Catheter Precision, Inc. (“Catheter Precision”), a medical
device company focused on cardiac electrophysiology, announces
receipt of three commercial orders in the past 60 days as usage of
the device continues to increase in the U.S. On September 12, 2022
privately held Catheter Precision announced a definitive merger
agreement with Ra Medical Systems (NYSE American: RMED), which, if
completed, will result in a combined publicly traded company
focusing on the cardiac electrophysiology market.
VIVO is a non-invasive 3D imaging system that enables physicians
to identify the location of arrhythmias pre-procedure, streamlining
workflow and reducing overall procedure time. The VIVO technology
received FDA clearance at the end of 2020 with Catheter Precision
initiating a limited strategic launch in the U.S. in 2021. To date
VIVO has been utilized in more than 780 procedures worldwide. For
the nine months ended September 30, 2022 Catheter Precision revenue
from VIVO sales was approximately $190,000. Catheter Precision
expects orders from two or three additional hospital centers before
the end of 2022. Catheter Precision anticipates 2022 revenue in the
range of $230,000 to $270,000.
David Jenkins, Catheter Precision CEO, commented, “Conventional
invasive mapping can be both time-consuming and unsuccessful for
arrhythmia localization. In clinical studies VIVO has shown an up
to 30% reduction in mapping time, which we see as a clear advantage
for arrhythmia procedures. We chose to conduct a limited launch
with VIVO to ensure our clinical teams were effective in gaining
clinical acceptance while building customer demand. Based on our
initial success, we believe our strategy is working in the U.S.
Even more promising, our current customers continue to order the
single use disposable accessory, providing us an additional revenue
stream and further validation of VIVO’s clinical acceptance as a
valued tool prior to a ventricular ablation. With successful
completion of the merger, we look forward to expanding our sales
team and ramping our commercial activities in early 2023.”
In addition to FDA clearance, VIVO has been awarded the CE mark.
Catheter Precision recently announced that the VIVO technology was
featured in multiple presentations at the Society of Cardiac
Robotic Navigation Annual Meeting in Budapest, Hungary held in
September 2022.
Under the terms of the definitive merger agreement with Ra
Medical Systems, Catheter Precision will become a wholly owned
subsidiary of Ra Medical Systems in a stock-for-stock reverse
merger transaction. The merger is expected to close before the end
of 2022, subject to satisfying certain closing conditions,
including the receipt of shareholder approval by both
companies.
About Catheter Precision
Catheter Precision is an innovative U.S.-based medical device
company bringing new solutions to market to improve the treatment
of cardiac arrhythmias. It is focused on developing groundbreaking
technology for electrophysiology procedures by collaborating with
physicians and continuously advancing its products.
VIVO Indications for Use
VIVO is intended for acquisition, analysis, display and storage
of cardiac electrophysiological data and maps for analysis by a
physician.
VIVO is intended to be used as a pre-procedure planning tool for
patients with structurally normal hearts undergoing ablation
treatment for idiopathic ventricular arrhythmias.
About Ra Medical Systems
Ra Medical Systems, Inc. is a medical device company that owns
intellectual property related to an advanced excimer laser-based
platform for use in the treatment of vascular immune-mediated
inflammatory diseases. Its excimer laser and single-use catheter
system, together referred to as the DABRA Excimer Laser System, is
used as a tool in the treatment of peripheral artery disease.
Proposed Merger Agreement
On September 12, 2022, Ra Medical (“Ra Medical” or the
“Company”) announced entering into an Agreement and Plan of Merger
(the “Merger Agreement”) with privately held Catheter Precision,
Inc., a medical device and technology company focused in the field
of cardiac electrophysiology. Under the terms of the Merger
Agreement, Catheter Precision will become a wholly owned subsidiary
of Ra Medical in a stock-for-stock reverse merger transaction (the
“Merger”). If completed, the Merger will result in a combined
publicly traded company that will focus on the cardiac
electrophysiology market, one of the most robust and growing areas
of medical devices.
