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New Expert Guidelines from IWGDF Highlight the Growing International Recognition of Topical

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Oxygen Therapy for Diabetic Foot Ulcers

 

Evidence-based recommendations support the effective use of TOT in diabetic foot ulcer management, revolutionizing treatment approaches worldwide

CAMBRIDGE, England, May 17, 2023 /PRNewswire/ — NATROX® Wound Care, a leading innovator in wound care technology, proudly announces the release of newly published expert recommendations on the use of topical oxygen therapy for wound healing1. The updated guidelines endorse topical oxygen therapy (TOT) as an adjunct therapy in the treatment of diabetic foot ulcers (DFUs) 1. With its endorsement by leading experts, this ground-breaking therapy is poised to transform the lives of millions of people worldwide, offering renewed hope for effective healing and improved quality of life.

New IWDGF Guidelines
The International Working Group on the Diabetic Foot (IWGDF) has just published its 2023 Guidelines. This set of recommended DFU interventions, developed by a panel of renowned experts, serves as a trusted resource for healthcare professionals worldwide.

Notably, among the 29 recommendations highlighted, TOT gained recognition as an accepted intervention when treating non-healing DFUs. “Consider the use of topical oxygen as an adjunct therapy to standard of care for wound healing in people with diabetes-related foot ulcers where standard of care alone has failed and resources exist to support this intervention1.”  With its inclusion in the IWGDF guidelines, topical oxygen therapy emerges as a vital tool, poised to revolutionize the management and healing of foot ulcers in individuals with diabetes.

In addition, the guidelines note that “evidence on topical oxygen has substantially expanded in the last four years with several new RCTs with a total of ten included in the systematic review for these guidelines (References 100-109) 1“, which includes an RCT study published in 2021² which compared the healing effects of using standard care against a combination of standard care plus NATROX® O₂ topical oxygen therapy. In the study, patients completing the therapy experienced 71% greater healing rates² and 73% greater reduction in wound size² with NATROX® O₂.


Experts recommend updating algorithms to include TOT
In the Journal of Wound Care, experts reached a “clear consensus that adjunctive treatments with a solid evidence base, including NPWT and TOT, must be included“3 in each of the four proposed regional guidelines. Most notably, the experts agreed that “all hard-to-heal wounds are likely to benefit from TOT³.”


TOT received “A grade” from the American Diabetes Association
The American Diabetes Association recently released its “Standards of Care in Diabetes⁴” which not only recommended TOT as an adjunctive therapy for chronic DFUs, but also gave it an “A grade” based on the quality of evidence⁴. The newly published recommendations acknowledge the remarkable potential of TOT⁴.

According to Dr. Windy Cole, DPM, CWSP, FAPWH, FACCWS, renowned authority in podiatric medicine and dedicated wound care advocate for over two decades, “The evidence supporting the efficacy of TOT is now undeniable. It is imperative that healthcare professionals embrace this innovative yet simple approach to achieve improved healing outcomes.”  After witnessing the positive impact topical oxygen therapy can have on healing DFUs in her own clinic, Windy recently joined the NATROX® team as Director of Global Medical Affairs to further advocate for the integration of topical oxygen therapy in the treatment pathway for chronic wounds.

NATROX® Wound Care CEO, Craig Kennedy, expressed great enthusiasm regarding the recognition and international acceptance of topical oxygen therapy, stating, “We’re delighted that topical oxygen therapy continues to gain international recognition, cementing its status as a game-changing treatment in wound care. The inclusion of topical oxygen in the IWGDF Guidelines further validates our mission to transform the quality of life for patients suffering from chronic wounds, particularly those with diabetic foot ulcers.”

What is NATROX® O₂ Topical Oxygen Therapy NATROX® Wound Care manufactures an award-winning5,6,7 topical oxygen therapy device known as NATROX® O₂. The compact, wearable device generates and delivers a continuous flow of oxygen directly to the wound bed to promote accelerated healing and foster a healthy wound environment. Its non-invasive nature, coupled with its remarkable effectiveness², offers a significant advancement in chronic wound treatment, even allowing patients to be treated from the comfort of home.

To learn about NATROX® O₂ and request a demo, visit: https://bit.ly/NO2therapy

About NATROX® Wound Care 
NATROX® Wound Care is an Inotec AMD brand. The specialist wound care company based in Cambridge, England was formed specifically to introduce new technologies to healthcare professionals around the world to promote faster and better healing to patients. The company’s flagship product, NATROX® O₂, is positioned to become an integral part of global wound care treatment regimes in the coming years. To learn more, explore the website: natroxwoundcare.com.

