Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S.

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim™ XR Spinal Cord Stimulation (SCS) System with Octrode™ leads. The new labeling lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan. The expanded labeling covers the majority of Proclaim XR patients, providing additional benefits to those patients and their health care providers.

Under the expanded MRI labeling , patients with a Proclaim XR SCS device can benefit from higher quality images with faster MRI scan times.

MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. Concern over how those magnets and radiofrequency energy could impact placement of implantable devices led to conditions being placed on the use of MRIs when a patient had a particular device. Restricted MRI labeling adds a layer of complexity on both patients and radiologists. They must find an imaging facility willing to modify their workflow and work within the MRI labeling limitations of the patient's implant.

"MRIs have increasingly become an important tool helping doctors diagnose an illness or injury. They are particularly important for patients who have certain comorbidities, such as cancer or multiple sclerosis," said Allen W. Burton , M.D., medical director of Abbott's neuromodulation business. "We made it our mission to secure expanded MRI labeling for our spinal cord stimulation devices – both those that were already implanted and those still to be implanted – for the sake of the patients and their doctors."

With the new labeling, Octrode lead tips can be placed anywhere they are needed along the spine and still be considered MR Conditional, which means a patient can undergo MRI scans within the approved outlined conditions. Radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode.

"The expanded labeling and reduced scan time address two major issues we face with these implantable devices. By improving the quality of imaging, as well as the experience for both the patient and radiologist, I can now enable more of my existing and new patients to benefit from MRI scans improving their care," said Steven Falowski , M.D., neurosurgeon at Neurosurgical Associates of Lancaster in Pennsylvania .

Under the expanded labeling, patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time. If a scan exceeds a certain amount of time without a break, radiofrequency energy used during the scans has the potential to heat up the implanted device, which can damage the surrounding tissue. In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants.

The label update will also benefit existing patients implanted with Proclaim XR SCS Systems with Octrode leads improving their access to MRI imaging. "Now more clinicians can utilize MRIs to improve quality of care among a patient population with complex needs. It allows clinicians to get to the source of a particular issue in less time and without fear of compromising safety or creating complications, " said Timothy Deer , M.D., president and chief executive officer at The Spine and Nerve Centers of the Virginias, serving West Virginia .

The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. More than 50 million Americans suffer from chronic pain. ⁱ There is a high level of clinical evidence for the efficacy of SCS on pain intensity after one year of therapy in patients suffering from a variety of chronic pain conditions. ⁱⁱ

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 109,000 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.

###

____________________

ⁱ Centers for Disease Control and Prevention. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults – United States, 2016. https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm . Accessed Oct. 7, 2020.

ⁱⁱ Burst Spinal Cord Stimulation : A Clinical Review . Kirketeig T, Schultheis C, Zuidema X, Hunter CW, Deer T. Pain Med. 2019 Jun 1;20(Suppl 1):S31-S40. doi: 10.1093/pm/pnz003.

View original content: https://www.prnewswire.com/news-releases/abbotts-proclaim-xr-spinal-cord-stimulation-system-now-offers-expanded-mri-compatibility-in-us-301451750.html

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Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	10,345				$	10,710
Costs and operating expenses:
Cost of revenues (a)		6,040		58.4	%		6,437		60.1	%
Selling, general and administrative expenses (b)		1,731		16.7	%		1,646		15.4	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Research and development expenses		331		3.2	%		346		3.2	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Total costs and operating expenses		8,682		83.9	%		9,147		85.4	%
Operating income		1,663		16.1	%		1,563		14.6	%
Interest income		279					146
Interest expense		(363	)				(300	)
Other income/(expense) (d)		10					(46	)
Income before income taxes		1,589					1,363
Provision for income taxes (e)		(281	)				(46	)
Equity in earnings/(losses) of unconsolidated entities		23					(25	)
Net income		1,331					1,292
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest		4					3
Net income attributable to Thermo Fisher Scientific Inc.	$	1,328		12.8	%	$	1,289		12.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	3.47				$	3.34
Diluted	$	3.46				$	3.32
Weighted average shares:
Basic		382					386
Diluted		384					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%
Cost of revenues adjustments (a)		15		0.1	%		41		0.4	%
Selling, general and administrative expenses adjustments (b)		19		0.2	%		8		0.1	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Adjusted operating income (non-GAAP measure)	$	2,278		22.0	%	$	2,330		21.8	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,328				$	1,289
Cost of revenues adjustments (a)		15					41
Selling, general and administrative expenses adjustments (b)		19					8
Restructuring and other costs (c)		29					112
Amortization of acquisition-related intangible assets		551					606
Other income/expense adjustments (d)		(11	)				46
Provision for income taxes adjustments (e)		50					(171	)
Equity in earnings/losses of unconsolidated entities		(23	)				25
Adjusted net income (non-GAAP measure)	$	1,959				$	1,956

