Spotlight on IlluminOss, an emerging small bones fracture repair company
This is the fifth year, as part of our Top Company Report issue, that Orthopedic Design & Technology has profiled small and midsize emerging growth firms positioning themselves alongside (perhaps with the goal of overtaking or being acquired by) larger market leaders. This year’s installment provides an overview of four orthopedic companies vying for rank, digests their technologies, examines their sectors and what’s kept them busy during the past year.
• Dirk Kuyper, President & CEO
• Robert Rabiner, Founder & Chief Technology Officer
• Gene DiPoto, Sr. VP of Research & Development
• Beth Money, Director of Operations
Sector: Fracture Repair
Location: East Providence, R.I.
Ultimate fighting is a tough sport: The kneebars, the joint locks, the heel hooks, and double-leg takedowns—among various other defensive moves—can cause some rather gruesome injuries. During a particularly brutal night in December 2008, Ultimate Fighting Championship lightweight Corey Hill fractured his tibia and fibula from a low kick by Dale Hartt; Razak ”The Razor” Al-Hassan dislocated his right elbow in an armbar from Steve Cantwell (he sported a large mass the size of a softball on his way backstage); and Jonathan Goulet tore his medial collateral ligament as he collapsed from a series of head punches by Mike Swick just 33 seconds into their match.
Robert Rabiner never cared much for the sport until a 2012 bout gave his fledgling company the chance to prove its worth. Rabiner is founder and chief technology officer at IlluminOss Medical Inc., an East Providence, R.I.-based firm that has developed a way to fix broken bones without screws, plates or casts (Hill would have been a prime candidate). The company’s Photodynamic Bone Stabilization System (PBSS) is not approved in the United States, but the innovation has healed several hundred patients in Europe over the last four years. Among the cured was an ultimate fighter who returned to the sport two weeks after fracturing the fifth metacarpal of his left hand.
Buoyed by its success in Europe (and recently adding Spain and Israel to the mix), IlluminOss executives currently are working with the U.S. Food and Drug Administration to launch clinical trials in America. ”It’s a much longer process getting approved here,” Rabiner told Brand RI, a monthly business publication of Rhode Island Monthly. ”We’ve spent more than $10 million on preclinical and clinical testing in support of this product and its safety. I believe this could be the next big idea.”
Venture capitalists appear to agree. Since its 2007 founding, IlluminOss has attracted $39 million in funding, with one investor calling the company’s technology ”an exceptionally versatile and powerful bone repair system.”
One of the factors contributing to the power of IlluminOss’ technology is its potential to remove the painful and costly obstacles of soft tissue damage, severe pain, temporary or permanent stiffness and long recovery times associated with traditional fracture fixation solutions (typically metal plates, screws and long incisions).
The company’s PBSS platform consists of inserting a permanent balloon filled with a cement-like substance into the bone to anchor it in place from within. The balloon not only leaves less scarring than conventional surgery for the insertion of plates and screws, but also eliminates the need for a second procedure for hardware removal after the bone heals. According to the company, the PBSS technique is ideal for both simple fractures and more serious ones, where the bone shatters into pieces and must be put back together again by surgeons. The procedure does not last very long and consists of several stages.
After first aligning the fracture manually, the surgeon makes a small incision in the skin, about three-quarters of an inch in length, and drills a small hole into the bone using a metal rod. A balloon-tipped catheter—similar to the kind used in angioplasties—then is inserted into the tiny canal inside the bone. When it reaches the fracture site, the surgeon fills the balloon with a liquid polymer that hardens with exposure to a special-frequency light. Next, a fiber-optic cable with a light on the end is fed through the same catheter; when the light is turned on, the liquid in the balloon solidifies in about 90 seconds, pushing the bone fragments back into place from within and encouraging natural healing.
One of the biggest advantages about the PBSS procedure is that patients can put weight on the broken bone within hours, and can return to their normal activities in just several weeks. The ultimate fighter who broke his metacarpal would have been out of action for at least six to eight weeks with traditional repair treatments.
”Two weeks later he went back to boxing,” Rabiner said in the Brand RI article. ”He’s now using that hand—quite successfully—to once again beat up other men.”
As a startup, IlluminOss does not have an extensive list of clinical success stories. But its track record nevertheless is spotless thus far: Data presented in late 2011 at the German Congress for Orthopaedics and Trauma Surgery showed the PBSS platform is effective in treating metacarpal fractures.
In a study presented at the Congress, 12 patients were treated with IlluminOss technology between January 2010 and March 2011 for metacarpal fractures (10 with fifth metacarpal fractures and two with fourth metacarpal fractures). Eleven of the patients had a fractured ray and one sustained breaks to two metacarpal bones. The patients’ average age was 27.2 years, the median operation time was 75.8 minutes and the time interval between trauma and the procedure was 5.8 days.
Four patients received an additional locking with fine-thread screws. The participants received a two-finger splint in intrinsic-plus-position of the finger for one week after surgery, then were given a twin-tape (buddy splint) for an additional one to three weeks. The average follow-up period was 13.6 months, give or take three and one-half months. All patients had free functioning with complete extension and bending of their fingers and none had rotational error. The average DASH-Score was 31.8 points. One patient had swelling and reddening around the operation site after the procedure but it healed under conservative therapy and without secondary damage.
”IlluminOss can prove itself to be a sensible alternative treatment for metacarpal fractures,” the study concluded. ”This indication has meanwhile been extended through the development of longer balloons with greater diameter for care of fractures of long tubular bones. Herewith, an implant is available that adjusts itself to the individual medullary space of the person.”
IlluminOss also has used its technology to heal fractures in the forearm, wrist and ankle. An 81-year-old woman who fell and broke her ulna was treated with the firm’s PBSS platform and left the hospital nine hours after her fracture was aligned, stabilized and closed with three sutures. She recovered uneventfully at home and maintained her independent lifestyle, according to the company.
Similarly, an 87-year-old woman who fell and broke both wrists initially was going to be stabilized, treated with casts on both arms and sent to a nursing home for recovery. Instead, her injuries were stabilized the IlluminOss way, with the fracture aligned, the implant cured and the incision closed with two sutures within 47 minutes. The patient was in the hospital overnight and was able to move both wrists without pain the next day.
In addition, a professional saxophone musician who suffered from a metastasis in his left humerus underwent the PBSS procedure to return to work quickly. Only a week after his injury was stabilized and treated, he performed a live concert.
”Our goal is to change the way surgeons and healthcare systems think about treating older patients with fractures, change the paradigm of treatment,” CEO Dirk Kuyper said. ”The whole goal is to get them back to their normal daily routine as quickly as possible. We do that substantially faster than traditional fixation methods.”