About STAAR Surgical

STAAR Surgical Company (STAAR) designs, develops, manufactures, and sells implantable lenses for the eye and accessory delivery systems used to deliver the lenses into the eye. The company is the leading manufacturer of lenses used worldwide in corrective or 'refractive' surgery. STAAR generates worldwide revenue almost exclusively from sales of the company's implantable Collamer lenses, or 'ICLs.' The company's ICLs are made from Collamer, which is a proprietary collagen copolymer material created and exclusively used by STAAR to make the company's lenses soft, flexible and biocompatible with the eye. The company's ICLs are phakic lenses, meaning that they are implanted into the eye without removing the eye's natural crystalline lens. This distinguishes an ICL procedure from other refractive procedures, as it does not involve the removal of corneal eye tissue. All of the company's ICLs are foldable, which allows the surgeon to insert them into the eye through a small incision during minimally invasive surgery. Further, while ICLs are intended to be permanent, the company's ICLs are reversible lens implants, meaning they can be removed by a doctor if desired. The company markets and sells its ICLs for refractive surgery to treat myopia (nearsightedness) as the company's 'EVO' family of lenses. The company's EVO lenses are an 'Evolution in Visual Freedom' designed to provide premium refractive outcomes while optimizing patient comfort. The company's EVO family of lenses includes the company's EVO ICL, EVO+ ICL, and EVO Visian ICL. The company's newest offering, EVO Viva, has an extended depth of focus (EDoF) optic, which is designed to treat myopia with presbyopia (age-related loss of ability to focus). The company also markets and sells an ICL lens to treat hyperopia (farsightedness), which the company calls its Visian ICL. The company makes its ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism (blurred vision). Not all of the company's products are available in all markets where the company sells ICLs. The company's growth strategy includes making its complete ICL product line available in the company's existing geographic markets and expanding into attractive markets where the company does not sell its products. In addition, the company is focused on driving awareness of the ICL procedure and the clinical benefits of the company's ICLs, and providing surgeon training, support and education, particularly in the company's newer markets. Historically, the company also manufactured and sold intraocular lenses (or 'IOLs') for use in surgery to treat cataracts. As the company has focused its business and strategy on its ICL product offerings, the company has phased out its cataract IOL product line. Outside the U.S., except for the company's direct commercial operations in Japan, Germany, Spain, Canada, the U.K. and Singapore, the company sells its products through independent distributors who generally control the importation and marketing of the company's product within their territories. Operations STAAR has significant operations globally. For the year ended December 29, 2023, the company generated 95% of its reported worldwide revenue from product sales outside the United States. STAAR sells its products in more than 75 countries, with direct distribution (i.e., via STAAR representatives) in Japan, the U.S., Germany, Spain, Singapore, Canada, and the U.K., with a combination of direct distribution and independent distribution (i.e., via distributors and STAAR representatives) in China, Korea, India, France, Benelux, and Italy; and with independent distribution in the remainder of the countries where the company sells. STAAR maintains operational and administrative facilities in the U.S., Switzerland, and Japan. Its global operations are as follows: The United States. STAAR operates its global administrative offices and principal manufacturing facility in Monrovia, California. The Monrovia site is the company's principal manufacturing facility and produces all of the company's ICLs. The company manufactures the raw material for Collamer lenses in its facility in Aliso Viejo, California. STAAR also operates a Technology Center housing its Research & Development team and labs in Tustin, California. STAAR's facility in Lake Forest, California serves as the company's corporate headquarters. It contains executive offices and operational facilities, and it is also expected to serve as the company's future manufacturing site for EVO Viva. Switzerland. STAAR operates an administrative, distribution and operational facility in Brugg, Switzerland under its wholly owned subsidiary, STAAR Surgical AG. The company is in the process of expanding its manufacturing capabilities for STAAR's ICL products in the company's Nidau, Switzerland facility. Japan. STAAR operates administrative and distribution facilities in Japan under its wholly owned subsidiary, STAAR Japan Inc. STAAR Japan's administrative facility is in Tokyo and its distribution facility is in Ichikawa City. The company also maintains commercial offices in China, Germany, Spain, India, Singapore, and the U.K. 100% of the company's sales are generated from the ophthalmic surgical product segment. The company's principal products are ICLs used in refractive surgery. Principal Products STAAR's principal products are ICLs used in refractive surgery, including the company's EVO family of lenses. In designing the company's ICL product offerings, the company seeks to delight patients and surgeons by improving patient outcomes; minimizing patient risk; and simplifying ophthalmic procedures and post-operative care for the surgeon and the patient. Refractive surgery corrects visual disorders that have traditionally been treated by eyeglasses or contact lenses. The field of refractive surgery includes both lens-based procedures, using