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.

Contacts:

Kira Jastive	Ryan Weispfenning
Public Relations	Investor Relations
+1-508-452-4238	+1-763-505-4626

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Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	December 31,			% of		December 31,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	11,395				$	10,886
Costs and operating expenses:
Cost of revenues (a)		6,492		57.0	%		6,390		58.7	%
Selling, general and administrative expenses (b)		1,846		16.2	%		1,672		15.4	%
Amortization of acquisition-related intangible assets		438		3.8	%		563		5.2	%
Research and development expenses		374		3.3	%		327		3.0	%
Restructuring and other costs (c)		228		2.0	%		80		0.7	%
Total costs and operating expenses		9,379		82.3	%		9,032		83.0	%
Operating income		2,016		17.7	%		1,854		17.0	%
Interest income		227					309
Interest expense		(316	)				(390	)
Other income/(expense) (d)		14					(33	)
Income before income taxes		1,941					1,740
Benefit from/(provision for) income taxes (e)		(150	)				(133	)
Equity in earnings/(losses) of unconsolidated entities		33					(1	)
Net income		1,824					1,606
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f)		(6	)				(24	)
Net income attributable to Thermo Fisher Scientific Inc.	$	1,830		16.1	%	$	1,630		15.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	4.79				$	4.22
Diluted	$	4.78				$	4.20
Weighted average shares:
Basic		382					387
Diluted		383					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	2,016		17.7	%	$	1,854		17.0	%
Cost of revenues adjustments (a)		22		0.2	%		22		0.2	%
Selling, general and administrative expenses adjustments (b)		16		0.1	%		31		0.3	%
Restructuring and other costs (c)		228		2.0	%		80		0.7	%
Amortization of acquisition-related intangible assets		438		3.8	%		563		5.2	%
Adjusted operating income (non-GAAP measure)	$	2,720		23.9	%	$	2,550		23.4	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,830				$	1,630
Cost of revenues adjustments (a)		22					22
Selling, general and administrative expenses adjustments (b)		16					31
Restructuring and other costs (c)		228					80
Amortization of acquisition-related intangible assets		438					563
Other income/expense adjustments (d)		(11	)				14
Benefit from/(provision for) income taxes adjustments (e)		(138	)				(111	)
Equity in earnings/losses of unconsolidated entities		(33	)				1
Noncontrolling interests adjustments (f)		(14	)				(27	)
Adjusted net income (non-GAAP measure)	$	2,338				$	2,203

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	4.78				$	4.20
Cost of revenues adjustments (a)		0.06					0.06
Selling, general and administrative expenses adjustments (b)		0.04					0.08
Restructuring and other costs (c)		0.60					0.20
Amortization of acquisition-related intangible assets		1.14					1.45
Other income/expense adjustments (d)		(0.03	)				0.04
Benefit from/(provision for) income taxes adjustments (e)		(0.36	)				(0.29	)
Equity in earnings/losses of unconsolidated entities		(0.08	)				0.00
Noncontrolling interests adjustments (f)		(0.04	)				(0.07	)
Adjusted EPS (non-GAAP measure)	$	6.10				$	5.67

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	3,289				$	3,723
Purchases of property, plant and equipment		(480	)				(405	)
Proceeds from sale of property, plant and equipment		17					11
Free cash flow (non-GAAP measure)	$	2,826				$	3,329

Business Segment Information	Three months ended
	December 31,			% of		December 31,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	2,604		22.9	%	$	2,469		22.7	%
Analytical Instruments		2,186		19.2	%		2,037		18.7	%
Specialty Diagnostics		1,157		10.2	%		1,105		10.2	%
Laboratory Products and Biopharma Services		5,936		52.1	%		5,719		52.5	%
Eliminations		(487	)	-4.3	%		(444	)	-4.1	%
Consolidated revenues	$	11,395		100.0	%	$	10,886		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	952		36.6	%	$	895		36.2	%
Analytical Instruments		666		30.5	%		587		28.8	%
Specialty Diagnostics		273		23.6	%		264		23.9	%
Laboratory Products and Biopharma Services		828		14.0	%		804		14.0	%
Subtotal reportable segments		2,720		23.9	%		2,550		23.4	%
Cost of revenues adjustments (a)		(22	)	-0.2	%		(22	)	-0.2	%
Selling, general and administrative expenses adjustments (b)		(16	)	-0.1	%		(31	)	-0.3	%
Restructuring and other costs (c)		(228	)	-2.0	%		(80	)	-0.7	%
Amortization of acquisition-related intangible assets		(438	)	-3.8	%		(563	)	-5.2	%
Consolidated GAAP operating income	$	2,016		17.7	%	$	1,854		17.0	%


