Endotronix has announced the expansion of its series D financing round, bringing the total to US$70 million. The expansion syndicate includes new investment from an additional unnamed medical device strategic investor, as well as participation from existing investors. The funds will be used to support the PROACTIVE-HF IDE clinical trial of the Cordella pulmonary artery sensor system (Cordella Sensor) and commercialisation of the Cordella heart failure system (Cordella System).
PROACTIVE-HF is a prospective, multicentre, randomised, controlled, single-blind trial to 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 USA. 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 pulmonary artery pressure-guided management in the reduction of heart failure hospitalisations and mortality, as well as provide the data required for access to the US market and reimbursement of the implantable Cordella Sensor across the US.
A press release from Endotronix explains that the Cordella System is designed to help patients suffering from heart failure to stay out of 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 pressure data into the Cordella System. Together, says Endotronix, 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 pulmonary artery pressure-guided management delivers on that need,” states Harry Rowland, CEO at Endotronix in the press release. “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: the second, the open-label SIRONA II CE Mark trial, is currently enrolling 60 patients at up to eight European medical centres to 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 USA and EU. The Cordella Sensor is an investigational device and is not available for commercial use in any geography.