Artrya on Track for FDA Application Submission Following Second Q-Submission Meeting

Artrya Limited (ASX:AYA), (‘Artrya’ or the ‘Company’), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has received feedback its application for regulatory approval for the Salix product with the US Food and Drug Administration (FDA) is on track following a Q-Submission meeting.

Highlights

Feedback and guidance were received during a second Q-Submission meeting held on the evening of 19 August 2024
Artrya received feedback its application for regulatory approval for Salix product with the US FDA is on track
Artrya plans to submit the 510(k) application to the FDA in the coming weeks.

As stated in Artrya’s 4Q FY24 report to the ASX, the Company had requested a second Q-Submission (Q-Sub) meeting as a key step in the process to finalise its US FDA application for Salix. The meeting was held on the evening of 19 August 2024.

A Q-sub is a formal written request from a company for feedback from the FDA to help guide application preparation. Artrya had requested this second meeting to validate and confirm the approach taken since the first Q-Sub meeting in June 2023.

Artrya CEO Mathew Regan said: "I am pleased to report the outcome of our second Q-sub meeting with the FDA was positive. The FDA provided valuable feedback and guidance on our upcoming application, confirming our approach is on track. This has validated the cautious approach we have taken to ensure we meet all requirements for the 510(k) application. We now have a clear path to submission, and I look forward to lodging our 510(k) application once the formal Q-Sub process is completed.”

Click here for the full ASX Release

This article includes content from Artrya Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

medical device investing asx:aya

Thermo Fisher Scientific Elects New Director to Board

Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced Karen S. Lynch has been elected to its board of directors, effective February 19, 2025. The appointment brings the total number of Thermo Fisher board members to 12.

Ms. Lynch is a seasoned health care executive with over three decades of experience in the industry. As the former president and chief executive officer of CVS Health Corporation (NYSE: CVS), a leading health solutions company, she was responsible for leading more than 300,000 employees. Under Ms. Lynch's leadership, CVS Health touched the lives of more than 120 million consumers through its health care benefits and pharmacy benefits management businesses, and presence in over 9,000 community health destinations across the U.S. Prior to her service as president and CEO of CVS Health, Ms. Lynch served as an Executive Vice President of CVS Health and President of Aetna, and prior to that, Ms. Lynch held a number of executive positions at Aetna Inc., a health insurance company, Magellan Health Services, a health care management company, and at Cigna Corporation, a global health insurance company. Ms. Lynch began her career as a Certified Public Accountant at the auditing firm Ernst & Young LLP, and has previously served as a board member of CVS Health and U.S. Bancorp.

News Provided by Business Wire via QuoteMedia

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MEDTRONIC PLC WORLD WIDE REVENUE ⁽¹⁾ (Unaudited)

	THIRD QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 3,037	$ 2,929	3.7 %	$ (38)	$ 3,075	$ 2,929	5.0 %	$ 9,145	$ 8,702	5.1 %	$ (62)	$ 9,207	$ 8,702	5.8 %
Cardiac Rhythm & Heart Failure	1,545	1,470	5.1	(18)	1,563	1,470	6.3	4,659	4,408	5.7	(26)	4,684	4,408	6.3
Structural Heart & Aortic	874	843	3.7	(13)	887	843	5.2	2,610	2,475	5.4	(21)	2,631	2,475	6.3
Coronary & Peripheral Vascular	618	616	0.3	(8)	626	616	1.6	1,876	1,818	3.2	(15)	1,891	1,818	4.0
Neuroscience	2,458	2,355	4.4	(21)	2,478	2,355	5.2	7,226	6,861	5.3	(29)	7,255	6,861	5.7
Cranial & Spinal Technologies	1,250	1,204	3.8	(9)	1,259	1,204	4.6	3,632	3,465	4.8	(15)	3,646	3,465	5.2
Specialty Therapies	732	726	0.8	(8)	740	726	1.9	2,181	2,126	2.6	(10)	2,191	2,126	3.1
Neuromodulation	476	425	12.0	(4)	480	425	12.9	1,413	1,270	11.2	(5)	1,417	1,270	11.6
Medical Surgical	2,072	2,112	(1.9)	(32)	2,104	2,112	(0.4)	6,196	6,219	(0.4)	(50)	6,246	6,219	0.4
Surgical & Endoscopy	1,596	1,616	(1.2)	(26)	1,622	1,616	0.4	4,790	4,803	(0.3)	(40)	4,829	4,803	0.5
Acute Care & Monitoring	476	495	(3.9)	(5)	481	495	(2.8)	1,406	1,416	(0.7)	(10)	1,417	1,416	—
Diabetes	694	640	8.4	(12)	706	640	10.4	2,027	1,829	10.8	(8)	2,035	1,829	11.3
Total Reportable Segments	8,260	8,035	2.8	(103)	8,363	8,035	4.1	24,593	23,610	4.2	(149)	24,742	23,610	4.8
Other ⁽²⁾	32	53	(41.1)	(1)	—	—	—	17	164	(89.9)	(3)	—	—	—
TOTAL	$ 8,292	$ 8,089	2.5 %	$ (104)	$ 8,363	$ 8,035	4.1 %	$ 24,610	$ 23,775	3.5 %	$ (152)	$ 24,742	$ 23,610	4.8 %