See the references:  https://bit.ly/nwc-iwgdf-guidelines

Media Contact:

NATROX® Wound Care 
Nancy Stahulak
VP Global Marketing
marketing@natroxwoundcare.com 
+1 (888) 354 9772

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Topical Oxygen Therapy Awarded Positive Treatment Recommendation by the International

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Working Group on the Diabetic Foot in their 2023 Diabetic Foot Ulcer Guidelines   OCEANSIDE, Calif., May 15, 2023 /PRNewswire/ — AOTI Inc, the global leader in multi-modality topical wound oxygen, announced exciting news from the 9th International Symposium on the Diabetic Foot (ISDF). The ISDF is often referred to as the Olympics of the Diabetic Foot, due…

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Largest Published Real-World Wound Imaging Study Reports MolecuLight®

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led to Wound Treatment Plan Changes in up to 53% Cases   Results from 211 Facilities Show MolecuLight Imaging is a Valuable Toolin Improving Bacterial Infection Management TORONTO, May 23, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that locates and detects elevated, pathogenic bacterial loads in and around wounds, announced the publication of their…

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Aurealis Therapeutics receives CTA approval for AUP-16 Phase 2 RCT in Diabetic Foot Ulcer patients

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Multi-center, randomized, placebo-controlled diabetic foot ulcer (DFU) Phase 2 study to start May 2023 in Italy, Germany, and Poland After completing 12 months follow-up of our DFU Phase 1 study, and 10M CHF Series A financing round to accelerate our clinical program, these are fantastic news for the company”— Juha Yrjänheikki, CEO BASEL, SWITZERLAND, May…

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Microbion Corp. Presents a Poster on Pravibismane’s Activity Against Diabetic Foot Infection Patient Isolates

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  • Poster highlights pravibismane’s MIC activity in testing against aerobic and anaerobic pathogens isolated from diabetic foot infection patients
  • Pravibismane demonstrated potent, broad-spectrum activity against a wide range
    of pathogens, including MRSA, MSSA, and P. aeruginosa

BOZEMAN, Mont., May 10, 2023 /PRNewswire/ – Microbion Corporation today announced that the company presented a poster focusing on pravibismane’s activity against diabetic foot ulcer infection pathogens at the 9th International Symposium on the Diabetic Foot that is currently ongoing from May 10th to 13th, 2023 at The Hague, Netherlands. The poster highlights pravibismane’s activity versus comparator antibiotics against pathogens isolated from diabetic foot infection (DFI) patients in an earlier Phase 1b clinical study.

Poster Details:
Representative image (CNW Group/Microbion Corporation)

Representative image (CNW Group/Microbion Corporation)

Title: Broad-Spectrum, Potent Activity of Pravibismane Versus Comparators Against Diabetic Foot Ulcer Infection Patient Isolates Collected in a Phase 1b Study

Presenter: Dr. Jeff Millard, CSO

Poster Highlights:
  • Most common pathogens isolated from DFI subjects (N = 44) at baseline were: methicillin-susceptible Staphylococcus aureus [MSSA (25%)]; methicillin-resistant Staphylococcus aureus [MRSA (18.2%)]; Enterococcus faecalis (13.6%); and Pseudomonas aeruginosa (11.4%).
  • Mean pravibismane minimum inhibitory concentration (MIC) (µg/mL) for S. aureus MSSA was 0.21, S. aureus MRSA was 0.17, E. faecalis was 2.53, and P. aeruginosa was 1.43.
  • Mean pravibismane MICs for 12 of the 13 anaerobic bacteria was ≤1 µg/mL, including against Finegoldia magna and Anaerococcus spp.
  • Pravibismane exhibited similar or lower MIC relative to a panel of comparator antibiotics, including (but not limited to) levofloxacin, linezolid, clindamycin, and piperacillin-tazobactam, against Gram-positive and Gram-negative, susceptible and resistant, aerobes and anaerobes.

"We are pleased that pravibismane demonstrated extremely potent MIC activity against clinical DFI isolates, which was in line with in vitro AST microbial pre-clinical studies," said Dr. Jeff Millard, CSO of Microbion Corp. "Diabetic foot infections are often infected by several different bacterial species concurrently, which may change over the chronicity of the wound, from predominantly aerobic to anaerobic. We believe pravibismane’s potent broad-spectrum activity is potentially a key treatment advantage since a single agent could eradicate both aerobic and anaerobic bacteria, thereby decreasing the need for multiple systemic therapies."

Bacterial cultures for this study were grown from swabs collected at the wound bed at baseline visit and antimicrobial susceptibility testing (AST) was performed on isolated pathogens. Pathogen isolation and AST was performed at Investigational Health Management Associates (IHMA, IL), using the Clinical & Laboratory Standards Institute (CLSI) standard methods.

Topical pravibismane has received QIDP and Fast Track drug designation from the US FDA for the adjunctive treatment of moderate and severe diabetic foot ulcer infections. Topical pravbismane is currently enrolling in a Phase 2 clinical study to further evaluate its safety and efficacy in subjects suffering from moderate infections associated with chronic diabetic foot ulcers.

About Microbion

Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion’s lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action offering unique potential to address the unmet needs of chronic and severe health conditions. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane with Orphan Drug, Fast Track, and QIDP designations.

For more information visit: www.microbioncorp.com.

