For the past six years, Minnesota device startup Respicardia has been trying to commercialize a product that President and CEO Bonnie Labosky believes has no rival worldwide.
It is an implantable device, the size of a pacemaker, that can be placed in the right or left side of chest to treat the problem of central sleep apnea. Unlike obstructive sleep apnea, which is a more common type of sleep apnea associated with an anatomical malfunction, central sleep apnea occurs when the brain cannot properly transmit signals that tell the body how to breathe. While the cause is unknown, one school of thought is that it is associated with cardiovascular issues, Labosky said. In fact, about 35 percent to 40 percent of all heart failure patients have central sleep apnea.
That association with cardiovascular problems led the founders of the company to design an implantable product that can deliver mild electrical pulses – neurostimulation – to manage the central sleep apnea nightly. Specifically the stimulation is provided to one of the two phrenic nerves that are responsible for transmitting the signals for breathing from the brain to the diaphragm, Labosky explained.
At the end of October, Respicardia announced that it had implanted 45 patients with the remede System – although Labosky clarified that 49 patients received the implants. Data from this study will help to move toward a pivotal trial. Labosky said that the company is working with the Food and Drug Administration to design the protocol for that. Labosky said that market researchers hired by Respicardia estimate that 10.5 million people suffer from CSA in North America, Canada, Europe and Asia Pacific while the BRIC (Brazil, Russia, India, China) countries account for $28.7 million.
This novel therapy is meant to prove better clinical outcomes than the standard treatments, which include CPAP masks, drugs and other types of airflow devices.
Labosky said that data from a feasibility study showed that the remede device is able to reduce the apnea hypopnea index by 50 percent. [Apnea is when breathing stops completely for 10 seconds or longer, hypopnea is constricted breath that lasts as long and the index measures the number of apneas and hypopneas that disrupts a sleeper in an hour.]
Such encouraging data from the feasibility study [Labosky couldn't provide data from the 49-patient pilot study] means that the no. 1 priority for Labosky and employees is winning regulatory approval from the FDA. In fact, so focused is the company on gearing up for the next step – the large-scale pivot trial that will support the startup’s pre-market approval (PMA) application to the FDA – that Labosky is not sure whether it makes sense to try and launch the remede System in Europe where it obtained CE Mark in 2010.
“Once we finish the pilot study, we have to make a decision on whether to launch in Europe. We would be ready to. The question is do we want to,” Labosky said.
That decision will be made if the company manages to raise enough money for both the European commercialization and the pivotal trial. Labosky won’t say how much the company is trying to raise from investors right now.
But Respicardia has not lacked in funds despite the fact that this is a novel therapy. Since inception, the company has raised nearly $55 million in three rounds of funding, Labosky said. Investors in the company are Three Arch Partners, Versant Ventures, Accuitive Medical Ventures, Affinity Capital Management and Polaris Venture Partners. The startup also has a strategic investor but Labosky declined to identify the company.
Money is what keeps the wheels of any startup spinning but Labosky said she and her colleagues are heartened by how patients of the pilot study have reacted to the product.
“They are sleeping better, feeling better, excited about the therapy,” Labosky said. “No one has said take it out, [that] they don’t like it. They are all pretty excited about the positive impact it is having on the quality of their life let alone their cardiovascular health.”