EAST PROVIDENCE, RI–(Marketwired – Jun 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. Benefitsobserved 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 www.ClinicalTrials.gov NCT 02338492.