Viemed Healthcare Announces First Quarter 2022 Financial Results

Viemed Healthcare, Inc. (the "Company" or "Viemed") (NASDAQ:VMD and TSX: VMD.TO), a home medical equipment supplier and the nation's largest independent provider of ventilation that provides post-acute respiratory care services, announced today that it has reported its financial results for the three months ended March 31, 2022.

Operational highlights (all dollar amounts are USD):

  • Net revenues attributable to the Company's core business for the quarter ended March 31, 2022 were $30.2 million, a new Company record, and an increase of $4.7 million or 18% over the quarter ended March 31, 2021. Total net revenues for the current quarter were $32.3 million, which included approximately $2.1 million for contact and vaccine tracing services related to the COVID-19 pandemic.
  • Net income before taxes for the quarter ended March 31, 2022 totaled approximately $2.5 million, compared to $1.5 million for the quarter ended March 31, 2021.
  • Adjusted EBITDA for the quarter ended March 31, 2022 totaled approximately $7.3 million, a 33% increase as compared to the quarter ended March 31, 2021. A reconciliation of reported non-GAAP financial measures to their most directly comparable U.S. GAAP financial measures can be found in the tables accompanying this press release.
  • The Company had a cash balance of $29.2 million at March 31, 2022 ($28.4 million at December 31, 2021) and an overall working capital balance of $30.1 million ($29.5 million at December 31, 2021). Total long-term debt as of March 31, 2022 was $4.5 million ($4.6 million at December 31, 2021).
  • The Company repurchased and cancelled 389,878 shares under the share repurchase program during the quarter ended March 31, 2022 and has continued its repurchase program during the current quarter.
  • The Company expects to generate net revenues attributable to its core business of approximately $32.1 million to $32.8 million during the second quarter of 2022. While the Company's COVID-19 response related business has slowed during the current year, the Company is continuing to pursue additional sales and support revenues and estimates second quarter 2022 revenues of approximately $0.2 million to $0.3 million related to the COVID-19 pandemic. Total revenues for the second quarter of 2022 are estimated to be approximately $32.3 million to $33.1 million.

"The record setting quarter in our core business is a reflection of the momentum we are beginning to see in a post pandemic environment," said Casey Hoyt, Viemed's CEO. "Our investments in people, technology, and inventory during the pandemic have positioned us extremely well to actively engage with patients, providers, and payors as pandemic restrictions abate. We are invigorated by the increasing opportunities for face-to-face interaction with the people we serve in the coming months."

Conference Call Details

The Company will host a conference call to discuss first quarter results on Wednesday, May 4, 2022 at 11:00 a.m. ET.

Interested parties may participate in the call by dialing:

877-407-6176 (US Toll-Free)
201-689-8451 (International)

Live Audio Webcast: https://services.choruscall.com/mediaframe/webcast.html?webcastid=xWYBk1hn

Following the conclusion of the call, an audio recording and transcript of the call can be accessed on the Company's website.

ABOUT VIEMED HEALTHCARE, INC.

Viemed is a provider of in-home medical equipment and post-acute respiratory healthcare services in the United States. Viemed's service offerings are focused on effective in-home treatment with clinical practitioners providing therapy and counseling to patients in their homes using cutting edge technology. Visit our website at www.viemed.com.

For further information, please contact:

Glen Akselrod
Bristol Capital
905-326-1888
glen@bristolir.com

Todd Zehnder
Chief Operating Officer
Viemed Healthcare, Inc.
337-504-3802
investorinfo@viemed.com

