Latest news with #AWG
Yahoo
5 days ago
- Health
- Yahoo
SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers
Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in Phase II Clinical Trials for treatment of venous leg ulcers Fast Track is designed to facilitate development and expedite review of drugs to treat significant unmet medical need, fostering closer collaboration with the FDA CAMBRIDGE, England, June 16, 2025--(BUSINESS WIRE)--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 rate123, 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 application4. 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 Contacts Media: Sarah JefferyEmail: 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
Yahoo
5 days ago
- Health
- Yahoo
SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers
Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in Phase II Clinical Trials for treatment of venous leg ulcers Fast Track is designed to facilitate development and expedite review of drugs to treat significant unmet medical need, fostering closer collaboration with the FDA CAMBRIDGE, England, June 16, 2025--(BUSINESS WIRE)--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 rate123, 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 application4. 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 Contacts Media: Sarah JefferyEmail: 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
Business Wire
5 days ago
- Business
- Business Wire
SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers
CAMBRIDGE, England--(BUSINESS WIRE)--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:
Biz Bahrain
7 days ago
- Business
- Biz Bahrain
Kumulus Water Raises $3.5M to Redefine Clean Water Access with Off-Grid Tech in MENA and Europe
Kumulus Water, the WaterTech startup transforming air into clean drinking water, has successfully raised $3.5 million in seed funding. The round was led by Bpifrance via France 2030 SGPI and the Île-de-France Region, and included participation from other international regional and investors, such as Plus VC, MENA's most active VC, Khalys Venture, Flat6Labs, Europe's leading bottled water group Spadel, and several family offices and founders from Europe and North Africa. This strategic investment marks a major step in Kumulus' mission to provide decentralized, sustainable drinking water in regions facing water scarcity or lacking reliable infrastructure. Founded in 2021 by Iheb Triki and Mohamed Ali Abid, Kumulus designs and manufactures atmospheric water generators that extract safe drinking water from air humidity, without requiring any existing water or electricity infrastructure. The company's systems are currently in use in schools, hotels, and remote communities across Europe, Africa, and the Middle East. 'We're deeply grateful to our existing and new investors for their trust and continued support,' said Iheb Triki, CEO and Co-founder of Kumulus Water. 'Their involvement is a strong vote of confidence in our technology and our vision. At Kumulus, we believe access to clean drinking water should not depend on existing infrastructure. With this funding, we're taking a major step toward making clean water accessible, sustainable, and decentralized—especially for the communities that need it most.' With this new funding, Kumulus will launch the Kumulus Boks, a new line of industrial-grade, cutting-edge Atmospheric Water Generators (AWG), that provide clean drinking water directly from air humidity, while scaling operations in Tunisia, France, Spain and preparing market entry into Saudi Arabia. Commenting on the fundraising announcement, Hasan Haider, Founder and Managing Partner at +VC said: 'Kumulus is building a scalable, climate-resilient solution to one of the most critical regional and global challenges-access to clean drinking water. At +VC, we invest in founders who are not only mission-driven, solving real-world problems but also executing with commercially scalable solutions. Kumulus fits that profile and is well-positioned for both regional and global growth. We're excited to support their journey as they scale meaningful impact, making them stand out in the climate-tech space.' 'We believe the world needs complementary solutions to address the growing challenge of drinking water scarcity,' added Clément Yvorra, Global Business Development Manager at Spadel. 'What convinced us is Kumulus' ability to produce water locally, without packaging or transportation, offering a truly sustainable alternative.' 'This funding allows us to scale not just production, but impact,' said Mohamed Ali Abid, Co-founder and CTO of Kumulus Water. 'We have spent the past few years refining a technology that can operate reliably in some of the harshest and most water-stressed environments. Now, we are ready to deploy it at scale and bring truly off-grid, sustainable water access to more communities across the region and beyond.' As climate change intensifies and water scarcity deepens, Kumulus offers a resilient, infrastructure-free solution that delivers safe drinking water to even the most remote and arid regions, building not just machines, but long-term climate resilience and empowered communities. Kumulus Water is redefining how clean water is delivered—turning air into drinking water without infrastructure, plastic waste, or grid dependency. By deploying off-grid atmospheric water generators, Kumulus provides a sustainable, decentralized solution for communities facing limited or unreliable access to clean water.
Yahoo
06-06-2025
- Business
- Yahoo
SPAR Group sees EPS dip despite steady H1 2025 revenue growth
Multinational South Africa-based retail chain SPAR Group's operational performance during the first half (H1) of fiscal 2025 (FY25) has shown mixed results across different regions, with headline earnings per share (EPS) from continuing operations dipping slightly by 0.4% to 450.1 cents. Revenue from ongoing operations held steady at R66.1bn ($3.72bn), with gross profit climbing to R7.1bn. Operating profit experienced a modest rise of 1.6%, reaching R1.5bn, bolstered by enhanced cost management efforts. The group's earnings before interest, taxation, depreciation and amortisation (EBITDA) also saw an uptick of 1.7%, amounting to R1.7bn. SPAR Group made headway on its strategic objectives amidst a tough market environment, focusing on five critical areas: exiting Poland, restructuring debt within the group, conducting a strategic review of European operations, expanding the implementation of SAP [systems, application and data processing], and targeting an improvement in southern Africa EBIT margin to 3%, alongside achieving a leverage ratio between 1.5 and 2.0 times by fiscal year-end 2026. During the first half of 2025, the group achieved three of these goals: finalising the sale of SPAR Poland in January, completing debt restructuring in March, and announcing plans in May to divest its Swiss operations as well as AWG in the UK after thorough strategic evaluation and consideration of capital allocation priorities and long-term strategic direction. The group is in advanced negotiations with potential buyers for these businesses. SPAR Switzerland and AWG have been classified as discontinued operations, with post-tax losses including impairments amounting to R4.4bn. The board believes that the divestments are consistent with SPAR's strategy to concentrate on strengthening its core businesses in Southern Africa and Ireland. Cash generation from total operations significantly increased 50.1% to R1.9bn. In Southern Africa, the group's wholesale turnover increased 1.7%, with its grocery and liquor segments contributing to this growth. Retail revenue in the region also saw an increase of 1.9%. The SPAR2U app's delivery volumes surged 174%, demonstrating the brand's growing on-demand presence. Build it, the group's building materials retail brand, posted a sales increase of 4.1% with strong like-for-like retail growth. In Ireland, despite a marginal local currency revenue decrease, the gross margin benefited from a favourable product mix. The minimum wage increase, however, led to higher labour costs. No interim dividend has been declared for the period, with future considerations dependent on macroeconomic and operating conditions. Looking forward, SPAR Group is concentrating on margin improvement and operational execution in its core markets. In southern Africa, SPAR aims to enhance retail segments and operational efficiencies, with initiatives such as expanding on-demand services and increasing private label product penetration. In Ireland, SPAR Group subsidiary BWG Group, a food retail and wholesale distribution company, is focusing on growing its convenience retail brands and exploring new opportunities. "SPAR Group sees EPS dip despite steady H1 2025 revenue growth" was originally created and published by Retail Insight Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