Safe Harbor Statement

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Microbion Corporation

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CūtisCare Launches Third Annual Hyperbaric Aware™ National Campaign To Elevate Awareness Of Hyperbaric Oxygen Therapy

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BOCA RATON, Fla., May 1, 2023 /PRNewswire/ — Hyperbaric Awareness USA™, a CutisCare initiative, has designated May Hyperbaric Awareness Month and is proud to announce the launch of the third annual Hyperbaric Aware™ national campaign to elevate awareness of hyperbaric oxygen therapy (HBOT). CutisCare launches a Hyperbaric Awareness USA campaign to elevate the awareness of hyperbaric oxygen…

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MolecuLight Featured in Unprecedented 24 Presentations and Posters at European

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Wound Management Association (EWMA) 2023 Annual Conference Wide-Spread Clinical Evidence using the MolecuLight Imaging Platform Reveals its Significant Global Adoption and Proven Utility in Wound Care TORONTO and MILAN, May 3, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that detects and locates elevated bacterial loads in wounds, announces that its MolecuLight wound imaging platform is featured in an unprecedented…

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Two 3M Veraflo Therapy dressings receive first-ever FDA clearance for hydromechanical removal of non-viable tissue

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Innovative therapy shown to help promote healing and reduce the need for surgical debridements creating potential savings for health care systems. ST. PAUL, Minn., April 27, 2023 /PRNewswire/ — 3M Health Care’s innovative 3M™ Veraflo™ Therapy, with both 3M™ Veraflo™ Cleanse Choice Complete™ Dressing and 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing, received the first-ever Food and Drug Administration (FDA)…

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Nevro Announces Enrollment of First Patient in PDN Sensory Study

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First Randomized Controlled Trial Specifically Powered to Assess Restoration of Neurological Function in Patients with Intractable Painful Diabetic Neuropathy Breakthrough Device Designation Provides Expedited Review for Marketing Application to Expand Nevro’s FDA Labeling REDWOOD CITY, Calif., April 24, 2023 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment…

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New Publication Reveals MolecuLight Imaging Significantly Improved

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Detection of Bacterial Burden Across Patients of All Skin Tones Findings show that MolecuLight is an Objective and Equitable Diagnostic Technology Positioned to Help Level Racial Disparity in Wound Care Outcomes TORONTO, April 25, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that locates and detects elevated bacterial loads in and around wounds,…

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Army R&D selects local biotech firm to prevent wound infection

Press release from MLM Biologics Inc.

 

GAINESVILLE, Fla. – The U.S. Army Medical Research and Development Command (USAMRDC) recently awarded MLM Biologics, Inc. almost $1.5 million to develop a device to prevent infection in battlefield wounds. The device will incorporate MLM Biologic’s proprietary collagen processing and stabilization technologies.

 

MLM Biologics competed for the award in the battlefield treatment area, focused on preventing infection in wounds from “…complex, traumatic, penetrating injuries in a far-forward, austere environment.”

 

“We’re honored to bring our innovative solutions to the men and women who stand in harm’s way as our focus has always been on wound closure—not just wound management,” says CEO Chandra Nataraj.

 

As part of the award, MLM Biologics will develop a new medical device using its proprietary technologies combined with proven anti-inflammatory and anti-microbial components, Nataraj said. He believes it will eventually be available for civilian clinical use.

 

“We expect to make a difference, not only for our military heroes but eventually for everyone dealing with possible wound infection. The potential health benefits are huge,” Nataraj says.

 

The company maintains labs at the University of Florida’s business incubator, UF Innovate | Accelerate @ Sid Martin Biotech, where it conducts product development activities. Karl R. LaPan, UF Innovate | Accelerate director, believes MLM Biologics represents the tangible benefits incubators provide.

 

“MLM Biologics, and the development of a treatment to prevent wound infection, is a great example of public-private partnerships translating research into meaningful, life-changing products for America’s service members,” LaPan said.

 

The award is part of the Military Prototype Advancement Initiative, funded by the Department of Defense and issued through the Medical Technology Enterprise Consortium, a collaboration of industry and academia to facilitate R&D activities with USAMRDC and other government agencies.

 

About MLM Biologics, Inc.

MLM Biologics is a privately held medical device company specializing in the design, manufacture, and marketing of biologic medical devices. The company was founded on the modern interpretation of the Gandhian economic principle of “More for Less for Many.” It currently distributes an FDA-cleared wound care device (bio-ConneKt® Wound Matrix) out of its ISO-13485-certified facility in Gainesville, Fla. For more information, visit www.MLMBiologics.com.

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An Alternate Explanation

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A 48-year-old man with long-standing type 2 diabetes mellitus and chronic kidney disease presented with a 3-month history of numbness, tingling, and faint violaceous discoloration of the tips of multiple fingers and toes. Tom Alsaigh, M.D., Gurpreet Dhaliwal, M.D., Eri Fukaya, M.D., Ph.D., Nicholas J. Leeper, M.D., and Nazish Sayed, M.D., Ph.D.

