Latest news with #woundhealing
Yahoo
11-07-2025
- Business
- Yahoo
FibroBiologics to Present at the Advanced Wound Care Summit USA
HOUSTON, July 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) ('FibroBiologics'), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Founder and Chief Executive Officer, Pete O'Heeron, will present at the Advanced Wound Care Summit USA in Boston, Massachusetts, on July 15, 2025. The presentation will include recent research advances using fibroblast-based technology for indications such as wound healing and psoriasis. 'The Advanced Wound Care Summit is an ideal forum to showcase how FibroBiologics is pioneering the next generation of wound healing through our fibroblast-based technology," said Mr. O'Heeron. "Our CYWC628 therapy represents a fundamentally different approach to treating diabetic foot ulcers, one that taps into the body's natural regenerative processes rather than simply managing symptoms. With our Phase 1/2 clinical trial set to kick off later this year, we are poised to deliver potentially transformative outcomes for patients with limited treatment options and high recurrence rates.' Details of the presentation are as follows: Date: Tuesday, July 15, 2025Time: 2 p.m. ETLocation: Marriott Courtyard Boston Downtown The Advanced Wound Care Summit, taking place July 15–17, will bring together global leaders in wound care innovation, clinical research, and advanced therapeutics to address unmet needs in chronic wound management. With a focus on accelerating product development and enhancing patient outcomes, the summit will feature keynote presentations, interactive panels, and strategic networking opportunities. For more information, please visit FibroBiologics' website or email FibroBiologics at info@ 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 plans for, and the anticipated timing of the initiation of and results from, FibroBiologics' current and future preclinical studies, clinical trials and research and development programs, and the potential clinical benefits of fibroblasts and fibroblast-derived materials. 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. 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) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; and (d) the ability of FibroBiologics to successfully prosecute its patent applications. 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 clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 275+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit General Inquiries:info@ Investor Relations:Nic JohnsonRusso Partners(212) 845-4242fibrobiologicsIR@ Media Contact:Liz PhillipsRusso Partners(347)
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
Medscape
04-07-2025
- Health
- Medscape
RDEB: Large Wounds Healed With Genetically Corrected Grafts
In a recently published phase 3 trial, credit card-sized cultured skin grafts corrected for the COL7A1 mutation that causes recessive dystrophic epidermolysis bullosa (RDEB) and enabled most patients to achieve at least 50% reductions in the size of large chronic wounds, with an overall mean pain score reduction of more than 2 points at week 24. In April 2025, prademagene zamikeracel (Zevaskyn, Abeona Therapeutics) became the first FDA-approved cell-based genetic therapy when it was approved for the treatment of wounds in adult and pediatric patients with RDEB. It is the first commercially available RDEB treatment to demonstrate sustained wound healing and pain reduction for large, chronic RDEB wounds, according to investigators. 'These wounds are the most terrible and difficult to treat in our patients,' the study's lead principal investigator Jean Y. Tang, MD , PhD, professor of dermatology at Stanford University School of Medicine in Stanford, California, said in an interview. 'To have a therapy using the patient's cells to suture on, hopefully close their wounds, and reduce their pain is monumental.' Jean Y. Tang, MD , PhD For the VIITAL trial, published online on June 23 in The Lancet , Tang and colleagues enrolled 11 patients with clinically and genetically confirmed RDEB (median age, 21 years) and no evidence of immune response to type VII collagen. To reduce the likelihood of immunogenicity, only patients with the amino-terminal NC1 fragment of type VII collagen could enroll. Investigators selected 43 wounds of at least 6 months' duration measuring at least 20 cm2 for treatment and compared these results against standard care for 43 randomly assigned control wounds matched for size, chronicity, and location. Grafting Process Using 8-mm punch biopsies from unaffected skin, investigators transduced isolated keratinocytes with a retrovirus carrying the full-length human COL7A1 gene, then used those keratinocytes to culture up to 12 40 cm2 sheets of autologous keratinocytes per patient. After 25 days, surgeons sutured up to six sheets of prademagene zamikeracel per patient, with each procedure taking 3-4 hours. To minimize pressure and friction, patients remained hospitalized with no changes of nonadhesive contact dressings for 7 days postsurgery. Images of wounds randomly assigned to prademagene zamikeracel or control at baseline, surgery, and week 24. Investigator assessments showed that 24 weeks posttreatment, 81% of treated patients achieved at