United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
Current Report
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Item 8.01 Other Events
As previously announced, on January 12, 2022, Viveon Health Acquisition Corp., a Delaware corporation (“Viveon”), entered into a Merger Agreement (the “Merger Agreement”) by and among Viveon, VHAC Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Viveon (“Merger Sub”), and Suneva Medical, Inc., a Delaware corporation (“Suneva”). Pursuant to the terms of the Merger Agreement, a business combination between Viveon and Suneva will be effected through the merger of Merger Sub with and into Suneva, with Suneva surviving the merger as a wholly owned subsidiary of Viveon (the “Merger”). The board of directors of Viveon has (i) approved and declared advisable the Merger Agreement, the Merger and the other transactions contemplated thereby and (ii) resolved to recommend approval of the Merger Agreement and related transactions by the stockholders of Viveon.
On January 12, 2022, Pat Altavilla, President and Chief Executive Officer of Suneva was interviewed by: (i) Nicole Petallides for live streaming and subsequent website posting on the TD Ameritrade Network, and (ii) Michelle F. Davis of Bloomberg for subsequent publication.
On February 8, 2022, Suneva issued a press release announcing its distribution of more than 1 million syringes of Suneva’s Bellafill® product.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
Exhibit | Description | |
99.1 | TD Ameritrade interview | |
99.2 | Article posted by Bloomberg | |
99.3 | Press release issued February 8, 2022 | |
104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: February 8, 2022
Viveon Health Acquisition Corp. | ||
By: | /s/ Jagi Gill | |
Name: | Jagi Gill | |
Title: | Chief Executive Officer |
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Exhibit 99.1
Transcript of Interview with Pat Altavilla, January 12, 2022
Nicole Petallides | It’s time for our spotlight now. We are spotlighting Suneva Medical. The regenerative aesthetics company announced its SPAC merger agreement this morning. Joining us with all the details is the company’s CEO, Pat Altavilla. Thank you so much for being with us. Very excited that you could be on with us today. I know all about your products and an exciting time for rejuvenation. Tell me a little bit about why now and what the goals are here. |
Pat Altavilla | Why now? Because it’s a – we are truly at an inflection point. The company over the last 18 months has really built out a comprehensive portfolio of regenerative aesthetics products and we are very excited about that and we are truly at that inflection point; that’s why now. |
Nicole Petallides | Absolutely and as I looked through your products the Bellafill seems to be getting all the hype as this filler can last for years, right? |
Pat Altavilla | Up to 5 years - we have a 5 year indication from the FDA. Very exciting. |
Nicole Petallides | Yeah, I’m sure it is. So, as you move forward with this merger, what are the expectations right now. You have VHAQ which is Vivian Health and then eventually you will be Renew – that will be the new ticker symbol upon closing. What’s the timing right now, the expectations? |
Pat Altavilla | The expectation is that the merger will close sometime in the first half of this year. |
Nicole Petallides | And when you look at what’s going on in the world of rejuvenation, the part that is so exciting about Suneva in particular is that it’s immediate results. It’s noninvasive. Right? Tell me a little bit about the company and your enthusiasm about it. |
Pat Altavilla | Well Suneva is a great company that has been building its portfolio over the last 18 months. We started the Pandemic with a simple product in our portfolio and we have been very purposeful about the products that we’ve brought on. We wanted these products to really meet the patient’s needs, really throughout each decade of life, and – from 20’s to 90’s – and each of our products offers something a little bit different. We fundamentally built the portfolio on 4 basic pillars: structure, volume, lift and rejuvenation. And our product portfolio really answers every one of those needs, So we really have a fulsome portfolio to offer to our practices. |
Nicole Petallides | Yeah, it certainly sounds like you have the right stuff needed for each decade of life. That being said this is in-office, non-invasive and that’s the easy part of it. It’s fast, it’s quick, it lasts, as I was reading through your notes. And, is this in, throughout the United States of America? What are the expansion plans? Where are you most prevalent. |
