OCULIGHT: iChopper for Cataract surgery, export to Swiss Eye Hospital and NewYork-Presbyterian Hospital, Columbia University, New York

There are many different eye diseases, but one of the most common is cataract. While factors like alcohol consumption, smoking, diabetes, and genetics can contribute to cataract formation, aging is by far the most significant cause. This means that cataracts are likely to become an increasingly important health issue, not just in Korea, but worldwide.

The most effective and fundamental treatment for cataracts is surgery to replace the lens. Cataract surgery is incredibly common, with over 30 million procedures performed globally each year. However, even with such a routine procedure, risks are still present—especially since it involves replacing the lens. Today, we introduce “OCULIGHT,” a specialized ophthalmic biotech startup dedicated to making cataract surgeries more precise and safer. Oculight is a company selected for the 2024 K-Startup Center (KSC) Program, hosted by 'the Ministry of SMEs and Startups of Korea' and KISED(Korea Institute of Startup and Entrepreneurship Development and organized) and operated by SCCEI(Seoul Center for Creative Economy & Innovation).

The typical cataract surgery process involves several steps. First, the outer layer of the eye, the cornea, is partially cut to allow the insertion of surgical tools. The anterior capsule, which surrounds the lens, is then opened, and an ultrasound device is used to break the lens into small fragments. These fragments are carefully vacuumed out, and an artificial lens is inserted through the corneal incision to complete the procedure.

During surgery, doctors rely on a microscope for precision. However, one issue is that the light used for cataract surgeries comes from the microscope itself. This creates a visibility problem: while the inside of the eye remains dark, the exterior is brightly lit, reducing overall visibility. If you search for cataract surgery videos online, you’ll often see the microscope light reflecting off the eye, causing glare. This light is so intense that patients can experience significant discomfort during the procedure. The U.S. FDA has even warned that the strong lights used in cataract surgeries can potentially damage the patient’s retina.

Dr. Dong Heun Nam, the founder of OCULIGHT, has performed thousands of cataract surgeries and was determined to solve this problem. He developed a solution called “SmartBeam,” designed to improve the accuracy and safety of cataract surgeries. SmartBeam consists of two key components: the “iChopper” and “iVision.”

The iChopper is a surgical tool used during cataract surgery that helps break up the lens, but Dr. Nam integrated a light-emitting device into it, enhancing surgical precision by providing better illumination inside the eye. This significantly improves visibility for the surgeon. When comparing surgeries performed with iChopper to conventional cataract surgeries, the difference in clarity is striking. OCULIGHT’s approach increases both the accuracy and safety of cataract surgery. The iVision, which connects to the iChopper, supplies light using an LED system, delivering the precise amount of light needed for the surgery without causing damage to the patient’s retina.

OCULIGHT’s iChopper received approval from the U.S. FDA in 2021 and the Korea FDA in 2023. It has also submitted an application for approval from Korea’s Health Insurance Review and Assessment Service (HIRA) and is awaiting approval from the European regulatory body, EU MDR in 2025.

To support its entry into the U.S. and global markets, OCULIGHT has partnered with Investible Solutions, an Israel-based biotech investor, and has already organized the medical advisory board with Cristos Ifantides, MD, MBA, Lisa Park, MD, and Nicole Fram, MD. Dr. Ifantides is an ophthalmic surgeon, entrepreneur, Tyson Eye, Fl and a principal investigator, US iChopper clinical trial. Dr. Park is a professor, Department of Ophthalmology, Columbia University Irving Medical Center, New York. And Dr. Fram is an ophthalmic surgeon, Advanced Vision Care, LA, CA and President Elect, ASCRS (American Society of Cataract and Refractive Surgery). With these developments, OCULIGHT is optimistic about its global expansion prospects.

Founded in 2017, OCULIGHT has invested years in research and development, and now that their product is ready, we eagerly await the positive outcomes from their participation in this program.

What issue is OCULIGHT trying to solve?
While it’s not widely known, cataract surgery is the most frequently performed surgery globally, with over 30 million procedures each year. Despite being a common and generally safe procedure, there are still issues with the current method used by ophthalmologists. These issues stem from the lighting used in standard cataract surgeries, which comes from the surgical microscope. This inadequate lighting can make visibility difficult for surgeons, leading to potential complications like capsular rupture or retinal damage. Additionally, patients often experience discomfort from being exposed to such intense light during surgery.

How does OCULIGHT address this issue?
Dr. Dong Heun Nam, with experience in thousands of cataract surgeries, developed a solution called “SmartBeam.” SmartBeam offers a new lighting method for cataract surgery, consisting of two key components: OCULIGHT’s proprietary single-use illuminated chopper, the “iChopper,” and an LED light source, “iVision.” The iChopper connects to iVision and provides light directly from the chopper rather than the microscope. This new approach makes cataract surgery safer and easier, with significant benefits in terms of functionality, cost, space, and time.

