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Boston Scientific Corp. (BSX) is a leading global medical technology company that specializes in the development, manufacture, and marketing of medical devices for interventional medical procedures. The company's operations are divided into two main segments: MedSurg and Cardiovascular. With a focus on less invasive medical devices, Boston Scientific's products are designed for insertion into the human body through small openings or cuts, making them essential in various medical fields.
The company's product portfolio includes devices for angioplasty, blood clot filtration, kidney stone management, cardiac rhythm management, catheter-directed ultrasound imaging, upper gastrointestinal tract diagnostics, interventional oncology, neuromodulation for chronic pain, and the treatment of incontinence. Boston Scientific markets its innovative solutions to healthcare professionals and institutions worldwide, with nearly half of its total sales coming from foreign markets.
Recently, the company made headlines with a successful public offering of €2,000,000,000 in aggregate principal amount of notes. These funds are intended to finance the acquisition of Axonics, Inc. and to repay existing debt, showcasing Boston Scientific's strategic financial management.
Significant advancements include the FDA approval for the AGENT™ Drug-Coated Balloon (DCB), aimed at treating coronary in-stent restenosis in patients with coronary artery disease. This novel device marks the first drug-coated coronary balloon available in the U.S., providing a dedicated treatment option for this challenging condition.
Boston Scientific is also expanding its strategic cooperation with Scivita Medical Technology Co., Ltd., focusing on the development and global distribution of endoscopic devices. This collaboration underscores the company's commitment to advancing medical technologies that enhance patient care.
On the financial front, Boston Scientific reported net sales of $3.856 billion for the first quarter of 2024, a 13.8% increase from the previous year. The company's diverse portfolio and robust pipeline, including the recent launch of the FARAPULSE™ Pulsed Field Ablation System, have been key drivers of this growth.
Looking ahead, Boston Scientific is actively involved in clinical trials such as the NAVIGATE-PF study for the FARAWAVE™ Nav Pulsed Field Ablation Catheter and the MODULAR ATP trial for the mCRM™ System. These trials aim to further improve patient outcomes and expand the company's product offerings.
As a global leader in medical technology, Boston Scientific remains committed to transforming lives through innovative solutions that address unmet patient needs and reduce healthcare costs. Stay updated with the latest developments by visiting their website and connecting on LinkedIn and X, formerly Twitter.
SoniVie , a medical device company developing a renal denervation system for hypertension treatment, has appointed Raymond W. Cohen as Chairman of its Board of Directors. Cohen, who is retiring from Axonics following its $3.7 billion sale to Boston Scientific , brings significant experience in the medical technology sector. He previously served as CEO of Axonics, which he co-founded in 2013 and led to become the top-ranked company in the 2021 Deloitte Technology Fast 500™. Cohen also has relevant expertise in renal denervation from his time as CEO of Vessix Vascular, which was acquired by Boston Scientific in 2012.
Boston Scientific (NYSE: BSX) has announced its participation in the 2024 UBS Global Healthcare Conference scheduled for Tuesday, November 12, 2024. The company will be represented by Nick Spadea-Anello, president of Electrophysiology, and Jon Monson, senior vice president of Investor Relations, who will engage in a 35-minute Q&A session starting at 7:15 a.m. PT / 10:15 a.m. ET. The session will be available via live webcast, with a replay accessible approximately one hour after the event's conclusion on the company's investor relations website.
Boston Scientific (NYSE: BSX) has announced a definitive agreement to acquire Cortex Inc., a private medical technology company specializing in diagnostic mapping solutions for atrial fibrillation (AF). The key asset is the OptiMap™ System, which received FDA 510(k) clearance in 2023. The system uses a basket catheter and proprietary algorithm to identify AF sources, enabling targeted ablation strategies.
Clinical data from the FLOW-AF trial showed OptiMap-guided treatment improved freedom from AF by 51% compared to conventional therapy. The acquisition is expected to close in first half 2025, with immaterial impact on adjusted EPS and slight GAAP dilution. The ongoing RESOLVE-AF trial is evaluating the system's effectiveness across 300 patients globally.
Boston Scientific (NYSE: BSX) announced results from the ACURATE IDE clinical trial evaluating their ACURATE neo2™ Aortic Valve System for treating severe aortic stenosis. The trial's primary endpoint showed a 16.16% composite rate of all-cause mortality, stroke, or rehospitalization at one year in the ACURATE neo2 arm versus 9.53% in the control arm, failing to meet non-inferiority criteria. A post-hoc analysis revealed approximately 20% of valves were under-expanded, with data showing similar outcomes between properly expanded ACURATE neo2 valves and the control group. The company continues working with the FDA on regulatory approval strategy.
