NEW YORK, April 25, 2019 /PRNewswire/ -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) has been investigating claims on behalf of investors who purchased shares of Apyx Medical Corporation ("Apyx Medical" or the "Company") (NASDAQ: APYX), a company developing J-Plasma technology, a plasma-based surgical product for cutting, coagulation and ablation of soft tissue. A complaint has been filed in the United States District Court for the Middle District of Florida against the Company and its Chief Executive Officer. Investors that acquired Apyx Medical securities between August 1, 2018 and April 1, 2019, inclusive (the "Class Period"), may be affected.
On December 21, 2018, Apyx Medical announced that it had submitted an application to the Food and Drug Administration (FDA) for regulatory clearance for the use of J-Plasma, branded Renuvion Cosmetic Technology, for dermal resurfacing procedures. Among other things, the press release announcing the submission stated "[o]ur submission is supported by data from our multi-center, single arm, evaluator-blind prospective study evaluating the safety and efficacy of our Renuvion technology for the reduction of facial wrinkles and rhytides" and "[w]e were very pleased with the clinical results of this study. . . ."
According to the complaint, on February 21, 2019, White Diamond Research released a report alleging, among other things, that "Apyx did not reveal the results of its clinical study on J-Plasma use for dermal resurfacing – a red flag that it may have missed its endpoints."
On this news, the Company's share price fell $2.10 per share, nearly 25%, to close at $6.40 per share on February 21, 2019.
On April 1, 2019, after the market closed, the Company revealed that it had withdrawn its application for regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures, citing concerns raised by the FDA, including that "the study did not meet the primary efficacy endpoint" and "concerns related to superior clinical results from one investigational center as compared to the other two investigational centers in the study."
On this news, Apyx Medical's shares fell $2.49 per share, nearly 36%, to close at $4.46 per share on April 2, 2019.
According to the complaint, the defendants made materially false and/or misleading statements and failed to disclose to investors, among other things, that (1) the clinical study on the use of J-Plasma for dermal resurfacing had not met its primary efficacy endpoint, and (2) that, as a result, the clinical study did not support the Company's application for regulatory clearance.
If you are a member of the proposed Class, you may move the court no later than June 17, 2019 to serve as a lead plaintiff for the purported class. You need not seek to become a lead plaintiff in order to share in any possible recovery. If you would like to discuss the complaint or our investigation, please contact us by emailing pmayer@kaplanfox.com or by calling 800-290-1952.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com. If you have any questions about this Notice, the action, your rights, or your interests, please contact:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail: jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California 94104
(415) 772-4700
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
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SOURCE Kaplan Fox & Kilsheimer LLP