2,000,000 TWO2 Treatments Milestone Reached as TWO2 Study Is Highlighted in Systemic Review of Topical Oxygen Therapies

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.

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 controlswith 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!”

 

 

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”