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	3.46				$	3.32
Cost of revenues adjustments (a)		0.04					0.10
Selling, general and administrative expenses adjustments (b)		0.05					0.02
Restructuring and other costs (c)		0.08					0.29
Amortization of acquisition-related intangible assets		1.44					1.56
Other income/expense adjustments (d)		(0.03	)				0.12
Provision for income taxes adjustments (e)		0.13					(0.44	)
Equity in earnings/losses of unconsolidated entities		(0.06	)				0.06
Adjusted EPS (non-GAAP measure)	$	5.11				$	5.03

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	1,251				$	729
Purchases of property, plant and equipment		(347	)				(458	)
Proceeds from sale of property, plant and equipment		4					6
Free cash flow (non-GAAP measure)	$	908				$	277

Business Segment Information	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	2,285		22.1	%	$	2,612		24.4	%
Analytical Instruments		1,687		16.3	%		1,723		16.1	%
Specialty Diagnostics		1,109		10.7	%		1,108		10.3	%
Laboratory Products and Biopharma Services		5,723		55.3	%		5,763		53.8	%
Eliminations		(460	)	-4.4	%		(496	)	-4.6	%
Consolidated revenues	$	10,345		100.0	%	$	10,710		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	840		36.8	%	$	836		32.0	%
Analytical Instruments		400		23.7	%		421		24.4	%
Specialty Diagnostics		294		26.5	%		280		25.3	%
Laboratory Products and Biopharma Services		744		13.0	%		793		13.8	%
Subtotal reportable segments		2,278		22.0	%		2,330		21.8	%
Cost of revenues adjustments (a)		(15	)	-0.1	%		(41	)	-0.4	%
Selling, general and administrative expenses adjustments (b)		(19	)	-0.2	%		(8	)	-0.1	%
Restructuring and other costs (c)		(29	)	-0.3	%		(112	)	-1.0	%
Amortization of acquisition-related intangible assets		(551	)	-5.3	%		(606	)	-5.7	%
Consolidated GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%


(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines. Adjusted results in 2023 exclude $10 of charges for the sale of inventory revalued at the date of acquisition.
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, and charges/credits for changes in estimates of contingent acquisition consideration.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, abandoned facility, and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $18 of net charges for pre-acquisition litigation and other matters.
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments.
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements.
Note:
Consolidated depreciation expense is $285 and $253 in 2024 and 2023, respectively.

Organic and Core organic revenue growth		Three months ended
		March 30, 2024
Revenue growth		-3%
Acquisitions		0%
Currency translation		0%
Organic revenue growth (non-GAAP measure)		-4%
COVID-19 testing revenue		-1%
Core organic revenue growth (non-GAAP measure)		-3%

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

Condensed Consolidated Balance Sheets (unaudited)

	March 30,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	5,499	$	8,077
Short-term investments		1,751		3
Accounts receivable, net		7,931		8,221
Inventories		5,133		5,088
Other current assets		3,326		3,200
Total current assets		23,640		24,589
Property, plant and equipment, net		9,324		9,448
Acquisition-related intangible assets, net		16,048		16,670
Other assets		4,241		3,999
Goodwill		43,843		44,020
Total assets	$	97,095	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	4,451	$	3,609
Other current liabilities		9,486		10,403
Total current liabilities		13,937		14,012
Other long-term liabilities		6,378		6,564
Long-term obligations		31,157		31,308
Redeemable noncontrolling interest		119		118
Total equity		45,504		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	97,095	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Three months ended
	March 30,			April 1,
(In millions)	2024			2023

Operating activities
Net income	$	1,331		$	1,292
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		837			859
Change in deferred income taxes		(253	)		(146	)
Other non-cash expenses, net		123			257
Changes in assets and liabilities, excluding the effects of acquisitions		(787	)		(1,533	)
Net cash provided by operating activities		1,251			729

Investing activities
Purchases of property, plant and equipment		(347	)		(458	)
Proceeds from sale of property, plant and equipment		4			6
Proceeds from cross-currency interest rate swap interest settlements		64			2
Acquisitions, net of cash acquired		—			(2,704	)
Purchases of investments		(1,758	)		(2	)
Other investing activities, net		7			14
Net cash used in investing activities		(2,030	)		(3,142	)

Financing activities
Net proceeds from issuance of debt		1,205			—
Net proceeds from issuance of commercial paper		—			1,027
Repayment of commercial paper		—			(523	)
Purchases of company common stock		(3,000	)		(3,000	)
Dividends paid		(135	)		(117	)
Other financing activities, net		110			20
Net cash used in financing activities		(1,821	)		(2,593	)

Exchange rate effect on cash		22			(31	)
Decrease in cash, cash equivalents and restricted cash		(2,578	)		(5,037	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	5,519		$	3,500

Free cash flow (non-GAAP measure)	$	908		$	277



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

Contacts:
Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8472	+1-763-505-4626

Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S.

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