UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): July 11, 2023
(Exact Name of Registrant Specified in Charter)
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Registrant's telephone number, including area code: 215 -619-3200
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
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Name of each exchange on which registered
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| Item 7.01. |
Regulation FD Disclosure.
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On July 11, 2023, STRATA Skin Sciences, Inc. (the “Company”) issued a press release
announcing that the Journal of Clinical and Aesthetic Dermatology (JCAD) published a review and an expert perspectives article in the June 2023 Supplemental edition titled, “Photopneumatic Technology for the Treatment of Mild-to-Moderate Acne
Vulgaris.”. In the review, Gilly Munavalli, MD, highlighted the TheraClear®X
system, which included its mechanism of action, key features of the device, and the clinical outcomes experienced. Dr. Munavalli also recounted anecdotal results of using the device in the treatment of acne. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the
purposes of Section 18 of the Securities Exchange Act or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall
be expressly set forth by specific reference in any such filing.
| Item 9.01. |
Financial Statements and Exhibits.
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(d)
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Exhibits.
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The following press release is furnished as an exhibit to this Current Report on Form 8-K and shall not be deemed to be “filed”:
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Exhibit No.
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Exhibit Description
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Press release dated July 11, 2023, issued by Strata Skin Sciences, Inc.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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SIGNATURE
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.
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STRATA SKIN SCIENCES, INC.
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Date: July 11, 2023
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By:
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/s/ Christopher Lesovitz
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Christopher Lesovitz
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Chief Financial Officer
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Exhibit 99.1
STRATA Announces JCAD Publication: Photopneumatic Technology for the Treatment of Mild-to-Moderate Acne Vulgaris
HORSHAM, Pa., July 11, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ:
SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced the Journal of Clinical and Aesthetic Dermatology (JCAD) published a review and an expert perspectives article in the June 2023 Supplemental edition titled, “Photopneumatic Technology for the Treatment of
Mild-to-Moderate Acne Vulgaris.”
In the review, Gilly Munavalli, MD, highlighted the TheraClear®X system, which included its mechanism of action, key features of the device, and the clinical
outcomes experienced. Dr. Munavalli also recounted anecdotal results of using the device in the treatment of acne.
“TheraClearX is a tool we often utilize in the clinic to treat mild-to-moderate acne,” stated Dr. Gilly Munavalli, Medical Director and Founder of Dermatology, Laser, &
Vein Specialists of the Carolinas in Charlotte, North Carolina. “With patients experiencing little-to-no downtime and visible reductions in redness early on in their treatment, we believe the TheraClearX system is an effective, non-pharmaceutical
acne treatment.”
The clinical perspective article expands on the expert perspectives derived from a virtual roundtable conducted in February 2023 which featured Ashish Bhatia, MD, FAAD,
Cheryl M. Burgess, MD, FAAD, Gilly S. Munavalli, MD, MHS, FACMS, and Jason L. Smith, MD. The roundtable participants discussed the TheraClearX system, its mechanism of action, the customizable device settings, treatment protocols, and practice
integration. Key takeaways from the expert perspectives article include:
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It is safe and efficacious, with visible improvement of acne as soon as the second treatment.
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Additional benefits include visible improvement of pore size, erythema, and skin texture.
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Settings can be customized to treat all Fitzpatrick skin types.
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Treatment sessions are quick and comfortable, with no downtime resulting in compliant and satisfied patients.
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Ideal for a new acne patient wanting to expedite their acne clearance and/or an existing patient wanting to enhance their current acne regimen.
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“The TheraClearX review and expert perspectives article highlights the device’s safety and efficacy and emphasizes the visible improvement patients often experience
soon after beginning treatment,” stated Bob Moccia, Chief Executive Officer of STRATA Skin Sciences. “Importantly, the information presented in the JCAD supplement expands on how the TheraClearX device fits into the acne treatment landscape and how
the device can be seamlessly integrated into a physician’s practice.”
About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company dedicated to developing, commercializing and
marketing innovative products for the in-office treatment of various dermatologic conditions such as psoriasis, vitiligo, and acne. Its products include the XTRAC® excimer laser, VTRAC® lamp systems, and the TheraClear®X Acne Therapy System.
STRATA is proud to offer these exciting technologies in the U.S. through its unique Partnership Program. STRATA’s popular partnership approach includes a fee per
treatment cost structure versus an equipment purchase, installation and use of the device, on-site training for practice personnel, service and maintenance of the equipment, dedicated account and customer service associates, and co-op advertising
support to help raise awareness and promote the program
within the practice.
Safe Harbor
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements
include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to
launch and sell an acne treatment device and to integrate that device into its product offerings, the Company’s ability to develop, launch and sell products recently acquired or to be developed in the future, the Company’s ability to develop
social media marketing campaigns, direct to dermatologist marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to
significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions labor supply
shortages, or supply chain interruptions resulting from the coronavirus, fiscal, and political factors, responses, or conditions affecting the Company, the medical device industry and our customers and patients in general, as well as more
specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release
are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances
occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.
Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
sskn@cg.capital
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