least 50% healing from baseline vs 16% of control wounds ( P < .0001). Mean pain reduction from baseline (measured with the Wong-Baker Faces scale within 3 hours after dressing change) was 3.07 among treated patients vs 0.90 for control wounds ( P = .0002). Also at week 24, 16% of treated wounds achieved complete healing, with a 2.0-point decrease in itch severity from baseline. The corresponding figures for control wounds were 0 (healing) and 0.5 (itch). In the past 3 years, the FDA and the European Medicines Agency also have approved topical beremagene geperpavec (Vyjuvek) and birch triterpenes (Filsuvez) for dystrophic EB. However, wrote Tang and colleagues, the wounds treated with these therapies were mostly less than 20 cm2, and both treatments require repeated application. Nor did they improve pain or itchin clinical trials, added Tang. Having the first permanent gene correction for RDEB is very exciting, said Amy Paller, MS, MD, professor and chair of Dermatology and professor of pediatrics at Northwestern University, Chicago. She was not involved with the phase 3 study but will run the first of several specialized centers where prademagene zamikeracel will be applied. Amy Paller, MS, MD 'This is the first instance in our field where a gene has been corrected for grafting and is commercially available,' Paller said. 'It's something that we and our patients dreamed about for genetic skin disorders.' Logistics and Labor Performing the treatment is logistically complex and 'incredibly labor-intensive,' Paller said. The process requires rushing biopsies to Abeona's good manufacturing practice facility in Cleveland, where over the next few weeks, the keratinocytes are grown out, corrected, expanded markedly, and quality tested. 'It's a very expensive procedure with many moving parts,' she said. Accordingly, Paller plans to start with three patients from her own practice, beginning in August. Additionally, she is consulting with other interested families in the Midwest and will soon expand outreach to her other patients. 'I want experience with the process in patients I have known for years before grafting additional patients,' she explained. Prademagene zamikeracel's retroviral component may provoke discussion. Tang explained, 'We take the biopsy from the patient's skin, grow their keratinocyte skin cells, and use a retrovirus containing wild-type collagen VII to introduce that into the patient's skin cells. There's always a theoretical concern of retroviruses maybe hitting off-target genes, but so far, we and others haven't seen that.' In a phase 1/2a study, investigators followed seven patients treated with what was then known as EB-101 for a mean of 5.9 years. There were no serious adverse events related to treatment, with no gene therapy-related cutaneous or extracutaneous malignancies or evidence of systemic replication-competent retrovirus infections in serum samples from patients. The beauty of grafting skin, Paller added, is that development of a tumor — while unexpected — would be easily visible and biopsied, just as dermatologists now biopsy for suspected squamous cell carcinoma, a feared complication related to the scarred skin in patients with RDEB. Treated patients will require a long-term commitment to surveillance, she said, with a low threshold for considering biopsy if a change suggesting carcinoma is seen. The FDA recommends that manufacturers of genetic products follow patients for 15 years posttreatment. Clinical and Research Implications Although the phase 3 study showed the utility of correcting genetically defective collagen VII in treating RDEB, said Tang, the cell therapy approach could prove useful for additional genetic skin diseases such as ichthyosis and Gorlin syndrome. Paller said she hopes that junctional EB will be the next candidate for gene-corrected grafts. However, she added, with more extensive clinical experience and cost reductions over time, grafting of gene-corrected skin could be considered to improve focal areas in other forms of EB and genetic skin disorders. For the near term, Paller said she also hopes that insurers will not block access to the other approved RDEB treatments for patients who undergo prademagene zamikeracel treatment. 'I trust that that won't happen because these patients are so needy,' she said. To help patients access treatment, Abeona offers the Abeona Assist program, which helps patients understand their insurance benefits and financial assistance options and provides travel and logistical assistance. 'As far as I'm concerned,' said Paller, 'each patient with EB should have everything at our disposal to help — this is such a horrible disease. If I can graft a 12 credit card-sized area and then keep them going with tricks for other areas, I'll be very happy.' The study was funded by Abeona Therapeutics, which developed prademagene zamikeracel, which also conducted data analysis and employs several study co-authors. Tang is listed on the prademagene zamikeracel patent, which is licensed by Stanford University to Abeona, but she receives no royalties. Additionally, Tang has consulted on EB-related therapeutics for BridgeBio and Fibroderm. Paller served on the VIITAL data safety monitoring board and has consulted for Chiesi, Krystal, and Castle Creek Biosciences.
