Financial

Philips Future Health Index 2025: AI poised to transform global healthcare, urging leaders to act now

Financial by Comments are Disabled

May 15, 2025AI has the power to cut care delays and manage data overload, but trust gaps among clinicians and patients threaten to slow adoption and impactAmsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has released its 10th annual Future Health Index (FHI) report, highlighting the growing strain on global healthcare systems. The FHI 2025 Report, the largest global survey of its kind analyzing key concerns of healthcare professionals and patients, indicates AI holds promise for transforming care delivery. However, gaps in trust threaten to stall progress at a time when innovation is most needed.“The need to transform healthcare delivery has never been more urgent,” said Carla Goulart Peron, M.D., Chief Medical Officer at Philips. “In more than half of the 16 countries surveyed, patients are waiting nearly two months or more for specialist appointments, with waits in Canada and Spain extending to four months or longer. As healthcare systems face mounting pressures, AI is rapidly emerging as a powerful ally, offering unprecedented opportunities to transform care and overcome today’s toughest challenges.”Long waits, worsening outcomesThe FHI 2025 report reveals 33% of patients have experienced worsening health due to delays in seeing a doctor, and more than 1 in 4 end up in the hospital due to long wait times. “Cardiac patients face especially dangerous delays, with 31% being hospitalized before even seeing a specialist. Without urgent action, a projected shortfall of 11 million health workers by 2030 could leave millions without timely care,” Dr. Peron added.Clinician burnout and data burdens call for digital reliefMore than 75% of healthcare professionals report losing clinical time due to incomplete or inaccessible patient data, with one-third losing over 45 minutes per shift, adding up to 23 full days a year lost by each professional. “These inefficiencies amplify stress on already understaffed teams and contribute to burnout,” said Gretchen Brown, RN, VP and Chief Nursing Information Officer at Stanford Health Care. “Recognizing this, as clinicians, we see AI as a solution and understand that delayed adoption can also carry major risks.”   Of the nearly 2,000 healthcare professionals surveyed, if AI is not implemented:

