Filed by Longview Acquisition Corp. II
Pursuant to Rule 425 under the Securities Act of
1933
and deemed filed pursuant to Rule 14a-12
under the Securities Exchange Act of 1934
Subject Company: Longview Acquisition Corp. II
Commission File No. 001-40242
Date: November 3, 2021
CMS Sets National Payment Rate for the HeartFlow
Analysis in Doctors’ Offices and Imaging Centers
REDWOOD
CITY, Calif. – November 3, 2021 – HeartFlow, Inc., the leader
in revolutionizing precision heart care, today announced the Centers for Medicare & Medicaid Services (CMS) have established a national
payment rate of $930.34 for the HeartFlow FFRct Analysis in office-based settings, such as doctors’ offices and imaging centers,
enabling more physicians and patients to gain access to the HeartFlow technology. The new rate will go into effect on January 1, 2022,
as part of the CMS Physician Fee Schedule (PFS) Final Rule for 2022.
“Having a national payment rate ensures that more Medicare patients
with coronary artery disease (CAD) will have access to the highly accurate1 HeartFlow Analysis without having to worry about
where they are receiving their care,” said John H. Stevens, MD, President, CEO and Co-Founder, HeartFlow. “Approximately 50%
of non-invasive cardiac imaging tests are performed in office-based settings2, so there is exciting potential for this reimbursement
decision to unlock new opportunity to further broaden adoption of our technology.”
CMS also continues to provide a national payment rate of $950.50 for
the HeartFlow Analysis in the hospital outpatient setting as part of the 2022 Outpatient Prospective Payment System (OPPS) Final Rule.
The CMS Final Rules for 2022 come on the heels of the release of the
new chest pain guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) in which the HeartFlow
Analysis was recommended as a Class 2a test, identifying it as an important tool for diagnosing CAD and guiding decision-making regarding
the use of revascularization procedures such as coronary stenting or bypass surgery. The guidelines also elevated coronary computed tomography
angiography (CTA) to Class 1 with Level of Evidence A, indicating the preeminent role of a CT-led diagnostic pathway for evaluating and
managing patients with CAD.
# # #
About the HeartFlow FFRct Analysis
Starting
with a standard coronary CTA, the HeartFlow Analysis leverages algorithms trained using deep learning (a form of AI) and highly trained
analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve
millions of complex equations to simulate blood flow and provides FFRct values along the coronary arteries. This information is used
by physicians in evaluating the impact a blockage may be having on blood flow and determine the optimal course of treatment for each
patient. A positive FFRct value (≤0.80) indicates that a coronary blockage is impeding blood flow to the heart muscle to a
degree which may warrant invasive management.
Data demonstrating the safety, efficacy and cost-effectiveness of the
HeartFlow Analysis have been published in more than 500 peer-reviewed publications, including long-term data out to five years. The HeartFlow
Analysis offers the highest diagnostic performance available from a non-invasive test.1 To date, clinicians around the world
have used the HeartFlow Analysis for more than 100,000 patients to aid in the diagnosis of heart disease.
About HeartFlow
HeartFlow
is the leader in revolutionizing precision heart care, uniquely combining human ingenuity with advanced technology. HeartFlow’s
non-invasive HeartFlow FFRct Analysis leverages artificial intelligence to create a personalized three-dimensional model of the heart.
Clinicians can use this model to evaluate the impact a blockage has on blood flow and determine the best treatment for patients. HeartFlow’s
technology is reflective of our Silicon Valley roots and incorporates over two decades of scientific evidence with the latest advances
in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, UK, Canada, Europe and Japan.
For more information, visit www.heartflow.com.
Important Information about the Business
Combination and Where to Find It
In
connection with the proposed Business Combination pursuant to the business combination agreement, dated as of July 15, 2021 (as amended,
the “Business Combination Agreement”), by and among Longview Acquisition Corp. II (“Longview”), HF Halo Merger
Sub, Inc. and HeartFlow Holding, Inc., the parent company of HeartFlow, Inc., Longview has filed with the Securities and Exchange Commission
(the “SEC”) a registration statement on Form S-4 (the “Registration Statement”), which includes a preliminary
proxy statement/prospectus and, as amended, will include a definitive proxy statement/prospectus, and certain other related documents,
which will be both the proxy statement to be distributed to holders of shares of Longview’s common stock in connection with Longview’s
solicitation of proxies for the vote by Longview’s stockholders with respect to the Business Combination and other matters as may
be described in the Registration Statement, as well as the prospectus relating to the offer and sale of the securities of Longview to
be issued in the Business Combination. Longview’s stockholders and other interested persons are advised to read the preliminary
proxy statement/prospectus included in the Registration Statement and the amendments thereto and the definitive proxy statement/prospectus,
as well as other documents filed with the SEC in connection with the proposed Business Combination, as these materials will contain important
information about the parties to the Business Combination Agreement, Longview and the proposed Business Combination. After the
Registration Statement is declared effective, the definitive proxy statement/prospectus and other relevant materials for the proposed
Business Combination will be mailed to stockholders of Longview as of a record date to be established for voting on the proposed Business
Combination and other matters as may be described in the Registration Statement. Stockholders will also be able to obtain copies of the
preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, and other documents filed with the SEC that will be
incorporated by reference therein, without charge, once available, at the SEC’s web site at www.sec.gov, or
by directing a request to: Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor, New York, NY 10153, Attention: Mark Horowitz,
Chief Financial Officer or to info@longviewacquisition.com.
