Ventilators are not designed to sit in storage for long periods of time unused. But that’s precisely what’s often required of this medical device, which then may require substantial repair and updates before it is functional. That’s a tale that’s been told repeatedly in this pandemic.

A pair of medical device entrepreneurs, Howard Levin and Mark Gelfand of medical device incubator Coridea LLC, decided to take on the challenge to develop a ventilator that can be stored for long periods of time, then pulled off the shelf and quickly put to use. The resulting company, New York-based Corvent Medical Inc., has already raised a $4.5 million seed financing to back an emergency use authorization submission, as well as a launch for the Corvent Single-Use Ventilator and to support development in the future of additional, next-gen respiratory insufficiency devices.

Field ventilation

“When the pandemic started, we were mostly motivated by the desire to help people,” Gelfand told BioWorld, noting that he and his partner both know physicians working to fight the pandemic, including Levin’s children. “The first thing we wanted to do was look at the production of ventilators.”

“We were at this time working with the Department of Defense on an unrelated project. They came to us with the specification for rapid deployment ventilators, something that can be stored for years and rapidly deployed in military fashion in the case of emergency and be operated by someone with a high school education,” he continued. “We started working on that with an altruistic intention, then we started realizing that health care is really poorly prepared for an infection of this kind where aeresolized highly infectious virus can rapidly infiltrate the health care environment and patients can infect health care providers.”

The device in development is expected to be a fraction of the $20,000 to $30,000 price tag for a standard ventilator at a cost of about $3,000 to $4,000. It’s intended to be used for just a few weeks with a single patient, which makes a simpler machine and a lower price point possible. This also reduces infection risk between patients, since multi-use devices are difficult to clean thoroughly. The single-use ventilator is also designed to be simpler and easier to use, requiring little to no training to use it. The lack of trained staff in the ICU has been a consistent barrier to treatment.

The expense of a standard ventilator is largely tied to the fact that it is designed to be a workhorse, to continue functioning for years across multiple patients, Gelfand observed. A much less expensive ventilator intended for use for only weeks at a time would be less complex.

Ambulances, for example, already carry simple ventilators designed to support a patient for as long as a few hours. But those emergency ventilators aren’t precisely suited for the pandemic either. The device design involves the attachment of a standard resuscitation bag, along the lines of what is used for manual ventilation, to an automated compression device that includes ICU-quality sensors to adjust ventilation pressure as needed.

With this single-use ventilator, the intention is to offer something simple that can be widely used by nonspecialists, along the lines of what was required to create automated external defibrillators (AEDs) that are situated in public places and intended to be used by any passerby, as needed.

"Our product is unique in that it is the only single-use, critical care ventilator that extends capacity when needed most," said Gelfand. "Whether it is in response to a pandemic or to address an underserved market, our single-use ventilator enables hospitals, states and countries to cost-effectively and efficiently address respiratory insufficiency so healthcare providers can immediately focus on critical patient needs."

Launch considerations

Corvent has not yet submitted the device for emergency use authorization by the FDA, but it aims to do so by about the middle of June. It has partnered with product design and engineering firm Design Catapult, which is based in Fountain Valley, Calif. to finalize the product. It is actively looking for a partnership with a medical device manufacturer to be able to make and distribute the device at scale.

The startup has already received significant interest from organizations and governments with the need to stockpile ventilators, Gelfand said, particularly from counties in the Southern Hemisphere such as Brazil who are just starting to see the pandemic swell.

Beyond the single-use ventilator, Corvent is also interested in developing additional devices to address respiratory insufficiency. Presuming that COVID-19 is likely to remain a menace and novel respiratory infectious diseases will continue to move from animals into humans, the company is also working to address other needs such as easier and faster weaning from ventilation and how to reduce the infection risk associated with manual intubation and the suctioning of ventilation tubing.

Incubator Coridea has founded about 10 companies since it was created in 2003. These include catheter-based hypertension treatment company Ardian Inc., which was acquired by Medtronic plc for $800 million in 2003, acute kidney injury company Renalguard Solutions Inc. and sleep apnea player Respicardia Inc. But it is typically involved early on, much like other incubators. In this case with Corvent, however it’s looking to go all the way to commercialization after just a few months.

Several venture capital firms bought into the vision for Corvent, despite it having been in the works for only a couple of months. European life sciences firm Sofinnova Partners led the round, with participation by Redmile Group, Exor Seeds, Genesis Medtech Group, The Deerfield Foundation, The Pagliuca Family Office, and Accel founder Jim Swartz.

"The COVID-19 pandemic has highlighted a significant need for emergency-use ventilators that can be rapidly deployed to enable on-demand, critical care ventilation," said Antoine Papiernik, managing partner at Sofinnova Partners. "Corvent has created an elegant yet simple, single-use solution for emergency preparedness that can be stored for long periods of time without the expense and delay of complicated service contracts. We are proud to partner with this proven team to bring a much-needed solution to market."