Continue Reading →

SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business Updates

Financial by Comments are Disabled

QUELIMMUNE adoption drives four-fold increase in sequential quarter net revenue NEUTRALIZE AKI trial exceeds 50% enrollment, triggers start of Interim AnalysisWebcast Today at 4:30 pm Eastern Time DENVER, May 14, 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 financial results for the three months ended March 31, 2025, and provided business updates on key initiatives. “This is our second full quarter of the QUELIMMUNE launch and we believe our four-fold increase in revenue represents the strong commitment by our customers to improve outcomes in their pediatric patients with Acute Kidney Injury (AKI) with this potential life-saving therapy,” said Eric Schlorff, CEO of SeaStar Medical. “We also continue to attract new customers, including a nationally recognized children’s medical center that just completed Institutional Review Board (IRB) approvals and placed its first order for the QUELIMMUNE therapy.” Mr. Schlorff continued, “Importantly, we are now looking to expand access to our promising technology into the adult AKI market, where this is also a very high unmet need. Our NEUTRALIZE-AKI trial in adult AKI patients is now 50% enrolled and we look forward to completing the trial and potentially filing the Premarket Approval (PMA) application in 2026. Our team is already actively engaging with health care providers in peer-to-peer nephrology venues to provide education and awareness of our Selective Cytopheretic Device (SCD) therapy. Given the same mechanism of action as QUELIMMUNE, albeit a larger device for the adult SCD therapy, we are excited to unveil results from this trial in 2026.” Key Business Highlights in 2025 Since the beginning of 2025, SeaStar Medical’s key business updates include the following: Reported a four-fold increase in QUELIMMUNE net product revenue in the first quarter of 2025 to approximately $293 thousand compared to approximately $68 thousand in the fourth quarter of 2024.Broadened the QUELIMMUNE customer base, securing three new customers in 2025, including a nationally recognized children’s medical center that recently completed IRB approvals and placed an initial order for QUELIMMUNE therapy.Achieved 50% enrollment in the NEUTRALIZE-AKI pivotal trial, triggering the initiation of the prespecified, per protocol Interim Analysis by the trial’s independent Data Safety Monitoring Review Board (DSMB). SeaStar Medical anticipates the DSMB will report its findings to the company in the third quarter of 2025.Awarded two new Breakthrough Device Designations for use of the SCD therapy to treat 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. This brings SeaStar Medical’s total Breakthrough Device Designations to six therapeutic indications, enabling a potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.Successfully completed an FDA site inspection of SeaStar Medical’s facility for QUELIMMUNE kitting operations, eliminating its contract manufacturer and enabling internal controls over the entire kitting process.Received from the FDA an Investigational Device Exemption (IDE) for a clinical trial to evaluate the SCD therapy as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure who have progressed to acute decompensated heart failure. This indication has been granted Breakthrough Device Designation by the FDA.  It represents a market where there is serious unmet need for effective treatments.  Awarded the NKF 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. Financial Results for the First Quarter 2025 Net revenue for the three months ended March 31, 2025, was approximately $0.3 million, reflecting sales of the QUELIMMUNE pediatric SCD therapy that was approved under a Humanitarian Device Exemption in February 2024 and launched as a commercial product by SeaStar Medical in July 2024. Research and development expenses for the three months ended March 31, 2025, and 2024, were $2.4 million and $1.7 million, respectively. The increase in research and development expenses was primarily driven by an increase in clinical trial costs related to the NEUTRALIZE-AKI pivotal trial, as well as medical affairs and personnel costs, partially offset by a decline in costs for external services. General and administrative expenses for the three months ended March 31, 2025, and 2024, were approximately $1.7 million and $2.3 million, respectively. The decrease in general and administrative expenses was the result of a decline in accounting-related costs, as well as legal-related and consulting expenses, partially offset by an increase in SEC-related expenses. Other expenses (net) decreased approximately $8.8 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily related to the retirement of outstanding debt obligations and the elimination of convertible notes and related warrants since March 31, 2024. Net loss for the three months ended March 31, 2025, SeaStar Medical was approximately $3.8 million, or $0.44 per share on approximately 8.6 million weighted-average shares outstanding. This compared with a net loss of approximately $12.7 million, or $4.73 per share, on approximately 2.7 million weighted-average shares outstanding for the three months ended March 31, 2024. The Company reported cash, cash equivalents and long-term investments of $5.3 million as of March 31, 2025, compared to $1.8 million as of December 31, 2024. In January 2025 the Company announced an approximately $6.0 million registered direct offering priced at-the-market. SeaStar Medical First Quarter Financial Results Conference Call Date/Time:Wednesday, May 14, 2025, at 4:30 p.m. ET / 2:30 p.m. MT  Webcast:The live webcast and replay can be found here.  