Yahoo
18-06-2025
- Business
- Yahoo
Polydeoxyribonudeotide (PDRN) Market to Surge with Anti-Aging & Regenerative Therapies Demand: Valuates Reports
BANGALORE, India , June 18, 2025 /PRNewswire/ -- Polydeoxyribonudeotide (PDRN) Market is Segmented by Type (Powder, Solution), by Application (Mesotherapy, Bone Injection & Dermal Fillers, Pharmaceutical, Cosmetic) Wound Healing Products and Others): Global Opportunity Analysis and Industry Forecast, 2024-2031. The global market for Polydeoxyribonudeotide (PDRN) was valued at USD 72.1 million in the year 2024 and is projected to reach a revised size of USD 855 million by 2031, growing at a CAGR of 43.0% during the forecast period. Claim Your Free Report: Major Factors Driving the Growth of Polydeoxyribonudeotide (PDRN) Market: The Polydeoxyribonucleotide (PDRN) market is witnessing accelerated growth due to increasing applications in aesthetics, wound healing, and regenerative medicine. With strong demand from cosmetic clinics, dermatologists, and biotech firms, PDRN is becoming a staple in modern therapeutic protocols. Solution and powder forms cater to both convenience and customization needs. Growing investments in R&D, rising consumer awareness, and favorable regulatory developments further bolster market momentum. The rise of anti-aging consciousness, medical tourism, and combination therapies ensures a strong future outlook. As more markets adopt biologic-based treatments, PDRN is poised to expand across global healthcare and cosmetic industries. Unlock Insights: View Full Report Now! TRENDS INFLUENCING THE GROWTH OF THE POLYDEOXYRIBONUDEOTIDE (PDRN) MARKET Solution-based PDRN formulations are playing a pivotal role in expanding the market due to their convenience, fast absorption, and targeted therapeutic efficiency. These liquid formats are widely used in mesotherapy, dermatological treatments, and regenerative injections, where rapid delivery to specific skin or tissue layers is crucial. Clinics and aesthetic centers prefer solution-based PDRN as they reduce preparation time and ensure consistent dosing. Moreover, solution formulations are compatible with a wide range of medical devices and allow for combination therapies with other active agents. Their versatility and effectiveness in promoting tissue repair, improving skin texture, and reducing inflammation significantly enhance their appeal, thereby propelling demand within the growing PDRN market. Powder-based PDRN products are gaining traction in the market due to their long shelf life, stability, and flexibility in formulation. These products are typically reconstituted with sterile water or saline before use, offering precision and control in dosage based on the treatment area. Powdered PDRN is especially popular in cosmetic clinics and research applications, where practitioners may customize concentrations for individual patients. The demand for minimally invasive aesthetic procedures has surged, and powdered formats meet the requirements for microneedling, skin rejuvenation, and scar treatment. Additionally, powdered PDRN reduces the risk of microbial contamination, making it a preferred option in sterile clinical environments, thus supporting market growth. The cosmetic industry is a major driver of the PDRN market due to its increasing reliance on biologically active ingredients for anti-aging, skin repair, and aesthetic treatments. PDRN, known for stimulating cell regeneration and collagen production, is widely incorporated in procedures like mesotherapy, skin boosters, and serums. As consumer preference shifts toward non-surgical and regenerative beauty solutions, cosmetic clinics and dermatologists are adopting PDRN-based products to deliver visibly youthful skin with minimal downtime. High demand from Asia, especially South Korea and Japan, where skin care innovations lead global trends, also contributes to rapid growth. Thus, cosmetics remain a cornerstone segment, fueling PDRN market expansion. The growing demand for regenerative therapies in aesthetics is significantly boosting the PDRN market. Consumers are increasingly seeking non-invasive treatments that provide natural, long-lasting results. PDRN, derived from salmon DNA, promotes tissue repair and cellular regeneration, making it ideal for skin rejuvenation, wound healing, and scar treatment. Its integration into mesotherapy and facial injectables aligns with patient demand for biologically active, safer alternatives to synthetic fillers. This regenerative trend is especially prominent in Asia and gradually expanding in Western markets, where clinics are offering combination treatments that include PDRN. The shift toward healing-based beauty solutions strongly supports market growth in the aesthetic domain. PDRN's effectiveness in accelerating wound healing is a key