IRIDEX Profile
Iridex Corporation operates as an ophthalmic medical technology company.
The company focuses on the development and commercialization of breakthrough products and procedures used to treat sight-threatening eye conditions, including glaucoma and retinal diseases.
The company’s propriety MicroPulse Technology and Endpoint Management Technology are used for the treatment of glaucoma and retina disorders. Both technologies are offered as optional treatment modes in select laser consoles in addition to the standard continuous-wave (CW) treatment mode. They allow low-energy, subvisible, tissue-sparing laser therapy by different means: MicroPulse technology uses short, microsecond-long laser pulses that allow tissue to cool between pulses giving physicians finer control of thermal elevation to minimize tissue damage. Endpoint Management technology uses a delivery algorithm to titrate the laser energy. CW laser photocoagulation can stabilize vision over the long term but can also result in varying degrees of vision loss. Both MicroPulse and Endpoint Management technologies have demonstrated clinical efficacy with a safer profile compared to standard high-energy CW laser for the treatment of both retinal diseases and glaucoma.
The company’s products consist of laser consoles, delivery devices and consumable probes.
The company’s laser consoles consist of the following product lines:
Glaucoma – the company’s primary glaucoma console line is the Cyclo G6 laser system with MicroPulse technology. In addition, the company’s medical retina consoles have features supporting glaucoma laser treatments.
Medical Retina – the company’s medical-retina product line includes its portable IQ 532 and IQ 577 laser systems with MicroPulse technology; and the Pattern Scanning Laser (PASCAL) System, an integrated workstation with Endpoint Management technology and MicroPulse technology. These systems are ideal for multispecialty practices because these lasers also can be used to treat glaucoma, i.e., single-spot laser trabeculoplasty using MicroPulse technology, iridotomy, and iridectomy using the IQ lasers; and pattern scanning laser trabeculoplasty (PSLT) using the PASCAL laser system.
Surgical Retina – The company’s surgical-retina product line includes its OcuLight TX and OcuLight SLx (with MicroPulse technology) laser photocoagulation systems. These systems are often used in vitrectomy procedures, which are used to treat proliferative diabetic retinopathy, macular holes, retinal tears and detachments.
The company’s business generates recurring revenues through sales of consumable products, predominantly single-use laser probe devices and other instrumentation, as well as repair, service and extended service contracts for its laser systems.
The company’s laser probes consist of the following product lines:
Glaucoma – Probes used in the company’s glaucoma product line include its patented single-use delivery devices - MicroPulse P3, G-Probe, and G-Probe Illuminate.
Surgical Retina – Probes used in the company’s surgical retina product line include its family of single-use EndoProbe handpieces.
Ophthalmologists typically use the company’s laser systems in hospital operating rooms and ambulatory surgical centers, as well as their offices and clinics. In operating rooms and ambulatory surgical centers, ophthalmologists use the company’s laser systems with either an indirect laser ophthalmoscope or a single-use consumable probe, including MicroPulse P3, G-Probe and G-Probe Illuminate delivery devices, and EndoProbe handpieces. In the offices and clinics, ophthalmologists use the company’s laser systems with either an indirect laser ophthalmoscope or a slit-lamp adapter.
In 2022, the company’s products were sold in the United States and Germany predominantly through a direct sales force and internationally (aside from Germany) primarily through Topcon Corporation (Topcon) and other independent distributors.
Solution
The company’s traditional laser technology was developed to perform laser photocoagulation by using a mode that delivers continuously-on laser light, which is referred to as continuous-wave (CW) mode. Laser photocoagulation generates a local healing response and has been demonstrated to be a safe and effective therapy with long-term benefits for certain ophthalmic procedures. However, use of the CW mode typically leads to local tissue damage and can cause loss of visual function, which limits the applications of the technology.
The company’s solutions build on traditional CW laser and innovative technology, such as:
The company’s proprietary MicroPulse technology chops a CW laser beam into an envelope of repetitive short ‘ON’ pulses with longer ‘OFF’ periods that allow tissue to cool between pulses. MicroPulse has been clinically proven to be effective and safe for the treatment of glaucoma and retinal diseases, with a growing body of clinical evidence published over the past decade. The company has developed three applications of its MicroPulse technology for the treatment of eye diseases, providing a range of options for physicians and patients seeking improved outcomes with reduced risks.
The company’s Endpoint Management technology allows clinicians to titrate the laser to subvisible, tissue-sparing levels using a proprietary energy delivery algorithm for the treatment of retinal diseases and glaucoma. By use of this formula, heat induced changes in the retina are controlled as Endpoint Management simultaneously modulates the laser power and duration providing linear control over a non-linear process.
The company’s pattern scanning laser technology efficiently delivers large laser patterns reducing treatment time and patient discomfort during treatment. PASCAL represents an improvement in ophthalmic treatment technology and is committed to helping physicians deliver effective results for patients. Ophthalmologists choose PASCAL because of its speed and ease of use.