products like the company's ICLs, and laser-based procedures like LASIK. The company's ICL products are designed to treat a wide range of refractive conditions within commonly known vision disorders, such as myopia (nearsightedness), hyperopia (farsightedness), astigmatism (blurred vision) and presbyopia (age-related loss of ability to focus). All of the company's ICLs fold for minimally invasive implantation. During a quick surgical procedure, the ICL will be implanted behind the iris and in front of the natural crystalline lens, using techniques similar to those used to implant an IOL during cataract surgery, except that the natural lens remains intact in the eye. Lenses of this type are generically called 'phakic IOLs' or 'phakic implants' because they work along with the patient's natural lens, or phakos, rather than replacing it. The surgeon typically implants the ICL using topical anesthesia on an outpatient basis. The patient usually experiences immediate vision improvement within a day. Typically, ICL surgery is an elective procedure paid for or financed by the patient. The company's EVO ICL is the only posterior chamber phakic IOL approved by the Food and Drug Administration (FDA) for marketing and sale in the U.S., and it is the world's largest selling phakic IOL. The company's biocompatible Collamer material belongs to a family of materials known as collagen copolymers. Collagen copolymers are compounds formed by joining molecules of collagen derived from biological sources with synthetic monomer molecules. The proprietary Collamer material is exclusive to the company. The biocompatibility of the Collamer material used for the company's ICL product line is a significant factor in the ability to place this lens safely in the posterior chamber of the eye. As of December 29, 2023, STAAR sold more than 2,500,000 ICLs worldwide. In September 2011, STAAR launched the ICL with CentraFLOW technology, commonly known as EVO ICL, which uses a port in the center of the ICL optic in markets outside the U.S. The port is of a size intended to optimize the flow of fluid within the eye without affecting the quality of vision. The central port also eliminates the need for the surgeon to perform a YAG peripheral iridotomy procedure days before the ICL implant. The CentraFLOW technology makes the visual outcomes of the ICL available through a relatively quick and comfortable surgical implantation experience. The company is authorized to sell the EVO ICL in all countries where the company sells its ICL family of lenses. In December 2015, the company received the CE Mark for EVO+, an ICL with CentraFLOW technology and an expanded optical zone of up to 20%. The expanded optical zone may further improve certain patients' visual experience, thus making the ICL increasingly desirable for both patients and ophthalmic surgeons. The company is authorized to sell the EVO+ in the following regions: the approximately 31 countries that require the European Union CE Mark, Korea, Japan, India, Canada, the U.S., Hong Kong, Turkey, and several countries in the Middle East. In March 2022, the FDA granted approval of the EVO ICL, EVO+ ICL, and the EVO Visian ICL (for the correction of myopia and myopia with astigmatism). The Visian ICL for hyperopia, which treats farsightedness, is sold primarily in countries that require the European Union CE Mark. In July 2020, the company received the CE Mark for EVO Viva, a presbyopia-correcting ICL with an aspheric EDoF optic. The company commenced certifying surgeons located in countries that recognize the CE Mark to implant the EVO Viva lens. The EVO Viva lens adds near and intermediate vision correction for patients with presbyopia. The EVO Viva lens will assist certain patients with eliminating the burdens of reading glasses or frequent replacement contact lenses. The company makes its ICL product offerings available in multiple models, powers and lengths, including some with toric ICL (TICL) versions to correct for astigmatism. As a result, the company manufactures hundreds of different types of lenses. This requires the company to carry a significant amount of inventory to meet customer preference for rapid delivery. The company is investing in its manufacturing and operations capabilities to be able to meet forecasted demand and further shorten lead times. The company plans to continue to develop and launch innovative products to support clinical needs and to address the increasing demands of the company's customers. As part of the company's sales and marketing efforts, the company attends and participates in major ophthalmic conventions around the world and invests in market development, practice support, healthcare professional training and patient outreach. The company has started working more closely with leading refractive clinics to advance surgeon training, drive awareness of the ICL procedure and the clinical benefits of the company's ICLs, and enhance education and practice development. The company's marketing programs seek to position its ICL products as a premium and primary option for appropriate patients at the clinic and via digital and social media. Since the second half of 2022, the company has announced its partnerships with singer, songwriter, and actor, Joe Jonas, professional basketball player, Max Strus, as well as actress and beauty entrepreneur Peyton List, to raise awareness of the EVO ICL lens. Other Products While STAAR generates worldwide revenue almost exclusively from sales of the company's ICLs, the company also records Other Products revenue. Historically, the company manufactured and sold IOLs for use in surgery to treat cataracts, as well as injectors for use in cataract surgery and injector parts. Sales from these cataract IOLs and other surgical products, as well as sales adjustments, such as return allowances, are recorded as Other