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BSX Raises 2025 Financial Outlook: What's Backing It?
ZACKS· 2025-06-24 13:30
Core Insights - Boston Scientific (BSX) has raised its full-year 2025 guidance for net sales growth to approximately 15-17% on a reported basis and nearly 12-14% on an organic basis, reflecting strong first-quarter results and ongoing momentum in key growth areas [1][8] - The company reported an organic sales growth of 18% in the first quarter, exceeding the guided range of 14-16%, with adjusted EPS at $0.75, a 34% year-over-year increase [2] - The Cardiology segment saw a significant sales increase of 31%, driven by products like WATCHMAN and AGENT drug-coated balloon, while the Electrophysiology business experienced a remarkable 145% year-over-year growth [3][8] Financial Performance - Full-year adjusted earnings per share are now expected to be in the range of $2.87-$2.94, up from the previous estimate of $2.80-$2.87 [1] - The company anticipates a $200 million tariff impact in 2025, primarily in the second half, but plans to offset this through organic sales growth and discretionary spending reductions [4] Competitive Landscape - Competitors like Edwards Lifesciences and Stryker have also adjusted their sales forecasts, with Edwards maintaining an 8-10% growth forecast and Stryker raising its guidance to 8.5-9.5% organic growth [5][6] - Boston Scientific's stock has outperformed the industry, gaining 33.4% over the past year compared to the industry's 8.8% growth [7] Valuation Metrics - Boston Scientific currently trades at a forward 12-month price-to-earnings ratio of 33.19X, which is above the industry average of 20.83X [9]
SeaStar Medical Announces Two Feature Stories on QUELIMMUNE Adoption and Patient Testimonial of Life-Saving Therapy
Globenewswire· 2025-06-24 13:05
Core Insights - SeaStar Medical Holding Corporation is focusing on the commercialization of QUELIMMUNE therapy for critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis [1][2] - The QUELIMMUNE therapy received approval in February 2024 under a Humanitarian Device Exemption, demonstrating safety and probable clinical benefit for a limited population of critically ill children [2] - The therapy aims to reduce destructive hyperinflammation that can lead to organ failure and increased mortality rates [5][6] Company Overview - SeaStar Medical is a commercial-stage healthcare company dedicated to transforming treatments for critically ill patients facing organ failure [4] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI due to sepsis in critically ill pediatric patients [4] - The company has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, facilitating a faster approval process and better reimbursement dynamics [6] Therapy Details - QUELIMMUNE therapy is designed for children weighing 10 kilograms or more who are treated in the ICU with Renal Replacement Therapy (RRT) [2] - The therapy was commercially launched in July 2025, following its approval [2] - The therapy addresses the urgent need for effective treatments in pediatric patients with few options available [2][3] Clinical Context - AKI is characterized by a sudden loss of kidney function and can result from various conditions, including sepsis and severe trauma [3] - Destructive hyperinflammation associated with AKI can lead to multi-organ dysfunction and increased healthcare costs due to prolonged ICU stays and reliance on dialysis [3] - The company is conducting a pivotal trial of its Selective Cytopheretic Device (SCD) therapy in adult patients with AKI, impacting over 200,000 adults in the U.S. annually [6]
Semler Scientific® Announces CardioVanta™, a New Entity that Seeks to Unlock Value of Future Medical Business Opportunities
Prnewswire· 2025-06-24 12:00
CAMPBELL, Calif., June 24, 2025 /PRNewswire/ -- Semler Scientific, Inc. (Nasdaq: SMLR), the second U.S. public company to adopt Bitcoin as its primary treasury reserve asset and a leader in medical device and software to combat chronic diseases, announced that it has formed CardioVanta, Inc., a wholly-owned subsidiary that will comprise its future healthcare business activities focused on early detection of heart failure and cardiac arrythmia monitoring. CardioVanta will be structured as a high-margin, soft ...
CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR
Prnewswire· 2025-06-24 11:00
PRINCETON, N.J., June 24, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device,  (the denial letter).  Drug ...
