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): February 9, 2022
(Exact Name of Registrant as Specified in Its Charter)
(Commission File Number)
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(State or Other Jurisdiction of Incorporation)
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(I.R.S. Employer Identification No.)
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(Address of principal executive offices, including zip code)
(215 ) 619-3200
(Registrant’s telephone number, including area code)
NOT APPLICABLE
(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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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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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. ☐
Item 7.01 Regulation FD Disclosure
On February 9, 2022 STRATA Skin Sciences, Inc. (“STRATA”), a medical
technology dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced its commercial launch, with the first installation in the U.S. market, of its next generation excimer laser system, XTRAC Momentum™ 1.0.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed "filed" for the
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor
shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such
filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
This report 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 generate the growth in
its core business, develop and grow an international recurring business model, the Company’s ability to develop social media 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 or supply chain interruptions resulting from the corona virus and political factors or conditions affecting the Company and the medical device industry 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 report are made as of the date of the
report, 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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 Strata Skin Sciences Press Release Dated February 9, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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: February 9, 2022
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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 Skin Sciences Announces Commercial Launch of XTRAC Momentum™ 1.0 and First Installation in the U.S.
Horsham, Pa, February 9, 2022 — 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 its commercial launch, with the first installation in the U.S. market, of its next
generation excimer laser system, XTRAC Momentum™ 1.0.
The XTRAC excimer laser technology allows for the precise delivery of targeted UVB light therapy to specific treatment areas of the skin, for both adult and
pediatric patients suffering from inflammatory skin conditions such as psoriasis, atopic dermatitis and vitiligo. STRATA’s new XTRAC Momentum 1.0 represents the latest in excimer laser technology, delivering higher power and a faster repetition
rate than the current models. The Momentum also offers a new user interface and slim design, both intended to improve the treatment experience.
Jeffrey Sugarman, MD, PhD, stated, “We are thrilled to be the first dermatology practice in the world to offer the benefits of the XTRAC Momentum 1.0 to our
patients with psoriasis, vitiligo and atopic dermatitis. We at Redwood Family Dermatology continue to provide XTRAC’s most advanced technology to deliver safe and highly effective treatments for our adult and pediatric patients.” Dr. Sugarman
continued, “We appreciate our long-standing partnership with STRATA, as it allows us to maximize the benefits of XTRAC in our practice.” Dr. Sugarman is a Clinical Professor in the Department of Dermatology at U.C. San Francisco, Medical Director
at Redwood Family Dermatology and President of the California Society of Dermatology and Dermatologic Surgery.
The combined value of the global psoriasis, atopic dermatitis and vitiligo treatment markets (procedures) exceeds $33B USD, with positive single to low
double digit percentage CAGR growth projected over the next 5 years1.
“With the growth projected among this patient population, coupled with the continuous need for innovative, non-systemic treatment options, STRATA is well
positioned to further expand XTRAC’s footprint by offering the most advanced excimer laser technology available today. STRATA is committed to being a leader in the treatment of dermatologic conditions and this successful installation further
enhances our commitment to that goal,” said Robert Moccia, President and CEO of STRATA Skin Sciences.
About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company in dermatology dedicated to developing, commercializing and marketing innovative products for the
in-office treatment of dermatologic conditions. Its products include the XTRAC® and Pharos® excimer lasers and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions.
The Company’s proprietary XTRAC and recently acquired Pharos excimer lasers deliver a highly targeted therapeutic beam of UVB light to treat psoriasis,
vitiligo, eczema, atopic dermatitis and leukoderma, diseases which impact over 31 million patients in the United States alone. The technology is covered by multiple patents.
STRATA’s unique business model in the US leverages targeted Direct to Consumer (DTC) advertising to generate awareness and utilizes its in-house call
center and insurance advocacy teams to increase volume for the Company’s partner dermatology clinics.
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1.
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Dermatology Devices Report, Grand View Research 2021 Base year 2020, historic information 2016 to 2019, and forecast 2021 to 2028
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Forward-Looking Statements
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 to be developed in the future, the Company’s ability to develop social media 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 or supply chain interruptions resulting from the coronavirus and political factors or conditions affecting
the Company and
the medical device industry in general, future responses to and effects of
COVID-19 pandemic and its variants including the distribution and effectiveness of the COVID-19 vaccines, 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
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Jack Droogan
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(203) 585-4140
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ir@strataskin.com
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