Month: December 2022

in their 2023 Standards of Care in Diabetes

 

OCEANSIDE, Calif., Dec. 13, 2022 /PRNewswire/ — Advanced Oxygen Therapy Inc. (AOTI), the global leader in noninvasive topical oxygen wound healing solutions, announced today that the American Diabetes Association has awarded an “A” grade recommendation for utilizing adjunctive topical oxygen therapy in treating Diabetic Foot Ulcers (DFU) in their 2023 standards of care in diabetes, the preeminent Clinical Practice Guidance (CPG) in the space, which was published today online: https://diabetesjournals.org/care/issue/46/Supplement_1

 

The American Diabetes Association is the leading clinical authority dedicated solely to combating diabetes and its complications. Based on the latest scientific research and clinical trials, their annually updated standards of care in diabetes provides the most comprehensive and trusted evidence-based clinical guideline on the prevention, diagnosis, and treatment of diabetes and its complications.

 

Dr. Mike Griffiths, CEO and President of AOTI commented; “We are delighted that the ADA’s Professional Practice Committee, in its 2023 update to their standards of care in diabetes, has assessed that the now overwhelming body of clinical evidence supports awarding topical oxygen therapy a converted “A” grade recommendation as an adjunctive treatment for healing DFU.”

 

AOTI’s unique Topical Wound Oxygen (TWO2) therapy is unlike any other topical oxygen approach, in that it is the only device that provides a multimodality treatment, combing higher pressure oxygen delivery with non-contact cyclical compression and humidity, in a therapeutic applied by the patient at home. This patented approach has been demonstrated in numerous Randomized Controlled Trial (RCT) and Real World Evidence (RWE) studies to not only heal chronic wounds at a far higher rate, but perhaps more importantly, keep them closed longer term, thereby reducing unnecessary hospitalizations and amputations.1, 2

 

“The more sustainable long-term healing elicited when utilizing TWO2 therapy was highlighted in the ADA guidance, with their citing of all of the RCT and RWE studies conducted with TWO2, along with multiple recent Systematic Reviews and Meta Analyses, leading to their “A” grade recommendation ” stated Dr. Griffiths

 

1 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.

 

2 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

 

About AOTI
AOTI is a privately-owned company based in Oceanside, California USA and Galway, Ireland that provides innovative solutions to resolve severe and chronic wounds worldwide. Our products reduce healthcare costs and improve the quality of life for patients with these debilitating conditions. Our patented non-invasive Topical Wound Oxygen (TWO2) homecare therapy is clinically proven to deliver Sustained Wound Healing that reduces both Amputations and Hospitalizations, So Life Can Get Back to Normal.

 

For more information see: www.aotinc.net

 

Contact:
Dr. Mike Griffiths
CEO & President
350571@email4pr.com
(760) 672 1920

 

This article was originally published here

and Helping to Reduce Surgical Site Infections

 

Article is a Follow-On to MolecuLight’s Receipt an Innovative Technology Contract from Vizient Last Year

 

PITTSBURGH, Dec. 6, 2022 /PRNewswire/ – MolecuLight Corp., the leader in point-of-care fluorescence imaging for detection of wounds containing elevated bacterial loads, is featured in Vizient’s newly released Tech Watch publication as a key technology for visualizing bacterial load and its locations, and helping to reduce surgical site infections. The article, “Fluorescence Imaging: New technology enables point-of-care surgical wound bacterial assessment” is featured in Vizient’s Tech Watch (Medical Device) Volume 3 issue, issued this past week.

 

The Tech Watch article describes how surgical site infections (SSIs) occur in up to 38% of surgeries1 (depending on anatomical location and type of surgery) and account for 20% of all healthcare-acquired infections2. SSIs are also the costliest of these infections, extending the average length of hospital stays by 9.7 days and costing more than $20,000 per patient admission3,4.

 

Early and accurate diagnosis of post-surgical bacterial loads and infection is critical to enable prompt treatment before the infection worsens. Some cases require lab testing to accurately diagnose the bacteria colonizing the wound, allowing the offending bacteria to grow and spread and delay effective treatments. Test results can take days to weeks to be available and, if positive, could be too late to prevent infection.

 

Clinicians need real-time diagnostic tools that they can use at the point-of-care to help provide immediate information on the state of the wound and possible growth of bacterial burden. The article argues that MolecuLight imaging helps eliminate unnecessary subjectivity in assessing wounds for the presence of harmful bacteria by allowing quick and accurate visualization of locations of elevated bacteria load in wounds, along with clinical signs and symptoms. As such, it provides “invaluable real-time information to inform clinical decision-making”.

 

A recent per-reviewed study5 supports this position in demonstrating the benefits of using MolecuLight to help clinician visualize bacterial burden in surgical site wounds:

• 76% of surgical sites in the study that reach the stage of referral to a wound specialist had clinically significant bacterial loads (10⁴ to 10⁹ CFU/g), however only 6.8% exhibited symptoms of infection, resulting in delayed infection management.
  
  
• Point-of-care fluorescence imaging (using the MolecuLight i:X device) for detecting high bacterial loads improved sensitivity by 5.7-fold compared to clinical signs and symptoms alone.
  
  
• Clinician experience with fluorescence imaging and interpretation (>200 imaging sessions) increased sensitivity of fluorescence imaging to 11.3-fold higher than clinical signs and symptoms alone, and accuracy to 2.6-fold higher.

 

“Clinicians need an objective means of detecting infection or another surgical wound complication without having to rely on subjective judgment,” says Kylie Sandy-Hodgetts, PhD, Founder and inaugural President of the International Surgical Wound Complications Advisory Panel (ISWCAP).

 

“Fluorescence imaging using MolecuLight is positioned to change contemporary paradigms of post-surgical wound management due to its ability to quickly and reliably detect bacterial burden and visualize contamination at the point-of-care”.

 

In addition to the profile in Vizent’s Tech Watch, last year the MolecuLight i:X® fluorescence wound imaging device received an Innovative Technology contract from Vizient, Inc., the nations’ largest member-driven health care performance improvement company. The new Innovative Technology contract for MolecuLight i:X signifies to Vizient members the device’s unique qualities that potentially bring improvement to the health care industry.

 

“We have been working with MolecuLight since 2021 when Vizient recognized the company as an awarded supplier through our Innovative Technology Program,” said Tami Maurer, VP, Contract & Program Services at Vizient, Inc. “Carefully evaluated and selected by our member council of clinical and supply chain professionals, Vizient’s Innovative Technology Program recognizes innovative advancements in care, enabling healthcare providers to offer the highest quality care while encouraging manufacturers to continue to pioneer new solutions.”

 

The MolecuLight i:X and DX are the only imaging devices for the real-time detection of elevated bacterial burden in wounds that are FDA cleared and CE and Health Canada approved. With clinical evidence including over 60 peer-reviewed publications involving 1,500 patients, they are used by leading wound care facilities globally.

 

About MolecuLight Corp.

MolecuLight Corp. is the US subsidiary of MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight ‘s suite of commercial devices, which include the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, are point-of-care handheld imaging devices for the real-time detection and localization of bacterial load in wounds and digital wound measurement. MolecuLight procedures performed in the United States benefit from an available reimbursement pathway which includes two CPT® codes for physician work to perform “fluorescence imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. The company is also commercializing its unique fluorescence imaging platform technology for other global markets with relevant unmet needs in food safety, consumer cosmetics and other key industrial markets.

 

This article was originally published here