Medtronic Receives FDA Breakthrough Designation for the Emprint Ablation Catheter Kit

Minimally Invasive Option Has Potential to Provide Long-Term Management of Lung Malignancies While Protecting Lung Function

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the Emprint™ ablation catheter kit an investigational device not yet approved or cleared in the United States . The catheter is intended to be used in conjunction with the Emprint™ microwave generator and Medtronic lung navigation platform to provide a minimally invasive, localized treatment of malignant lesions in the lung, and it can be used together with standard of care therapy when indicated.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding clinical trial designs through to commercialization decisions.

Current clinical guidelines for the management of malignant lung lesions support a multimodal approach, which may include surgery, radiotherapy, and/or systemic drug therapy depending on the tumor stage. Because patients with lung malignancies have been shown to have survival benefit from a combination of systemic and local therapy, less invasive local treatment modalities such as the Emprint ablation catheter kit have been developed. 1 Using an endoluminal approach, the Emprint ablation catheter kit will be studied with the Medtronic lung navigation system to allow for accurate delivery of microwave energy to the targeted lung lesion(s). Clinical guidelines recommend incorporating local therapies such as thermal ablation, in combination with systemic therapies when suitable.

Though not yet available in the United States , the Emprint ablation catheter kit is CE Marked and the NAVABLATE study completed enrollment of 30 subjects in Europe and Hong Kong in 2020.

"This new technology has allowed me to personalize treatment of lung lesions for each patient, particularly lesions that may be challenging to manage," said Mr. Kelvin Lau, MA, DPhil, FRCS(CTh), a consultant thoracic surgeon at St. Bartholomew's Hospital, London , and principal investigator for the NAVABLATE study.

The Medtronic lung navigation platform enables precise and accurate placement of the ablation catheter within the target lesion, which is critical for the success of this minimally invasive procedure. 2 With 15 years of experience, the navigation platform has been used in more than 200,000 lung procedures.

"At Medtronic, we strive to transform outcomes by taking bold actions to ensure that patients with tumors in the lung receive care sooner, less invasively, and more effectively," said Emily Elswick , vice president and general manager, Lung Health & Visualization, within the Surgical Innovations business, which is part of the Medical Surgical Portfolio at Medtronic. "Breakthrough designation from the FDA is just the first-step in realizing our broader commitment to providing less invasive treatment options to patients with lung disease."

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services, and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.




1 Uhlig J, Case MD, Blasberg JD, Boffa DJ, Chiang A, Gettinger SN, Kim HS. (CAN BE "et al."); JAMA Netw Open. 2019 Aug 2;2(8):e199702. doi: 10.1001/jamanetworkopen.2019.9702.

2 Bhadra K, MattingleyJ, Pritchett M. Electromagnetic navigation bronchoscopy with advanced fluoroscopy-based localization and intraprocedural local registration for the evaluation of peripheral pulmonary nodules. Paper presented at: CHEST Annual Meeting; October 23, 2019; New Orleans, LA.

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Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

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Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

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Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B

  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

"The sale of the Purification & Filtration business is part of phase three of our transformation plan and follows a thorough analysis of the value and strategic alignment of our businesses," said Bryan Hanson , Solventum CEO. "This transaction will enhance our strategic focus and key metrics while reducing leverage and significantly strengthening our balance sheet. It also enables us to invest in the innovation, programs and talent we need to execute our mission and deliver shareholder value."

Mr. Hanson continued, "Solventum is committed to ensuring a smooth transition for employees, customers and other stakeholders, and we are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions."

Solventum will discuss the transaction on its upcoming fourth quarter and full-year 2024 earnings call scheduled for February 27, 2025 . With this significant change in the Company's portfolio and the other major actions taken since becoming an independent publicly traded company on April 1, 2024 , Solventum has scheduled an Investor Day on March 20, 2025 , to provide investors with an update on the progress made, its go-forward positioning and long-range plan. The Investor Day will be held in New York City , and the Company will share additional logistical details in due course.

Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

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SOURCE Solventum

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Thermo Fisher Scientific to Acquire Solventum's Purification and Filtration Business

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- For the one million people diagnosed with Parkinson's disease in the United States 1 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration (FDA) approval of BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI).

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