Core Viewpoint - InspireMD, Inc. has received FDA premarket application approval for its CGuard Prime Carotid Stent System, marking a significant milestone in the treatment of carotid artery disease [1][3]. Group 1: FDA Approval and Clinical Evidence - The FDA approval is supported by data from the C-GUARDIANS pivotal trial, which included 316 patients across 24 sites in the U.S. and Europe, demonstrating the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates in carotid intervention studies [2][5]. - The C-GUARDIANS trial showed strong evidence of the neuro-protective benefits of the MicroNet™ mesh technology used in the CGuard Prime system, with the lowest event rates for stroke, death, and myocardial infarction reported in any carotid revascularization trial [3][6]. Group 2: Product Features and Market Impact - The CGuard Prime Carotid Stent System features a novel mesh-covered design aimed at improving patient safety through sustained embolic protection, combining a large open-cell frame with a small mesh pore size to prevent plaque protrusion [4]. - With over 65,000 implants sold and studies involving over 2,000 patients, the CGuard Prime is positioned as a proven technology for treating obstructive carotid artery disease, with plans for an immediate U.S. launch following FDA approval [3][4]. Group 3: Financial Implications - The FDA approval triggers the second of four milestone-driven warrant tranches from a private placement financing of up to $113.6 million, with gross proceeds expected to be $17.9 million if fully exercised [3]. - Proceeds from the warrant tranche will support the commercial launch of the CGuard Prime system in the U.S., regulatory pathways for advanced applications, and the development of new products [3].

BPH Market & Aquablation Therapy - Benign Prostatic Hyperplasia (BPH) affects approximately 40 million men in the U S [21] - The U S BPH surgical market represents a ~$20 billion opportunity [27] - Approximately 70% of prostates treated with Aquablation in the U S are less than 100ml in size [41] - Aquablation therapy provides effective, safe, and durable outcomes independent of prostate size, shape, and surgeon experience [36] Financial Performance & Guidance - Total revenue increased by 72% year-over-year to $24 4 million in Q1 2023 [51] - U S Aquabeam install base increased by 106% year-over-year to 192 systems in Q1 2023 [51] - U S handpieces sold increased by 139% year-over-year in Q1 2023 [51] - The company projects total revenue of $128 0 million for 2023, representing approximately 71% year-over-year growth [53, 54] - The company anticipates a gross margin of 54% for 2023 [54] Commercial Strategy & Expansion - The company is targeting 860 high-volume hospitals in the U S with an annual resective volume of ≥100 procedures [62] - 17 Strategic IDNs account for ~29% of BPH hospitals and ~26% of high-volume centers [70] - 65% of high volume hospitals are within a 100-mile radius of Robotic Sales Representatives [73]

Investor Event © 2024 PROCEPT BioRobotics Corporation. All Rights Reserved. Safe Harbor Statement This presentation and accompanying oral presentation contain "forw ard-looking statements" w ithin the meaning of the Private Securities Litigation Reform Act of 1995, including the ex pected financial results of PROCEPT BioRobotics Corporation (the "Company"). W ords such as "anticipates," "believes," "ex pects," "intends," "projects," "anticipates," and "f uture" or similar ex pressions are intended to identi ...

Smith+Nephew's family of TRIGEN Nails have delivered proven performance and industry-leading design for more than two decades.*4-7 The new TRIGEN MAX Tibia Nailing System is poised to be the next flagship product setting the standard of care and performance for intramedullary nails. "What takes the TRIGEN MAX Tibia Nailing System to the next level is its ability to reach fractures we never imagined treating with an intramedullary implant before – but we're there now," said Joseph R. Hsu, MD, Orthopaedic Tra ...

The future of fracture fixation with novel side-specific nails featuring variable angle locking technology Dave Snyder +1 (978) 749-1440 Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces the launch of its new TRIGEN MAX Tibia Nailing System for stable and unstable fractures of the tibia, including the shaft. It is the only system to now offer trauma surgeons the choice of side-specific (right and left) nails for anatomic screw trajectories, which help to optimize fragme ...

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]

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, Inc. is the second U.S. public company to adopt Bitcoin as its primary treasury reserve asset and is a leader in medical devices and software to combat chronic diseases. By using proceeds from equity and debt financings, as well as cash flows from operations, Semler Scientific intends to strategically accumulate Bitcoin. In addition, through its healthcare businesses, Semler Scientific and its wholly-owned subsidiary, CardioVanta, Inc. develop and market products and services for early de ...

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). DrugSo ...

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 ...