Other News

Volta Medical Appoints Bill Hoffman as Executive Chairman of the Board of Directors

Marseille (France), April 8, 2025 – Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced the appointment of Bill Hoffman as Executive Chairman of its Board of Directors. Bill brings a track record of guiding innovative startups to global success. As former Chief […]

Agitated Solutions Receives IND Clearance from FDA to Initiate Phase 3 Clinical Trial of a Novel Contrast Agent

Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies. ST. PAUL, Minn.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has cleared Agitated Solutions, Incorporated (ASI)’s Investigational New Drug (IND) application for its novel contrast agent, ASI-02, enabling the initiation of the company’s Phase 3 clinical trial. […]

FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac Surgery

DENVER, April 08, 2025 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new Breakthrough Device Designations are indicated for the treatment of systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. Approximately 15 percent of the estimated 300,000 adults that undergo cardiac surgery each year are considered high risk and, we believe, could benefit most from the SCD therapy to prevent post-surgical complications. Of the 40,000 pediatric patients that undergo congenital heart surgery each year, we believe that approximately one third might benefit from SCD therapy.

CardioVia Announces FDA Clearance for ViaOne, Opening a New Frontier in Minimally Invasive Heart-Surface Treatments

TEL AVIV, Israel, April 8, 2025 /PRNewswire/ — CardioVia, an innovative medical device company specializing in advanced cardiac care solutions, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This breakthrough device is…

AMA Approves CPT Codes for Caristo’s AI-Powered Heart Disease Risk Stratification and Prevention Technology

New CPT codes mark a major step toward making Caristo’s CaRi-Heart®—the first AI-powered tool to detect coronary inflammation from routine CT scans—available in everyday clinical care Rewriting the rules of cardiac risk assessment, Caristo moves beyond anatomy to reveal the biological…

Teladoc Health Introduces Next Generation Cardiometabolic Health Program

New resources aim to improve population health and prevent the progression of diabetes, hypertension and obesityPURCHASE, NY, April 08, 2025 (GLOBE NEWSWIRE) — Teladoc Health (NYSE: TDOC), the global leader in virtual care, today introduced its next generation Cardiometabolic Health Program to improve population health and prevent the progression of diabetes, hypertension and obesity. Building on the company’s industry-leading chronic condition management programs, the new offering is designed to support optimal cardiometabolic health for all populations. The program drives healthier behaviors by targeting fundamental measures of cardiometabolic health: diet, physical activity, sleep, stress management, weight, blood lipids, blood glucose, blood pressure and nicotine exposure. These behaviors and health factors also align with Life’s Essential 8, the American Heart Association’s key measures for improving and maintaining cardiovascular health. Studies show that only 12% of adults in the U.S. have optimal cardiometabolic health. Without intervention and support, the vast majority of the working population is at risk of progressing to serious and costly conditions. Teladoc Health’s Cardiometabolic Health Program addresses these challenges and provides the tools, coaching and support necessary to drive improved outcomes. New features for members and customers include: A premium subscription to BetterSleep, the award-winning app that promotes sleep quality and well-being.Access to a registered dietitian for 1:1 support, medical nutrition therapy and personalized nutrition planning.Proactive outreach from expert health coaches for those at highest risk.Convenient at-home testing for key cardiometabolic measures, including A1c and blood lipids.Dynamic health insights that leverage patient-reported data and inputs from Teladoc Health’s connected devices— blood glucose meters, blood pressure monitors and connected scales—as well as CGM devices to help empower better outcomes.Seamless integration with Teladoc Health’s 24/7 Care and primary care providers, as well as connected care partners who can care for related conditions like joint pain and digestive health needs. “Nutrition, activity, sleep and stress management all have an outsized impact on population health. Our program comprehensively addresses these foundational pillars of cardiometabolic health because we know that’s what it takes to deliver meaningful outcomes—both for those managing multiple conditions and those looking to avoid progression of disease,” said Kelly Bliss, Teladoc Health President of U.S. Group Health. “Conditions and their risk factors are often interconnected, and with the right tools and behavior changes, they can be prevented.” The new program builds on Teladoc Health’s industry-leading individual condition management programs, which deliver proven results. For example, a recent analysis of more than 210,000 members enrolled in Teladoc Health’s diabetes management program showed 58% of participants achieved remission-level A1c. In the hypertension program, 88% of participants improved or maintained their blood pressure after one year. Data also shows that Teladoc Health’s digital mental health support accelerates positive results across the company’s hypertension, diabetes and weight management programs. Teladoc Health also places 100% of program fees at risk, as a sign of confidence for customers that the programs will help their populations achieve new levels of cardiometabolic health. The new program is part of Teladoc Health’s integrated care segment strategy to deepen its impact on healthcare outcomes and follows recent enhancements in its chronic care management offerings. In the last few months alone, the company has expanded its at-home testing and preventative care capabilities, enhanced its weight management programs, and unveiled new collaborations, partnerships and platform capabilities to help more people discover and enroll in eligible programs. To learn more about Teladoc Health’s cardiometabolic health solutions, click here. About Teladoc HealthTeladoc Health empowers all people everywhere to live their healthiest lives by transforming the healthcare experience. As the world leader in virtual care, Teladoc Health uses proprietary health signals and personalized interactions to drive better health outcomes across the full continuum of care, at every stage in a person’s health journey. Teladoc Health leverages more than two decades of expertise and data-driven insights to meet the growing virtual care needs of consumers and healthcare professionals. For more information, please visit www.teladochealth.com. Media: Lou SerioPR@teladochealth.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6d73b64d-10ae-44ab-a6c5-2994eadae02a

