Medtronic reports first quarter fiscal 2025 financial results

Product innovation driving growth across diversified health tech portfolio, including Automated Insulin Delivery, Transcatheter Aortic Valve Replacement, Pulsed Field Cardiac Ablation, Pain Stimulation, and Deep Brain Stimulation

- Medtronic plc (NYSE: MDT) today announced financial results for its first quarter (Q1) of fiscal year 2025 (FY25), which ended July 26, 2024 .

Key Highlights

  • Revenue of $7.9 billion , adjusted revenue of $8.0 billion , increased 2.8% as reported and 5.3% organic

  • GAAP diluted earnings per share (EPS) of $0.80 ; non-GAAP diluted EPS of $1.23

  • Company increases FY25 organic revenue growth and EPS guidance

  • Multiple franchises delivering, with growth acceleration in Cardiac Ablation Solutions and Neuromodulation and continued strength in Spine, Structural Heart, and Diabetes

Financial Results
Medtronic reported Q1 worldwide revenue of $7.915 billion and adjusted revenue of $8.004 billion , an increase of 2.8% as reported and 5.3% on an organic basis. Organic revenue growth comparison excludes:

  • Other revenue of - $52 million in the current year and $50 million in the prior year; and

  • Foreign currency translation of - $90 million on the remaining segments.

As reported, Q1 GAAP net income and diluted earnings per share (EPS) were $1.042 billion and $0.80 , respectively, representing increases of 32% and 36%, respectively. As detailed in the financial schedules included at the end of this release, Q1 non-GAAP net income and non-GAAP diluted EPS were $1.592 billion and $1.23 , respectively, representing flat results and an increase of 3%, respectively. Included in Q1 non-GAAP diluted EPS was a -6 cent impact from foreign currency translation. Non-GAAP diluted EPS grew 8% on a constant currency basis.

"We executed, exceeded our commitments, and delivered another good quarter. Our underlying markets are healthy, we're driving operating rigor, and new product innovation is fueling diversified growth across key health tech markets," said Geoff Martha , Medtronic chairman and chief executive officer. "As we deliver innovation and execute on our transformation, we expect this to translate into strong returns for our shareholders."

Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.007 billion increased 5.5% as reported and 6.9% organic, with high-single digit increases in CRHF and SHA, and a mid-single digit increase in CPV, all on an organic basis.

  • CRHF results included high-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Defibrillation Solutions and low-double digit growth in Cardiac Pacing Therapies, including low-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions grew mid-single digits on strong growth of the PulseSelect™ pulsed field ablation (PFA) system

  • SHA results driven by low-double digit Cardiac Surgery and high-single digit Structural Heart growth, excluding Congenital

  • CPV delivered high-single digit Coronary growth with strength in guide catheters and balloons; Peripheral Vascular Health grew low-single digits, with high-single digit growth in drug-coated balloons and low-single digit growth in endoVenous products

  • Evolut™ FX+ TAVR system limited U.S. commercial release initiated during the quarter; full market release now underway

Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.317 billion increased 4.4% as reported and 5.3% organic, with a low-double digits increase in Neuromodulation, a mid-single digit increase in CST, and a low-single digit increase in Specialty Therapies, all on an organic basis.

  • CST performance driven by continued adoption of the AiBLE™ ecosystem of spine implants and enabling technology, with high-single digit growth in both Core Spine and Biologics

  • Specialty Therapies results driven by mid-single digit growth in Neurovascular with continued strength in hemorrhagic stroke products; Pelvic Health increased low-single digits on continued adoption of the InterStim X™ system; ENT grew low-single digits on strength in capital and localized drug delivery sinus implants

  • Neuromodulation drove above market performance, with mid-teens growth in Brain Modulation on the continued launch of the Percept™ RC deep brain stimulator (DBS) with BrainSense™ technology; Pain Therapies grew high-single digits, including low-double digit growth in Pain Stim on the U.S. launch of the Inceptiv™ spinal cord stimulator

Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $1.996 billion decreased 0.4% as reported and increased 1.0% organic, with a low-single digit increase in SE and flat result in ACM, both on an organic basis.