factor driving its medical adoption. It enhances tissue repair, reduces inflammation, and improves skin regeneration, making it suitable for treating chronic wounds, burns, ulcers, and post-surgical scars. Dermatologists use PDRN in creams, gels, and injections to treat skin conditions such as eczema, acne scars, and atopic dermatitis. Its anti-inflammatory properties and ability to boost microcirculation improve patient outcomes and reduce recovery times. As healthcare providers prioritize tissue repair in both clinical and homecare settings, the demand for PDRN in therapeutic dermatology continues to grow, positively impacting the overall market. The global anti-aging market is expanding rapidly, creating new opportunities for PDRN-based solutions. PDRN's ability to stimulate fibroblast activity, improve skin elasticity, and reduce fine lines has made it a key ingredient in injectable serums and creams. Clinics offer skin booster treatments using PDRN to restore hydration and radiance, particularly in the face, neck, and hands. As consumers seek safer alternatives to Botox and dermal fillers, PDRN stands out for its regenerative approach with fewer side effects. With aging populations and beauty consciousness rising worldwide, particularly among millennials and older adults, the anti-aging segment remains a strong growth pillar for the PDRN market. PDRN is increasingly used in combination therapies, which is driving innovation and market growth. It is often paired with hyaluronic acid, peptides, vitamins, and growth factors to enhance overall treatment efficacy. Such combinations offer synergistic effects—while PDRN accelerates cellular repair, other agents provide hydration, nourishment, and tightening. This integration allows for comprehensive solutions addressing multiple skin concerns, including dullness, sagging, and pigmentation. Aesthetic practitioners prefer these formulations for customized treatments tailored to patient needs. The success of combination-based injectable products has led to new launches and broader adoption, pushing the PDRN market to evolve rapidly in both medical and cosmetic fields. Medical tourism, particularly in Asia-Pacific countries like South Korea, Thailand, and Malaysia, is contributing significantly to the PDRN market. These destinations are known for offering high-quality aesthetic and regenerative treatments at lower costs, attracting international patients. Clinics in these countries often market advanced therapies including PDRN-based injectables and facials as part of their service portfolio. The rising global interest in Korean beauty standards has also helped promote PDRN usage in non-invasive skincare. Coupled with government support and private investment in healthcare tourism, the influx of patients from Europe, the Middle East, and North America is boosting demand for sterile, effective PDRN products. Claim Yours Now! POLYDEOXYRIBONUDEOTIDE (PDRN) MARKET SHARE ANALYSIS Global key players of Polydeoxyribonudeotide (PDRN) include HTL Biotechnology and ReaLi Tide Biological. The top two players hold a share over 44%. China is the largest market, with a share of about 40%, followed by Europe and South Korea, with 24% and 33%, separately. The PDRN market is dominated by Asia-Pacific, particularly South Korea, China, and Japan, where aesthetic and regenerative medicine are deeply integrated into healthcare. China and South Korea are leading the Asia pacific market with widespread adoption of PDRN in dermatology and beauty clinics. In terms of product type, Powder is the largest segment, occupying a share of 65%, and in terms of application, Mesotherapy has a share of about 31%. Key Players: Mastelli BR PHARM BNF Solution Ruijiming Biological HENGYU BIOPH ReaLi Tide Biological HTL Biotechnology PharmaResearch Co., Ltd. Humedix Dongkook BMI KOREA Purchase Regional Data: SUBSCRIPTION We have introduced a tailor-made subscription for our customers. Please leave a note in the Comment Section to know about our subscription plans. DISCOVER MORE INSIGHTS: EXPLORE SIMILAR REPORTS! Polydeoxyribonucleotide (PDRN) and Polynucleotide (PN) Market Medical Grade Polydeoxyribonucleotide (PDRN) Market The global market for Cosmetic Grade Polydeoxyribonudeotide (PDRN) was valued at USD 45.7 million in the year 2024 and is projected to reach a revised size of USD 550 million by 2031, growing at a CAGR of 43.3% during the forecast period. The global market for Mesenchymal Stem Cells was valued at USD 226 million in the year 2024 and is projected to reach a revised size of USD 306 million by 2031, growing at a CAGR of 4.5% during the forecast period. The global Platelet Rich Plasma market is projected to grow from USD 302.1 million in 2024 to USD 342.2 million by 2030, at a Compound Annual Growth Rate (CAGR) of 2.1% during