biocqr
11 years ago
STAAR Surgical Reports Strong Second Quarter Financial Results
Total Sales of $18.2 Million Increased 14% from Q2 2012 / 20% Increase on Constant Currency Basis
Visian® ICL™ Sales Grew 31% to Record $11.3 Million
Visian ICL with CentraFLOW™ Technology Continues to Drive Growth
Company Increases Revenue Growth Metric for the Year
GAAP Net Income of $0.01 per share; Non-GAAP Adjusted Net Income of $0.05 per share
MONROVIA, Calif., July 31, 2013 /PRNewswire/ -- STAAR Surgical Company (STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported revenue for the second quarter ended June 28, 2013 of $18.2 million, which represented 14% growth compared to $15.9 million reported for the second quarter of 2012. The results included sales of $11.3 million of the Company's Visian ICL product portfolio and $5.9 million of its IOL products. In addition, low margin Other Product sales increased to $1.0 million. The effect of foreign currency exchange during the quarter versus prior year second quarter reduced total sales by $1.0 million. On a constant currency basis revenues grew 20% during the second quarter of 2013 compared to the second quarter of 2012.
"We delivered a second consecutive quarter of solid revenue growth with some very positive trends that we believe can be built on over the next several quarters," said Barry Caldwell, President and CEO. "In our focused major markets, our Visian ICL continues to gain share over LASIK. We have now successfully implanted over 20,000 ICLs with CentraFLOW and this technology continues to be a key growth driver. During June we received approval of the ICL with CentraFLOW in Argentina and Korea. The ICL with CentraFLOW launch events took place this month in Korea and also in India where we now expect to receive the final product approval during the third quarter. Based upon our experience in Europe, the wider approval range of the Visian ICL with CentraFLOW opens up the refractive market for increased market share gains."
"We saw good growth in ICL revenues from all three of our regions despite the continued downward pressure on LASIK," added Mr. Caldwell. "Our European region grew 47% during the quarter driven by the new CentraFLOW technology, productivity from our expanded sales team in the region and the shift to a direct selling model in Spain. Our Asia Pacific region grew Visian ICL sales by 29% which was driven by 77% growth in China. With the growth renewal in China during the quarter that market was our number one market in Visian ICL revenues. During the second half of this year the region will have the new CentraFLOW approvals in Korea and India to drive incremental growth. North America grew ICL revenues by 9%. The U.S. continues to show market share gains as revenue grew 10% while units increased 15% during the quarter. Our competitors promoting LASIK continue to profile the U.S. as a very challenging market for refractive procedures."
"We sold our first nanoFLEX™ Toric IOLs in Europe during the quarter with encouraging results. IOL growth overall continued to be negatively impacted by KS IOL product supply and the worsening value of the yen. The negative impact from the value of the yen on IOL sales was $827,000 during the quarter. We had to suspend delivery of our new KS IOL products to China until we have additional supply which is dependent on our third party supplier. This interruption in supply for China resulted in reduced sales of $810,000 as compared to second quarter of 2012 and $347,000 sequentially. Our backorders in Europe increased to $1.2 million at the end of the second quarter."
"Our manufacturing consolidation project remained basically on schedule as all IOLs and 21% of myopic ICLs through final inspection were manufactured in Monrovia during June. Throughout this three year process, supply and product quality have remained our priority. As a result of higher than expected demand for the Visian ICL during the first half of the year our ICL inventory levels in Switzerland have declined below our level of comfort. We need to build more ICL units during the second half for both the increased demand and inventory replenishment. In order to accomplish this we have decided to extend completion of our manufacturing consolidation initiative until the first half of 2014. By the end of December we expect to have two thirds of all myopic ICLs and one third of all TICLs manufactured in the U.S. as well as 100% of all IOL products. Production in Switzerland will continue into the first half of next year to build more robust inventory levels for our ICL products and we plan to begin a second shift in Monrovia at the end of August. We do not anticipate this slight shift will interfere with the planned use of all of the NOLs after consolidation," Mr. Caldwell continued.
