Amniox Announces Initiation for First of Two Phase 3 Clinical Trials of Cryopreserved Umbilical Cord TTAX01 Allograft to Treat Complex Wagner Grade 3-4 Diabetic Foot Ulcers

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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 that may have 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 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.”

References
1. 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.
2. D., 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.
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. Fife CE, Eckert KA, Carter MJ. Publicly reported wound healing rates: the fantasy and the reality. Adv Wound Care 2018; 7: 77–94.

About Amniox Medical, Inc.
AMNIOX® Medical, Inc. is the first provider of a cryopreserved matrix comprised of human umbilical cord that can be stored in a refrigerator for up to two years and is ready to use without thawing, transplanting the benefits of regenerative healing for non-healing and chronic wounds.

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.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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