  • SE results included low-single digit growth in both Advanced Surgical Technologies and General Surgical Technologies, and low-single digit growth in Endoscopy, driven by strength in Endoflip™ and GI Genius™ sales

  • ACM performance included low-single digit growth in Blood Oxygen Management

Diabetes
Revenue of $647 million increased 11.8% as reported and 12.6% organic.

  • U.S. revenue grew mid-teens on the continued adoption of the MiniMed™ 780G automated insulin delivery (AID) system, including low-thirties CGM growth driven by very high CGM attachment, high-single digit pump growth, and a return to growth in consumables

  • International revenue grew low-double digits on increasing CGM attachment rates and the continued roll-out of Simplera Sync™

  • Received FDA approval of Simplera™ CGM and announced global partnership with Abbott to complement future Medtronic integrated CGM offerings

Guidance
The company today raised its FY25 revenue growth and EPS guidance.

The company raised its FY25 organic revenue growth guidance to 4.5% to 5% versus the prior range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on an adjusted basis would be in the range of 3.4% to 4.3%.

The company raised its FY25 diluted non-GAAP EPS guidance to the new range of $5.42 to $5.50 versus the prior $5.40 to $5.50 . This includes an estimated -5% impact from foreign currency exchange based on recent rates, unchanged from the prior guidance. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.

"Overall revenue outperformance flowed through to the bottom line, with adjusted EPS ahead of expectations," said Gary Corona , Medtronic interim chief financial officer. "We're raising our guidance today as we expect to sustain growth from new product introductions, continue to make the investments to support those launches, and deliver on our commitment to restore earnings power."

Video Webcast Information
Medtronic will host a video webcast today, August 20 , at 8:00 a.m. EDT ( 7:00 a.m. CDT ) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com , and this earnings release will be archived at news.medtronic.com . Within 24 hours of the webcast, a replay of the webcast and transcript of the company's prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com .

Medtronic plans to report its FY25 second, third, and fourth quarter results on November 19, 2024 , February 18, 2025 , and Wednesday, May 21, 2025 , respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules and Earnings Presentation
The first quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com . To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here . To view the first quarter earnings presentation, click here .

MEDTRONIC PLC

WORLD WIDE REVENUE (1)

(Unaudited)



FIRST QUARTER


REPORTED




ORGANIC

(in millions)

FY25


FY24


Growth


Currency
Impact (3)


Adjusted
FY25 (4)


Adjusted
FY24 (4)


Growth

Cardiovascular

$       3,007


$       2,850


5.5 %


$          (39)


$       3,046


$       2,850


6.9 %

Cardiac Rhythm & Heart Failure

1,535


1,446


6.2


(19)


1,555


1,446


7.5

Structural Heart & Aortic

856


814


5.1


(12)


868


814


6.6

Coronary & Peripheral Vascular

616


589


4.5


(8)


624


589


5.8

Neuroscience

2,317


2,219


4.4


(18)


2,336


2,219


5.3

Cranial & Spinal Technologies

1,147


1,103


4.0


(9)


1,156


1,103


4.8

Specialty Therapies

713


695


2.5


(7)


719


695


3.4

Neuromodulation

457


420


8.9


(3)


460


420


9.6

Medical Surgical

1,996


2,005


(0.4)


(29)


2,024


2,005


1.0

Surgical & Endoscopy

1,544


1,546


(0.1)


(22)


1,566


1,546


1.3

Acute Care & Monitoring

452


459


(1.5)


(6)


458


459


(0.1)

Diabetes

647


578


11.8


(4)


651


578


12.6

Total Reportable Segments

7,967


7,652


4.1


(90)


8,057


7,652


5.3

Other (2)

(52)


50


(203.7)


(2)




TOTAL

$       7,915


$       7,702


2.8 %


$          (93)


$       8,057


$       7,652


5.3 %



(1)

The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.

