Virtual symposium showcases results from study follow-up in which 86.2% of patients achieved complete closure of Wagner Grade 3-4 Diabetic Foot Ulcers (DFUs) with TTAX01 Cryopreserved Umbilical Cord allograft.
Miami, FL – July 27, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, in conjunction with the Symposium on Advanced Wound Care (SAWC) Spring Meeting and the Wound Healing Society (WHS) Annual Meeting, was proud to host a virtual symposium on Saturday, July 25. The symposium showcased the results from TissueTech’s one-year follow-up study to their Phase 2 open label, multicenter pilot study of the investigational Cryopreserved Umbilical Cord allograft TTAX01 for the treatment of Wagner Grade 3-4 DFUs, followed by a concise overview of the company’s transition from a 361 to a 351 regulatory framework. The session was moderated by SAWC Co-Chair Robert Kirsner, MD, PhD, FAAD, Director of the University of Miami Hospital and Clinics Wound Care Center, and featured distinguished faculty William Marston, MD, Professor of Surgery, University of North Carolina School of Medicine, and Herbert Slade, MD, Chief Medical Officer, TissueTech, Inc.
The symposium, titled Amniox: Promising Advancement in the Management of Complex Wounds, highlighted the outcomes of the 1-year follow-up to the study of which 86.2% of patients with severe Wagner Grade 3 and 4 DFUs achieved complete closure with use of TTAX01.1 These results are significantly higher than the U.S. Wound Registry’s reported rate of only 45% healing of all DFUs regardless of the severity of the DFU or the time period of treatment2 and comparable to previously reported retrospective study results using Amniox’s commercially available NEOX® Cryopreserved Umbilical Cord allograft .3
For many of these patients with chronic and complex wounds, delayed healing can lead to psychological factors, such as anxiety and depression.4 Not being able to achieve closure can also result in infection and lower limb amputation.
The five-year mortality rate following a diabetic patient undergoing a major limb amputation ranges from 52 to 80 percent.5 As such, TTAX01 represents a promising alternative to help manage wound healing and to allow patients to return to their normal activities of daily living.
“We’ve chosen to study TTAX01 to help patients with these complex DFU wounds extending to the muscle, fascia or bone, and with clinical and radiographic evidence of underlying osteomyelitis, because it is currently a critical, unmet need,” said Dr. Slade. “The ability to close these wounds and hopefully eliminate the need for an amputation, as well as to keep these patients out of the hospital and healing at home, are truly welcomed advancements in today’s COVID-19 environment, as well as for the patient’s lifestyle and the cost to the overall health system.”
About Amniox Medical, Inc.
Amniox Medical, Inc., a TissueTech, Inc. company, is a leader in the clinical application of human birth tissue-based products (amniotic membrane & umbilical cord) processed using TissueTech’s proprietary CRYOTEK® Cryopreservation 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 our Website, Facebook, LinkedIn and Twitter.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue, Inc., 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 that are marketed under these subsidiaries. Since the company’s inception, clinicians have performed more than 500,000 human implants of the company’s products and published more than 360 peer-reviewed studies supporting its platform technology. TissueTech is committed to an unwavering culture of integrity that places our patients’ safety and clinical outcomes above all else. Learn more at https://tissuetech.com/.
1 Marston WA, Lantis II JC, Wu SC, et al. One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01). Wound Rep Reg. 2020;1–6. https://doi.org/10.1111/wrr.12809
2 Caroline E. Fife, Kristen A. Eckert, and Marissa J. Carter. Advances in Wound Care. Mar 2018.77-94.http://doi.org/10.1089/wound.2017.0743
3 Caputo, W. J., Vaquero, C., Monterosa, A., Monterosa, P., Johnson, E., Beggs, D., et al. (2016). A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis. Wound Repair Regen. Off. Publ. Wound Heal. Soc. Eur. Tissue Repair Soc. 24, 885–893.doi: 10.1111/wrr.12456.
4 International consensus. Optimizing wellbeing in people living with a wound. An expert working group review. London: Wounds International, 2012. Available from: http://www.woundsinternational.com