CVRx receives FDA approval for expanded labeling of Barostim
2023年12月26日 - 10:05PM
CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical
device company, announced today that the U.S. Food and Drug
Administration (FDA) has approved revised Instructions For Use
(IFU) for Barostim incorporating key long-term clinical data from
the BeAT-HF randomized clinical trial.
“We are very pleased to receive this important validation from
FDA of the long-term results of the post-market phase of the
BeAT-HF clinical trial and excited we can now share this data with
physicians and patients,” said Nadim Yared, President and CEO of
CVRx. “We remain grateful to all patients, investigators, research
teams, the executive steering committee and FDA personnel, for
supporting our efforts to conduct this landmark study over seven
years, including the difficulties encountered during the COVID-19
pandemic.”
Labeling UpdateThe updated Indications
statement for Barostim in the IFU now reads:
Barostim is indicated for patients
who are NYHA Class III or Class II (who had a recent history of
Class III) despite treatment with guideline-directed medical
therapies (medications and devices), have a left ventricular
ejection fraction of ≤ 35%, and a NT-proBNP <1600 pg/ml.
Barostim delivers Baroreflex
Activation Therapy to improve patients’ heart failure functional
status, six-minute hall walk, and quality of life.
The revised Clinical Summary section of the IFU now includes the
primary endpoint results, the 6, 12 and 24 month symptomatic data,
the win ratio, and the all-cause mortality data. The Clinical
Summary concludes:
In summary, the primary safety
endpoint in the Pre-Market Phase was previously met and confirmed
in the Post-Market Phase. In the Pre-Market Phase, all
effectiveness endpoints were previously met, demonstrating 6-months
improvements in 6MHW, quality of life, NYHA Class and NT-proBNP.
The Post-Market Phase effectiveness primary endpoint of CV death
and HF hospitalization was not met. Additional Post-Market Phase
effectiveness analyses (Win Ratio, freedom from all-cause
mortality) suggested a favorable effect of Barostim therapy. The
totality of the 6, 12 and 24-month data demonstrated symptomatic
improvements for heart failure patients who are NYHA Class III or
Class II (who had a recent history of Class III) despite treatment
with guideline-directed therapies and have a left ventricular
ejection fraction ≤35% and a NT-proBNP <1600 pg/ml.
The revised IFU document can be found at www.cvrx.com/ifu, and
the Clinical Summary section of that IFU can be found at pages 24
to 39.
Annual Market Opportunity UpdateOur estimate of
the U.S. annual market opportunity for Barostim has been revised to
increase the number of patients considered by physicians based on
this new long-term safety and efficacy data as well as our
commercial experience, and to account for the new reimbursement
assignment for Barostim. We believe the U.S. annual market
opportunity is now $2.2 billion, or 76,000 new patients, as
compared to our earlier estimate of $1.4 billion, or 55,000 new
patients, representing increases of approximately 60% and 38%,
respectively.
About CVRx, Inc.CVRx is focused on the
development and commercialization of the Barostim™ System, the
first medical technology approved by FDA that uses neuromodulation
to improve the symptoms of heart failure. Barostim is an
implantable device that delivers electrical pulses to baroreceptors
located in the wall of the carotid artery. Baroreceptors activate
the body’s baroreflex, which in turn triggers an autonomic response
to the heart. The therapy is designed to restore balance to the
autonomic nervous system and thereby reduce the symptoms of heart
failure. Barostim received the FDA Breakthrough Device designation
and is FDA-approved for use in heart failure patients in the U.S.
It has also received the CE Mark for heart failure and resistant
hypertension in the European Economic Area. To learn more about
Barostim, visit www.cvrx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
other than statements of historical facts are forward-looking
statements, including statements regarding the expected market for
Barostim. The forward-looking statements in this press release are
only predictions and are based largely on our current expectations
and projections about future events and financial trends that we
believe may affect our business, financial condition, and results
of operations. These forward-looking statements speak only as of
the date of this press release and are subject to a number of known
and unknown risks, uncertainties and assumptions, including, but
not limited to, our ability to demonstrate to physicians and
patients the merits of our Barostim and other important factors
that could cause actual results, performance or achievements to
differ materially from those that are found in “Part I, Item 1A.
Risk Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2022, as such factors may be updated from time to time
in our other filings with the Securities and Exchange Commission.
Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Media Contact:Laura O’NeillFinn
Partners917.497.2867 laura.oneill@finnpartners.com
Investor Contact:Mark Klausner or Mike
VallieICR Westwicke443.213.0501ir@cvrx.com
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