Latest news with #fluidmanagement
Yahoo
2 days ago
- Business
- Yahoo
Reprieve Cardiovascular raises $61M; Conformal Medical nets $32M for LAAO
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Reprieve Cardiovascular said Wednesday it closed a $61 million Series B financing that will fund its pivotal clinical trial and preparations to commercialize its heart failure fluid management system. The Milford, Massachusetts-based company is developing a system for removing excess fluid in patients with acute decompensated heart failure. The goal is to personalize decongestion management by removing fluid and sodium through precise administration of diuretics. "Reprieve Cardiovascular is addressing a significant unmet need in today's heart failure management paradigm,' Anita Watkins, managing director of Rex Health Ventures, said in a statement. Rex Health is the corporate venture fund of UNC Health and a Reprieve investor. CEO Mark Pacyna said the funding will help Reprieve generate the clinical and economic evidence needed to pursue regulatory approval and commercialization of the system. He said the company believes its approach to decongestion management can lead to better outcomes for both patients and healthcare systems. The randomized pivotal FASTR II trial will compare the Reprieve system to optimal diuretic therapy in patients hospitalized with ADHF to assess whether the device can decongest patients more effectively than the standard of care. The study plans to enroll up to 400 patients across the U.S. and Europe and will be used to support a Food and Drug Administration premarket approval submission. The first patient has been enrolled by a team at the Washington University School of Medicine in St. Louis. The FASTR II trial follows the completion late last year of the FASTR randomized pilot study, which met its primary efficacy and safety endpoints. The company's oversubscribed Series B round was led by Deerfield Management. Along with Rex Health, other backers were Arboretum Ventures, Lightstone Ventures, Sante Ventures, Genesis Capital, Cadence Capital and an undisclosed strategic investor. The financing combined equity investment with a debt facility. Reprieve's Series A financing raised $42 million in 2024. Conformal aims to advance left atrial appendage occlusion Conformal Medical said Tuesday it raised $32 million in a Series D extension round to fund an ongoing pivotal trial and pre-commercialization work for its left atrial appendage occlusion system. The device, called CLAAS AcuFORM, is designed to seal the left atrial appendage in patients with atrial fibrillation not caused by a heart valve problem, to reduce the risk of stroke without long-term anticoagulants. The foam-based architecture is intended to work in a broad range of LAA anatomies with just two sizes. The company said its technology could make left atrial appendage closure a same-day, single-operator procedure and eliminate the need for general anesthesia and intubation. The CONFORM pivotal trial is evaluating the safety and efficacy of the system compared to other commercially available LAAO devices and will be used to support FDA pre-market approval, the company said in the funding announcement. The study, which is expected to randomize about 1,600 patients at sites worldwide, is now more than 30% enrolled. Nashua, New Hampshire-based Conformal said a new partner joined inside investors in the latest funding round. Recommended Reading SetPoint Medical secures $140M to fund neuromodulation for arthritis 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
Globe and Mail
05-08-2025
- Business
- Globe and Mail
Nuwellis Announces the First Successful Outpatient Application of the Aquadex Smartflow® System Under New CMS Code
MINNEAPOLIS, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming fluid management, today announced that the first patients have been successfully treated with Aquadex ® ultrafiltration therapy in a hospital-based outpatient setting. This milestone reflects a major advancement in the company's mission to improve access to fluid management and support better care across the continuum. The treatments were performed at a leading healthcare institution in the southeastern United States using the same Aquadex SmartFlow ® system and clinical protocols trusted in inpatient environments. By enabling therapy in a hospital-based outpatient setting, Nuwellis is helping to reimagine how and where patients with fluid overload can be supported—offering a potential new model for earlier, more proactive care. 'For patients struggling with fluid overload, access to consistent, effective therapy can make a life-changing difference,' said John Erb, CEO of Nuwellis. 