Thermo Fisher Scientific Reports First Quarter 2021 Results

- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended April 3, 2021 .

First Quarter 2021 Highlights

  • First quarter revenue increased 59% to $9.91 billion .
  • First quarter GAAP diluted earnings per share (EPS) increased 198% to $5.88 .
  • First quarter adjusted EPS increased 145% to $7.21 .
  • Continued significant role in enabling the COVID-19 response, helping to scale vaccine production and supporting testing globally, and accelerated growth in the base business.
  • Strong start to the year in terms of product launches including two Thermo Scientific Orbitrap Exploris Gas Chromatography-Mass Spectrometers , which bring high-resolution analysis to a range of applications, including toxicology and metabolomics, the Thermo Scientific Spectra Ultra electron microscope for improved throughput and workflow in materials science applications, the Kingfisher Apex Purification System for high throughput sample preparation and the Thermo Scientific AerosolSense Sampler , an in-air surveillance solution for pathogens, including SARS-CoV-2.
  • Continued to increase our capacity to meet customer demand. In the quarter, we began shipping single use technologies from our new facility in Suzhou to bioproduction customers in China . We also brought additional capacity online in Singapore for bioproduction and at two sites in North America for laboratory plastics.
  • Advanced our environmental, social and governance priorities and committed to an impact investment of $25 million in financial institutions focused on minority communities.
  • Very active capital deployment to start the year including repurchasing $2 billion of stock, increasing our dividend by 18% and completing the acquisition of Mesa Biotech, Inc., a point-of-care molecular diagnostic company.
  • After quarter end, announced an agreement to acquire PPD, Inc., a leading global provider of clinical research services, for $17.4 billion .

Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We are off to an excellent start to the year. Market conditions are strong, and our team is executing at an incredibly high level. From a financial perspective, we again delivered exceptional growth in revenue, earnings and free cash flow for the quarter," said Marc N. Casper , chairman, president and chief executive officer of Thermo Fisher Scientific. "We began accelerating our investments in talent, capabilities and capacity in the second half of 2020 and we are already starting to see the benefits of those actions which will ensure an even brighter future for our company."

Casper added, "I am also very excited about our recently announced agreement to acquire PPD, Inc. This is a great fit for our company and will strengthen our value proposition for our largest and fastest growing end market, provide exciting career opportunities for our colleagues, and create significant shareholder value."

First Quarter 2021

Revenue for the quarter grew 59% to $9.91 billion in 2021, versus $6.23 billion in 2020. Organic revenue growth was 53%; acquisitions increased revenue by 2% and currency translation increased revenue by 4%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2021 increased 198% to $5.88 , versus $1.97 in the same quarter last year. GAAP operating income for the first quarter of 2021 was $3.05 billion , compared with $0.91 billion in the year-ago quarter. GAAP operating margin was 30.8%, compared with 14.5% in the first quarter of 2020.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2021 increased 145% to $7.21 , versus $2.94 in the first quarter of 2020. Adjusted operating income for the first quarter of 2021 grew 155% compared with the year-ago quarter. Adjusted operating margin was 35.4%, compared with 22.1% in the first quarter of 2020.

Annual Guidance for 2021

The company will provide updates on its 2021 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern time .

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company's four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

Life Sciences Solutions Segment revenue grew 137% to $4.20 billion in the first quarter of 2021, compared with revenue of $1.77 billion in the first quarter of 2020. Segment adjusted operating margin was 54.2%, versus 38.0% in the 2020 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 26% to $1.39 billion in the first quarter of 2021, compared with revenue of $1.10 billion in the first quarter of 2020. Segment adjusted operating margin was 19.6%, versus 15.5% in the 2020 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 69% to $1.62 billion in the first quarter of 2021, compared with revenue of $0.96 billion in the first quarter of 2020. Segment adjusted operating margin was 26.5%, versus 24.7% in the 2020 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment revenue grew 32% to $3.60 billion in the first quarter of 2021, compared with revenue of $2.73 billion in the first quarter of 2020. Segment adjusted operating margin was 14.8%, versus 10.8% in the 2020 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company's performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the first quarter of 2021, adjusted EPS will exclude approximately $3.45 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher's management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company's core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher's results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher's results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher's results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 29, 2021 , at 8:30 a.m. Eastern time . To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 7956359. You may also listen to the call live on our website, www.thermofisher.com , by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, May 14, 2021 .