Strategy
As a global leader in developing, manufacturing, marketing, selling and servicing innovative medical laser systems and associated instrumentation for the treatment of sight-threatening eye diseases, the company intends to capitalize on its strong brand and distribution network within the ophthalmology market. The company is committed to pursuing a variety of organic initiatives, with potential acquisitions serving as a complementary strategy and complementary inorganic initiatives.
Products
The company’s products are designed with a system approach in mind, with each system consisting of a laser console that generates laser energy, along with a range of interchangeable delivery devices or single-use disposable probes for use in specific clinical applications. This enables the company’s customers to invest in a basic laser system and expand their therapeutic capabilities over time, with the ability to add additional delivery devices or disposable probes as needed. The company’s product line comprises three main categories: laser consoles, delivery devices, which are optical-mechanical products that can be mounted to ophthalmologists' diagnostic equipment and transmit the laser energy, and single-use disposable probes, which deliver the laser energy to targeted regions inside the eye.
Laser Consoles
The company’s laser consoles, which incorporate the economic and technical benefits of solid state and semiconductor laser technology to design small, portable and reliable lasers.
Glaucoma
Cyclo G6 Laser System: The Cyclo G6 is an infrared (810nm) laser designed to treat patients diagnosed with a range of glaucoma disease states. The Cyclo G6 system is sold with a family of probes that are disposable, including the company’s patented MicroPulse P3 probe that utilizes its MicroPulse technology, its G-Probe and G-Probe Illuminate.
PASCAL Laser System: The new Iridex PASCAL is available in either 532 nm or 577 nm wavelengths. Pattern Scanning Laser Trabeculoplasty (PSLT) is a tissue-sparing laser treatment for reducing IOP in open angle glaucoma. PSLT provides a rapid, precise, and minimally traumatic computer-guided treatment that applies a sequence of patterns onto the trabecular meshwork.
Medical Retina
IQ Laser System: The company’s IQ laser systems offer its MicroPulse technology but also have CW capabilities. The company’s IQ 577 delivers visible yellow (577nm) laser light and its IQ 532 delivers visible green (532nm) laser light. The company’s IQ laser systems are typically used with its TxCell Scanning Laser Delivery System and its Slit Lamp Adapters when used to treat retinal disorders with MicroPulse.
PASCAL Laser System: The new Iridex PASCAL is available in either 532 nm or 577 nm wavelengths. It offers the ultimate combination of pattern scanning, Endpoint Management Technology, Pattern Scanning Laser Trabeculoplasty, and MicroPulse Technology, providing physicians with expanded treatment capabilities in a smaller, ergonomically-optimized laser platform.
Surgical Retina: The company’s OcuLight TX laser delivers visible green (532nm) laser light. Its OcuLight SLx laser delivers infrared (810 nm) laser light.
Delivery Devices
The following delivery devices are typically used with the company’s IQ and OcuLight laser systems:
Slit Lamp Adapter (SLA): These adapters allow the physician to utilize a standard slit lamp in both diagnosis and treatment procedures. Physicians can install an SLA in a few minutes and convert standard diagnostic slit lamps into a therapeutic laser delivery system. SLAs are used in treatment procedures for both retinal diseases and glaucoma.
Laser Indirect Ophthalmoscope (LIO): The indirect ophthalmoscope is designed to be worn on the physician’s head and to be used in procedures to treat peripheral retinal disorders, particularly in infants or adults requiring treatment in the supine position. This product can be used in both diagnosis and treatment procedures at the point-of-care.
Single-use Disposable Probes
The following delivery device is typically used with the company’s IQ laser systems:
TxCell Scanning Laser Delivery System (TxCell): TxCell allows the physician to perform multi-spot pattern scanning for efficient delivery of MicroPulse laser therapy.
MicroPulse P3 Probe: The MicroPulse P3 delivery device is used with the company’s Cyclo G6 laser system to perform transscleral laser therapy (TLT) using MicroPulse technology. The MicroPulse P3 probe is used on an anesthetized eye in the doctor’s office or in the operating rooms. The non-incisional procedure takes just a few minutes and results in minimal post-operative recovery for the patient. MicroPulse TLT may be used to treat a wide variety of glaucoma types, including open-angle and closed-angle glaucoma, and a broad range of disease severity.
Since the launch of the MicroPulse P3 probe, the company has worked with physicians to optimize treatment techniques and clinical outcomes. During its collaborations, the company learned that minor ergonomic probe modifications could facilitate easier use and result in more consistent clinical outcomes. In 2019, the company released a revised MicroPulse P3 probe that reflects these modifications. Two peer-reviewed manuscripts from Clinical Ophthalmology, an international peer-reviewed journal, document their findings and recommendations, and conclude that used with proper energy settings, techniques and treatment indications, MicroPulse TLT is a safe and effective treatment for many cases of glaucoma and is a useful addition to the glaucoma treatment armamentarium.
