0001564590-22-029547.txt : 20220816 0001564590-22-029547.hdr.sgml : 20220816 20220816073041 ACCESSION NUMBER: 0001564590-22-029547 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220816 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220816 DATE AS OF CHANGE: 20220816 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LENSAR, Inc. CENTRAL INDEX KEY: 0001320350 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 320125724 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39473 FILM NUMBER: 221168500 BUSINESS ADDRESS: STREET 1: 2800 DISCOVERY DRIVE STREET 2: SUITE 100 CITY: ORLANDO STATE: FL ZIP: 32826 BUSINESS PHONE: 888-536-7271 MAIL ADDRESS: STREET 1: 2800 DISCOVERY DRIVE STREET 2: SUITE 100 CITY: ORLANDO STATE: FL ZIP: 32826 FORMER COMPANY: FORMER CONFORMED NAME: LensAR Inc DATE OF NAME CHANGE: 20070703 FORMER COMPANY: FORMER CONFORMED NAME: LaserSoft Vision Inc DATE OF NAME CHANGE: 20050310 8-K 1 lnsr-8k_20220816.htm 8-K lnsr-8k_20220816.htm
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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): August 16, 2022

 

LENSAR, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-39473

32-0125724

(State or Other Jurisdiction  of Incorporation)

(Commission File Number)

(IRS Employer Identification Number)

 

2800 Discovery Drive,

Orlando, Florida 32826

 

(Address of principal executive offices)

 

Registrant’s telephone number, including area code:

(888) 536-7271

 

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 registrants under any of the following provisions (see General Instruction A.2. below):

 

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))

 

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, par value $0.01 per share

LNSR

The Nasdaq Stock Market LLC

 

 

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 August 16, 2022, LENSAR, Inc. (the “Company”) issued a press release announcing the first commercial cases performed with the ALLY™ Adaptive Cataract Treatment System (“ALLY” or the “ALLY System”). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated into this Item 7.01 by reference.

 

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for 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 incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

 

Item 8.01.  Other Events

 

On August 16, 2022, the Company announced the performance of the first commercial cases with the ALLY System. Dr. Robert Weinstock of The Eye Institute of West Florida performed 15 laser-assisted cataract surgery cases following the recent installation of his ALLY System

 

Following ALLY’s FDA clearance in June 2022, as previously announced, LENSAR has been working closely with select cataract surgeons and surgery centers to integrate the ALLY System. The Company expects to install 8 to 12 ALLY Systems in 2022 as part of a controlled, commercial launch.

 

Forward-Looking Statements

 

Statements in this Current Report on Form 8-K regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited, to statements regarding the Company’s development and commercialization of ALLY. Forward-looking statements may be identified by words such as “anticipates,” “believe,” “continue,” “expect,” “intend,” “may,” “plan to,” “potential,” “projects,” “will,” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors, including, without limitation, the risks referred to under the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as such factors may be updated from time to time in the Company’s other filings with the SEC, which filings are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of the Company’s website at https://ir.lensar.com. All forward-looking statements speak only as of the date of this Current Report on Form 8-K and, except as required by applicable law, the Company has no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

 

 

Exhibit No.

Description

 

99.1

Press Release of LENSAR, Inc., dated August 16, 2022

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 


 

 

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.

 

 

LENSAR, INC.

 

 

 

Date: August 16, 2022

By:    

/s/ Nicholas T. Curtis

 

Name:

Nicholas T. Curtis

 

Title:

Chief Executive Officer

 

 

EX-99.1 2 lnsr-ex991_34.htm EX-99.1 lnsr-ex991_34.htm

Exhibit 99.1

 

First Patients Treated with LENSAR’s® ALLY™ Adaptive Cataract Treatment System

 

August 16, 2022 ORLANDO, Fla.--(BUSINESS WIRE)-- LENSAR, Inc. (NASDAQ: LNSR) (“LENSAR” or the “Company”), a global medical technology company focused on advanced femtosecond laser surgical solutions for the treatment of cataracts, today announced the first commercial cases performed with the ALLY™ Adaptive Cataract Treatment System (“ALLY” or the “ALLY System”) by Robert Weinstock, MD at The Eye Institute of West Florida. Dr. Weinstock performed 15 laser-assisted cataract surgery cases following the recent installation of his ALLY System.

 

“This marks the culmination of our dedication and focus to bringing the next generation technology to cataract surgeons. We are proud to partner with Dr. Weinstock as the first surgeon to integrate ALLY into his renowned practice for refractive cataract surgery. Dr. Weinstock brings a wealth of surgical expertise and is leading this paradigm shift for cataract surgeons,” said Nick Curtis, Chief Executive Officer of LENSAR. “I’d also like to personally thank Dr. Weinstock for his unwavering belief in LENSAR and for working closely with us through the years.”

