SAN DIEGO, Jan. 28, 2022 /PRNewswire/ -- Suneva Medical,
Inc. ("Suneva" or the "Company"), an innovative medical technology
company using regenerative medicine to change the standard of care
in aesthetic treatments, today announced that the U.S. Food and
Drug Administration (FDA) accepted updates to the Plasma
IQ™ label, including the removal of the
product's eye contraindication. The removal of this specific
contraindication was due in part to a compilation of literature
provided to the FDA showing the safety and efficacy of the ablative
device on skin tissue, particularly around the eye area. This label
update allows Suneva to address treatment around the eye with
patients in the United States.
"On the heels of our announcement of the planned merger with
Viveon Health Acquisition Corp. to build on our leadership in the
regenerative aesthetics sector, we are pleased with the FDA's
decision to update the Plasma IQ label," said Pat Altavilla, Chief Executive Officer of
Suneva. "We believe Suneva's innovations have always been led by
science and I look forward to working with our partner Neauvia to
provide access of our Plasma IQ device to a larger patient
population looking to improve their aesthetics through a focused
energy treatment."
Suneva has built its product portfolio to consist of several
"only" and "first to market" products. Plasma IQ is the first
handheld FDA-cleared plasma energy device indicated for the removal
and destruction of skin lesions and coagulation of tissue. It is
the latest advancement in aesthetics that delivers focused,
controlled energy to effectively create microinjuries on the skin,
renewing and restoring it. Plasma IQ is prescription only and
should only be used by medically licensed and certified
practitioners. Plasma IQ is owned and manufactured by Neauvia.
Suneva is responsible for distribution of Plasma IQ within
North America. For full product
and safety information, visit:
https://www.sunevamedical.com/ifu/.
On January 12, 2022, Suneva
Medical and Viveon Health Acquisition Corp. (NYSE American: VHAQ)
("Viveon Health" or "VHAQ"), a special purpose acquisition company,
announced that they entered into a definitive merger agreement.
Upon completion of the transaction, the combined company's
securities are expected to be traded on the NYSE under the symbol
"RNEW."
About Suneva Medical, Inc.
Suneva Medical, Inc.,
headquartered in San Diego, CA, is
a leader in regenerative aesthetics. It is focused on developing,
manufacturing and commercializing branded products for providers
and their patients. Suneva Medical offers a portfolio of products
to address the impact of the aging process to deliver solutions
that leverage the body's own restorative capacity. The product
portfolio is composed of several "only" and "first to market"
solutions with both FDA PMA approval and 510(k) clearance. For more
information, visit www.sunevamedical.com.
Important Information About the Proposed Business Combination
and Where to Find It
In connection with the proposed
business combination, Viveon Health will file a registration
statement on Form S-4 containing a proxy statement/prospectus (the
"Form S-4") with the U.S. Securities and Exchange Commission (SEC).
The Form S-4 will include a proxy statement to be distributed to
holders of Viveon Health's common stock in connection with the
solicitation of proxies for the vote by Viveon Health's
stockholders with respect to the proposed transaction and other
matters as described in the Form S-4, as well as the prospectus
relating to the offer of securities to be issued to Suneva's
stockholders in connection with the proposed business combination.
After the Form S-4 has been filed and declared effective, Viveon
Health will mail a definitive proxy statement, when available, to
its stockholders. Investors, security holders and other interested
parties are urged to read the Form S-4, any amendments thereto and
any other documents filed with the SEC carefully and in their
entirety when they become available because they will contain
important information about Viveon Health, Suneva and the proposed
business combination. Additionally, Viveon Health will file other
relevant materials with the SEC in connection with the business
combination. Copies may be obtained free of charge at the SEC's web
site at www.sec.gov. Securityholders of Viveon Health are
urged to read the Form S-4 and the other relevant materials when
they become available before making any voting decision with
respect to the proposed business combination because they will
contain important information about the business combination and
the parties to the business combination. The information contained
on, or that may be accessed through, the websites referenced in
this press release is not incorporated by reference into, and is
not a part of, this press release.
Participants in the Solicitation
Viveon Health and its
directors and executive officers may be deemed participants in the
solicitation of proxies from Viveon Health'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 Viveon Health will be included in the Form S-4 for the
proposed business combination and be available at www.sec.gov.