Conference ID:2078693  Dial-in numbers:1 (800) 715-9871 within the U.S. 1 (646) 307-1963 from outside the U.S.   A replay of the call will be available after 7:30 pm ET and can be accessed as follows: The webcast replay is available here.The call replay number is 1 (609) 800-9909 and will be available through May 20, 2025. About QUELIMMUNE The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with Renal Replacement Therapy (RRT). The QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. SeaStar Medical commenced its commercial launch of the QUELIMMUNE therapy in July 2025. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. About NEUTRALIZE-AKI Pivotal Trial  The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.  About Acute Kidney Injury (AKI) and Hyperinflammation  AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About the SeaStar Medical Selective Cytopheretic Device Therapy The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing nearly a million patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.   About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit www.seastarmedical.com or visit us on LinkedIn or X. Forward-Looking Statements  This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for adult SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to the total addressable market for adult SCD applications; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. 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 significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.  Contact:  IR@SEASTARMED.COM — Financial Tables to Follow —     SeaStar Medical Holding CorporationCondensed Consolidated Balance Sheets(in thousands, except for share and per-share amounts)     March 31,2025 December 31,2024 (unaudited)  ASSETSCurrent assets   Cash$5,296  $1,819 Accounts receivable, net 110   112 Inventory 44   — Prepaid expenses 1,334   1,835 Total current assets 6,784   3,766 Other assets 813   892 Total assets$7,597  $4,658     LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT)Current liabilities   Accounts payable$3,397  $3,046 Accrued expenses 3,255   3,188 Notes payable, net of deferred financing costs 363   574 Liability classified warrants 17   33 Total current liabilities 7,032   6,841 Total liabilities 7,032   6,841     Commitments and contingencies (Note 10)           Stockholders’ equity/(deficit)   Preferred stock – $0.0001 par value, 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 —   — Common stock – $0.0001 par value per share; 450,000,000 and 500,000,000 shares authorized at March 31, 2025 and December 31, 2024, respectively; 9,257,763 and 5,977,246 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 2   2 Additional paid-in capital 143,899   137,379 Accumulated deficit (143,336)  (139,564)Total stockholders’ equity/(deficit) 565   (2,183)Total liabilities and stockholders’ equity/(deficit)$7,597  $4,658          SeaStar Medical Holding CorporationCondensed Consolidated Statements of Operations(unaudited)(in thousands, except for share and per-share amounts)   Three Months Ended March 31, 2025 2024    Net revenue$293  $— Cost of goods sold —   — Gross profit 293   — Operating expenses   Research and development 2,431   1,697 General and administrative 1,684   2,253 Total operating expenses 4,115   3,950 Loss from operations (3,822)  (3,950)Other income (expense)   Interest expense (11)  (143)Interest income 48   — Change in fair value of convertible notes —   (5,758)Change in fair value of liability classified warrants 16   (2,846)Total other income (expense), net 53   (8,747)Loss before provision for income taxes (3,769)  (12,697)Provision for income taxes 3   — Net loss$(3,772) $(12,697)Net loss per share of common stock, basic and diluted$(0.44) $(4.73)Weighted-average shares outstanding, basic and diluted 8,617,932   2,684,243          SeaStar Medical Holding CorporationCondensed Consolidated Statements of Cash Flows(unaudited)   Three Months Ended March 31, 2025 2024    Cash flows from operating activities   Net loss$(3,772) $(12,697)Adjustments to reconcile net loss to net cash used in operating activities   Amortization of deferred financing costs 11   27 Change in fair value of convertible notes (issued, converted and outstanding) —   5,758 Change in fair value of liability classified warrants (exercised and outstanding) (16)  2,846 Stock-based compensation 167   434 Change in operating assets and liabilities   Accounts receivables, net 2   — Inventory (44)  — Prepaid expenses 501   614 Other assets 79   2 Accounts payable 351   (493)Accrued expenses 67   21 Net cash used in operating activities (2,654)  (3,488)    Cash flows from financing activities   Proceeds from issuance of convertible notes —   979 Proceeds from issuance of shares, net of issuance costs 1,566   4,543 Proceeds from sale of pre-funded warrants 4,785   3,769 Proceeds from exercise of warrants 2   853 Payment of notes payable (222)  (1,813)Net cash provided by financing activities 6,131   8,331 Net increase in cash 3,477   4,843 Cash, beginning of period 1,819   176 Cash, end of period$5,296  $5,019  Supplemental disclosure of cash flow informationThree Months Ended March 31, 2025 2024Cash paid for interest$—  $— Exercise of pre-funded warrants$—  $3,106 Shares issued as payment of convertible notes$—  $9,387 Issuance of convertible note warrants$—  $586 

