Nashville, TN, April 30, 2020 – Enexor BioEnergy (“Enexor”), a U.S. organic waste-to-energy company, has formed Breathe Strong, LLC, committed to the design and manufacturing of the XVENT, a ventilator designed to help with current ventilator shortages during the COVID-19 pandemic, and future pandemics. In less than thirty days, Breathe Strong designed and started manufacturing the XVENT. The XVENT will be manufactured at Enexor’s manufacturing facilities in Franklin, Tennessee, and Huntsville, Alabama, with a capacity to produce up to 200 units per day. Additionally, the XVENT will be manufactured in other countries to address their medical device shortages, mitigating the financial burden associated with full-featured ventilators. Breathe Strong will be donating the XVENT to Ghana, the Dominican Republic, Panama, and other countries, as soon as export permission is granted. On April 11, 2020, Breathe Strong submitted a request for Emergency Use Authorization (EUA) by the FDA and will submit for final FDA approval in June.
The XVENT is a continuous, positive pressure ventilator that is capable of assisting a patient with respiratory insufficiency or respiratory failure. The XVENT utilizes a precision machined piston system controlled by an industrial-grade programmable logic computer (PLC). The system is self-calibrating, equipped with back-up battery power, and designed for many years of use. Qualified medical professionals can control and remotely monitor pressure, volume, inspiratory time, and respiratory ratio to provide life-sustaining ventilatory assistance.
“Less than a month ago, a doctor partner of ours in a developing country reached out to me looking for ventilators. I asked him how many he needed. He answered, ‘one ventilator saves two lives; you do the math,’” said Lee Jestings, founder and CEO of Enexor.
“That evening, I challenged my team to design and build a ventilator that is reliable, affordable, and deployable in any remote hospital in the world. The Enexor team, led by Scott Auerbach, Director of Engineering, quickly went to work, and delivered within three weeks.”
“We immediately made some important design decisions. First, we would not use a bag valve mask (BVM) resuscitator but instead would use a precision machined piston air pumping system. Second, we would design with industrial-grade programmable controllers and electronics. Third, we would design a ventilator with the intent of getting full FDA approval; and finally, the ventilator must be competitive in function, but affordable,” said Scott Auerbach.
Immediately, Breathe Strong put together an advisory team of medical professionals consisting of critical care physicians and current respiratory therapists to define ideal modes, features, performance, and operating parameters. They then reached out to several companies that could assist with the initiative. What emerged was a world-class team of Tennessee companies and consultants from Maine to Oregon.
“The user’s ability to control the XVENT is our design’s most critical component. So we immediately reached out to Schneider Electric, Casco Systems, and Border States Electric. These companies are the gold standard for designing, producing, and distributing the best industrial controls components on the market.”
Breathe Strong’s local Tennessee neighbors also responded immediately. Wolfe Industrial in LaVergne, John W. McDougall Co. in Nashville, and Ironcraft Inc. in Lewisburg worked nights and weekends to support us with high-quality steel parts and components. Nemo Design, a Portland, Oregon based brand-design agency, volunteered their time to provide expert product-design, branding and marketing support.
About Breathe Strong, LLC
Breathe Strong, LLC, a subsidiary of Enexor BioEnergy, an organic waste-to-energy company based in Franklin, Tennessee, manufactures the XVENT ventilator. The XVENT utilizes a precision machined piston system, controlled by an industrial-grade programmable logic computer (PLC). The XVENT is self-calibrating, equipped with back-up battery power, designed for many years of use at medical facilities anywhere in the world. Breathe Strong submitted a request for Emergency Use Authorization (EUA) by the FDA and will submit for final FDA approval in June. Learn more at www.breathestrongtn.com.
Schneider Electric provides energy and automation solutions for efficiency and sustainability. We combine world-leading technologies, real-tie automation, software, and services into integrated solutions for homes, buildings, data centers, infrastructure, and industries. We make process and energy safe and reliable, efficient and sustainable, open and connected. Learn more at www.se.com.
Casco Systems is an established engineering and control system integration firm focused on providing innovative, cost-effective, and reliable automation solutions. The Casco technical team specializes in applying technology to automate, protect and control utility, industrial and process control systems. Their subject matter experts will work with you to understand and help solve your most difficult automation problems. Learn more at www.casco-systems.com.
About Border States Electric
Border States Electric (BSE) provides products and services to construction, industrial, and utility customers. The 100 percent employee-owned company is rated the seventh-largest electrical distributor in the U.S. by Electrical Wholesaling magazine. BSE has approximately 2,600 employees and 98 branches in 22 states. The Branch Support Center (corporate office) is in Fargo, North Dakota. Learn more at www.borderstates.com.
About McDougall Processing
McDougall Processing, a division of John W. McDougall Co., Inc., is an 82-year-old sheet metal fabricator located in Nashville, TN. McDougall Processing provides 2D and 3D laser cutting and precision forming services through-out the Southeast. Learn more at www.jwmcd.com.
About Nemo Design
Nemo is a brand design agency that exists to stoke the irresistible desire to belong. We create effective marketing using a potent blend of logic and magic. For 21 years we’ve helped the world’s best culture brands know and grow their audiences. Our independent, multi-disciplinary 35-person shop is located in Portland, Oregon. Learn more at www.nemodesign.com.
About Nashbox Digital Solutions
Nashbox Digital Solutions provides digitally rendered photorealistic visuals to product manufacturers and designers in the United States. They combine principles of CAD (computer-aided design) and photography to produce images, videos as well as interactive three-dimensional animations. Learn more at www.nashboxdigital.com.
The Breathe Strong XVENT Emergency Ventilator has not been FDA cleared or approved. Breathe Strong, LLC has filed for this ventilator to be authorized by the FDA in accordance with the Ventilator EUA dated March 24, 2020. The XVENT will be authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators under section 564(b)(1) of the Action 21 U.S.C 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The XVENT is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency or Respiratory Failures. It is specifically for the care of adult and pediatric patients >13 years of age and >35 kgs. It is intended to be used by hospitals or institutional health care environments as well as spaces converted for the care of large numbers of COVID-19 patients (e.g., convention centers, dormitories, hotels). The XVENT is intended to be used by qualified, trained personnel under the direction of a physician.