Navigation Links
STAAR Surgical's Collamer(R) IOL Designated as a New Technology Intraocular Lens by the Centers for Medicare and Medicaid Services
Date:3/17/2008

MONROVIA, Calif., March 17 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the Afinity Collamer(R) Aspheric foldable intraocular lens (IOL) Model CQ2015A has been designated as a New Technology Intraocular Lens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). To receive NTIOL recognition an IOL must first be an FDA approved IOL with labeling and advertising consistent with the specific claim or characteristic for which CMS approval is being sought. In addition, there must be evidence that the use of the IOL results in measurable, clinically meaningful improved patient outcomes in comparison with use of currently available IOLs. The STAAR Afinity Collamer Aspheric IOL has proven to reduce spheric aberrations leading to improved visual acuity and increased contrast sensitivity.

This approval for NTIOL reimbursement status means that Medicare will provide an additional reimbursement of $50 per Collamer Aspheric lens when provided to a Medicare patient in an Ambulatory Surgical Center (ASC). ASCs perform well over one half of all cataract surgeries in the U.S. according to Market Scope, a leading market research provider for the ophthalmic market. The majority of STAAR's current IOL business is in the ASC segment. The NTIOL subset for Reduced Spherical Aberrations to which the STAAR Afinity Collamer Aspheric IOL has been approved will allow this enhanced reimbursement beginning today March 17, 2008 until February 26, 2011.

"STAAR is very pleased that CMS has recognized the benefits of the Collamer material in our Three Piece Aspheric IOL," said Barry G. Caldwell, President and CEO of STAAR Surgical. "This approval will allow us to compete more effectively in the market while increasing our average selling price which will assist in our gross margin improvement efforts. This is the first step in our plans to refresh our entire U.S. cataract product offerings. The next milestone will be our new nanoPOINT(R) delivery system which can inject the current STAAR Collamer Single Piece IOL through a 2.2 mm incision as compared to the current requirement of a 2.8 mm to 3.0 mm incision. This smaller incision size will help reduce surgically induced astigmatism, improve chamber maintenance during the surgical procedure and reduce healing time for the patient. The nanoPOINT injector is currently in pre-release marketing evaluations. The next steps include additional NTIOL submissions followed with clear regulatory pathways for the Collamer Aspheric Single Piece IOL, additional improved delivery systems, the Collamer Toric IOL, and the preloaded silicone IOL offerings."

"The Visian(R) ICL is made from the same Collamer material as the Afinity IOL product line," continued Mr. Caldwell. "The recent live Visian ICL procedure on the NBC Today Show has increased the interest of ophthalmologists and potential patients in the Visian ICL option for refractive surgery. An indication of that interest is that our website, http://www.visianinfo.com, has experienced a dramatic increase in the number of hits. We understand that the NBC link to the Visian ICL video has also experienced a very high hit rate compared to other similar live surgery videos. In addition, more live testimonies are being shared on local networks around the country about the life-changing experiences of the Visian ICL procedure.

About the Collamer IOL

Exclusive to STAAR Surgical Company, Collamer is a unique lens material that is composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer. The Afinity Collamer Aspheric IOL Model CQ2015A produces excellent optical performance including reduced spherical aberration and achieves significant biocompatibility. The Afinity Three Piece Collamer IOL combines foldable IOL technology with traditional design. This cataract IOL has modified "C" loop polyimide haptics with five degrees of angulation. These loops offer flexibility comparable to polypropylene and PMMA haptics, with greater tensile strength, and superior "shape memory." The lens edge of model CQ2015A has a square posterior edge and rounded anterior edge.

About STAAR Surgical

STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's products are distributed in over 40 countries by a combination of direct representation with a network of independent distributors. Collamer(R) is a registered trademark for STAAR's proprietary collagen co-polymer lens material. More information is available at http://www.staar.com.