(2)

Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(3)

The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(4)

The three months ended July 26, 2024 excludes $142 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $38 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $50 million of inorganic revenue related to the transition activity noted in (2).

MEDTRONIC PLC

U.S. (1)(2) REVENUE

(Unaudited)



FIRST QUARTER


REPORTED


ORGANIC

(in millions)

FY25


FY24


Growth


Adjusted
FY25


Adjusted
FY24


Growth

Cardiovascular

$       1,403


$       1,350


3.9 %


$       1,403


$       1,350


3.9 %

Cardiac Rhythm & Heart Failure

766


720


6.4


766


720


6.4

Structural Heart & Aortic

368


357


3.3


368


357


3.3

Coronary & Peripheral Vascular

268


273


(1.6)


268


273


(1.6)

Neuroscience

1,565


1,497


4.5


1,565


1,497


4.5

Cranial & Spinal Technologies

855


821


4.2


855


821


4.2

Specialty Therapies

398


392


1.5


398


392


1.5

Neuromodulation

312


284


9.8


312


284


9.8

Medical Surgical

881


867


1.6


881


867


1.6

Surgical & Endoscopy

630


619


1.6


630


619


1.6

Acute Care & Monitoring

251


248


1.4


251


248


1.4

Diabetes

215


188


14.3


215


188


14.3

Total Reportable Segments

4,064


3,903


4.1


4,064


3,903


4.1

Other (3)

18


22


(15.6)




TOTAL

$       4,082


$       3,924


4.0 %


$       4,064


$       3,903


4.1 %



(1)

U.S. includes the United States and U.S. territories.

(2)

The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.

(3)

Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested.

MEDTRONIC PLC

INTERNATIONAL REVENUE (1)

(Unaudited)



FIRST QUARTER


REPORTED




ORGANIC

(in millions)

FY25


FY24


Growth


Currency
Impact (3)


Adjusted
FY25 (4)


Adjusted
FY24 (4)


Growth

Cardiovascular

$       1,604


$       1,500


6.9 %


$          (39)


$       1,643


$       1,500


9.5 %

Cardiac Rhythm & Heart Failure

769


726


5.9


(19)


789


726


8.6

Structural Heart & Aortic

487


457


6.5


(12)


499


457


9.2

Coronary & Peripheral Vascular

347


317


9.7


(8)


355


317


12.2

Neuroscience

752


721


4.3


(18)


770


721


6.8

Cranial & Spinal Technologies

292


282


3.4


(9)


301


282


6.6

Specialty Therapies

314


303


3.8


(7)


321


303


5.9

Neuromodulation

146


136


7.2


(3)


149


136


9.4

Medical Surgical

1,115


1,137


(2.0)


(29)


1,143


1,137


0.5

Surgical & Endoscopy

915


926


(1.3)


(22)


937


926


1.1

Acute Care & Monitoring

200


211


(5.0)


(6)


207


211


(2.0)

Diabetes

432


390


10.7


(4)


436


390


11.7

Total Reportable Segments

3,903


3,749


4.1


(90)


3,993


3,749


6.5

Other (2)

(70)


28


(347.5)


(2)




TOTAL

$       3,832


$       3,777


1.5 %


$          (93)


$       3,993


$       3,749


6.5 %



(1)

The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.

(2)

Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(3)

The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(4)

The three months ended July 26, 2024 excludes $161 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $19 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $28 million of inorganic revenue related to the transition activity noted in (2).