Products revenue. As the company has focused its business and strategy on its ICL product offerings, the company has phased out sales of its cataract IOLs and other surgical products. The company does not expect to record revenue from cataract IOL or other surgical products sales in fiscal 2024 or thereafter. Patents, Trademarks, and Licenses As of December 29, 2023, the company owned approximately 61 United States and foreign patents and had 21 patent applications pending. Worldwide, the company sells all of its major products under trademarks the company considers to be important to the company's business. STAAR, STAAR Surgical, EVO ICL, EVO+ ICL, EVO Visian ICL, EVO Viva, Evolution in Visual Freedom, Visian, Collamer, CentraFLOW, and AquaPORT, are trademarks or registered trademarks of STAAR in the U.S., the European Union, or other countries. Distribution and Customers The company markets its products to a variety of health care providers, including ophthalmic surgeons, vision centers, surgical centers, hospitals, government facilities, and distributors. The primary user of the company's products is an ophthalmologist. The company sells its products directly through its own sales representatives in Japan, the U.S., Germany, Spain, Singapore, Canada, and the U.K. The company sells through a combination of its own representatives and independent distributors in China, Korea, India, France, Benelux, and Italy. The company sells through independent distributors in other countries. The company's products are sold in more than 75 countries worldwide. The company maintains a global marketing team, as well as regional marketing personnel to support the promotion and sale of the company's products. Where the company distributes products directly, the company relies on local sales representatives to help generate sales by promoting and demonstrating the company's products with physicians. The company's clinical affairs personnel provide training and educational courses globally. One customer, Shanghai Lansheng, the company's China distributor who sells into China and Hong Kong, accounted for approximately 58% of the company's consolidated net sales during the year ended December 29, 2023. Regulatory Matters Most of the company's products are classified as medical devices intended for human use within the meaning of the United States Federal Food, Drug & Cosmetic Act, as amended (the Act), and therefore, are subject to FDA regulation. The company's lens injector systems are Class I devices subject to the 510(k) premarket review and clearance process. The company's ICL products are Class III devices subject to the PMA approval process and not 510(k) clearance. The company is also subject to periodic inspection by the FDA for compliance with the FDA's QSR and other requirements, such as requirements for advertising and promotion. The FDA's Bioresearch Monitoring Program (BIMO) reviews the company's activities as a sponsor of clinical research. The company has affixed the CE Mark to all the company's principal products sold in CE Mark jurisdictions, including ICLs and delivery systems. STAAR Japan holds shonin approval for the ICL products, preloaded injectors, and their associated lenses, and kyoka licensing as a manufacturer and MAH of medical devices. The sponsor of a clinical trial submitted to the PMDA must strictly follow Good Clinical Practice (GCP) standards and must follow the trial with standard Good Post-Market Study Practice (GPSP) reporting and a follow-up program. MHLW and PMDA also assess the quality management systems of manufacturers and the conformity of products to the requirements of the PMD Act. STAAR is subject to inspection for compliance by these agencies. In China, medical devices such as the company's ICLs are mainly regulated by Regulations on the Supervision and Administration of Medical Device (Decree No. 739) promulgated by the State Council. Most of STAAR's medical devices are Class II and Class III devices and are subject to a restricted registration pathway. In Korea, a registration of medical devices such as the company's ICLs is overseen by the Ministry of Food and Drug Safety (MFDS) pursuant to the Medical Device Act. The company's facilities, operations, employees, and products are regulated by the Environmental Protection Agency, the Occupational Health & Safety Administration, the Department of Labor, the Department of Commerce, the Department of Treasury, the Department of Justice, and others. In the U.S., the FDA and the Federal Trade Commission regulate the advertising and promotion of the company's products and require that the claims the company makes are consistent with its regulatory clearances and approvals, that there is adequate and reasonable data to substantiate the claims and that the company's promotional labeling and advertising is neither false nor misleading. Research and Development The company focuses on furthering technological advancements in the ophthalmic products industry through the development of innovative premium ophthalmic products (lenses and accessory delivery systems), materials and designs. The company maintains active internal research and development programs. During 2024, the company intends to continue its focus on research and development in the following areas: Development of a presbyopia-correcting ophthalmic medical device that corrects cylinder (i.e., astigmatism), including clinical trials of the same; Development of preloaded injector systems for ophthalmic medical devices; and Development of a new generation of ophthalmic medical devices and materials. Competition The company's primary competitors are Alcon, Johnson & Johnson, Bausch Health Companies, and Carl Zeiss Meditec AG. History STAAR Surgical Company was founded in 1982. The company was incorporated in California in 1982 and reincorporated in Delaware in 1986.