"We remain focused on expanding our market share and gaining additional approvals for our technology in key markets. I am encouraged that we have executed so well against the plan we laid out at the start of this year. While we expect to have continued headwinds due to the yen valuation, as a result of our performance during the first half of the year, and the positive momentum going into the second half of the year, we are increasing our annual revenue growth metric from the original 8 to 10% to the 12 to 14% range," concluded Mr. Caldwell.
Gross profit margin for the quarter was 69.5% compared to 69.3% in the second quarter of 2012. The highest gross margin product, the Visian ICL, represented 62% of all revenue during the quarter. Gross margin expansion was limited primarily by a 23% sequential increase in very low margin IOL injector systems sales to a third party supplier for the buildup of their acrylic preloaded product supply, which appears in the Other Product sales category. These sales generated a gross margin considerably below the Company's Visian ICL and IOL product lines gross margins. Those differences accounted for a 150 basis point difference in the gross margin results during the quarter which would have otherwise been 71%.
Operating expenses for the second quarter of 2013 were $11.9 million, up 6.4% from the $11.2 million prior year period reflecting $613,000 in related charges associated with the Company's manufacturing consolidation project and a $293,000 increase in sales and marketing expenses driven by the additions to the Company's headcount throughout 2012. The effect of foreign currency exchange on overall operating expenses was a positive $505,000.
Income taxes increased to $599,000 during the second quarter of 2013 compared to $327,000 during the second quarter of 2012. The overall tax rate was 68.3% during the quarter and the estimated tax rate for 2013 has been increased to 45% due to the Company's decision to extend the completion date of its manufacturing consolidation project to focus on meeting near term demand. Additionally, the effective tax rate for the quarter was negatively impacted because under GAAP jurisdictions with losses are excluded from the calculation for interim reporting purposes.
GAAP net income for the second quarter of 2013 was $278,000, or $0.01 on a per diluted share basis, compared with net loss of $491,000, or $0.01 on a per diluted share basis, in the second quarter of 2012, a $769,000 improvement. Adjusted net income (excluding manufacturing consolidation expenses, gain (loss) on foreign currency transactions, fair value adjustment of warrants, and stock-based compensation expense) for the quarter ended June 28, 2013 was $1.8 million or $0.05 per diluted share versus adjusted net income for the year ago quarter of $1.2 million or $0.03 per diluted share. The reconciliation between GAAP and non-GAAP financial matters is provided with financial tables included with this release.
Cash and cash equivalents on June 28, 2013 totaled $19.7 million, compared to $19.2 million at the end of the first quarter of 2013. Cash generation from operations during the quarter was $788,000, which includes the use of $613,000 for the manufacturing consolidation project. The Company also used $799,000 for the purchase of property and equipment and generated $929,000 in proceeds from stock option exercises.
For the six month period ended June 28, 2013, sales increased to $36.2 million versus $31.5 million during the first half of 2012, a 15% increase in U.S. dollars and 21% increase in constant currency. Gross profit increased by 15%. Operating expenses increased $1.7 million or 7.6%, which included key investments of $1.5 million for the consolidation project ($262,000 above prior year) and incremental spending of $916,000 in sales and marketing. Operating income increased by $1.7 million during the six month period. Income taxes were $355,000 higher and the new medical device tax was $104,000. Net Income on a GAAP basis was $749,000 or $0.02 per diluted share and the non-GAAP adjusted net income increased to $5.0 million or $0.13 per diluted share basis as compared to $2.6 million or $0.07 per diluted share during the first half of 2012.
Recent Visian Implantable Collamer® Lens (ICL) Highlights
ICL sales represented 62.0% of total sales, compared to 54.0% of sales in Q2 2012.
ICL sales increased 31% to $11.3 million from $8.6 million in Q2 2012 reflecting a 27% increase in unit sales and a 3% increase in price.
Of total Visian ICLs the mix of TICLs was approximately 33% of units and 39% of dollars.
