Like many companies, Enexor BioEnergy, a renewable energy company based in Williamson County, pivoted during the pandemic.
The company began producing ventilators in March 2020 in an effort to help address a looming global ventilator shortage. But unlike many of the companies who manufactured hand sanitizer, masks and other PPE to generate cash flow during an uncertain time, Enexor BioEnergy made its pivot permanent.
One year later, in March of 2021, Enexor BioEnergy announced the launch of its spinoff health care company Enexor Health Systems, which aims to disrupt the $7.2 billion global ventilator market through its new design and competitive price point. Developed by a team of critical care physicians and respiratory therapists, Enexor Health Systems’ Vent-LS is an EUA piston-driven, self-calibrating, adult ventilation system that costs up to 50 percent less than similar systems. Because of its unique design, the VENT-LS can be deployed in developing countries like Kenya and Ghana as well as in domestic hospitals.
Two months before Tennessee confirmed it’s first case of COVID-19, Enexor BioEnergy CEO Lee Jestings received a call from a physician friend in a developing country asking for ventilators. The request drove home just how dire the ventilator shortage was becoming worldwide, Jestings says.
He reached out to veteran health care executive Steve Rector, who now serves as Enexor Health Systems' CEO, and renowned neonatal physician Dr. Bill Walsh of the Monroe Carell Jr. Children’s Hospital at Vanderbilt University to discuss designs. Prior to Enexor, Rector was an executive at Corizon, CHS and HCA and a director at LifePoint Health and Ascension Saint Thomas.
“Enexor wanted to develop an effective, relatively inexpensive ventilator as fast as possible, which seemed like a very daunting task,” says Walsh, who was one of the design team members of the original oscillating ventilator approved for neonatal use in the United States. “The motivation for them to do it is what attracted me, essentially making it a break-even, humanitarian effort to save lives. They saw a need and had the ability.”
Enexor’s engineers did just that. By March of 2020, Enexor BioEnergy successfully designed and manufactured a device at its headquarters in Franklin. In June, the VENT-LS received an Emergency Use Authorization from the U.S. Food and Drug Administration.
Unlike traditional bag or blower ventilator systems, which require external connections to high pressurized oxygen via a headwall or mechanized pressure, Enexor’s ventilator is piston driven, which allows it to generate its own pressure and use low-flow canister oxygen. Thus, the VENT-LS can be operated in some of the poorest areas of the world where access to pressurized oxygen and resources are scarce, explains Rector. It’s currently in use in the U.S., Kenya, Ghana, the Dominican Republic and Colombia.
“Think of it like a bike pump,” Rector says. “When the pump is pulled upward, the piston sucks in air from the outside. Press down and the compressed air is pushed out.”
Any ventilator can injure a patient’s lungs by causing too much strain as the machines force in oxygen through a throat tube, which the body typically fights.
“There is significantly less risk of damaging the lungs when employing a ventilator than [with] low-flow oxygen,” Walsh says. “This is especially critical when treating COVID patients whose lungs are already compromised.”
As a safety precaution early on during the pandemic, doctors and hospitals limited the access of health care workers to coronavirus patients on ventilators, giving them fewer opportunities to check on them. The VENT-LS can be securely and remotely monitored from mobile devices, so health care workers can adhere to safety measures without sacrificing attention to the patient.
Its simplistic design also plays an important role in reducing expenses. Ventilators can be costly — ranging in price from $25,000 to $50,000 apiece. Respiratory therapists, nurses and doctors all have to be trained on how to operate each of the different models of machines, which are normally replaced every three-to-five years. Ideally, hospital administrators could purchase the same model when it comes time to replace the machine. But due to ever-changing technology, product supply and fluctuating budgets, most hospitals own multiple makes and models of ventilators. Health care professionals have to be trained on every make and model of ventilator in a hospital due to each system’s variable design and liability concerns.
“Training expenses include not only the cost of the instructor, but the wages of all the employees attending the session and the additional wages of the personnel scheduled at the hospital in place of those attending training,” Rector says.
Enexor’s first ventilator sells for less than half the industry standard price, at $10,700 per unit. Rector says its redesigned model, the NXR Continuum, will also be priced competitively, somewhere in the range of $20,000-$25,000. Training expenses are significantly less too, according to Rector. He expects FDA approval for the second device in the first quarter of 2021.
“Comparable ventilators require a minimum of six hours of training, but often take 10-12 hours,” Rector says. “Users are trained on the VENT-LS in less than an hour and a half.”
Additionally, the VENT-LS has one of the lowest life cycle costs on the market, Rector says. It self-calibrates to minimize maintenance costs, runs on low oxygen and is compatible with universal, non-proprietary disposables including ventilator circuits (typically changed every 24-48 hours) and bacterial and viral filters that are generally replaced every 24 hours. Non-proprietary disposables are ordinarily half the price of proprietary products, according to a National Center for Biotechnology report detailing medical device costs.
Two months ago, Enexor Health Systems applied and filed the paperwork to receive full FDA approval on its redesigned device, the NXR Continuum. According to Rector, the main difference between the original VENT-LS and the redesigned version is its ability to be used for both adult and pediatric patients. The original VENT-LS was designed for adult use only.
“Many ventilators are authorized for adult use only because infant and children’s lungs are so fragile,” Walsh says. “Typically, hospitals have separate ventilators for adults and children because there aren’t many machines that are strong enough for mature patients but gentle enough for a newborn.”
The NXR Continuum will be safe to operate on both infants and adults, the company says.
“The ability to treat patients of all ages with one machine will advance our company’s commitment to efficiency and value,” Rector says.