Iridex Announces First Patient Enrolled in an Independent Landmark Investigator-Led UK Study Evaluating MicroPulse® Technology as an Adjunct to anti-VEGF Therapy for Diabetic Macular Edema
Globenewswire· 2025-06-24 11:00
MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, announced today that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments ...
Sensus Healthcare (SRTS) Earnings Call Presentation
2025-06-24 07:46
1 in 5 Americans will develop skin cancer in their lifetime – AAD INVESTOR OVERVIEW NASDAQ: SRTS August 2024 SAFE HARBOR STATEMENT Forward-Looking Statements This presentation includes statements that are, or may be deemed, ''forward-looking statements.'' In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximatel ...
NPCE Investors Have Opportunity to Join NeuroPace, Inc. Fraud Investigation with the Schall Law Firm
Prnewswire· 2025-06-24 07:42
Group 1 - The Schall Law Firm is investigating claims on behalf of investors of NeuroPace, Inc. for potential violations of securities laws [1] - The investigation centers on whether NeuroPace made false or misleading statements or failed to disclose important information to investors [2] - NeuroPace's press release on May 27, 2025, revealed that the NAUTILUS study did not achieve statistical significance for its primary effectiveness endpoint, leading to a nearly 28.4% drop in shares on the same day [2]
TNDM Stock Gains on t:slim X2's Compatibility With FreeStyle Libre 3 +
ZACKS· 2025-06-23 14:51
Key Takeaways TNDM launched early U.S. access for t:slim X2 pump compatible with Abbott's FreeStyle Libre 3 Plus sensor. Abbott's Libre 3 Plus sends glucose data every minute to TNDM's t:slim mobile app. TNDM plans to integrate Abbott's future sensors for broader diabetes management solutions.Tandem Diabetes Care, Inc.’s (TNDM) t:slim X2 insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now compatible with Abbott’s FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) senso ...
摩根大通:年中展望-医疗保健行业
摩根· 2025-06-23 13:16
Asia Pacific Equity Research 20 June 2025 J P M O R G A N Mid-Year Prospects Healthcare This report forms part of the J.P. Morgan Australia Mid-Year Prospects series as we take stock at the mid-point of 2025 and set out our Top Picks and Least Preferred stocks for the remainder of the year. Top Pick – ResMed (RMD AU, OW) Earnings upside as sectoral trends pull forward demand Demand and diagnosis supported by industry tailwinds. Awareness of obstructive sleep apnoea is on the rise, supported by consumer mark ...
BioStem Technologies Completes Enrollment in Clinical Trial Evaluating BioREtain® Amnion Chorion for Treatment of Diabetic Foot Ulcers
Globenewswire· 2025-06-23 12:17
Core Insights - BioStem Technologies, Inc. has completed patient enrollment for a clinical trial comparing BioREtain® Amnion Chorion (BR-AC) to standard care for non-healing diabetic foot ulcers (DFUs) [2][3] - The BR-AC-DFU-101 study aims to evaluate the effectiveness of BR-AC in achieving complete wound closure over a 12-week period [3][5] - Topline results from the study are expected in Q4 2025, with the trial initiated in Q4 2024 across 11 sites in the U.S. [3][4] Company Overview - BioStem Technologies focuses on developing, manufacturing, and commercializing placental-derived products for advanced wound care [2][10] - The company utilizes a proprietary BioREtain processing method that preserves the natural properties of perinatal tissue [8][10] - BioStem's quality management systems are accredited by the American Association of Tissue Banks and adhere to Good Tissue Practices and Good Manufacturing Processes [11] Clinical Trial Details - The primary objective of the BR-AC-DFU-101 study is to determine if the combination of standard care and BR-AC leads to a higher probability of complete wound closure compared to standard care alone [5] - Secondary outcome measures include comparing treatment group differences in wound closure rates, wound area, and volume [7] - The study has enrolled 71 patients, exceeding the initial target of 60 [3][4] Market Context - Diabetic foot ulcers affect approximately 15% of individuals with diabetes, with 6% requiring hospitalization due to complications [5] - The economic burden of DFUs in the U.S. is significant, with annual treatment costs estimated between $9 billion and $13 billion [6] - In 2023, 2.2 million patients received treatment for DFUs, with numbers projected to rise [6]