American and Korean Medical Device Manufacturers Collaborate on Ventilator Production
IRVINE, CA — BIOLASE Inc. announced that it expects to partner with MEKICS Co. Ltd, an intensive care unit (ICU) equipment manufacturer, to supply ICU-grade portable ventilator through BIOLASE's FDA-registered manufacturing facility in California. The MEKICS's MTV-1000 ventilator received FDA authorization for emergency use during the COVID-19 pandemic.
“In this time of global crisis, it is vital that companies come together to support the fight against COVID-19, leveraging every tool available, and that's exactly what we intend to do,” says Todd Norbe, CEO of BIOLASE. “Without hesitation, we expect to pivot quickly and leverage our FDA-registered facility for the manufacturing and delivery of the MTV-1000 ventilator and have already received over $10 million in orders. We expect to continue to focus our efforts to quickly ramp up production, with the expectation to double the number of orders over the next few weeks.”
BIOLASE has received authorization to manufacture and supply the MTV-1000 ventilator under the FDA Emergency Use Authorization and an exemption from the state of California to operate, market and produce this critically needed product. BIOLASE expects to use its years of experience in manufacturing and distributing FDA-cleared medical equipment to help supply ventilators and support the global backorder on ventilators during the COVID-19 crisis.
The BIOLASE and MEKICS collaboration aims to bring the MTV-1000 to the United States for the first time. The MTV-1000 is a field-tested, ICU-level, portable ventilator that has pressure-control and an internal positive end-expiratory pressure feature, which is often required for COVID-19 patients.
MEKICS Co. Ltd., a medical equipment company based in South Korea, has 20 years of experience in manufacturing various respiratory products, including ventilators.
“Collaborating with the team at BIOLASE, who have years of experience manufacturing, marketing and selling medical equipment in the United States, is a great opportunity for us to provide this much-needed product to the U.S. public,” says Jong Cheol Kim, CEO for MEKICS. “We are doing our very best to meet the demand of the U.S. market and believe it is an honor to help the American public in any way we can.”