Overall sales in the Company's 11 key markets reflected a 33% increase in revenues and 28% increase in units.
Key regulatory approvals were obtained during the quarter:
Visian ICL with CentraFLOW was approved in Korea and Argentina.
Progress was made in India with approval of the CentraFLOW technology expected within the third quarter.
The Company has been told by the FDA that the current intent is to take the TICL to the Advisory Panel. A date has not been established and the Company is responding to questions from the FDA and preparing the information needed for the Panel Package necessary for that meeting to occur.
Regional ICL Updates
Europe, Middle East, Africa (EMEA)
Visian ICL revenues grew by 47% while units increased 30% and price increased 13%.
Europe increased 52% in revenue due to gains from the CentraFLOW technology, and new sales personnel hired in 2012.
Spain grew 127% driven by the conversion from a distributor sales model to a direct model which occurred at the end of second quarter 2012. This provided end customer pricing for the market. Visian ICL unit growth was 100% for the quarter. During the second quarter of 2012 the Company credited the past distributor for their inventory in the market.
Strong growth was also seen in France +41%, Italy +35% and the UK +107%.
The Middle East revenues grew 37% after a very strong first quarter with the release of the Visian ICL with CentraFLOW.
Latin America grew 39% in revenue. Approval of the ICL with CentraFLOW in Argentina allowed the first orders to be placed late in the quarter.
Asia Pacific (APAC)
APAC grew 29% in revenue while units increased 28% and price increased 1%.
China returned to more historical growth rates as revenues increased 77% while units increased 82%. The Company believes that the impact of the negative press on LASIK one year ago may now be subsiding.
Korea grew 7% as the distributor prepared for the first sales of the Visian CentraFLOW technology which was approved in late June with the official launch at the end of July.
Japan grew 12% in revenue with unit growth at 17% as revenue was negatively impacted by currency and price.
India grew 20% in revenue. Visian CentraFLOW was launched during a key meeting in early June and regulatory approval is expected during the third quarter.
North America (NA)
NA increased revenues by 9% while units increased 13% with a 3% decline in price.
Sales in the U.S. grew 10% while units grew 15% in a market with increasing evidence that LASIK procedures are declining or flat at best.
A major corporate provider of LASIK procedures reported their refractive procedures declined 10% in the U.S. during Q2 based upon their belief that new flexible spending account guidelines are having a negative impact on elective surgeries.
Recent Intraocular Lens (IOL) Highlights
Second quarter IOL sales were $5.9 million as compared to $6.8 million during the second quarter of 2012. The negative impact of foreign exchange was $827,000 for IOLs. Without the impact of foreign exchange, global IOL revenue would have declined by approximately 1% on a constant currency basis.
IOL gross margin declined from 60% in the second quarter of 2012 to 55% in the current quarter. This was driven primarily by the negative impact of foreign exchange as the preloaded silicone IOLs are cost based in U.S. dollars and primarily sold in yen. If not for this impact the gross margin would have remained at the 60% level for the quarter.
IOLs represented 32% of total sales in the second quarter of 2013, compared to 43% of total sales in the same period of the prior year.
The Company ended the quarter with approximately $1.2 million in backorders from European customers which is a 30% increase over the backorders at the end of the first quarter. The Company's supplier of acrylic IOLs has been unable to meet the high demand for the new KS IOL products, but is working to increase supply during the second half of the year.
IOL sales in Japan represented 57% of all IOL revenues and 45% of all IOL units. During the quarter there was a 15% increase in units as compared to the second quarter of 2012. Units during the quarter increased by 2% over the first quarter of this year yet revenue declined by 6% due to the weakening of the yen value. In U.S. dollars, this reflects a flat performance to the prior year though a 21% increase in constant currency.
Due to the lack of supply in the KS IOL products, the Company has suspended delivery of product to the China market. IOL revenues during the second quarter were $810,000 less than prior year and $347,000 less than the first quarter of this year.
Shipments of the nanoFLEX Toric IOL began late in the quarter to customers in Europe.
