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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

Feb 4, 2021 – Toronto, ON: ClaroNav Kolahi Inc, a leader in surgical navigation systems, is pleased to announce that it has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its Navient ENT product in China. Navient ENT previously had been granted US FDA, European CE mark, Health Canada, Korean FDA, Brazilian ANVISA and Taiwan FDA.

Navient, a computer-assisted surgical navigation system, is like a GPS for the surgeon to navigate inside the patient skull. It provides three-dimensional visualization and assists surgeons with finding their ways inside the patient sinuses and avoid critical structures such as the optic nerve and brain, while safely navigating their way to the diseased area.

“Navient is an innovative surgical navigation system offering a compact and truly portable cart, unparalleled accuracy, reusable instruments and simple workflow.” Said Mr. Pan Wang, CEO at Nanning Xinzizhu Trading Co., Ltd., Navient’s exclusive distributor in China. “Navient’s powerful and intuitive software utilizes the latest technologies in the surgical navigation field and is aligned with our corporate strategy of benefiting Chinese patients and surgeons with advanced technologies.”

“We are very excited that our Navient ENT product has been granted NMPA approval. It was a major milestone and it opens a significant market to our product.” said Ahmad Kolahi, CEO of CKI, a subsidiary of ClaroNav “Navient has been designed with simplicity and ease of use in mind. The result is a product that enables the surgeons to operate the system more confidently and accurately. We are looking forward to working with our partner in China and making image-guided surgery standard-of-care in China.”

About ClaroNav Kolahi Inc. (CKI)
CKI is a medical device hardware and software company headquartered in Toronto, Canada, and is represented worldwide by authorized distributors. CKI is dedicated to innovation and developing state-of-the-art surgical navigation systems.

About Nanning Xinzizhu Trading Co. Ltd (XZZ)
XZZ is Navient’s exclusive distributor in China headquartered in Nanning, capital of Guangxi Province in South of China. XZZ’s is focused on improving medical conditions in China by importing innovative and state-of-the-art international medical devices. XZZ’s marketing network covers more than 20 provinces around China, and services more than 50 hospitals.

The ARTORG spinout SurgeonsLab has been attracting considerable attention in recent weeks, not least because it was awarded the Ypsomed Innovation Prize 2021. Now Swiss Radio and Television has interviewed the two founders for SRF's science magazine about the medical and engineering background to their project.

Neurosurgeons David Bervini and biomedical engineer Fredrick Joseph discussion how the surgery simulator needs to render the aneurysm surgery ahead (Photo: Adrian Moser © University of Bern)

SurgeonsLab develops simulating systems for high-precision neurosurgical interventions, such as intracranial aneurysm microsurgery. The startup was founded by the biomedical engineer Fredrick Johnson Joseph, Image Guided Therapies, ARTORG Center, and the neurosurgeon David Bervini, Department of Neurosurgery, Inselspital. The innovative concept that allows for surgeon training, reduction of operative risks and intervention planning, has received several awards in the past months and weeks - including Innosuisse Core Coaching, the Venture Kick final stage and the Ypsomed Innovation Prize 2021.

The biggest problem was to simulate the blood flow.

Fredrick Joseph about the major challenge in creating a life-like training environment for the extremely delicate procedure of aneurysm clipping: “We tried to replicate the optics and tactility of the human brain using a mix several polymers. The biggest problem was to simulate the blood flow. The pulsation of the blood vessels seen here corresponds anatomically to 99 percent to the real blood circulation in the brain. It has the same fluid dynamics as is found in the aneurysm balloon.”

The scientific evidence is mounting for Navident and dynamic navigation.

There has been 26 studies published since 2015, with 2 published recently.

To view all the full text of each study, please visit the scientific evidence section of this website.

OCEANSIDE, Calif., June 7, 2021 /PRNewswire/ — Advanced Oxygen Therapy Inc. (AOTI) today announced that 2,000,000 treatments of its unique cyclical-pressure Topical Wound Oxygen (TWO2) therapy have now been applied by patients safely at home.

“This is another enormous milestone for our company and a testament to the ease-of use and durable clinical efficacy of TWO2 therapy, as well as to the tenacity of our entire dedicated care team. AOTI is proud to have been able to help heal the Diabetic Foot Ulcers and Venous Leg Ulcers of so many high-risk patients safely at home. Effective homecare therapeutics, such as provided by TWO2, have become vital in maintaining continuity-of-care by caregivers for their patients, especially during the recent COVID-19 pandemic,” stated Dr. Mike Griffiths, CEO and Medical Director of AOTI.

Additionally, a high-quality paper published on April 19, 2021 in the journal Diabetic Medicine, entitled Topical oxygen therapy for diabetes-related foot ulcers: A systematic review and meta-analysis  (https://onlinelibrary.wiley.com/doi/10.1111/dme.14585), from the team headed by Professor Golledge at the independent Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), James Cook University, Queensland, Australia, conducted a detailed meta-analysis of six recent RCTs involving 530 participants and concluded that “TOT significantly increased the likelihood of ulcer healing compared to controls” with the three trials judged to provide a low risk of bias producing a “Risk Ratio (RR) of (2.37; 95% CI 1.52, 3.68; I2 = 0%).”

The authors went further in assessing the quality of all the studies analyzed, utilizing a modified version of the foremost Cochrane Collaboration’s tool, with our TWO2 study published in Diabetes Care in 2020, entitled A 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 (https://doi.org/10.2337/dc19-0476), being highlighted by a perfect 100% score.

Dr. Mike Griffiths commented: “It is refreshing to see a leading independent systematic review and meta-analysis not only affirming the now clearly proven complete healing efficacy of topical oxygen therapy, but also emphasizing the importance of the quality of such evidence, especially that supporting our unique TWO2 approach. The TWO2 study investigators purposely developed their protocol to address deficiencies and commonly seen areas for bias in most DFU studies. This included meeting all the points detailed in the 21-item checklist proposed by Professor Jeffcoate et al., in their paper entitled: Current Challenges and Opportunities in the Prevention and Management of Diabetic Foot Ulcer, published in Diabetes Care in 2018 (https://doi.org/10.2337/dc17-1836). As the saying goes, Quality Matters!”