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): December 29, 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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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
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On December 29, 2023 STRATA Skin Sciences, Inc. (“STRATA”), a medical technology company in Dermatology and Plastic Surgery dedicated to developing,
commercializing and marketing innovative products for the treatment of dermatologic conditions, issued a press release announcing that it had renewed its services agreement with Cutech, Inc. (the parent company of Kosmo Meditech) for a combination
of direct recurring revenue sales and direct capital sales and in Korea. A copy of the press release is filed herewith as Exhibit 99.1.
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.
| Item 8.01 |
Other Events.
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Effective January 1, 2024, the CPT® Editorial Panel of the American Medical Association which is responsible for maintaining CPT codes, has revised CPT codes
96920-96922. Prior to the change, the codes were described as “Laser treatment for inflammatory skin diseases (psoriasis)”. Each of the codes defines the reimbursement for treatments of different skin surface areas. Post change, the codes are
described as “Excimer laser treatment for psoriasis”. The Company’s flagship product, XTRAC, as well as the Pharos technology acquired by the Company in 2021 (no longer marketed) are the only excimer laser devices currently marketed in the United
States that meet the requirements of the revised description. These changes directly impact patients covered by Medicare and may impact others as private insurers decide to implement or reject the changes.
Safe Harbor Statement
The information in this filing 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, 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 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.
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Item 9.01
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Financial Statements and Exhibits
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(d) Exhibits
99.1 Strata Skin Sciences Press
Release Dated December 28, 2023
SIGNATURES
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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| Dated: December 29, 2023 | ||
| By: | /s/ Christopher Lesovitz | |
| Christopher Lesovitz | ||
| Chief Financial Officer | ||
Exhibit 99.1
STRATA Skin Sciences Announces Expansion of Distribution Agreement with Kosmo Meditech
Agreement further solidifies the strength and growth of the partnership between STRATA Skin Sciences and Kosmo Meditech
HORSHAM, Pa., Dec. 29, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to
developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced the expansion of a direct distribution agreement with Kosmo Meditech (“Kosmo”), which is now assigned to Kosmo's corporate
parent, Cutech, Inc., effective as of January 1, 2024, for a combination of direct capital sales and direct recurring revenue sales in Korea.
The key highlights of this amendment, which reinforce STRATA's commitment to innovation and customer satisfaction, include:
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Extended term through December 31, 2026, ensuring a prolonged and stable partnership
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Established defined annual and quarterly performance-based purchase requirements, including STRATA becoming sole provider of gas and consumables, securing a consistent demand for STRATA’s
products, providing a reliable forecast for production and inventory management, and ensuring stronger top-line revenue
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“This agreement not only signifies the strength and growth of the partnership between STRATA and Kosmo but also reinforces STRATA's dedication to upholding the highest
standards in product and service offerings for dermatological treatments worldwide,” stated Dr. Dolev Rafaeli, President and Chief Executive Officer of STRATA. “Korea continues to present a significant opportunity for us, leveraging Kosmo’s
extensive in-country distribution network. This ongoing collaboration allows us to provide our customers with innovative therapeutic solutions while ensuring a framework for sustainable growth and market leadership.”
About Kosmo Meditech
Kosmo Meditech is a Korean distributor of medical devices in Dermatology and other medical markets. Kosmo Meditech has been a distributor of the XTRAC®
excimer laser in partnership with STRATA Skin Sciences (and its predecessor) for over 16 years. The Kosmo platform in combination with the know-how generated by STRATA in the US will enable an efficient deployment of the business model into existing
and new Dermatology clinics.
The Korean Dermatology clinic market comprises 1,800 physicians. XTRAC has been sold and is used by over 250 hospital and private practice clinics.
Korea’s Vitiligo and Psoriasis patient population is approximately 1 million. The treatment by 308nm Excimer is covered by the national health insurance with
reimbursement rates of $15 to $50 per procedure.
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