Endotronix is developing hemodynamic monitoring solutions to help detect worsening heart failure earlier than ever before.
In 2007, Harry Rowland, Ph.D., a mechanical engineer, met Dr. Anthony Nunez, a cardiothoracic surgeon, and bonded over their shared experience of witnessing a family member suffer from heart failure.
The two men realized they were uniquely qualified to invent a more effective solution to improve the quality of life for heart failure sufferers, their loved ones, and caregivers. With that goal in mind, they assembled a small team, including Michael Nagy, an experienced research and development leader, and founded Endotronix. The company then began to develop the core technology that would eventually become the Cordella™ Pulmonary Artery (PA) Pressure Sensor, a wireless, implantable sensor
"As time progressed, we began to understand the market required more than a tool for early detection of worsening heart failure – it needed a solution that extended clinical care into the home for ongoing management," says Harry Rowland, CEO and Co-Founder of Endotronix.
In late 2016, Endotronix introduced the Cordella™ Heart Failure System, a heart failure management solution that provides a comprehensive clinical picture to detect early signs of worsening heart failure outside of the clinical setting and to enable proactive guideline-based care.
"We seamlessly integrated two distinct products: the Cordella Sensor, and a patient management platform for remote management using daily patient clinical data," explains Rowland.
The Cordella System integrates non-invasive tools such as a blood oxygen saturation level monitor, a blood pressure monitor, a weight scale, and an electrocardiogram that wirelessly communicates with a tablet hub. These devices collect data from the patient and communicate it to a server for access by a clinician.* PA-pressure guided therapy has been shown to provide early detection of worsening heart failure as well as reduce heart failure-related hospitalizations and provide mortality benefits in patients suffering from heart failure.
The system broadens the use of guideline-based management with a streamlined workflow, allowing physicians to scale efficient heart failure management and improve patient outcomes.
Today, Endotronix has over 80 employees and has raised over $100 million in financing. The Cordella System is in commercial use in the U.S. and the Cordella Sensor is under clinical evaluation in the E.U., expanding to the U.S. in 2019.
Endotronix is eager to provide a better solution that improves outcomes for the 26 million people worldwide suffering from heart failure.
“Healthcare providers do their best to provide high quality patient care but the current reactive care model has a limited impact on heart failure-related readmissions and mortality. We aim to change that,” says Rowland.
“It is an exciting time as we turn the corner from preparation into execution.”
Last year Endotronix initiated the first in-human clinical trial of the Cordella Sensor, executed a soft launch of the Cordella System, and closed a $42 million Series D financial round.
Building on those successes, the company is currently focused on initiating a landmark IDE trial for the Cordella Sensor and extending the commercial launch of their data-driven platform in the U.S. as well as executing a CE Mark trial for the Cordella Sensor in the E.U.
“With FDA approval of the Cordella Sensor expected in 2020, we are well positioned to create a duopoly in the space and provide a comprehensive solution that can truly advance the treatment of heart failure, improve patient quality of life and prevent heart failure-related events.,” says Rowland.
Heart failure is a devastating disease for patients and family members and has a substantial social and economic impact in the larger population. Endotronix is dedicated to working with patients, clinicians, and hospitals to develop and commercialize solutions that advance the treatment of heart failure.
Endotronix has worked with the McDonald Hopkins team of Mark Masterson and Dave Cupar for over 10 years.
“They have been with us every step of the way as our Cordella product suite grew from a concept shared by a few dreamers to a fully developed system that is poised to redefine heart failure management for patients around the world,” says Mike Nagy, Chief Technology Officer and Co-Founder of Endotronix. “Their ability to formulate big picture IP strategy, as well as deep-dive into near term IP exigencies, has resulted in a robust and growing global patent portfolio around Cordella. They were and continue to be the right fit for Endotronix through all stages of our growth. Their genuine enthusiasm for our technology and mission complements their skill and responsiveness, which makes them a pleasure to work with. Their ability to draw on resources elsewhere in McDonald Hopkins when necessary supplements their sustained, individual focus. They get the startup’s need for speed and budget realities. They understand appetite for risk but will speak up if they perceive a bad risk."
"As the Endotronix/McDonald Hopkins team progresses to the next phase of Endotronix’s growth, we look forward to continuing successful collaboration, more great IP, many challenges, and a lot of fun."
*Inclusion of ECG reader is under development.
The Cordella™ Heart Failure System is commercially available in the U.S. and E.U.
The Cordella™ PA Pressure Sensor is an investigational device and is not currently approved for clinical use in any geography.
CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use.
Exclusively for Clinical Investigation.