The newly enhanced nanoFLEX II IOLs were shipped along with the reading cards for the clinical trials which started during July. The protocol is designed to measure near and intermediate visual results as well as rotational stability.
Project Comet Update
The Company's manufacturing consolidation project continued to be basically on plan through the first half of the year. The Company has decided that due to the higher demand needs resulting from increased sales of the Visian ICL products and the expected Visian Preloaded V5 ICL approval for Europe, to extend the completion date for consolidation until the first half of 2014.
Validations were successfully completed for the Visian Toric ICLs as expected and the Company plans to ship the first TICLs from Monrovia during the third quarter.
Sterile IOLs began shipping from Monrovia to Japan during the quarter and the Company exited the quarter with all IOLs globally being manufactured in Monrovia.
Manufacturing consolidation expenses were $613,000, as compared to $697,000 reported in the second quarter of 2012. Costs associated with the wind down of manufacturing operations in Japan are expected to decrease in the second half of the year.
2013 Metrics- Revenue Growth Metric Increased; Manufacturing Consolidation Extended
The Company updated its metrics as follows and will continue to report and update on each of the 2013 metrics quarterly:
Total revenue growth in the range of 12 to 14%, up from an original metric of 8 to 10%.
Gross margin expansion by a minimum of 250 bps for the year.
Profitable on a GAAP basis each quarter.
Continuous quarterly progress toward the full implementation of manufacturing consolidation from Japan and Switzerland facilities to the U.S. The timetable for complete implementation of this program has been extended to the first half of 2014. During the month of December the Company expects to have 100% of all IOL production, two thirds of ICLs and one third of TICLs manufactured in the U.S.
Conference Call
The Company will host a conference call and video webcast today, July 31, 2013 at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the Company's second quarter 2013 financial results and recent corporate developments. The dial-in number for the conference call is 877-703-6105 for domestic participants and 857-244-7304 for international participants, both using a passcode 23510067.
The Company will also be using slides to illustrate its second quarter results and operational progress. The slides and live webcast of the call can be accessed from the investor relations section of the STAAR website at www.staar.com.
A taped replay of the conference call will also be available beginning approximately one hour after the call's conclusion and will be available for seven days. This replay can be accessed by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers, both using passcode 40120994. An archived webcast will also be available at www.staar.com.
Use of Non-GAAP Financial Measures
This press release includes supplemental non-GAAP financial information, which STAAR believes investors will find helpful in understanding its operating performance.
The Company conducts a significant part of its activities outside the U.S. It receives sales revenue and pays expenses principally in U.S. dollars, Swiss francs, Japanese yen and Euros. The exchange rates between dollars and non-U.S. currencies can fluctuate greatly and can have a significant effect on our results when reported in U.S. dollars. When preparing its financial statements in conformance with GAAP, the Company translates foreign currency sales and expenses denominated in Japanese yen to dollars at the weighted average of exchange rates in effect during the period. As a result, the Company's reported performance may be significantly affected by currency fluctuations. In order to compare the Company's performance from period to period without the effect of currency, the Company will apply the same average exchange rate applicable in the prior period, or the "constant currency" rate to sales or expenses in the current period as well. Because changes in currency are outside of the control of the Company and its managers, management finds this non-GAAP measure useful in determining the long term progress of its initiatives and determining whether its managers are achieving their performance goals. The Company believes that the non-GAAP constant-currency sales results measures provided in this press release are similarly useful to investors to give insight on long term trends in the Company's performance without the external effect of changes in relative currency values. The table below shows sales results calculated in accordance with GAAP, the effect of currency, and the resulting non-GAAP measure expressed in constant currency.
"Adjusted Net Income" excludes the following items that are included in "Net Income" as calculated in accordance with U.S. generally accepted accounting principles ("GAAP"): manufacturing consolidation expenses, Spain distribution transition expenses, gain or loss on foreign currency transactions, the fair value adjustment of outstanding warrants issued in 2007, and stock-based compensation expenses.
