PolarityTE™, Inc recently announced preclinical large animal model results for their new product, OsteoTE, which shows promise for bone regeneration.
OsteoTE Shows Promise for Bone Regeneration
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Secondary#boneregeneration#osteote#polarityte
During the preclinical studies, the researchers found that OsteoTE not only recapitulated the cortical and cancellous architecture of native uninjured bone, but also regenerated bone with function and composition reflective of native bone.
OsteoTE uses the same platform technology (CoreTE) as their product SkinTE, a human cellular and tissue-based product that is derived from a patient’s own skin and regenerates into functionally polarized skin of full-thickness with all the appendages including hair and glands.
How OsteoTE works is that it uses a patient’s own tissue which once harvested is sent to PolarityTE to be processed and returned to be injected into the defect in the bone. With this technology, the autologous tissue can be prepared and injected into the patient in less than 24 hours.
This new product can be especially useful in the case of a large traumatic orthopedic injury where the doctor has to try to span a gap within a tibia, femur or humerus. It has application in craniofacial, neurosurgical, orthopedic, spine and foot/ankle surgeries.
“The results of these studies using OsteoTE to treat critically-sized bone defects mirror the significance of those seen with SkinTE, and again confirm that our platform technologies can be successfully used to regenerate complex functional tissues in the most challenging settings, said Denver. Lough, M.D., Ph.D., chairman and CEO of PolarityTE.
“We believe there are substantial limitations of the existing treatment options across the numerous applications of OsteoTE, including treatment of bone defects and nonhealing bone within craniomaxillofacial, orthopedic, spine, hand, and foot/ankle specialties. We look forward to continued development and commercialization of products that will change the practice of medicine.”
Right now PolarityTE is running preclinical studies for spine, hand, foot, ankle and dental applications and is hoping to bring OsteoTE to market by early next year.
PolarityTE, headquartered in Salt Lake City, Utah, is a commercial-stage biotechnology and regenerative biomaterials company. Learn more at: https://www.polarityte.com/
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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