(a) Adjusted results in 2024 and 2023 exclude charges for the sale of inventory revalued at the date of acquisition and accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations.
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $3 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, charges for environmental-related matters, net charges/credits for pre-acquisition litigation and other matters, net gains/losses on the sale of real estate, and abandoned facility and other expenses of headcount reductions and real estate consolidations.
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments.
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements. Adjusted results in 2023 also exclude $14 of net charges for pre-acquisition matters.
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests.
Note:
Consolidated depreciation expense is $304 and $276 in 2024 and 2023, respectively.

Organic and Core organic revenue growth	Three months ended
	December 31, 2024
Revenue growth	5	%
Acquisitions	1	%
Currency translation	0	%
Organic revenue growth (non-GAAP measure)	4	%
COVID-19 testing revenue	0	%
Core organic revenue growth (non-GAAP measure)	5	%

Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Statements of Income (unaudited)
	Year ended
	December 31,			% of		December 31,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	42,879				$	42,857
Costs and operating expenses:
Cost of revenues (a)		24,818		57.9	%		25,295		59.0	%
Selling, general and administrative expenses (b)		7,003		16.3	%		6,569		15.3	%
Amortization of acquisition-related intangible assets		1,952		4.6	%		2,338		5.5	%
Research and development expenses		1,390		3.2	%		1,337		3.1	%
Restructuring and other costs (c)		379		0.9	%		459		1.1	%
Total costs and operating expenses		35,542		82.9	%		35,998		84.0	%
Operating income		7,337		17.1	%		6,859		16.0	%
Interest income		1,078					879
Interest expense		(1,390	)				(1,375	)
Other income/(expense) (d)		12					(65	)
Income before income taxes		7,037					6,298
Benefit from/(provision for) income taxes (e)		(657	)				(284	)
Equity in earnings/(losses) of unconsolidated entities		(42	)				(59	)
Net income		6,338					5,955
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f)		3					(40	)
Net income attributable to Thermo Fisher Scientific Inc.	$	6,335		14.8	%	$	5,995		14.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	16.58				$	15.52
Diluted	$	16.53				$	15.45
Weighted average shares:
Basic		382					386
Diluted		383					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	7,337		17.1	%	$	6,859		16.0	%
Cost of revenues adjustments (a)		47		0.1	%		95		0.2	%
Selling, general and administrative expenses adjustments (b)		(8	)	0.0	%		59		0.1	%
Restructuring and other costs (c)		379		0.9	%		459		1.1	%
Amortization of acquisition-related intangible assets		1,952		4.6	%		2,338		5.5	%
Adjusted operating income (non-GAAP measure)	$	9,707		22.6	%	$	9,810		22.9	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	6,335				$	5,995
Cost of revenues adjustments (a)		47					95
Selling, general and administrative expenses adjustments (b)		(8	)				59
Restructuring and other costs (c)		379					459
Amortization of acquisition-related intangible assets		1,952					2,338
Other income/expense adjustments (d)		(19	)				50
Benefit from/(provision for) income taxes adjustments (e)		(329	)				(645	)
Equity in earnings/losses of unconsolidated entities		42					59
Noncontrolling interests adjustments (f)		(19	)				(46	)
Adjusted net income (non-GAAP measure)	$	8,380				$	8,364

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	16.53				$	15.45
Cost of revenues adjustments (a)		0.12					0.24
Selling, general and administrative expenses adjustments (b)		(0.02	)				0.15
Restructuring and other costs (c)		0.99					1.18
Amortization of acquisition-related intangible assets		5.09					6.03
Other income/expense adjustments (d)		(0.05	)				0.13
Benefit from/(provision for) income taxes adjustments (e)		(0.86	)				(1.66	)
Equity in earnings/losses of unconsolidated entities		0.11					0.15
Noncontrolling interests adjustments (f)		(0.05	)				(0.12	)
Adjusted EPS (non-GAAP measure)	$	21.86				$	21.55

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	8,667				$	8,406
Purchases of property, plant and equipment		(1,400	)				(1,479	)
Proceeds from sale of property, plant and equipment		57					87
Free cash flow (non-GAAP measure)	$	7,324				$	7,014

