Latest news with #diabeticfootulcers
Associated Press
08-07-2025
- Business
- Associated Press
Eluciderm, Inc. Announces U.S. FDA Clearance of IND Application for ELU42
SAN DIEGO--(BUSINESS WIRE)--Jul 8, 2025-- Eluciderm, Inc., a clinical-stage pharmaceutical company developing small molecule therapeutics designed to promote healing and regenerative repair of injured tissue, announced today that on June 30, 2025 the company received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND), ELU42, for a Phase 1/2a open-label study evaluating safety and efficacy in patients with diabetic foot ulcers (DFUs). ELU42 is a novel, topical, small molecule Wnt modulator with bacteriostatic properties for the treatment of chronic open wounds. 'The FDA's IND clearance of ELU42 marks an exciting transition for Eluciderm from preclinical research to full clinical-stage company,' said Daniel D. Holsworth, PhD, Chief Executive Officer of Eluciderm. 'ELU42 is the first in our pipeline of Wnt signaling modulators developed around a novel mechanistic approach to tissue healing and repair that we believe will shift the paradigm from simply managing patients' wounds to truly healing them.' The ELU42 Phase 1/2a trial is an open-label study evaluating the topical spray for safety and efficacy in a cohort of 15 patients with diabetic foot ulcers (DFUs). The study is set to begin the first week of August 2025 at three U.S. sites and will assess multiple clinical endpoints, including wound area reduction, closure rates, and safety metrics. The data from this trial will establish the foundation of a Phase 2 clinical trial in 2026, with strong potential for a Breakthrough Therapy designation in early 2027. 'This first-in-human trial is a defining moment for Eluciderm. ELU42 has the potential to change the standard of care for patients worldwide who suffer from non-healing wounds and underscores our commitment to transforming wound care,' said John P. Delgado, MD, Chief Medical Officer of Eluciderm. 'We believe everyone can be a SuperHealer TM.' About Eluciderm, Inc. Eluciderm is a San Diego-based clinical-stage pharmaceutical company pioneering topical small-molecule therapies that awaken the body's innate healing capacity. The company's approach is grounded in a targeted mechanism of action that selectively modulates the Wnt signaling pathway, with the goal of redefining wound healing and clinical outcomes. Eluciderm's platform, anchored by ELU42, includes therapeutics designed to promote healing and regenerative repair of a wide variety of wound injuries, including those from third-degree burns, surgical incisions, elastic cartilage reconstructions, pulmonary fibrotic damage from environmental factors, and inflammatory skin diseases. Based on favorable data from the National Cancer Institute's NCI-60 screening program, Eluciderm is also in the early stages of investigating oncological applications of their mechanistic methodology. For more information, visit and follow Eluciderm on LinkedIn. Forward-Looking Statements This press release may contain 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the initiation, timing, and progress of clinical trials; the potential therapeutic benefits of ELU42; and the development plans for Eluciderm, Inc.'s pipeline. These forward-looking statements are based on current expectations and beliefs and are subject to a number of risks and uncertainties, including those related to clinical development, regulatory approvals, manufacturing, and commercialization. Actual results may differ materially from those expressed or implied in the forward-looking statements. Eluciderm, Inc. disclaims any obligation to update these statements except as required by law. View source version on Dr. Daniel D. Holsworth, CEO;[email protected]; (734) 255-0366 KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH FDA DIABETES CLINICAL TRIALS SOURCE: Eluciderm, Inc. Copyright Business Wire 2025. PUB: 07/08/2025 03:29 PM/DISC: 07/08/2025 03:28 PM
Yahoo
23-06-2025
- Business
- Yahoo
BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain® Amnion Chorion for Treatment of Diabetic Foot Ulcers
Head-to-head study comparing BioREtain®- processed Amnion Chorion (BR-AC) allograft to standard of care initiated in Q4 2024 to demonstrate healing superiority Topline results and full data analysis expected in Q4 2025 POMPANO BEACH, Fla., June 23, 2025 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. ('BioStem' or the 'Company') (OTC: BSEM), a leading MedTech company focused on the development, manufacturing, and commercialization of placental-derived products for advanced wound care, today announced that patient enrollment has been completed in the Company's clinical trial evaluating BioREtain® Amnion Chorion (BR-AC) versus standard of care for patients with non-healing diabetic foot ulcers (DFUs). The BR-AC-DFU-101 study is a multicenter, randomized, controlled trial that was initiated in Q4 2024 at 11 sites across the U.S. to evaluate at least 60 patients with non-healing DFUs. The primary objective is to determine whether DFUs treated with standard care plus BR-AC achieve a higher probability of complete wound closure over a 12-week period when compared to standard care alone. BioStem recently completed enrollment of 71 patients in the study, with topline data expected to be reported during the fourth quarter of 2025. 'We are currently advancing three clinical trials to demonstrate the efficacy and competitive advantage of BioREtain®-processed allografts,' said Jason Matuszewski, CEO and Chairman of the Board of BioStem Technologies. 