Continue Reading →

BioCardia Reports First Quarter 2025 Business Highlights and Financial Results

Financial by Comments are Disabled

SUNNYVALE, Calif., May 14, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the first quarter of 2025 and filed its quarterly report on Form 10-Q for the three months ended March 31, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) On March 30, 2025, two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of its CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Sessions, demonstrating increased survival, decreased cardiovascular events such as stroke, heart attacks, and hospitalizations and improved quality of life for treated patients at two years. Statistically significant and clinically meaningful improvements were seen in the subset of patients suffering from active heart stress (50% of enrolled patients), as demonstrated by elevated NTproBNP and BNP biomarkers. The Company is on track to share the two-year data with both the FDA and Japan Pharmaceuticals and Medical Devices Agency in the coming weeks and align on pathways to make CardiAMP available for physicians and their patients.The CardiAMP HF II Trial is underway in the United States, with three sites actively enrolling patients. This confirmatory trial focuses on patients with active heart stress with a primary endpoint based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, are (1) all-cause death, including cardiac death equivalents, (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. In the CardiAMP HF Trial, this composite efficacy endpoint was achieved with statistical significance in the subset of patients with elevated NTproBNP that are the focus of the CardiAMP HF II study (p=0.02). CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The last roll-in cohort patient has recently reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO Cell Therapy in Ischemic Heart Failure (BCDA-03) The low dose cohort of 20 million cells in the phase 1/2 clinical trial was completed in the first quarter 2025 and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. The Company plans to progress the trial to enrollment of 39 participants in the United States and fund development through nondilutive grant applications and partnering. Helix Biotherapeutic Delivery The Company’s Helix transendocardial biotherapeutic delivery system performed well in the recent CardiAMP HF Trial as presented on March 30, with no procedure-related deaths, embolism, or need for surgical cardiac or endovascular repair occurring. This contributes to the growing body of experience using this delivery platform and supports the independent FDA submission for approval that we are currently pursuing. Helix procedures are also now using the advanced Morph DNA bidirectional steerable platform to navigate, and physician feedback has been positive. Intellectual Property The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide. In March, the Company announced that the Japan Patent Office granted Japanese Patent No: 7641330 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire on or after September 30, 2034. The patent describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. Two additional patents have also been allowed this year and are expected to issue in the near future. “This has been a great quarter for all of our therapeutic programs in development,” said BioCardia CEO Peter Altman, Ph.D. “Most importantly, the CardiAMP HF Trial has provided significant rigorous evidence supporting both safety and meaningful benefits of CardiAMP cell therapy for heart failure patients who still have elevated biomarkers of heart stress, despite being on maximal guideline directed medical therapy. Our top priorities are the regulatory submissions for the CardiAMP Cell Therapy System clinical consultation with Japan PMDA and for the Helix transendocardial delivery system application for approval in the United States. Both are anticipated this quarter.” First Quarter 2025 Financial Results: Research and development expenses were approximately $1.5 million for the three months ended March 2025 compared to approximately $1.2 million for the three months ended March 2024, primarily due to closeout activities in the CardiAMP HF Trial and the inception of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses were approximately $1.2 million for the three months ended March 2025 compared to approximately $1.1 million for the three months ended March 2024.Our net loss was approximately $2.7 million for the three months ended March 2025, compared to approximately $2.3 million for the three months ended March 2024.Net cash used in operations for the three months ended March 2025 was approximately $1.6 million, as compared to approximately $1.5 million for the three months ended March 2024. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01: CardiAMP Autologous Cell Therapy for Ischemic Heart Failure CardiAMP HF ManuscriptJapan PMDA Clinical Consultation request / submissionFDA Meeting request / submissionCardiAMP Heart Failure II Trial – additional sites and enrollment BCDA-02: CardiAMP Autologous Cell Therapy in Chronic Myocardial ischemia Completed roll-in cohort data submitted for presentation / publication BCDA-03: CardiALLO Allogeneic Cell Therapy in Inflammatory Ischemic Heart Failure Dose cohort 2 completed enrollment Helix Biotherapeutic Delivery Business FDA approval milestonesPartnering Morph Access Innovations Business Revenues and case reportsIndication specific deals About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. 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 the enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. 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” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.  BioCardia, Inc.Condensed Consolidated Statements of Operations (Unaudited in thousands, except share and per share amounts)            Three Months endedMarch 31,    2025 2024Revenue:     Collaboration agreement revenue$—$55Costs and expenses:     Research and development 1,530 1,241 Selling, general and administrative 1,196 1,089  Total costs and expenses 2,726 2,330  Operating loss (2,726) (2,275)Other income (expense):      Total other income, net 14 8Net loss$(2,712) $(2,267)       Net loss per share, basic and diluted$(0.59)$(1.35)       Weighted-average shares used in computing   net loss per share, basic and diluted 4,635,764 1,675,539        BioCardia, Inc.     Selected Balance Sheet Data     (amounts in thousands)                   March 31,  December 31,  2025(1)  2024(1)      Assets:     Cash and cash equivalents$949 $2,371Other current assets 224  251Property, plant and equipment and other noncurrent assets 993  1,102Total assets$2,166 $3,724Liabilities and Stockholders’ Equity (Deficit)     Current liabilities$3,234 $2,321Operating lease liability – noncurrent 452  566Total stockholders’ equity (deficit) (1,520)  837Total liabilities and stockholders’ equity (deficit)$2,166 $3,724      (1) March 31, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

