Israel’s Respinova is developing Pulsehaler, a device designed to prevent or delay the need for mechanical ventilation.
By Abigail Klein Leichman, ISRAEL21c
In many countries, the Covid-19 pandemic led to a mad scramble for ventilators and hospital ventilator specialists.
Israel forestalled a shortage by fast-tracking ventilator innovation in the private, nonprofit and public sectors.
But everyone agrees that the best solution would be to prevent patients from needing ventilation at all.
Long before the pandemic began, Israeli startup Respinova was developing Pulsehaler, a novel medical device to help chronic obstructive pulmonary disease patients improve their lungs and avoid ventilation. COPD kills 3 million people annually; 150,000 in the US alone.
Pulsehaler administers air pressure pulsations throughout the breathing cycle, reopening closed airways and clearing mucus clogs. The noninvasive 20-minute “air chopping” treatment can be self-administered.
An initial trial, conducted at Hadassah Medical Center in Jerusalem on 22 COPD patients, demonstrated significant improvement in exercise capacity, a key predictor of sickness and death in COPD. A second trial, at Yitzhak Shamir Medical Center in Tzrifin, showed that Pulsehaler achieved this result by reopening closed airways.
Neither study measured mucus production specifically. However, “investigators observed in many subjects a substantial increase in mucus production and decrease in mucus viscosity, together with improvement in mucus color,” Respinova CEO Cliff Ansel tells ISRAEL21c.
As Respinova began producing prototype devices for final testing and submission to regulatory agencies in the United States and Europe, Covid-19 entered the picture.
The novel coronavirus leads to severe double pneumonia requiring ventilation. And data from China indicates that Covid-19 causes a significant mucus component blocking small airways.
Based on data from Respinova’s COPD studies, Ansel believes Pulsehaler can complement other therapies used to treat moderate Covid-19 patients. The pulsating pressure waves might improve oxygenation, reduce the thick mucus and the risk of secondary infection, and help avoid deterioration to a state requiring mechanical ventilator support.
Prevention, Treatment, Rehab
“We’re trying to treat Covid on our way to treating a massively undertreated disease, COPD,” Ansel says. “We’ve recognized that the high rate of infection in nursing homes – where about 20% of patients have COPD — is becoming more relevant to what we do.”
Pulsehaler could potentially aid Covid-19 care in three scenarios: pre-treating high-risk COPD patients at home or in a nursing facility in order to improve lung function and reduce the risk if they become infected; treating hospitalized Covid-19 patients to prevent deterioration; and treating recovered patients with long-term lung impairment.
“Much has been published about the use of vibrations to mobilize mucus secretions and improve oxygenation in ventilated patients, including those with acute respiratory distress syndrome (ARDS). ARDS is often what happens when Covid-19 patients become critical,” says Ansel.
Dr. Ishay Ostfeld, a cardiothoracic surgeon and retired IDF Medical Corps colonel, agrees that Pulsehaler could help Covid-19 patients.
“We have seen that the most vulnerable patients, such as those with COPD in nursing homes, are at the highest risk of developing a severe case if infected. If this device can improve these patients’ lungs before infection, it could mitigate the severity,” says Ostfeld.
“From what we know about air pressure pulse ventilation in ARDS, I believe the Pulsehaler can also help treat the infected patients, whether they are moderate or severe.”
Repinova is preparing for clinical trials in Israeli hospitals and nursing homes on ARDS patients. The company also is pursuing emergency use authorization for Pulsehaler in several countries.
Multiple Patients Could Use One Unit
Ansel says moderate to severe Covid-19 patients are sometimes treated with noninvasive ventilation devices such as CPAP and BiPAP, but these can be a vector for infection.
“Pulsehaler can be configured with an outlet filter to prevent spread. Unlike CPAP and BiPAP, it also allows patients the benefits of airway opening and mucus clearance, in a device that can be simply self-administered and has clinical evidence in COPD to back it up.”
Every part of the Pulsehaler that touches the patient can be removed for reuse by that patient, while the base and handheld units can be disinfected. Since each Pulsehaler treatment takes only 20 minutes, hospitals could use one for multiple patients. That would make it attractively cost efficient.
Prior to Respinova, Ansel was the CEO of a US Armed Forces contractor, Thornhill Medical. Under his guidance, Thornhill developed a portable ICU and anesthesia system that became the standard of care in US Marine Corps critical care and is currently being deployed on Covid-19 patients.
Respinova is co-funded by the Horizon 2020 program of the European Union. Its founder and chief technical officer, Yuval Avni, is a serial entrepreneur, inventor and medical device product developer. Also on the team is lung specialist Dr. Noam Gavriely, whose new ventilator mask just went on the market.
“We have extensive medical device manufacturing contacts in the US, Canada, Europe, Asia, and Israel, and we are able to partner with one or more of them to speed up full scale manufacturing deployment of Pulsehaler,” Ansel says.
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