Electrophysiologists (EPs) who are managing atrial fibrillation (AF) patients who also suffer from sleep apnea have found that catheter ablation is most effective when used in conjunction with a CPAP regimen, yet there is a huge disconnect between the EPs and the sleep experts. That disconnect is what inspired Itamar Medical to develop SleePath, an integrated digital health sleep apnea care pathway monitoring system that allows cardiologists to monitor patients with AF sleep apnea status and compliance with CPAP devices on demand.
The Caesarea, Israel-based company unveiled SleePath last May at Heart Rhythm 2018, the annual meeting of the Heart Rhythm Society. This week the company announced that it has finalized the terms of a private placement worth $11.5 million. Itamar plans to use the proceeds to accelerate its revenue growth through direct expansion of its sales and marketing initiatives.
"The product was born out of our [cardiology] customers telling us that the big missing link for them is once they refer a patient to the sleep side, it's radio silence," Gilad Glick, CEO of Itamar Medical, told MD+DI in May. "They have no idea if the patient is undergoing a sleep study, they have no idea if a CPAP was fitted on them, and they have no idea if the patients complied with the therapy."
Using data from a CPAP machine from Philips Respironics, SleePath includes a cardio sleep dashboard that allows physicians to track multiple aspects of a patient's sleep apnea status from anywhere, anytime. The system is designed to monitor care pathway progress, diagnosis status and results, CPAP compliance, the number of days and hours on CPAP, and residual sleep apnea. That data is presented in a user-friendly visual format that makes it easy to see progress or deviation toward specific treatment goals and changes in metrics over time, according to Itamar.
The company has agreed to its ordinary shares at NIS 1.1693 a piece, or $9.55 per American Depositary Share (ADSs), each representing 30 ordinary shares. Of the $11.5 million, $8 million will be made through purchases of ADSs by U.S. accredited investors. While the company expects the Israeli tranche to occur within the next several weeks, Itamar said there is no assurance as to the timing of the closing of the U.S. tranche in light of, among other things, the U.S. federal shutdown.
The U.S. tranche consists of a fund managed by Deerfield Management Company as well as Triple Gate Capital, West Elk Partners, and Alpha Capital Anstalt. The $3.5 million Israeli tranche will be by way of issuing ordinary shares to More Investment House.
“Effective management of sleep apnea is now believed to be critical for controlling atrial fibrillation post ablation. The ability for us, the electrophysiologists, to assess patients’ sleep apnea status and their adherence to CPAP on demand, and correlating it to the AF manifestations, is a big help,” said Elad Anter, MD, of Beth Israel Deconess in Boston, MA. “The information that SleePath provides is important for achieving optimal outcomes following catheter ablation. Knowing that a patient isn’t using their CPAP as prescribed is an important first step in opening a dialog with the sleep experts that can identify obstacles and help improve adherence.”
Itamar also offers the WatchPAT, a home-use diagnostic device for sleep apnea, and the EndoPAT, a device designed to test endothelial dysfunction and to evaluate the risk of heart disease and other cardiovascular diseases.
Digital healthcare has already shown promise in the sleep apnea space. Last year FDA granted a de novo request allowing Fresca Medical to market its Curve CPAP system for the treatment of obstructive sleep apnea. Philips Respironics, a division of Royal Philips that makes CPAP devices, has also turned to digital healthcare to address the CPAP compliance problem.