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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 23, 2018


STRATA SKIN SCIENCES, INC.
(Exact Name of Registrant Specified in Charter)
 
 
 
Delaware
000-51481
13-3986004
(State or Other
(Commission File
(I.R.S. Employer
Jurisdiction of
Number)
Identification No.)
Incorporation)
 
 
 
  
100 Lakeside Drive, Suite 100, 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. ☐
 




Item 7.01 Regulation FD Disclosure

On July 23, 2018 the Company issued a press release announcing that it had entered into an exclusive and perpetual license agreement with a strategic entity for a de-identified digital image library of pigmented lesions and their related documentary information related to the Company's discontinued MelaFind device. The Company retains all intellectual property rights related to the MelaFind device and product line, including patents, design files and PMA approval to market.  The strategic entity will be allowed exclusive rights to the de-identified digital images. The perpetual license agreement is subject to customary closing conditions.

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.


Safe Harbor Statement
Statements in this report that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, the Company's continuing efforts to implement changes to our business with the goal of enhancing our strategic position in the medical and aesthetic dermatology market; ability to achieve growth in recurring revenues and other business sectors, ability to achieve and sustain a successful direct to customer marketing strategy and execution of that strategy, and the Company's ability to close on the referenced perpetual license agreement, or to monetize any remaining MelaFind assets are based on the Company's current expectations and are inherently subject to significant uncertainties and changes in circumstances.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any results expressed or implied by such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this report as a result of new information, future events or otherwise.


Item 9.01 Financial Statements and Exhibits

(d) Exhibits
 
  
      99.1
Strata Skin Sciences Press Release Dated July 23, 2018






Exhibit No.
Exhibit Description 
      99.1

 
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: July 23, 2018
By:
/s/ Matthew Hill                
 
 
 
Matthew Hill
 
 
 
Chief Financial Officer
 






 
 
EXHIBIT 99.1
 
 
 

STRATA Skin Sciences Announces Licensing Agreement for Certain MelaFind Assets


Horsham, PA, July 23, 2018 — STRATA Skin Sciences (NASDAQ: SSKN) ("STRATA") a medical technology company in Dermatology and Plastic Surgery dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, today announced a fully paid exclusive and perpetual license agreement with a strategic entity for a de-identified digital image library of pigmented lesions and their related documentary information, related to STRATA's discontinued MelaFind device.  STRATA retains all intellectual property rights related to the MelaFind device and product line, including patents, design files and PMA approval to market.  The strategic entity will be allowed exclusive rights to the de-identified digital images.

"We are pleased to come to agreement with this licensing partner for the de-identified images related to the MelaFind device.  Rationalizing the MelaFind assets is one step in our ongoing strategic turn-around efforts following our recent financing," said Dr. Dolev Rafaeli, chief executive officer of STRATA.  "While we will look for additional licensing opportunities and continue to evaluate potential M&A opportunities, our main focus is on rebuilding our XTRAC network, expanding internationally and executing on our proven revenue strategy."

The perpetual license agreement is subject to customary closing conditions.

About STRATA Skin Sciences, Inc.
STRATA Skin Sciences is a medical technology company in Dermatology and Plastic Surgery dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions.  Its products include the XTRAC® excimer laser and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions; and the STRATAPEN® MicroSystem, marketed specifically for the intended use of micropigmentation.

The Company's proprietary XTRAC® excimer laser delivers a highly targeted therapeutic beam of UVB light to treat psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma, diseases, which impact over 35 million patients in the United States alone.  The technology is covered by multiple patents, including exclusive rights for patents for the delivery of treatments to vitiligo patients.

STRATA's unique business model 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.

The XTRAC® business has used this proven DTC model to grow its domestic dermatology partner network to over 740 clinics, with a worldwide installed base of over 2,000 devices.  The Company is able to offer 90% of DTC patients an introduction to physicians prescribing a reimbursable solution, using XTRAC®, within a 10 mile radius of their house.  The Company is a leader in dermatology in-clinic business generation for its partners.

About MelaFind 
MelaFind® was developed by the Company with intention to provide a dermatologist with a software-driven image analysis of clinically irregular pigmented moles when they choose to obtain additional info to help decide whether or not to biopsy (at the most curable and cost-effective stage).  MelaFind® is both FDA Pre-Market Approved (PMA) for the U.S. and has CE Marking certification for the European Union.

The MelaFind® system utilizes innovative software-driven technology and state-of-the-art 3-D imaging to non-invasively extract data 2.5 mm below the skin surface from patient's clinically irregular pigmented moles and objectively analyzes them with proprietary algorithms.  MelaFind provides important additional perspective to physicians to help them better understand the structural disorganization of a patient's pigmented irregular moles (before cutting the skin) during the evaluation and diagnosis process for melanoma.

On March 10, 2017 the company announced its intention to discontinue the development and sales of the MelaFind product line effective on September 30, 2017.

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 generate the growth in its core business, the Company's ability to continue to monetize the remaining MelaFind assets, 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 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 of these forward-looking statements may prove to be incorrect or unreliable.  The Company assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.

 
 

 
Investor Contacts:
Dr. Dolev Rafaeli, Chief Executive Officer
  
Jeremy Feffer, Managing Director
STRATA Skin Sciences, Inc.
  
LifeSci Advisors, LLC
215-619-3200
  
212-915-2568
ir@strataskin.com
 
jeremy@lifesciadvisors.com