Continue Reading →

Artivion Announces Agreements to Exchange $95 Million in Principal Amount of its 4.250% Convertible Notes Due 2025 for Common Stock

Financial by Comments are Disabled

ATLANTA, May 14, 2025 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that it entered into separate, privately negotiated exchange agreements with certain holders of its 4.250% Convertible Senior Notes…

Continue Reading →

Maze Therapeutics Reports First Quarter 2025 Financial Results and Reiterates Upcoming Milestones

Financial by Comments are Disabled

MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease; Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in Q3 2025 Strong Balance Sheet with $294.4 Million in Cash and Cash Equivalents, Expected to Provide Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, metabolic and cardiovascular diseases, today reported financial results for the first quarter ended March 31, 2025, and reiterated upcoming milestones. “With two clinical programs underway – an important milestone that underscores the strength of our Compass platform and drug development expertise – Maze is entering a new phase of growth,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We’re particularly excited about MZE782, a genetically informed therapy that we believe could be best-in-class for PKU and first-in-class for CKD. We expect to report Phase 1 healthy volunteer data, including biomarker results, later this year to support Phase 2 trials in both indications. In addition, our Phase 2 HORIZON trial of MZE829 continues to actively enroll, on track for a readout in Q1 2026. With a strong balance sheet following our IPO, we’re well-positioned to deliver on our pipeline and mission.” Key Anticipated Milestones MZE829 for APOL1 Kidney Disease (AKD) MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States (U.S.) alone. Maze continues to enroll patients in the Phase 2 HORIZON trial of MZE829. The trial includes a broad population of patients with AKD, including those with diabetes, those with non-diabetic kidney disease, and patients with severe focal segmental glomerulosclerosis (FSGS).Maze expects to announce initial proof-of-concept data from the Phase 2 HORIZON trial in the first quarter of 2026. MZE782 in CKD and Phenylketonuria (PKU) MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a first-in-class treatment for the approximately five million U.S. patients with CKD who inadequately respond to currently available CKD therapies, as well as potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder. MZE782 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers.Maze expects to report initial data, including proof-of-mechanism biomarker results, in the third quarter of 2025.Based on Phase 1 results, Maze plans to initiate two separate Phase 2 clinical trials of MZE782 in CKD and PKU. First Quarter 2025 Financial Results Cash Position: Cash and cash equivalents were $294.4 million as of March 31, 2025, compared to $196.8 million as of December 31, 2024. Maze expects that its current cash and cash equivalents will fund operations into the second half of 2027. Research & Development (R&D) Expenses: R&D expenses were $27.6 million and $21.9 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher clinical trial expenses for MZE829 and MZE782 and personnel-related expenses, including non-cash stock-based compensation expense. General & Administrative (G&A) Expenses: G&A expenses were $7.8 million and $6.1 million for the first quarter of 2025 and 2024, respectively. This increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and professional services fees. Net Loss: Net loss was $32.8 million and $32.5 million for the first quarter of 2025 and 2024, respectively. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. IR/Corporate Contact:Amy Bachrodt, Maze Therapeuticsabachrodt@mazetx.com Media Contact:Dan Budwick, 1ABdan@1abmedia.com   Maze Therapeutics, Inc.Select Condensed Financial Information(in thousands, except share and per share amounts)(unaudited)  Condensed Statements of Operations        Three Months Ended  March 31,  2025  2024 Operating expenses:     Research and development$27,580  $21,877 General and administrative 7,821   6,137 Total operating expenses 35,401   28,014 Loss from operations (35,401)  (28,014)Interest and other income, net 2,615   281 Change in fair value of convertible promissory notes —   (4,761)Net loss$(32,786) $(32,494)Net loss per share, basic and diluted$(1.15) $(13.91)Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted 28,628,430   2,336,613            Condensed Balance Sheet Data        March 31,  December 31,  2025  2024 Cash and cash equivalents$294,374  $196,812 Total assets$332,840  $240,542 Total liabilities$40,772  $43,638 Total redeemable convertible preferred stock$—  $508,087 Total stockholders’ equity (deficit)$292,068  $(311,183)        