'I'm pleased that this trial has completed patient enrollment and remains on schedule to report results later this year. We continue to enroll patients in two additional studies targeting venous leg ulcers using BR-AC and diabetic foot ulcers using BR-A. Both trials remain on schedule and reflect our commitment to building a strong body of clinical evidence. We believe the results of these studies will further validate the BioREtain® allograft platform and support expanded physician adoption and commercial expansion.' Trial Primary & Secondary Outcome Objectives:The primary outcome of the study is to determine whether DFUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone over a 12-week period. Secondary outcome measures include: Comparing treatment group differences in proportions of wounds achieving complete wound closure based on time in days. Comparing treatment group differences in wound area and volume. Assessing total number of applications of BR-AC required to achieve complete wound closure. Clinical Trial Information:For more information about the BR-AC-DFU-101 study, please visit Clinical for a full overview: Title: A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated with Standard Care with or Without BR-AC Link: HERE Diabetic Foot Ulcer Market Statistics:Diabetic foot ulcers (DFUs) are a serious and chronic condition affecting millions of individuals within the diabetic population. According to the American Podiatric Medical Association (APMA), a leading authority on foot and ankle health, approximately 15% of people with diabetes will develop foot ulcers. Alarmingly, 6% of these individuals may require hospitalization due to infections or other complications related to their ulcers. The risks for diabetic patients are substantial, as DFUs are the leading cause of lower extremity amputations in the U.S. Studies indicate that between 14% and 24% of individuals with diabetes who develop foot ulcers will ultimately need an amputation. Recent data analysis from GlobalData Plc., a prominent global data provider, revealed that 2.2 million patients received treatment for DFUs in 2023, with numbers projected to rise in the coming years. The economic burden of these ulcers on healthcare systems is significant, with annual treatment costs estimated between $9 billion and $13 billion in the United States alone. About BioREtain®:BioStem's allografts are processed utilizing the Company's proprietary BioREtain® method, which retains the tissue's native properties while maintaining the structure and matrix found in fresh perinatal tissue. The patented six-step BioREtain® process is gentle, minimally invasive, and preserves the natural integrity of the amniotic tissue components critical to wound treatment. For a full overview of BioREtain®, please visit: HERE. Join BioStem's Distribution List & Social Media:To stay informed on the latest developments, sign-up for the Company's email distribution list HERE, and follow us on X and LinkedIn. About BioStem Technologies, Inc. (OTC: BSEM):BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for advanced wound care. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in advanced wound care, focused on maintaining growth factors and preserving tissue structure. BioStem's quality management systems and standard operating procedures are accredited by the American Association of Tissue Banks ('AATB') and adhere to Good Tissue Practices (cGTP and Good Manufacturing Processes ('cGMP'). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, VENDAJE OPTIC®, American Amnion and American Amnion AC. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit and follow us on X and LinkedIn. Contact BioStem Technologies, Inc.:Phone: 954-380-8342Website: info@ @BSEM_TechFacebook: BioStemTechnologies Investor Relations:Adam HoldsworthE-Mail: adam@ 917-497-9287 Note Regarding Forward-Looking Statements: Except for statements of historical fact, this press release also contains forward-looking statements. These forward-looking statements relate to expectations or forecasts of future events, including with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company. Forward-looking statements may be identified using words such as 'forecast,' 'intend,' 'seek,' 'target,' 'anticipate,' 'believe,' 'expect,' 'estimate', 'plan,' 'outlook,' and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this press release include, among other things, statements regarding the Company's: ability to clear all current SEC comments; expectations regarding filing an amended Form 10, including the timeframe therefor and the content therein; and expectations regarding the Company's plan and ability to satisfy Nasdaq listing requirements. Forward-looking statements are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from the expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the risk that the Company may be unable to list its stock on Nasdaq or maintain compliance with Nasdaq's continued listing standards; the impact of any changes to the accounting treatment of the Company's revenue and expenses; the risk of receiving additional comments from the SEC; the competition that the Company faces, which could adversely affect its business, results of operations and financial condition; the risk of rapid technological change, which could cause the Company's products to become obsolete or cause the Company to become unable to effectively compete; the risk that the Company is unable to successfully market its products to the end users of such products; the risk that the Company may be unable to raise funds to expand its business; changes in applicable laws or regulations; and the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
CBS News
11-06-2025
- Health
- CBS News
Study from Pittsburgh researchers detects invisible diabetic wounds