MolecuLight Successfully Completes SOC 2® Type l Audit and Accreditation

Successful completion of recent audit demonstrates
MolecuLight’s commitment to data security

 

TORONTO, April 19, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that locates and detects elevated bacterial loads in and around wounds, announced that it is in compliance with SOC 2® Type I, having successfully completed its audit in accordance with the American Institute of Certified Public Accountants (AICPA) standards for Systems and Organization Controls (SOC). This enables MolecuLight to better serve the needs of its customers globally by ensuring the Company’s data management practices and organizational controls meet the highest international standards.

 

SOC ll (CNW Group/MolecuLight)

SOC ll (CNW Group/MolecuLight)

MolecuLight’s compliance with SOC 2® standards validates that the company has implemented controls relevant to the security, availability, and processing integrity of the systems used to process users’ data as well as the confidentiality and privacy of the information.

 

“Obtaining the SOC 2 certification reinforces MolecuLight’s ongoing commitment to the security, availability, and processing integrity of MolecuLight’s point-of-care fluorescence imaging technologies,” said Anil Amlani, MolecuLight’s CEO. “Our certification demonstrates our commitment and our business processes to maintain the highest level of security, privacy, availability, and confidentiality for our customers.”

 

As part of the process for achieving SOC 2® compliance, MolecuLight worked with PwC, an accredited auditor to review the design and operating effectiveness of the controls on its core MolecuLightDX® imaging platform against the applicable Trust Services Criteria for Security, Availability, and Confidentiality. These included the operating software of the imaging platform, how the devices manage customer and user data, as well as security policies and procedures. Over the course of the audit, MolecuLight demonstrated the ability to safely manage customers’ data and use of the platform, as well as its security controls and processes.

 

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 75 peer-reviewed publications involving 1,600 patients, they are used by leading wound care facilities globally.

 

About MolecuLight Inc.
MolecuLight Inc. is 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.

 

For more information, contact:

Rob Sandler
Chief Marketing Officer
MolecuLight Inc.
T. +1.647.362.4684
rsandler@moleculight.com
www.moleculight.com

Images:

Title: MolecuLight Successfully Completes SOC 2® Type l Audit and Accreditation
Download image: https://moleculight.box.com/s/9ycfyicr4fsxn8jfqdlo57q8sohqw1qz

SOURCE MolecuLight

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Diabetic Wound Care (video)

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Wound Problem After Below Knee Amputation Treated with new age creams (boric acid and Hypericum perforatum ( Sarı kantaron ), Calendula officinalis , Neem oil ( Azadirachta indica ) and Centellin.

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Recommendations for Wounds After Flaps and Grafts

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Michael Desvigne, MD, FACS, CWS, FACCWS Dr. Desvigne will present practical examples and case studies regarding the treatment of flaps and grafts after procedures, such as metatarsal amputation and the treatment of non-healing wounds. Dr. Desvigne will also discuss tools and methods he has used in the treatment of these amputation sites and non-healing wounds.

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Managing the Landscape of Wound Types Working from a Comprehensive Algorithm

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Vickie R. Driver, DPM, MS, FACFAS System Wide Medical Director INOVA Wound Healing and Hyperbaric Centers Falls Church Virginia Barry University , Miami Shores Florida Anderson Island, WA Daniel L. Kapp, MD Plastic Surgeon Daniel Kapp MD Plastic Surgery and Wound Care West Palm Beach, Florida Andrew J. Rader, DPM, FAENS, FACFAOM, FASPS, FAPWCA, FACCWS…

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REGENATIVE LABS AND BROTHERS IN ARMS FOUNDATION ANNOUNCE NEW

PARTNERSHIP TO OFFER STATE OF THE ART CARE TO INJURED VETERANS WITH 5 MILLION DOLLAR DONATION

Both organizations call on physicians to assist Veterans.

PENSACOLA, Fla. , Feb. 27, 2023 /PRNewswire/ — Regenative Labs (Regenative), a leading HCT/P manufacturer, is partnering with Brothers in Arms Foundation (BIAF), a 501©3 nonprofit providing logistical and financial support to wounded, ill, injured and fallen Marines, sailors, and the families of those who served. Together, both organizations are dedicated to giving back and improving the quality of life for those who have served our country.

 

Regenative will donate approximately $5 million dollars of its state-of-the-art Wharton’s Jelly product, ProText™, to BIAF which will facilitate the care of qualifying veterans. To bring this care to veterans, Regenative and BIAF need the help of physicians to apply the product.

 

Physicians across the country may join in supporting our veterans by making a qualified donation of their time under the Brothers in Arms Foundation 501©3 non-profit.

 

“We’re extremely proud of this partnership,” shared Regenative Labs CEO, Tyler Barrett. “Ultimately our products are about improving patient quality of life. My grandfather served in the Marines in Korea, and so being able to serve those like him in unison with the mission of Brothers in Arms is important to me,” Barrett concluded.

