SerenaGroup, Inc.

First diabetic foot ulcer (DFU) study in the US utilizing a modified platform trial design to demonstrate the efficacy of multiple products in a single clinical trial. First to incorporate continuous glucose monitoring in a cellular, acellular, matrix-like product (CAMP) DFU study ROSWELL, Ga., June 4, 2024 /PRNewswire/ -- StimLabs, a leading regenerative medicine company, announced Institutional Review Board (IRB) authorization to begin the CAMPSTIM clinical trial, a multi-center randomized controlled trial to demonstrate the real-world benefits of StimLabs' placental-based tissue products in treating patients with hard-to-heal diabetic foot ulcers (DFUs). "This trial is the first US master trial design in non-healing DFU studies to demonstrate the efficacy of multiple products in a single trial, the first DFU trial to utilize continuous glucose monitoring, and the largest prospective DFU trial involving placental-based CAMPs," said Thomas E. Serena, MD, FACS, FACHM, MAPWCA, Founder and Medical Director of SerenaGroup®, and Principal Investigator for the trial. He added, "This platform, and similar master trial designs, represent the future of clinical research in the industry. SerenaGroup is excited to manage this innovative study with the StimLabs team, who have consistently demonstrated innovation in wound care." In the United States, DFUs occur in 1.6M patients with diabetes annually1. These ulcers commonly recur and often lead to severe complications such as skin and soft tissue infections, osteomyelitis, amputation, sepsis, and death. The longer a DFU remains open, the greater the risk of complication.2 Despite advances in treatment, less than 50% of DFUs are healed at 12 weeks.3 Additionally, greater than 90% of DFUs with less than a 50% area reduction at 4 weeks of standard of care (SOC) do not go on to heal.4 These alarmingly poor healing rates highlight the need for effective CAMPs, also known as skin substitutes, in patients suffering from DFUs. "In collaboration with SerenaGroup, we have carefully designed a comprehensive and standardized trial utilizing advanced technologies to ensure the highest quality results," said John Daniel, Founder and CEO of StimLabs. The CAMPSTIM trial features a protocol that will drive consistency across sites through the inclusion of digital devices to provide wound measurements and bacterial load and the incorporation of continuous glucose monitoring for every patient. Furthermore, it standardizes the use of Mölnlycke Health Care's market-leading dressing, Mepilex® Border Flex as well as the additional use of Mölnlycke's gelling fibre dressing, Exufiber® in highly exudating wounds. CAMPSTIM will evaluate at least four separate StimLabs CAMPs (Enverse®, Revita®, Relese® and Cogenex®) with SOC compared to SOC alone, in treating patients with non-healing DFUs. The study utilizes a unique modified platform trial design, adapted from clinical trials developed during the pandemic to test multiple interventions within a single trial. It is the first such design used for DFUs in the US. As the largest planned prospective clinical study to date on placental tissue allografts, CAMPSTIM will enroll approximately 272 patients across multiple sites in the US. The primary endpoint of the study will be the percentage of target ulcers achieving complete wound closure in 12 weeks. Secondary endpoints include time to closure, percentage of wound area reduction, number of adverse events, and changes in pain and quality of life. "This highly vulnerable patient population will benefit greatly from the best technologies to support their wound care. Through this novel trial, we look forward to showcasing the power of our unique placental tissue allograft portfolio," said John Daniel. Unlike many placental allografts on the market, the StimLabs product configurations used in this study retain all three layers of the native placental membrane: the amnion, chorion, and intermediate layer. This is made possible using the patented Clearify® technology, which preserves the integrity of the membrane by ensuring it remains intact during processing. By never delaminating the tissue, StimLabs grafts result in complete, full-thickness products which retain the essential structural proteins and growth factors that play a crucial role in wound resolution. About StimLabs StimLabs LLC's mission is to advance the state of regenerative medicine, with a current focus in wound care and surgical applications. Comprised of industry leaders, StimLabs is dedicated to offering patients the best possible care while recognizing the urgency of providing solutions in areas with unmet needs. StimLabs has a comprehensive product portfolio addressing various clinical applications and has established a strong intellectual property catalog. Committed to delivering superior products, StimLabs is a trusted partner to physicians and patients alike. . About Mölnlycke Mölnlycke Health Care is a world-leading MedTech company that specialises in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, health care providers and patients in over 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and headquartered in Sweden. 1. Voelker R. What Are Diabetic Foot Ulcers? JAMA. 2023;330(23):2314. doi:10.1001/jama.2023.17291 2. National Diabetes Foot Care Audit: . Accessed 3February2024. 3. Fife CE, Eckert KA, Carter MJ. Publicly Reported Wound Healing Rates: The Fantasy and the Reality. Adv Wound Care (New Rochelle). 2018 Mar 1;7(3):77-94. doi: 10.1089/wound.2017.0743. PMID: 29644145; PMCID: PMC5833884. 4. A Post-hoc Analysis of Reduction in Diabetic Foot Ulcer Size at 4 Weeks as a Predictor of Healing by 12 Weeks. (2010). Wound Management & Prevention, 56(3).

