October 5, 2020
ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce full enrollment of its 200-patient Duo™ Expandable Interbody Fusion (IBF) System Post-Market Study, called RaDical. The RaDical Study is a prospective, Institutional Review Board (IRB)-approved, multi-center lateral interbody fusion study. It follows subjects for two years and measures intraoperative and postoperative metrics along with short- and long-term outcomes in a real-world patient population.
The Duo Expandable IBF System offers a unique implant design that is placed through an 18 mm portal tube. This minimizes retraction of the neural structures and psoas muscle to reduce or eliminate the neurological deficits commonly associated with traditional lateral interbody fusion procedures. The Duo implant is then filled with bone graft in situ to expand the device in all directions, providing a large, endplate-conforming, load-sharing interbody construct.
Data from the first 115 patients enrolled in the RaDical study demonstrated the Duo System’s benefits to the patient, surgeon and hospital when compared to traditional lateral interbody fusion systems, including:
– Reduced neurological deficits following surgery1
– 33 percent decrease in total operative time1
– 37 percent shorter hospital stay1
– Lower complication rate1
“The RaDical Study is one of the most innovative lateral studies ever conducted,” said study investigator Dr. Pierce Nunley, Shreveport, Louisiana. “We’re measuring subjective and objective data and looking at anterior thigh pain and weakness as early as two weeks post-op, which, to my knowledge, has not been done before. We have seen exciting results with the Duo System, including a very low onset of new neurological events, reduced surgical times, and shorter hospital stays.”
“We are extremely pleased to complete enrollment in the RaDical Study and see the positive impact of the Duo System design,” said John Booth, CEO, Spineology Inc. “Based on the data compiled to date, patients are experiencing long-term, clinically meaningful improvements in pain and function; high fusion rates; and fewer neurological deficits and complications compared to traditional lateral interbody fusion surgery. The data also shows a very positive economic impact to hospitals with shorter operative times and hospital stays compared to traditional lateral interbody fusion surgery. We look forward to collecting complete data on all 200 patients enrolled in the study and expect to see continued favorable outcomes, which will provide further evidence of the system’s benefits to patients, surgeons and hospitals.”
“My patients have had no neurologic issues post-operatively and far less pain,” added study investigator Dr. John Malloy, Coconut Creek, Florida. “This has resulted in shorter hospital stays and faster recovery.”
- Data on file
About Spineology Inc.
At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh® and Duo implants, which expand in three dimensions to create a large footprint and allow placement of an anatomy-conforming interbody fusion device through a very small incision. This technology preserves spinal anatomy, accelerates patient recovery, and increases procedural efficiency. Learn more at spineology.com.
John J. Booth, Chief Executive Officer