Abbott Reports First-Quarter 2023 Results; Increases Outlook For Underlying Base Business

Sales of $9.7 billion driven by strong underlying base business performance
Reported sales decreased 18.1 percent due to anticipated decline in COVID-19 testing-related sales versus prior year
Organic sales growth for underlying base business of 10.0 percent, led by Medical Devices, Established Pharmaceuticals and Nutrition

Abbott (NYSE: ABT) today announced financial results for the first quarter ended March 31, 2023 .

First-quarter GAAP diluted EPS of $0.75 and adjusted diluted EPS of $1.03 , which excludes specified items.
Projected full-year 2023 diluted EPS from continuing operations on a GAAP basis of $3.05 to $3.25 remains unchanged.
Projected full-year adjusted EPS from continuing operations of $4.30 to $4.50 remains unchanged and now reflects an increased outlook for the underlying base business offset by a lower forecasted earnings contribution from COVID-19 testing-related sales.
Abbott now projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales ¹ , of at least high single-digits ² and COVID-19 testing-related sales of approximately $1.5 billion .
In January, Abbott announced U.S. Food and Drug Administration (FDA) approval of Navitor ^® , its second-generation transcatheter aortic valve implantation system, for people with severe aortic stenosis who are at high risk for surgery.
In March, data was presented at the American College of Cardiology Scientific Sessions showing Abbott's TriClip ^® system was superior to current medical therapy in treating patients with severe tricuspid regurgitation, or a leaky tricuspid heart valve.
In March, Abbott's market-leading FreeStyle Libre ^® continuous glucose monitoring system received U.S. FDA clearance for integration with automated insulin delivery systems. Abbott is partnering with leading insulin pump manufacturers to integrate their systems with FreeStyle Libre 2 and FreeStyle Libre 3 as soon as possible.

"Our first-quarter results reflect a very strong start to the year," said Robert B. Ford , chairman and chief executive officer, Abbott. "Growth in our underlying base businesses accelerated, including particularly strong results in Medical Devices, Established Pharmaceuticals and Nutrition."

FIRST-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, as well as the impact of exiting the pediatric nutrition business in China , is an appropriate way for investors to best understand the core underlying performance of the business.

Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic shifts to an endemic state, resulting in significantly lower expected demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Total Company

Reported Sales

Sales 1Q23 ($ in millions)	Total Company	Nutrition	Diagnostics	Established Pharmaceuticals	Medical Devices
U.S.	3,928	812	1,335	—	1,778
International	5,819	1,155	1,353	1,189	2,122
Total reported	9,747	1,967	2,688	1,189	3,900

% Change vs. 1Q22
U.S.	(20.4)	19.9	(50.8)	n/a	15.1
International	(16.4)	(5.1)	(46.9)	3.7	3.5
Total reported	(18.1)	3.8	(48.9)	3.7	8.5


Organic Sales

% Change vs. 1Q22	Total Company	Nutrition	Diagnostics	Established Pharmaceuticals	Medical Devices
Reported	(18.1)	3.8	(48.9)	3.7	8.5
Impact of foreign exchange	(3.3)	(3.9)	(1.8)	(7.4)	(3.9)
Impact of business exit	(0.3)	(2.6)	—	—	—
Organic	(14.5)	10.3	(47.1)	11.1	12.4
Impact of COVID-19 testing sales ³	(24.5)	—	(51.5)	—	—
Organic excluding COVID-19 tests	10.0	10.3	4.4	11.1	12.4

U.S.	12.6	19.9	0.3	n/a	15.1
International	8.6	4.8	6.8	11.1	10.4

n/a = Not Applicable.

