SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
April 20, 2015
Commission File Number: 000-50867
Syneron Medical Ltd.
(Translation of registrant’s name into English)
Industrial Zone, Yokneam Illit 20692, P.O.B. 550, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F S Form 40-F £
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes £ No S
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- ________
Attached hereto and incorporated herein by reference is a press release of the Company, dated April 20, 2015, entitled “Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance for Treatment of Pigmented Lesions.”
This Form 6-K is incorporated by reference into the Company’s Registration Statements on Form S-8 filed with the Securities and Exchange Commission on November 16, 2004 (Registration No. 333-120559), on January 8, 2010 (Registration No. 333-164250), on January 15, 2010 (Registration No. 333-164351), and on December 9, 2013 (Registration No. 333-192729).
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, thereunto duly authorized.
| | SYNERON MEDICAL LTD. | |
| | | | |
| | By: | /s/ Hugo Goldman | |
| | | Name: Hugo Goldman | |
| | | Title: Chief Financial Officer | |
Date: April 20, 2015
Syneron Candela’s PicoWay Picosecond Laser Receives U.S. FDA Clearance
for Treatment of Pigmented Lesions
Expanded indication builds on existing FDA clearance for tattoo removal
Announces Health Canada Clearance for PicoWay for pigmented lesions and tattoo removal
Yokneam, Israel, April 20, 2015 – Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that the PicoWay® picosecond laser received U.S. Food and Drug Administration (FDA) clearance for the treatment of pigmented lesions. The PicoWay picosecond laser previously received FDA clearance for the removal of tattoos in November 2014 and was launched in the U.S. late in the fourth quarter 2014.
PicoWay incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink or pigmentation. The innovative PicoWay Technology™ is integrated into a proven, reliable Candela platform which offers high reliability, superior performance and low cost of ownership.
Amit Meridor, Chief Executive Officer of Syneron Medical, said, “PicoWay offers our customers a reliable and easy-to-use system featuring the shortest picosecond pulse and the highest peak power on the market. The expansion of PicoWay’s FDA clearance to include pigmented lesions further enhances the utility of the system, allowing practitioners to offer this next-generation technology for more of their pigment-related procedures. It is also indicative of our commitment to add new applications that leverage the PicoWay technology for other treatments. Since launching the product late last year, there has been strong interest in PicoWay and we expect the addition of the pigmented lesion indication will further enhance its attractiveness to customers.”
The Company also announced Health Canada clearance of the PicoWay picosecond laser for the treatment of pigmented lesions and tattoo removal. PicoWay is a dual wavelength device, with 532nm and 1064nm wavelengths, which utilizes proprietary PicoWay Technology to generate picosecond pulses for the treatment of pigmented lesions and tattoos of all colors. The Health Canada clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength.
The launch of PicoWay in Canada will begin during the second quarter 2015, building on the launch of the product in the U.S. and other international markets during the fourth quarter 2014. The Company sells its products in Canada through its direct North American sales organization.
William Griffing, Chief Executive Officer of Syneron Candela North America, said, “Based on the strong early reception to PicoWay, we believe we are well positioned to drive adoption in Canada based on our unique PicoWay technology, strong Candela brand, and broad existing customer base.”
About Syneron Candela
Syneron Candela is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company's technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, tattoo removal, improving the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch, and has a wide portfolio of trusted, leading products including UltraShape, VelaShape, GentleLase, VBeam Perfecta, PicoWay, Profound and elōs Plus.
Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Candela are located in Israel. Syneron Candela also has R&D and manufacturing operations in the U.S. The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.
For additional information, please visit http://www.syneron-candela.com.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including product efficacy, market acceptance of new products, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Company's most recent Annual Report on Form 20-F, and in the filings that Syneron Medical makes with the SEC, and other factors beyond the Company's control. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.'s actual results, performance or achievements may vary materially from those expressed or implied by these forward-looking statements. These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.'s views as of any date after the date of this document. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Contacts:
Syneron Medical – Public Relations
pr@syneron.com
Hugo Goldman, Chief Financial Officer
+ 972 73 244 2283
Email: hugo.goldman@syneron.com
Zack Kubow, The Ruth Group
646-536-7020
Email: zkubow@theruthgroup.com