the forecast period. The global Stem Cell Therapy market size was USD 685 million in 2024 and is forecast to a readjusted size of USD 2373 million by 2031 with a CAGR of 19.7% during the forecast period 2025-2031. The global market for Anti-Inflammatory Cytokine was valued at USD 28920 million in the year 2024 and is projected to reach a revised size of USD 44960 million by 2031, growing at a CAGR of 6.6% during the forecast period. The global market for Exosomes Skincare was valued at USD 423 million in the year 2024 and is projected to reach a revised size of USD 796 million by 2031, growing at a CAGR of 9.6% during the forecast period. Polynucleotides Injectable Market The global Regenerative Medicine Market revenue was USD 33370 million in 2022 and is forecast to a readjusted size of USD 115660 million by 2029 with a CAGR of 19.2% during the review period (2023-2029). The global market for Skin Substitutes was valued at USD 1635 million in the year 2023 and is projected to reach a revised size of USD 4665 million by 2030, growing at a CAGR of 16.8% during the forecast period. DISCOVER OUR VISION: VISIT ABOUT US! Valuates offers in-depth market insights into various industries. Our extensive report repository is constantly updated to meet your changing industry analysis needs. Our team of market analysts can help you select the best report covering your industry. We understand your niche region-specific requirements and that's why we offer customization of reports. With our customization in place, you can request for any particular information from a report that meets your market analysis needs. To achieve a consistent view of the market, data is gathered from various primary and secondary sources, at each step, data triangulation methodologies are applied to reduce deviance and find a consistent view of the market. Each sample we share contains a detailed research methodology employed to generate the report. Please also reach our sales team to get the complete list of our data sources. GET A FREE QUOTE Valuates Reportssales@ U.S. Toll-Free Call 1-(315)-215-3225WhatsApp: +91-9945648335 Website: Blog: Pinterest: Twitter: Facebook: YouTube: Logo - View original content to download multimedia: SOURCE Valuates Reports Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
16-06-2025
- Business
- Associated Press
SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers
CAMBRIDGE, England--(BUSINESS WIRE)--Jun 16, 2025-- SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound healing, today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational Aurase Wound Gel (AWG), in the treatment of patients with calciphylaxis ulcers. The designation recognises the potential of AWG in the treatment of this new indication, widening its application in the healing of chronic wounds whilst expediting the speed at which the new therapy could be available to patients. Calciphylaxis is a rare but serious condition involving the calcification of small blood vessels in the fat and skin tissues. It leads to blood clots, painful skin ulcers, and can progress to severe infections and sepsis. Although most commonly associated with end-stage renal disease, the condition can also occur in individuals with normal kidney function. With limited treatment options and a high one-year mortality rate 123, AWG offers an alternative debridement solution that potentially reduces the risk of infection and sepsis, opening up treatment options for patients previously considered too fragile to receive the current standard of care and improving outcomes in this vulnerable population. AWG is a hydrogel releasing Tarumase, a recombinant enzyme originally isolated from medical maggots, which selectively targets fibrin, collagen and elastin in wounds to promote healing through debridement and wound bed preparation. It is currently in Phase II Clinical trials for the treatment of venous leg ulcers, having established proof-of-concept, a strong safety profile and pain-free application 4. David Fairlamb, Chief Development Officer at SolasCure said:'Given the unmet medical need and the poor outcomes for patients with calciphylaxis, the FDA's granting Fast Track Designation is a significant milestone. Not only does it reflect the promise of Aurase Wound Gel in the treatment of calciphylaxis ulcers, but it also adds a new indication, increasing its potential to help more patients, therefore opening up an even larger target market for SolasCure.' For more information about SolasCure, please visit: References View source version on CONTACT: Media: Sarah Jeffery Email:[email protected] KEYWORD: UNITED KINGDOM EUROPE INDUSTRY KEYWORD: HEALTH FDA CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: SolasCure Copyright Business Wire 2025. PUB: 06/16/2025 06:23 AM/DISC: 06/16/2025 06:22 AM