(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 three months ended July 26, 2024, impacting year-to-date figures, $90 million 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.
(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 January 24, 2025 excludes $71 million of revenue adjustments related to $32 million of inorganic revenue for the transition activity noted in (2) and $103 million of unfavorable currency impact on the remaining segments. The three months ended January 26, 2024 excludes $53 million of inorganic revenue related to the transition activity noted in (2).
(5)	The nine months ended January 24, 2025 excludes $132 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $106 million of inorganic revenue related to the transition activity noted in (2), and $149 million of unfavorable currency impact on the remaining segments. The nine months ended January 26, 2024 excludes $164 million of inorganic revenue related to the transition activity noted in (2).

MEDTRONIC PLC U.S. REVENUE ⁽¹⁾⁽²⁾ (Unaudited)

	THIRD QUARTER						YEAR-TO-DATE
	REPORTED			ORGANIC			REPORTED			ORGANIC
(in millions)	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth
Cardiovascular	$ 1,405	$ 1,373	2.4 %	$ 1,405	$ 1,373	2.4 %	$ 4,242	$ 4,149	2.2 %	$ 4,242	$ 4,149	2.2 %
Cardiac Rhythm & Heart Failure	775	745	4.1	775	745	4.1	2,309	2,247	2.8	2,309	2,247	2.8
Structural Heart & Aortic	372	363	2.6	372	363	2.6	1,129	1,087	3.9	1,129	1,087	3.9
Coronary & Peripheral Vascular	258	265	(2.8)	258	265	(2.8)	804	816	(1.4)	804	816	(1.4)
Neuroscience	1,689	1,556	8.5	1,689	1,556	8.5	4,931	4,614	6.9	4,931	4,614	6.9
Cranial & Spinal Technologies	943	875	7.8	943	875	7.8	2,724	2,560	6.4	2,724	2,560	6.4
Specialty Therapies	419	407	3.0	419	407	3.0	1,235	1,202	2.7	1,235	1,202	2.7
Neuromodulation	327	275	19.0	327	275	19.0	972	852	14.1	972	852	14.1
Medical Surgical	893	947	(5.8)	893	947	(5.8)	2,718	2,763	(1.6)	2,718	2,763	(1.6)
Surgical & Endoscopy	623	663	(6.1)	623	663	(6.1)	1,928	1,971	(2.2)	1,928	1,971	(2.2)
Acute Care & Monitoring	269	284	(5.1)	269	284	(5.1)	790	792	(0.2)	790	792	(0.2)
Diabetes	236	224	5.6	236	224	5.6	683	629	8.7	683	629	8.7
Total Reportable Segments	4,223	4,100	3.0	4,223	4,100	3.0	12,573	12,154	3.4	12,573	12,154	3.4
Other ⁽³⁾	15	20	(26.4)	—	—	—	51	65	(21.3)	—	—	—
TOTAL	$ 4,237	$ 4,120	2.8 %	$ 4,223	$ 4,100	3.0 %	$ 12,624	$ 12,219	3.3 %	$ 12,573	$ 12,154	3.4 %


(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)