MEDTRONIC PLC

CONSOLIDATED STATEMENTS OF INCOME

(Unaudited)



Three months ended

(in millions, except per share data)

July 26, 2024


July 28, 2023

Net sales

$            7,915


$            7,702

Costs and expenses:




Cost of products sold, excluding amortization of intangible assets

2,761


2,628

Research and development expense

676


668

Selling, general, and administrative expense

2,655


2,613

Amortization of intangible assets

414


429

Restructuring charges, net

47


54

Certain litigation charges, net

81


40

Other operating expense, net

1


1

Operating profit

1,278


1,268

Other non-operating income, net

(157)


(76)

Interest expense, net

167


148

Income before income taxes

1,268


1,196

Income tax provision

220


400

Net income

1,049


797

Net income attributable to noncontrolling interests

(6)


(6)

Net income attributable to Medtronic

$            1,042


$                791

Basic earnings per share

$               0.81


$               0.59

Diluted earnings per share

$               0.80


$               0.59

Basic weighted average shares outstanding

1,293.3


1,330.5

Diluted weighted average shares outstanding

1,296.5


1,333.8


The data in the schedule above has been intentionally rounded to the nearest million.

MEDTRONIC PLC

GAAP TO NON-GAAP RECONCILIATIONS (1)

(Unaudited)



Three months ended July 26, 2024

(in millions, except per share data)

Net Sales


Cost of
Products
Sold


Gross
Margin
Percent


Operating
Profit


Operating
Profit
Percent


Income
Before
Income
Taxes


Net Income
attributable to
Medtronic


Diluted EPS


Effective
Tax Rate

GAAP

$  7,915


$   2,761


65.1 %


$     1,278


16.1 %


$    1,268


$       1,042


$     0.80


17.4 %

Non-GAAP Adjustments:


















Amortization of intangible assets




414


5.1


414


340


0.26


18.1

Restructuring and associated costs (2)


(9)


0.1


62


0.8


62


51


0.04


19.4

Acquisition and divestiture-related items (3)


(10)


0.1


12


0.1


12


11


0.01


8.3

Certain litigation charges, net




81


1.0


81


68


0.05


16.0

(Gain)/loss on minority investments (4)






(17)


(17)


(0.01)


Medical device regulations (5)


(11)


0.1


14


0.2


14


11


0.01


21.4

Other (6)

90



0.6


90


1.1


90


70


0.05


22.2

Certain tax adjustments, net







17


0.01


Non-GAAP

$  8,004


$   2,730


65.9 %


$     1,953


24.4 %


$    1,925


$       1,592


$     1.23


17.0 %

Currency impact

91


(31)


0.8


100


1.0






0.06



Currency Adjusted

$  8,095


$   2,699


66.7 %


$     2,053


25.4 %






$     1.29






















Three months ended July 28, 2023

(in millions, except per share data)

Net Sales


Cost of
Products
Sold


Gross
Margin
Percent


Operating
Profit


Operating
Profit
Percent


Income
Before
Income
Taxes


Net Income
attributable to
Medtronic


Diluted EPS


Effective
Tax Rate

GAAP

$  7,702


$   2,628


65.9 %


$     1,268


16.5 %


$    1,196


$          791


$     0.59


33.4 %

Non-GAAP Adjustments:


















Amortization of intangible assets




429


5.6


429


364


0.27


15.2

Restructuring and associated costs (2)


(16)


0.2


91


1.2


91


76


0.06


16.5

Acquisition and divestiture-related items (3)


(6)


0.1


50


0.6


50


46


0.03


6.0

Certain litigation charges, net




40


0.5


40


31


0.02


22.5

(Gain)/loss on minority investments (4)






64


64


0.05


Medical device regulations (5)


(21)


0.3


31


0.4


31


25


0.02


22.6

Certain tax adjustments, net (7)







198


0.15


Non-GAAP

$  7,702


$   2,586


66.4 %


$     1,909


24.8 %


$    1,902


$       1,596


$     1.20


15.8 %


See description of non-GAAP financial measures contained in the press release dated August 20, 2024.

(1)

The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.

(2)

Associated and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs.

(3)

The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges.