Unprecedented Body of New Clinical Evidence using the MolecuLight Wound Imaging Platform Demonstrates Improved Clinical Decision-Making and Patient Outcomes TORONTO and LAS VEGAS, Nov. 2, 2023 /PRNewswire/ -- MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of elevated bacterial loads in wounds, announces that MolecuLight data will be presented in 12 clinical posters and presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2023. The results to be presented include new data from recent investigations using MolecuLight device from over 1,500 patients. The international conference is being hosted from November 2 - 5, 2023 in Las Vegas, Nevada, and is one of the largest multidisciplinary meetings of wound care professionals in the world. "We are proud to see once again abundant and consistently favorable outcomes being presented by MolecuLight imaging platform users at this week's SAWC conference", says Anil Amlani, CEO of MolecuLight. "The volume of our clinical evidence continues to grow and confirms that MolecuLight improves healing outcomes. Our devices inform the appropriate use of antibiotics and help empower patients during the treatment and recovery of their wounds. We are particularly motivated by of our impactful clinical results in vulnerable patient populations that suffer from health care inequities. Our device has proven to be an equitable diagnostic tool that delivers quality results for patients of all skin tones. This sets us apart and makes us part of the solution, and we couldn't be more proud of this." "Good wound hygiene is a game-changer for taking wound care to the next level and boosting those outcomes. I always say, 'Clean it like you mean it', but we can only clean what we can see. MolecuLight is an objective tool that, for the first time, allows providers to visualize in real-time and more effectively remove bacterial burden that is otherwise invisible to the naked eye," says Dot Weir, RN, CWON, CWS, wound care nurse at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine in Saratoga Springs, New York and Co-Chair of the Symposium on Advanced Wound Care (SAWC). Dot is speaking at a hands-on pre-conference workshop showing how MolecuLight can be used to guide and improve wound hygiene practices. "We can and should do better. The MolecuLight device is evidence-backed, equitable for all patients, and is instrumental in the care of every single patient who walks through our doors. This amazing piece of hand-held technology is revolutionizing the way we clean wounds. I can't imagine delivering the highest quality of care without it." Continue Reading 12 Posters and Presentations Featuring MolecuLight to be presented at SAWC Fall 2023 (CNW Group/MolecuLight) 12 Posters and Presentations Featuring MolecuLight to be Presented at the SAWC Fall 2023 Conference (CNW Group/MolecuLight) The clinical presentation and posters featuring the MolecuLight i:X and DX from SAWC Fall 2023 are as follows: CLINICAL PRESENTATIONS Hands-On Pre-Conference Workshop: Wound Infection Day Dot Weir (Saratoga Hospital Wound Healing Center) will be presenting cases and a hands-on workshop showing how the application of point-of-care fluorescence imaging can help guide wound hygiene practices. Thursday, November 2, 2023, 1:00 PM – 5:00 PM, Julius 1-4 A Multidisciplinary Panel Looks at Debridement Dot M. Weir, RN, CWON, CWS, Saratoga Hospital Wound Healing Center, Gansevoort, NY Friday, November 3, 2023, 10:30 AM – 11:30 AM PDT, Milano I-III Wound Imaging Oscar M. Alvarez, PhD, CCT, FAPWCA, Rutgers, New Jersey Medical School Saturday, November 4, 3:10 PM – 3:35 PM PDT, Milano I-III New Wound Diagnostics Charles A. Andersen, MD FACS, Chief of Vascular/Endovascular Surgery/Limb Preservation Service, Madigan Army Medical Center, Milton, WA Saturday, November 4, 2023, 3:45 PM – 4:10 PM PDT, Milano I-III Advanced Clinical Practice and Emerging Research (SAWC Oral Abstracts) Multimodal imaging device for real-time bacterial load and thermal imaging: a study of synergy in clinical wound assessment workflow Charles A. Andersen, MD Vascular/Endovascular/Limb Preservation Surgery Service, Madigan Army Medical Center, WA Saturday, November 4, 4:20 PM – 4:45 PM PDT, Julius 7-10 RAPID FIRE: Poster Oral Presentations (previously SAWC Poster Grand Rounds) Pseudomonas Scrub Down: Advances in Wound Imaging