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

Nutrition

Reported Sales

Sales 1Q23 ($ in millions)	Total	Pediatric	Adult
U.S.	812	459	353
International	1,155	465	690
Total reported	1,967	924	1,043

% Change vs. 1Q22
U.S.	19.9	36.1	3.9
International	(5.1)	(8.6)	(2.6)
Total reported	3.8	9.2	(0.5)


Organic Sales

% Change vs. 1Q22	Total	Pediatric	Adult
Reported	3.8	9.2	(0.5)
Impact of foreign exchange	(3.9)	(2.8)	(4.7)
Impact of business exit	(2.6)	(6.4)	—
Organic	10.3	18.4	4.2

U.S.	19.9	36.1	3.9
International	4.8	5.3	4.4

Worldwide Nutrition sales increased 3.8 percent on a reported basis and 10.3 percent on an organic basis in the first quarter. Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

In Pediatric Nutrition, global sales increased 9.2 percent on a reported basis and 18.4 percent on an organic basis. In the U.S., sales growth of 36.1 percent includes the impact of lower sales in the first quarter of the prior year due to a voluntary recall of certain infant formula products. Following a temporary manufacturing stoppage of these products, Abbott subsequently restarted production last year and continues to make good progress recovering market share in this business.

In Adult Nutrition, global sales decreased 0.5 percent on a reported basis and increased 4.2 percent on an organic basis, which was led by strong global growth of Ensure ^® , Abbott's market-leading complete and balanced nutrition brand.

Diagnostics

Reported Sales

Sales 1Q23 ($ in millions)	Total	Core Laboratory	Molecular	Point of Care	Rapid Diagnostics *
U.S.	1,335	289	47	93	906
International	1,353	893	100	41	319
Total reported	2,688	1,182	147	134	1,225

% Change vs. 1Q22
U.S.	(50.8)	7.7	(72.7)	2.9	(58.4)
International	(46.9)	(2.5)	(59.7)	9.2	(76.3)
Total reported	(48.9)	(0.2)	(65.0)	4.7	(65.3)


Organic Sales

% Change vs. 1Q22	Total	Core Laboratory	Molecular	Point of Care	Rapid Diagnostics *
Reported	(48.9)	(0.2)	(65.0)	4.7	(65.3)
Impact of foreign exchange	(1.8)	(5.3)	(1.0)	(1.0)	(0.8)
Organic	(47.1)	5.1	(64.0)	5.7	(64.5)
Impact of COVID-19 testing sales ³	(51.5)	(2.0)	(39.2)	—	(72.5)
Organic excluding COVID-19 tests	4.4	7.1	(24.8)	5.7	8.0

U.S.	0.3	9.0	(36.7)	2.9	(0.9)
International	6.8	6.5	(18.9)	12.7	23.2

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $29 million of sales for the first quarter of 2022 were moved from Rapid Diagnostics to Heart Failure.

As expected, Diagnostics sales growth in the first quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales ³ . Worldwide COVID-19 testing sales were $730 million in the first quarter of 2023 compared to $3.304 billion in the first quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 4.4 percent on an organic basis. Organic sales growth, excluding COVID-19 testing-related sales, was led by Core Laboratory, Point of Care and Rapid Diagnostics. In Molecular Diagnostics, growth was negatively impacted by lower demand for seasonal respiratory testing compared to significantly higher-than-usual demand in the first quarter of the prior year.

Established Pharmaceuticals

Reported Sales

Sales 1Q23 ($ in millions)	Total	Key Emerging Markets	Other
U.S.	—	—	—
International	1,189	912	277
Total reported	1,189	912	277

% Change vs. 1Q22
U.S.	n/a	n/a	n/a
International	3.7	0.7	15.0
Total reported	3.7	0.7	15.0


Organic Sales

% Change vs. 1Q22	Total	Key Emerging Markets	Other
Reported	3.7	0.7	15.0
Impact of foreign exchange	(7.4)	(7.6)	(6.8)
Organic	11.1	8.3	21.8

U.S.	n/a	n/a	n/a
International	11.1	8.3	21.8

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 11.1 percent on an organic basis in the first quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies increased 0.7 percent on a reported basis and 8.3 percent on an organic basis, led by growth in Brazil , China and Southeast Asia , and across several therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Medical Devices

Reported Sales

Sales 1Q23 ($ in millions)	Total	Rhythm Management	Electro- physiology	Heart Failure *	Vascular	Structural Heart	Neuro- modulation	Diabetes Care
U.S.	1,778	260	238	218	218	210	155	479
International	2,122	267	267	63	399	251	41	834
Total reported	3,900	527	505	281	617	461	196	1,313