Catheter Precision has three product areas that it intends to
pursue. Its lead product, named VIVO™ (an acronym for View Into
Ventricular Onset) is an FDA-cleared and CE mark product that
utilizes non-invasive inputs to locate the origin of ventricular
arrhythmias, and, through its use, the physician can identify
patients for invasive catheter ablation, and with those patients,
reduce the amount of time in the invasive procedure. Ventricular
arrhythmias include ventricular tachyarrhythmias and premature
ventricular arrhythmias, diseases that affect millions of patients
who are not well treated today. While much past growth in the
electrophysiology market has been for atrial fibrillation, Catheter
Precision believes that ventricular arrhythmias represent a large
growth area moving forward. It also intends to pursue a second
generation of Amigo®, a robotic arm previously cleared by the FDA
and awarded the CE mark, which serves as a catheter control device
that can be remotely controlled outside of the procedure room.
Catheter Precision has demonstrated that patient outcomes could
potentially be enhanced by utilization of this device. Catheter
Precision is working toward a third product release in the first
half of 2023, which is a vessel closure device that would assist in
the closure of the insertion site of the percutaneous catheter or
other device used within the body. It is estimated that the
worldwide market for this closure assist device is over one million
procedures per year.
The Merger is currently expected to close before the end of
2022, subject to satisfying certain closing conditions, including
the receipt of shareholder approval by both companies. The
descriptions of the Merger, the proposals to be voted on in
connection with the Merger at the Ra Medical Special Meeting of
Stockholders, Catheter Precision and the other transactions and
matters contemplated thereby or referenced herein do not purport to
be complete and are qualified in their entirety by reference to Ra
Medical’s Current Reports on Form 8-K, including the Current
Reports on Form 8-K filed on September 12, 2022 and September 2,
2022, Ra Medical’s Quarterly Report on Form 10-Q for the period
ended June 30, 2022 and any prior or subsequent reports on Form
10-K, Form 10-Q or Form 8-K filed with the Securities and Exchange
Commission (the “SEC”) from time to time and available on the SEC
website, as well as Ra Medical’s website. On September 23, 2022, Ra
Medical filed a preliminary proxy statement relating to the Merger
with Catheter Precision with the SEC, as further described
below.
No Offer or Solicitation
This communication is not intended to and shall not constitute
an offer to buy or sell or the solicitation of an offer to buy or
sell any securities, or a solicitation of any vote or approval, nor
shall there be any sale of securities in any jurisdiction 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
U.S. Securities Act of 1933, as amended.
Additional Information and Where to Find It
The shares of Common Stock being issued in the Merger (the
“Securities”) are being offered and sold in transactions exempt
from registration under the Securities Act, in reliance on Section
4(a)(2) thereof. Catheter Precision and Ra Medical intend to
distribute a Private Placement Memorandum/Joint Information
Statement (the “PPM/Joint Information Statement”) to the
stockholders of Catheter Precision, and Catheter Precision
stockholders are encouraged to carefully read the PPM/Joint
Information Statement, together with Ra Medical’s concurrent SEC
filings, which will contain important information concerning the
transaction.
The Securities have not been registered under the Securities Act
and such Securities may not be offered or sold in the United States
absent registration or an exemption from registration under the
Securities Act and any applicable state securities laws.
On September 23, 2022, Ra Medical filed a preliminary proxy
statement (the “Preliminary Proxy”) and intends to file a
definitive proxy statement (the “Definitive Proxy”) to call, give
notice of and hold a meeting of its stockholders to vote to
approve, among other matters, (a) the Merger, and (b) the issuance
of the shares of Ra Medical Common Stock to be issued pursuant to
the terms of the Merger Agreement. Catheter Precision also intends
to furnish an information statement to its stockholders in
connection with the proposed Merger as part of the PPM/Joint
Information Statement. The only matters that Ra Medical is seeking
approval for at the Special Meeting of Stockholders are the matters
that are set forth in the Definitive Proxy.
