Log in
Show password
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 


SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

MEDTRONIC PLC : Regulation FD Disclosure (form 8-K)

10/15/2021 | 04:34pm EST

Item 7.01 Regulation FD Disclosure

Medtronic plc (the "Company") is providing an update on its SPYRAL HTN-ON MED clinical study ("ON MED study") of its Symplicity™ Renal Denervation System to lower blood pressure in typical hypertensive patients taking up to three anti-hypertensive medications.

On September 10, the Company announced that it was expecting a prespecified interim data analysis of its ON MED study in October. The Company is announcing today that it has received notification from its ON MED study independent data safety monitoring board ("DSMB") that it has conducted the prespecified interim data analysis and has recommended that clinical trial enrollment continue as planned, until the full, predefined sample size is reached.

A prespecified interim analysis is designed to enable early stoppage of clinical trial enrollment should the results be significantly better than the planned clinical trial design assumptions. The trial was designed to follow 260 randomized patients for 6 months post procedure and is powered to detect a statistically significant and clinically relevant therapeutic benefit at the final analysis. The Company estimates that the follow-up of the full cohort of patients will be complete in the second half of calendar year 2022.

The statistically significant results from the Company's three previous sham-controlled SPYRAL studies (the ON MED and OFF MED pilot studies and the pivotal OFF MED study), and the data from the Company's Global Symplicity Registry of more than 3,000 real-world patients, give the Company confidence in its renal denervation program, including ultimate approval of the therapy. These data, in addition to the full clinical cohort, will complete the Company's robust premarket application to the U.S. FDA.

The Company expects renal denervation to become a multi-billion dollar market, with global market revenue now expected to exceed $500 million by calendar year 2026 and $2-3 billion by calendar year 2030. Of note, today's update does not impact the Company's fiscal year 2022 revenue and EPS guidance, nor does it affect the Company's long-range plan to deliver 5%+ organic revenue growth and 8%+ adjusted EPS growth. Management remains confident in its outlook and its pipeline, including its renal denervation program.

The information in this Item 7.01 of this Form 8-K shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to difficulties and delays inherent in the development, testing, approval, manufacturing, marketing and sale of medical products, government regulation and general economic conditions and other risks and uncertainties described in the Company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the Company, as filed with the U.S. Securities and Exchange Commission. In some cases, you can identify these statements by forward-looking words, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this Current Report on Form 8-K, including to reflect future events or circumstances.


© Edgar Online, source Glimpses

All news about MEDTRONIC PLC
12/02MEDTRONIC PLC Management's Discussion and Analysis of Financial Condition and Results ..
12/01Cloud DX selected by Medtronic for national collaboration
11/30Medtronic receives Health Canada licence for GI Genius™ intelligent endoscopy mod..
11/28Vincent Medical Strikes Product Distribution Deal with NYSE-listed Medtronic; Shares Ra..
11/24JPMorgan Adjusts Medtronic's Price Target to $130 from $148, Keeps Overweight Rating
11/24Bernstein Adjusts Medtronic's Price Target to $143 from $148, Keeps Outperform Rating
11/24Raymond James Adjusts Medtronic's Price Target to $127 from $142, Keeps Outperform Rati..
11/24Stifel Adjusts Medtronic's Price Target to $140 from $145, Keeps Buy Rating
11/24Truist Securities Adjusts Medtronic's Price Target to $142 from $148, Keeps Buy Rating
11/24Wells Fargo Adjusts Medtronic's Price Target to $137 From $144, Reiterates Overweight R..
More news
Analyst Recommendations on MEDTRONIC PLC
More recommendations
Financials (USD)
Sales 2022 32 396 M - -
Net income 2022 5 378 M - -
Net Debt 2022 22 296 M - -
P/E ratio 2022 27,4x
Yield 2022 2,35%
Capitalization 144 B 144 B -
EV / Sales 2022 5,12x
EV / Sales 2023 4,73x
Nbr of Employees 90 000
Free-Float 99,8%
Duration : Period :
Medtronic plc Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends MEDTRONIC PLC
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus BUY
Number of Analysts 27
Last Close Price 106,87 $
Average target price 141,32 $
Spread / Average Target 32,2%
EPS Revisions
Managers and Directors
Geoffrey Straub Martha Chairman & Chief Executive Officer
Karen L. Parkhill Chief Financial Officer & Executive Vice President
Laura Mauri Chief Clinical & Regulatory Officer, Senior VP
Richard E. Kuntz Chief Medical & Scientific Officer, Senior VP
Gregory L. Smith Executive VP-Global Operations & Supply Chain
Sector and Competitors
1st jan.Capi. (M$)
MEDTRONIC PLC-8.77%143 693
DEXCOM, INC.40.51%50 350