News January 2023

MiMedx to Expand Wound & Surgical Product Pipeline Expansion With Agreement With Turn Therapeutics

MiMedx Group, Inc. recently announced it has licensed worldwide exclusive rights to Turn Therapeutics’ proprietary antimicrobial technology platform, PermaFusion^®, for the development of future biologic products focused on wound and surgical recovery applications, according to a press release.

PermaFusion^® is petrolatum-based, liquid-in-oil suspension technology that involves the creation of nanodroplets without binding agents or emulsifiers and also includes a process to coat materials with antimicrobial-infused petrolatum, notes MiMedx. Turn’s IP estate includes “mixing” and “coating” IP and provides protection up to 20 years. MiMedx expects this technology to be included in the creation of a number of new antimicrobial biologic products for the wound and surgical markets.

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MolecuLight Featured in Vizient Tech Watch as Key Technology for Visualizing Bacterial Burden and Helping Reduce SSI

MolecuLight Corp. 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 Tech Watch article, “Fluorescence Imaging: New technology enables point-of-care surgical wound bacterial assessment,” describes how surgical site infections (SSIs) occur in up to 38% of surgeries (depending on anatomical location and type of surgery) and account for 20% of all healthcare-acquired infections. 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 admission. 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.”
 
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, notes MolecuLight.
 
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Topical Oxygen Therapy Awarded "A" Grade Treatment Recommendation by the American Diabetes Association

Advanced Oxygen Therapy Inc. (AOTI) recently announced that the American Diabetes Association (ADA) has awarded an "A" grade recommendation for utilizing adjunctive topical oxygen therapy in treating Diabetic Foot Ulcers (DFU) in the ADA’s 2023 standards of care in diabetes, the preeminent Clinical Practice Guidance (CPG) in the space, which was recently published online.

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, combining 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 trials and real world evidence 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.

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SoftOx Solutions AS Gets Positive Phase 1 Results for Eradicating Biofilm

SoftOx Solutions AS recently announced it has received the final report and analysis of its Phase 1 study evaluating the safety and tolerability of SoftOx Biofilm Eradicator (SBE-01) (EudraCT no. 2021-000314-42), an antimicrobial solution for the treatment of chronic wounds.
 
SBE-01 is a first-in-human study investigating the safety, tolerability, and antimicrobial efficacy of single and multiple doses of SBE in patients with chronic leg wounds. The Phase 1 study was divided into two parts: a randomized, blinded, Single Ascending Dose (SAD) phase, followed by an open label, Multiple Ascending Dose (MAD) phase, where patients were treated once-daily or twice-daily over five days.
 
The company notes the final report reaffirms previous findings that SBE is safe and well-tolerated by patients suffering from chronic leg wounds. There were no statistically significant differences in the evaluation of pain during and after the wound cleaning procedure comparing SBE with placebo. The study found that formulations of SBE consistently reduced the bacterial burden in the wound compared with pre-treatment. There was also evidence of wound healing with a reduction in wound area of between 24 to 36% after just 5 days’ treatment.
 
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NEJM Publishes Phase 3 Data on B-VEC in Patients with Dystrophic Epidermolysis Bullosa

Krystal Biotech, Inc. recently announced that data from the pivotal Phase 3 (GEM-3) trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa (DEB) have been published here in the New England Journal of Medicine (NEJM). The full manuscript, titled “Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa,” appeared in the December 15, 2022 issue of the NEJM.

In this GEM-3 trial of 31 patients, complete wound healing at 6 months occurred in 67.4% of B-VEC wounds compared to 21.6% for placebo (difference, 45.8 percentage points; 95% confidence interval [CI], 23.6 to 68.0; P = .002), according to the study. Complete wound healing at 3 months occurred in 70.6% of the wounds exposed to B-VEC as compared with 19.7% of those exposed to placebo (difference, 51.0 percentage points; 95% CI, 29.3 to 72.6; P = .0005).

The GEM-3 trial was a randomized, double-blind, intra-patient placebo-controlled multi-center trial designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB, notes Krystal Biotech. In the trial, matched wounds receiving topical B-VEC or placebo were evaluated in 31 DEB patients over 26 weeks. The pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-months and its secondary endpoint of complete wound healing at three-months. B-VEC was well tolerated, with no drug-related serious adverse events or discontinuations due to treatment.

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