The Definitive Proxy and PPM/Joint Information Statement contain
or will contain important information about Catheter Precision, the
proposed Merger and related matters. In addition, on September 12,
2022, Ra Medical filed a Current Report on Form 8-K that included
certain audited financial statements of Catheter Precision for the
two-year period ended December 31, 2021 (the “Catheter Audited
Financial Statements”), the unaudited financial statements of
Catheter Precision for the periods ended June 30, 2022 and June 30,
2021 (the “Catheter Precision Unaudited Financial Statements and
together with the Catheter Precision Audited Financial Statements,
the “Catheter Precision Financial Statements”), and the unaudited
pro forma combined financial information of the combined company as
of June 30, 2022 and for the year ended December 31, 2021 and the
six months ended June 30, 2022 (the “Pro Forma Financial
Information,” and collectively with the Catheter Precision
Financial Statements, the “Financial Information”).
Ra Medical intends to mail the Definitive Proxy to Ra Medical
stockholders, and Catheter Precision intends to electronically
disseminate the PPM/Joint Information Statement. INVESTORS AND
SECURITYHOLDERS OF RA MEDICAL AND CATHETER PRECISION ARE URGED TO
READ THESE MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT RA MEDICAL, CATHETER PRECISION
AND THE PROPOSED MERGER. THIS COMMUNICATION IS NOT A SUBSTITUTE FOR
THE PPM/JOINT INFORMATION STATEMENT, THE DEFINITIVE PROXY, THE
CURRENT REPORTS ON FORM 8-K, INCLUDING THE CURRENT REPORT ON FORM
8-K FILED ON SEPTEMBER 12, 2022, RA MEDICAL’s QUARTERLY REPORT FOR
THE PERIOD ENDED JUNE 30, 2022, OR ANY OTHER DOCUMENTS THAT RA
MEDICAL AND/OR CATHETER PRECISION MAY FILE WITH THE SEC OR SEND TO
THEIR RESPECTIVE SECURITYHOLDERS IN CONNECTION WITH THE PROPOSED
TRANSACTIONS. INVESTORS AND SECURITYHOLDERS MAY OBTAIN FREE COPIES
OF RA MEDICAL’S DOCUMENTS FILED WITH THE SEC, ONCE AVAILABLE, ON
THE RA MEDICAL WEBSITE OR ON THE SEC’S WEBSITE.
The unaudited pro forma combined financial information does not
purport to represent the actual results of operations that Ra
Medical and Catheter Precision would have achieved had the
companies been combined during the periods presented in the
unaudited pro forma combined financial statements and is not
intended to project the future results of operations that the
combined company may achieve after the Merger. The unaudited pro
forma combined financial information does not reflect any potential
cost savings that may be realized as a result of the Merger and
also does not reflect any restructuring or integration-related
costs to achieve those potential cost savings.
Participants in the Solicitation
Ra Medical, Catheter Precision and their respective directors
and executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Ra Medical in
connection with the proposed transaction. Information about Ra
Medical’s directors and executive officers is set forth in Ra
Medical’s Annual Report on Form 10-K for the year ended December
31, 2021, which was filed with the SEC on March 17, 2022, as
amended, and in subsequent filings made by Ra Medical with the SEC.
Other information regarding the interests of such individuals, as
well as information regarding Catheter Precision’s directors and
executive officers and other persons who may be deemed participants
in the proposed transaction, are set forth in the Preliminary Proxy
and will be set forth in the Definitive Proxy and other relevant
materials to be filed with the SEC when they become available. You
may obtain free copies of these documents as described in the
preceding paragraph.
