EAST PROVIDENCE – IlluminOss Medical Inc. said Monday that it has completed enrollment in its first U.S. clinical trial toward U.S. Food and Drug Administration approval of its IlluminOss System, a minimally invasive system to repair bone fractures.
The clinical outcomes data collected will allow IlluminOss to submit a DeNovo marketing application to the FDA and seek marketing clearance for its advanced fracture repair solution in the United States next year.
“We are pleased to have completed enrollment in our U.S. trial and exceedingly satisfied with the feedback we have received so far from participating surgical sites,” Manny Avila, president and CEO of IlluminOss, said in a statement. “Consistent with what we have observed in international use cases, the IlluminOss System has demonstrated benefits to both orthopedic surgeons and their patients. The IlluminOss implant has the potential to redefine how complex fracture repair may be approached, pending FDA clearance.”
According to a company press release, 13 surgical sites around the country participated in the trial, including Rhode Island Hospital, and 80 patients were treated, all of whom had impending or pathologic fractures in the humerus due to metastatic carcinoma.
“We’ve seen that the IlluminOss implant can be a game changer for patients with humeral metastatic disease. This technology allows us to stabilize the bone with less pain, less surgical time and less difficulty for the patients. We can therefore treat this problem on an outpatient basis in some patients, and can condense treatments fairly dramatically,” Dr. Richard McGough, chief of musculoskeletal oncology at the University of Pittsburgh Medical Center, said in a statement. “I’m very excited by where this can go in the future, pending FDA approval, as I think this technology could allow us to treat conditions we formerly could not, and can offer ways to treat cancer in the skeleton that were previously impossible.”
The privately-held, commercial stage medical device company’s system incorporates the use of a thin-walled PET balloon infused with a liquid monomer that is inserted into the intramedullary canal of the bone conforming to the shape of the patient’s specific bone.
The device then forms a hardened 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, according to the company.
Developed as an alternative to the currently used nails and plates, IlluminOss said its implant has the potential to provide better patient experiences and outcomes.
The IlluminOss System has been approved for clinical use since 2010 in international markets, and has been used in the treatment of more than 1,500 patients worldwide. The company said it results in smaller incisions, shorter procedure times and quicker post-procedure patient mobility with decreased hospital stays and lower complication rates.
In addition to Rhode Island Hospital and the University of Pittsburgh Medical Center, surgical sites participating in the trial included: Memorial Sloan Kettering Cancer Center, Marshall University Medical Center, Duke University Medical Center, Hackensack University Medical Center, Wake Forest Baptist Medical Center, Medstar Franklin Square Medical Center, Stanford University Medical Center, Ohio State University Wexner Medical Center, Medstar Washington Hospital Center, Emory University Hospital, and Rush University Medical Center.