Full Press Release Details
Totality of Evidence from BeAT-HF Study Shows
CVRx's Barostim Provides Long-term Benefits for Patients with Heart Failure
MINNEAPOLIS, Mar. 21, 2023 -
CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), a commercial-stage medical device company focused on developing, manufacturing
and commercializing Barostim , an innovative extravascular implantable neuromodulation device for patients with cardiovascular
diseases, announced detailed preliminary results of the post-market phase of the BeAT-HF trial at the second annual Technology and Heart
Failure (HF) Therapeutics (THT) conference on Tuesday, March 21, 2023. These results are being presented by Dr. Michael Zile,
Professor of Cardiology at the Medical University of South Carolina (MUSC).
Highlights of the data presented by Dr. Zile include:
Dr. Zile's presentation concludes
that the "Totality of evidence indicates that BAT is a safe, effective and durable treatment for patients with heart failure with
reduced ejection fraction." The slides from Dr. Zile's featured presentation, as well as key slides that will be presented
as part of the CVRx-sponsored THT symposium, can be found at ir.cvrx.com.
are happy to see the significant long-term data that favored Barostim," added Nadim Yared, President and CEO of CVRx. "Interest
and adoption of the therapy continue to expand based on the previously-approved claims, and now we look forward to submitting this new
data to the FDA to pursue expanded labeling for Barostim. We are forever grateful to the patients, investigators, nurses, and research
staff involved in the study."
full results of BeAT-HF, including a number of additional analyses and endpoints, will be submitted by the executive steering committee
for publication in one or more peer-reviewed journals. CVRx anticipates that regulatory submission to the FDA for expanded labeling will
be made in the coming months.
CVRx is a commercial-stage medical device company focused on the developing,
manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim is
the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with 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 Statements
This 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 our future financial performance, our anticipated growth strategies, anticipated trends in
our industry, our business prospects and our opportunities, including specifically those related to potential new indications, labelling
or marketing opportunities, our continued review and analysis of trial data and future business and financial impacts. In some cases,
you can identify forward-looking statements by terms such as "may," "will," "should," "expect,"
"plan," "anticipate," "could," "outlook," "guidance," "intend,"
"target," "project," "contemplate," "believe," "estimate," "predict,"
"potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking
statements contain these words.
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, uncertainties related to obtaining
regulatory approvals, further analysis and understanding of clinical trial data, physician and patient adoption, and other important
factors that could cause actual results, performance or achievements to differ materially from those projected in the forward-looking
statements 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.
Mark Klausner or Mike Vallie