Continue Reading →

Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update

Financial by Comments are Disabled

Resolution of CRL Manufacturing issues in progress – Type A meeting requested No clinical safety or efficacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) — Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ended March 31, 2025. The Company also announced the submission of a meeting request to the U.S. Food and Drug Administration (FDA) as the next step in the resolution of CRL issues. “Our immediate priority is to engage with the U.S. FDA in order to address the CMC-related issues raised in the CRL received for CARDAMYST as a treatment for PSVT,” said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We are confident we can work with the FDA to fully respond to the CRL and remain committed to the potential of CARDAMYST. If approved, it will be the first and only self-administered therapy for the rapid termination of episodes of PSVT.” First Quarter and Recent Program Updates Etripamil for Patients with PSVT CRL for CARDAMYST™ for PSVT received from FDA.  In March 2025, Milestone received a CRL regarding its NDA for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). In the letter, the Agency highlighted two key Chemistry, Manufacturing and Controls (CMC) issues to be addressed: 1) additional information on nitrosamine impurities was requested, based on new draft guidance that was issued during the review of the NDA , and 2) a new inspection of a facility listed in the NDA is required, to ensure it is in compliance with current Good Manufacturing Practices (GMP).  The facility, which previously performed a portion of the testing required to release etripamil final product, changed ownership during the review of the NDA. Milestone is prepared to discuss the issues raised in the CRL during the Type A meeting with the FDA.Patent Issued by the U.S. Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray. The new patent (U.S. Patent No. 12,257,224) covers the repeat dose regimen that was used in the RAPID Phase 3 study that evaluated etripamil in PSVT and is included in the proposed package insert for CARDAMYST. The issued patent potentially extends the intellectual property protection for CARDAMYST in the United States until July 2042, which would be an additional six years of protection for the company’s intellectual property portfolio.CARDAMYST highlighted in independent Survey of Managed Care professionals. Results from an independent survey conducted by Managed Healthcare Executive and The American Journal of Managed Care were published on May 6, 2025. CARDAMYST was selected by 40% of respondents (which included payers, providers and academics) when asked which new drug is expected to make the biggest difference in patient health.   A copy of the article can be accessed here.Commercial Launch Plan investor event held in February. The event, held on February 25, 2025 in New York City, provided an in-depth overview of the Company’s commercial strategy for CARDAMYST nasal spray, if approved. A replay of the event, as well as a copy of the slides, can be found on the corporate website here.Poster on etripamil presented at American College of Cardiology Annual Meeting (ACC.25). The poster titled, “Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) treated with Etripamil: Outcomes from the NODE-303 trial,” was presented at the meeting on March 30, 2025 by James Ip, M.D., Professor, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital. A copy of the poster can be accessed here. Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Phase 3 protocol in AFib-RVR finalized Milestone has finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the Agency to proceed. The Company is pausing initiation of enrollment of the study due to prioritizing resources to resolve the CRL received on the NDA for etripamil in PSVT. First Quarter 2025 Financial Results   As of March 31, 2025, Milestone had cash, cash equivalents, and short-term investments of $56.0 million, compared to $69.7 million as of December 31, 2024.There was no revenue for the first quarter ended March 31, 2025 or for the first quarter of 2024.Research and development expense for the first quarter of 2025 was $5.0 million, compared with $3.6 million for the prior year period. The increase was primarily due to higher consulting costs in drug manufacturing and regulatory costs.General and administrative expense for the first quarter of 2025 was $5.2 million, compared with $4.0 million for the prior year period. This increase was driven primarily by an increase in outside service costs, partially offset by a decrease in personnel costs.Commercial expense for the first quarter of 2025 was $10.4 million, compared with $2.9 million for the prior year period. This increase is a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. As a result of the CRL, Milestone has temporarily paused the ramping of operational expenditures related to launch, but will maintain the capability to launch quickly, pending approval of CARDAMYST by the FDA.For the first quarter of 2025, net loss was $20.8 million, compared to $10.4 million for the prior year period. For further details on the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC. About EtripamilEtripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone PharmaceuticalsMilestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the outcomes of future interactions with the FDA, including the potential Type A meeting; Milestone’s ability to address the issues raised in the CRL on a timely basis, if at all; the outcome of the potential NDA resubmission; CARDAMYST’s potential as a novel treatment option to help patients with PSVT; potential protections afforded by U.S. patents; CARDAMYST’s ability to make the biggest difference in patient health, as compared to other available treatment options; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended March 31, 2025, in each case under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com   Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands of US dollars, except share data)         March 31, 2025 December 31, 2024Assets             Current assets      Cash and cash equivalents $45,085  $25,314 Short-term investments  10,873   44,381 Research and development tax credits receivable  994   901 Prepaid expenses  2,356   1,840 Other receivables  1,167   1,490 Total current assets  60,475   73,926 Operating lease right-of-use assets  1,234   1,376 Property and equipment  176   197 Total assets $61,885  $75,499        Liabilities, and Shareholders’ (Deficit) Equity             Current liabilities      Accounts payable and accrued liabilities $12,421  $7,555 Operating lease liabilities  542   571 Total current liabilities  12,963   8,126 Operating lease liabilities, net of current portion  758   874 Senior secured convertible notes  54,287   53,352 Total liabilities  68,008   62,352               Shareholders’ (Deficit) Equity      Common shares, no par value, unlimited shares authorized, 53,464,273 shares issued and outstanding as of March 31, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024  288,188   288,048 Pre-funded warrants – 12,910,590 issued and outstanding as of March 31, 2025 and 12,910,590 as of December 31, 2024  53,076   53,076 Additional paid-in capital  40,919   39,568 Accumulated deficit  (388,306)  (367,545)       Total shareholders’ (deficit) equity  (6,123)  13,147        Total liabilities and shareholders’ equity $61,885  $75,499           Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)(in thousands of US dollars, except share and per share data)     Three months ended March 31,       2025    2024        Revenue $—  $—        Operating expenses      Research and development, net of tax credits  4,978   3,639 General and administrative  5,167   3,953 Commercial  10,378   2,884        Loss from operations  (20,523)  (10,476)       Interest income  697   994 Interest expense  (935)  (872)       Net loss and comprehensive loss $(20,761) $(10,354)       Weighted average number of shares and pre-funded warrants outstanding, basic and diluted   66,285,406   50,155,111        Net loss per share, basic and diluted $(0.31) $(0.21)

