AOTI Receives China FDA Approval for Topical Wound Oxygen (TWO2) Therapy Providing Renewed Hope for World’s Largest Diabetic Foot Ulcer Population
OCEANSIDE, Calif., March 23, 2022 /PRNewswire/ — Advanced Oxygen Therapy Inc. (AOTI), the global leader in noninvasive topical oxygen wound healing solutions, announced today that is has received Chinese National Medical Products Administration (NMPA), commonly referred to as China FDA, approval for its unique cyclically pressurized Topical Wound Oxygen (TWO2) therapy. Making it the only advanced sustained wound healing therapeutic to have achieved such a designation and allowing the company to now commence marketing in China with its local partner.
China has the world’s largest Diabetic and resultingly Diabetic Foot Ulcer (DFU) population. The International Diabetes Federation estimates that 10.6% of the Chinese adult population now have diabetes that equates to 141 million people. This represents a 56%, or 50 million person, increase in the last 10 years alone.1 In China, the annual incidence of DFU and Amputation has recently been reported to be 8.1% and 5.1% respectively, representing a staggering 11.4 million ulcerations and 7.2 million preventable lower extremity amputations every year.2
AOTI’s globally patented TWO2 homecare therapy has been demonstrated in recently published high-quality Randomized Controlled Trial 3 and Real Word Evidence 4 studies to provide more durable complete DFU healing. Resulting in six-fold reductions in ulcer recurrence, with an unprecedented 88% reduction in hospitalizations and 71% reduction in lower extremity amputations seen over 12 months. Such sustained healing provides patients with renewed hope of limb preservation, while offering significant reductions in healthcare resource utilization with resultant health economic savings.
Professor Andrew Boulton, past-President of the European Association for the Study of Diabetes and Professor of Medicine at the University of Manchester, UK and University of Miami, USA, and Chairman of AOTI’s Scientific and Clinical Advisory Board, commented: “Diabetes is one of the fastest growing global health emergencies of the 21st century. It is a real game-changer to finally have clinically proven homecare therapeutics like TWO2 available that make meaningful impact in such critical outcomes as hospitalizations and amputations. Now that TWO2 therapy is authorized in China, the world’s largest diabetic foot ulcer population has a renewed hope for better outcomes.”
1 International Diabetes Federation. IDF Diabetes Atlas, 10th Edition. Brussels, Belgium: 2021. Available at: https://www.diabetesatlas.org
2 Development and validation of a brief diabetic foot ulceration risk checklist among diabetic patients: a multicenter longitudinal study in China. Zhou, Q., Peng, M., Zhou, L. et al. Nature, Sci Rep 8, 962 (2018). https://doi.org/10.1038/s41598-018-19268-3
3 Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study. Robert G. Frykberg et al, Diabetics Care 2020; 43:616-624. https://doi.org/10.2337/dc19-0476.
4 Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Jessica Izhakoff Yellin, et al; Advances in Wound Care 2022; http://doi.org/10.1089/wound.2021.0118
