ReconSports Medicine

IlluminOss Medical Announces the Successful Treatment of First U.S. Patients with Innovative Light-Curable Bone Stabilization System

East Providence, RI  (June 23, 2015) – IlluminOss Medical, a commercial stage medical device company focused on minimally invasive orthopaedic fracture repair, today announced that the first two U.S. patients have been treated through Marshall University Joan C. Edwards School of Medicine in  collaboration with Cabell-Huntington Hospital and the Marshall Clinical Research Center  as part of its U.S. Lightfix clinical trial for the treatment of impending and pathologic fractures in the humerus due to metastatic carcinoma.

The surgeries were performed by Felix Cheung, MD, associate professor and chief of the Division of Orthopaedic Oncology. Dr. Cheung is a board certified orthopaedic surgeon specializing in tumors of the musculoskeletal system and joint replacement surgery.

Gene DiPoto, senior vice president of R&D at IlluminOss Medical, worked closely with Dr. Cheung and his team to facilitate the successful treatment of the first U.S. patients.

IlluminOss Medical’s groundbreaking approach to orthopedic fracture repair leverages its proprietary bone stabilization technology, the IlluminOss System – the world’s first and only system of its kind offering significant advantages for the treatment of fractures. IlluminOss’ minimally invasive technology allows for fracture fixation through patient-specific intramedullary implants utilizing a light-curable polymer, contained within a balloon catheter. The simple, percutaneous surgical approach enables surgeons to create a first-of-its-kind patient-conforming implant providing internal support of bones affected by cancer.

With the assistance of his colleague, Franklin D. Shuler, MD, PhD, an associate professor and vice chair of research in the Department of Orthopaedics, and the staff at the Marshall Clinical Research Center, Dr. Cheung utilized IlluminOss’ technology in the treatment of two patients, both of whom had metastatic cancer with pathologic fractures of the humerus.

“We are excited for the opportunity to be the first clinical site in the U.S. to apply IlluminOss’ technology to the treatment of a patient with a complex fracture and the results have been remarkable,” said Dr. Cheung. “The patients were completely stable immediately following the procedure and reported little to no discomfort. Having seen firsthand how effective the IlluminOss System is, I believe the benefits it provides to both the surgeon and the patient have the potential to make it a true game-changer in the way fracture repair can be approached.”

The IlluminOss System has proven successful in the treatment of over a thousand patients in Europe, where it is commercially available and has been in clinical use since 2010.  Benefits observed from the use of the IlluminOss product in patients include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant and the small diameter of the flexible catheter gives the surgeon greater freedom of surgical approach. In many cases it allows the patient to get back to daily activities more quickly without the hindrance of a hard cast.

“We have had tremendously successful results treating complex fractures with the IlluminOss System internationally and are excited to now begin applying it to the treatment of patients with impending and pathologic fractures in our first U.S. trial,” said Robert Rabiner, president of IlluminOss Medical. “The Joan C. Edwards School of Medicine is renowned for its commitment to providing excellence in both medical education and patient care and we are appreciative for the opportunity to work with such a well-respected team – led by Dr. Cheung – to help validate the effectiveness of our technology in the U.S.”

IlluminOss is currently enrolling patients at other U.S. surgical sites in the Lightfix clinical trial. For additional information about this trial please refer to NCT 02338492.

About Marshall University School of Medicine

The Marshall University School of Medicine was established in the 1970s through federal legislation which authorized the creation of five new medical schools in conjunction with existing VA hospitals.   The West Virginia Legislature appropriated funding for the school in 1975, the Liaison Committee on Medical Education granted provisional accreditation in 1977, and the first class entered in January 1978.

Today, the highly-qualified health care providers of Marshall University’s Joan C. Edwards School of Medicine, collectively known as Marshall Health, care for patients at more than a dozen locations in the region. Offering the latest in high-quality, multi-disciplinary health care, they serve patients from nearly 29 counties in three states and is the largest, most comprehensive health care provider group in the region.

About IlluminOss

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, the IlluminOss System. This minimally invasive technology allows for fracture fixation through patient specific intramedullary implants. The 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-specific, 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.

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