 

Regenative’s Wharton’s Jelly product is a structural connective tissue allograft intended for homologous use to replace or supplement missing or damaged tissue directly at the site of a structural defect. Some doctors have used the product for muscle and cartilage tears and to replace missing or damaged tissue due to wounds and tissue defects, instead of masking the underlying connective tissue issue.

 

Regenative has been tracking patient outcomes of applications of their product for over two years. Retrospectively, the results have shown improvements greater than 33 percent in patient reported WOMAC improvement.

 

It is Regenative’s and BIAF’s goal to provide veterans with the best quality of life possible.

 

“We’re committed to bettering the quality of life for our veterans,” said Brothers in Arms Foundation President, Phillip Noblin. “This new, innovative treatment will give them the hope and support needed to heal. The partnership with Regenative Labs will further our mission of serving those who’ve served us,” said Noblin.

 

Physicians interested in taking care of qualified veterans by donating their services through a 501©3 non-profit may visit: https://regenativelabs.com/biaf-physician-time-and-services-donation/

Veterans who wish to learn more, or to refer their physician today may visit: https://regenativelabs.com/biaf/

 

One can make a monetary donation through the BIAF.

 

About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient’s conditions using Wharton’s Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs’ expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative’s website: www.regenativelabs.com

 

About Brothers in Arms Foundation: Brothers in Arms Foundation is a 501c3 non-profit founded in 2009 that exists to provide financial and logistical support to wounded, ill, injured and fallen Marines, sailors, and the families of those who served within the Marines Special Operations community. Over the years, the foundation has supported active-duty Marines, sailors, veterans and military families with programs and services ranging from financial assistance, funding vocational and quality of life initiatives, as well as funeral support and childcare. Learn more at:

https://www.brothersinarmsfoundation.org

 

SOURCE Regenative Labs

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Wound Masterclass | Emerging Technologies in Clinical Practice

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Yuanwen Jiang, Artem Trotsyuk, Simiao Niu, Dominic Henn, Kellen Chen, Chien-Chung Shih, Madelyn R. Larson, Alana M. Mermin-Bunnell, Smiti Mittal, Jian-Cheng Lai, Aref Saberi, Ethan Beard, Serena Jing, Donglai Zhong, Sydney R. Steele, Kefan Sun, Tanish Jain, Eric Zhao, Christopher R. Neimeth, Willian G. Viana, Jing Tang, Dharshan Sivaraj, Jagannath Padmanabhan, Melanie Rodrigues, David P.…

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Chronic Inhibitory Bacterial Load (CIBL): New Clinical Terminology for Elevated Levels of Bacteria in Wounds that Preclude Healing

 

Findings from a New Clinical Study Using MolecuLight Imaging of Diabetic Foot Ulcers Prompts New Diagnostic Terminology Enabling Proactive Infection Management

 

TORONTO, Feb. 14, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that locates and detects elevated bacterial loads in and around wounds, announced the publication of “Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers“1 in International Wound Journal. The publication reports on the analysis of 138 diabetic foot ulcer wounds, highlighting the frequent presence of healing delays and elevated bacterial burden as identified through standard clinical assessment, fluorescence imaging (MolecuLight i:X®), and quantitative microbiology.

 

Chronic inhibitory bacterial load (

Chronic inhibitory bacterial load (“CIBL”) on the bacterial-infection continuum. Based on the International Wound Infection Institute (IWII) 2022 wound infection continuum (CNW Group/MolecuLight)

The emergence of data on the link between bacterial load and healing over the last decade, together with this current study, prompted study authors David G. Armstrong, Michael E. Edmonds, and Thomas E. Serena to define new clinical terminology, chronic inhibitory bacterial load (CIBL). CIBL is defined as “the chronic presence of bacterial microorganisms in a wound or its surrounding tissue at loads which can damage tissues and be inhibitory to healing, as well as require clinical intervention, with or without the presence of clinical symptoms”.

 

MolecuLight fluorescence imaging is currently the only way to detect and locate CIBL at the point of care. This term enables the proactive diagnosis of CIBL early along the bacterial-infection continuum, to facilitate its targeted removal, promote healing, and prevent the sequelae of infection in frequently asymptomatic diabetic ulcers.

 

Key findings of the study include:

  • Less than 12% of diabetic ulcers exhibited clinical symptoms of bacteria and infection, despite the presence of loads >104 CFU/g in over 90% (average bacterial load of 108 CFU/g). Even as bacterial loads increased up to >108 CFU/g, detection of clinical signs and symptoms of infection did not increase.
  • Bacterial loads >104 CFU/g can preclude wounds from healing through various biological mechanisms and are contraindicated for many advanced therapies. This study showed that the occurrence of delayed healing increased alongside bacterial load.
  • Fluorescence imaging using MolecuLight increased sensitivity for the detection of CIBL across loads 104–109 (p < .0001), peaking at 92.6% for bacterial loads >108 CFU/g. This was 8.3 times superior to standard clinical assessment alone.
  • Fluorescence imaging further showed that 84.2% of ulcers contained high loads in the periwound region, an area that is frequently overlooked.

