[E-Daily Reporter Hong Ju-yeon ] "The key to entering the U.S. market lies in thorough preparation and strategic execution tailored to the local market. CLASSYS Inc.(214150)achieved all key milestones in its first year, from securing FDA approval to establishing a premium market position."

Kim Rae-hee, Head of Division, made these remarks on the 15th at the “Seminar on Strengthening the Competitiveness of K-Bio and Healthcare Exports to the U.S.,” held at Harmony Hall in KG Tower, the E-Daily headquarters in Seodaemun-gu, Seoul. Hosted by “Pharm eDaily,” eDaily’s premium bio content service, and co-sponsored by the Korea Medical Device Industry Association (KMDIA) and Wise birds Inc., this seminar was specially organized to assist domestic biotech companies seeking to enter the U.S. market.

Kim Rae-hee, Head of the Marketing Division at CLASSYS Inc., presented the company’s successful entry into the U.S. market at the event. CLASSYS Inc., a global medical aesthetics company, boasts an EBD portfolio that addresses a wide range of skin concerns, including skin lifting, pigmentation treatment, and skin regeneration. Currently, the company operates in approximately 80 countries worldwide, primarily through its directly managed subsidiaries in South Korea, Brazil, and Japan, and has established a global installed base of over 45,000 units.

Key Milestones Achieved Just One Year After Entering the U.S. Market

According to Division Head Kim, CLASSYS Inc. made a full-scale entry

into the U.S. market

in 2024 and achieved all key

milestones

in its first year, including securing FDA approval and establishing a premium market position. Division Head Kim explained that these achievements were the result of thorough market analysis and meticulous preparation tailored to those findings.

“The U.S. market is not merely about securing sales; it is an essential gateway to establishing the strongest reference point for global market expansion and making the leap to becoming a global brand,” said Kim. To target the U.S. market, CLASSYS Inc. secured FDA approval in April 2024 through more than two years of thorough preparation and strategic investment, thereby laying the foundation for its U.S. market entry.

In addition, CLASSYS Inc. invested more than a year in market research to formulate its Go-to-Market (GTM) strategy. This strategy incorporated an analysis of the size of the U.S. medical aesthetics market, customer needs, treatment trends, and the identification of unmet consumer needs.

Local Branding and Marketing Are Key

Division Head Kim stated, “Just because a brand is successful in Korea doesn’t mean it will be successful overseas, so for the U.S. market, local brand naming and branding are necessary.” This includes crafting value-centered messages that U.S. consumers can easily understand and relate to—not simply translating them from Korean, but rewriting them in the language of U.S. consumers. With this in mind, CLASSYS Inc. has renamed a product sold domestically as “Volnemer” to “Everesse” for distribution in the U.S.

Price competitiveness is also essential. Director Kim said, “Since the competitive environment varies by country, a pricing strategy tailored to the local competitive landscape—rather than a global price—is essential.” Regarding local marketing strategies, Director Kim noted, “In the U.S., marketing takes precedence over sales, and the key is to build initial market trust by combining Key Opinion Leaders (KOLs), influencers, targeted regional marketing activities, and education.”

Korean companies typically enter the U.S. market either directly or through local partners. CLASSYS Inc. is targeting the market through a local partner. Director Kim explained, “Considering that the U.S. is a large market and there are limitations to operating with a small sales force, we opted to select a local partner.” CLASSYS Inc. selected its distributors based on seven key criteria: △sales organization/sales experience, △marketing capabilities, △technical service organization, △clinical/training organization, △existing product portfolio, △KOL network, and △financial stability. Director Kim said, “After selecting a distributor, it is crucial to establish a solid collaborative framework in the first year through close communication.”

“CLASSYS Inc.’s successful entry into the U.S. market was ultimately made possible by thorough preparation, localization, strong partnerships, brand-centric marketing, and close collaboration with local distributors,” said Director Kim. “Building on this experience, we plan to expand our entry into global markets, including the Chinese market, by the end of this year.”