One-year Follow-up Study Results Find Cryopreserved Umbilical Cord Allograft for Treatment of Wagner Grade 3-4 Diabetic Foot Ulcers to be Safe with Higher than Expected Rates of Healing

MIAMI, June 1, 2020 /PRNewswire/ -- Amniox Medical, Inc. (Amniox), a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today the results from the one-year follow-up study to their Phase 2 open label, multicenter pilot study of Cryopreserved Umbilical Cord allograft TTAX01. The objectives of the study were to examine the safety and efficacy of TTAX01, plus standard of care, in achieving complete wound closure of complex non-healing Diabetic Foot Ulcers (DFUs) with evidence of exposed bone, tendon, muscle and/or joint capsule and clinical suspicion of osteomyelitis. Results of this one-year study are published in the peer-reviewed journal Wound Repair and Regeneration.

The follow-up study indicates that TTAX01 is a promising adjunct therapy for the management of complex, non-healing DFUs complicated by osteomyelitis.¹ The results of this one-year follow-up study with TTAX01 demonstrate an overall 86.2% wound closure rate and are comparable to previously reported results using the commercially available Cryopreserved Umbilical Cord NEOX® in a retrospective study.² In that study by Caputo, 26 of 33 (79%) of the wounds achieved complete wound closure in 16 ±9.3 (range: 4–44) weeks with 1.2 ± 0.4 NEOX applications. The average wound size was 16 ± 18 cm.

"Although there have been numerous other studies published on the management of DFUs, the majority of these studies have been with less severe and more superficial Wagner Grades 1 and 2 DFUs – where there is no infection and little or no exposure of muscle, fascia, joint capsule, or bone. More severe and higher-grade Wagner 3 and 4 DFUs presenting with exposed bone and the presence of osteomyelitis are usually excluded in clinical trials as they are the most challenging wounds to manage," said William A. Marston, MD, Vascular Surgeon at University of North Carolina at Chapel Hill and lead investigator for the Phase 2 trial. "We've chosen to go after the most severe DFUs to address a critical, unmet clinical need with the goal of identifying a successful treatment option to help this diabetic population exhibiting high morbidity and mortality.  We are looking forward to the Phase 3 trials to be initiated soon, which will provide an opportunity to confirm these results in larger pivotal trials."

There were 29 patients who participated in this follow-up study conducted at 11 U.S. healthcare facilities. An independent medical reviewer evaluated images to confirm each DFU closure as assessed by the principal investigator. Trial results showed that only an average of 1.5 applications were necessary to facilitate complete wound closure in 25 of the 29 total patients.

"The results of this Phase 2 study show not only higher than standard of care healing rates, but also fewer applications than studies using other amniotic membrane and similar wound care products for less severe wounds, which is ideal in today's COVID-19 environment where we are doing all we can to reduce these high-risk patients' exposure to a virus that could have dire consequences for their health," said Amy Tseng, President and Chief Executive Officer of TissueTech. "I truly believe our strong scientific research background, combined with our willingness to look for clinical solutions for unmet needs in hard-to-heal patients is what distinctly differentiates TissueTech from other companies. The findings in the Phase 2 trial related to less frequent applications and persistent wound closure are of particular importance right now and offer new hope for a future treatment option in this vulnerable population where we see many wound care centers leveraging less frequent patient visits to the clinic to reduce risk as a result of the COVID-19 health crisis."

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, W. A., Lantis, J. C., Wu, S. C., Nouvong, A., Lee, T. 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.
2. 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

SOURCE Amniox Medical, Inc.