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion . Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

Safe Harbor Statement

The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the duration and severity of the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions, including our pending acquisition of PPD, Inc., may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our Annual Report on Form 10-K for the year ended December 31 , 2020, which is on file with the SEC and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

Condensed Consolidated Statement of Income (unaudited) (a)(b)











Three Months Ended



April 3,


% of


March 28,


% of

(In millions except per share amounts)


2021


Revenues


2020


Revenues










Revenues


$

9,906





$

6,230




Costs and Operating Expenses:









Cost of revenues (c)


4,557



46.0

%


3,365



54.0

%

Selling, general and administrative expenses (d)


1,543



15.6

%


1,251



20.1

%

Amortization of acquisition-related intangible assets


423



4.3

%


425



6.8

%

Research and development expenses


320



3.2

%


245



3.9

%

Restructuring and other costs (e)


14



0.1

%


38



0.6

%



6,857



69.2

%


5,324



85.5

%

Operating Income


3,049



30.8

%


906



14.5

%

Interest Income


12





36




Interest Expense


(125)





(126)




Other (Expense) Income (f)


(183)





12




Income Before Income Taxes


2,753





828




Provision for Income Taxes (g)


(416)





(40)




Net Income


$

2,337



23.6

%


$

788



12.6

%










Earnings per Share:









Basic


$

5.93





$

1.99




Diluted


$

5.88





$

1.97




Weighted Average Shares:









Basic


394





397




Diluted


397





400






















Reconciliation of Adjusted Operating Income and Adjusted Operating Margin









GAAP Operating Income (a)


$

3,049



30.8

%


$

906



14.5

%

Cost of Revenues Charges (c)


8



0.1

%


2



0.1

%

Selling, General and Administrative Charges (d)


16



0.1

%


6



0.1

%

Restructuring and Other Costs (e)


14



0.1

%


38



0.6

%

Amortization of Acquisition-related Intangible Assets


423



4.3

%


425



6.8

%

Adjusted Operating Income (b)


$

3,510



35.4

%


$

1,377



22.1

%










Reconciliation of Adjusted Net Income









GAAP Net Income (a)


$

2,337





$

788




Cost of Revenues Charges (c)


8





2




Selling, General and Administrative Charges (d)


16





6




Restructuring and Other Costs (e)


14





38




Amortization of Acquisition-related Intangible Assets


423





425




Other Expense (Income) (f)


197





14




Benefit from Income Taxes (g)


(130)





(98)




Adjusted Net Income (b)


$

2,865





$

1,175













Reconciliation of Adjusted Earnings per Share









GAAP Diluted EPS (a)


$

5.88





$

1.97




Cost of Revenues Charges, Net of Tax (c)


0.01





0.01




Selling, General and Administrative Charges, Net of Tax (d)


0.03





0.01




Restructuring and Other Costs, Net of Tax (e)


0.03





0.07




Amortization of Acquisition-related Intangible Assets, Net of Tax


0.84





0.83




Other Expense (Income), Net of Tax (f)


0.43





0.03




(Benefit from) Provision for Income Taxes (g)


(0.01)





0.02




Adjusted EPS (b)


$

7.21





$

2.94













Reconciliation of Free Cash Flow









GAAP Net Cash Provided by Operating Activities (a)


$

1,978





$

356




Purchases of Property, Plant and Equipment


(628)





(253)




Proceeds from Sale of Property, Plant and Equipment


5





4




Free Cash Flow


$

1,355





$

107




Segment Data


Three Months Ended



April 3,


% of


March 28,


% of

(In millions)