Objectively Confirm the Efficacy of Acetic Acid Against this Pathogen Alisha Oropallo, MD1; Amit Rao, MD1; Angelin Mathew, BS2 Saturday, November 4, 5:00 PM – 6:00 PM PDT, Julius 7-10 Download poster b) CLINICAL POSTERS Poster#CS-086 Wounds Illuminated: Unveiling the Shades of Red Fluorescence Charles A. Andersen1, Raymond J. Abdo2, Misael Alonso3, Katherine McLeod1, Nathan Krehbiel4, Ashley Jacob4 Download poster Poster #PI-003 Strategies to improve equity in wound bacterial-infection assessments on skin of color Charles Andersen1, Jonathan Johnson2, Alton R. Johnson Jr.3, Angelin Mathew, BS4 Download poster Poster # CR-030 Co-localization of High Bacterial Load with Regions of Pain in Venous Leg Ulcers: Imaging Informs Interventions and Validates Patient Self-Reported Pain Amit Rao, MD1; Farisha Baksh, BS1; Sally Kaplan, RN1; Alisha Oropallo, MD1,2 Download poster Poster #CR-035 Does bacterial fluorescence imaging improve chronic wound biofilm detection over standard clinical assessment and blotting? Liis Teene, Laura M Jones*, Perry V. Mayer, Monique Y. Rennie, Hanna Varonina*, Ashley Jacob*, Phil Bowler Download poster Poster #CS-183 Enhancing Wound Bed Preparation: Combining Bacterial Load Imaging Detection Technology with a Hypochlorous Acid Preserved Cleanser Dot Weir, Saratoga Hospital Wound Healing Center, Gansevoort, NY Poster #EBP-011 Systemic and topical antimicrobial prescribing trends in outpatient wound care: Observational multi-centric study from 1447 baseline wound assessments and impact of Bacterial Fluorescence Imaging Nancy Trafelet, SerenaGroup Advanced Wound Care & Hyperbaric Medicine, Cambridge, MA In addition to the clinical posters and presentations at SAWC Fall 2023, the MolecuLight i:X® and DX™ imaging devices will be available for demonstration in the MolecuLight booth #430 in the Octavius Ballroom (Level 3) at Caesars Palace, Las Vegas, NV. 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 unmatched clinical evidence including over 80 peer-reviewed publications and 2,600 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. Rob Sandler, Chief Marketing Officer, MolecuLight Inc., T. +1.647.362.4684, [email protected], Photo - Photo - SOURCE MolecuLight Inc.

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 24 presentations and posters at the European Wound Management Association (EWMA) 2023 Annual Conference, being hosted from May 3 - 5, 2023 in Milan, Italy. Held annually, EWMA is the largest wound care conference in Europe and one of the largest events globally for wound care professionals. "We are humbled by the number of clinicians globally that have made our MolecuLight point-of-care device an invaluable tool in their wound care practices", says Anil Amlani, MolecuLight's CEO. "The impressive collection of 24 talks and posters from so many facilities globally shows how the MolecuLight imaging device is becoming a new standard-of-care in wound care. This clinical evidence is echoed in the 75+ peer-reviewed publications, showing the significant benefit of the MolecuLight i:X® and DX™ to clinical wound assessment, practice, and outcomes." "The MolecuLight imaging platform is a "must have" device for wound care clinics and is a standard of care in our clinics. The abundance of published clinical evidence showing improvements in bioburden detection, better clinical decision making, and improved outcomes is clear validation for its medical necessity," says Dr. Thomas Serena, the Founder and Medical Director of The SerenaGroup® and author and presenter of 2 talks and posters featuring MolecuLight at EWMA 2023. "There are tangible clinical benefits for using the MolecuLight alongside a broad range of wound care procedures, in all wound care settings. Evidence now proves that clinical signs and symptoms underperform and contribute to haphazard prescribing of antimicrobials and antibiotics. When added to clinical assessment, information from MolecuLight images flags at risk wounds earlier. This leads to proactive bacterial infection management, reduced antibiotic overprescribing, fewer infection complications, and faster healing." The collection of 9 presentations and 15 posters featuring the MolecuLight imaging devices show how the devices inform clinical decision-making through its digital wound measurement feature, detection of high bacterial burden