Additional information regarding the interests of such participants
will be contained in the proxy statement/prospectus for the
proposed business combination when available. Information about
Viveon Health's directors and executive officers and their
ownership of Viveon Health's common stock is set forth in Viveon
Health's prospectus, dated December 22,
2020, as modified or supplemented by any Form 3 or Form 4
filed with the SEC since the date of such filing. Other information
regarding the direct and indirect interests of the participants in
the proxy solicitation will be included in the proxy
statement/prospectus pertaining to the proposed business
combination when it becomes available. These documents can be
obtained free of charge from the SEC's web site
at www.sec.gov.
Suneva and its directors and executive officers may also be
deemed to be participants in the solicitation of proxies from the
stockholders of Viveon Health in connection with the proposed
business combination. A list of the names of such directors and
executive officers and information regarding their interests in the
proposed business combination will be included in the Form S-4 for
the proposed business combination.
Forward-Looking Statements
Certain statements made in
this press release are "forward-looking statements" within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be
identified by the use of words such as "target," "believe,"
"expect," "will," "shall," "may," "anticipate," "estimate,"
"would," "positioned," "future," "forecast," "intend," "plan,"
"project," "outlook" and other similar expressions that predict or
indicate future events or trends or that are not statements of
historical matters. Examples of forward-looking statements include,
among others, statements made in this press release regarding:
increased access to Plasma IQ; the combined company's shares being
traded on the NYSE; the proposed transactions contemplated by the
merger agreement, including the benefits of the proposed business
combination; and becoming a leader in the regenerative aesthetics
sector. Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
Viveon Health's and Suneva's current beliefs, expectations and
assumptions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Actual results and outcomes may
differ materially from those indicated in the forward-looking
statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause
actual results and outcomes to differ materially from those
indicated in the forward-looking statements include, among others,
the following: (1) the occurrence of any event, change, or other
circumstances that could give rise to the termination of the merger
agreement; (2) the institution or outcome of any legal proceedings
that may be instituted against Viveon Health and/or Suneva
following the announcement of the merger agreement and the
transactions contemplated therein; (3) the inability of the parties
to complete the proposed business combination, including due to
failure to obtain approval of the stockholders of Viveon Health or
Suneva, certain regulatory approvals, or satisfy other conditions
to closing in the merger agreement; (4) the occurrence of any
event, change, or other circumstance that could give rise to the
termination of the merger agreement or could otherwise cause the
transaction to fail to close; (5) the failure to meet the minimum
cash requirements of the merger agreement due to Viveon Health
stockholder redemptions and the failure to obtain replacement
financing; (6) the inability to complete a concurrent PIPE; (7) the
impact of COVID-19 pandemic on Suneva's business and/or the ability
of the parties to complete the proposed business combination; (8)
the inability to obtain or maintain the listing of Viveon Health's
shares of common stock on the NYSE American following the proposed
business combination; (9) the risk that the proposed business
combination disrupts current plans and operations as a result of
the announcement and consummation of the proposed business
combination; (10) the ability to recognize the anticipated benefits
of the proposed business combination, which may be affected by,
among other things, competition and the ability of Suneva to grow
and manage growth profitably and retain its key employees; (11)
costs related to the proposed business combination; (12) changes in
applicable laws or regulations; (13) the possibility that Suneva
may be adversely affected by other economic, business, and/or
competitive factors; (14) the amount of redemption requests made by
Viveon Health's stockholders; (15) the inability for Plasma IQ to
reach as wide of a patient population as anticipated; and (16)
other risks and uncertainties indicated from time to time in the
final prospectus of Viveon Health for its initial public offering
dated December 22, 2020 filed with
the SEC and the Form S-4 relating to the proposed business
combination, including those under "Risk Factors" therein, and in
Viveon Health's other filings with the SEC. Viveon Health and
Suneva caution that the foregoing list of factors is not exclusive.
Viveon Health and Suneva caution readers not to place undue
reliance upon any forward-looking statements, which speak only as
of the date made. Viveon Health and Suneva do not undertake or
accept 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,
whether as a result of new information, future events, or
otherwise, except as may be required by applicable law. Neither
Viveon Health nor Suneva gives any assurance that the combined
company will achieve its expectations.
No Offer or Solicitation
This press release shall not
constitute a solicitation of a proxy, consent, or authorization
with respect to any securities or in respect of the proposed
business combination. This press release 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, or an exemption therefrom.
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SOURCE Suneva Medical, Inc.