[Edaily Reporter YU JIN-HEE ] In the global market for laser medical devices used in dermatological aesthetics and treatment, South Korea’s first-generation solid-state laser venture, Laseroptek Co., Ltd.(199550), is leading a paradigm shift. At the heart of this shift is the “VASCURA 589,” a high-power solid-state laser device that has solved a long-standing challenge that global Big Pharma and medical device giants had been unable to overcome for decades.

For decades, the market for treating vascular skin conditions has been dominated by pulsed dye lasers (PDLs), which use liquid dye as a consumable medium. However, the astronomical maintenance costs resulting from periodic replacement of dye kits, chronic power degradation during procedures, and safety risks associated with handling toxic organic solvents have been major challenges and operational risks in clinical settings.

ASCURA 589 is an innovative platform that replaces consumable liquid dye with a solid medium. It features a 589-nanometer (nm) yellow wavelength based on Laseroptek Co., Ltd.’s proprietary Raman laser design techniques and optical technology. By maximizing output stability while dramatically reducing maintenance costs, it simultaneously meets the economic and technical needs of dermatologists worldwide.

First unveiled this year at the Korea International Medical Equipment & Hospital Supplies Exhibition (KIMES), this device received overwhelming acclaim from global medical professionals at the American Society for Laser Medicine and Surgery (ASLMS) conference held in Savannah, Georgia, in May. Dr. Rox Anderson of Harvard Medical School, known as the “father of modern dermatological lasers,” personally visited the booth and highly praised the company’s high-power solid-state implementation and “Quasi-long pulse” technology.

In addition, the adverse factors that had long weighed down the company’s value have been resolved. As Strata Skin Sciences, a U.S. competitor, began delisting procedures from the NASDAQ market due to financial difficulties, the uncertainty stemming from legal litigation has effectively vanished.

Building on these changes, Laseroptek Co., Ltd. aims for high growth in the Latin American market—using its directly operated subsidiary in Brazil as a springboard—alongside a recovery in sales in the North American market. Furthermore, the company plans to further accelerate its earnings growth by expanding into the market for urological surgical lasers based on thulium fiber lasers. If these plans materialize, annual revenue is expected to surpass 30 billion won again next year and exceed 50 billion won within three years. According to market research firm Allied Markets, the global skin clinic market (including treatments and procedures)—which the Vascula 589 targets—is projected to grow from 17 trillion won in 2020 to 35 trillion won by 2030.

On the 4th, we met with CEO Lee Chang-jin at Laseroptek Co., Ltd.’s headquarters in Seongnam, Gyeonggi Province, to discuss the clinical value of the Vascula 589 and the company’s global expansion strategy. The following is a Q&A with him.

- What are the economic and technical advantages of the Vascula 589 compared to existing liquid-dye laser products?

△The 589 nmwavelength has extremely high absorption by oxyhemoglobin within blood vessels, making it the most optimized wavelength for treating vascular skin conditions. However, existing pulsed dye laser products had structural limitations due to their reliance on liquid dye as a consumable medium. High maintenance costs due to periodic replacement of dye kits, power degradation during continuous use, and the burden of managing organic solvents were significant practical risks for hospital operations. The Bascula 589 was developed as a solid-state laser platform, fundamentally resolving these issues. Since it uses a solid-state medium, energy output remains stable and maintenance costs are dramatically reduced. It allows for a wide range of pulse widths tailored to the size of the lesion, from fine to large blood vessels. A single device can precisely treat a variety of vascular lesions, including port-wine stains, telangiectasia, hemangiomas, facial flushing, acne scars, and warts.

-Reactions in the U.S. and pre-order status are

△ASLMS 2026, held in Savannah, served as the successful global debut stage for the Vascula 589. The most meaningful moment was when Dr. Rox Anderson of Harvard Medical School personally visited the booth to thoroughly evaluate the technology. Dr. Anderson praised the implementation of the 589 nm high-power solid-state laser, its quasi-long-pulse characteristics, and the initial clinical data. He also noted that the technology presents a new direction for replacing existing liquid-based equipment. Prominent dermatologists from the U.S., Europe, and Latin America—including Dr. Weiss and Dr. Bernstein—expressed their intention to participate in clinical projects. Pre-orders received since the official domestic launch event last June have already exceeded the initial production volume. Given the nature of medical devices, deliveries will proceed gradually starting in the middle of the third quarter, following additional demonstration procedures.