% Change vs. 1Q22
U.S.	15.1	4.4	10.0	11.3	4.8	10.5	8.4	39.7
International	3.5	(3.2)	(1.0)	16.6	(2.7)	13.7	13.5	6.5
Total reported	8.5	0.4	3.9	12.4	(0.2)	12.2	9.4	16.6


Organic Sales
% Change vs. 1Q22	Total	Rhythm Management	Electro- physiology	Heart Failure *	Vascular	Structural Heart	Neuro- modulation	Diabetes Care
Reported	8.5	0.4	3.9	12.4	(0.2)	12.2	9.4	16.6
Impact of foreign exchange	(3.9)	(3.6)	(4.9)	(1.2)	(4.1)	(4.2)	(1.8)	(4.4)
Organic	12.4	4.0	8.8	13.6	3.9	16.4	11.2	21.0

U.S.	15.1	4.4	10.0	11.3	4.8	10.5	8.4	39.7
International	10.4	3.7	7.8	22.3	3.4	21.4	22.5	12.9

Worldwide Medical Devices sales increased 8.5 percent on a reported basis and 12.4 percent on an organic basis in the first quarter, including double-digit organic sales growth in both the U.S. and internationally.

Sales growth was led by double-digit organic growth in Diabetes Care, Structural Heart, Heart Failure and Neuromodulation. Several recently launched products and new indications contributed to the strong performance, including Amplatzer ^® Amulet ^® , Navitor, TriClip, Aveir ^® and CardioMEMS ^® .

In Electrophysiology, internationally, sales grew double-digits on a reported basis and high-teens on an organic basis in Europe , which was partially offset by soft market conditions in China during the first several weeks of the first quarter.

In Diabetes Care, FreeStyle Libre sales were $1.2 billion , which included U.S. growth of approximately 50 percent.

ABBOTT'S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2023 diluted earnings per share from continuing operations under GAAP of $3.05 to $3.25 . Abbott forecasts specified items for the full-year 2023 of $1.25 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for the full-year 2023.

ABBOTT DECLARES 397 ^TH CONSECUTIVE QUARTERLY DIVIDEND
On February 17, 2023, the board of directors of Abbott declared the company's quarterly dividend of $0.51 per share. Abbott's cash dividend is payable May 15, 2023 , to shareholders of record at the close of business on April 14, 2023 .

Abbott has increased its dividend payout for 51 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

Abbott will live-webcast its first-quarter earnings conference call through its Investor Relations website at www.abbottinvestor.com at 8 a.m. Central time today. An archived edition of the webcast will be available later in the day.

— Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2022 , and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1	For the full-year 2022, COVID-19 testing-related sales were $8.368 billion and total worldwide sales were $43.653 billion.

2	Abbott has not provided the related GAAP financial measure for organic sales growth, excluding COVID-19 testing-related sales, on a forward-looking basis because the company is unable to predict the impact of foreign exchange due to the unpredictability of future changes in foreign exchange rates, which could significantly impact reported sales growth.

3	Diagnostic sales and COVID-19 testing-related sales in 2023 and 2022 are summarized below:

	Sales 1Q23			COVID Tests Sales 1Q23
($ in millions)	U.S.	Int'l	Total	U.S.	Int'l	Total
Total Diagnostics	1,335	1,353	2,688	608	122	730
Core Laboratory	289	893	1,182	2	4	6
Molecular	47	100	147	10	10	20
Rapid Diagnostics	906	319	1,225	596	108	704

	Sales 1Q22			COVID Tests Sales 1Q22
($ in millions)	U.S.	Int'l	Total	U.S.	Int'l	Total
Total Diagnostics	2,712	2,545	5,257	1,988	1,316	3,304
Core Laboratory	268	916	1,184	5	23	28
Molecular	172	248	420	114	132	246
Rapid Diagnostics	2,181	1,344	3,525	1,869	1,161	3,030

