The FDA instituted its expedited access pathway a year or so ago to speed innovative and valuable medical devices through the relatively lengthy US approval process, and with just 14 devices granted premarket approval in the first four months of 2016 the more products awarded this designation the better.
The latest is a neurostimulation device developed by Canadian start-up Lungpacer Medical, used to cause contraction of the diaphragm with the aim of weaning intensive care patients off mechanical ventilators. “The FDA believes these patients are in a life-threatening situation and the Lungpacer technology has potential to save them,” the group’s chief executive, Doug Evans, tells EP Vantage.
Worldwide there are around 10 million patients in intensive care units who, owing to the level of anaesthetic necessitated by their injuries or disease, cannot breathe and require mechanical ventilation. This works well enough temporarily, but the diaphragm is used to contracting every couple of seconds and when it is sidelined it atrophies rapidly. “In three days a patient can lose about half their diaphragm muscle,” Mr Evans says.
Consequently when the time comes to take the patient off the ventilator they sometimes find that they do not have the muscular strength to breathe for themselves.
“50-60% of patients can recover and wean off a ventilator in one or two days,” Mr Evans says. “30% take a week, and about 10% take two to three weeks.” Some patients, usually the older, sicker ones, cannot be weaned off the ventilator at all and have to go to long-term facilities. The prognosis for these patients is poor.
Take a deep breath
This is where Lungpacer’s technology comes in. The IntraVenous Electrode (Live) catheter is a variant of the central line catheters used routinely to deliver drugs or other fluids to unconscious patients in the ICU. In addition to delivering medication like a standard central line, Live incorporates electrodes along its length which can stimulate the phrenic nerves, causing the diaphragm to contract.
Permanently implanted diaphragm stimulators already exist, Mr Evans says, and tend to be used in patients with spinal cord injury who will never be able to breathe again. But many patients are too frail for the implant procedure, and in any case there is a need for a temporary solution.
The company has just completed a 24-patient feasibility trial, Pacer, conducted in Paraguay. This showed that the catheter could be inserted and removed safely and successfully stimulated the target phrenic nerves, producing contractions of the diaphragm muscle in synchrony with the mechanical ventilator.
There was another benefit, Mr Evans says. Besides muscle atrophy patients on ventilators are susceptible to lung injury thanks to the pressure of air forced into their lungs. Repeated inflation causes inflammation of the small cells of the lung; these release cytokines which can cause organ failure.
“Everyone is trying to figure out how to lower the pressure so you get gas exchange but don’t blow up the lungs too much. As the Lungpacer stimulates the diaphragm while the ventilator is pushing air, it requires less pressure to fully ventilate the lungs,” he says. The Pacer study showed that the air pressure could be reduced by 20-30%.
Next will come trials to measure the therapeutic benefits of the Lungpacer technology, with studies to begin in both Europe and the US in the first half of 2017 with the aim of proving that the system can shorten weaning time. The trial in Europe will be designed to secure CE mark whereas the first study in the US will be another feasibility trial which will be quickly followed by the pivotal trial.
The company hopes to get CE mark next year, and if all goes to plan the expedited access designation could permit an FDA submission in 2018, with approval the year after. It might also permit reimbursement: there is a bill before the US Senate that, if passed, will guarantee temporary Medicare coverage for all approved breakthrough devices.
The Ensuring Patient Access to Critical Breakthrough Products Act would enable breakthrough devices such as the Live catheter CMS reimbursement for three years. Manufacturers could use this period to negotiate future coverage by supplying further data to the CMS if necessary. It is not clear, however, when this bill might become law.
Hold your nerve
Trials will take money. The company has been funded by high net worth individuals to date, to the tune of around $16.5m, and is now on the hunt for more. Management is in discussions over a series B financing of around $18m, and the group expects that VCs will be involved this time. The round should close within the next six months.
The fact that the company is focused on a trade sale ought to play well with venture investors. Mr Evans says that with a neurostimulation technology on a cardiovascular platform that is addressing a respiratory market, the company could appeal to a wide range of buyers.
“The technology would have a great fit with a neurostimulation company like Medtronic, Boston Scientific, or Abbott-St Jude, or a cardiovascular company that has neurostimulation,” he says.
It is also possible that one of the ventilator makers might want to add the Lungpacer device to its portfolio. There are five major ventilation companies, Mr Evans says, and none have been able to differentiate themselves or improve their market share from around 20%.
“I think Lungpacer will eventually be acquired,” he says.
The company makes a convincing-sounding economic argument for its technology. Patients in ICUs each cost around $5,000 per day. More than half the patients on mechanical ventilation today are 65 and older, and this population is growing fast. Healthcare systems are going to be interested in any technology that can get patients off ventilators and out of the hospital quicker.
Mr Evans says that broad use of the Lungpacer technology could save healthcare systems around $10,000 per patient.
If the company can show that to be true, VCs, acquirers and payers alike will be beating down its doors.
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