BURLINGTON, Mass., May 01, 2025 (GLOBE NEWSWIRE) — LeMaitre Vascular, Inc. (Nasdaq: LMAT), a provider of vascular devices, implants, and services, today reported Q1 2025 results, announced a quarterly dividend of $0.20/share, and provided guidance.
Other News
Elutia Transitions to Direct Distribution of Its Cardiovascular Product Portfolio
Move expected to drive both top-line growth and gross margin improvement SILVER SPRING, Md., May 01, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced it is reclaiming U.S. sales and distribution responsibilities for its cardiovascular portfolio—including ProxiCor®, VasCure®, and Tyke®—following the conclusion of its distribution agreement with LeMaitre Vascular, Inc. The move allows Elutia to directly capture top-line revenue and should improve the gross margin and profitability of this product segment. Elutia has appointed Dwayne Montgomery as Head of Cardiovascular to lead this newly established business unit. A seasoned commercial executive, Mr. Montgomery brings proven senior leadership experience from Osiris Therapeutics, Smith & Nephew, Guidant, and C.R. Bard. Under Mr. Montgomery’s leadership, Elutia has recruited and mobilized a high-performing team of 26 independent (1099) sales representatives specifically for the cardiovascular line. Operating independently from the EluPro™ commercial organization, this focused structure allows both commercial teams to stay laser-focused on their respective missions. With training of the cardiovascular team now complete, Elutia has commenced direct sales as part of a coordinated transition of accounts from LeMaitre, ensuring continuity and minimizing disruption for customers. “While we’re grateful for our partnership with LeMaitre, bringing this asset back in-house allows us to fully unlock its value,” said Dr. Randy Mills, CEO of Elutia. “Direct control over sales to the end user allows us to sharpen our execution, drive top-line growth, improve profitability and cash flow, and gives us greater strategic flexibility. Under Dwayne’s leadership, the team has already made impressive progress—and we’re just getting started.” Elutia’s cardiovascular portfolio is expected to deliver approximately 80% gross margins and maintain a premium price position in the market. The Company also expects growth at the top-line. In 2024, sales of cardiovascular products accounted for $2.9 million, or about 12%, of total revenue. Unlike synthetic grafts, these regenerative biomatrix products promote a healthy immune response and avoid the typical foreign body reaction associated with synthetics. The portfolio includes: ProxiCor® PC, for pericardial closure; ProxiCor® CTR, for cardiac tissue repair; Tyke®, the only extracellular matrix cleared for neonatal and infant patch, pledget, and intracardiac repair; and VasCure®, for vascular repair. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding: improving future results of our cardiovascular portfolio by assuming sales responsibility for it, including any predictions as to future revenues, pricing or gross margins of our cardiovascular products; the timing of commencement of sales through our independent sales force; and the efficiency of the transition. . These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our ability to successfully commercialize, market and sell our products; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
BioCardia Announces First Patient in Phase 3 Randomized Controlled Double-Blind CardiAMP HF II Clinical Trial of the Company’s Lead Cell Therapy for Treatment of Heart Failure
SUNNYVALE, Calif., May 01, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the first patient enrolled in the Phase III randomized procedure placebo-controlled double-blind CardiAMP HF II clinical trial of the Company’s lead autologous cell therapy program for the treatment of heart failure at BayCare Morton Plant Hospital in Clearwater, Florida. “We are excited to lead enrollment in the CardiAMP HF II trial and be able to offer this cell therapy study to our heart failure patients. This investigational therapy has been shown to enhance microvascular function and demonstrated promising clinical outcomes in the recently completed CardiAMP HF Trial, particularly for the patients we are targeting for this trial,” said Dr. Leslie Miller, M.D., Chief of the Congestive Heart Failure and Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida. Dr. Miller is also a CardiAMP HF II Trial Principal Investigator and member of the Executive Steering Committee. “The unique ability to personalize this treatment based on a patient’s own cellular characteristics make CardiAMP cell therapy attractive for treating heart failure. The approach preserves all therapeutic options for our patients, including repeated cell therapy, and avoids the need for immune suppression. I congratulate and thank our team at Morton Plant Hospital for achieving this important milestone in enrolling the first patient in the world’s first confirmatory Phase 3 cardiac cell therapy trial for heart failure.” “Our first CardiAMP HF II study procedure went smoothly and per protocol,” said Dr. Rakesh Sharma, M.D., Interventional Cardiologist at BayCare Morton Plant Hospital in Clearwater, and CardiAMP HF II investigator. “Our efforts in cardiac cell therapy over many years have supported the potential of this CardiAMP cell therapy where cells are harvested, processed, and delivered into the heart muscle by our research team. I value the Helix minimally invasive cell intramyocardial delivery platform for its ability to enable targeting of specific segments in the heart with confidence and find the new Morph DNA steerable navigation catheter to be an elegant enhancement.” “We are thankful for the BayCare Morton Plant team led by Dr. Miller and Dr. Sharma as well as the many other world-class clinical teams engaged in the CardiAMP cell therapy trials,” said Peter Altman, PhD, BioCardia President and Chief Executive Officer. “We are preparing regulatory submissions in Japan and the USA intended to seek separate approvals of the CardiAMP cell therapy and Helix biotherapeutic delivery platform based on our existing TABMMI1, TAC-HFT2,3, and CardiAMP HF4 clinical data. The CardiAMP HF II trial is intended to collect confirmatory evidence to support this autologous cell therapy with respect to approvals, adoption, and reimbursement.” About the CardiAMP Heart Failure II Study CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study of the CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP. The study is intended to confirm the safety and efficacy results in these patients observed in the CardiAMP HF study4. The CardiAMP HF II study uses a similar three-tier composite primary outcome measure to CardiAMP HF, with tier 1 all cause death, tier 2 nonfatal major adverse cardiac events, but with tier 3 using a validated quality of life patient self-assessment instrument. In CardiAMP HF, this composite efficacy endpoint was achieved with statistical significance in the patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02). Advances in this therapeutic approach in CardiAMP HF II include using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, which include the introduction of the FDA approved Morph DNA steerable platform. About CardiAMP Autologous Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, are all targets of CardiAMP cell therapy, largely through production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: www.BioCardia.com. Forward Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to our investigational product candidates, the potential benefits and mechanism of actions of the CardiAMP cell therapy, future regulatory approvals, enrollment in our clinical trials, and the safety and efficacy of our product candidates and therapies. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. References: de la Fuente LM, Stertzer SH, Argentieri J, et al. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase I safety study (the TABMMI study). EuroIntervention. 2011 Nov;7(7):805-12.Heldman AW, DiFede DL, Fishman JE, et al. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014 Jan 1;311(1):62-73.Wong Po Foo et al., The transendocardial autologous cells in ischemic heart failure trial bone marrow mononuclear cells (TAC-HFT-BMC) randomized placebo controlled blinded study, Regenerative Medicine 2015, 10(7s), S169.Raval A, on behalf of the CardiAMP HF Investigators. A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF: Principal Results from the CardiAMP-HF Trial, American College of Cardiology Scientific Sessions, March 30, 2025. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
HeartSciences Announces Launch of MyoVista Insights™ Platform and Related Early Adopter Program
Southlake, TX, May 01, 2025 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, announced today that it has launched the MyoVista InsightsTM platform and related early adopter program for select reference sites.