Abbott Laboratories and Subsidiaries Condensed Consolidated Statement of Earnings First Quarter Ended March 31, 2023 and 2022 (in millions, except per share data) (unaudited)

	1Q23	1Q22	% Change
Net Sales	$9,747	$11,895	(18.1)

Cost of products sold, excluding amortization expense	4,331	4,987	(13.2)
Amortization of intangible assets	491	512	(4.0)
Research and development	654	697	(6.2)
Selling, general, and administrative	2,762	2,787	(0.9)
Total Operating Cost and Expenses	8,238	8,983	(8.3)

Operating Earnings	1,509	2,912	(48.2)

Interest expense, net	52	117	(56.1)
Net foreign exchange (gain) loss	6	(3)	n/m
Other (income) expense, net	(111)	(78)	41.5
Earnings before taxes	1,562	2,876	(45.7)
Taxes on earnings	244	429	(43.0)	1)

Net Earnings	$1,318	$2,447	(46.1)

Net Earnings excluding Specified Items, as described below	$1,815	$3,077	(41.0)	2)

Diluted Earnings per Common Share	$0.75	$1.37	(45.3)

Diluted Earnings per Common Share, excluding Specified Items, as described below	$1.03	$1.73	(40.5)	2)

Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options	1,752	1,775


NOTES:
See tables tables titled "Non-GAAP Reconciliation of Financial Information" for an explanation of certain non-GAAP financial information.
n/m = Percent change is not meaningful.
See footnotes below.

1)	2023 Taxes on Earnings includes the recognition of approximately $22 million of net tax expense as a result of the resolution of various tax positions related to prior years.

	2022 Taxes on Earnings includes the recognition of approximately $30 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $30 million in excess tax benefits associated with share-based compensation.

2)	2023 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $497 million, or $0.28 per share, for intangible amortization, charges related to restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses.

	2022 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $630 million, or $0.36 per share, for intangible amortization, charges related to a voluntary recall and other net expenses primarily associated with acquisitions.

Abbott Laboratories and Subsidiaries Non-GAAP Reconciliation of Financial Information First Quarter Ended March 31, 2023 and 2022 (in millions, except per share data) (unaudited)

	1Q23
	As Reported (GAAP)	Specified Items	As Adjusted

Intangible Amortization	$ 491	$ (491)	$ —
Gross Margin	4,925	520	5,445
R&D	654	(26)	628
SG&A	2,762	(2)	2,760
Earnings before taxes	1,562	548	2,110
Taxes on Earnings	244	51	295
Net Earnings	1,318	497	1,815
Diluted Earnings per Share	$ 0.75	$ 0.28	$ 1.03


Specified items reflect intangible amortization expense of $491 million and other net expenses of $57 million associated with restructuring actions, costs associated with acquisitions and other expenses. See table titled " Details of Specified Items First Quarter Ended March 31, 2023" for additional details regarding specified items.

	1Q22
	As Reported (GAAP)	Specified Items	As Adjusted

Intangible Amortization	$ 512	$ (512)	$ —
Gross Margin	6,396	636	7,032
R&D	697	(33)	664
SG&A	2,787	(39)	2,748
Other (income) expense, net	(78)	(15)	(93)
Earnings before taxes	2,876	723	3,599
Taxes on Earnings	429	93	522
Net Earnings	2,447	630	3,077
Diluted Earnings per Share	$ 1.37	$ 0.36	$ 1.73


Specified items reflect intangible amortization expense of $512 million and other net expenses of $211 million that includes costs associated with a product recall, acquisitions and other net expenses. See table titled "Details of Specified Items First Quarter Ended March 31, 2022" for additional details regarding specified items.

A reconciliation of the first-quarter tax rates for 2023 and 2022 is shown below:

	1Q23
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$ 1,562	$ 244	15.6 %	1)
Specified items	548	51
Excluding specified items	$ 2,110	$ 295	14.0 %


	1Q22
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$ 2,876	$ 429	14.9 %	2)
Specified items	723	93
Excluding specified items	$ 3,599	$ 522	14.5 %


1)	2023 Taxes on Earnings includes the recognition of approximately $22 million of net tax expense as a result of the resolution of various tax positions related to prior years.

