Isoflurane

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025. "The completion of the INSPiRE-ICU 1 study marks a true milestone for Sedana Medical. Launching the randomized controlled multicenter studies across the large and diverse US healthcare landscape, in mixed surgical and medical ICUs with a different staffing and workflow compared to Europe, has been exciting. There is a lot of enthusiasm and interest in using inhaled sedation in US practice, which we hope will be possible soon", said Peter Sackey, Chief Medical Officer of Sedana Medical. Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025". "Working on these trials from initial design to implementation and completion has been very rewarding and has brought together many experienced clinical researchers in critical care across the US. We, and the clinicians at the bedside, are eager to see inhaled sedation available also in the US", said Christopher Hughes, Professor of Anesthesiology at Vanderbilt University Medical Center and Senior Lead Investigator for the INSPiRE-ICU 1 study. Johannes Doll, President and CEO of Sedana Medical, expressed gratitude, stating: "I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards making the benefits of inhaled sedation accessible to patients in the United States." INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021. For additional information, please contact: Johannes Doll, CEO, +46 (0)76 303 66 66 Johan Spetz, CFO, +46 (0)730 36 37 89 [email protected] About Sedana Medical Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care. Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors. Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden. This information was brought to you by Cision The following files are available for download:

World's leading provider of veterinary care will be first to introduce innovative in-clinic solution to support sustainability goals BIRMINGHAM, England, April 3, 2024 /PRNewswire/ -- Mars Veterinary Health, through its UK veterinary group Linnaeus and in partnership with Waltham Petcare Science Institute, today announced a first-of-its-kind partnership with SageTech Veterinary to pilot an innovative anaesthetic gas capture solution to help prevent harmful greenhouse gases from entering the atmosphere. During a typical anaesthetic procedure, less than five percent of the volatile anaesthetic agent delivered to a patient is absorbed and metabolised, leaving approximately 95 percent it to be exhaled. Continue Reading Mars Veterinary Health pilots industry-leading anaesthetic gas capture technology to reduce carbon emissions SageTech's trusted gas-capture technology—which is currently used in human healthcare—works by capturing the waste anaesthetic agent breathed out during an operation by safely adsorbing it into a specially developed reusable capture canister. These waste anaesthetic agents can then be extracted from the filter, avoiding current routes for disposal of volatile anaesthetic agents of incineration or release into the atmosphere. "As a leading provider of veterinary care, we have a responsibility to take climate action at scale and lead the way toward more sustainable practices," said Ellie West, RCVS and EBVS® European Specialist in Veterinary Anaesthesia and Analgesia, and Linnaeus Environmental Sustainability Lead. "Our innovative collaboration should help us take a significant step forward in our sustainability journey, aimed at contributing to a better future for the planet—and the people and pets who depend on it." A veterinary-industry first, Mars Veterinary Health's one-year pilot will start with 10 Linnaeus primary care and referral veterinary practices in the UK with the aim of reducing anaesthesia-related carbon emissions resulting from release or disposal of these agents and determining the efficiency of capture in its clinics, ultimately supporting its goal of reducing climate-change impacts. Mars Veterinary Health aims to use these learnings to explore the potential application of this technology across other parts of its business in the years to come. "At SageTech Veterinary, we are excited to share our developed technology and work alongside Mars Veterinary Health to significantly reduce the carbon footprint associated with the direct release of waste volatile anaesthetic agents to the environment," said Iain Menneer, CEO of SageTech Medical. "It has been wonderful to work with the Linnaeus and Waltham teams, and we are confident this pilot project will demonstrate to the veterinary profession how such collaborations can be a collective force for good." This industry-first pilot in sustainable veterinary care is consistent with Mars, Incorporated's Net Zero Roadmap, a detailed action plan for achieving net zero greenhouse gas emissions by 2050, as well as details on the company's progress and history of working on climate action. Details about Mars, Incorporated's wider sustainability—including climate—work can be found in its Sustainable in a Generation Scorecard. About Mars Veterinary Health Mars Veterinary Health is a global division of Mars Petcare dedicated to delivering high-quality pet healthcare to further its collective Purpose: A BETTER WORLD FOR PETS™. Mars Veterinary Health's 70,000 Associates across 3,000 global veterinary clinics put pets, people, and the planet first. The Mars Veterinary Health family includes Associates at AniCura, Banfield, BluePearl, Creature Comforts, Gentle Oak, Hillside, Linnaeus, Mount Pleasant, Tai Wai, VCA, VES, and VSH who demonstrate compassion and expertise while enabling 35 million pet visits each year. Learn more at marsveterinary.com. About Linnaeus Part of Mars Veterinary Health, Linnaeus is a highly respected community of more than 50 primary care and 17 referral veterinary practices based in the UK. Linnaeus employs over 6,000 pet-loving Associates with some of the country's finest vet and nursing teams who together are committed to excellence and delivering high-quality care to patients. Learn more at linnaeusgroup.co.uk. About Mars Science & Diagnostics Mars Science & Diagnostics is a division of Mars Petcare, a diverse business dedicated to one purpose: A BETTER WORLD FOR PETS™. Science & Diagnostics brings together the power of leading pet health science with expertise across diagnostics, data, and technology to improve outcomes in pet health. Antech, our global veterinary diagnostics business, spans in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software; reference laboratories; veterinary imaging and technology; education; and telemedicine with board-certified specialist support services. Our at-home diagnostics offering includes Wisdom Panel, the world's most accurate pet DNA test. For 60 years, our Waltham Petcare Science Institute has been advancing science to better understand pet health. About SageTech Veterinary The manufacture of virgin anaesthetic agents and their release as waste volatile gases is highly damaging to the environment and contributes significantly to the total carbon footprint of healthcare. SageTech Veterinary is part of SageTech Medical, a medical device and pharmaceutical company focused on the research, design, manufacture, and distribution of technologies for the capture and recycling of waste volatile anaesthetic agents in human and animal healthcare. Their unique circular economy solution safely captures volatile anaesthetic agents (sevoflurane, isoflurane, desflurane) through actively controlled adsorption onto a reusable capture canister. Learn more at sagetechveterinary.com. Photo - SOURCE Mars PetCare