QUONSET, R.I. & NEW YORK--(BUSINESS WIRE)--Quonset Rhode Island based, Subsalve USA and Brooklyn, New York based, Nanotronics Health, have teamed up in their first domestic partnership, to provide humanitarian relief to clinicians in Rhode Island as they face a tremendous COVID-19 surge, and potential shortage of hospital beds and staff. Both Nanotronics Health and Subsalve USA received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for their respective devices to treat COVID-19. Paired together, the non-invasive respiratory support package significantly minimizes aerosolized spread in hospitals and aims to free-up critical ICU resources for those with more severe symptoms.
The Subsalve-Nanotronics partnership initially formed through an international aid distribution effort.
“The system is fantastic and already saved and is continuing to save lives in Bolivia,” said primary care physician Dr. Cesar Vargas on the front lines of COVID-19 treatment in Bolivia. “Our physicians are more familiar and eager to use the device and share the benefits with other hospitals."
Subsalve USA’s Subsalve Oxygen Treatment Hood is a patient interface intended for helmet-based Non-Invasive Positive Pressure Ventilation, according to clinician-established protocols to treat Acute Respiratory Distress Symptoms resulting from COVID-19. The device is for use with adult patients only in Intensive Care Unit settings and is a mode of non-invasive ventilation (NIV) that provides increased patient airway pressure, delivery of therapeutic oxygen.
Nanotronics Health’s nHale™ is a bi-level positive air pressure (BiPAP) device that supports the respiratory therapy of spontaneously breathing COVID-19 patients. It is approved under EUA for patients suffering from COVID-19 disease in private homes, 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, hotels, etc.)
Michael Lombardi, founder and president of Lombardi Undersea LLC and partner to Subsalve’s NIV interests said, “After months of evaluating multiple BiPAP/CPAP devices for suitability in helmet ventilation, we believe the nHale™ affords the most suitable turn-key solution for ease of use, simple helmet interfacing, and eliminates considerable guesswork for the clinicians.”
Nanotronics and Subsalve are prepared to scale this solution for hospitals worldwide. A technical demonstration was hosted at Subsalve USA earlier this week to demonstrate treating multiple patients simultaneously to help emergency management decision makers visualize mass-triage capabilities for respiratory distress.
This current effort was made possible through cooperative recognition that urgent action was needed in the State of Rhode Island, who as of this week, had the highest COVID-19 infection rate worldwide. The humanitarian action was supported by anonymous charitable donations and private individuals contributing to Ocean Opportunity Inc., a RI based 501(c)3 not for profit organization that is sponsoring the initiative.
Subsalve is the worldwide leader and innovator in the design and manufacture of engineered inflatables. The company’s underwater lift bags are specified to meet the toughest challenges in recreational, commercial, scientific, and military applications. Since 1977, we have provided solutions and expertise for aircraft recovery, ship, yacht, and boat salvage, marine construction, offshore oilfield diving, and explosive ordnance disposal.
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 immediately began producing and shipping devices.
The 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.). The 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.
Nanotronics Health LLC, a subsidiary of Nanotronics, applied Nanotronics’ deep in-house expertise, incorporating advanced AI, Intelligent Factory Control (IFC), and sophisticated engineering to build a machine that is easily manufactured at scale and at a reduced cost to increase accessibility for all Americans. The nHale™ device is designed for comfort and ease-of-use with the simplicity of one button.
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.
Product Landing Page: www.oxygentreatmenthoods.com
Subsalve USA: www.subsalve.com
Nanotronics Health: www.nanotronicshealth.com
Lombardi Undersea LLC: www.lombardiundersea.com
Ocean Opportunity Inc.: https://oceanopportunity.com/portfolio/oxygentreatmenthoods