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 or "forward-looking information" as such term is defined in applicable Canadian securities legislation (collectively, "forward-looking statements"). Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "potential", "scheduled", "estimates", "forecasts", "intends", "anticipates", "believes", or "projects", or the negatives thereof or variations of such words and phrases or statements that certain actions, events or results "will", "should", "may", "could", "would", "might" or "will be taken", "occur" or "be achieved" or the negative of these terms or comparable terminology. All statements other than statements of historical fact, including those that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance, including the Company's net revenue guidance for the second quarter, are not historical facts and may be forward-looking statements and may involve estimates, assumptions and uncertainties that could cause actual results or outcomes to differ materially from those expressed in the forward-looking statements. Such statements reflect the Company's current views and intentions with respect to future events, and current information available to the Company, and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking statements to vary from those described herein should one or more of these risks or uncertainties materialize. These factors include, without limitation: the general business, market and economic conditions in the regions in which the Company operates; the impact of the COVID-19 pandemic and the actions taken by governmental authorities, individuals and companies in response to the pandemic on our business, financial condition and results of operations, including on the Company's patient base, revenues, employees, and equipment and supplies; significant capital requirements and operating risks that the Company may be subject to; the ability of the Company to implement business strategies and pursue business opportunities; volatility in the market price of the Company's common shares; the Company's novel business model; the risk that the clinical application of treatments that demonstrate positive results in a study may not be positively replicated or that such test results may not be predictive of actual treatment results or may not result in the adoption of such treatments by providers; the state of the capital markets; the availability of funds and resources to pursue operations; reductions in reimbursement rates and audits of reimbursement claims by various governmental and private payor entities; dependence on few payors; possible new drug discoveries; dependence on key suppliers and the recall of certain Royal Philips BiPAP and CPAP devices and ventilators that we distribute and sell; granting of permits and licenses in a highly regulated business; competition; low profit market segments; disruptions in or attacks (including cyber-attacks) on the Company's information technology, internet, network access or other voice or data communications systems or services; the evolution of various types of fraud or other criminal behavior to which the Company is exposed; the failure of third parties to comply with their obligations; difficulty integrating newly acquired businesses; the impact of new and changes to, or application of, current laws and regulations; the overall difficult litigation and regulatory environment; increased competition; changes in foreign currency rates; increased funding costs and market volatility due to market illiquidity and competition for funding; critical accounting estimates and changes to accounting standards, policies, and methods used by the Company; the Company's status as an emerging growth company and a smaller reporting company; and the occurrence of natural and unnatural catastrophic events or health epidemics or concerns, such as the COVID-19 pandemic, and claims resulting from such events or concerns; as well as those risk factors discussed or referred to in the Company's disclosure documents filed with the U.S. Securities and Exchange Commission (the "SEC") available on the SEC's website at www.sec.gov, including the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and with the securities regulatory authorities in certain provinces of Canada available at www.sedar.com. Should any factor affect the Company in an unexpected manner, or should assumptions underlying the forward-looking statements prove incorrect, the actual results or events may differ materially from the results or events predicted. Any such forward-looking statements are expressly qualified in their entirety by this cautionary statement. Moreover, the Company does not assume responsibility for the accuracy or completeness of such forward-looking statements. The forward-looking statements included in this press release are made as of the date of this press release and the Company undertakes no obligation to publicly update or revise any forward-looking statements, other than as required by applicable law.


VIEMED HEALTHCARE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Expressed in thousands of U.S. Dollars, except share amounts)
(Unaudited)

At
March 31, 2022
At
December 31, 2021
ASSETS
Current assets
Cash and cash equivalents $ 29,248 $ 28,408
Accounts receivable, net of allowance for doubtful accounts of $8,484 and $7,031 at March 31, 2022 and December 31, 2021, respectively 13,599 12,823
Inventory, net of inventory reserve of $0 and $1,418 at March 31, 2022 and December 31, 2021, respectively 2,503 2,457
Income tax receivable 676 1,893
Prepaid expenses and other assets 1,778 1,729
Total current assets $ 47,804 $ 47,310
Long-term assets
Property and equipment, net 63,977 62,846
Equity investments 2,359 2,157
Deferred tax asset 3,985 4,787
Other long-term assets 882 862
Total long-term assets $ 71,203 $ 70,652
TOTAL ASSETS $ 119,007 $ 117,962
LIABILITIES
Current liabilities
Trade payables $ 3,697 $ 3,239
Deferred revenue 3,888 3,753
Accrued liabilities 8,739 8,875
Current portion of lease liabilities 361 464
Current portion of long-term debt 1,049 1,480
Total current liabilities $ 17,734 $ 17,811
Long-term liabilities
Accrued liabilities 731 757
Long-term lease liabilities 232 268
Long-term debt 4,266 4,306
Total long-term liabilities $ 5,229 $ 5,331
TOTAL LIABILITIES $ 22,963 $ 23,142
Commitments and Contingencies
SHAREHOLDERS' EQUITY
Common stock - No par value: unlimited authorized; 39,293,778 and 39,640,388 issued and outstanding as of March 31, 2022 and December 31, 2021, respectively 14,348 14,014
Additional paid-in capital 8,720 7,749
Accumulated other comprehensive loss (115 ) (278 )
Retained earnings 73,091 73,335
TOTAL SHAREHOLDERS' EQUITY $ 96,044 $ 94,820
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 119,007 $ 117,962


