Company’s first biologic license application (BLA) candidate TTAX01 to enter Investigational New Drug (IND) Phase 3 Trials for Diabetic Foot Ulcer (DFU) indication as first biologic product to seek FDA approval for complex Wagner Grade 3 and 4 DFUs
Miami, FL – June 30, 2020 – Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the initiation of the first of two planned multi center randomized controlled Phase 3 Clinical Trials that will be conducted at 20 investigational sites across the U.S. with an enrollment of 220 patients in each trial. These trials, titled AMBULATE DFU and AMBULATE DFU II, will study the benefits and risks of using TTAX01 to achieve complete wound closure of complex non-healing DFUs with high-risk factors of ulcer depth indicating exposed bone, tendon, muscle, and/or joint capsule, and clinical suspicion of osteomyelitis.
Results from an earlier one-year follow-up study published in the peer-reviewed journal Wound Repair and Regeneration indicate that TTAX01 is a promising adjunct therapy with a higher healing rate than Standard of Care (SOC) for the management of advanced DFUs complicated by osteomyelitis.1 During the study, investigators found that 86.2% of patients achieved complete wound closure with use of TTAX01, which is comparable to the healing rates observed in retrospective studies using Amniox’s currently commercially available form of Cryopreserved Umbilical Cord Allograft NEOX®1,2,3 and is significantly higher than the U.S. Wound Registry’s reported rate of 45% healing of all DFUs regardless of time period.4
“TissueTech has been the pioneer in studying and characterizing the natural healing elements of human birth tissue for more than 30 years. We have multiple INDs currently in various stages of clinical trials with the goal of obtaining BLA approval,” said TissueTech co-founder Amy Tseng, MBA, President and Chief Executive Officer. “We are proud to be advancing toward the BLA submission process as evidenced by our commitment to build this much needed high-quality evidence as well as our compliance with industry-wide FDA guidance.”
Herbert Slade, MD, FAAAI, Chief Medical Officer at TissueTech cites the company’s contribution to scientific research as such: “These trials represent a landmark in wound care. No other wound care company has risen to the challenge of developing a biologic to meet this unmet medical need. Only TissueTech has chosen to work with the most severe DFUs with the goal of identifying a successful treatment option to increase healing rates, minimize the risk of amputation, and positively impact patients’ lives.”
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/.
- Marston, WA, Lantis, 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 Marston, W. A., Lantis, J. C., Wu, S. C., Nouvong, A., Lee, T.
- , McCoy, N. D., et al. (2019). An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. Wound Repair Regen. 27, 680–686. doi: 10.1111/wrr.127542.
- 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
- Fife CE, Eckert KA, Carter MJ. Publicly reported wound healing rates: the fantasy and the reality. Adv Wound Care 2018; 7: 77–94.