CVRx receives FDA approval for expanded labeling of Barostim
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The FDA's approval of revised Instructions For Use (IFU) for Barostim, based on the BeAT-HF clinical trial, represents a significant milestone for CVRx. This development is particularly relevant for stakeholders given the potential expansion of the patient base eligible for the therapy. Barostim's ability to improve heart failure functional status, quality of life and exercise capacity, as indicated by the six-minute hall walk (6MHW) metric, aligns with the clinical need for effective heart failure management strategies.
The revised clinical data included in the IFU, such as the primary endpoint results and win ratio, provides healthcare professionals with a comprehensive understanding of the device's performance. Notably, the post-market phase did not meet the primary endpoint of cardiovascular death and heart failure hospitalization, which could influence the perceived efficacy of Barostim therapy. However, the additional analyses suggest a favorable effect, which may support its adoption in clinical practice.
The projected increase in the U.S. annual market opportunity to $2.2 billion underscores the financial implications for CVRx and its investors. The 60% increase in market size estimate and the 38% increase in the anticipated new patient population reflect both the therapy's potential and the strategic importance of FDA approvals in driving commercial success. Stakeholders should monitor adoption rates and reimbursement policies, as these will be critical in realizing the projected market growth.
The FDA's approval of the revised IFU for Barostim therapy, which incorporates long-term data from the BeAT-HF clinical trial, could have a substantial impact on CVRx's market positioning. The inclusion of new symptomatic data and mortality statistics in the IFU is likely to influence physician prescribing behavior and patient acceptance. The New York Heart Association (NYHA) functional classification and N-terminal pro b-type natriuretic peptide (NT-proBNP) levels are critical metrics in heart failure management and the updated IFU now clearly defines the patient population that could benefit from Barostim therapy.
From an industry perspective, the potential increase in the annual market opportunity for Barostim, as estimated by CVRx, suggests a significant growth trajectory for the product. However, this optimistic projection must be balanced against the clinical effectiveness and safety concerns that may arise from the post-market phase data. The revised reimbursement assignment for Barostim will also play a crucial role in determining the product's commercial viability and uptake.
Investors should consider the competitive landscape of heart failure treatments and the barriers to market entry, such as regulatory hurdles and insurance coverage, when evaluating the long-term prospects of CVRx. The company's ability to leverage the revised IFU and capitalize on the expanded market opportunity will be key to its future financial performance.
The FDA's approval of the revised IFU for CVRx's Barostim device, with its inclusion of long-term clinical data, represents a pivotal development that could significantly influence the company's revenue streams. The adjustment of the U.S. annual market opportunity from $1.4 billion to $2.2 billion suggests a substantial increase in the total addressable market, which is a critical metric for investors evaluating the growth potential of medical device companies.
It is important to scrutinize the underlying assumptions behind the revised market opportunity estimates. The 60% increase in market size and the 38% increase in the new patient population forecast should be weighed against the actual market penetration and the rate of adoption post-FDA approval. Additionally, the financial impact of the new reimbursement assignment for Barostim will be a determining factor in the product's profitability.
Investors should also consider the operational and logistical challenges associated with scaling up to meet the increased market demand. CVRx's ability to manufacture and distribute Barostim effectively, as well as to navigate the competitive landscape of heart failure treatments, will be essential for translating the revised IFU into tangible financial success.
U.S. annual market opportunity increases based on real world adoption and strength of long-term BeAT-HF data
MINNEAPOLIS, Dec. 26, 2023 (GLOBE NEWSWIRE) -- 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 Update
The 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 ≤
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 ≤
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 Update
Our 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
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 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 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’Neill
Finn Partners
917.497.2867
laura.oneill@finnpartners.com
Investor Contact:
Mark Klausner or Mike Vallie
ICR Westwicke
443.213.0501
ir@cvrx.com
FAQ
What did CVRx announce regarding Barostim and the FDA approval?
What are the new indications for Barostim as per the updated IFU?
What does the revised Clinical Summary section of the IFU include?
Where can the revised IFU document be found?
How has the U.S. annual market opportunity for Barostim been revised?