(4)

We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(5)

The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(6)

Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(7)

The charge relates to an income tax reserve adjustment associated with the June 2023 Israeli Central-Lod District Court decision in Medtronic Ventor Technologies Ltd v. Kfar Saba Assessing Office and amortization of previously established deferred tax assets from intercompany intellectual property transactions.

MEDTRONIC PLC

GAAP TO NON-GAAP RECONCILIATIONS (1)

(Unaudited)



Three months ended July 26, 2024

(in millions)

Net Sales


SG&A
Expense


SG&A Expense
as a % of
Net Sales


R&D
Expense


R&D Expense
as a % of
Net Sales


Other Operating
(Income)
Expense, net


Other Operating
(Inc.)/Exp.,
net as a % of
Net Sales


Other
Non-Operating
Income, net

GAAP

$      7,915


$     2,655


33.5 %


$       676


8.5 %


$             1


— %


$          (157)

Non-GAAP Adjustments:
















Restructuring and associated costs (2)


(5)


(0.2)






Acquisition and divestiture-related items (3)


(7)


(0.3)




6


0.1


Medical device regulations (4)




(3)





Other (5)

90








(Gain)/loss on minority investments (6)








17

Non-GAAP

$      8,004


$     2,642


33.0 %


$       673


8.4 %


$             7


0.1 %


$          (140)


See description of non-GAAP financial measures contained in the press release dated August 20, 2024.

(1)

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

(2)

Associated and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs.

(3)

The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges.

(4)

The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(5)

Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.

(6)

We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

MEDTRONIC PLC

GAAP TO NON-GAAP RECONCILIATIONS (1)

(Unaudited)



Three months ended

(in millions)

July 26, 2024


July 28, 2023

Net cash provided by operating activities

$                        986


$                        875

Additions to property, plant, and equipment

(520)


(354)

Free Cash Flow (2)

$                        466


$                        521


See description of non-GAAP financial measures contained in the press release dated August 20, 2024.

(1)

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

(2)

Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC

CONSOLIDATED BALANCE SHEETS

(Unaudited)


(in millions)


July 26, 2024


April 26, 2024

ASSETS





Current assets:





Cash and cash equivalents


$               1,311


$               1,284

Investments


6,532


6,721

Accounts receivable, less allowances and credit losses of $170 and $173, respectively


6,011


6,128

Inventories


5,414


5,217

Other current assets


2,679


2,584

Total current assets


21,947


21,935

Property, plant, and equipment, net


6,282


6,131

Goodwill


41,084


40,986

Other intangible assets, net


12,819


13,225

Tax assets


3,554


3,657

Other assets


4,062


4,047

Total assets


$             89,749


$             89,981

LIABILITIES AND EQUITY





Current liabilities:





Current debt obligations


$               1,553


$               1,092

Accounts payable


2,291


2,410

Accrued compensation


1,776


2,375

Accrued income taxes


1,063


1,330

Other accrued expenses


3,604


3,582

Total current liabilities


10,287


10,789

Long-term debt


26,312


23,932

Accrued compensation and retirement benefits


1,107


1,101

Accrued income taxes


1,917


1,859

Deferred tax liabilities


496


515

Other liabilities


1,470


1,365

Total liabilities


41,589


39,561

Commitments and contingencies





Shareholders' equity:





Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,494,588 and
1,311,337,531 shares issued and outstanding, respectively



Additional paid-in capital


20,810


23,129

Retained earnings


30,547


30,403

Accumulated other comprehensive loss


(3,410)


(3,318)

Total shareholders' equity


47,947


50,214

Noncontrolling interests


213


206

Total equity


48,160


50,420

Total liabilities and equity


$             89,749


$             89,981


The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

MEDTRONIC PLC

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)



Three months ended

(in millions)

July 26, 2024


July 28, 2023

Operating Activities:




Net income

$                1,049


$                   797

Adjustments to reconcile net income to net cash provided by operating activities:




