Latest news with #TechnologyandHeartFailureTherapeutics
Associated Press
18-02-2025
- Business
- Associated Press
Berlin Heals Holding AG Successfully Raises Over 7Million CHF Round for Initiating First Studies of New Less Invasive Approaches
ZUG, Switzerland, Feb. 18, 2025 /PRNewswire/ -- Berlin Heals Holding AG, a late stage MedTech start up, has developed a breakthrough method and a product for the therapy of heart failure. The product - an electronic device called C-MIC - has already successfully been tested in patients in a pilot study and recently completed enrollment in an International Multi-Center Controlled Randomized Clinical Trial for CE certification. The company will present the new data at upcoming conferences and publish the results soon. With the therapeutic method now well supported, the company is ready to test the next generation technology in less invasive implant approaches. To reach these next milestones, the company has successfully raised over CHF 7Million from investors in a recently executed financing round. This funding will support First-In-Human studies to evaluate the safety and efficacy of these new approaches to prepare for the large pivotal trial for global regulatory and reimbursement approvals. This funding will also support further development of the product and preparation for CE submission for the first-generation device. Berlin Heals Holding AG has already demonstrated the unprecedented success of its dilated cardiomyopathy therapy in a first-in-human pilot study. The company recently presented the Long-Term sustainable results of that study in a Late Breaking Clinical Trial session at the Technology and Heart Failure Therapeutics (THT) conference on February 11th in Boston and has plans to publish the results in an upcoming journal. John Brumfield, Chief Executive Officer, Berlin Heals Holding AG comments: 'We are very grateful to our internal investors that continue to support our mission to heal Heart Failure. We are also excited to welcome our new investors that have joined us on this journey. The results from our early clinical work showed strong potential for this new therapeutic approach. We are excited to share the results of our new Randomized Clinical Trial later this year. This funding round will give us the opportunity to test the method through several new less invasive approaches to determine which technique should be used in our Pivotal Trial for FDA and global market entry. Dr. Felix Baader, Chairman of the Board, Berlin Heals Holding AG comments: 'I had the pleasure of meeting several patients together with Co-Founder Marko Bagaric from our first two studies and can see the real impact our innovation has had on returning significant quality of life to them. They were so grateful to have their lives back and be active again. With this funding round, we further our progress to impact many more lives ahead.' Berlin Heals Holding AG is a Swiss joint-stock company founded in 2014. The company has developed a revolutionary implantable device called 'C-MIC' (Cardiac Microcurrent), which - by way of a constant electrical microcurrent and the ensuing electrical field - results in a sustainable and swift improvement of outcomes in heart failure patients according to recent studies.
Yahoo
13-02-2025
- Health
- Yahoo
WhiteSwell Announces New Data Supporting Acute Decompensated Heart Failure Treatment with eLym System
Results from expanded cohort of ongoing DELTA-HF study show patients were decongested with stable renal function and with few rehospitalizations at 90 days following treatment eLym System recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) GALWAY, Ireland, February 13, 2025--(BUSINESS WIRE)--WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive data from 21 patients treated in its DELTA-HF trial evaluating the WhiteSwell eLym™ System. The data were presented at the Technology and Heart Failure Therapeutics (THT) meeting in Boston by Jan Biegus, M.D., deputy scientific director at the Institute of Heart Diseases at Wroclaw Medical University in Poland. "Persistent congestion in acute heart failure patients is associated with a high risk of rehospitalization and death. The lymphatic system is believed to be critical in effectively removing excess fluid from the tissues and organs, yet can be dysfunctional in heart failure patients," said Dr. Biegus. "The eLym System is designed to support lymphatic function during decongestive therapy. In the first 21 patients treated, all patients lost weight and demonstrated concordant signs of decongestion, while maintaining stable renal function. At 90 days, having just 9.5% of patients rehospitalized for heart failure with no deaths is substantially better than rates we see with standard-of-care diuretics alone, which is quite promising." WhiteSwell previously reported early feasibility data studying nine patients treated with the eLym System and followed those patients through six months. The newly-presented data expand to a larger cohort of 21 hospitalized patients who received eLym therapy in conjunction with diuretic therapy and were followed through 90 days. Summary of key findings: The device was deployed successfully in all 21 patients in the study cohort. Patients who underwent therapy with the eLym System plus loop diuretic lost a mean of -10.7 lbs (±7.1) from baseline to hospital discharge, with every patient losing weight and demonstrating resolution or reduction of peripheral edema and orthopnea. Kidney function was stable during treatment and through discharge, as measured by creatinine (mean Δ 0.02 ± 0.26 mg/dL). One patient experienced a serious procedure-, device- or therapy-related adverse event, which resolved prior to discharge. At 90 days, 9.5% of patients were rehospitalized for heart failure and there were no deaths. The DELTA-HF feasibility study is continuing to enroll patients in Europe. A randomized controlled trial will begin in the United States, Canada and Europe later this year. WhiteSwell also announced that the eLym System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This prioritizes the review process for novel technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The company has also been accepted into the Total Product Lifecycle Advisory Program (TAP), which the FDA has established to expedite patient and physician access to innovative medical devices. "We are encouraged by the clinical results as more patients are treated with the eLym System. WhiteSwell is entering an important phase as we expand our clinical trial