SAN DIEGO, April 16, 2020 – ResMed has released the following statement regarding CPAP’s role in mitigating the effects of COVID-19 from ResMed Chief Medical Officer Carlos M. Nunez, M.D.:



“ResMed’s primary focus is to put as many lifesaving respiratory devices as possible into the hands of frontline heroes – the healthcare providers treating patients worldwide impacted by the COVID-19 pandemic.



“Since the COVID-19 crisis began, the industry is facing unprecedented global demand for ventilators and other respiratory devices. We are working closely with hospitals, physicians, and government officials worldwide to understand their specific needs and have committed to tripling our global production of ventilators and bilevel devices to maximize the number of patients who get the help they need.



“ResMed sincerely appreciates the interest and ideas offered by other companies, government agencies, health systems, clinicians, and academic and security researchers. There are reports that CPAPs might be modified to serve as ventilators. While technically it is possible to convert CPAPs to bilevel devices, it would take valuable time and resources to test and validate modifications to ensure we are delivering safe and effective devices that meet regulatory requirements during the COVID-19 pandemic. In addition, the hospitals, health systems, and governments who are working directly with ResMed to prioritize their needs are not requesting modified single-purpose CPAP devices that are commonly used in the home to treat sleep apnea. For these reasons, we have prioritized the production of devices that address the immediate needs of hospitals and what clinicians are asking for.



“Instead of modifying CPAP devices that are needed and used by sleep apnea patients, we’ve modified our manufacturing process, shifting teams and tools to maximize the production and delivery of the devices healthcare providers are telling us they need most – ventilators and bilevel machines. We can already build them at scale without further research and testing, and without putting patients’ safety and lives at risk.



“ResMed has worked closely with the FDA and other government regulators on which applications of our devices – on and off-label – can help save more lives while maintaining the safety of patients and the healthcare teams who care for them. To this end, with guidance from the FDA enforcement policy on ventilators during the COVID-19 emergency, ResMed has worked with the FDA on its emergency use authorizations (EUAs) for using some bilevel devices to treat respiratory insufficiency that aren’t indicated to, and informing clinicians regarding the use case and risk of using all bilevel devices to deliver invasive ventilation (both off-label use cases). We will continue talking with FDA and other regulators about potential applications of those and other respiratory devices – including CPAP machines – while prioritizing maximum production of the ventilators and bilevel devices governments and health systems are demanding today.



“There is another very important way that those millions of home CPAP devices can be used to save lives. They should be used as prescribed by those who rely on them for the treatment of their sleep apnea. If you have one, I urge you to use it. I’ve used mine faithfully, every night for many years.



“Patients in need of more complex respiratory support need a wholly different device. ResMed has already ramped up production of such devices, and together with others in the industry, we will not stop until there is a ventilator or bilevel device for every patient worldwide who needs one.”





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CONTACTS:



MEDIA: Jayme Rubenstein, 858.836.6798, news@resmed.com

INVESTORS: Amy Wakeham, 858.836.5000, investorrelations@resmed.com

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