	THIRD QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 1,632	$ 1,556	4.9 %	$ (38)	$ 1,670	$ 1,556	7.3 %	$ 4,904	$ 4,552	7.7 %	$ (62)	$ 4,966	$ 4,552	9.1 %
Cardiac Rhythm & Heart Failure	770	726	6.1	(18)	788	726	8.6	2,350	2,161	8.7	(26)	2,376	2,161	9.9
Structural Heart & Aortic	502	480	4.6	(13)	515	480	7.2	1,482	1,389	6.7	(21)	1,503	1,389	8.2
Coronary & Peripheral Vascular	360	350	2.6	(8)	368	350	4.9	1,072	1,002	7.0	(15)	1,087	1,002	8.5
Neuroscience	769	799	(3.7)	(21)	790	799	(1.1)	2,295	2,248	2.1	(29)	2,324	2,248	3.4
Cranial & Spinal Technologies	307	329	(6.7)	(9)	316	329	(3.9)	907	905	0.3	(15)	922	905	1.9
Specialty Therapies	313	319	(2.0)	(8)	321	319	0.4	947	924	2.4	(10)	957	924	3.5
Neuromodulation	149	150	(0.7)	(4)	153	150	1.8	441	419	5.4	(5)	446	419	6.5
Medical Surgical	1,180	1,164	1.3	(32)	1,211	1,164	4.0	3,478	3,456	0.6	(50)	3,528	3,456	2.1
Surgical & Endoscopy	973	953	2.1	(26)	999	953	4.9	2,862	2,832	1.1	(40)	2,902	2,832	2.5
Acute Care & Monitoring	206	211	(2.3)	(5)	212	211	0.2	616	624	(1.4)	(10)	626	624	0.3
Diabetes	457	416	9.9	(12)	470	416	12.9	1,344	1,200	12.0	(8)	1,351	1,200	12.6
Total Reportable Segments	4,038	3,935	2.6	(103)	4,141	3,935	5.2	12,020	11,456	4.9	(149)	12,169	11,456	6.2
Other ⁽²⁾	17	34	(49.8)	(1)	—	—	—	(35)	99	(134.8)	(3)	—	—	—
TOTAL	$ 4,055	$ 3,968	2.2 %	$ (104)	$ 4,141	$ 3,935	5.2 %	$ 11,986	$ 11,555	3.7 %	$ (152)	$ 12,169	$ 11,456	6.2 %

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

	Three months ended		Nine months ended
(in millions, except per share data)	January 24, 2025	January 26, 2024	January 24, 2025	January 26, 2024
Net sales	$ 8,292	$ 8,089	$ 24,610	$ 23,775
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets	2,779	2,782	8,485	8,172
Research and development expense	675	695	2,048	2,060
Selling, general, and administrative expense	2,717	2,673	8,129	7,971
Amortization of intangible assets	416	419	1,243	1,274
Restructuring charges, net	43	20	120	114
Certain litigation charges, net	22	—	104	105
Other operating (income) expense, net	(5)	17	(38)	(13)
Operating profit	1,646	1,483	4,519	4,091
Other non-operating income, net	(72)	(177)	(403)	(407)
Interest expense, net	179	188	555	517
Income before income taxes	1,540	1,472	4,367	3,982
Income tax provision	237	135	737	936
Net income	1,303	1,337	3,630	3,045
Net income attributable to noncontrolling interests	(9)	(15)	(24)	(23)
Net income attributable to Medtronic	$ 1,294	$ 1,322	$ 3,606	$ 3,022
Basic earnings per share	$ 1.01	$ 0.99	$ 2.80	$ 2.27
Diluted earnings per share	$ 1.01	$ 0.99	$ 2.79	$ 2.27
Basic weighted average shares outstanding	1,282.4	1,329.7	1,286.7	1,330.1
Diluted weighted average shares outstanding	1,286.2	1,331.7	1,290.6	1,332.4

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Three months ended January 24, 2025
(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	$ 8,292	$ 2,779	66.5 %	$ 1,646	19.9 %	$ 1,540	$ 1,294	$ 1.01	15.4 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	416	5.0	416	339	0.26	18.5
Restructuring and associated costs ⁽²⁾	—	(4)	—	46	0.6	46	37	0.03	19.6
Acquisition and divestiture-related items ⁽³⁾	—	(1)	—	28	0.3	28	23	0.02	17.9
Certain litigation charges, net	—	—	—	22	0.3	22	18	0.01	22.7
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	68	52	0.04	22.1
Medical device regulations ⁽⁵⁾	—	(8)	0.1	11	0.1	11	9	0.01	18.2
Certain tax adjustments, net	—	—	—	—	—	—	15	0.01	—
Non-GAAP	$ 8,292	$ 2,766	66.6 %	$ 2,169	26.2 %	$ 2,130	$ 1,787	$ 1.39	15.7 %
Currency impact	104	61	(0.3)	(4)	(0.4)			(0.01)
Currency Adjusted	$ 8,396	$ 2,827	66.3 %	$ 2,165	25.8 %			$ 1.38

	Three months ended January 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	$ 8,089	$ 2,782	65.6 %	$ 1,483	18.3 %	$ 1,472	$ 1,322	$ 0.99	9.2 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	419	5.2	419	354	0.27	15.5
Restructuring and associated costs ⁽²⁾	—	(12)	0.1	55	0.7	55	46	0.03	16.4
Acquisition and divestiture-related items ⁽³⁾	—	(12)	0.1	58	0.7	58	52	0.04	10.3
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	24	24	0.02	—
Medical device regulations ⁽⁵⁾	—	(18)	0.2	26	0.3	26	21	0.02	19.2
Certain tax adjustments, net ⁽⁶⁾	—	—	—	—	—	—	(92)	(0.07)	—
Non-GAAP	$ 8,089	$ 2,740	66.1 %	$ 2,042	25.2 %	$ 2,055	$ 1,728	$ 1.30	15.2 %


