Ventilator Maker IPM Chirana Picks RTP for US Headquarters
The new site opens as COVID-19 cases mount across the country and around the world, driving demand for medical equipment such as IPM Chirana's ventilators.
The company’s lead product, the Aura V Critical Care Ventilator, is marketed as an “advanced” ventilator. Its capabilities include different ventilation modes to help patients breathe, and programmed ventilation levels that IPM Chirana says lead to improved gas distribution in the lungs.
The device, which was designed to aid breathing in adults, children, and infants, is already available in Europe and other regions of the world. Marketing applications for the device are currently under regulatory review in the U.S. and Canada.
In March, the United States Food and Drug Administration issued an umbrella Emergency Use Authorization (EUA) for ventilators and ventilator accessories as one of its measures to address the COVID-19 pandemic.
IPM Chirana CEO Bud Reeves told the North Carolina Biotechnology Center that some aspects of the Aura V are covered by that EUA, but the FDA is asking for more information on newer aspects of the technology that aren’t found in other FDA-cleared ventilators. The company is answering those questions and Reeves said an EUA will be followed by the more-routine filing for 510(k) marketing clearance.
“We are currently under review for the EUA, however we expect to file a full 510(k) in the future as we want to continue to sell into the addressable market once the emergency is over,” he said.
IPM Chirana is a partnership between Chirana Medical, a Slovakia-based medical device company, and IPM Group, an investment firm that focuses on “infratech,” which it defines as the intersection of infrastructure and technology. IPM Group says it has more than $1 billion in assets under management. Chirana Medical’s origins date to 1935, when the company initially focused on water meters and then gas meters, according to its website. The years that followed saw the company move into medical devices. Respiratory and anesthesia products were added in the late 1960s. The first version of Aura launched about seven years ago.
Corporation records filed with the office of the North Carolina Secretary of State show that IPM Chirana formed in July with a North Raleigh address. The company’s new office is on Creekstone Drive in Durham, just outside of RTP.
Reeves, whose experience includes sales roles at Electromed and Philips Healthcare, was appointed CEO of IPM Chirana in September. He told NCBiotech that the company chose the RTP site for its headquarters because it’s a biotechnology hub with a number of clinical research organizations. Another factor was proximity to Duke University and the University of North Carolina at Chapel Hill, both of which have research hospitals.
These research resources will support IPM Chirana’s regulatory plans and help the company gather additional clinical data supporting the development of new products, Reeves said. He added that the office is a 10-minute drive from the Raleigh-Durham International Airport, which makes it convenient for customers who will visit the site for training.
Reeves said IPM Chirana’s European headquarters handles sales, administers contracts, and distributes the Aura V outside of the Americas. The North Carolina site will oversee manufacturing, quality and regulatory affairs, legal, research, marketing, and finance. The office, which currently employs three people, will also be responsible for all sales activities in Latin America, plus sales in North America, upon securing the regulatory authorizations to launch the ventilator. He said the company will add positions in finance, marketing, engineering, and sales, pegged to the company’s growth.
In addition to opening its new North Carolina location, IPM Chirana also announced the production launch of its ventilators at Boston contract manufacturer SMTC. IPM Chirana expects to make 300 ventilators by the end of 2020. When the company announced its new U.S. leadership team in September, it said that annual global production of its ventilators could reach 5,000 annually.