Continue Reading →

Anteris Announces Results for the First Quarter of 2025

Financial by Comments are Disabled

MINNEAPOLIS and BRISBANE, Australia, May 13, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2025, and provided a corporate update. First Quarter 2025 Highlights Investigational Device Exemption (“IDE”) for the DurAVR® THV’s global, pivotal clinical trial (the “PARADIGM Trial”), submitted to the FDA during the First QuarterScale up for commencement of the PARADIGM Trial ongoing – including expanding the Clinical Specialist Team and contracting with planned centers in the U.S., Canada and EuropeClinical milestone of 100 patients successfully treated with the DurAVR® THV – comprised of de novo aortic stenosis cases including complex anatomies, and valve-in-valve patientsReported one-year clinical data for DurAVR® THV – demonstrating sustained, favourable hemodynamic outcomes, a consistent safety profile and high implant successOngoing expansion of global manufacturing capacity to scale for the PARADIGM Trial and meet initial anticipated commercial demandAnteris included in the FTSE Russell 2000® IndexConcluded the First Quarter with a cash position of $49.0m (A$78.0m) “Our focus this quarter has been on completing the substantial technical, clinical and regulatory work required to lodge our IDE application, which was successfully submitted during the period. We are also proud to have reached a major clinical milestone with over 100 patients treated with DurAVR®, the first new class of product in this space for many years – an incredible achievement which reflects the strength of our clinical program and growing physician confidence in our technology. Finally we continue to scale our field based Clinical Team, Manufacturing and Quality organizations to ensure we are able to meet the demands of the PARADIGM Trial” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Preparations for the PARADIGM Trial The proposed DurAVR® THV global pivotal registration trial has been formally designated as the PARADIGM Trial, signifying the trial’s central role in the DurAVR® THV Clinical Development Program. PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices An IDE application for the PARADIGM Trial was submitted to the U.S. Food and Drug Administration (FDA) during the First Quarter. An approved IDE allows the investigational device (the DurAVR® THV) to be used in a clinical study to collect safety and effectiveness data. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (“PMA”*) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. The Company remains on track to commence the PARADIGM Trial in the third quarter of 2025, pending FDA approval of the IDE. The naming of the PARADIGM Trial reflects both the paradigm-shifting hemodynamic performance observed to date in over 110 patients treated with the DurAVR® THV and the trial’s head-to-head, comparative design. It is proposed that patients will be randomized 1:1 to either the DurAVR® treatment arm or to a commercially available device in the control arm (SAPIEN or Evolut series THV). Patients with an existing failed surgical valve, needing valve-in-valve (“ViV”) TAVR are proposed to be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. Scale up activities for the PARADIGM Trial The Company continues to develop infrastructure to support the PARADIGM Trial including building out the global Clinical Specialist Team to provide on-site expert clinical support in addition to working with its Contract Research Organisation to engage with planned centers and investigators in the U.S., Canada and Europe. These teams will provide oversight and guidance to site based clinical staff to ensure appropriate use of the DurAVR® THV System, high-quality data collection and adherence to regulatory and protocol requirements throughout the PARADIGM Trial. These preparatory steps are intended to increase the speed of enrolment following IDE approval. Clinical Milestone – 100 patients successfully treated with the DurAVR® THV During the First Quarter, Anteris achieved a major clinical milestone when the 100th patient was successfully treated with the DurAVR® THV System. This marks a significant achievement for Anteris and its goal to restore heart valve patients to healthy function. The patients included de novo (first time) aortic stenosis cases, some with complex anatomies such as bicuspid aortic valve patients. Additionally, a cohort of ViV patients were treated—these are patients who underwent a previous surgical or transcatheter aortic valve replacement procedure (SAVR or TAVR) and subsequently experienced failure of their bioprosthetic aortic valve. At the end of the First Quarter, 65 of the 100 patients treated with the DurAVR® THV, had successfully completed the primary endpoint measures of safety and efficacy including hemodynamic benefit at 30-days post implant. These results are both clinically relevant and significantly differentiated to current therapies available to aortic stenosis patients. Clinical Data – One-year patient outcomes for DurAVR® THV patients Anteris released one-year clinical data for patients treated with the DurAVR® THV, as a late breaking clinical trial podium presentation by Rishi Puri, M.D. PhD, at the Sydney Valves structural heart conference in March 2025. The one-year data, which was included in the IDE submission to the FDA, demonstrated a consistent safety and efficacy profile, with high implant success across the clinical program. Highlights from the one-year data include: Favorable hemodynamics sustained to one-year: DurAVR® THV demonstrated an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.Strong safety profile at one year: No valve or cardiovascular related mortality. Importantly, there was no prosthesis-patient mismatch (PPM) reported in small annuli patients with aortic annulus area of 395.80 + 37.26 mm2, while current commercial devices have rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. The clinical presentation is available on the Company’s website. Expansion of global manufacturing capacity During the First Quarter, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) are being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success. First Quarter 2025 Financial Results The financial results for Anteris for the quarter ended March 31, 2025 compared to March 31, 2024 are reviewed below. All amounts in $ refer to US dollars. Net sales during the three months ended March 31, 2025 were $0.6 million, a decrease of $0.2 million (27%), compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products in 2025. Loss after Income Tax was $21.9 million for the three months ended March 31, 2025, an increase of $5.8 million (36%) compared to $16.2 million for the same period in the prior year. R&D expenses during the three months ended March 31, 2025 were $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year. This is primarily due to $3.5 million relating to the upscaling of manufacturing capabilities including process design and validation activities and the expansion of headcount and $1.5 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients;Selling, general and administrative expenses during the three months ended March 31, 2025 were $5.7 million, a decrease of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, primarily due to a reduction of $1.2 million relating to costs incurred in the first quarter of 2024 associated with the plans to re-domicile, list on Nasdaq and conduct our initial public offering, partly offset by a $0.8 million increase in legal, tax and compliance costs linked to dual listing requirements and other operational matters. There was also a decline in share based payment expense of $0.5 million. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing, including the Management Discussion & Analysis and the risks described therein. Corporate and Financing Activities In January 2025, TD Cowen, Barclays and Cantor, the Underwriters to the December 2024 US IPO, partially exercised the green shoe option granted by Anteris. This green shoe option was in respect of 78,481 shares of Common Stock at the purchase price of US$6.00 per share, less underwriting discounts and commissions, to raise a further $0.47 million. During the First Quarter, Anteris was included as one of seven IPO additions to the FTSE Russell 2000® Index, effective as of March 24, 2025. The FTSE Russell 2000® Index measures the performance of the small-cap segment of the US equity market. The FTSE Russell® 2000 Index is a subset of the Russell 3000® Index which is designed to represent approximately 98% of the investable US equity market. 1 Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261. *A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison between treatment groups. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of and plans for Anteris’ studies and trials, the timing of the PARADIGM Trial, the goals of the expansion of the global manufacturing capacity and the sourcing of ADAPT® tissue for the DurAVR® THV in the future. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release by the Board of Directors. For more information:   Investor RelationsInvestor Relations (US)investors@anteristech.commchatterjee@bplifescience.comDebbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269   Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech 

