Suneva Medical Launches 30 mL PRP Gel Tubes of Amplifine, Allowing for More Variety and Efficiency in PRP Treatments
Suneva Medical has launched a new 30 mL iteration of their Amplifine Platelet Rich Plasma (PRP) gel tubes, which have received FDA 510(k) clearance. This larger volume is designed to enhance patient treatment efficiency and accommodate various clinical applications, offering providers a more effective solution in the regenerative aesthetics market. CEO Pat Altavilla emphasized the commitment to delivering high-quality products. The launch comes as part of Suneva's ongoing development strategy in regenerative medicine, following a merger agreement with Viveon Health Acquisition Corp. (NYSE American: VHAQ).
- Launch of 30 mL Amplifine PRP gel tubes enhances treatment efficiency.
- FDA 510(k) clearance for the new product ensures safety and compliance.
- Addresses growing demand for larger volume PRP treatments.
- Part of a strategic focus on regenerative aesthetics and patient care.
- None.
SAN DIEGO, Sept. 13, 2022 /PRNewswire/ -- Suneva Medical, Inc. ("Suneva" or the "Company"), an innovative medical technology company using regenerative products to change the standard of care in patient treatments, today launched the 30 mL iteration of their Amplifine Platelet Rich Plasma (PRP) gel tubes, which will provide patients and practices with a larger volume of PRP to address varying areas of concern more efficiently. The 30 mL PRP tubes received a 510(k) clearance by the U.S. Food and Drug Administration (FDA) earlier this year.
Suneva's 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 patients while also making the clinical practice more efficient by offering a wider array of regenerative treatments to their patients in an emerging and vast regenerative medicine market in North America.
PRP is a regenerative treatment that allows providers to access the patient's natural growth factors, via centrifugation of the patient's blood, in order to separate the red and white blood cells and concentrate the platelets.
"We are building upon our PRP platform with the launch of Amplifine's 30mL PRP gel tube, so both patients and providers will be getting the greatest value when performing or receiving their PRP treatment of choice," said Pat Altavilla, Chief Executive Officer of Suneva. "Our commitment to offering the best products in regenerative aesthetic practices and patients is stronger than ever, as we continue to find new ways to optimize our portfolio of minimally invasive and high impact aesthetic treatments."
The availability of the Amplifine 30mL PRP gel tube directly addresses the growing demand from practices and their patients to capture a higher volume of PRP for various clinical applications. As part of Amplfine's PRP platform, the new 30mL gel tubes will offer larger volume PRP while maintaining the key features that practices have come to expect: practice efficiency with a short 10-minute processing time, the ability to capture a high concentration of platelets and a safe and effective product that has been cleared by the FDA.
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 as an autonomous entity.
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 four hours after drawing blood. For more information including indications for use and complete Instructions for Use, visit www.Sunevamedical.com
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.
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: Mr. Brower's instrumentality in fundraising and partnership development; expansion of Suneva in the regenerative aesthetic market; Suneva's growth within its announced SPAC deal and continued evolution and adoption of Suneva's regenerative medical products; 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) changes in the competitive landscape, including the introduction of competitive products or improvements in existing products; 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.
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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/suneva-medical-launches-30-ml-prp-gel-tubes-of-amplifine-allowing-for-more-variety-and-efficiency-in-prp-treatments-301622904.html
SOURCE Suneva® Medical, Inc.
FAQ
What is the significance of Suneva Medical's 30 mL PRP gel tube launch?
When was the 30 mL PRP gel tube cleared by the FDA?
What company is merging with Viveon Health Acquisition Corp (NYSE American: VHAQ)?
How does the new PRP gel tube benefit clinical practices?
What are the features of the Amplifine PRP gel tube?