Boston Scientific (BSX) reported strong Q3 2024 results with net sales of $4.209 billion, representing a 19.4% increase year-over-year. The company achieved adjusted EPS of $0.63, exceeding guidance of $0.57-$0.59. Notable segment growth includes Cardiovascular at 25.0% and MedSurg at 10.3%. Regional performance showed U.S. sales growth of 23.5% and EMEA growth of 15.2%. The company received multiple regulatory approvals, including FDA approval for the FARAWAVE™ NAV Ablation Catheter and completed the acquisition of Silk Road Medical. For full-year 2024, BSX projects net sales growth of approximately 16.5% on a reported basis.
Boston Scientific (NYSE: BSX) has received FDA approval for the FARAWAVE™ NAV Ablation Catheter and FDA 510(k) clearance for the FARAVIEW™ Software. These technologies enhance the FARAPULSE™ Pulsed Field Ablation (PFA) System for treating paroxysmal atrial fibrillation (AF).
The FARAWAVE NAV Ablation Catheter adds magnetic navigation capabilities, allowing cardiac mapping and PFA therapy delivery in a single integrated catheter. The FARAVIEW Software provides visualization for cardiac ablation procedures, offering a dynamic view of catheter placement, shape, and rotation.
These advancements are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures. The FARAPULSE PFA System has been used to treat over 125,000 patients globally. Boston Scientific will immediately launch these new technologies in the U.S.
Boston Scientific (NYSE: BSX) has announced two upcoming events:
1. A conference call on October 23, 2024, at 8:00 a.m. ET to discuss third quarter 2024 financial results and business highlights. The call will be hosted by Mike Mahoney, chairman and CEO, and Dan Brennan, executive VP and CFO. Financial results will be released prior to the call.
2. A virtual investor event on October 30, 2024, from 4:00 – 5:00 p.m. ET following the Transcatheter Cardiovascular Therapeutics (TCT) symposium. This event will feature a cardiology business update and Q&A session with key executives from the company's cardiology division.
Live webcasts and replays for both events will be available on the Boston Scientific investor relations website.
Boston Scientific (NYSE: BSX) has received PMDA approval in Japan for the FARAPULSE™ Pulsed Field Ablation (PFA) System. This system is indicated for the isolation of pulmonary veins in treating paroxysmal atrial fibrillation (AF). Unlike traditional thermal ablation, the FARAPULSE PFA System uses non-thermal electrical fields, avoiding damage to surrounding structures.
The system has been used to treat over 125,000 patients globally and is now approved in more than 65 countries. AF affects over one million people in Japan and an estimated 38 million worldwide. Boston Scientific plans to launch the system in Japan following reimbursement approval and expects to initiate the OPTION-A clinical trial in early 2025 to study concomitant procedures using the FARAPULSE PFA System and the WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device.
Boston Scientific (NYSE: BSX) has completed its acquisition of Silk Road Medical, Inc. (Nasdaq: SILK) for $27.50 per share, representing an enterprise value of approximately $1.18 billion. This acquisition strengthens Boston Scientific's vascular technology solutions by integrating the innovative transcarotid artery revascularization (TCAR) platform for stroke prevention and carotid artery disease treatment.
The deal is expected to have a minimal impact on Boston Scientific's adjusted earnings per share in 2024 and 2025, becoming accretive thereafter. The impact on GAAP earnings may be less favorable due to amortization expenses and acquisition-related charges. This strategic move aims to expand the availability of TCAR to more physicians and patients through Boston Scientific's extensive commercial network.
Boston Scientific (NYSE: BSX) has received FDA approval to expand the indication for its INGEVITY™+ Pacing Leads to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA). This expansion allows for an alternative to traditional right ventricular pacing in treating symptomatic bradycardia. The LBBA pacing approach may promote greater ventricular synchrony and reduce long-term heart failure risk.
The approval was supported by data from the INSIGHT-LBBA study, involving approximately 400 patients. The INGEVITY+ Pacing Lead, which received initial FDA approval in 2019, features a stylet-driven design for precise positioning and continuous pacing and impedance monitoring capabilities.
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