Continue Reading →

Ernst & Young LLP Names Brian Webster of Kestra Medical Technologies as an Entrepreneur Of The Year® 2025 Mountain West Award Finalist

Financial by Comments are Disabled

Entrepreneur Of The Year celebrates ambitious entrepreneurs who are shaping the future KIRKLAND, Wash., May 13, 2025 (GLOBE NEWSWIRE) — Ernst & Young LLP (EY US) announced the finalists for the Entrepreneur Of The Year 2025 Mountain West Award. Now in its 40th year, the Entrepreneur Of The Year program celebrates the bold leaders who disrupt markets through the world’s most ground-breaking companies, revolutionizing industries and making a profound impact on communities. The Mountain West program celebrates entrepreneurs from Alaska, Colorado, Idaho, Montana, Oregon, Utah, Washington, and Wyoming. An independent panel of judges selected Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), among 41 finalists for their entrepreneurial spirit, purpose, growth, and lasting impact in building long-term value. “Being named a finalist for the Entrepreneur Of The Year® 2025 Mountain West Award is a meaningful acknowledgment of the work we’re doing at Kestra,” said Brian Webster. “Our goal has always been to challenge the status quo in cardiac care by developing innovative, inclusive solutions that address real patient needs. This recognition underscores our commitment to transforming healthcare through purposeful innovation and building a company culture that values diversity and impact.” Founded in 2014, Kestra Medical Technologies is a commercial-stage wearable medical device company focused on transforming outcomes in cardiovascular care through intuitive, intelligent, and connected technologies. Its flagship product, the ASSURE® Wearable Cardioverter Defibrillator, delivers life-saving defibrillation therapy through a design centered on patient comfort, connectivity, and recovery support. Entrepreneur Of The Year honors business leaders for their ingenuity, courage, and entrepreneurial spirit. The program celebrates original founders who bootstrapped their business from inception or who raised outside capital to grow their company; transformational CEOs who infused innovation into an existing organization to catapult its trajectory; and multigenerational family business leaders who reimagined a legacy business model to strengthen it for the future. Regional award winners will be announced on June 20 during a special celebration in Salt Lake City, Utah, and will become lifetime members of an esteemed community of Entrepreneur Of The Year alumni from around the world. The winners will then be considered by the National judges for the Entrepreneur Of The Year National Awards, which will be presented in November at the annual Strategic Growth Forum®. SponsorsFounded and produced by Ernst & Young LLP, the Entrepreneur Of The Year Awards include presenting sponsors PNC Bank, Cresa, LLC, Marsh USA, and SAP. In the Mountain West region, sponsors also include regional Gold sponsors, Perkins Coie, Strong & Hanni Law Firm and Truss and regional Silver sponsors, Big Picture, Pierpont Communications, and Silicon Slopes. About Entrepreneur Of The Year Founded in 1986, Entrepreneur Of The Year has celebrated more than 11,000 ambitious visionaries who are leading successful, dynamic businesses in the US, and it has since expanded to nearly 60 countries globally. The US program consists of 17 regional programs whose panels of independent judges select the regional award winners every June. Those winners compete for national recognition at the Strategic Growth Forum® in November where National finalists and award winners are announced. The overall National winner represents the US at the EY World Entrepreneur Of The Year™ competition. Visit ey.com/us/eoy. About EYEY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. All in to shape the future with confidence. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via ey.com/privacy. EY member firms do not practice law where prohibited by local laws. For more information about our organization, please visit ey.com. About Kestra Medical Technologies, Ltd.Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com

Continue Reading →
1 … 35 36 37 38 39 … 481