Press release

Solutions in Critical Care to Distribute nHale, a New Non-Invasive Ventilation Device for the Treatment of COVID-19

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Solutions in Critical Care (SCC) has partnered with Nanotronics Health, LLC, to distribute nHale™, a non-invasive respiratory support device authorized for the treatment of COVID-19 patients in the hospital, spaces converted for the treatment of COVID-19 patients, and in the private home. The new agreement allows for Nanotronics Health, LLC, to work with a leading distributor to deliver affordable and easy-to-use respiratory support devices for hospital systems within the United States that are experiencing surging COVID-19 patients.

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Non-invasive ventilation is critical for COVID-19 patient care in the hospital and beyond. To meet this need, Nanotronics Health, LLC, leveraged Nanotronics’ deep in-house expertise, incorporating advanced AI, Intelligent Factory Control (IFC) and sophisticated engineering to conceive, design and manufacture nHale™ in under 90 days. The incorporation of IFC enables optimized manufacturing efficiency and the ability to scale production quickly while also avoiding a complex global supply chain. The quick production allows for healthcare providers to rely on Nanotronics Health, LLC, for cost-effective respiratory support devices for the treatment of COVID-19 patients.

“We are pleased to partner with an established distributor who understands the need to deliver accessible devices to patients and healthcare professionals when they need it,” said Julie Orlando, President of Nanotronics Health, LLC. “As hospitals continue to be strained throughout the country, it is our hope that we can provide a solution to both ease that strain while also providing reliable at-home support.”

SCC is a national network of well-established specialty distribution partners in the medical device industry. With eight distribution partners across the U.S., SCC offers medical device manufacturers a national strength with a local sales presence to grow their product line. “We intentionally choose products and companies that will make an impact and nHale™ is a much-needed disruption in the single bi-level system space,” says John Marmo, President of Solutions in Critical Care. “We look forward to bringing this and other critical care products to the forefront through our partnership with Nanotronics Health.”

About Nanotronics Health, LLC

Nanotronics Health, LLC, is a subsidiary of and powered by Nanotronics. The company uses Intelligent Factory Control (IFC) to build and scale medical devices that are affordable, accessible and well-designed. Our first product, nHale™, a non-invasive ventilator, was conceived, built, and obtained Emergency Use Authorization by the FDA within 90 days to treat patients suffering from COVID-19. After obtaining Emergency Use Authorization, Nanotronics Health, LLC, immediately began producing and shipping devices. Their mission is to speed recover and ensure a more stable future.

About nHale

nHale™ is a bi-level positive air pressure device to support respiratory therapy of spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease. It is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, such as a patient in need of breathing assistance but not in need of invasive ventilatory support based on standard medical protocols.

The machine is for use in traditional healthcare facilities (e.g., hospitals, assisted living facilities, nursing homes) as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, university dormitories, motels, etc.). nHale™ is also intended for use in home settings with a doctor’s prescription.

Supplemental oxygen may be used with the nHale™ device to increase the oxygen concentration of the airflow being delivered to the patient only when prescribed and trained by a qualified medical professional. The warnings must be observed when using supplemental oxygen with the nHale™ device.

nHale™ has been authorized by FDA under an Emergency Use Authorization [EUA]; nHale™ is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the device; nHale™ has not been FDA cleared or approved.

nHale™ is a trademark of Nanotronics in the U.S. which can be found at nanotronics.co/nhale.

About Solutions in Critical Care

With more than 75 specialty-trained sales representatives throughout the U.S. and Canada, SCC offers manufacturers an experienced and dedicated, local sales force with well-established customer relationships. To learn more about the SCC distribution network or the products offered, contact Solutions in Critical Care at 866-367-7221 or visit www.solutionsincriticalcare.com.