sites and look ahead to a randomized controlled trial in the U.S. and other countries," said Eamon Brady, WhiteSwell CEO. "By supporting the lymphatic system to drain interstitial tissues and organs in conjunction with diuretic therapy, we hope to break the cycle of repeated heart failure hospitalizations for people with ADHF and improve patient outcomes." About the DELTA-HF Trial The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) Trial is a non-randomized early feasibility trial evaluating the safety and performance of the eLym System in the treatment of fluid overload or congestion in patients with ADHF. A study design manuscript was recently published (Biegus et al, Design and Rationale of the eLym™ System for Decompensation of Excess Lymphatic Fluid via the Thoracic Duct in Acute Heart Failure [DELTA-HF]. ESC Heart Fail. 2024 Dec 24. DOI: 10.1002/ehf2.15192). About the eLym™ System The eLym System is a minimally invasive, catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system in draining fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system's major highway, the thoracic duct, connects. It creates a low pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics. About Acute Decompensated Heart Failure (ADHF) ADHF is an episode of worsening heart failure symptoms that results in millions of hospitalizations worldwide each year, including three million in the U.S. alone.1 Patients with ADHF experience difficulty breathing, fatigue, and edema (swelling) due to fluid back-up in the lungs and other parts of the body (congestion). The condition requires hospital-based treatment to remove excess fluid in a process called decongestion. Complete decongestion is the goal of ADHF treatment, since residual congestion at hospital discharge is the strongest predictor of rehospitalization and death.2 As many as half of ADHF patients are discharged from the hospital not fully decongested, and one out of four ADHF patients is readmitted to the hospital within one month.3,4,5 About the Lymphatic System and ADHF In healthy individuals, the lymphatic system continuously captures fluid from tissues throughout the body and pumps it back into the vascular system to maintain homeostasis. In ADHF, excess fluid collects in the tissues of the body (the interstitial compartment) causing edema and an increase in venous blood pressure. Excess tissue fluid and high venous blood pressure interfere with the lymphatic system's ability to move fluid back to the vascular system, which can further exacerbate congestion. About WhiteSwell WhiteSwell is a patient-focused company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland. For more information visit 1 Hollenberg et al., J Am Coll Cardiol 2019;74:1966–2011. (1M annual hospital discharges with HF as primary diagnosis and 2M hospital discharges with HF as secondary contributing diagnosis.)2 Martens & Mullens, How to tackle congestion in acute heart failure, Korean J Intern Med 2018;33:462-4733 Girerd et al, Integrative Assessment of Congestion in Heart Failure Throughout the Patient Journey, J Am Coll Cardiol HF 2018;6:273–854 Arrigo et al, Nature Reviews Disease Primers volume 6, Article number: 16 (2020)5 Rubio-Gracia, J. et al. (2018). International Journal of Cardiology, 258, pp. 185-191. View source version on Contacts MEDIA CONTACT: Dunia Cristandunia@
Yahoo
12-02-2025
- Health
- Yahoo
CVRx announces new real-world evidence demonstrating significant reductions in healthcare utilization with Barostim
New real-world evidence presented at THT 2025 and published simultaneously in the Journal of Cardiac Failure (JCF) demonstrates large and statistically significant reductions in hospital visits and length of stay in patients with heart failure and reduced ejection fraction MINNEAPOLIS, Feb. 12, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) ('CVRx'), a commercial-stage medical device company, announced today the presentation of new real-world evidence at the Technology and Heart Failure Therapeutics (THT) conference in Boston. The study demonstrated large and statistically significant reductions in hospital visits (hospitalizations and emergency department visits) and length of stay after Barostim implantation, compared to before. The research was published simultaneously and is available now in the Journal of Cardiac Failure. 'Despite contemporary medications, the clinical and economic burden of heart failure remains unacceptably high. This new study showing significant reductions in real-world healthcare utilization associated with the Barostim implant is critically important for clinicians and payers when considering this device for their patients,' said Jacob Abraham, MD, Section Head of Advanced Heart Failure at Providence Heart Institute in Portland, Ore. 'While we know Barostim plus medications demonstrates long-term improvements in symptoms and quality of life, we now have compelling real-world evidence supporting a significant reduction in healthcare utilization as well.' This analysis was performed using data from the Premier Healthcare Database, a large all-payer database including data from more than 1,300 institutions. Three hundred and six (306) Barostim patients were identified in the data set. Comparisons were performed for the 12 months prior to Barostim implant and for an average of almost two years post-implant (1.92±1.87 years). Length of stay was found to be significantly reduced. Hospital visits (hospitalizations and emergency department visits) were categorized as all-cause, cardiovascular, and heart failure related. The analysis found: 86% reduction in all-cause hospital visits (p<0.0001) 84% reduction in cardiovascular hospital visits (p<0.0001) 85% reduction in heart-failure hospital visits (p<0.0001) 'Congratulations to Dr. Jacob Abraham and co-authors for this important real-world analysis demonstrating remarkable reductions in healthcare utilization with Barostim,' said Dr. Philip Adamson, Chief Medical Officer of CVRx. 'We believe this study adds to the growing and consistent body of evidence supporting the clinical utility of Barostim. This is another example of our commitment to further develop and disseminate a strong pipeline of clinical and economic data supporting the many benefits of this therapy.' About CVRx, is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body's baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit Media Contact:Emily Meyers651.338.6204emeyers@ Investor Contact:Mark Klausner or Mike VallieICR Healthcare443.213.0501ir@ in to access your portfolio