Windtree Announces Strategic Transaction to Drive Revenue Generation in Support of Ongoing Therapeutic Pipeline Development
Initial transaction provides the right to buy the target asset which may provide consistent revenue to Windtree while it continues to develop its biotech pipeline drug candidatesWARRINGTON, Pa., May 01, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered an Assignment and Conditional Assumption Agreement with a seasoned real estate investment group pursuant to which it has gained the rights to purchase a 436 unit, multifamily residential property in Houston, Texas. The property is expected to contribute consistent rental revenue to the Company while it continues to develop its therapeutic pipeline. The planned acquisition would be effectuated through a separate wholly owned subsidiary division of the Company with the anticipated addition of certain new management. The acquisition is expected to be funded primarily from non-recourse secured mortgage financing, with the balance of the purchase price coming from proceeds of the issuance of preferred stock. The Company’s obligation to purchase the property is contingent upon the satisfactory completion of standard property due diligence and finalization of acceptable terms of the financing. The initial planned closing date is May 23, 2025, however, the Company has the option to extend the closing date for two periods of no greater than thirty days each. The Company’s new corporate strategy seeks to acquire assets that contribute revenue including the acquisition of small biotech companies with FDA approved products. Windtree will continue to develop its pipeline of unique drug candidates in the cardiovascular and oncology disease spaces. “Windtree is expected to become a revenue generating company and these additional assets are intended to diversity and stabilize the Company,” said Jed Latkin, Chief Executive Officer of Windtree. “By identifying opportunities to bring in stable revenue, we believe the Company can reduce its need for capital that could be dilutive to the stock price. We are actively looking at multiple acquisition candidates that could provide near term revenue and profits. We will continue in our mission to help patients in need with our existing unique drug candidates in cardiogenic shock, heart failure and cancer. We believe that this new approach will allow the Company to grow and limit future stockholder dilution.” About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward Looking StatementsThis press release contains statements related to the acquisition of the real estate property discussed above; rental revenue if such property is acquired; potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company could lose its deposit on the real estate property discussed above; the Company may fail to acquire such real estate property; the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information:Eric Curtisecurtis@windtreetx.com
New Clinical Data Presented about VIVO at the 46th Annual Heart Rhythm Association Conference
FORT MILL, S.C., May 01, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that new clinical data about VIVO is available.
EnChannel Medical Raises $82.2M in Oversubscribed Series-B Financing to Advance Full-Chamber 5D Atrial Fibrillation Mapping and Personalized Pulsed-Field Ablation Therapy
GUANGZHOU, China, May 1, 2025 /PRNewswire/ — EnChannel Medical, a breakthrough innovator in cardiac electrophysiology, today announced the successful completion of an oversubscribed Series B financing, raising $82.2M (600M RMB). The round was co-led by Dragonball Capital and existing…
AtriCure Reports First Quarter 2025 Financial Results
Worldwide revenue of $123.6 million – an increase of 13.6% year over year (14.1% constant currency) Net loss of $6.7 million – an improvement of $6.5 million year over year Adjusted EBITDA of $8.8 million – an increase of $6.0 million year over year MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a […]
United Therapeutics Corporation Reports First Quarter 2025 Financial Results
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended March 31, 2025. Total revenues in the first quarter of 2025 grew 17 percent year-over-year to $794.4 million, compared to $677.7 million in the first […]
Viz.ai Launches Viz 3D CTA™ to Deliver Enhanced Imaging and Accelerate Clinical Decision-Making
ew feature provides AI-enhanced 3D imaging to improve neurovascular visualization and streamline workflows SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced the launch of Viz 3D CTA, a new solution that automatically converts computed tomography angiography (CTA) scans into high-resolution, AI-enhanced 3D images […]
Recent
GE HealthCare announces U.S. FDA 510(k) clearance and CE Mark for Allia Moveo and marks first global installation, advancing precision care in the interventional suite
Santé Ventures Raises $330 Million for Fifth Fund to Advance Breakthrough Healthcare Innovation
Brainomix Launches Award-Winning Next Generation Stroke AI Platform with Novel Net Water Uptake Technology at the International Stroke Conference (ISC)
Popular
- No commented posts yet