San Francisco Frontiers - CGBio’s Novosis Achieves Bone Union in All Seven Patients in Scaphoid Nonunion Study

CGBio, a regenerative medicine company, announced Friday that its bone graft substitute Novosis achieved bone union in all seven patients enrolled in a preliminary clinical study for scaphoid nonunion. The treatment was administered alongside screw fixation, and the results indicate the product’s potential as an alternative to autologous bone grafting.

The clinical investigation was conducted by a research team from the Department of Orthopedic Surgery at Wonju Severance Christian Hospital, affiliated with Yonsei University Wonju College of Medicine. The study was led by Professors Park Ji-soo, Kwon Ki-youn, Ahn Hyung-joon, and Oh Jin-rok. Their findings were published in the international journal Orthopaedic Surgery under the title "Clinical and Radiologic Outcomes of NOVOSIS Grafting for Scaphoid Waist Nonunion: A Preliminary Clinical Study."

The scaphoid is one of eight small bones in the wrist, playing a critical role in wrist movement and stability. Due to its limited blood supply, fractures in this bone carry a high risk of nonunion, a condition where the fractured bone fails to heal properly. Delayed or ineffective treatment can result in chronic pain, wrist deformity, impaired mobility, and eventual wrist arthritis.

Standard surgical intervention for scaphoid nonunion typically involves harvesting autologous bone from the patient’s pelvis or the area surrounding the wrist. This procedure requires an additional incision, extends operating time, and can lead to complications such as pain or sensory abnormalities at the donor site.

Between August 2023 and December 2024, the research team treated seven patients diagnosed with scaphoid waist nonunion using Novosis combined with fixation via two compression screws. The participants had a mean age of 30 years, and surgery was performed an average of 11.5 months after the initial injury. The mean follow-up period for the study was 12.4 months.

The study included only patients in whom stable screw fixation was possible and who did not suffer from severe avascular necrosis or advanced collapse. Consequently, the effectiveness of Novosis-based surgery in such severe cases was not established within this trial.

Novosis used in the procedures consisted of 0.5 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) and a porous hydroxyapatite (HA) carrier. After removing fibrous tissue and sclerotic bone from the nonunion site, researchers implanted Novosis and stabilized the fracture with two compression screws. No additional autologous or allogeneic bone graft was utilized.

The primary outcome indicated that at the end of the follow-up period, all seven patients had achieved bone union. Radiographic confirmation of union occurred in most patients approximately three to four months after surgery.

One patient, who had previously undergone surgery with an iliac crest autograft but experienced persistent nonunion and loosening of fixation screws, underwent revision surgery. During this procedure, Novosis was used without an additional autologous bone graft, resulting in complete bone union within six months.

Pain levels and wrist function improved significantly across the cohort. The mean Visual Analog Scale (VAS) pain score decreased from 4.9 before surgery to 0.4 after surgery. The mean Mayo Wrist Score, which evaluates wrist pain, function, range of motion, and grip strength, increased from 59.3 to 94.3.

Post-surgery assessments showed that grip strength recovered to approximately 87.5 percent of that of the unaffected hand, while wrist range of motion recovered to about 89 percent. All seven patients reported satisfaction with the reduction in pain and improvement in function.

Radiographic assessments also demonstrated improved carpal alignment. The lateral intrascaphoid angle, an indicator of scaphoid deformity, improved from a mean of 51.7 degrees before surgery to 31.5 degrees after surgery. The scapholunate angle, which reflects alignment between the scaphoid and lunate bones, decreased from 65.7 degrees to 52.2 degrees.

No major complications, including infection, screw loosening, or heterotopic ossification (bone forming in unintended locations), were observed during the follow-up period. Because no autologous bone was harvested, there were also no donor-site complications such as pain or nerve injury.

Novosis is a bone graft substitute that combines rhBMP-2, which induces new bone formation, with an HA carrier that serves as a scaffold for bone growth. It is designed to provide both osteoinductive and osteoconductive properties.

The researchers stated that the findings demonstrate Novosis can achieve reliable bone union and functional recovery in scaphoid nonunion cases, potentially reducing the burden associated with autologous bone grafting. The study is significant for extending clinical evidence for Novosis, previously accumulated mainly in spine and long bone applications, to small wrist bones with limited blood supply.

The researchers cautioned that the study was a retrospective preliminary investigation involving only seven patients and lacked a control group. They noted that larger prospective comparative studies are necessary to establish the treatment's long-term safety and efficacy.

"The scaphoid is a small bone with limited blood supply, making nonunion particularly difficult to treat, so it is very encouraging that all patients treated with Novosis in this study achieved bone union and meaningful functional recovery," CGBio CEO Yu Hyun-seung said.

Yu added, "Most importantly, the findings demonstrate the potential to support bone regeneration while reducing patients’ pain and surgical burden without the need to harvest a separate autologous bone graft."

"We will continue to build clinical evidence for Novosis not only in the spine and long bones but also across a wide range of bone regeneration applications, including the hand and foot, and expand its clinical value so that more patients can regain their everyday function," Yu said.

F.Edwards--SFF