Depreciation and amortization

662


672

Provision for credit losses

18


21

Deferred income taxes

88


Stock-based compensation

83


73

Other, net

(9)


135

Change in operating assets and liabilities, net of acquisitions and divestitures:




Accounts receivable, net

110


164

Inventories

(217)


(410)

Accounts payable and accrued liabilities

(604)


(673)

Other operating assets and liabilities

(194)


96

Net cash provided by operating activities

986


875

Investing Activities:




Additions to property, plant, and equipment

(520)


(354)

Purchases of investments

(1,879)


(1,916)

Sales and maturities of investments

2,157


1,748

Other investing activities, net

(17)


(17)

Net cash used in investing activities

(259)


(539)

Financing Activities:




Change in current debt obligations, net

(624)


500

Issuance of long-term debt

3,209


Dividends to shareholders

(898)


(918)

Issuance of ordinary shares

89


77

Repurchase of ordinary shares

(2,492)


(152)

Other financing activities

(15)


(8)

Net cash used in financing activities

(731)


(501)

Effect of exchange rate changes on cash and cash equivalents

31


(39)

Net change in cash and cash equivalents

27


(204)

Cash and cash equivalents at beginning of period

1,284


1,543

Cash and cash equivalents at end of period

$                1,311


$                1,339





Supplemental Cash Flow Information




Cash paid for:




Income taxes

$                   394


$                   117

Interest

119


84


The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

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 on LinkedIn .

FORWARD LOOKING STATEMENTS
  This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "going to," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.

NON-GAAP FINANCIAL MEASURES
  This press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2024.

Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company's underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.

Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.

Contacts:



Erika Winkels

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-8478

+1-763-505-4626

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SOURCE Medtronic plc

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Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. (TSX: PNE) ("Pine Cliff" or the "Company") announces its first quarter 2024 financial and operating results, an operational update and information regarding the annual meeting of shareholders.

First Quarter 2024 Results

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Canadian Natural Resources Limited Announces 2024 First Quarter Results

Canadian Natural's (TSX: CNQ) (NYSE: CNQ) President, Scott Stauth, commented on the Company's first quarter results, "Canadian Natural is a world class company and during our 35 years of operations, we've delivered significant value, including recently reaching a position where, commencing in 2024, we are returning 100% of our free cash flow to our shareholders. Crude oil price forecasts have strengthened for the remainder of 2024, including improvements in West Texas Intermediate ("WTI"), Western Canadian Select ("WCS") and Synthetic Crude Oil ("SCO") pricing over those prices experienced in the first quarter of 2024, driving significant targeted free cash flow generation going forward.

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Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. (TSX: PNE) (OTCQX: PIFYF) ("Pine Cliff" or the "Company") is pleased to announce the appointments of Mr. Daniel Keenan P. Eng to the position of Vice President Exploitation and Mr. Austin Nieuwdorp CA, CPA to the position of Vice President Finance and Controller both effective May 1, 2024.

Mr. Keenan became part of Pine Cliff in 2016. He holds a Bachelor of Mechanical Engineering Degree from the University of Victoria obtained in 2001. Throughout his 20-year career, he has taken on increasingly challenging roles in exploitation, production operations and facilities engineering, culminating in his most recent position as Pine Cliff's Manager of Exploitation. Notably, Mr. Keenan has played a pivotal role in identifying and expanding Pine Cliff's asset portfolio and drilling opportunities, showcasing his leadership and strategic vision.

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ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. (TSX: ACO.X) (TSX: ACO.Y)

2024 ATCO AGM (CNW Group/ATCO Ltd.)

ATCO Ltd. (ATCO) will hold its 57th Annual General Meeting of share owners at 10 a.m. MDT on Wednesday , May 15, 2024. In addition to the formal business of the meeting, attendees will hear management's view of ATCO's full year 2023 and first quarter 2024 operational and financial performance.

