SAN DIEGO, Feb. 8, 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 it reached a
milestone of distributing more than 1 million syringes of
Bellafill® at the close of 2021. Bellafill, which
has been available for regenerative aesthetic use since 2007, is
Suneva's five-year, FDA-approved filler for the correction of
nasolabial folds and moderate to severe, atrophic, distensible
facial acne scars on people's cheeks.
Bellafill is one of the most studied dermal fillers on the
market, with more than 1,542 patients enrolled across multiple
clinical studies, demonstrating its safety and efficacy. In a
14-year post-market surveillance study, data shows Bellafill had a
consistently low adverse event rate (0.11%) comparable to other
injectable hyaluronic acid (HA) fillers.
"The distribution of Bellafill's millionth syringe is an
extraordinary milestone for believers like myself at Suneva, but
what's more important to us is the improvement in self-image for
the countless patients who have benefited from this product," said
Pat Altavilla, Chief Executive
Officer of Suneva. "Bellafill's popularity has grown in recent
years, as there are a growing number of patients who are looking
for longer-term replacements to shorter-acting fillers, which
typically last roughly one to two years. Bellafill can address this
growing patient demand and energize the treatment-related needle
and budget fatigue many aesthetic patients are likely to feel."
A Harris Poll1 survey of U.S.-based dermal filler
patients revealed that almost 90% of patients interviewed
experienced "filler fatigue."2 This phenomenon refers to
the feeling of frustration as a result of having to return to
dermal filler providers regularly in order to maintain the filler's
benefits. This poll demonstrated that many of these patients are
impacted by the time, pain and cost of regular and on-going filler
injections.
Suneva has built its product portfolio to consist of several
"only" and "first to market" products. Bellafill is the only filler
that stimulates the patient's own natural collagen, providing
immediate correction and lasting up to five years with each
treatment. For full product and safety information, visit:
https://www.sunevamedical.com/ifu/.
"Bellafill has been revolutionary for both my patients and
practice," said Dr. Jason Rupeka, at
Youthology Medspa in Warren, OH.
"Bellafill is a game changing product that has differentiated
myself from other aesthetic providers. By offering my patients
instant volume results along with future endogenous collagen
production, I've been able to serve their immediate aesthetic needs
that will only improve over time. Bellafill provides an innovative
alternative for patients who had grown tired of the redundancy and
cost of other HA filler treatments."
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 American under the
symbol "RNEW."
About Bellafill®
Bellafill® is the only FDA-approved collagen-based
dermal filler with polymethyl methacrylate (PMMA) microspheres. The
collagen gel in Bellafill provides immediate volume and lift to
correct wrinkles and acne scars for up to five years. Once
injected, these microspheres work to stimulate the patient's own
natural collagen that provides structural support for
smoother-looking skin. Bellafill is only available via injection by
a physician, for patients 21 years or older. For more information,
visit https://bellafill.com/.
1 The survey was conducted online by The Harris Poll
on behalf of Suneva Medical and Vance & Associates within
the United States between February 26 and March 14, 2018 among 503
U.S. adults ages 30-65 who have had dermal fillers in the past.
Data was weighted where necessary to bring it into line with actual
proportions in the population.
2"Filler fatigue" is defined as those who selected
strongly or somewhat agree for any of the following statements: If
I could, I would get fillers more often; There are times that I've
felt that my filler doesn't last as long as it used to; Having to
frequently get fillers gets in the way of me living my life the way
I want to; I don't get fillers as often as I would like; It is a
hassle to find time to schedule a filler appointment; I have to
frequently make appointments to get fillers.
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: the
ability for Bellafill to provide an alternative for patients,
address "filler fatigue" and differentiate providers; continued and
increasing demand for long-lasting derma fillers; the combined
company's shares being traded on the NYSE American; 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 Bellafill to reach as wide of
a patient population as anticipated or to continue to perform as it
has in the past; 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.