Month: May 2023

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

admin

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

Posted in Articles

Topical Oxygen Therapy Awarded Positive Treatment Recommendation by the International

by on

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…

Continue reading →

Posted in Articles

Largest Published Real-World Wound Imaging Study Reports MolecuLight®

by on

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…

Continue reading →

Posted in Articles

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

by on

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…

Continue reading →

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

admin
  • 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

Posted in Articles

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

by on

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…

Continue reading →

Posted in Articles

MolecuLight Featured in Unprecedented 24 Presentations and Posters at European

by on

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…

Continue reading →

Posted in Articles

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

by on

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)…

Continue reading →

Posted in Articles

Nevro Announces Enrollment of First Patient in PDN Sensory Study

by on

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…

Continue reading →

Posted in Articles

New Publication Reveals MolecuLight Imaging Significantly Improved

by on

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,…

Continue reading →