 

Following ALLY’s FDA clearance in June 2022, LENSAR has been working closely with select cataract surgeons and surgery centers to integrate the ALLY System and provide more of their patients with a premium cataract surgery experience. ALLY’s size and ergonomics are designed to facilitate completing the entire cataract surgery procedure in a single, sterile setting, reducing the overall time and improving the experience for the patient and surgeon. In addition to increased efficiencies, ALLY’s proprietary features are designed to enable surgeons to deliver improved clinical outcomes. ALLY’s state-of-the-art Augmented Reality™ and Cataract Density Imaging is intended to provide surgeons with a new level of guidance and confidence while performing surgery. LENSAR expects to install 8 to 12 ALLY Systems in 2022 as part of a controlled, commercial launch.

 

“ALLY is changing the way surgeons are approaching cataract surgery. With improved efficiencies, ALLY is designed to enable surgeons to offer a premium cataract surgery experience to more patients. ALLY is primed to assist surgeons in meeting the increasing demands of the large, fast-growing, cataract patient population with a premium, efficient experience,” added Mr. Curtis. “We look forward to strengthening our relationships and providing responsive, best-in-class customer service to each center using LENSAR technologies. With ALLY coming to market at a time where first generation femtosecond lasers have significantly aged, ALLY provides an opportunity for surgeons to continue to provide laser cataract surgery with a reliable, next generation platform. LENSAR’s first-generation LLS systems have demonstrated a 99.7% uptime rating – a true laser workhorse – and we are


 


 

 

aiming for ALLY to exceed these service ratings. Overall, our objective is to exceed surgeon, staff and patient expectations across all measures of performance.”

 

About LENSAR

LENSAR is a commercial-stage medical device company focused on designing, developing, and marketing advanced systems for the treatment of cataracts and the management of visually significant astigmatism as an integral aspect of the cataract procedure. LENSAR has developed its next-generation ALLY™ Adaptive Cataract Treatment System, its first platform to integrate its proprietary imaging with an optimized femtosecond laser in a compact system. ALLY is designed to transform cataract surgery by utilizing LENSAR’s advanced technologies with the ability to perform the entire procedure in an operating room or in-office surgical suite, delivering operational efficiencies and reduced overhead. ALLY includes LENSAR’s proprietary Streamline® software technology, designed to guide surgeons to achieve better outcomes.

 

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s development and commercialization of the ALLY™ Adaptive Cataract Treatment System (“ALLY” or the “ALLY System”), ALLY’s potential performance and the anticipated market response. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company’s assets and business include, without limitation, its history of operating losses and ability to generate revenue; its ability to maintain, grow market acceptance of and enhance its LENSAR Laser System; the impact of the COVID-19 pandemic and the Company’s ability to grow revenues; the Company’s ability to obtain any additional necessary clearances or approvals for ALLY ; the willingness of patients to pay the price difference for LENSAR products; its ability to grow a U.S. sales and marketing organization; its ability to meet its future capital needs; the impact of any material disruption to the supply or manufacture of the LENSAR Laser Systems; the ability of the Company to compete against competitors that have longer operating histories and more established products than the Company; the Company’s ability to address numerous international business risks; and the other important factors that are disclosed under the heading “Risk Factors” contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from


 


 

time to time in its other filings with the SEC, each accessible on the SEC’s website at www.sec.gov and the Investor Relations section of the Company’s website at https://ir.lensar.com. All forward-looking statements are expressly qualified in their entirety by such factors. Except as required by law, the Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise. These forward-looking statements should not be relied upon as representing LENSAR’s views as of any date subsequent to the date of this press release.

 

Investor Contacts: 

Thomas R. Staab, II, CFOLee Roth / Cameron Radinovic

ir.contact@lensar.comBurns McClellan for LENSAR

lroth@burnsmc.com /

cradinovic@burnsmc.com

 

Trade Contacts:

Lauren Gyoerkoe, VP Marketing Levi Hall
lauren.gyoerkoe@lensar.comL COMMUNICATION for LENSAR

levi@lcommunications.me

Source: LENSAR, Inc.

 

 

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Document and Entity Information
Aug. 16, 2022
Cover [Abstract]  
Entity Registrant Name LENSAR, INC.
Document Type 8-K
Amendment Flag false
Entity Central Index Key 0001320350
Document Period End Date Aug. 16, 2022
Entity Emerging Growth Company true
Entity File Number 001-39473
Entity Tax Identification Number 32-0125724
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 2800 Discovery Drive
Entity Address, City or Town Orlando
Entity Address, State or Province FL
Entity Address, Postal Zip Code 32826
City Area Code 888
Local Phone Number 536-7271
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Ex Transition Period false
Title of 12(b) Security Common stock, par value $0.01 per share
Trading Symbol LNSR
Security Exchange Name NASDAQ
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