Form 8-K STAAR SURGICAL CO For: May 13

 

 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):

May 13, 2016

 

STAAR Surgical Company
__________________________________________

 

(Exact name of registrant as specified in its charter)

 

Delaware	0-11634	95-3797439
(State or other jurisdiction	(Commission	(I.R.S. Employer
of incorporation)	File Number)	Identification No.)
1911 Walker Ave, Monrovia, California		91016
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code:

626-303-7902

 

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:

 

¨

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))

 

 

Item 7.01 Regulation FD Disclosure.

 

STAAR Surgical Company issued a press release regarding the approval of its EVO Visian ICL, STAAR’s Implantable Collamer^® Lens, for distribution in Canada by the Medical Devices Bureau of Health Canada. A copy of the press release is furnished as Exhibit 99.1 to this Report, and is incorporated herein by this reference.

 

The information furnished herewith pursuant to Item 7.01 of this Current Report, including Exhibit 99.1, shall not be deemed to be “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. The information in Item 7.01 of this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.	Description
99.1	Press Release dated May 13, 2016.

 

 

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.

 

	STAAR Surgical Company
May 13, 2016	By:	/s/ Caren Mason
		Caren Mason
		President and Chief Executive Officer

  

 

Exhibit 99.1

 

 

STAAR Surgical Announces Approval By Health Canada of Its EVO Visian ICL™ for Surgeons and Their Patients in Canada

  

MONROVIA, CA, May 13, 2016---STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, was notified yesterday of the approval of its EVO Visian ICL, STAAR’s Implantable Collamer^® Lens, for distribution in Canada by the Medical Devices Bureau of Health Canada.

 

With extensive clinical experience globally, the EVO ICL is STAAR’s next-generation lens implanted in the eye that works with the patient’s natural eye to correct vision. Unlike traditional contact lenses that are placed on the surface of the eye, the EVO ICL is positioned inside the eye between the iris and the natural lens where it stays indefinitely.

 

“We are very pleased with Health Canada’s approval that allows us to offer the EVO ICL for myopia, with a broad power range of -3.0 to -18.0 diopters, to our surgeons and their patients in Canada. This represents an important new treatment option for eligible patients between 21 and 45 years old living with nearsightedness. This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO ICL portfolio. STAAR looks forward to bringing this visual freedom choice to the Canadian refractive surgery market,” said Caren Mason, President and CEO.

 

The EVO ICL has an extensive clinical history of safety and effectiveness, as was recently reinforced at the American Society of Cataract and Refractive Surgery (ASCRS) Meeting earlier this month in New Orleans, Louisiana, as part of the Evolution of Visual Freedom™ initiative. The EVO ICL, with its central hole, offers premium refractive outcomes with efficiency and comfort for both the patient and the surgeon by eliminating the extra surgical step of the peripheral iridotomy. Approximately 200,000 lenses from the EVO ICL product family have been implanted globally to date. Clinical data show that the EVO ICL provides outstanding, predictable correction of high degrees of refractive errors, with the vast majority of patients achieving and maintaining 20/20 or better visual acuity through five years of follow up.¹ Review of the peer-reviewed published literature demonstrates an excellent safety profile: specifically, eight studies including data from 1,291 eyes followed for up to five years describe a zero incidence of significant complications.²

 

 

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL”. Nearly 600,000 Visian ICLs have been implanted to date. To learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 360 employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA. For more information, please visit the Company’s website at www.staar.com.

 

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: statements regarding products and their safety or efficacy, or potential future sales in Canada or elsewhere, and any statements of assumptions underlying any of the foregoing. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the Company’s Annual Report on Form 10-K for the year ended January 1, 2016, under the caption “Risk Factors”, which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the company’s website under the heading “SEC Filings.”

These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements.

 

 

1.

Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism. Medicine. 2016 Apr;95(14):e3270.

2.

Packer M. Meta-Analysis and Review: Effectiveness, Safety and Central Port Design of the Intraocular Collamer Lens (ICL). In press.

 

CONTACT:	Investors	Media
	EVC Group	EVC Group
	Brian Moore, 310-579-6199	Dave Schemelia, 646-445-4800
	Doug Sherk, 415-652-9100

 

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