What are OCULIGHT’s competitive and technological advantages?
The first major advantage of SmartBeam is improved visibility during surgery. Just as there’s a stark difference in visibility between looking into a show window during the day versus at night, the iChopper significantly improves the surgeon’s visibility by illuminating the area near the lens. This improvement greatly enhances the accuracy and safety of the surgery.
Another advantage is for the patients themselves. During cataract surgery, patients must keep their eyes open, which can expose them to potentially harmful light. By using the iVision LED system, OCULIGHT minimizes the risk of light-induced retinal damage, ensuring patient safety.

(source=OCULIGHT)


What products does OCULIGHT offer, and what is their current status?
OCULIGHT’s flagship product is the trademarked single-use medical device “iChopper” for cataract surgery. This device eliminates the need for microscope lighting by providing its own illumination and also functions as a chopper to break up the lens. iChopper is already available in Korea, and an application for approval has been submitted to the Health Insurance Review and Assessment Service (HIRA). Once approved, the company expects significant domestic sales growth. The device was approved by the U.S. FDA in 2021, and OCULIGHT has also submitted an application to the European regulatory body, EU MDR, with approval expected in the first half of 2025.

What is the market size for OCULIGHT’s products, and who are the target customers?
More than 30 million cataract surgeries are performed globally each year, with 3.8 million in the U.S. and 700,000 in Korea. The potential market for OCULIGHT’s iChopper and iVision is estimated to be worth 4 trillion KRW globally, 1 trillion KRW in the U.S., and 140 billion KRW in Korea. While all cataract patients are potential customers, the initial focus is on complex cataract cases, such as those with corneal abnormalities or small pupils, with the target global market size estimated at around 400 billion KRW.

What is OCULIGHT’s business model?
OCULIGHT’s primary business model involves selling the iChopper for cataract surgery at a price of 150,000 KRW per unit. The company operates a B2B model, targeting ophthalmologists and eye hospitals that perform cataract surgeries.

What achievements has OCULIGHT’s team made?
OCULIGHT has secured six patents in Korea and two in the U.S. for its iChopper device, with an additional ten patents currently under review. The device has been approved by both the Korean and U.S. FDA, and the EU MDR approval process is ongoing. OCULIGHT has completed clinical trials in Korea and the U.S., and its application for approval as a reimbursable treatment by HIRA is under review, with results expected in 2025. Since Jan 2025, the iChoppers have been exported to Augenarztpraxis Aare, a Swiss Eye Hospital and NewYork-Presbyterian Hospital, Columbia University, New York. MicroSurgical Technology (MST), Redmond, WA has proposed a M&A intention and the process has started since Jan 2025. MST is an US-based ophthalmic medical device manufacturer, founed in 1976 and acquired by Halma in 2012.

What gives OCULIGHT’s team a competitive edge?
OCULIGHT’s founder and CEO, an experienced ophthalmologist specializing in both retinal and cataract surgeries, invented and patented the iChopper. Since the company’s founding, the entire team has been dedicated to the research and development of the iChopper, successfully commercializing it as the world’s first illuminated chopper for cataract surgery. Three globally renowned ophthalmologists have joined Oculight as medical advisors (Cristos Ifantides, MD, MBA, Lisa Park, MD, and Nicole Fram, MD). Dr. Ifantides is an ophthalmic surgeon, entrepreneur, Tyson Eye, Fl and a principal investigator, US iChopper clinical trial. Dr. Park is a professor, Department of Ophthalmology, Columbia University Irving Medical Center, New York. And Dr. Fram is an ophthalmic surgeon, Advanced Vision Care, LA, CA and President Elect, ASCRS (American Society of Cataract and Refractive Surgery).

Why should investors consider OCULIGHT?
OCULIGHT’s product has been fully patented and approved for use, with treatment reimbursement decisions expected soon, signaling a need for full-scale production.
Positive feedbacks from U.S. ophthalmologists and a global ophthalmic medical device company have led OCULIGHT to assemble a U.S. team and begin its market entry strategy.
The growing cataract surgery market, especially in aging societies, presents a blue ocean opportunity for OCULIGHT’s business model.

What efforts has OCULIGHT made toward international expansion, and what results have been achieved?
OCULIGHT has successfully obtained U.S. FDA approval and completed clinical trials in the U.S. Partnering with Investible Solutions, an Israeli biotech accelerator, OCULIGHT has assembled a U.S. team and is actively pursuing investments and market entry opportunities.

(source=OCULIGHT)


By Moon-kyoo Lee (munch@itdonga.com)