Diabetic foot ulcers are a common and major complication for people living with type 1 and type 2 diabetes that can lead to amputation and even death. When it comes to healing these ulcers, looks can be deceiving. But a new study published by University of Pittsburgh researchers is offering solutions. One of the lead authors told KDKA that what they found could change the definition of wound closure and save lives. Pitt study could change how wound closure is defined Jim Bennett, a retired Franklin Park Borough police officer, developed diabetes in his 40s and started getting diabetic foot ulcers. These wounds have high rates of recurrence. "It does take away from your quality of what you want to do, not really your quality of life, just something ot deal with," Bennett said. He eventually had several surgeries to amputate six of his toes, including all of them on his left foot. "I could not continue working because I couldn't wear the uniform shoes, so I had to retire eight months earlier than I had planned," he said. Bennett's 40-year career in the Franklin Park police force ended in 2014. Now, the 73-year-old said he goes to the wound clinic at UPMC Passavant once a week. "There are some open wounds that appeared at the bottom of my foot, and that's what's taking so long to heal right now. It starts to close up, then it opens up. And then another infection comes along and starts all over again," Bennett said. Because of the on-again, off-again wounds and the special boots he has to wear, there are a lot of things Bennett enjoys doing that he can't anymore. "I've always been pretty active, and I like to do things outside at the home and do things that you can't do anymore. I am hoping when I get out of these boots to be able to do those things again, some of them," said Bennett. Dr. Chandan Sen, director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh, calls diabetic foot ulcers "invisible wounds." Sen is also a professor in the Department of Surgery at Pitt and the chief scientific officer of Wound Healing Services at UPMC. He said the diabetic ulcers may appear healed and meet the FDA's definition of wound closure, which is when it's covered by new skin and has not had any discharge for two weeks. "That definition does not consider the functionality of the skin that just grew back," Sen said. In a new study with nearly 400 participants, Dr. Sen and his team show it's possible to detect invisible wounds by measuring water loss with a handheld device. "When we place the pen-like device, it gives us how much water is the body leaking," he said. "Using this device, you can test the functionality in a matter of five to 10 minutes know whether the skin that is covering the wound is properly functioning or now that we know which wounds are more likely recurr, we need additional care for them so that they stay closed," Dr. Sen added. He said these findings show the Food and Drug Administration's definition of wound closure needs to be updated. "Because it is not sufficient to close the wound with the skin, you also need to restore barrier function. That aspect is missing in today's definition of wound closure. This study and studies after this hopefully will go on to make a policy change in how wound closure is defined going forward. And that's a significant contribution to overall care of wounds clinically," Dr. Sen said. "The goal is to keep on going until we have no amputation," he added. If you have diabetes and find an ulcer on your foot, even if it's a tiny wound, seek help and see a doctor as soon as possible.
Associated Press
23-05-2025
- Health
- Associated Press
Cigna Adds Kerecis Intact Fish-Skin Grafts to Coverage Policy
ARLINGTON, Va. & REYKJAVIK, Iceland--(BUSINESS WIRE)--May 23, 2025-- Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration, today announced that Cigna, one of the largest health insurers in the United States, now includes Kerecis products in its medical coverage policy for the treatment of diabetic foot ulcers. This press release features multimedia. View the full release here: MariGen® With this policy update, Kerecis fish-skin grafts — including the MariGen ® and Shield ® product lines — became available to tens of millions of additional Americans. In total, nearly 200 million people in the United States are now covered under commercial insurance plans that recognize fish-skin grafts as medically necessary for chronic wound care. Cigna's inclusion adds to the growing list of national and regional payers that support the clinical and economic value of intact fish skin for non-healing wounds. The coverage applies to patients whose diabetic foot ulcers have not adequately responded to conventional treatments and meet specified clinical criteria. 'Access is a critical part of improving outcomes in chronic wound care,' said Fertram Sigurjonsson, Founder and CEO of Kerecis. 'We are pleased that Cigna recognizes the clinical value of our technology and that more patients can now benefit from regenerative fish skin as part of their treatment options.' About Kerecis Kerecis, founded by Fertram Sigurjonsson, develops fish skin and fatty acid products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body's own processes to heal and regenerate. Because no disease-transfer risk exists between cold-water fish and humans, the Kerecis fish-skin is only gently processed and retains its similarity to human tissue. The gentle processing preserves the skin's original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies show that Kerecis products heal wounds faster than competitors. Kerecis is the only global manufacturer of medical devices containing intact fish-skin and is the fastest growing company in the U.S. biologics skin market. Products include SurgiBind ® /SuriClose ®, GraftGuide ®, MariGen ®, and Shield™ for various medical applications. Committed to the UN Sustainable Development Goals, Kerecis uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products. For more information about Kerecis and its clinical research, visit Trademarks and registered trademarks are the property of their respective owners. View source version on Media Relations Agency (952) 697 5220 KEYWORD: EUROPE UNITED STATES ICELAND NORTH AMERICA DISTRICT OF COLUMBIA VIRGINIA INDUSTRY KEYWORD: DIABETES HEALTH INSURANCE SURGERY PROFESSIONAL SERVICES OTHER SCIENCE ENVIRONMENT MEDICAL DEVICES SUSTAINABILITY HOSPITALS HEALTH TECHNOLOGY HEALTH INSURANCE SCIENCE MEDICAL SUPPLIES SOURCE: Kerecis Copyright Business Wire 2025. PUB: 05/23/2025 09:30 AM/DISC: 05/23/2025 09:29 AM
