Company: STAA
Filing Date: 2025-09-29
Form Type: DFAN14A
Source: 0001213900-25-093211
Chunk: 12

Company: STAAR SURGICAL CO
Filing Date: 2025-09-29
Form: DFAN14A
Chunk 12
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CLs are the market standard, commanding roughly 73% of all refractive procedures in the 
 country.                                                                                 |

| ● | China: STAAR                                                                              
 holds about 23% of the refractive surgery market, making it its largest market by volume, 
 though recent volatility has hurt sales.                                                  |

| ● | United                                                                         
 States: Roughly 17% share, but growing quickly since EVO ICL’s FDA approval in 
 2022.                                                                          |

| ● | Global                                                                          
 Average: EVO ICL accounts for more than 12% of refractive procedures worldwide, 
 leaving significant room to take share from LASIK globally.                     |

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The company’s biggest challenges have centered on China. In Q1 2025, China revenue collapsed 99% as distributors worked through bloated inventory and consumer demand dried up amid macroeconomic weakness. Staar had previously front-loaded shipments, including a $27.5 million December 2024 order it agreed to defer revenue on, leaving distributors with excess product they didn’t need. The company even shipped consignment inventory that still sat on its books, delaying true order flow.

The fallout was severe. Staar faced a demand cliff just as markets outside China were accelerating. CEO Stephen Farrell was brought on to help the company rebalance.

Proven Technology and a 30-Year Head Start

Concerns around eye implants, as seen in lawsuits involving other medical devices, center on the risk of malfunction, infection, or device failure. STAAR’s ICL franchise stands apart as the only FDA-approved posterior chamber phakic IOL in the United States, with a safety record backed by decades of real-world use.

STAAR’s ICL Timeline:

1982: STAAR founded as an IOL maker

1990s: Development of Collamer, STAAR’s proprietary collagen-copolymer lens material

1993: First ICL procedures performed in Europe

1997: CE Mark approval in Europe

2005: FDA approval for the Visian ICL

2011: EVO ICL launches internationally

2022: EVO and EVO+ ICL receive FDA approval, spurring U.S. growth

With nearly 30 years of commercial use and millions of successful implants worldwide, the ICL has a highly-credible safety profile among refractive implants.

A Patented Moat

STAAR does not just manufacture ICLs, it owns them. The company holds multiple patents covering:

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