Cautionary Note Regarding Forward-Looking Statements
This communication contains forward-looking statements which
include, but are not limited to, statements regarding anticipated
Catheter Precision revenues and sales team expansion, expected
timing, completion and effects of the proposed Merger, future
access to capital markets, and the plans and expectations of the
combined company regarding Catheter Precision’s products, including
its plans, strategies, projected timelines and estimated markets,
for and/or related to VIVO and the Amigo and vessel closure devices
described above. These forward-looking statements are subject to
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. Ra Medical’s and Catheter Precision’s
expectations and beliefs regarding these matters may not
materialize. Actual outcomes and results may differ materially from
those contemplated by these forward-looking statements as a result
of uncertainties, risks and changes in circumstances, including but
not limited to risks and uncertainties related to: the ability of
the parties to consummate the proposed Merger, satisfaction of
closing conditions precedent to the consummation of the proposed
Merger, potential delays in consummating the Merger and the ability
of Ra Medical and Catheter Precision to timely and successfully
achieve the anticipated benefits of the Merger, including the
ability of the combined company to access the capital markets at
such times and in such amounts, and on such terms, as needed to
meet the Net Cash requirements of the Merger Agreement, execute its
future business strategies and maintain its listing on the NYSE
American or other national stock exchange, potential application of
SEC and/or exchange “shell company” rules, and the ability of the
combined company to successfully pursue its product lines in the
manner and in the timeframe described here. The Merger Agreement
contains certain closing conditions, including a minimum prevailing
stock price for Ra Medical and Net Cash amount at closing, which do
not constitute representations or covenants of either party, and
are subject to waiver by the parties. If Ra Medical’s stock price
drops below certain levels, the amount of merger consideration, if
any, received by Catheter stockholders will be adversely impacted.
The parties have reserved the right to waive conditions to the
closing of the Merger and revise the Merger Agreement. Additional
risks and uncertainties that could cause actual outcomes and
results to differ materially from those contemplated by the
forward-looking statements are included under the caption “Risk
Factors” and elsewhere in Ra Medical’s most recent filings with the
SEC, including Ra Medical’s Preliminary Proxy Statement filed on
September 23, 2022, the Quarterly Report on Form 10-Q for the
quarter ended June 30, 2022, the Current Reports on Form 8-K,
including the Current Report on Form 8-K filed on September 12,
2022, and any prior or subsequent reports on Form 10-K, Form 10-Q
or Form 8-K filed with the SEC from time to time and available at
www.sec.gov. Important business and financial information about
Catheter Precision’s business and the related discussion and
analysis of financial condition and results of operations of
Catheter Precision is set forth in the Current Report on Form 8-K
being filed on September 12, 2022and the exhibits thereto and
should be read in conjunction with the Catheter Precision Financial
Statements and the pro forma financial statements for the combined
company that are attached as exhibits thereto. Risks and
uncertainties related to the Merger, Catheter Precision, and the
projections and estimates described above that may cause actual
results to differ materially from those expressed or implied in any
forward-looking statement are included “Risk Factors – Risk Related
to the Merger with Catheter Precision and – Risks Related to Our
Evaluation of Strategic Alternatives for our Legacy Assets,” and
“Risk Factors – Risks Related to the Business of Catheter
Precision,” which are filed as the exhibits to the Current Report
on Form 8-K filed on September 12, 2022. These documents can be
accessed on Ra Medical’s Investor Relations page at
https://ir.ramed.com/ by clicking on the link titled “SEC Filings.”
The risks and uncertainties may be amplified by the COVID-19
pandemic, which has caused significant economic uncertainty, and
ongoing volatility in the stock markets and the U.S. economy in
general. The extent to which the COVID-19 pandemic impacts Ra
Medical’s and Catheter Precision’s businesses, operations, and
financial results, including the duration and magnitude of such
effects, will depend on numerous factors, which are unpredictable,
including, but not limited to, the duration and spread of the
outbreak, its severity, the actions to contain the virus or treat
its impact, and how quickly and to what extent normal economic and
operating conditions can resume.
The forward-looking statements included in this communication
are made only as of the date hereof. Ra Medical and Catheter
Precision assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
Disclaimer
This press release relates to a proposed business combination
between Ra Medical and Catheter Precision. This document does not
constitute an offer to sell or exchange, or the solicitation of an
offer to buy or exchange, any securities, nor shall there be any
sale of securities in any jurisdiction in which such offer, sale or
exchange would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221020006020/en/
For Catheter Precision Missiaen Huck 973-691-2000
mhuck@catheterprecision.com
For Ra Medical Systems LHA Investor Relations Jody Cain
310-691-7100 jcain@lhai.com
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