2)	2022 Taxes on Earnings includes the recognition of approximately $30 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $30 million in excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries Non-GAAP Revenue Reconciliation First Quarter Ended March 31, 2023 and 2022 ($ in millions) (unaudited)

	1Q23			1Q22			% Change vs. 1Q22
								Non-GAAP
	Abbott Reported	Impact from business exit (a)	Adjusted Revenue	Abbott Reported	Impact from business exit (a)	Adjusted Revenue	Reported	Adjusted	Organic
Total Company	9,747	(8)	9,739	11,895	(52)	11,843	(18.1)	(17.8)	(14.5)
U.S.	3,928	—	3,928	4,937	—	4,937	(20.4)	(20.4)	(20.4)
Intl	5,819	(8)	5,811	6,958	(52)	6,906	(16.4)	(15.9)	(10.2)

Total Nutrition	1,967	(8)	1,959	1,894	(52)	1,842	3.8	6.4	10.3
U.S.	812	—	812	677	—	677	19.9	19.9	19.9
Intl	1,155	(8)	1,147	1,217	(52)	1,165	(5.1)	(1.5)	4.8

Pediatric Nutrition	924	(8)	916	847	(52)	795	9.2	15.4	18.4
U.S.	459	—	459	338	—	338	36.1	36.1	36.1
Intl	465	(8)	457	509	(52)	457	(8.6)	0.2	5.3


(a)	Reflects the impact of exiting the pediatric nutrition business in China. This action was initiated in December 2022.

Abbott Laboratories and Subsidiaries Details of Specified Items First Quarter Ended March 31, 2023 (in millions, except per share data) (unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 5	$ 21	$ 491	$ 3	$ 520
R&D	(4)	1	—	(23)	(26)
SG&A	(4)	(4)	—	6	(2)
Other (income) expense, net	(6)	—	—	6	—
Earnings before taxes	$ 19	$ 24	$ 491	$ 14	548
Taxes on Earnings (d)					51
Net Earnings					$ 497
Diluted Earnings per Share					$ 0.28


The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information."

a)	Acquisition-related expenses include legal and other costs related to business acquisitions as well as integration costs, which represent incremental costs directly related to integrating acquired businesses.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives.
c)	Other includes incremental costs to comply with the European Union's Medical Device Regulations (MDR) and In Vitro Diagnostics Medical Device Regulations (IVDR) requirements for previously approved products.
d)	Reflects the net tax benefit associated with the specified items.

Abbott Laboratories and Subsidiaries Details of Specified Items First Quarter Ended March 31, 2022 (in millions, except per share data) (unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 21	$ (6)	$ 512	$ 109	$ 636
R&D	(2)	(1)	—	(30)	(33)
SG&A	(11)	—	—	(28)	(39)
Other (income) expense, net	(7)	—	—	(8)	(15)
Earnings before taxes	$ 41	$ (5)	$ 512	$ 175	723
Taxes on Earnings (d)					93
Net Earnings					$ 630
Diluted Earnings per Share					$ 0.36


The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information."
a)	Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for the integration of systems, processes and business activities.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives. The Gross Margin amount includes a credit associated with the charges taken in the second quarter of 2021 for a restructuring plan related to Abbott's manufacturing network for COVID-19 diagnostic tests.
c)	Other includes charges related to a voluntary recall within the Nutrition segment and incremental costs to comply with the European Union's Medical Device (MDR) and In Vitro Diagnostics Medical Device (IVDR) Regulations for previously approved products.
d)	Reflects the net tax benefit associated with the specified items, excess tax benefits associated with share-based compensation and net tax expense as a result of the resolution of various tax positions related to prior years.

View original content: https://www.prnewswire.com/news-releases/abbott-reports-first-quarter-2023-results-increases-outlook-for-underlying-base-business-301801684.html

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Star Jones , award winning television personality & women's heart health advocate, helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. ¹ Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases ^2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

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.

References

Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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