G-Probe: The G-Probe is used in procedures to treat uncontrolled glaucoma, typically described as ‘refractory glaucoma’. The G-Probe delivers CW laser to the ciliary body and is believed to stop the production of aqueous humor, thus reducing IOP. The G-Probe’s non-invasive procedure takes approximately ten minutes and is performed on an anesthetized eye in the doctor’s office or operating rooms. The G-Probe is a sterile disposable product.
G-Probe Illuminate: The G-Probe Illuminate is also used in procedures to treat refractory glaucoma. The proprietary illumination feature allows for more targeted treatment and may offer additional clinical benefits. The G-Probe Illuminate is a sterile disposable product.
EndoProbe Handpieces: The company’s EndoProbe family of products are used for endophotocoagulation, a retinal treatment procedure performed in the hospital operating rooms or ambulatory surgical centers during a vitrectomy procedure. Vitrectomy procedures are performed to treat proliferative diabetic retinopathy, macular holes, retinal tears and detachments. These disposable probes are available in tapered, angled, stepped, aspirating, illuminating, and adjustable styles, as well as a wide variety of sizes. The EndoProbe is a sterile disposable product.
Customers and Customer Support
The company’s products are sold for use by ophthalmologists specializing in the treatment of eye disease in retina, glaucoma and pediatric eye diseases. Other customers include research and teaching hospitals, government installations, surgical centers, hospitals, veterinary practices, and office clinics (outpatient).
The company seeks to provide superior customer support and service and its customer service and technical support distinguish its product offerings from those of its competitors. The company provides depot service at its Mountain View facility for its products. The company’s customer support representatives assist customers with orders, warranty returns and other administrative functions. The company’s technical support engineers provide customers with answers to technical and product-related questions. The company maintains an around-the-clock telephone service line to service its customers. The small size and rugged design of the company’s products allows for economical shipment and quick response to customers worldwide.
Sales and Marketing
The company has 28 direct sales personnel in the United States, one in Germany, and seven team members dedicated to managing the company’s distribution sales efforts globally. Sales operations are managed from the company’s headquarters in Mountain View, California. The company’s customers are located in Europe, Asia, the Pacific Rim, the Middle East, Africa, and Latin America. Its customers include key opinion leaders in ophthalmology, often heads of departments or university professors.
Patents and Proprietary Rights
The company’s patent portfolio includes 62 active United States patents and 85 active international patents on the technologies related to its products and processes. In addition, the company has 11 patent applications pending in the United States and 21 international patent applications pending.
Government Regulation
The Food and Drug Administration (FDA) has the authority to request repair, replacement or refund of the cost of any device the company manufactures or distributes.
The company has obtained 510(k) clearances for all of its medical device products marketed within the United States that require 510(k) clearance. The company has also modified aspects of its products since receiving regulatory clearance, and it has submitted 510(k)s for those modifications as required by FDA regulations.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires devices to be manufactured to comply with applicable Quality System Regulations (QSR) regulations which impose certain procedural and documentation requirements upon the company with respect to design, development, manufacturing and quality assurance activities.
The company is subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Public Health, to determine its compliance with the QSR and other regulations.
Export of the company’s products is regulated by the FDA and subject to the FD&C Act, 21 U.S.C. §§321-397, and other statutes FDA administers, which greatly expanded the export of approved and unapproved United States medical devices.
The company is also regulated under the Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) which are located in Sections 531 through 542 of the FD&C Act, which requires laser products to comply with performance standards, including design and operation requirements, and manufacturers to certify in product labeling and in reports to the FDA that their products comply with all such standards.
Seasonality
The company’s quarterly results have been, and are expected to continue to be, affected by seasonal factors. For example, the company’s European sales during the third quarter (year ended December 2022) are generally lower due to many businesses being closed for the summer vacation season.
Research and Development
The company’s research and development expenses were $7.2 million in 2022.
Competition
The company’s principal ophthalmic laser competitors are Alcon Inc.; Novartis AG; Bausch Health Companies Inc.; Carl Zeiss Meditec AG; Lumenis Ltd.; Nidek Co. Ltd.; Lumibird; and Norlase. The company also competes with alternative glaucoma surgical device companies, such as Alcon, Inc.; Allergan, Inc.; Glaukos Corporation; New World Medical, Inc.; and Ivantis, Inc. Pharmaceuticals represent alternative treatments to the company’s laser procedures. Some of the company’s principal pharmaceutical competitors are Alcon, Inc.; Allergan, Inc.; Astellas Pharma Inc.; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; Roche Holding Ltd. (Genentech); and Bausch Health Companies Inc.
History
The company was founded in 1989. It was incorporated in California in 1989. The company was reincorporated in Delaware in 1995. It was formerly known as IRIS Medical Instruments, Inc. and changed its name to IRIDEX Corporation in 1995.