Nicole Petallides | We, traditionally, in aesthetic medicine you have what we call the aesthetics smile across the United States. But truthfully, the amazing part of our product offering is we really meet the needs of every patient across the country and truly around the world. Regenerative aesthetics is truly a growing market opportunity and that’s what we intend to conquer with our portfolio, and, I think when you really look at the ways Suneva has established its portfolio, has been truly focused on, how do we make sure we get patients natural long-lasting clinical outcomes? And our physicians have truly responded well to our portfolio and it’s been a very exciting time for the organization. |
Nicole Petallides | And what, and as we look at this, I mean, there must be parts that are very surprising to you or exciting when you think about how this world of rejuvenation has grown over the last decade, right? I mean, it used to be, 10 years ago everybody just, 15 years ago, everybody just ran for a face lift. Now, what is available is completely different. |
Pat Altavilla | I completely agree and I’ve been in this industry now for 34 years, so I have followed the ebb and flow of the way the industry has grown and it’s been remarkable to really see that gravitational pull because our lifestyles are very busy and the thought process of having a lot of downtime is difficult. And I think what we offer is really quick procedures that allow people to get back into the work world very quickly. And, after all, with the pandemic, we certainly have spent a lot of time on Zoom, so we get to see ourselves every day whether we like it or not. |
Nicole Petallides | Yeah, absolutely and you want to look good in doing so. So you will be trading at the New York Stock Exchange under the ticker symbol RNEW: R N E W. I should be very specific with the ticker symbol. Obviously the New York Stock Exchange, you know, was originally the financial capital of the world. Why at the NYSE, obviously an exciting time on the corner of Wall and Broad. |
Pat Altavilla | Yes, it’s very exciting for us. We have found the. The very exciting thing for us is that we have found a real partnership with Viveon. The two companies think very much alike. So it’s actually afforded us a wonderful opportunity. Jagi Gill, who is the Chairman, excuse me, is the Chief Executive Officer of Viveon will actually join our board and that will be very meaningful to us. So, we look forward to this opportunity to have this partnership further enhance what, we are excited about this because it is such a perfect fit with the two companies. |
Nicole Petallides | And Pat, we thank you so much. Everybody always wants to look and feel their best and you’re helping everybody do that. Right now with Suneva, thank you and we look forward to hearing from you again as this really moves forward throughout the year. Pat, thank you so much. Pat Altavilla, of Suneva Thank you CEO, Suneva Medical, thank you. |
Exhibit 99.2
Bloomberg
Aesthetics Firm Suneva Is in Talks for Viveon Health SPAC Deal
By Michelle F Davis
January 12, 2022
Suneva Medical Inc., which sells beauty and anti-aging products to doctors’ offices, has agreed to go public through a merger with blank-check company Viveon Health Acquisition Corp.
The deal values the combined company at about $511 million including debt, according to a statement Wednesday that confirmed an earlier Bloomberg News report. Existing Suneva backers will invest $10 million in a private investment in public equity deal, according to Chief Executive Officer Pat Altavilla.
The combined company will operate as Suneva Medical and trade on the New York Stock Exchange under the symbol RNEW, according to the statement.
“It’s a wonderful way for Suneva to become fully capitalized to take advantage of the remarkable capabilities of the capital markets and to grow the business the way we intend to,” Altavilla said in an interview.
Suneva expects to grow by developing new products like a hair-restoration offering, acquiring businesses and catering to more men and millenials, she said.
Suneva specializes in so-called regenerative aesthetics that use the body’s own collagen to improve the skin’s appearance. Its biggest product is Bellafill, a Food and Drug Administration-approved dermal filler that is advertised to “smooth smile lines” and reduce the appearance of acne scars. Its products and procedures, all of which Altavilla said have a “biostimulatory component” are sold into medical offices and conducted by doctors, nurses or nurse practitioners. It has about 1600 customers, she said.
Viveon Health Acquisition, a special purpose acquisition company, or SPAC, raised $201 million in its initial public offering in 2020.
“People are looking toward more natural solutions,” Altavilla said. “The regenerative properties of these procedures allow them to have better longer-lasting results.”
Exhibit 99.3
Suneva Surpasses
1 Million
Syringes of Bellafill® Distributed
Since the Biostimulator’s
Inception
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. |
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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.
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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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