- OsteoAdapt SP demonstrated extra sturdy and quicker bone formation than the gold normal autograft in a big animal mannequin of spinal fusion
- The research demonstrated the security and efficacy of AMP2 and the utility of OsteoAdapt SP at a number of dosages, in assist of human IDE Section I/II scientific research, that are at the moment underway
FREDERICK, Md., Nov. 6, 2024 /PRNewswire/ — Theradaptive, a privately held, scientific stage biologics firm creating focused protein therapeutics for spine, orthopedics, smooth tissue restore and focused immuno-oncology, immediately introduced the peer-reviewed publication of a preclinical spinal fusion research. This research options Theradaptive’s lead candidate, OsteoAdapt SP, in Backbone, the preeminent journal for spinal surgeons (Quantity 49, Situation 19). The research, entitled “In vivo Evaluation of AMP2, a Novel Ceramic-Binding BMP-2, in Ovine Lumbar Interbody Fusion,” demonstrated the preclinical security and efficacy of OsteoAdapt SP in a clinically related giant animal mannequin. Outcomes confirmed quicker and extra sturdy new bone formation throughout the interbody cage, performing in addition to or higher than the gold normal, autologous iliac crest bone graft (ICBG), in all evaluated measures.
“The findings from this research spotlight the transformational potential of OsteoAdapt SP to revolutionize spinal fusion procedures by considerably enhancing bone formation and enhancing outcomes, doubtlessly giving surgeons the choice to fully get rid of the necessity for autograft,” acknowledged Luis Alvarez, PhD, CEO and Founding father of Theradaptive. “Now we have already superior into human scientific trials and count on that these preclinical outcomes will translate into equally excellent outcomes in a affected person inhabitants that’s rising and has vital unmet wants”.
OsteoAdapt SP: A Novel Strategy to Treating Degenerative Disc Illness
OsteoAdapt SP is an investigational therapeutic designed for sufferers with degenerative disc illness, a situation characterised by the deterioration of spinal joints that ends in ache and dysfunction. It combines Theradaptive’s next-generation engineered protein AMP2™, a modified, adhesive variant of the highly effective bone-forming development issue bone morphogenetic protein-2 (BMP-2), with an artificial bone graft. This modification permits OsteoAdapt SP to retain BMP-2’s therapeutic advantages whereas minimizing off-target results usually related to BMP-2. Theradaptive is at the moment enrolling sufferers in OASIS, its Section I/II scientific trial evaluating the security and efficacy of OsteoAdapt SP for the remedy of degenerative illnesses of the lumbosacral spine.
Research Design and Outcomes
The preclinical research was designed to match OsteoAdapt SP with ICBG in a lumbar interbody fusion mannequin. Sheep underwent lateral lumbar fusion surgical procedure with both PEEK or Titanium interbody cages filled with low or excessive doses of OsteoAdapt SP or ICBG. Outcomes have been evaluated at 8-, 16- and 26- week intervals. Newly fashioned bone high quality, bone mineralization, and fusion have been assessed by guide palpation, qualitative and semi-quantitative histopathology, histomorphometry, computed tomography (CT), and micro-CT (μCT) evaluation.
Key findings embrace:
- The usage of AMP2, Theradaptive’s proprietary adhesive variant of BMP-2, confirmed therapeutic outcomes equal to or higher than ICBG
- The exact supply of the protein assisted therapeutic and diminished the chance of off-target results
The total outcomes can be found within the journal Backbone (Quantity 49, Situation 19) and on-line right here
About Theradaptive
Theradaptive is a privately held, scientific stage biologics firm creating focused protein therapeutics for spine, orthopedics, smooth tissue restore and immuno-oncology. Primarily based in Frederick, Maryland, the Firm is leveraging its therapeutic supply platform to ship recombinant biologics to focused tissues within the physique with excessive precision and persistence to deal with unmet medical wants. For extra info on Theradaptive and its scientific growth program, go to www.theradaptive.com and observe the corporate on LinkedIn. OsteoAdapt SP is an Investigational Machine. Restricted by US Federal legislation to investigational use.
Contacts:
Theradaptive
Serena Lertora
serena.lertora@theradaptive.com
Buyers:
ICR Healthcare
Stephanie Carrington
stephanie.carrington@icrhealthcare.com
(646)277-1282
SOURCE Theradaptive
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