'This milestone represents more than just a shift in setting—it reflects our vision for expanding how care is delivered and making fluid management more flexible, scalable, and patient-centered.' In addition to the clinical benefits, hospitals may also realize significant economic advantages by transitioning appropriate therapies to outpatient care. With outpatient reimbursement increasing from approximately $413 to $1,639 per treatment day, this model offers a more sustainable path forward for health systems facing pressure to reduce readmissions while managing complex patients more effectively. The hospital-based outpatient setting provides an opportunity to treat patients using existing venous access and care teams, without requiring hospitalization. This approach may offer significant advantages to patients who are repeatedly admitted due to volume challenges, while also helping healthcare systems manage resources more efficiently. Nuwellis continues to work closely with providers to support hospital-based outpatient program development, including training, protocols, and workflow integration. The company sees this as a foundational step in building sustainable access to ultrafiltration therapy—and a key part of its long-term strategy to expand the impact of Aquadex. For more information, please visit and to learn more about the Company's reimbursement for outpatient, please visit the reimbursement page. About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow ® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit or visit us on LinkedIn or X, formerly Twitter. About the Aquadex SmartFlow ® System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies. Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise. For further information, please contact:
National Post
17-06-2025
- Health
- National Post
World's First Wearable Doppler Ultrasound Patch Expands to East Coast to Enhance Patient Safety at The Mount Sinai Hospital
Article content Nationally ranked academic medical center adopts FloPatch by Flosonics Medical, empowering ICU teams with fast, data-driven insights to avoid fluid overload Article content LOS ANGELES — Flosonics Medical, the leader in wearable ultrasound for critical care, today announced that The Mount Sinai Hospital has adopted FloPatch, the first wireless Doppler ultrasound device, in its surgical and transplant intensive care units. This milestone marks the company's first East Coast deployment, expanding its U.S. footprint and reinforcing growing demand for real-time, individualized fluid management in ICUs. Article content Article content FloPatch is an FDA-cleared, non-invasive wearable device that enables ICU clinicians to perform rapid, repeatable hemodynamic assessments to guide intravenous (IV) fluid management, a critical intervention in post-surgical care. Although fluid boluses are commonly used to treat hypotension after surgery, many patients are not fluid responsive and may face adverse effects from unnecessary fluids, leading to complications and longer hospital stays. Unlike existing tools, which can be time-consuming or invasive, FloPatch delivers real-time blood flow data at the bedside in under three minutes, helping clinicians avoid delays and make more targeted decisions. Article content 'The wireless ultrasound device addresses a longstanding need in critical care for accessible and repeatable assessments to understand a patient's fluid responsiveness at the bedside,' said John Oropello, MD, Professor of Surgery and Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Transplant ICU at Mount Sinai Hospital. 'It allows our team to make timely, physiologically guided decisions in complex, high-acuity situations.' Article content Since introducing FloPatch in April 2025, Mount Sinai clinicians have used it to bring greater precision to fluid therapy, moving beyond protocolized care to personalized decisions grounded in real-time patient data. According to early internal data at Mount Sinai, 42% of the patients assessed with FloPatch were unresponsive to fluids, a key insight that has helped clinicians tailor treatment to meet the needs of each individual. Article content 'Critical care ultrasound for targeted intravenous volume management is now a Society recommendation, but widespread application is limited by time, training, and inconsistency,' said Jon-Emile Kenny, MD, Chief Medical Officer and co-founder of Flosonics Medical. 'We built FloPatch to make ultrasound best practices available not only to physicians, but to nurses, nurse practitioners, physician assistants, and others involved in frontline decision-making. As the first hospital on the East Coast to adopt wearable ultrasound technology, Mount Sinai strengthens its reputation of leadership and innovation in precision medicine.' Article content Mount Sinai's adoption of FloPatch signals a broader shift toward precision medicine in critical care. As the first hospital to implement this wearable technology in surgical and transplant ICUs, it is setting a new benchmark for individualized fluid management. Flosonics is proud to lead this innovation and support clinicians coast to coast in delivering safer, smarter care. Article content About Flosonics Medical: Article content Article content Article content Article content Article content Media: Article content Jamie Gray, Article content Article content Article content