VIEMED HEALTHCARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND COMPREHENSIVE INCOME
(Expressed in thousands of U.S. Dollars, except outstanding shares and per share amounts)
(Unaudited)

Three Months Ended March 31,
2022 2021
Revenue $ 32,255 $ 28,416
Cost of revenue 12,512 10,674
Gross profit $ 19,743 $ 17,742
Operating expenses
Selling, general and administrative 15,776 14,509
Research and development 632 339
Stock-based compensation 1,305 1,307
Depreciation 237 200
Other (income) expense (455 ) 55
Income from operations $ 2,248 $ 1,332
Non-operating income and expenses
Income from equity method investments (323 ) (220 )
Interest expense, net of interest income 64 91
Net income before taxes 2,507 1,461
Provision (benefit) for income taxes 745 (223 )
Net income $ 1,762 $ 1,684
Other comprehensive income
Change in unrealized gain/loss on derivative instruments, net of tax 163 106
Other comprehensive income $ 163 $ 106
Comprehensive income $ 1,925 $ 1,790
Net income per share
Basic $ 0.04 $ 0.04
Diluted $ 0.04 $ 0.04
Weighted average number of common shares outstanding:
Basic 39,621,741 39,129,407
Diluted 40,363,456 40,663,368


VIEMED HEALTHCARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Expressed in thousands of U.S. Dollars)
(Unaudited)

Three Months Ended March 31,
2022 2021
Cash flows from operating activities
Net income $ 1,762 $ 1,684
Adjustments for:
Depreciation 3,397 2,609
Change in allowance for doubtful accounts 3,445 1,819
Change in inventory reserve (1,418 ) (4 )
Share-based compensation 1,305 1,307
Distributions of earnings received from equity method investments 221
Income from equity method investments (323 ) (220 )
(Gain) Loss on disposal of property and equipment (14 ) 76
Deferred income tax expense (benefit) 745 (222 )
Net change in working capital
Increase in accounts receivable (4,221 ) (2,728 )
Decrease in inventory 1,372 94
Increase in prepaid expenses and other assets (68 ) (161 )
(Decrease) increase in trade payables (467 ) 438
Increase in deferred revenue 135 13
Increase (decrease) in accrued liabilities 58 (77 )
Change in income tax payable/receivable 1,217
Net cash provided by operating activities $ 7,146 $ 4,628
Cash flows from investing activities
Purchase of property and equipment (3,963 ) (1,797 )
Investment in equity investments (100 )
Proceeds from sale of property and equipment 256 99
Net cash used in investing activities $ (3,807 ) $ (1,698 )
Cash flows from financing activities
Proceeds from exercise of options 65
Principal payments on notes payable (39 ) (37 )
Principal payments on term note (433 ) (414 )
Shares repurchased under the share repurchase program (1,887 )
Shares redeemed to pay income tax (119 ) (1,434 )
Repayments of lease liabilities (21 ) (994 )
Net cash used in financing activities $ (2,499 ) $ (2,814 )
Net (decrease) increase in cash and cash equivalents 840 116
Cash and cash equivalents at beginning of year 28,408 30,981
Cash and cash equivalents at end of period $ 29,248 $ 31,097
Supplemental disclosures of cash flow information
Cash paid during the period for interest $ 66 $ 117
Refunds received during the period for income taxes $ 1,217 $
Supplemental disclosures of non-cash transactions
Net non-cash changes to finance leases $ $ 12
Net non-cash changes to operating leases $ $ 85

