8-K

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): January 8, 2024

STRATA SKIN SCIENCES, INC.

(Exact Name of Registrant Specified in Charter)

Delaware	000-51481	13-3986004
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

5 Walnut Grove Drive, Suite 140, Horsham, Pennsylvania	19044
(Address of Principal Executive Offices)	(Zip Code)

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:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	SSKN	The NASDAQ Stock Market LLC

Item 7.01. Regulation FD Disclosure.

On January 8, 2024, STRATA Skin Sciences, Inc. (the “Company”) issued a press release announcing that  the Company will be presenting a poster titled “Pulsed Broadband Light with Vacuum Suction (Photopneumatic Therapy) and Needle Insert to Treat Acne” at the Maui Derm 2024 Meeting to be held at the Grand Wailea in Maui, Hawaii from January 22-26, 2024..  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.

(d) Exhibits.

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”:

Exhibit No.	Exhibit Description
99.1	Press release dated January 8, 2024, issued by Strata Skin Sciences, Inc.

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.

	STRATA SKIN SCIENCES, INC.
Date: January 8, 2024	By:	/s/ Christopher Lesovitz
		Christopher Lesovitz
		Chief Financial Officer

EX-99.1

Exhibit 99.1

STRATA Skin Sciences to Present Poster Showcasing Safety and Efficacy of TheraClear®X for Acne at Maui Derm 2024 Conference

HORSHAM, Pa., Jan. 08, 2024 (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 that the Company will be presenting a poster titled “Pulsed Broadband Light with Vacuum Suction (Photopneumatic Therapy) and Needle Insert to Treat Acne” at the Maui Derm 2024 Meeting to be held at the Grand Wailea in Maui, Hawaii from January 22-26, 2024.

The poster highlights the safety and efficacy of one treatment session using STRATA’s TheraClear®X technology for cystic and papular acne reduction. TheraClear®X uses Photopneumatic technology that delivers intense pulsed light utilizing vacuum technology with an additional needle insert; the vacuum pulls the tissue into the needle, penetrating the acne lesion and thereby creating a pathway for sebum extraction.

● Majority of lesions demonstrated ≥50% clearing by 1-2 weeks, exceeding the criteria of ≥30% reduction in lesion size at two follow-up visits.

● An average reduction in lesion size was rated 2.0 (30-50% reduction) at 24-72 hours post-treatment and 3.5 at 1-2 weeks (≥50-75% reduction).

● At 1-2 weeks, the most frequently reported event was mild hyperpigmentation; erythema, edema, and flaking were observed in ≤10% of lesions.

“We are thrilled with our results of the clinical experience study for patients suffering from moderate to severe acne,” stated Suneel Chilukuri, MD, FAAD, FACMS, Director of Cosmetic Surgery at Refresh Dermatology in Houston, TX, and author of the study. “The TheraClear®X Photopneumatic acne system used with the additional needle insert is a very effective and safe treatment for both cystic and pustular acne lesions. Most importantly, the procedure is extremely well tolerated by patients with all types of acne.”

“The results from the clinical evaluation continue to highlight the efficacy and safety of the TheraClear®X system for treating acne, and we would like to thank Dr. Chilukuri for his contributions,” stated Dolev Rafaeli, President and Chief Executive Officer of STRATA Skin Sciences. “This evaluation not only emphasizes our focus for providing clinically reimbursed procedures, but also holds us true to our commitment of delivering tailored solutions for individuals afflicted with acne and other dermatologic conditions.”

The Company will be hosting a medical booth at the conference, offering attendees valuable insights into TheraClear®X as well as other product offerings.

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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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XML

Document and Entity Information	Jan. 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 08, 2024
Entity File Number	000-51481
Entity Registrant Name	STRATA Skin Sciences, Inc.
Entity Central Index Key	0001051514
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	13-3986004
Entity Address, Address Line One	5 Walnut Grove Drive
Entity Address, Address Line Two	Suite 140
Entity Address, City or Town	Horsham
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19044
City Area Code	215
Local Phone Number	619-3200
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	SSKN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false