Participants in the Solicitation
Longview
and its directors and executive officers may be deemed participants in the solicitation of proxies from Longview’s stockholders
with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests
in Longview is contained in the Registration Statement for the Business Combination and is available free of charge at the SEC’s
web site at www.sec.gov, or by directing a request to Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor,
New York, NY 10153, Attention: Mark Horowitz, Chief Financial Officer or to info@longviewacquisition.com. Additional information
regarding the interests of such participants is contained in the Registration Statement.
HeartFlow and its directors and executive
officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Longview in connection with the
Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the Business
Combination is contained in the Registration Statement.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.
HeartFlow’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on
these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,”
“budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,”
“could,” “should,” “indicate,” “believes,” “predicts,” “potential,”
“continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such
forward-looking statements. These forward-looking statements include, without limitation, HeartFlow’s statements regarding the anticipated
impact of the CMS payment rates . These forward-looking statements involve significant risks and uncertainties that could cause the actual
results to differ materially from the expected results. Most of these factors are outside Longview’s and HeartFlow’s control
and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of Longview and
HeartFlow prior to the Business Combination, and the combined company following the Business Combination, to meet the closing conditions
in the Business Combination Agreement, including due to failure to obtain approval of the stockholders of Longview and HeartFlow or certain
regulatory approvals, or failure to satisfy other conditions to closing in the Business Combination Agreement; (2) the occurrence of any
event, change or other circumstances, including the outcome of any legal proceedings that may be instituted against Longview and HeartFlow
following the announcement of the Business Combination Agreement and the transactions contemplated therein, that could give rise to the
termination of the Business Combination Agreement or could otherwise cause the transactions contemplated therein to fail to close; (3)
the inability to obtain or maintain a stock exchange listing of the combined company’s Class A common stock, as applicable, following
the Business Combination; (4) the risk that the Business Combination disrupts current plans and operations as a result of the announcement
and consummation of the Business Combination; (5) the inability to recognize the anticipated benefits of the Business Combination, which
may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain
its key employees; (6) costs related to the Business Combination; (7) changes in applicable laws or regulations or the healthcare industry;
(8) the inability of the combined company to raise financing in the future; (9) the success, cost and timing of HeartFlow’s and
the combined company’s product development activities, including market adoption of their current and future products; (10) the
inability of HeartFlow or the combined company to obtain and maintain regulatory approval for their current and future products, and any
related restrictions and limitations of any approved product; (11) the inability of HeartFlow or the combined company to build effective
sales and marketing capabilities to support the combined company’s growth strategy; (12) the inability of HeartFlow or the combined
company to maintain HeartFlow’s existing customer, license, and collaboration agreements, and arrangements with commercial and government
payers; (13) future changes in clinical guidelines, or the timing of increased adoption and use, if any, of HeartFlow’s products
as a result of the publication of positive clinical guidelines that support the use of HeartFlow’s and the combined company’s
products; (14) the inability of HeartFlow or the combined company to compete with other companies marketing or engaged in the development
of products that aid physicians in the evaluation and treatment of coronary artery disease; (15) the size and growth potential of the
markets for HeartFlow’s and the combined company’s products, and each of their ability to serve those markets, either alone
or in partnership with others; (16) the pricing of HeartFlow’s and the combined company’s products and reimbursement for medical
procedures conducted using HeartFlow’s and the combined company’s products, future changes to or reductions in reimbursement
and payment rates, and whether improvements in reimbursement rates will actually result in increased adoption of HeartFlow’s products;
(17) HeartFlow’s and the combined company’s estimates regarding expenses, future revenue, capital requirements and needs for
additional financing; (18) HeartFlow’s and the combined company’s financial performance; (19) the impact of COVID-19 on HeartFlow’s
business and/or the ability of the parties to complete the Business Combination; and (20) other risks and uncertainties indicated from
time to time in the proxy statement/prospectus relating to the Business Combination, including those under “Risk Factors”
in the Registration Statement, and in Longview’s other filings with the SEC.
The foregoing list of factors is not exclusive.
and investors should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Neither HeartFlow
nor Longview undertakes or accepts any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements
to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based.
No Offer or Solicitation
This communication shall not constitute a
solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This communication
shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities
in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements
of section 10 of the Securities Act of 1933, as amended.
Contact
For Investors:
Leigh Salvo or Jack Droogan
Gilmartin Group
Investors@heartflow.com
For Media:
Jennie Kim
HeartFlow
media@heartflow.com
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1.
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Driessen, R., et al. J Am Coll Cardiol. 2019;73(2),161-73
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2.
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Reeves, R., et al. Radiology: Cardiothoracic Imaging 2021; 3(5):e210156
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