2021


Revenues


2020


Revenues










Revenues









Life Sciences Solutions


$

4,203



42.4

%


$

1,774



28.5

%

Analytical Instruments


1,387



14.0

%


1,101



17.7

%

Specialty Diagnostics


1,615



16.3

%


958



15.4

%

Laboratory Products and Services


3,597



36.3

%


2,730



43.8

%

Eliminations


(896)



-9.0

%


(333)



-5.4

%

Consolidated Revenues


$

9,906



100.0

%


$

6,230



100.0

%










Operating Income and Operating Margin









Life Sciences Solutions


$

2,279



54.2

%


$

675



38.0

%

Analytical Instruments


272



19.6

%


171



15.5

%

Specialty Diagnostics


428



26.5

%


236



24.7

%

Laboratory Products and Services


531



14.8

%


295



10.8

%

Subtotal Reportable Segments


3,510



35.4

%


1,377



22.1

%










Cost of Revenues Charges (c)


(8)



-0.1

%


(2)



-0.1

%

Selling, General and Administrative Charges (d)


(16)



-0.1

%


(6)



-0.1

%

Restructuring and Other Costs (e)


(14)



-0.1

%


(38)



-0.6

%

Amortization of Acquisition-related Intangible Assets


(423)



-4.3

%


(425)



-6.8

%

GAAP Operating Income (a)


$

3,049



30.8

%


$

906



14.5

%



















(a) "GAAP" (reported) results were determined in accordance with U.S. generally accepted accounting principles (GAAP).

(b) Adjusted results are non-GAAP measures and, for income measures, exclude certain charges to cost of revenues (see note (c) for details); certain credits/charges to selling, general and administrative expenses (see note (d) for details); amortization of acquisition-related intangible assets; restructuring and other costs (see note (e) for details); certain other gains or losses that are either isolated or cannot be expected to occur again with any predictability (see note (f) for details); and the tax consequences of the preceding items and certain other tax items (see note (g) for details).

(c) Reported results in 2021 include charges for the sale of inventories revalued at the date of acquisition. Reported results in 2020 include charges to conform the accounting policies of a recently acquired business with the company's accounting policies.

(d) Reported results in 2021 and 2020 include certain third-party expenses, principally transaction/integration costs related to recent/terminated acquisitions. Reported results in 2021 also include $2 of charges for changes in estimates of contingent acquisition consideration.

(e) Reported results in 2021 and 2020 include restructuring and other costs consisting principally of severance, abandoned facility and other expenses of headcount reductions within several businesses and real estate consolidations. Reported results in 2021 also include $13 of charges for compensation contractually due to employees of acquired businesses at the date of acquisition.

(f) Reported results in 2021 include $197 of losses on the early extinguishment of debt. Reported results in 2020 include $17 of costs for a subsequently terminated acquisition, primarily for entering hedging contracts and amortization of bridge loan commitments fees; and $1 of net charges for the settlement/curtailment of pension plans, offset in part by $4 of gains from investments.

(g) Reported provision for income taxes in 2021 and 2020 includes incremental tax benefit for the pre-tax reconciling items between GAAP and adjusted net income and $4 and $(6) of incremental tax benefit (provision), respectively, from adjusting the company's non-U.S. deferred tax balances as a result of tax rate changes.

Notes:

Consolidated depreciation expense is $198 and $149 in 2021 and 2020, respectively.