- Status of the U.S. Food and Drug Administration (FDA) approval process and the timeline for reflecting local sales

△The FDA510(k) process is proceeding smoothly, with the goal of obtaining approval by the end of this year. Beyond simply securing approval, the company is focusing on expanding the clinical evidence base to build trust in the U.S. market. Discussions are underway with leading U.S. vascular specialists regarding joint clinical research. Immediately following approval, the company plans to prioritize supplying the device to key opinion leaders (KOLs) to establish clinical references, and then significantly expand commercialization through conference presentations and peer-reviewed publications. After completing the establishment of reference sites and securing historical data in the first half of next year, U.S. sales are expected to see a steep upward trend starting in the second half of 2027. The financial results from entering the premium medical device market are projected to reach tens of billions of won.

-Regarding the litigation issues with the U.S. competitor (Strata) that have plagued the company in recent years:

△Strata Skin Sciences, a competitor in the U.S.ultraviolet (UV) laser market, recently faced financial difficulties and was delisted from the NASDAQ. In response, Laseroptek Co., Ltd.’s U.S. subsidiary took a firm stance by filing a counterclaim against Strata and its representatives in the U.S. District Court for the Eastern District of Pennsylvania. With the uncertainty that had previously hindered U.S. sales growth now resolved, sales in the North American market are expected to enter a clear recovery phase starting in January of next year. The company’s export share is also expected to recover to around 60% this year.

-The proportion of the therapeutic laser portfolio is

△While aestheticlasers are subject to economic cycles, treatments for chronic inflammatory skin conditions—such as psoriasis, vitiligo, and atopic dermatitis—as well as vascular conditions like port-wine stains, represent essential demand based on medical necessity. These treatments are minimally affected by economic fluctuations and serve as a stable source of cash flow. With “Palas” and “Palas Premium”—the world’s first 311nm solid-state UV lasers—already established in the U.S. psoriasis and vitiligo treatment markets, the addition of Vascula 589 has further strengthened the company’s therapeutic portfolio. These new products are designed to drive concurrent growth in sales of consumables and accessories, such as applicators, thereby supporting stable profitability.

- Momentum for improving our financial health and recovering our stock price

△We take our shareholders’concerns very seriously. The recent rights offering was not merely a means of raising capital, but a decisive move to simultaneously achieve growth investment and financial stability. The funds raised were allocated to securing raw materials, developing new products, and obtaining overseas certifications and marketing. Despite undertaking aggressive investments—such as strengthening our North American branch and establishing a directly managed office in Brazil—amid challenging conditions, we have maintained an excellent financial structure with a debt-to-equity ratio of less than 40% as of the end of June. The momentum for the second half of the year is clear. Revenue recognition will begin in earnest with the official domestic launch of Bascula 589 in the third quarter, following approval from the Ministry of Food and Drug Safety. With FDA approval in the pipeline and sustained overseas demand for existing flagship products such as “Helios 785 Pico” and “Piccolo Premium,” the company is poised to achieve a definitive turnaround in performance.

-Regarding the timeline for medium- to long-term profit margin improvement and plans for shareholder returns

△We are confident that we will recover double-digit operating profit margins starting in 2027, when sales in the U.S.—where pricesare highest—rebound and are coupled with high growth in Latin American markets such as Brazil. In 2028, we will enter a phase of profit margin maximization. Management’s purchase of new share subscription rights and participation in the subscription were a demonstration of responsible leadership. Shareholder return measures, such as share buybacks or dividends, will be actively pursued by the Board of Directors once the normalization of earnings is confirmed.

- I understand the company is preparing to enter the surgical laser market beyond aesthetic dermatology

△The surgicallaser market demands a high level of clinical evidence and safety standards, and the regulatory approval process is rigorous. However, once trust is established, it generates long-term, stable revenue that is not subject to trends. We possess sufficient competitiveness as we have proprietary core light source technologies, ranging from resonator design to wavelength conversion and energy amplification. As our first foray into this market, we are developing a thulium fiber laser-based device for treating urinary stones. We are targeting the urology sector, which is growing amid an aging population. We plan to enter the market with a product of proven quality.

-Our mid- to long-term vision is

△We will establish threekey pillars. First, we will establish the Vascula 589 as the new standard in the global vascular laser market. Second, we will build a balanced portfolio where the three major categories—aesthetics, disease treatment, and surgery—support the company with their distinct demand cycles. Third, we will establish a global sales infrastructure connecting the United States, Europe, Asia, and Latin America. Laseroptek Co., Ltd.’s ultimate goal is clear: as a company that continuously achieves world-firsts through its core solid-state laser technology, we will bring technological leadership in the global medical laser market to Korea.