 

Infection prevention is a key goal of CIBL’s introduction, adoption, and management. CIBL is the result of these seasoned wound care clinicians’ long-time advocacy for proactive wound management as they see firsthand the devastating consequences of delayed treatment. “Infection is the greatest destroyer of the diabetic foot. It is the final common pathway for most amputations, and we need to fight it as early as possible in its natural history”, says Dr. Michael E. Edmonds, one of the paper’s authors and Consultant of Diabetologist at the Diabetic Foot Clinic, King’s College Hospital Foundation Trust in London, UK. “CIBL localization and proactive management is a crucial strategy in reducing unnecessary amputations and saving lives”, he concludes.

 

As MolecuLight is the only device capable of detecting elevated bacterial loads in wounds in real-time, regions of CIBL can be non-invasively and accurately detected and mapped. The device provides clinicians with immediate feedback to guide their therapeutic decision-making process in a number of clinical settings from the outpatient clinic to the operating room. Multiple routine procedures are enhanced by its proven capabilities, such as debridement, wound hygiene, and preparation for advanced therapies resulting not only in better outcomes,3,4 but more rational resource consumption and antimicrobial stewardship.4

 

“There is also a meaningful role for fluorescence imaging with MolecuLight in antimicrobial stewardship. This is critical considering that approximately 70% of patients with diabetic foot ulcers are prescribed antibiotics at some point during their care, and over 80% are prescribed antimicrobial dressings3, often in a haphazard manner”, says Dr. Thomas Serena, study author and the Founder and Medical Director of The SerenaGroup®. “Diagnostic uncertainty has been listed as a key factor in antibiotic overuse in wound care. Fluorescence signals as a real-time imaging biomarker of CIBL could enable clinicians to more effectively leverage hygiene-based strategies to remove bacteria rather than resorting to antibiotics”.

 

“The definition of an infection’s genesis and its resolution is a clinical one”, notes Dr. David G. Armstrong, study author, Professor of Surgery at the University of Southern California, and founder and co-Director of the Southwestern Academic Limb Salvage Alliance (SALSA). “The problem is that many objective local signs may be blunted in the chronic wound and it is likely that we are not yet effectively measuring what we manage. Fluorescence imaging of chronic inhibitory bacterial load (CIBL) is positioned to potentially change contemporary paradigms of wound management. We are hopeful that this new clinical term, CIBL, can be a key indicator to enable pre-infection intervention such as debridement or modification of wound therapy.”

 

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 65 peer-reviewed publications involving 1,500 patients, they are used by leading wound care facilities globally.

References
1 Armstrong DG, Edmonds ME, Serena TE. Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers. Int Wound J. 2023;20(2):554-566
2 Wounds International (2022) International Consensus Update 2022 International Wound Infection Institute (IWII) Wound Infection in Clinical Practice: Principles of best practice. Available from https://woundinfection-institute.com/
3 Price N. Routine fluorescence imaging to detect wound bacteria reduces antibiotic use and antimicrobial dressing expenditure while improving healing rates: retrospective analysis of 229 foot ulcers. Diagnostics (Basel). 2020;10(11):927.
4 Rahma S, Woods J, Nixon JE, Brown S, Russell DA. The use of point-of-care bacterial autofluorescence imaging in the Management of Diabetic Foot Ulcers: a pilot randomised controlled trial. Diabetes Care. 2022;45:1601-1609.

About MolecuLight Inc.
MolecuLight Inc. is 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.

 

SOURCE MolecuLight

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Where: San Diego Convention Center, San Diego, California, USA When: Friday, June 23, 2023 (beginning at 10:30 a.m.) through Monday, June 26, 2023 (concluding at 4:15 p.m.) conferences and events

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WoundCon Spring 2023 – March 10, 2023

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Based on the latest evidence and innovations in wound care, WoundCon Spring 2023 offers practical strategies that you can immediately implement into your practice. Featuring free registration for licensed healthcare professionals and the convenience of interactive education with world-renowned specialists on March 10, this a must-attend CME/CNE meeting. conferences and events

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Allogenic Adipose-Derived Stem Cells in Diabetic Foot Ulcer Treatment

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Clinical Effectiveness, Safety, Survival in the Wound Site, and Proteomic Impact Beata Mrozikiewicz-Rakowska, Ilona Szabłowska-Gadomska, Dominik Cysewski, Stefan Rudziński, Rafał Płoski, Piotr Gasperowicz, Magdalena Konarzewska, Jakub Zieliński, Mateusz Mieczkowski, Damian Sieńko, Tomasz Grzela0, Maria Noszczyk1, Barbara Paleska, Leszek Czupryniak, Malgorzata Lewandowska-Szumiel

REGENATIVE LABS AND DR. MICHAEL LAVOR ANNOUNCE CASE STUDY DEMONSTRATING

NOVEL APPLICATION OF UMBILICAL CORD FLOWABLE TISSUE ALLOGRAFTS IN DECUBITUS ULCERS

NEWS PROVIDED BY Regenative Labs

 

PENSACOLA, Fla., Jan. 23, 2023 /PRNewswire/ — A case study analysis of two patients has been presented by Regenative Labs (Regenative), a leading HCT/P manufacturer, in collaboration with Dr. Michael Lavor of Saguaro Surgical. This case study demonstrates the use of Wharton’s Jelly, a connective tissue, allografts in combination with standard of care wound practices to accelerate the healing of refractory, Stage IV sacral wounds in paralyzed patients.

