FDA Accepts Label Update for Plasma IQ™, the First FDA-Cleared Handheld Plasma Energy Device
Suneva Medical announced FDA acceptance of updates to the Plasma IQ label, notably removing the eye contraindication, enhancing treatment options around the eye. This update supports the company’s merger with Viveon Health Acquisition Corp. (VHAQ), aiming for increased market access. Plasma IQ is the first handheld FDA-cleared plasma energy device for skin lesion treatment. The merger is set to allow shares to trade under the symbol RNEW upon completion. Suneva, located in San Diego, continues to innovate in regenerative aesthetics, focusing on patient solutions.
- FDA accepted updates to Plasma IQ label, removing the eye contraindication, enhancing treatment options.
- Merger with Viveon Health Acquisition Corp. (VHAQ) set to increase market access and patient reach.
- Plasma IQ is the first FDA-cleared handheld plasma energy device for skin lesion treatment.
- Potential risks associated with the merger, including regulatory approvals and stockholder redemptions.
- Uncertainties regarding reaching the anticipated patient population with Plasma IQ.
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.
FAQ
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