded in 2007, IlluminOss is headquartered in East Providence, RI, and funded by Foundation Medical Partners, New Leaf Venture Partners, Tekla Capital, Life Sciences Partners, SR One, Longwood Fund, Excel Venture Management, Pappas Ventures, Mieza Capital and Slater Technology. Learn more at www.illuminoss.com.
The IlluminOss products are Investigational Devices; limited by Federal law to Investigational Use and are not approved for sale in the USA.