 

In reference to what he’s seen in the patient population regarding Wharton’s Jelly allografts, Lavor shared, “the patients have begged for more because it is the only thing that has helped them. I believe this is an excellent step prior to surgery, and will save hundreds of thousands of dollars.”

 

This case study demonstrates an application of Wharton’s Jelly allografts in late-stage sacral decubitus ulcers (SDU), also known as pressure sores, with associated tunneling in combination with standard of care. In the future, research may focus on the frequency and combination of procedural techniques that most efficiently promote granulation tissue formation and volumetric contracture of deep wounds with Wharton’s Jelly allografts.

 

“This, for wounds, is excellent for closing tunnels,” explained Dr. Lavor.

 

It was reported that for the first time in ten years, one patient experienced a highly accelerated wound closure rate, and observed volumetric reduction in the wound bed, healthy granulation tissue, and the resolution of deep tunneling. One patient achieved full one closure and epithelization.

 

Both patients in the presented case study had SDU classified as Stage IV with tissue loss and bone or tendon involvement. One patient had previously experienced a mid-sacral pressure sore with exposed tendon, bone, and tunneling for ten years. The other, had an ischial pressure sore with the same features that persisted for 30 months. After failing multiple conservative treatments such as wound vac placement, antibiotics, wet-to-dry dressings, and silver sulfadiazine dressings, both patients received several applications of Regenative’s Wharton’s Jelly allograft.

 

In both cases, after eight months of standardized wound care treatment combined with six applications of Regenative’s Wharton’s Jelly allograft, the wounds contracted by over 90% in depth, tunneling, and diameter.

 

Annually, thousands of individuals are affected by SDU. Treatment for these conditions is costly and far from perfect, with prices as high as an eye-watering 240,000 dollars for skin flap surgery. Inevitably, Stage II pressure ulcers can become serious if not handled swiftly. When deep, tunneling, and with both tendon and bone involvement, such as the two patients in this case study, late-stage pressure sores occur, and pose a great challenge to medical professionals.

 

Regenative is committed to providing patients with alternative options, and through what may be revealed in these studies, offering proven treatments to better address the root cause of their pain.

 

Regenative hopes to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine.

 

“The research at Regenative is very promising, and we’re calling on physicians across the country to engage with us and advance regenerative medicine,” shared Regenative Labs CEO, Tyler Barrett.

 

Contact Regenative to get your practice involved today.

 

About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient’s conditions using Wharton’s Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs’ expert product research and development team comply with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative’s website: www.regenativelabs.com

 

About Dr. Michael Lavor: Dr Michael Lavor has worked for over 28 years bringing the highest quality of medicine to his patients. He is currently based out of Arizona, and is planning to open his own practice within the first 2 quarters of 2023. In addition to his work as Assistant Medical Director at Saguaro Surgical, Dr. Lavor was a member of the Trauma Team at Tucson Medical Center where he also served as Chairman of the Department of General and Vascular Surgery. Dr. Lavor was board certified in General Surgery and was a fellow in the American College of Surgeons, past president of the Rocky Mountain Vascular Surgical Society, a Fellow in the Southwestern Surgical Congress, a member of the Tucson Surgical Society, a member of the International Society of Endovascular Surgery and the Pima County Medical Society. Lavor served in the Navy for ten years as a Navy Corpsman with the Marines; he returned to service in 2009 and served as a Commander / OIC of a wound surgical base in Afghanistan from 2012-2013. He also was a Clinical Associate Professor at the University of Arizona Medical Center Department of Surgery.

This article was originally published here

HMP Global’s SAWC Spring | WHS announces record number of wound care abstract submissions for 2023 meeting

More than 500 abstracts featuring late-breaking wound care research, new advances and techniques to improve care and outcomes for patients were submitted for poster at the 2023 event, co-located with the Diabetic Limb Salvage meeting.

 

HMP Global, the leading omnichannel healthcare events and education company, today announced that its 2023 Symposium on Advanced Wound Care (SAWC) Spring and Wound Healing Society (WHS) received a record-breaking number of abstract submissions for the event taking place April 26-30, strengthened by a new partnership co-locating the symposium with the Diabetic Limb Salvage conference.

 

Now in its 36th year, SAWC Spring | WHS is the leading meeting dedicated to the research, management, treatment, and prevention of wounds; and through the partnership with DLS, this year’s event will feature more limb salvage-focused topics on the conference agenda. The meeting is the premier multidisciplinary forum to connect practitioners, researchers, and students with the foremost experts in wound care to improve patient outcomes through education.