CVRx Reports Preliminary First Quarter 2025 Financial Results

First quarter revenue expected to be approximately $12.3 million, representing growth of approximately 15% over first quarter 2024MINNEAPOLIS, April 07, 2025 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced certain preliminary unaudited first quarter 2025 revenue results. “While we continue to make significant progress in driving adoption of Barostim, first quarter revenue fell short of our expectations,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “A core element of the commercial strategy initiated last year has been to build a world-class sales organization. As part of this effort, we brought in a number of new high-quality sales representatives in the back half of 2024 and the first quarter of 2025. We are thrilled with the level of talent we have attracted to strengthen our team, but many of these newer sales representatives are still in the early stages of territory development. In addition, the first quarter of 2025 was impacted by seasonal softness, as patients and customers schedule procedures around insurance coverage and deductibles. We did not fully anticipate this impact because past first quarter events, including COVID spikes, material clinical data releases, and management changes, likely obscured the magnitude of first-quarter seasonality.” “Despite the disappointing revenue performance in the quarter, we remain confident in our ability to drive growth in Barostim adoption. We continue to believe that our strategic focus on driving deep penetration within high-potential accounts will unlock higher future growth. We look forward to providing further information on the earnings call with the release of our full first quarter results in early May.” First Quarter 2025Total revenue for the first quarter of 2025 is expected to be approximately $12.3 million, representing an increase of approximately 15% over first quarter 2024 revenue of $10.8 million. Total revenue generated in the first quarter of 2024 is expected to be comprised of approximately $11.2 million in U.S. revenue and $1.1 million in European revenue. As of March 31, 2025, the Company had a total of 227 active implanting centers in the U.S., as compared to 223 as of December 31, 2024. The number of sales territories in the U.S. decreased by 3 to a total of 45 during the three months ended March 31, 2025. As of March 31, 2025, cash and cash equivalents were $102.7 million. During the three months ended March 31, 2025, the Company issued 543,462 shares of common stock for gross proceeds of $9.5 million under its at-the-market offering. First Quarter 2025 Earnings Release Webcast and Conference Call InformationThe Company plans to release first quarter 2025 financial and operating results after market close on Thursday, May 8, 2025. The Company will host a conference call to review its results at 4:30 p.m. Eastern Time the same day. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time. Please reference the following conference ID to access the call: CVRXQ125. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. 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 www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our expected first quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.   The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Preliminary First Quarter 2025 Results This press release includes estimated financial results for the first quarter of 2025, which are preliminary, unaudited and represent the most recent current information available to Company management. The Company’s actual results may differ from these estimated financial results, including due to the completion of its financial closing procedures and final adjustments. The Company expects to issue full financial results and provide information about its outlook for fiscal year 2025 in early May. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.651-338-6204emeyers@cvrx.com