Diabetic foot ulcer

Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025 DALLAS, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the final group of burn center patients in the Company’s U.S. Burn Pivotal Study have successfully completed their clinical visits. One of the largest domestic burn center studies ever conducted, the U.S. Burn Pivotal Study is expected to be the final clinical trial before the Company seeks U.S. Food and Drug Administration (“FDA”) approval of its DeepView® System for burn indication (“DeepView AI®-Burn”) in the first half of 2025. DeepView AI®-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue in order to provide clinicians with an immediate and binary assessment of a burn wound’s healing potential. The Company expects to report topline results from this study in December 2024. “The completion of this aspect of the U.S. Burn Pivotal Study marks a critical milestone on our path towards commercialization,” said Dr. J. Michael DiMaio, Chairman of the Board. “These results will form the foundation of our forthcoming U.S. regulatory submission and brings us one step closer to delivering a potentially groundbreaking advancement in burn wound assessment that can support clinical decision-making regarding next step treatment plans, broaden equity in access to burn care treatment, and improve clinical outcomes. I want to thank our investigators, their dedicated staff, and study enrollees for their support in this endeavor.” About the U.S. Burn Pivotal Study The U.S. Burn Pivotal Study was initiated in January 2024 and involves 160 adult and pediatric patients at 14 burn centers across the country. It is designed to validate the AI-driven closed loop algorithm used by DeepView AI®-Burn. Each patient underwent non-invasive imaging of their wound using DeepView AI®-Burn beginning at the initial clinical assessment and until the treatment plan was defined. An end image was required at 21 days following initial assessment. About Spectral AI Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView™ System. The DeepView™ System is a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, the DeepView™ System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView™ System, visit www.spectral-ai.com. Forward Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Investors: The Equity Group Devin Sullivan Managing Director dsullivan@equityny.com Conor Rodriguez Analyst crodriguez@equityny.com

Chosen for List After Comprehensive Evaluation by Team of Wound Care ExpertsTEL AVIV, Israel and JACKSONVILLE, Fla., Oct. 24, 2024 (GLOBE NEWSWIRE) -- RedDress®, developers of the ActiGraft® Pro system, a personalized and autologous wound care solution created from a patient’s own whole blood, today announced that ActiGraft Pro has been added to the Wound Care Advantage (WCA) Formulary after a comprehensive evaluation by the WCA Product Council, a team of wound care experts. The WCA Product Council focuses on reviewing products for safety, effectiveness, and accessibility for wound centers. WCA offers a wide range of services and support for wound care centers, empowering the centers to seamlessly transition from outsourced management to in-house support. With more than 20 years of experience, WCA supports a national network of wound centers with a strong focus on reducing costs and improving patient outcomes. The WCA network of wound care centers has access to the formulary for comprehensive education and information, allowing providers to make well-informed decisions that best support their patients’ care. The ActiGraft Pro system from RedDress is an autologous, point-of-care wound management solution created from a patient’s whole blood. The ActiGraft Pro blood clot is created at the patient’s bedside in under five minutes by mixing fresh whole blood with a proprietary coagulation powder. Once applied, the blood clot reignites the body’s healing cascade while serving as a protective covering. A recent randomized controlled trial revealed significant benefits to using ActiGraft Pro for diabetic foot ulcers. Patients treated with ActiGraft Pro were more than twice as likely to heal compared to those receiving standard of care alone. The ActiGraft Pro treatment resulted in a 51% healing rate compared to 18% in the control group. It also showed a shorter time to heal and greater durability of wound closure. Since RedDress received FDA clearance and a CE Mark in 2020, ActiGraft has helped over 7,000 patients across the spectrum of healthcare facilities in the USA and 30 other countries. While reimbursement for ActiGraft Pro currently applies only to chronic wounds in diabetic patients via National Coverage Determination NCD 270.3, ActiGraft Pro is indicated for a wide variety of chronic wounds including but not limited to: Diabetic and Neuropathic Ulcers, Venous Ulcers, Traumatic Wounds, Post-Surgical Wounds, Skin Tears and Surgical Wounds. Disclaimer: The information provided shall not be constructed as a statement, promise, or guarantee that reimbursement will be received. Reimbursement requirements are subject to change at any time. Check with your local payer regularly. About Wound Care AdvantageFor over 20 years WCA has supported a national network of wound centers focused on reducing costs and improving patient outcomes. WCA empowers these centers by seamlessly transitioning from outsourced management to in-house support, leveraging Luvo – the industry's most powerful business intelligence platform. Learn more at www.thewca.com. About RedDress®RedDress is the leading provider of personalized and autologous wound management solutions created from a patient’s own blood. The company’s suite of ActiGraft® products is transforming wound care, treating a wide variety of chronic wounds including diabetic and neuropathic ulcers, venous ulcers, pressure injuries, traumatic wounds, post-surgical wounds, skin tears, surgical wounds, and more. RedDress is a privately held, Israel-based company with its U.S. subsidiary, RedDress Inc., located in Jacksonville, Florida. Founded to develop more effective, natural, and economically viable treatments for chronic wounds, RedDress is dedicated to using its whole-blood technology to find solutions to other human ailments. www.reddressmedical.com.

Oct. 18, 2024 -- FibroBiologics, Inc., (Nasdaq: FBLG) (“FibroBiologics”) and Charles River Laboratories (“Charles River”), a leading global drug discovery, development, testing, and manufacturing solutions provider established a master services agreement to develop and manufacture FibroBiologics’ therapeutic master cell bank, working cell bank, and fibroblast-based spheroids product, CYWC628, for utilization in a diabetic foot ulcer (DFU) clinical trial slated to begin in 2025. FibroBiologics, a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and fibroblast-derived materials. Indications being studied include wound healing, multiple sclerosis, degenerative disc disease, psoriasis, thymic involution reversal, and cancer. The technology transfer from FibroBiologics to Charles River for current good manufacturing practice (CGMP) manufacturing has been successfully completed, along with feasibility studies evaluating FibroBiologics’ proprietary cell manufacturing processes. With the positive results from these feasibility studies and the signed master services agreement, Charles River will now serve as the contract development and manufacturing organization (CDMO), to produce the drug products for FibroBiologics’ upcoming clinical trial. Charles River’s cell and gene therapy CDMO portfolio helps to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with Charles River’s legacy testing capabilities, Charles River offers an industry-leading “concept to cure” advanced therapies solution. “Charles River’s work with FibroBiologics is part of a larger commitment to supporting next-generation regenerative medicine through the adoption of innovative therapies. We are excited to collaborate with FibroBiologics and support the development of a therapy that has the potential to transform patient care for those impacted by diabetic foot wounds,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “The formalization of our working relationship with Charles River is a pivotal step as we advance toward a significant wound care clinical trial in 2025 with CYWC628,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Working with Charles River opens new possibilities for innovation with its global reach and scalability potential. By combining our unique therapeutic fibroblast-based spheroids approach with Charles River’s expertise and unparalleled support, we are positioned to accelerate progress in delivering this treatment to patients.” Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 160+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com. The content above comes from the network. if any infringement, please contact us to modify.