With a mission to redefine what gene therapy can do, Spur is optimizing every component of its product candidates to develop a new generation of gene therapies Spur is advancing two potentially life-changing gene therapy candidates in clinical trials and a bold research strategy to move gene therapy beyond rare diseases into more prevalent conditions Lead program FLT201 for Gaucher disease poised to enter Phase 3 development in 2025 Acquired SwanBio, adding Phase 1/2 program for adrenomyeloneuropathy to its clinical-stage pipeline and strengthening CNS expertise Founding investor Syncona commits additional $50 million to support development of pipeline LONDON, June 17, 2024 (GLOBE NEWSWIRE) — Spur Therapeutics, formerly Freeline Therapeutics, today announced a new name and brand to reflect its focus on developing a new generation of gene therapies and advancing the practice of genetic medicine. Building on compelling data for its lead program FLT201, a highly differentiated gene therapy candidate for Gaucher disease, Spur is pursuing an ambitious research strategy to unlock the promise of gene therapy for more prevalent chronic conditions, starting with Parkinson’s disease and certain forms of cardiovascular disease. “At Spur Therapeutics, our mission is to redefine what gene therapy can do,” said Michael Parini, Spur’s Chief Executive Officer. “Our new name and new brand reflect our determination to alter the course of a disease with a single dose of genetic medicine and change the course of people’s lives. By optimizing every component of our product candidates to get just the right expression, packaged and delivered to the body in just the right way, we are working to develop a new generation of therapies that spur gene therapy forward to transform the lives of even more patients.” Spur today also announced its acquisition of SwanBio Therapeutics, which adds a potential first-in-class gene therapy program for adrenomyeloneuropathy (AMN), a devastating neurodegenerative disease, to its clinical-stage pipeline, as well as strengthened capabilities in central nervous system (CNS) disorders that can be leveraged across both its AMN and Parkinson’s disease programs. The AMN program, SBT101, is currently in a Phase 1/2 clinical trial, and Spur plans to report an initial safety update from the higher-dose cohort in this trial in the first half of next year. There are no approved treatments for AMN, and SBT101 is the only gene therapy candidate in development for the disease. Syncona Ltd., the founding shareholder in both Freeline and SwanBio and a leading life science investor focused on creating, building and scaling global leaders in life science, has committed an additional $50 million (£40 million) to support development of the expanded pipeline. Syncona Executive Partner and former SwanBio Executive Chair John Tsai has joined Spur’s Board of Directors. “We see great promise across Spur’s broadened pipeline, with a highly differentiated lead clinical program backed by compelling data and a second potentially first-in-class clinical asset,” said Chris Hollowood, CEO of Syncona Investment Management Limited and Chairman of the Board of Directors of Spur. “Building on its work, Spur has an exciting opportunity to become a leading gene therapy company developing one-time treatments for debilitating chronic diseases, potentially setting new standards of care and changing lives.” Spur expects to initiate a Phase 3 trial for FLT201 in 2025 in Gaucher disease. There is no cure for Gaucher disease, and even with current treatments, many patients continue to experience debilitating symptoms. Recently reported data from its Phase 1/2 GALILEO-1 trial highlight FLT201’s potential to set a new standard of care for Gaucher disease. The data show that a single dose of FLT201 resulted in dramatic reductions in the toxic buildup of glucosylsphinogsine (lyso-Gb1), one of the best predictors of clinical response and disease severity in Gaucher disease, in patients who have had persistently high levels despite years of treatment on currently approved therapies. Early signs of clinical improvement in fatigue and bone marrow burden were also observed. FLT201 has demonstrated a favorable safety and tolerability profile. Building on its work in Gaucher disease, Spur’s research program in Parkinson’s disease is focused on a subset of patients with mutations in the GBA1 gene, the same gene implicated in Gaucher disease. The program leverages the same transgene as FLT201. Spur is further optimizing the transgene for expression in the brain and identifying the best capsid and route of administration to deliver its proprietary GBA1-85 transgene to key areas of the brain affected by Parkinson’s disease. Spur expects to select a development candidate later this year to progress into preclinical studies designed to support the program’s advancement into clinical trials. No disease-modifying therapies currently exist for Parkinson’s disease, and this program could be a first step toward a gene therapy for hundreds of thousands of people with GBA1 Parkinson’s worldwide. Additionally, Spur has a research program, leveraging a suite of promising cardioprotective