We believe that "Adjusted Net Income" is useful to investors in gauging the outcome of the key drivers of our business performance: our ability to increase sales revenue and our ability to increase profit margin by improving the mix of high value products while reducing the costs over which we have control.
We have excluded manufacturing consolidation and Spain distribution transition expenses because these are non-recurring expenses and their inclusion may mask underlying trends in our business performance. Expenses associated with the Company's plans to consolidate its manufacturing operations to the U.S. are largely expected to be completed at the end of 2013 and the Spain distribution transition expenses were completed at the end of the first quarter of 2013.
We have excluded gains and losses on foreign currency transactions and the fair value adjustment of warrants because of the significant fluctuations that can result from period to period as a result of market driven factors.
Stock-based compensation expenses consist of expenses for stock options and restricted stock under Statement of Financial Accounting Standards ("SFAS") No. 123R. In calculating Adjusted Net Income STAAR excludes these expenses and the fair value adjustment of outstanding warrants because they are non-cash expenses and because of the complexity and considerable judgment involved in calculating their values. In addition, these expenses tend to be driven by fluctuations in the price of our stock and not by the same factors that generally affect our other business expenses.
We have provided below a detailed reconciliation table, which is useful to investors in providing the context to understand our Adjusted Net Income and how it differs from Net Income calculated in accordance with GAAP.
biocqr
12 years ago
Staar Surgical (STAA): Sounds pretty confident that implantable lenses can replace LASIK surgery
Staar Surgical (STAA), which makes implantable lenses for the eye and which was recently re-added to our Emerging Growth rankings (added May 7 at $8.99), just wrapped up its presentation at the Deutsche Bank Healthcare Conference in Boston. It sounds like its biggest competitor (LASIK surgery) is on the decline and Staar is filling the void. Since Staar is not a well known name in the US (81% of 2012 revenue was from outside the US), we wanted to provide some highlights from the presentation.
In terms of what Staar does, they make implantable lenses for the eye both to correct vision (Visian ICL lens, which is an alternative to LASIK surgery) and to treat cataracts (IOLs). All of its lenses are foldable and can be inserted through a small incision in the eye. It's basically an implantable contact lens. STAA believes its Visian ICL lens is better than LASIK as it has better results, fewer side effects and, unlike LASIK, can be removed if the patient is not satisfied. That's a big selling point to nervous consumers. Management believes its competitive position has improved over the past six months as it appears LASIK procedures are declining in major markets. Also, lenses which are in the anterior segment of the eye all seem to be facing new clinical challenges. The Visian ICL sits behind the iris in the posterior segment. As a result, STAA believes it is taking market share. The stock jumped in early May on a surprisingly strong Q1 report and the favorable comments about its improved competitive positioning.
Probably the most interesting point to come out of today's presentation is STAA being pretty confident that LASIK surgery is on the decline. Basically, they said that there are always evolutions in healthcare. In this space, it was originally glasses then contact lenses etc. "There is clear evidence that LASIK is on the downturn and there is evidence that ICL is taking over. This is the moment for the ICL." LASIK and the related complications have seen a good deal of negative press over the past few years. While this is good for Staar, which has a competing product, unfortunately this tends to weigh down the entire elective eye surgery market as consumers lump all of them together. In particular, there has been a lot of negative press about LASIK in China over the past year. This hurt STAA's results in this important region but they have seen some improvement recently.
In terms of the R&D pipeline, STAA has regularly introduced new products over the past few years. Perhaps most importantly, STAA introduced the ICL V4c with CentraFLOW technology in Europe and other territories in 2011. The CentraFLOW technology optimizes the flow of fluid within the eye, and eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. By simplifying the procedure to a one-time visit like LASIK, STAA is much better able to compete with LASIK. STAA expects to get approval in India and Korea for the CentraFLOW technology. In the first year after approval in Europe it had a big impact on STAA's results and they expect a similar impact in other countries. Another key launch was the Toric ICL in Japan to treat patients primarily affected by astigmatism.