At this year's meeting, members of the ATCO executive leadership team will also outline growth strategies and goals for ATCO Structures, ATCO EnPower and ATCO Energy Systems.

Attendees will hear from:

  • Nancy Southern , Chair & Chief Executive Officer
  • Katie Patrick , Executive Vice President, Chief Financial & Investment Officer
  • Adam Beattie , President, ATCO Structures
  • Bob Myles , Chief Operating Officer, ATCO EnPower
  • Wayne Stensby , Chief Operating Officer, ATCO Energy Systems

Share owners and interested parties can view the meeting virtually using Microsoft Teams via this link using a web browser (Chrome, Safari, Edge or Firefox) on a smartphone, tablet or computer. Using Internet Explorer is not recommended as it is no longer supported and may not function properly.

Attendees who are share owners or proxyholders wishing to vote their shares should review the information contained in the ATCO Management Proxy Circular dated March 11, 2024 , beginning on page one.

As a global enterprise ATCO Ltd. and its subsidiary and affiliate companies have approximately 20,000 employees and assets of $25 billion . ATCO is committed to future prosperity by working to meet the world's essential energy, housing, security and transportation challenges. ATCO Structures designs, builds and delivers products to service the essential need for housing and shelter around the globe. ATCO Frontec provides operational support services to government, defence and commercial clients. ATCO Energy Systems delivers essential energy for an evolving world through its electricity and natural gas transmission and distribution, and international operations. ATCO EnPower creates sustainable energy solutions in the areas of renewables, energy storage, industrial water and clean fuels. ATCO Australia develops, builds, owns and operates energy and infrastructure assets. ATCOenergy and Rümi provide retail electricity and natural gas services, home maintenance services and professional home advice that bring exceptional comfort, peace of mind and freedom to homeowners and customers. ATCO also has investments in ports and transportation logistics, the processing and marketing of fly ash, retail food services and commercial real estate. More information can be found at www.ATCO.com .

Investor & Analyst Inquiries:  
Colin Jackson
Senior Vice President, Finance, Treasury & Sustainability
Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
Kurt Kadatz
Director, Corporate Communications
Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

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PrairieSky Announces First Quarter 2024 Results, Record Oil Royalty Production

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PrairieSky Royalty Ltd. ("PrairieSky" or the "Company") (TSX: PSK) is pleased to announce its first quarter ("Q1 2024") operating and financial results for the three-month period ended March 31, 2024.

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

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 .

(PRNewsfoto/Medtronic plc)

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

  1. 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.
  2. 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.
  3. 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.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. 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

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 receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

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

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.

(PRNewsfoto/Medtronic plc)

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

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SOURCE Medtronic plc

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Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

Orchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting

  • FDA recently granted Breakthrough Device Designation to AVIM therapy for use in patients with uncontrolled hypertension at increased cardiovascular risk
  • HRS Satellite Symposium will feature leading experts in electrophysiology, hypertension management and heart failure
  • Presentations will detail clinical results from prior studies demonstrating AVIM therapy's ability to immediately, substantially and persistently reduce systolic blood pressure, as well as improve cardiac function
  • Symposium will also feature presentation on the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an industry-sponsored satellite symposium at the Heart Rhythm Society ("HRS") 2025 Annual Meeting, taking place April 24–27, 2025, in San Diego, California featuring recent advancements in the Company's atrioventricular interval modulation ("AVIM") therapy program. The April 25 th 6:45 am PT symposium titled " The Future of Cardiac Pacing: Unlocking the Potential of Atrioventricular Interval Modulation (AVIM) Therapy " will convene leading electrophysiologists, hypertension and heart failure specialists to discuss the unmet need in hypertension, AVIM therapy mechanism of action, and growing body of clinical evidence supporting this novel therapy for the treatment of patients with uncontrolled hypertension who have increased cardiovascular risk with or without an indication for a pacemaker.

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Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

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