proteins to develop gene therapy candidates for cardiovascular diseases, starting with a severe subset of chronic heart failure. About Spur TherapeuticsSpur Therapeutics is a clinical-stage biotechnology company focused on developing life-changing gene therapies for debilitating chronic conditions. By optimizing every component of its product candidates, Spur aims to unlock the true potential of gene therapy to realize outsized clinical results. Spur is advancing a breakthrough gene therapy candidate for Gaucher disease and a potential first-in-class gene therapy candidate for adrenomyeloneuropathy, as well as a research strategy to move gene therapy into more prevalent diseases, including forms of Parkinson’s, dementia, and cardiovascular disease. Expanding our impact, and advancing the practice of genetic medicine. Toward life-changing therapies, and brighter futures. Toward More™ For more information, visit www.spurtherapeutics.com or connect with Spur on LinkedIn. Media Contact:Naomi Aokinaomi.aoki@spurtherapeutics.com+ 1 617 283 4298 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e68ddce-d346-46c3-b5bf-d03686e6d5e9
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Avive Solutions Recognized as One of the 2024 Bay Area Best Places to Work
SAN FRANCISCO, June 14, 2024 /PRNewswire/ — Avive Solutions, Inc., a Brisbane, CA-based manufacturer of lifesaving Automated External Defibrillators (AEDs) has been recognized as a Top 3 winner of the 2024 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.
Select employers from the Bay Area were named winners of the awards at a celebratory event on June 13th, 2024 in San Francisco. These winning organizations were honored for having created exceptional workplaces with collaborative, supportive workplace cultures that their employees value highly.
Award applicants were evaluated and ranked across 5 categories according to the number of Bay Area employees. The rankings find companies in the region whose employees rate them as the highest on such values as fun, collaborative culture, solid compensation, benefits offerings and other amenities, as well as management practices. The rankings were unveiled on June 14th, 2024 in the San Francisco Business Times and the Silicon Valley Business Journal.
“We are honored and thrilled to be named to the 2024 list of Bay Area Best Places to Work,” said Jess Koenig, Head of People at Avive. “With so many fantastic, established companies with amazing culture and perks located in the region to choose from, we are proud to know that our employees value our culture, lifesaving mission, and workplace environment so highly and are excited to come to work every day at Avive.”
Co-founder and CEO Sameer Jafri added, “I’m proud of our team’s commitment to attracting and retaining exceptional talent that connects with our mission to save lives, contributes positively to our culture, and is driven to do what it takes to push our company forward to new heights. We’re building something special here, and the tremendous emphasis we place on building a great culture has, and continues to pay off. It’s humbling to be recognized with this award, and we are committed to Avive continuing to be one of the best places to work in the Bay Area for many years to come.”
About Avive Solutions, Inc.Avive Solutions is a new kind of AED company. We are revolutionizing Sudden Cardiac Arrest response with our innovative platform that brings together a 21st-century AED device and first-of-its-kind software solutions. With our award-winning product, the Avive Connect AED, we are the first new company to bring an AED to market in the U.S. in over 20 years. Focused on portability, accessibility, and connectivity, the Avive Connect AED is one of the most advanced products in the industry. Additionally, our software solutions not only make owning and managing AEDs simple, they also deliver a comprehensive cardiac arrest response solution to communities, with the goal of increasing bystander intervention, decreasing time-to-defibrillation, and getting valuable data to the people who need it, when they need it. Founded in 2017, we are on a mission to empower bystanders, first responders, and 911 telecommunicators to provide lifesaving care as quickly and easily as possible. Our versatile platform is designed to meet the needs of all types of industries – schools, gyms, places of worship, any size business and even your home. Join us on our mission to save lives and learn more at avive.life.
About 2024 Bay Area Best Places to Work Best Places to Work is an innovative publication and awards program produced by the San Francisco Business Times and the Silicon Valley Business Journal. The rankings were determined by surveys that went directly to employees who answered a series of questions. The survey was administered online by the employers and through a service provided by Quantum Workplace, our research partner. The rankings are numeric based on Quantum’s scoring process. By ranking companies and sharing best practices we facilitate idea sharing and help other companies learn from the best.
Media Contact:Kyle Noble[email protected](415) 287-6881
SOURCE Avive Solutions, Inc.
Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)
Niagara Falls, NY, June 14, 2024 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical services, is pleased to announce its membership in the national alliance “Cardiac PET Industry Coalition” (CPIC), an organization at the forefront of quality of patient care, advocacy and innovation to advance the field of cardiovascular PET imaging. Positron joins forces with the coalitions founding members, Bracco Diagnostics, CDL Nuclear Technologies and Siemens Healthcare who have come together to promote federal policies that advance health outcomes for patients with cardiovascular disease and improve the availability of cardiac PET diagnostics throughout the United States. The CPIC will be a leading advocate for fair and transparent coverage and reimbursement policies that facilitate access to cardiac PET, align practitioners with regard to research opportunities, highlight the clinical and economic benefit of the modality, and provide expanded opportunities to educate healthcare providers and policymakers on the overall value of cardiac PET. CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda. Adel Abdullah, President of Positron stated, “Positron welcomed the opportunity to join the coalition, and personally, and I am honored to be part of current and future CPIC committees focused on the education, availability and advancement of the PET modality for cardiac studies. We believe Positron’s PET/PET-CT technology and ability to deliver the best value in the industry will play a key role in the adoption and growth of cardiac PET. Positron and our team will support and serve the coalition as best as possible for the future of the industry, concluded Mr. Abdullah.” Cardiac PET Industry Coalition CPIC passionately advocates for and protects the reimbursement of Cardiac PET, ensuring equitable access to innovative and life-saving technologies for healthcare providers and patients. For more information please visit www.cpicoalition.com About Positron Corporation Positron Corporation is a medical technology company that co-develops, manufactures, and sells state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers throughout North America. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging, the gold standard in cardiac diagnostics. Positron’s innovative PET/PET-CT technologies, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron’s Attrius® PET and NeuSight PET-CT imaging systems and distinct market position are substantial advantages unique to Positron that will facilitate the adoption of cardiac PET and the growth of the nuclear imaging market. Positron will soon offer a state-of-the-art PET-CT 4D molecular imaging device in the Affinity PET-CT 4D 64-Slice. Positron’s PET-CT(s) will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT systems will also enable the Company to fully service and meet the demands of the vast oncology imaging segment of nuclear medicine. Positron is committed to expanding the cardiac and oncology PET modality by delivering the best technology and value to imaging specialists and will continue to advance its technology through its co-developer, supplier, and R&D venture with Shenyang Intelligent Neuclear Technology Co. a subsidiary of Neusoft Medical Systems. For more information please visit www.positron.com Forward-Looking Statements This press release contains statements which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results even if new information becomes available in the future. FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: investor@positron.com
Mineralys Therapeutics Appoints Biopharmaceutical Executive Alexander M. Gold, M.D. to its Board of Directors
RADNOR, Pa., June 14, 2024 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced that Alexander M. Gold, M.D. has been appointed to the Company’s Board of Directors (the Board), effective June 13, 2024. “We are delighted to welcome Alex to our Board of Directors as we advance the late-stage clinical development of lorundrostat for the treatment of hypertension and related cardiorenal metabolic disorders,” stated Jon Congleton, Chief Executive Officer of Mineralys. “As a cardiologist and accomplished biopharmaceutical clinical development executive, Alex brings tremendous experience driving value for biopharmaceutical companies. We believe Alex’s track record of successful pipeline development, regulatory approvals, and joint ventures will make him be a valuable director and resource for the Company’s team.” “I am honored to join the Mineralys Board of Directors,” stated Dr. Gold. “I look forward to working with the Company’s executive team and fellow Board members to advance the treatment of cardiorenal metabolic disorders. There is significant potential with lorundrostat in offering a targeted treatment approach for hypertension and other diseases driven by dysregulated aldosterone.” Dr. Gold is a cardiologist with more than 20 years of experience leading the development, approval, and commercialization of new therapies. He has held executive positions at several biopharmaceutical companies that targeted numerous therapeutic areas, including cardiometabolic, renal, and inflammation. Currently, Dr. Gold is the Chief Medical Officer of a clinical-stage biotech company. Prior to his current role, he held the role of Head Medical Officer at Sanifit-CSL. He originally joined as Chief Medical Officer and President of Sanifit Inc. in 2017, which was then acquired by Vifor Pharma in January 2022 and subsequently by CSL Ltd. in August 2022. Prior to Sanifit, Dr. Gold held the role of Senior Vice President and Head of Clinical Development at Portola Pharmaceuticals. Prior to Portola Pharmaceuticals, Dr. Gold was Head of Clinical Development at Reata Pharmaceuticals. For 11 years he held multiple leadership positions at AstraZeneca, including the Executive Director and Development Leader for BRILINTA, CRESTOR and ONGLYZA. Dr. Gold is currently an Adjunct Professor at Stanford