A big reason STAA is not well known in the US is because its two most advanced lenses are not yet approved in the US. In particular, management concedes that the Toric not being approved in US has been a cloud over the company. STAA has shown it can do well outside of the US but cracking the US market in a bigger way would be a big positive. STAA has filed its application and has had dialogue with the FDA. STAA has been pushing that it would like some sort of decision this year (either approval, go to panel, not approved). Overall, STAA says he has felt a change at the agency that the process seems to finally be moving along.
In terms of other topics, STAA is moving its manufacturing operations from Japan and Switzerland to the US. This manufacturing consolidation should improve gross margins further. The process is wrapping up this year and it's on plan. This is a major project and gross margins should get near 80% after the consolidation. Another topic was STAA's heavy investment in sales/marketing last year. They expect to start to see some benefit this year. They also have some key new product launches and approvals coming up in 2013. Also, Spain has been converted to a direct model (instead of using distributors) which will help margins. Finally, STAA says it wants to crack the US market in a bigger way as it's an attractive opportunity but they do not expect much additional penetration until the Toric ICL gets approved.
Overall, we remain a fan of STAA. They seem confident that LASIK surgery is on the way out and the implantable lens is the next step in corrective vision technology. A huge selling point is that the lens can be removed if the patient is not happy. The unfortunate part about the STAA story is that its latest technology is not yet approved in the US, it's mostly being used in Asia and Europe. But they are working on that and if they get approval, that would be a big boost for them. Another recent development in its favor, we believe, is the recent announced acquisition of lens supplier Bausch & Lomb by Valeant Pharma (VRX). STAA is tiny but has some attractive technology that we think would be attractive to a larger player in this space.
Read more: http://www.briefing.com/DisplayArticle/Article.aspx?ArticleId=NS20130529120310EmergingGrowthStocks#ixzz2WlpxAlKf
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scott64
16 years ago
NEWS! NEWS!!!!!!
Free Stock Symbol Lookup - Scottrade: Leading stock research
Press Release Source: STAAR Surgical Company
STAAR Surgical Receives FDA Clearance for the Epiphany(TM) Injector System
* On Thursday June 11, 2009, 8:00 am EDT
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* STAAR Surgical Company
MONROVIA, Calif., June 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA - News), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the FDA has granted 510(k) clearance for its Epiphany Injector System for use with the Affinity(TM) Collamer® Three-Piece NTIOL and the Elastimide(TM) Silicone NTIOL. Introduction of the Epiphany will usher in a new era of insertion devices for the company and pave the way for the future introduction of a preloaded injector for the U.S. market.
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STAAR named this product "Epiphany" based on the genesis of the product: the realization that the revolutionary proprietary technology used in our preloaded products outside of the U.S. could be modified and incorporated into a stand-alone injector for IOLs in other markets. Epiphany has been designed to combine both ease of use with controlled delivery. The Epiphany injector system is intended for single use and offers the flexibility of either twist or push insertion techniques - a unique feature of STAAR's IOL delivery systems.
"The Epiphany Injector System is an important extension of STAAR Japan's expertise in the area of preloaded delivery systems for foldable IOLs which have been very successful in the Japanese market," said Barry G. Caldwell, President and CEO of STAAR Surgical. "This product will enhance the ability of surgeons to accurately deliver the Collamer Three-Piece NTIOL into the eye and it serves as the forerunner in our regulatory pathway for potential approval of the preloaded delivery system in the U.S."
As the Epiphany provides for effortless yet controlled insertion through a 2.8mm incision and, being a single use product, ensures a sterile pathway into the eye. The Epiphany's planar delivery of the lens into the eye offers controlled release of the lens haptics which is another clear advantage that will help differentiate this the new system in the market place.
First shipments of the product should begin in July with full release to the market in the August timeframe.
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 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. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. Collamer® is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available at www.staar.com.
