October 11, 2019
Amniox Medical Announces Publication of Phase 2 Clinical Trial Results Utilizing Neox® Cord 1K (Trial Code Name: TTAX01) in Wound Repair and Regeneration
Data demonstrates 60 percent of wounds achieved complete wound closure, which is compatible with the healing rates observed in previous NEOX Cord 1K retrospective studies.
Miami, FL – October 10, 2019 – Miami, FL – October 10, 2019 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and leader in the clinical application of amniotic membrane and umbilical cord-based products, announced today the publication in Wound Repair and Regeneration of results from the completed Phase 2 pilot trial titled “Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft.” William A. Marston, MD, served as lead investigator for the trial.
“We are extremely pleased with the publication of our Phase 2 results in such a well-respected, peer-reviewed medical journal specifically targeted to wound care specialists,” said Herbert B. Slade, MD, Chief Medical Officer for TissueTech. “The results demonstrate how Neox may help with serious unmet patient needs for those suffering from diabetic foot ulcers with osteomyelitis. Additionally, it is encouraging to see the study successfully demonstrated similar healing rates as we have observed through retrospective studies with Neox.”
Neox® is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility, and placenta suitability. Neox is manufactured by TissueTech utilizing the proprietary CryoTek® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue.
TissueTech, and its wholly owned subsidiaries Amniox and BioTissue, are committed to addressing unmet patient needs. As such, the organization maintains a product portfolio of amniotic membrane and umbilical cord birth tissue products to help manage complex and chronic wounds, ocular surface disease, and musculoskeletal disease and injury.
About Amniox Medical, Inc.
Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of amniotic membrane and umbilical cord-based products processed using TissueTech’s proprietary CryoTek cryopreserved technology. Established in 2011, Amniox serves an unmet need for better surgical and therapeutic outcomes for chronic and complex wounds, orthopedics, sports medicine, spine, urology, gynecology, plastics, and general surgery. Connect with Amniox on Website, Facebook, LinkedIn, and Twitter.
About TissueTech, Inc.
TissueTech is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care and soft tissue products to support regenerative tissue healing using amniotic membrane and umbilical cord birth tissue donated from healthy, pre-screened mothers after elective cesarean section delivery of a live birth. The organization brings a skilled approach to innovation in evidence-based medicine with more than 20 years of clinical experience and more than 30 years of scientific research funded by the National Institutes of Health. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at www.biotissue.com.
These Phase II clinical trial results were obtained using a cGMP experimental trial biologic drug (TTAX01), prepared under stringent 351 Chemical Manufacturing Controls and release criteria. The currently marketed Neox Cord 1K is a homologous HCT/P utilizing the same Umbilical Cord (UC) graft tissue as TTAX01, but is only subject to current GTP 361 Chemical Manufacturing Controls and release criteria requirements.
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