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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.

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.

 

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

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

 

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.

 

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

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

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