 

Symposium participants will have access to 450 posters featuring late-breaking wound care research, new advances, strategies, and techniques to improve care and outcomes for patients. More than 500 abstracts — a record number — were submitted to undergo the peer review process for poster consideration.

 

In addition to presenting posters in person at SAWC Spring | WHS | DLS, wound care researchers can elevate their work further by submitting abstracts for publication in the field’s preeminent, peer-reviewed journal WOUNDS, focusing on the latest advances in wound care and wound research. WOUNDS is indexed in MEDLINE/PubMED and publishes research and commentary on tissue repair and regeneration, biology and biochemistry of wound healing, and clinical management of various wound etiologies. Submission information and guidelines are available on HMP Global’s Wound Care Learning Network.

 

“The record-breaking number of abstract submissions this year is a testament to the dedication of the wound care community to advancing their knowledge and skills,” said Tiffney Oliver, Vice President, Wound Care Learning Network, HMP Education. “For our 2023 meeting, we are excited to offer a world-class lineup of educational sessions as well as a record number of abstracts about the latest research in wound care.”

 

Submitted abstracts are blind reviewed by a panel of expert judges, based on specific criteria for the category in which it was submitted. Researchers may also be considered for poster grand rounds, oral abstracts, SAWC Young Investigator, and highest scoring abstract honors.

 

“We are excited to host one symposium for every member of the wound care team, allowing us to provide the highest caliber training and education that all clinicians can incorporate into their practice,” said WHS President Dr. Kenneth Liechty, Division Chief of Pediatric Surgery and Director of Fetal Medicine, University of Arizona, and Surgeon in Chief of Diamond Children’s Hospital. “The quantity and high caliber of the posters presented this year spotlights the most up-to-date research on wound care and limb salvage. This level of exposure to innovation is unparalleled in the wound care community.”

 

Posters will be on view from 7:30 a.m. to 5 p.m. Friday, April 28, and from 7:30 a.m. to 5 p.m. Saturday, April 29. In addition, SAWC Spring | WHS | DLS participants will have the opportunity to interact with the researchers during the Poster Reception and Awards Presentation from 7:15-8:30 p.m. on April 28, presented by WOUNDS.

 

Educational Program

The SAWC Spring | WHS | DLS agenda features more than 80 high-impact sessions from expert presenters led by the giants and emerging voices in the field, providing more than 25 CME/CE credits. Participants will have access to sessions in traditional as well as new formats, including hands-on workshops, rapid-fire, case-based, and patient panels. Learning tracks encompass the business of wound care as well as separate tracks through DLS and WHS.

 

“We have partnered with the Wound Healing Society for 15 years, providing a robust educational experience for meeting participants, and this year will be even stronger with the addition of multiple topics on amputation prevention, said SAWC Spring Co-Chair Dr. Robert S. Kirsner, Harvey Blank Professor and chairman, Dr. Philip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine. “No other wound care conference offers this level of education, advanced state-of-the-art clinical reviews, and emerging research findings.”

 

The interdisciplinary agenda is designed for every aspect of wound research, prevention, and healing, with an important focus on limb salvage. Sessions are designed for all members of the wound care team, including physicians, nursing professionals, podiatrists, physician assistants, physical therapists, researchers, scientists, dietitians, and healthcare, sales, and marketing professionals.

 

For more information or to register, visit sawcspring.com.

 

ABOUT HMP GLOBAL
HMP Global is the force behind Healthcare Made Practical — and is an omnichannel leader in healthcare content, events, and education, with a mission to improve patient care. The company produces accredited medical education events — in person and online via its proprietary VRTX virtual platform — and clinically relevant, evidence-based content for the global healthcare community across a range of therapeutic areas. Its brands include the HMP Global Learning Network, healthcare’s most comprehensive source for news and information; Psych Congress, the largest independent mental health meeting in the U.S.; the Evolution of Psychotherapy, the world’s largest independent educational event for mental health professionals; the Leipzig Interventional Course (LINC), the leading, global gathering for interdisciplinary cardiovascular specialists; EMS World Expo, North America’s largest EMT and paramedic event; and the Symposium on Advanced Wound Care (SAWC), the largest wound care meeting in the world. For more information, visit hmpglobal.com.

 

This article was originally published here

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Wound Masterclass – Emerging Technologies in Clinical Practice

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Negin Shamsian, Chien-Chung Shih, Madelyn R. Larson, Alana M. Mermin-Bunnell, Smiti Mitta, Jian-Cheng Lail, Aref Saberil, Ethan Beard, Serena Jing, Donglai Zhong, Sydney R. Steele, Kefan Sunl, Tanish Jain, Eric Zhaol, Christopher R. Neimeth, Willian G. Viana, Jing Tang, Dharshan Sivaraj, Jagannath Padmanabhan, Melanie Rodrigues, David P. Perrault, Arhana Chattopadhyay, Zeshaan N. Maan, Melissa C.…

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