Varicose Ulcer

SARASOTA, Fla., March 14, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today presented positive interim data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 91 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 63 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1 The interim data are being presented at the Cellular, Acellular, and Matrix-Like Products Wound Care Summit (CAMPs) March 13-14 in Miami, and the completed data set demonstrating even stronger results is being submitted for publication in a peer-reviewed wound journal. "Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. Promedica conducted the DFU clinical trial. "In evaluating Omeza®'s platform, the first twelve patients treated in the study demonstrated significant healing—and in some cases, complete closure—of their diabetic wounds in twelve weeks or less, which is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the Promedica clinical trial site. In the study, patients with DFUs were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also received standard of care, which included offloading—no weight-bearing by the foot—to support healing. By week four of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week twelve, the average PAR was 91 percent, with two additional patients achieving complete closure of their DFUs. Both of these cases were of ≥1 year duration prior to treatment with OCM™ and off-loading. No adverse events related to treatment were reported during the study. "We continue to be encouraged by the high rates of wound closure experienced by patients in our three studies that are currently underway, and we look forward to obtaining further confirmation of OCM's™ ability to treat advanced wounds from day one, as well as to transition chronic wounds from a stalled state to a healing state more quickly and completely than other products on the market," said Desmond Bell, DPM, Chief Medical Officer at Omeza®. "All of the components in our platform are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting." Reference: 1 (22)02154-1/fulltext About OMEZA Omeza is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising essential omega fatty acids and hydrolyzed fish collagen infused with cod liver oil. Founded in 2014, the company currently markets Omeza Complete Matrix (OCM™) designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Omeza is currently conducting three clinical trials in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other etiologies to evaluate the effects of Omeza Combination Therapy versus standard of care on wound healing, pain reduction, quality of life, and additional secondary endpoints. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida. Media Contact: Bernadette Cupit [email protected] 908-334-4554 SOURCE Omeza LLC

HOUSTON, March 13, 2024 /PRNewswire/ -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 150+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced that it will present an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, Massachusetts, from April 16-17, 2024. The Advanced Wound Care Summit USA is a forum where industry leaders share the latest innovations and advancements in Wound Care and tackle pressing challenges in areas such as regulation, clinical trials, reimbursement, and investment. FibroBiologics will be represented by Chief Scientific Officer, Hamid Khoja, Ph.D., and Associate Scientist, Subhiksha Raghuram, MS, MD, who will present on FibroBiologics' fibroblast cell therapies and their potential to treat chronic wounds. Details of the presentations are as follows: Oral Presentation: Presentation Title: Fibroblast Spheroid-mediated Accelerated Chronic Wound Healing in a Diabetic Mouse Model Presenter: Hamid Khoja, Ph.D., Chief Scientific Officer, FibroBiologics Session Title: Research and Development - Biologics Session Date and Time: April 16, 2024, at 12:20 p.m. Eastern Standard Time Poster Presentation: Presentation Title: Dermal Fibroblast Spheroid-based Treatment of Chronic Wounds in a Diabetes Mouse Model Presenter: Subhiksha Raghuram, MS, MD, Associate Scientist, FibroBiologics Poster Session: Available Virtually "The data we will present highlights the clinical potential of fibroblast cell-based treatment for chronic wounds such as diabetic foot ulcers and venous ulcers," said Dr. Khoja. "Fibroblasts are key participants in every single stage of wound healing. We believe that by harnessing the specific capacity of fibroblasts in wound healing, we have the potential of revolutionizing wound care as we know it. We look forward to attending the meeting to share our data, and connecting with fellow experts in the field." For more information, please visit FibroBiologics' website or email FibroBiologics at: [email protected]. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential of fibroblast cell therapies to treat chronic wounds such as diabetic foot ulcers, and venous ulcers, and the potential of such treatments to revolutionize wound care by harnessing the specific capacity of fibroblasts in wound healing. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, 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 FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, . These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) the ability of FibroBiologics to continue to meet Nasdaq listing requirements; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; and (c) the ability to effectively manage the business as a result of the super-voting proxy given to the Board of Directors. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a cell therapy and regenerative medicine company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit . Investor Relations: Nic Johnson or Harrison Seidner, Ph.D. Russo Partners (646) 942-5599 [email protected] Media Contact: Liz Phillips Russo Partners (347) 956-7697 [email protected] General Inquiries: [email protected] SOURCE FibroBiologics

Merakris Therapeutics to present poster at CAMPs Wound Care Summit in Miami, FloridaRESEARCH TRIANGLE PARK, N.C., March 12, 2024 (GLOBE NEWSWIRE) -- A recent multicenter study has demonstrated encouraging effectiveness and safety of Merakris Therapeutics’ Dermacyte® Amniotic Wound Care Matrix in treating hard-to-heal diabetic and venous leg ulcers (VLUs). Wounds with an average size of 20 cm2 showed a significant reduction in volume after a single application and a 50% reduction in wound size was observed after approximately two applications of Dermacyte Matrix, the study reported. The study, a real-world, multicenter, retrospective clinical study, analyzed 18 hard-to-heal wounds in 11 patients who received Dermacyte Matrix between August 2022 and August 2023. Thirteen of the wounds were diabetic ulcers and five were chronic venous insufficiency (CVI)-related VLUs. All the patients in the study had failed to respond favorably to prior standard of care wound treatment. The results suggest that Dermacyte Matrix – a human amniotic membrane allograft that protects soft tissue and wounds from the external environment – may improve treatment outcomes for diabetic and venous leg ulcers and help reduce a major healthcare and economic burden on society. The findings from this multicenter clinical study have been published in the March addition of the peer reviewed Journal of Wound Care (JWC). Merakris also will present a poster at the JWC- sponsored CAMPs (Cellular Acellular and Matrix-Like Products) Wound Care Summit in Miami, Florida, March 13-14. “We are delighted to share the results of this study, which provides positive evidence of Dermacyte Matrix use in addressing hard-to-treat wounds that were not resolved through standard-of-care wound treatment,” said Merakris CEO Chris Broderick. “A growing body of evidence indicates that amnionic membranes like Dermacyte Matrix offer a better option for protecting serious wounds that have not responded well to other treatments.” Overall, treatment with Dermacyte Matrix resulted in significantly decreased wound size over time. “Together, these findings suggest that placental biologics, including amniotic membranes, drive wounds through the productive phases of wound healing and can ultimately reduce wound duration and potentially scarring,” the study reported. “A likely indirect effect of these is the salvage of limbs that may otherwise face amputation as a last resort intervention.” The research was supported, in part, by Merakris. About Merakris Research Triangle Park-headquartered Merakris Therapeutics, founded in 2016, is at the forefront of scientific advancement in regenerative medicine. Dedicated to championing a precision medicine approach to wound care, the company seeks to improve global patient care and outcomes with cell-free regenerative therapies. In addition to Dermacyte® Matrix, its products include: Dermacyte® Amniotic Wound Care Liquid, a cell-free amniotic injection developed under Merakris’ Investigational New Drug (IND) clearance that is being evaluated for the treatment of non-healing venous stasis ulcers.Opticyte® Matrix, which provides an ophthalmic barrier to the corneal surface of the eye for use with various ocular procedures.Opticyte® Serum Tears, which can be used for the treatment of dry eye and corneal epithelial (outer layer) defects, and as an adjunct therapy to support optimization of the ocular surface before and after various clinical and surgical procedures. Merakris Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole. Bryant HaskinsOtter Creek Communicationsbryanthaskins@gmail.com(c) 973 590 9537