A prominent Harvard and Brigham and Women’s Hospital investigator presented 24-month outcomes data from the SCOUT clinical trial last week at the Society for Minimally Invasive Surgery (SMISS) Annual Meeting in Las Vegas, Nevada. The study evaluated the Spineology Interbody Fusion System (SIFS) as part of an investigational minimally invasive surgery for patients with degenerative disc disease.
The Investigational Product & Procedure
The SCOUT study uses the Spineology interbody Fusion System (SIFS) graft containment device was used in this study. The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Spineology’s OptiMesh deployable implant received 510(k) clearance from the FDA many years ago back in 2003 for graft containment within the vertebral body. The SCOUT trail is designed to generate clinical data in support of a regulatory submission to FDA for expanded indications, enabling the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful degenerative disc disease.
The SCOUT Trial
SCOUT (Spineology Clinical Outcomes Trial) addressed lumbar degenerative disc disease and the use of advanced fusion implants for reduction end points in pain reduction, function fusion and safety assessments. This FDA regulated prospective, multi-center, Institutional Review Board (IRB) approved single-arm performance goals, and a clinical investigation was planned to be conducted at a minimum of 15 centers with no more than 102 participants enrolled and treated. The study sponsors planned on a 24 month study. Participants were actively evaluated to 24-month postoperative and depending on enrollment duration, considered remotely assessment through self-administration surveys at 36- and 48-months. The primary end point, assessed at 24-months postoperative, is a composite score that includes pain, function and safety assessments.
Clinical Investigational Sites
Clinical investigational sites for this study included Florida Orthopaedic Associates (DeLand, FL); Spine Institute of Louisiana (Shreveport, LA); Thibodaux Regional Medical Center (Thibodaux, LA); Georgetown University Hospital (Clinton, MD); Brigham & Women’s Hospital (Boston, MA); Sports Medicine North (Peabody, MA); Bronson Healthcare Methodist Hospital—Neuroscience Center (Kalamazoo, MI); May Clinic Hospital—College of Medicine (Rochester, MN); University of Buffalo/SUNY (Buffalo, NY) and University of Vermont Medical Center (South Burlington, VT).
The Results Thus Far
Thus far the study met its enrollment targets—102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion, the patients have been enrolled thus far at one of 10 participating clinical study sites—again study enrollment is complete. 82 of the patients have completed 24-month follow-up to date and 17 patients remain to be treated and assessed.
Substantial improvements were seen at six, 12 and 24 months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. Current data available through 24 months yields a fusion rate of 98.0 percent, as read on CT by two independent radiologists. Approximately 90 percent of subjects reported “Excellent” or “Good” patient satisfaction at six, 12 and 24 months. An excellent safety record was reported as there were no unanticipated adverse events and no interbody device-related serious adverse events.
Spineology’s John Booth reports, “We are very pleased to know that SCOUT patients have reported highly positive outcomes early on, and these improvements have been maintained or increased over time. We look forward to completing follow-up and gaining the clearance that will allow us to market this unique fusion device. We are grateful to Dr. Chi and all the SCOUT investigators for their commitment to this important clinical trial.”
Spineology: The SCOUT Sponsor
Spineology positions itself as a “anatomy conserving company.” Founded by Dr. Stephen Kuslich (who tragically passed in 2004) in 1997, the St. Paul, MN-based venture positions itself as a pioneer in minimally invasive spine surgery and the inventor of the company’s Optimesh technology, they embrace surgeon-driven innovative design. Led by John Booth, their product portfolio centers on next-generation interbody, fixation, and access systems all designed to conserve bone, nerve and muscle tissue. A company mission, they are committed to increasing procedural efficiency, reducing post-operative pain and accelerating patient recovery.
Business & Financial
They have raised over $21 million and presently leverage debt financing tactics. For example, a couple of years ago they raised $5 million via Hermed Capital, a Chinese private equity fund based in Shanghai, China, infused $5 million into the company in the form of a convertible debenture. This means that the proceeds are a loan but could be converted to stock. Dr. Jerry Xiao, Managing Director of Hermed Capital noted, “Spineology possess a very novel product portfolio in an otherwise homogenous market. We look forward to working with them as they grown in the U.S. and hope to be able to leverage our resources as they begin to explore global opportunities.”
TrialSite News estimates Spineology employs about 75 to 100 employees and incurs costs of about $10 million per annum. Undoubtedly the financing from the Chinese PEG was used to continue the R&D, clinical and commercialization momentum.
The Rampart One and Duo system were recently approved for market. The Duo System reduces the surgical access required for lateral procedures while offering a large conforming device footprint. The Rampart One System minimizes exposure requirements associated with anterior spinal fusion procedures and is made from Invibio® PEEK-OPTIMA® HA Enhanced material.
John Chi, MD, MPH, Associate Professor of Neurosurgery, Harvard Medical School; Director of Neurosurgical Spinal Oncology, Brigham and Women’s Hospital, Boston, MASource: Spinology