FDA approves SFU professor's invention to wean COVID-19 patients from ventilators

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Reviewed by James Ives, M.Psych. (Editor)May 4 2020

Simon Fraser University professor Andy Hoffer hopes the SFU spinoff company he founded, Lungpacer Medical Inc., will help save the lives of COVID-19 patients using mechanical ventilators--and get them off more quickly, so that more ventilators can be available for all critically ill patients.

The company has received Emergency Use Authorization (EUA) clearance by the U.S. Food and Drug Administration, paving the way for immediate use of its Diaphragmatic Pacing Therapy System (DPTS).

The system has been authorized for use among patients at a high risk of weaning failure from ventilators. Ventilators are used in intensive care units (ICU) to provide breathing support during treatment or as the patient's body overcomes disease.

According to Hoffer, about 30 per cent of ventilated patients typically fail to wean and die in hospitals, but the death rate appears to be much higher for ventilated COVID-19 patients in the U.S.

Headquartered in Vancouver, with offices in Exton, Pennsylvania, Lungpacer has developed a temporary, non-surgical, minimally invasive technology to make mechanical ventilation more effective and safer.

Hoffer, a professor in SFU's Biomedical Physiology and Kinesiology (BPK) department and Lungpacer's founder and lead inventor, says:

A big problem with inflating the lungs using positive pressure to deliver oxygen is that high pressure causes ventilator-induced lung injury, and in COVID-19 patients this may compound the lung damage caused by the virus.

In contrast, pacing the diaphragm distributes the breathed oxygen more evenly throughout the lungs and this helps protect the tissue from mechanical injury."

A second problem is that mechanical ventilation sidelines the diaphragm muscle and causes it to rapidly atrophy, which is a major reason for failure to wean. "Pacing the diaphragm helps maintain or restore its size, strength and endurance, which is key to enabling successful weaning," he says.

The diaphragm stimulation therapy is delivered through a central venous catheter (CVC), similar to central lines currently placed in mechanically ventilated ICR patients.

The unique central line is used to deliver both fluids and medications, while also incorporating electrodes that activate the diaphragm muscle, via transvenous phrenic-nerve stimulation.

The system's goal is to enable and accelerate the recovery of ventilated patients, reduce the hospital care cost of critically ill patients, improve the lifespan and quality of life of survivors of mechanical ventilation and save ICU patients' lives.

The company has met several clinical milestones to bring its device to market.

The FDA granted the Lungpacer DPTS an expedited access pathway (EAP) designation in 2016. The company has since completed two clinical trials including a randomized, controlled, multicenter study in Europe with 110 patients, and is currently enrolling patients in a pivotal trial to support FDA approval.

The company's CEO, Doug Evans, based in Philadelphia, says "I am very proud of the Lungpacer team who have worked diligently to make this therapy available in a very short period of time."

FAST FACTS:

Hoffer conceived the idea after his mother, who had pneumonia and was placed on a ventilator, failed to wean and eventually died in hospital. In 2008 he submitted his first US patent application, which has led to about 50 patents granted to date, and with his SFU Neurokinesiology Lab students subsequently designed, developed and tested transvascular pacing devices in pigs.
He founded Lungpacer the following year and served as the CEO until 2014 and as the Chief Scientific Officer and a director until December 2016.
The company received invaluable early business development support from SFU's Venturelabs and its former executive director Ian Hand.
In 2014, Hoffer and Evans raised $5.5 million in private equity funding for proof of concept and completion of preclinical studies, and then raised over $9.6 million in 2015 as convertible debt to improve upon the device prototype.
To date, Lungpacer has raised US$75.4 million and is the only Canadian medical device company listed among the Top Ten Canadian Health Technologies in The Narwhal List 2020.
Hoffer earlier founded Neurostream Technologies, also an SFU spinoff company, based on his 30 years of research on safe and effective implantable electrodes that can sense microvolt-level signals produced by nerves. This enabled the production and clinical testing of the only fully implanted walking assistive system for people with hemiplegia, a technology that was eventually acquired by Ottobock Healthcare.
Hoffer's research has explored how to apply emerging technologies to restore normal functioning in patients suffering from severe disabilities such as spinal cord damage, stroke, limb amputations, tremors or chronic pain.