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RELEASE: Endotronix Publishes Data from the SIRONA 2 Trial for Remote Control of Heart Failure

- Endotronix Expands on Positive Results with Publication of 12-Month Data from the SIRONA 2 Trial for Remote Monitoring of Heart Failure with the Cordella Pulmonary Artery Sensor.

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RELEASE: Endotronix Publishes Data from the SIRONA 2 Trial for Remote Control of Heart Failure

- Endotronix Expands on Positive Results with Publication of 12-Month Data from the SIRONA 2 Trial for Remote Monitoring of Heart Failure with the Cordella Pulmonary Artery Sensor

The study met the study's secondary endpoints and long-term sensor use was associated with significant improvements in patient quality of life metrics and low rates of heart failure hospitalization events and death.

LISLE, Ill., May 22, 2023 /PRNewswire/ -- Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive 12-month data of the SIRONA 2 clinical trial that demonstrated the long-term use of the Cordella pulmonary artery (PA). The sensor was associated with significant improvements in patient quality of life metrics and low rates of heart failure hospitalization and death (HFH/D) events for New York Class III heart failure (NYHA) patients. The results extend previously published positive 90-day primary endpoint data on device safety and pressure accuracy for the Cordella PA sensor. The 12-month results were presented May 20 at the European Society of Cardiology's annual conference, Heart Failure 2023, by Professor Birgit Aßmus, a heart failure cardiologist at the University of Giessen in Giessen, Germany.

"Adding to a strong clinical evidence base supporting the use of Cordella, the 12-month SIRONA 2 data further validate the benefit of PA pressure-guided therapy in improving outcomes in NYHA class III patients," stated Professor Aßmus. "Cordella's comprehensive approach consists of BP data plus non-invasive data, including blood pressure, weight and heart rate, allowing my team to remotely assess key heart failure medications and help patients patients to feel better. By actively monitoring trending health data, we are able to lower BP pressures to prevent acute heart failure hospitalizations, providing significant benefits to our overall healthcare system and to patients' lives."

The Cordella solution is the first and only patient management platform that provides critical BP pressure data with an implanted sensor and non-invasive vital signs for comprehensive clinical management in the patient's home. The easy-to-use devices securely transmit a patient's daily health status for up-to-date information that supports optimal dosing of Guideline-Directed Medical Therapy (GDMT) in all types of heart failure. The patient-friendly system engages the patient and allows them to view their trending health data that has been shown in clinical evaluation to support healthy lifestyle choices. The streamlined workflow improves current clinical practice, providing a scalable solution that enables new treatment standards to reduce and prevent HF congestion.

SIRONA 2 is a single-arm, open-label trial of 70 European patients that met its primary safety and precision endpoints with the previously reported 90-day results. The 12-month results extended both the strong safety profile, with no BP sensor failure or additional device/system-related complications (DSRC=1.3%), as well as accurate BP pressure measurement, with a good agreement with the fluid reference standard. filled reference catheter (Swan Ganz). Recent results also met secondary endpoints for validated patient quality of life metrics and demonstrated low heart failure hospitalization/death (HFH/D) event rates, as noted below.

SIRONA 2 12 month key findings

"We are delighted with the significant improvement in patients' quality of life and the low event rates demonstrated in the 12-month data from SIRONA 2, which lays the groundwork for upcoming results from the PROACTIVE-HF trial early next year." said Harry Rowland, CEO of Endotronix. "Together, this clinical evidence will serve as the foundation for our next commercial launch and enable clinicians to improve the lives of patients."

About Endotronix

Endotronix innovates at the intersection of Medtech and Digital Health to improve care for people living with heart failure (HF). Cordella's end-to-end solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing for early and targeted therapy. The Cordella HF system is a patient health management platform, combining comprehensive vital sign data from non-invasive devices to support physician and patient engagement and care decisions. By combining trend insights, the versatile and scalable Cordella improves current clinical practice and supports guideline-based care across the HF continuum. More information at www.endotronix.com.

The Cordella sensor is under clinical investigation and is not available for commercial use in any geography. The Cordella HF system, without the sensor, is available for commercial use in the US and EU.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain predictions, estimates or other information that could be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

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