Mek ICS Begins First U.S. Shipment of FDA-Certified Respiratory Device, Targeting Trillion-Won Market

Mek ICS, a respiratory therapy specialist, is accelerating its entry into the U.S. market by beginning the first shipment of its portable high-flow respiratory therapy device, the 'HFT750U (OmniOx Series),' which has received U.S. Food and Drug Administration (FDA) certification.

Mek ICS (CEO Kim Jongcheol) announced that on June 24, it held a ceremony at its headquarters to commemorate the first shipment for the U.S. market. The event was attended by CEO Kim Jongcheol, key executives, and stakeholders, reaffirming the company's commitment to expanding its presence in the global market.

This initial shipment is seen as significant not only as a simple product export but also as the company's entry into the revenue-generating phase within the U.S. respiratory therapy device market. In the wake of a series of global manufacturer recalls, standards for quality and safety in the U.S. medical device market have become more stringent, and the company is leveraging Korean technology to target this market.

Mek ICS previously demonstrated its competitiveness in the U.S. market by obtaining FDA Emergency Use Authorization (EUA) for its ventilator 'MTV1000' during the COVID-19 pandemic. Since then, the company has continuously strengthened its product development, performance validation, and quality control systems, culminating in the full FDA certification of the 'HFT750U.'

In particular, after obtaining certification, the company signed an exclusive supply contract with a major partner that maintains a nationwide medical distribution network in the United States and secured its first supply volume. This means Mek ICS moved quickly beyond mere certification to a phase where revenue is becoming visible.

The company has completed both production and final quality inspection of the initial shipment as scheduled, and the shipped products are set to be delivered sequentially to U.S. hospitals and medical institutions starting in July, following logistics procedures.

The 'HFT750U' is a portable high-flow oxygen therapy device that embodies Mek ICS's advanced respiratory therapy technology. By integrating high-flow oxygen delivery and a heated humidification system into a single device, it can provide patients with breathing gases at appropriate temperatures and humidity without the need for a separate large humidification unit.

Additionally, its enhanced mobility and user convenience allow it to be used not only in general wards and emergency rooms but also during patient transport and in disaster settings where access to medical care is limited.

Mek ICS plans to use the supply gap in the U.S. respiratory therapy device market, which emerged after global recalls, as an opportunity to expand its market share. The U.S. is the world's largest market for respiratory therapy devices, with annual demand reaching trillions of won. The company intends to focus on expanding its local supply chain and strengthening its brand competitiveness, building on this initial shipment.

Kim Jongcheol, CEO of Mek ICS, stated, "This first shipment to the U.S. is an important milestone toward becoming a major player in the global market. We will ensure stable delivery through shipping and local handover in July, and further enhance the competitiveness of our products and the trustworthiness of the 'OmniOx' brand in the U.S. market, where a supply gap has arisen."

A company representative added, "The United States is the world's largest market for respiratory therapy devices. With this first shipment, we aim to establish a foundation for global sales growth by gaining the trust of local partners and customers."

Mek ICS plans to leverage its FDA certification and exclusive U.S. supply network to secure new global growth momentum in the U.S. respiratory therapy device market, with the 'HFT750U' at the forefront.

This content was produced with the assistance of AI translation services.