Acquisition to expand interventional oncology offerings with complementary therapy to treat liver-dominant metastases

MARLBOROUGH, Mass., Nov. 25, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has entered into a definitive agreement to acquire Intera Oncology® Inc., a privately held medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine – a chemotherapy drug – both of which are approved by the U.S. Food and Drug Administration. The Intera 3000 pump is used to administer hepatic artery infusion (HAI) therapy to treat tumors in the liver primarily caused by metastatic colorectal cancer.

There are approximately 1.4 million people in the U.S. living with primary colorectal cancer, and more than 150,000 new cases are diagnosed each year.ⁱ For nearly 25% of these patients, the cancer will spread to the liver during their illness.ⁱⁱ In patients who receive HAI therapy to treat their cancer, the Intera 3000 pump is implanted under the skin and a connected catheter is placed in the hepatic artery, which supplies the liver with oxygenated blood. The pump then provides a continuous flow of floxuridine directly into the liver to treat tumors that have metastasized, most commonly from the colon.

"Liver cancer is a leading cause of cancer-related death, and we are committed to providing meaningful solutions to safely and effectively treat various forms of this disease with minimal systemic side effects and improved outcomes for patients," said Peter Pattison, president, Interventional Oncology and Embolization, Boston Scientific. "Interest in HAI therapy has grown in the oncology community given improved techniques, positive clinical results and ongoing trials. We believe this acquisition will enable us to provide a more comprehensive set of solutions to physicians and their patients to treat both primary and metastatic forms of liver cancer."

The Intera 3000 pump is the only constant flow implantable pump for HAI therapy approved in the United States. The safety and effectiveness of the Intera 3000 pump is supported by data from randomized controlled trials demonstrating the clinical benefits of HAI therapy for patients with unresectable colorectal metastases to the liver, both prior to and following resection. Data from these trials have highlighted that HAI therapy significantly improves tumor response, time to progression and overall survival compared to systemic chemotherapy,^iii,iv,v and that combining HAI with systemic chemotherapy may lead to extended survival and higher conversion-to-resection rates in both chemotherapy-naïve and previously treated patients.^vi,vii Current Phase II and III studies are exploring HAI therapy use in larger patient groups for first-line, second-line and post-surgery adjuvant treatments.

Boston Scientific expects to complete the transaction in the first half of 2025, subject to closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be more dilutive on a GAAP basis due to acquisition-related net charges and amortization expense. Specific terms of the transaction have not been disclosed.

About Boston Scientific

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us 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 our business plans, the financial and business impact of the transaction and the anticipated benefits of the transaction, the closing of the transaction and the timing thereof, and product performance and impact. If our 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 our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the forward-looking statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; market competition for our products; expected procedural volumes; new product introductions; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Intera's operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this press release.

CONTACTS:

Blake Rouhani

Media Relations

+1 (763) 494-2268

blake.rouhani@bsci.com

Jon Monson

Investor Relations

+1 (508) 683-5450

BSXInvestorRelations@bsci.com

ⁱ Colorectal Cancer — Cancer Stat Facts

ⁱⁱ Colorectal liver metastases: Current management and future perspectives - PMC

ⁱⁱⁱ Perioperative Hepatic Arterial Infusion Pump Chemotherapy Is Associated With Longer Survival After Resection of Colorectal Liver Metastases: A Propensity Score Analysis - PubMed

^iv Hepatic Arterial Infusion in Combination with Modern Systemic Chemotherapy is Associated with Improved Survival Compared with Modern Systemic Chemotherapy Alone in Patients with Isolated Unresectable Colorectal Liver Metastases: A Case-Control Study - PubMed

^v Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481) - PubMed

^vi Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential - PubMed

^vii ASO Visual Abstract: Combined Hepatic Artery Infusion Pump and Systemic Chemotherapy in the Modern Era for Chemotherapy-Naive Patients with Unresectable Colorectal Liver Metastases | Annals of Surgical Oncology

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SOURCE Boston Scientific Corporation