As a founding member of closely-held Sensible Medical Innovations, Amir Ronen also has held the title of CEO since the company’s inception in late 2007. Mr. Ronen has over 15 years of experience in senior management roles at leading global companies, including VP of marketing and business development at M-Systems, which was acquired by Sandisk; as a senior strategic planning manager at Intel; and as VP of strategic alliances at Saifun, which was acquired by Spansion. In this interview with BioTuesdays.com, Mr. Ronen discusses the company’s solution for managing and reducing readmissions of patients with heart failure – a novel sensor, used once a day for 90 seconds, to provide an accurate measurement of lung fluid content.
Let’s begin with a brief history of Sensible.
Most of the founding team came from the elite technology unit of the intelligence force in Israel, which also is where our technology came from. The military’s “see through wall” radar technology was used to look inside buildings and find survivors in rubble. It was developed over 30 years in Israel and has been used in disaster areas such as Haiti, Japan and Thailand. We all knew the technology from our army days and decided to apply it to a medical device.
What’s the basis of your ReDS technology?
We spent about five years adapting the “see through wall” radar technology for imaging in the body. Essentially, we developed a miniature radar system that can see through different tissue walls of the body in order to provide a non-invasive measurement of the fluid level in the lungs. The ReDS system employs low-power electromagnetic energy. The vest has a sensor on the front and back, and can be used by patients in the comfort of their home, for a short daily measurement that takes only 90 seconds. Patients measure their lung fluid content and the results are automatically uploaded to a secure cloud application for a healthcare professional to review. We also set up a service center and field support nationwide to help patients comply with the daily measurement and alert physicians.
How are you targeting your technology?
We believe the technology is well positioned to be a game changer in a wide range of applications and become the next generation monitoring and imaging modality in hospitals and the home care market. Heart failure impacts approximately 26 million patients worldwide. The disease poses a significant cost to society with an estimated $40-billion spent on heart failure in the U.S. alone. Hospital readmissions account for a significant portion of these costs. Once admitted to hospital, 25% of heart failure patients will be readmitted within the first month and 50% within the first six months. Effective non-invasive lung fluid status management is expected to improve the quality of care while reducing the overall cost of care related to readmissions.
Do you have clinical evidence of how ReDS impacts hospital readmissions?
We recently completed a two-year study (ReDS-HF) in Israel to assess the feasibility and safety of heart failure management guided by the ReDS system as an adjunct to standard of care. We followed 50 patients for 90 days following discharge from hospital. The number of readmissions was compared to a three-month pre-ReDS period and three months post-ReDS period. The study found that ReDS guided management decreased the amount of hospitalizations by 87%. After the 90-day study, patients returned the ReDS system and we found a 78% increase in hospital readmissions.
What’s the regulatory status of ReDS-guided fluid management?
Last August, we obtained FDA clearance. The system is also CE marked since 2014.
Can you tell us about the SMILE study?
Last October, we enrolled the first patient in SMILE, which is a post-marketing study designed to measure the readmission reduction effect in U.S. heart failure patients and the health economics impact of ReDS-based remote patient monitoring. The two-year study is expected to enroll approximately 380 patients in 35 centers in the U.S.
Do you have any competition in the market?
St. Jude Medical has introduced CardioMEMS, a miniaturized, wireless monitoring sensor device that is implanted in the pulmonary artery to measure artery pressure. CardioMEMS is paving the way for the introduction of our product. Our competitive advantage is that ReDS, being a non-invasive technology, does not require an implantation, imposes a lower risk, and therefore physicians perceive it as a much better fit for patient monitoring. In addition the monitoring may start immediately upon admission to the hospital and can apply to a much wider patient population and broader physician reach.
What’s in your pipeline?
Sensible is the leader in medical radar technology. Our mission is to become a game changer in the management of heart failure and enable millions of typically elder patients worldwide to enjoy their years with a higher quality of life and avoid unnecessary hospitalizations. We have just received our FDA clearance and our work has just begun.