Suneva Medical Inc. Announces Multiple Regulatory Approvals in the U.S. and Canada
Suneva Medical has received Canadian regulatory approval for its Dermapose® all-in-one fat sizing syringe, enhancing its presence in the regenerative aesthetics market. Additionally, the U.S. FDA granted 510(k) clearance for the larger 30 mL Amplifine PRP Gel Tube, allowing for greater efficiency in regenerative treatments. These advancements highlight Suneva's commitment to providing innovative, minimally invasive solutions in aesthetic procedures, catering to the growing demand for natural-looking treatment options.
- Canadian approval for Dermapose® syringe expands market presence.
- U.S. FDA 510(k) clearance for larger Amplifine PRP Gel Tube enhances product offerings.
- None.
Canadian Regulators have approved Dermapose® All-In-One fat sizing syringe
U.S. FDA 510(k) clearance for a larger volume Amplifine PRP Gel Tube
SAN DIEGO, May 3, 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, and partner Bimini Health Tech ("Bimini"), today announced that they have received approval from Canada's Medical Devices Directorate to market the Dermapose® all-in-one fat sizing syringe in Canada. In the U.S., Suneva has also received an additional 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its larger volume 30 mL Amplifine PRP gel tube.
Dermapose is a cutting-edge fat transfer technology from the experts who created Puregraft, dedicated to volumization and rejuvenation. Dermapose is an all-in-one device designed to purify, size and reinject a patient's fat while maximizing revascularization.
Suneva has also received U.S. FDA 510(k) clearance for a larger volume 30 mL gel tube. Amplifine PRP gel tubes use a proprietary gel designed to capture a high concentration of platelets in a short processing time, delivering clinical benefits to the patient while also making the clinical practice more efficient with the ability to offer a wider array of regenerative treatments to their patients in the largest North American market.
PRP is a regenerative treatment that allows providers to access the patient's own growth factors that exist by taking a small amount of the patient's blood and spinning it through a centrifuge to separate out the red blood cells and white blood cells.
"These domestic and international regulatory approvals display the growing number of regenerative aesthetic treatment options, and Suneva is proud to add to those options," said Pat Altavilla, Chief Executive Officer of Suneva. "Dermapose and Amplifine offer innovative and minimally invasive solutions to patients seeking natural looking alternatives to help them look and feel their best."
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 Bimini Health Tech
Bimini Health Tech is a global leader in the medical aesthetics and regenerative market. The Bimini Health Tech portfolio includes Puregraft, Healeon, Dermapose and Kerastem. The company develops and commercializes products that are elegant in their simplicity, yet impactful and proven in their aesthetic and therapeutic benefit. Since 2013, they have been developing innovative products to provide premium aesthetic care options to consumers and physicians alike. Learn more about Bimini Health Tech at www.biminihealthtech.com.
About Dermapose Refresh
Dermapose Refresh is a Suction Lipoplasty system. The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation. See the Instructions for Use that accompanies the product for important Warnings, Precautions, and Directions. Learn more about Dermapose at www.Sunevamedical.com.
About Amplifine PRP Gel Tubes
Amplifine PRP Gel Tube is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient point-of-care. Each gel tube is provided sterile and non-pyrogenic and with a gel separator that contains a proprietary blend of anticoagulant citric acid, sodium citrate and dextrose solution (ACD-A) and is to be used only for the preparation of PRP with Amplifine PRP gel tube. The Amplifine gel tube must be processed via centrifuge at a designated speed and length of time following blood draw. The PRP must be used within 4 (four) hours after drawing blood. For more information or complete Instructions for Use, visit www.Sunevamedical.com
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 https://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 continued international growth of regenerative aesthetic treatment options; Dermapose's and Amplifine's ability to continue performing as designed; providers' ability to offer a wider array of regenerative treatments;; and the combined company's shares being traded on the NYSE. 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) decline in the international demand for regenerative aesthetic treatments; (16) decline in the supply of components necessary to make Dermapose and Amplifine or for them to perform as designed; (17) changes in the competitive landscape, including the introduction of competitive products or improvements in existing products; and (18) 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.
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