Safe Harbor
leoncio1
16 years ago
STAAR Surgical Receives CE Mark Approval for KS-X Preloaded Hydrophobic Acrylic Lens Injector System
MONROVIA, Calif., June 9 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that it has received CE Mark approval for its KS-X Preloaded Hydrophobic Acrylic Injector for use in minimally invasive cataract surgical procedures. The CE Mark allows STAAR Surgical to market this foldable intraocular (IOL) KS-X lens delivery system in the European Union as well as other countries that recognize the CE Mark. It also signifies that STAAR's preloaded acrylic lens delivery system complies with applicable safety and quality standards.
STAAR has been offering the KS-X system, which mates a preloaded delivery system manufactured by STAAR Japan with an independently sourced acrylic lens, in the Japanese market for two years. The STAAR system enables lens delivery into the eye through a 2.8 millimeter incision and is compatible with the most commonly used small incision cataract extraction procedures. It is the only preloaded lens delivery system in the world that provides single or bi-manual injection options in one single design, allowing for the smoothest IOL injection methods compared with traditional delivery systems.
"Receipt of the CE Mark is an important accomplishment and a validation of STAAR Japan's expertise in the development of preloaded delivery systems for foldable IOLs that enable precise delivery of the lens during cataract surgeries," said David Bailey, President of International Operations. "The CE Mark illustrates STAAR Japan's expertise in delivery systems for intraocular lenses, including their use with advanced material lenses. This expertise was one of the major factors behind our recent creation of operational Centers of Excellence throughout our global operations, which is expected to drive continued product enhancements as we move forward."
A foldable IOL is a prosthetic lens used to replace a cataract patient's natural lens after it has been extracted in minimally invasive small incision cataract surgery. STAAR manufactures IOLs out of silicone and Collamer(R), STAAR's proprietary biocompatible collagen copolymer lens material. STAAR Japan introduced the first preloaded IOL lens injector system to the international markets during 2003. STAAR introduced the Centers of Excellence Project in the fourth quarter of 2008. It is designed to enhance STAAR's ability to deliver innovative surgical products to customers by focusing the Japanese operations on developing and manufacturing innovative lens delivery systems and focusing the U.S. operations on optics design and manufacturing. The expected result is costs savings and more rapid introduction of new technologies.
"The introduction of our KS-X preloaded delivery system will be primarily focused on our direct markets and other key markets in Europe where reimbursement for our end customers are higher. The outstanding functionality of our preloaded system has already won market share in the more difficult silicone segment, and this approval allows us to bring the technology to the growing number of surgeons who prefer the hydrophobic acrylic lenses for their patients. With the introduction of this product in these markets, we believe we are moving toward our goal of establishing our preloaded delivery systems as the global standard of care in all IOL lens segments," Mr. Bailey said.
First shipments of the product in key European and Australian markets are expected to begin in late June. The acrylic-lens-based preloaded injector is not approved for sale in the U.S.
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 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. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 50 countries. Collamer(R) is the brand name for STAAR's proprietary collagen copolymer lens material. More information is available 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: projections of any financial items; the plans, strategies, and objectives of management for future operations or prospects for achieving such plans; the success of the KS-X injector system in the European Union or elsewhere, our future performance; 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 the need to satisfy the forthcoming judgment in the Parallax case or post an appeal bond and the resulting effect on our liquidity, our limited capital resources and limited access to financing, the need to defend other litigation similar to the Parallax case and to satisfy judgment in the event of an adverse ruling in that case, for which we have taken no reserve, the effect the global recession may have on sales of products, especially products such as the ICL used in non-reimbursed elective procedures, the challenge of managing our foreign subsidiaries, the risk that we will not succeed in introducing improved products that restore the profitability of our U.S. IOL product line, our ability to resolve FDA concerns over the clinical study for the Toric ICL and to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S.
CONTACT: Investors Media
EVC Group EVC Group
Douglas Sherk, 415-896-6820 Christopher Gale 646-201-5431
Michael Pollock, 415-896-6862
SOURCE STAAR Surgical Company
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