MCRA Assists IlluminOss Medical with Successful De Novo Decision: 1st Orthopedic De Novo Approved by the FDA

WASHINGTON, Jan. 23, 2018 /PRNewswire-USNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of a de novo by the U.S. Food and Drug Administration (FDA) on December 19, 2017, enabling IlluminOss Medical, Inc. to initiate commercialization in the U.S. of the Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.

IlluminOss Medical retained MCRA in August of 2016 to lead interactions and correspondence with the FDA for the Bone Stabilization System. The IlluminOss System is a PET balloon infused with a photodynamic monomer, which when exposed to light, polymerizes the monomer, resulting in a solid intramedullary (IM) rod. This is an important treatment option for the fixation and stabilization of actual and impending pathological fractures of the humerus through a minimally invasive procedure. IlluminOss Medical's Founder & Chief Technical Officer, Robert Rabiner said "Being granted the first orthopedic de novo by the FDA is a significant achievement for both IlluminOss Medical and our partner, MCRA. We knew messaging and presentation of data was critical to the success of our submission, and we knew MCRA had an incredible track record of positive FDA interactions, regulatory strategies, and success. After our successful U.S. clinical trial, MCRA was able to effectively present our clinical and performance data to the FDA in a clear concise manner. Their interactions minimized the potential miscommunications with the agency, and delivered the first Ortho de novo."

Dave McGurl, Director of Regulatory Affairs, at MCRA, said "We are pleased that FDA has implemented the de novo pathway which allows innovative technologies, such as those being developed by IlluminOss Medical, find a pathway to U.S. market and ultimately to patients. MCRA is at the forefront of helping companies navigate this relatively new regulatory pathway, and achieve success in bringing novel devices to the U.S. market that was not possible even a few years ago."

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA's integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

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David W. Lown
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SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC