LISLE, Ill: Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure (HF), today announced the expansion of its Series D financing round, bringing the total for the round to $70 million. The expansion syndicate for the LSP-led round includes new investment from an additional unnamed medical device strategic investor as well as participation from existing investors, including Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and an unnamed corporate strategic investor. The funds will be used to support the landmark PROACTIVE-HF IDE clinical trial of the Cordella® Pulmonary Artery Sensor System (Cordella Sensor) and commercialization of the Cordella® Heart Failure System (Cordella System).
"Endotronix has built a strong syndicate of both institutional and strategic investors who believe in the benefits of remote heart failure management with the Cordella Sensor and System," commented Fouad Azzam Ph.D., General Partner at LSP. "The team is set to deliver an elegant solution that we believe will show a definitive benefit in reducing heart failure related hospitalizations and improving outcomes for patients and clinicians."
The Cordella System is designed to help patients suffering from heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools to securely collect and share health-related data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.
"Heart failure care providers are seeking better solutions to manage patients and we believe the Cordella System with PA pressure-guided management delivers on that need," stated Harry Rowland, CEO at Endotronix. "This financing expansion allows us to execute on the PROACTIVE-HF trial to provide the highest level of clinical evidence which will redefine the standard of care for heart failure patients and accelerate our time to market."
Endotronix has two active clinical studies for the Cordella Sensor:
PROACTIVE-HF is a prospective, multi-center, randomized, controlled, single-blind trial that will evaluate the safety and efficacy of the Cordella Sensor in over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the U.S. The trial has received FDA approval and enrollment is expected to begin in the fourth quarter of 2019. The pivotal trial is designed to show a definitive benefit for PA pressure-guided management in the reduction of HF hospitalizations and mortality as well as provide the data required for access to the U.S. market and reimbursement of the implantable Cordella Sensor across the U.S.
The open-label SIRONA II CE Mark trial is currently enrolling 60 patients at up to 8 European medical centers. The trial will evaluate the safety and efficacy of the Cordella Sensor for the management of NYHA Class III heart failure patients and provide data for market access to the European market.
The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella Sensor is an investigational device and is not available for commercial use in any geography. CAUTION Investigational device. Limited by Federal (or United States) law to investigational use.