Biolase is partnering with MEK-ICS Co Ltd, a Korean intensive care unit (ICU) equipment manufacturer, to supply MEK-ICS’s MTV1000 ICU-grade portable ventilator through Biolase’s FDA-registered manufacturing facility in California. The MTV1000 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,” said 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 MTV1000 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,” Norbe said.
Biolase will manufacture and supply the MTV1000 under the FDA Emergency Use Authorization and an exemption from the State of California to operate, market, and produce it. The company says it 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 them during the pandemic.
The Biolase and MEK-ICS collaboration aims to bring the MTV1000 to the United States for the first time. The MTV1000 is a field-tested, ICU-level, portable ventilator that has pressure control and an internal positive end-expiratory pressure feature, which often is required for COVID-19 patients, the companies said.
“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 US public,” said Jong Cheol Kim, CEO of MEK-ICS. “We are doing our very best to meet the demand of the US market and believe it is an honor to help the American public in any way we can.”