Non-GAAP Financial Measures

This press release refers to "Adjusted EBITDA" which is a non-GAAP financial measure that does not have a standardized meaning prescribed by U.S. GAAP. The Company's presentation of this financial measure may not be comparable to similarly titled measures used by other companies. Adjusted EBITDA is defined as net income (loss) before interest expense, income tax expense (benefit), depreciation, and stock-based compensation. Management believes Adjusted EBITDA provides helpful information with respect to the Company's operating performance as viewed by management, including a view of the Company's business that is not dependent on the impact of the Company's capitalization structure and items that are not part of the Company's day-to-day operations. Management uses Adjusted EBITDA (i) to compare the Company's operating performance on a consistent basis, (ii) to calculate incentive compensation for the Company's employees, (iii) for planning purposes, including the preparation of the Company's internal annual operating budget, and (iv) to evaluate the performance and effectiveness of the Company's operational strategies. Accordingly, management believes that Adjusted EBITDA provides useful information in understanding and evaluating the Company's operating performance in the same manner as management. The following table is a reconciliation of net income (loss), the most directly comparable U.S. GAAP measure, to Adjusted EBITDA, on a historical basis for the periods indicated:

VIEMED HEALTHCARE, INC.
Reconciliation of Net Income to Non-GAAP Adjusted EBITDA
(Expressed in thousands of U.S. Dollars)
(Unaudited)

For the quarter ended March 31,
2022
December 31,
2021
September 30,
2021
June 30,
2021
March 31,
2021
December 31,
2020
September 30,
2020
June 30,
2020
Net Income $ 1,762 $ 4,087 $ 1,789 $ 1,566 $ 1,684 $ 5,071 $ 2,804 $ 19,412
Add back:
Depreciation 3,397 3,120 2,867 2,716 2,609 2,835 2,425 2,190
Interest expense 64 69 75 83 91 100 116 135
Stock-based compensation 1,305 1,305 1,302 1,236 1,307 1,301 1,234 1,196
Income tax expense (benefit) 745 968 1,386 1,246 (223 ) 151 1,141 (6,646 )
Adjusted EBITDA $ 7,273 $ 9,549 $ 7,419 $ 6,847 $ 5,468 $ 9,458 $ 7,720 $ 16,287

Use of Non-GAAP Financial Measures

Adjusted EBITDA should be considered in addition to, not as a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP. It is not a measurement of the Company's financial performance under U.S. GAAP and should not be considered as an alternative to revenue or net income, as applicable, or any other performance measures derived in accordance with U.S. GAAP and may not be comparable to other similarly titled measures of other businesses. Adjusted EBITDA has limitations as an analytical tool and you should not consider it in isolation or as a substitute for analysis of the Company's operating results as reported under U.S. GAAP. Adjusted EBITDA does not reflect the impact of certain cash charges resulting from matters the Company considers not to be indicative of ongoing operations; and other companies in the Company's industry may calculate Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure.

VIEMED HEALTHCARE, INC.
Key Financial and Operational Information
(Expressed in thousands of U.S. Dollars, except vent patients)
(Unaudited)

For the quarter ended March 31,
2022
December 31,
2021
September 30,
2021
June 30,
2021
March 31,
2021
December 31,
2020
September 30,
2020
June 30,
2020
Financial Information:
Revenue $ 32,255 $ 31,962 $ 29,285 $ 27,399 $ 28,416 $ 31,202 $ 33,447 $ 42,854
Gross Profit $ 19,743 $ 19,662 $ 18,381 $ 17,625 $ 17,742 $ 19,178 $ 19,453 $ 25,927
Gross Profit % 61 % 62 % 63 % 64 % 62 % 61 % 58 % 61 %
Net Income $ 1,762 $ 4,087 $ 1,789 $ 1,566 $ 1,684 $ 5,071 $ 2,804 $ 19,412
Cash (As of) $ 29,248 $ 28,408 $ 26,867 $ 31,151 $ 31,097 $ 30,981 $ 32,396 $ 29,707
Total Assets (As of) $ 119,007 $ 117,962 $ 115,486 $ 111,014 $ 113,001 $ 112,560 $ 113,969 $ 112,178
Adjusted EBITDA (1) $ 7,273 $ 9,549 $ 7,419 $ 6,847 $ 5,468 $ 9,458 $ 7,720 $ 16,287
Operational Information:
Vent Patients (2) 8,434 8,405 8,200 8,103 7,733 7,892 7,788 7,705

(1) Refer to "Non-GAAP Financial Measures" section above for definition of Adjusted EBITDA.

(2) Vent Patients represents the number of active ventilator patients on recurring billing service at the end of each calendar quarter.



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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

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html

SOURCE Medtronic plc

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

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

(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
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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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