See description of non-GAAP financial measures contained in the press release dated February 18, 2025.
(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 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)	The net tax benefit primarily relates to a change in a Swiss Cantonal tax rate associated with previously established deferred tax assets from intercompany intellectual property transactions and the step up in tax basis for Swiss Cantonal purposes.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Nine months ended January 24, 2025
(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	$ 24,610	$ 8,485	65.5 %	$ 4,519	18.4 %	$ 4,367	$ 3,606	$ 2.79	16.9 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	1,243	4.9	1,243	1,017	0.79	18.3
Restructuring and associated costs ⁽²⁾	—	(24)	0.1	154	0.6	154	124	0.10	19.5
Acquisition and divestiture-related items ⁽³⁾	—	(17)	—	15	0.1	15	3	—	73.3
Certain litigation charges, net	—	—	—	104	0.4	104	86	0.07	17.3
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	41	14	0.01	61.0
Medical device regulations ⁽⁵⁾	—	(27)	0.1	38	0.2	38	30	0.02	21.1
Other ⁽⁶⁾	90	—	0.2	90	0.4	90	70	0.05	22.2
Certain tax adjustments, net ⁽⁷⁾	—	—	—	—	—	—	49	0.04	—
Non-GAAP	$ 24,700	$ 8,417	65.9 %	$ 6,162	24.9 %	$ 6,051	$ 4,999	$ 3.87	17.0 %
Currency impact	150	(72)	0.5	241	0.9			0.15
Currency Adjusted	$ 24,850	$ 8,345	66.4 %	$ 6,403	25.8 %			$ 4.02

	Nine months ended January 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	$ 23,775	$ 8,172	65.6 %	$ 4,091	17.2 %	$ 3,982	$ 3,022	$ 2.27	23.5 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	1,274	5.4	1,274	1,078	0.81	15.4
Restructuring and associated costs ⁽²⁾	—	(43)	0.2	237	1.0	237	198	0.15	16.5
Acquisition and divestiture-related items ⁽³⁾	—	(24)	0.1	165	0.7	165	149	0.11	9.7
Certain litigation charges, net	—	—	—	105	0.4	105	81	0.06	22.9
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	113	109	0.08	4.4
Medical device regulations ⁽⁵⁾	—	(60)	0.3	88	0.4	88	70	0.05	20.5
Certain tax adjustments, net ⁽⁸⁾	—	—	—	—	—	—	282	0.21	—
Non-GAAP	$ 23,775	$ 8,046	66.2 %	$ 5,961	25.1 %	$ 5,965	$ 4,988	$ 3.74	16.0 %


See description of non-GAAP financial measures contained in the press release dated February 18, 2025.
(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)	January 24, 2025	April 26, 2024
ASSETS
Current assets:
Cash and cash equivalents	$ 1,240	$ 1,284
Investments	6,682	6,721
Accounts receivable, less allowances and credit losses of $204 and $173, respectively	6,115	6,128
Inventories	5,610	5,217
Other current assets	2,865	2,584
Total current assets	22,513	21,935
Property, plant, and equipment, net	6,593	6,131
Goodwill	40,819	40,986
Other intangible assets, net	12,184	13,225
Tax assets	3,614	3,657
Other assets	4,250	4,047
Total assets	$ 89,973	$ 89,981
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations	$ 2,622	$ 1,092
Accounts payable	2,286	2,410
Accrued compensation	2,281	2,375
Accrued income taxes	1,125	1,330
Other accrued expenses	3,526	3,582
Total current liabilities	11,840	10,789
Long-term debt	23,985	23,932
Accrued compensation and retirement benefits	1,063	1,101
Accrued income taxes	1,485	1,859
Deferred tax liabilities	452	515
Other liabilities	1,533	1,365
Total liabilities	40,358	39,561
Commitments and contingencies
Shareholders' equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,283,266,154 and 1,311,337,531 shares issued and outstanding, respectively	—	—
Additional paid-in capital	20,910	23,129
Retained earnings	31,317	30,403
Accumulated other comprehensive loss	(2,839)	(3,318)
Total shareholders' equity	49,387	50,214
Noncontrolling interests	228	206
Total equity	49,615	50,420
Total liabilities and equity	$ 89,973	$ 89,981

Contacts:

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

Artrya on Track for FDA Application Submission Following Second Q-Submission Meeting

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