IlluminOss Aims to Change the Standard of Fracture Repair

Officials with IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, report that the first two U.S. patients have been treated 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 procedures took place at Marshall University Joan C. Edwards School of Medicine in collaboration with Cabell-Huntington Hospital and the Marshall Clinical Research Center in Huntingdon, W.V. The surgeries were performed by Felix Cheung, M.D., associate professor and chief of the Division of Orthopaedic Oncology. Cheung is a board certified orthopedic surgeon specializing in tumors of the musculoskeletal system and joint replacement surgery.

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

IlluminOss Medical’s approach to orthopedic fracture repair leverages its proprietary bone stabilization technology, the IlluminOss System. IlluminOss’ minimally invasive technology allows for fracture fixation through patient-specific intramedullary implants using a light-curable polymer, contained within a balloon catheter. The percutaneous surgical approach enables surgeons, according to the company, 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, M.D., Ph.D., an associate professor and vice chair of research in the Department of Orthopaedics, and the staff at the Marshall Clinical Research Center, Cheung used 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 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 been used on more than a thousand patients in Europe, where it is commercially available and has been in clinical use since 2010. 

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, company officials noted.

“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 trial.

To discuss the trial, the technology and the company’s plans moving forward, Orthopedic Design & Technology chatted with Gene DiPoto, senior vice president of R&D for IlluminOss.

ODT: Please describe the market for the technology.
DiPoto: The global fracture repair (trauma) market is more than $5 billion and growing greater than 10 percent annually. An aging, active population suffering from osteoporosis contributes to the growing issue of fragility fractures, those occurring as a result of a fall from standing height. Fragility fractures are common in women over 50 years of age and about half will suffer from one in their lifetime.  In men over 50, the occurrence of fragility fractures is one in five. In more dramatic terms, an osteoporotic fragility fracture is estimated to occur every three seconds.

ODT: What’s the need vs. current standard of care?
DiPoto: The IlluminOss implant is capable of addressing all types of bone fractures, but our initial focus has been to address the unmet need of the elderly and cancer patients.  Fractures that occur to the elder osteoporotic patient are not well treated by current standard of care metal hardware such as plates, screws and rods. As we may have observed in our aging parents, grandparents, and other relatives, the soft tissue trauma caused by the invasive surgical methods to fix broken bones are extremely slow to heal and dramatically affect their ability to function on their own. Through our experience in Europe in hundreds of these cases, the IlluminOss system can dramatically improve the recovery time for these patients, offering them a quick return to normal activities.  In the same manner, patients with impending or fractured bones as a result metastatic cancer can be treated with the IlluminOss System in a minimally invasive way to provide pain relief, quick return to function and quality of life.
 
ODT: Where did the idea for the system originate?
DiPoto: Orthopedic surgery has traditionally been quite invasive in nature. It seemed to us that there had to be a better way. Our founder, Bob Rabiner, is an avid fly fisherman and had been using light-curable adhesives for tying flies for many years, which helped spark this idea for a new, less-invasive bone stabilization system using a low-profile balloon percutaneously inserted through a tiny incision, positioned inside the intramedullary canal of a bone, and filled from the outside with the light curable liquid. As they say, “the rest is history.”
 
ODT: Would you explain how the technology works?
DiPoto: The patented IlluminOss System incorporates the use of balloon catheter constructed using a thin-walled PET balloon that is inserted percutaneously into the intramedullary canal of a fractured bone. After the balloon is positioned across the fracture, it is infused with a biocompatible light-curable liquid monomer that is fully contained within the confines of the balloon. Once filled, the balloon conforms to the shape of the patient’s intramedullary canal.  The implant is then formed when the surgeon activates the visible light source, and that light energy is transported to the inside of the PET balloon by a unique fiber optic cable about 1mm in diameter.  When the light activation cycle is completed, a strong, hardened implant provides longitudinal and rotational stability to support the bone fracture during the healing process. In many cases, the IlluminOss minimally invasive procedure allows the patient to get back to daily activities more quickly without the hindrance of a hard cast.  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.
 
ODT: What has the R&D process been like for this device?
DiPoto: The development of the IlluminOss System has been truly rewarding for the team in a number of ways. Since the technology is so unique and nothing has ever been done like this before, we had to learn, problem solve, adapt and iterate quickly. This was accomplished across many technologies including optics and light science, implant polymer science, surgical instrumentation design, and surgical technique development. During the development process, we have had the pleasure of collaborating with renowned orthopaedic surgeons from both Europe and in the US.  With the full support of our board (of directors) and investors, we have had the opportunity to continually improve the complete system making it safe, fast, simple and easy for surgeons to use.
 
ODT: How many sites will be part of your U.S. trial?
DiPoto: Approximately 15 sites across the U.S. will be participating in the IlluminOss LightFix clinical trial. The sites will include major institutions in New York (New York), Chicago (Illinois), Los Angeles (California), Atlanta (Georgia) and Boston (Massachusetts) as well as a number of academic and community hospitals in less populated areas. This geographic strategy is designed to leverage a broad base of experience which will efficiently drive enrollment and highlight the true benefits of the system.
 
ODT: What’s your expected timeline for commercialization in the United States? When do you plan to submit for U.S. Food and Drug Administration (FDA) clearance? Would this would be a 510(k) pathway?
DiPoto: We expect patient enrollment of the U.S. clinical trial to be completed in the first half of 2016. After the completion of the trial enrollment, data acquisition and analysis, a submission to FDA will immediately follow.  Based on our meetings and discussions with FDA, we anticipate clearance of the system will be through a 510(k) pathway.

IlluminOss Medical is a privately held company based in East Providence, R.I. It’s primary technology, the IlluminOss System, is designed to allow for fracture fixation through patient specific intramedullary implants. The system uses a light-curable polymer, contained within an expandable balloon catheter, to achieve bone stabilization. The procedure is made through a small percutaneous surgical approach providing patients and clinicians with a fast, patient-specific, method of orthopedic bone stabilization.

Click here to watch a simulation of how the IlluminOss technology works.