Safe Harbor Statement

All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for improved sales or profit margins as a result of NTIOL status, other NTIOL submissions, plans to develop or introduce other products, statements of belief and any statements of assumptions underlying any of the foregoing. 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. The risks and uncertainties include our limited capital resources and limited access to financing, the priorities and subjective judgments of CMS in any further NTIOL designations, the willingness of surgeons and patients to adopt a new product and procedure and other factors beyond our control, including those detailed from time to time in our reports filed with the Securities and Exchange Commission. Product development plans are inherently subject to unexpected delays or obstacles. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

CONTACT: Investors Media

EVC Group EVC Group

Douglas Sherk, 415-896-6820 Steve DiMattia, 646-277-8706

Matthew Selinger, 415-896-6817 Christopher Gale, 646-201-5431


'/>"/>
SOURCE STAAR Surgical
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. STAAR Surgical Receives Approval to Market Visian(R) Toric Implantable Collamer Lens in China
2. China Aoxing Pharmaceutical Designated as a Key Manufacturer of Cancer Pain Drug by China SFDA
3. Lambert, Edwards & Associates Named Agency of Record for The West Michigan Science & Technology Initiative
4. Cellectis Sues Precision BioSciences for Infringement of its Patents Concerning Meganuclease Technology
5. Signalife Wins Second Frost & Sullivan Technology Award
6. Argonnes Lithium-Ion Battery Technology to be Commercialized by Japans Toda Kogyo
7. Altogen Biosystems Launches Custom Biotechnology Research Services: Generation of Stable Cell Lines and RNAi Cell Transfection Services
8. New nanotechnology television series does sweat the small stuff
9. A Communitys Fight to Preserve its Historical and Rural Culture in Virginia: Biotechnology CEO Gets Involved
10. Elekta Chosen to Deliver Sophisticated Brain Mapping Technology to Froedtert Hospital in Milwaukee
11. Sigma-Aldrich, Oxford BioMedica and Open Biosystems Settle Patent Dispute Over Use of LentiVector Technology in Research Reagents
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... Rolf K. Hoffmann, ... faculty of the University of North Carolina Kenan-Flagler Business School effective ... at UNC Kenan-Flagler, with a focus on the school’s international efforts, leading classes ...
(Date:6/24/2016)... Epic Sciences unveiled a liquid biopsy ... PARP inhibitors by targeting homologous recombination deficiency (HRD) ... test has already been incorporated into numerous clinical ... Over 230 clinical trials are investigating ... PARP, ATM, ATR, DNA-PK and WEE-1. Drugs targeting ...
(Date:6/23/2016)... ... 2016 , ... UAS LifeSciences, one of the leading manufacturers ... Probiotics, into Target stores nationwide. The company, which has been manufacturing high quality ... list of well-respected retailers. This list includes such fine stores as Whole Foods, ...
(Date:6/23/2016)... , June 23, 2016 Houston Methodist ... the Cy-Fair Sports Association to serve as their ... agreement, Houston Methodist Willowbrook will provide sponsorship support, ... connectivity with association coaches, volunteers, athletes and families. ... the Cy-Fair Sports Association and to bring Houston ...
Breaking Biology Technology:
(Date:6/22/2016)... WASHINGTON , June 22, 2016 On ... highly-anticipated call to industry to share solutions for the ... by U.S. Customs and Border Protection (CBP), explains that ... nationals are departing the United States ... criminals, and to defeat imposters. Logo - ...
(Date:6/15/2016)... June 15, 2016 Transparency ... titled "Gesture Recognition Market by Application Market - Global Industry Analysis ... 2024". According to the report, the  global gesture recognition ... 2015 and is estimated to grow at a ... by 2024.  Increasing application of gesture ...
(Date:6/3/2016)... , June 3, 2016 ... Management) von Nepal ... und Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, ... führend in der Produktion und Implementierung von ... der Ausschreibung im Januar teilgenommen, aber Decatur ...
Breaking Biology News(10 mins):