in wounds at the bedside, and its ability to monitor and track wound size and bioburden over time. Presented studies span the wound care continuum, including: Accelerated wound healing results as shown in RCT findings, Accuracy of MolecuLight across all skin pigmentations and chronic wound types, Fluorescence-targeted wound debridement, Novel diagnostic approaches using MolecuLight to detect wound-associated cellulitis and to monitor unexpected or difficult to access bacterial locations, and Enhanced patient adherence and engagement The results being presented illustrate the significant clinical improvements to multiple aspects of wound care provided by the MolecuLight platform. A selection of the clinical posters and presentation featuring the MolecuLight i:X and DX from European Wound Management Association (EWMA) 2023 Annual Conference are as follows: (a) Select Clinical Posters citing the MolecuLight point-of-care device include: AUTO-FLUORESCENCE IMAGING AS A PREDICTOR OF CONTAMINATED/INFECTED DIABETIC ULCERS' OUTCOMES Nicola Riitano, Pisa - Italy Thursday May 4th, 10.00-11.15 E-POSTER SCREEN 1, DIABETIC FOOT 2 UNDERAPPRECIATED BACTERIAL BURDEN IN PRESSURE ULCERS: CLINICAL TRIAL AND REAL-WORLD EVIDENCE Charles Andersen, USA Thursday May 4, 11.45-13.15 E-POSTER SCREEN 4 PRESSURE ULCER 1 FLUORESCENCE-BASED EVALUATION OF BACTERIAL LOAD IN CHRONIC WOUNDS AND PERILESIONAL SKIN: A COMPARISON BETWEEN COMPRESSIVE MULTILAYER BANDAGE AND ZINC OXIDE BANDAGE Alessandra Michelucci, Pisa - Italy Wednesday May 3rd, 20:48 - 20:51, E-Posters On Display EVALUATION OF AN AUTO-FLUORESCENT SPECTOMETRY ANALYZING DEVICE FOR WOUND INFECTION DIAGNOSTIC Aharon Wanszelbaum, Jerusalem - Israel Wednesday May 3rd, 11.45-13.15 E-POSTER SCREEN 1 - DEVICES & INTERVENTION FLUORESCENCE LIGHT ENERGY AND WOUND HEALING: A NEW ERA? Carlotta Scarpa, Padova - Italy Wednesday May 3rd, 11.45-13.15 E-POSTER SCREEN 1, DEVICES & INTERVENTION (b) Select Clinical Presentations citing the MolecuLight point-of-care device include: "Wound Imaging" Workshop, Presentation on MolecuLight by Dr. Valentina Dini (University of Pisa , Pisa , Italy) and Dr. Thomas Serena, Founder, Serena Group, USA Thursday 4th May, 13:00 – 14:00, Room Amber 8 12-WEEK RCT EVALUATING IMPACT OF ROUTINE FLUORESCENCE IMAGING OF BACTERIA ON DFU HEALING RATES Laura Jones, Toronto - Canada Friday May 05th, 13:30 - 14:30, Free paper session: Diabetic Foot 5, Room BROWN 1 PATIENT PERSPECTIVE: HOW FLUORESCENCE IMAGING OF CHRONIC WOUND BACTERIA SUPPORTS PATIENT ADHERENCE AND EMPOWERMENT Charles Andersen, Joint Base Lewis-McChord - United States Thursday May 4th, 11:30 - 12:30, Free paper session: Quality of Life, Room AMBER 7 USE OF A BACTERIAL FLUORESCENCE IMAGING DEVICE FOR BACTERIAL DETECTION AND GUIDANCE OF WOUND DEBRIDEMENT Rosemarie Derwin, Dublin - Ireland Thursday May 4th, 08:30 - 09:30, Free paper session: Wound Assessment, Room AMBER 7 FLUORESCENCE IMAGING PROMPTS MORE THOROUGH DEBRIDEMENT OF BACTERIA & BIOFILM: REAL-WORLD DATA FROM 1000 WOUND ASSESSMENTS ACROSS 36 STATES Laura Jones, Toronto - Canada Thursday May 4th, 10.00-10.45 E-POSTER SCREEN 4 WOUND ASSESSMENT The complete listing of the 24 presentations & posters is available here. 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, CE-Marked and approved by Health Canada. With clinical evidence including over 75 peer-reviewed publications, the devices are used by leading wound care facilities globally. About MolecuLight Inc. MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight's suite of commercial devices, which include the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, are point-of-care handheld imaging devices for the real-time detection and localization of bacterial load in wounds and digital wound measurement. MolecuLight procedures performed in the United States benefit from an available reimbursement pathway which includes two CPT® codes for physician work to perform "fluorescence imaging for bacterial presence, location, and load" and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. The company is also commercializing its unique fluorescence imaging platform technology for other global markets with relevant unmet needs in food safety, consumer cosmetics and other key industrial markets. Download for Image: View original content to download multimedia: SOURCE MolecuLight