Radiographic Evaluation of MI-TLIF Procedures Utilizing Novel Allograft Growth Factor
isto logo with name of study
HOPKINTON, Mass., October 31, 2023 (Newswire.com) - Isto Biologics, a global leader in regenerative and autologous therapies, announced today the publication of the first, peer reviewed, retrospective study, utilizing ProteiOS® in patients undergoing MI-TLIF procedures.
The study titled, ‘Radiographic Evaluation of MI-TLIF Procedures Utilizing Novel Allograft Growth Factor’ was published in the Journal of Spine and examined lumbar interbody fusion rates of ProteiOS at various time points from 3 months to 24 months. ProteiOS usage resulted in superior fusion rates as compared to reported fusion rates for autograft and other advanced orthobiologics products such as rhBMP-2 (Infuse™ Bone Graft, Medtronic) and growth factor enriched allograft bone (OsteoAMP®, Bioventus).
The publication includes 102 patients with numerous data points; a total of 124 levels evaluated for radiographic fusion at various time periods (3, 6, 12, 18, and 24 months) were assessed by a blinded, independent radiologist. At three months, 69.2% of levels assessed demonstrated radiographic fusion (BSF-3), at 12 months, 94.7% of levels assessed exhibited radiographic fusion (BSF-3), and finally at 21 months, all levels, 100 %, demonstrated radiographic fusion (BSF-3).
Dr. Samuel A. Joseph, Jr., a Board Certified Orthopedic Surgeon in Tampa, Florida and lead investigator in this study stated "I was initially intrigued by the science and product concept, yet the reliability that ProteiOS has demonstrated in my clinical results shows it is a viable option for a surgeon and their patients."
ProteiOS is a unique, first of its kind allograft-derived growth factor that offers a number of distinct advantages over current products in the orthobiologic market. It provides an array of osteoinductive, angiogenic, proliferative, and chemotactic growth factors including but not limited to BMP-2, PDGF, TGF-β1, and VEGF. The product is provided in a lyophilized powder form that supports the use of virtually any FDA approved scaffold during implantation, providing flexibility for the surgeon and hospital.
“We are excited to announce the publication of these findings alongside our recent merger with Isto Biologics,” said Amit Govil, Isto Biologics’ new Chief Technology Officer. “These results validate the efficacy of ProteiOS in lumbar spine fusions and bolster incredible confidence in Isto’s growing line of allograft products. We look forward to bringing ProteiOS into the hands of even more surgeon partners who are dedicated to patient healing.”
About Isto Biologics
Isto Biologics is a 100% biologics-focused company dedicated to helping patients heal faster. With a portfolio comprised of the market leading autologous concentration device as well as a differentiated bone grafting portfolio that offers functional solutions to meet patient and procedural challenges, Isto is equipped to offer a range of customizable options to surgeons of varying specialties. Isto Biologics merged with Advanced Biologics/Biologica Technologies on October 18, 2023. For more information, visit istobiologics.com.
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Original Source: Isto Biologics Publishes ProteiOS Lumbar Spine Fusion Results in Journal of Spine