IlluminOss Medical, Inc. is pleased to report that it has received a conditional “green light” from the FDA to conduct a clinical trial for the treatments of impending and pathologic fractures in the humerus due to metastatic carcinoma.
According to the November 18, 2014 news release, IlluminOss’ Photodynamic Bone Stabilization System (PBSS) is the world’s first and only system of its kind and offers significant advantages for the treatment of complex fractures. “Benefits observed from the use of the product in patients include smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates.”
“The minimally invasive procedure incorporates the use of a thin walled PET [pericardial effusion with tamponade] balloon that is infused with a liquid monomer and inserted into the intramedullary canal of the bone conforming to the shape of the patient’s specific bone. The device forms as an implant once the surgeon activates the visible light delivered within the PET balloon. Once cured, the implant provides longitudinal strength and rotational stability over the length of the implant.”
Dr. Martin Malawer, director of the Orthopedic Surgical Oncology and Professor of Orthopedic Surgery at George Washington University Hospital and Professor (Clinical Scholar) of Orthopedic Surgery at Georgetown University, will lead the first U.S. trial of PBSS.
“From what I have seen to date, IlluminOss’ Photodynamic Bone Stabilization System could prove to be a true disruptive technology in the treatment of pathological and non-pathological fractures by orthopedic surgeons, ” said Dr. Malawer in the November 18, 2014 news release. “This technology will potentially reduce surgery time and morbidity rates, as well as lessen complications and improve patient outcomes.”
“We have been exceedingly pleased with the results that surgeons internationally have achieved using our Photodynamic Bone Stabilization System and we are confident that we will see similar benefits for patient outcomes in the U.S. clinical trials, ” said Robert Rabiner, president and founder of IlluminOss Medical, in the news release. “Obtaining this FDA approval has been the vital first step towards ultimately applying our technology to the treatment of fractures in the U.S. and we look forward to serving this critical market.”
Dr. Malawer told OTW, “With the first U.S. clinical trial we expect to duplicate the successful findings that have been achieved in Europe where IlluminOss’ PBSS has been safely and effectively used in over 500 procedures to date. In my opinion, based on 35 years of experience as an orthopedic oncologist, PBSS will prove to be a truly disruptive technology that will change the surgical method of choice for providing stability for most metastatic tumors, and potentially also for non-metastatic fractures.”
