Company: BSX
Filing Date: 2025-05-28
Form Type: 8-K
Source: 0000885725-25-000033
Chunk: 0

Company: BOSTON SCIENTIFIC CORP
Filing Date: 2025-05-28
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

On May 28, 2025, Boston Scientific Corporation (the “ Company”) announced it is discontinuing worldwide sales of the ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems and no longer pursuing U. S. FDA approval for ACURATE or approval in other geographies. The Company made this decision based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions. The additional resources and investments needed to satisfy these requirements are prohibitive for the Company.

Based on the information known today and despite the anticipated financial impacts from the discontinuation of ACURATE, the Company expects to achieve its second quarter and full year 2025 reported and organic sales and adjusted earnings per share guidance issued on April 23, 2025. The Company is not reaffirming its second quarter and full year 2025 GAAP EPS guidance issued on April 23, 2025 at this time and expects to provide more information during the Company’s second quarter 2025 earnings call.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend,” “will” and similar words. These forward-looking statements are based on the Company’s beliefs, assumptions and estimates using information available to it at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding ACURATE, expected financial and operational impacts of the decisions announced herein and the Company’s management of such impacts, clinical trials, second quarter and full year 2025 guidance, business plans and product performance. If the Company’s underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by the forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement its business strategy and may cause actual results to differ materially from those contemplated by the forward-looking statements expressed in this Current Report on Form 8-K. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements.

Risks and uncertainties that may cause such differences include,