Business Segment Information	Year ended
	December 31,			% of		December 31,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	9,631		22.5	%	$	9,977		23.3	%
Analytical Instruments		7,463		17.4	%		7,263		16.9	%
Specialty Diagnostics		4,512		10.5	%		4,405		10.3	%
Laboratory Products and Biopharma Services		23,157		54.0	%		23,041		53.8	%
Eliminations		(1,885	)	-4.4	%		(1,829	)	-4.3	%
Consolidated revenues	$	42,879		100.0	%	$	42,857		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	3,503		36.4	%	$	3,420		34.3	%
Analytical Instruments		1,955		26.2	%		1,908		26.3	%
Specialty Diagnostics		1,159		25.7	%		1,124		25.5	%
Laboratory Products and Biopharma Services		3,090		13.3	%		3,358		14.6	%
Subtotal reportable segments		9,707		22.6	%		9,810		22.9	%
Cost of revenues adjustments (a)		(47	)	-0.1	%		(95	)	-0.2	%
Selling, general and administrative expenses adjustments (b)		8		0.0	%		(59	)	-0.1	%
Restructuring and other costs (c)		(379	)	-0.9	%		(459	)	-1.1	%
Amortization of acquisition-related intangible assets		(1,952	)	-4.6	%		(2,338	)	-5.5	%
Consolidated GAAP operating income	$	7,337		17.1	%	$	6,859		16.0	%


(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines, accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations, and charges for the sale of inventory revalued at the date of acquisition.
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $7 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, charges for environmental-related matters, net charges for pre-acquisition litigation and other matters, net gains/losses on the sale of real estate, and abandoned facility and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $26 of contract termination costs associated with facility closures.
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments.
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes and the tax impacts from audit settlements. Adjusted results in 2023 also exclude $14 of net charges for pre-acquisition matters.
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests.

Notes:
Consolidated depreciation expense is $1,156 and $1,068 in 2024 and 2023, respectively.
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Condensed Consolidated Balance Sheets (unaudited)

	December 31,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	4,009	$	8,077
Short-term investments		1,561		3
Accounts receivable, net		8,191		8,221
Inventories		4,978		5,088
Other current assets		3,399		3,200
Total current assets		22,137		24,589
Property, plant and equipment, net		9,306		9,448
Acquisition-related intangible assets, net		15,533		16,670
Other assets		4,492		3,999
Goodwill		45,853		44,020
Total assets	$	97,321	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	2,214	$	3,609
Other current liabilities		11,118		10,403
Total current liabilities		13,332		14,012
Other long-term liabilities		5,257		6,564
Long-term obligations		29,061		31,308
Redeemable noncontrolling interest		120		118
Total equity		49,551		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	97,321	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Year ended
	December 31,			December 31,
(In millions)	2024			2023

Operating activities
Net income	$	6,338		$	5,955
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		3,108			3,406
Change in deferred income taxes		(1,209	)		(1,300	)
Other non-cash expenses, net		808			882
Changes in assets and liabilities, excluding the effects of acquisitions		(379	)		(537	)
Net cash provided by operating activities		8,667			8,406

Investing activities
Purchases of property, plant and equipment		(1,400	)		(1,479	)
Proceeds from sale of property, plant and equipment		57			87
Proceeds from cross-currency interest rate swap interest settlements		252			70
Acquisitions, net of cash acquired		(3,132	)		(3,660	)
Purchases of investments		(3,396	)		(208	)
Proceeds from sales and maturities of investments		1,770			15
Other investing activities, net		8			33
Net cash used in investing activities		(5,841	)		(5,142	)

Financing activities
Net proceeds from issuance of debt		1,204			5,942
Repayment of debt		(3,607	)		(5,782	)
Proceeds from issuance of commercial paper		—			1,620
Repayment of commercial paper		—			(1,935	)
Purchases of company common stock		(4,000	)		(3,000	)
Dividends paid		(583	)		(523	)
Other financing activities, net		195			56
Net cash used in financing activities		(6,792	)		(3,622	)

Exchange rate effect on cash		(91	)		(82	)
Decrease in cash, cash equivalents and restricted cash		(4,057	)		(440	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	4,040		$	8,097


Free cash flow (non-GAAP measure)	$	7,324		$	7,014



Note:
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release.

Contacts:
Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8478	+1-763-505-4626

Medtronic Receives FDA Breakthrough Designation for the Emprint Ablation Catheter Kit

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