University School of Medicine. Dr. Gold completed his residency in internal medicine and fellowship in cardiology at the Beth Israel Deaconess Medical Center / Harvard Medical School in Boston and conducted translational and clinical research as a fellow in cardiovascular research at the Harvard Clinical Research Institute and was a Scholar in Clinical Science. Dr. Gold received his M.D. from Harvard Medical School and his B.A in Biology from Brandeis University. In addition, the Company announced the resignation of Olivier Litzka, Ph.D. from its Board, effective June 13, 2024. Dr. Litzka stated: “It was an honor for me to serve on the Mineralys Board since the Company’s final private financing round prior to the initial public offering. The Company has shown tremendous progress, which is due to its exceptionally talented and hard working team. As a venture capital investor, I’ve decided to step down in order to make room for new, well-suited board members like Alex Gold to support the Company going forward. I wish Mineralys all the best on its path forward.” “The Board and I would like to express our collective gratitude to Olivier for his contributions and dedication to the Board. We wish him future success as he turns his attention to other venture investments at Andera Partners,” stated Mr. Congleton. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension, in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com
Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
HANGZHOU, China, June 14, 2024 /PRNewswire/ — Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine. This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center.
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This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.
The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve’s registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.”We’re honored to be part of the VenusP-Valve PROTEUS trial,” said Prof. Scott Lim after the procedure. “We’ve just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.” “That went really smoothly in this teenage patient with free pulmonary insufficiency”, commented Prof. Michael Hainstock. “I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.””The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, General Manager and CEO of Venus Medtech. “The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”About VenusP-ValveAs the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.About Venus MedtechVenus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.For more information, please visit https://www.venusmedtech.com
*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.
*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.
*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.
Copyright 2024. Venus Medtech (Hangzhou) Inc. All Rights Reserved.
Contacts:Jill Liu Public Relations [email protected]Ophelia ChenInvestor Relations[email protected]SOURCE Venus Medtech (Hangzhou) Inc.
New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation
Temporary vessel occlusion a growing practice for trauma patients.
SALT LAKE CITY, June 13, 2024 /PRNewswire/ — Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.
REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.
“Landmark was easy to use and easy to deliver with a smooth insertion,” said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. “REBOA can be an important tool to aid in patient resuscitation.” It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2
“We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage,” said Ryan Murri, Emergency Scientific’s Chief Executive Officer. “With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options.”
The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.
Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023).
Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.
SOURCE Emergency Scientific
CARMAT Announces the Start of the Equitization of the First Tranche of Its EIB Loan
June 13, 2024 12:00 PM Eastern Daylight Time PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR): On February 14, 2023, the French financial markets authority (Autorité des marchés financiers) invited companies issuing equity securities or securities giving access to capital on a staggered basis to adopt a standard communication and warning on the […]
Viz.ai Collaborates with Hypertrophic Cardiomyopathy Association to Improve Care for Hypertrophic Cardiomyopathy Patients
SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with the Hypertrophic Cardiomyopathy Association (HCMA), the preeminent organization improving the lives of those with hypertrophic cardiomyopathy (HCM), to support, educate and advance research for HCM. “We’re thrilled to collaborate with the HCMA […]
Anteris Provides Update on DurAVR™ THV Valve-in-Valve Experience Presented at New York Valves 2024
DurAVR ViV restores similar aortic valve gradients to initial post-surgical results June 13, 2024 06:00 AM Eastern Daylight Time BRISBANE, Australia & EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of TAVR and the world’s only balloon-expandable, single-piece biomimetic aortic replacement […]
FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials
With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.
Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for lead wires while maintaining high-quality data collection and accelerating trial timelines.
PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.
“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”
Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model. With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”
This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.
About ClarioClario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.
For more information, go to Clario.com or follow us on LinkedIn.
Media Contact:Alexis NavratilCommunications Manager[email protected]
SOURCE Clario
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