Condensed Consolidated Balance Sheet (unaudited)












April 3,


December 31,

(In millions)


2021


2020






Assets





Current Assets:





Cash and cash equivalents


$

5,583



$

10,325


Accounts receivable, net


5,554



5,741


Inventories


4,342



4,029


Other current assets


2,206



1,862


Total current assets


17,685



21,957


Property, Plant and Equipment, Net


6,133



5,912


Acquisition-related Intangible Assets, Net


12,831



12,685


Other Assets


2,459



2,457


Goodwill


26,823



26,041


Total Assets


$

65,931



$

69,052












Liabilities and Shareholders' Equity





Current Liabilities:





Short-term obligations and current maturities of long-term obligations


$

4



$

2,628


Other current liabilities


6,991



7,676


Total current liabilities


6,995



10,304


Other Long-term Liabilities


5,237



5,134


Long-term Obligations


18,641



19,107


Total Shareholders' Equity


35,058



34,507


Total Liabilities and Shareholders' Equity


$

65,931



$

69,052

















Condensed Consolidated Statement of Cash Flows (unaudited)












Three Months Ended



April 3,


March 28,

(In millions)


2021


2020






Operating Activities





Net income


$

2,337



$

788







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





Depreciation and amortization


621



574


Change in deferred income taxes


24



(41)


Other non-cash expenses, net


317



110


Changes in assets and liabilities, excluding the effects of acquisitions and disposition


(1,321)



(1,075)


Net cash provided by operating activities


1,978



356







Investing Activities





Acquisitions, net of cash acquired


(1,343)



(4)


Purchases of property, plant and equipment


(628)



(253)


Proceeds from sale of property, plant and equipment


5



4


Other investing activities, net


(32)



(7)


Net cash used in investing activities


(1,998)



(260)







Financing Activities





Net proceeds from issuance of debt




2,185


Repayment of debt


(2,804)



(1)


Net proceeds from issuance of commercial paper




382


Repayment of commercial paper




(321)


Purchases of company common stock


(2,000)



(1,500)


Dividends paid


(87)



(76)


Net proceeds from issuance of company common stock under employee stock plans


20



48


Other financing activities, net


21



(98)


Net cash (used in) provided by financing activities


(4,850)



619







Exchange Rate Effect on Cash


137



(127)


(Decrease) Increase in Cash, Cash Equivalents and Restricted Cash


(4,733)



588


Cash, Cash Equivalents and Restricted Cash at Beginning of Period


10,336



2,422


Cash, Cash Equivalents and Restricted Cash at End of Period


$

5,603



$

3,010












Free Cash Flow (a)


$

1,355



$

107













(a) Free cash flow is net cash provided by operating activities less net purchases of property, plant and equipment.


(PRNewsfoto/Thermo Fisher Scientific)

Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com

Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/thermo-fisher-scientific-reports-first-quarter-2021-results-301279550.html

SOURCE Thermo Fisher Scientific

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
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

Cision 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

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
New Simplera Sync sensor for the MiniMed 780G System now FDA approved

New Simplera Sync sensor for the MiniMed 780G System now FDA approved

Latest approval expands Medtronic CGM portfolio in the U.S.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

FN Media Group News Commentary - Artificial intelligence (AI) is being utilized for disease detection in the global markets. In today's AI-driven world, the use of deep learning algorithms and AI tools in diagnostics can improve the accuracy, speed and efficiency for diagnosing patients with minimal errors. The introduction of AI tools in diagnostics has revolutionized the healthcare industry with supporting the doctors in advanced disease diagnosis and providing personalized treatments to patients with better judgements and quick results. According to Precedence Research, the global artificial intelligence in diagnostics market size was exhibited at USD 1.61 billion in 2024 and is projected to hit around USD 8.54 billion by 2033, growing at a CAGR of 20.37% during the forecast period 2024 to 2033. The report said: "The advances in digital biomarkers technology which uses real-time monitoring systems for early disease diagnosis and prediction has also enhanced the AI in diagnostics market growth. The application of AI tools in diagnostics has led to analyzing medical images for assessing disease progression, predicting patient outcomes, processing and storing of patient data which includes electronic health records (EHRs), identifying patterns and anomalies in patient data and symptom checkers for providing potential diagnosis."   Active healthcaretech companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Illumina Inc. (NASDAQ: ILMN), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Spectral AI, Inc. (NASDAQ: MDAI).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology .

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×