Endotronix Extends Positive Outcomes with 12-month Data Release from the SIRONA 2 Trial for Remote Heart Failure Management Using the Cordella Pulmonary Artery Sensor

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The study met secondary study endpoints and long-term sensor use was associated with significant improvements in patient quality-of-life metrics and low event rates for heart failure hospitalization 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 from the SIRONA 2 clinical trial that demonstrated long-term use of the Cordella Pulmonary Artery (PA) Sensor was associated with significant improvements in patient quality-of-life metrics and low HF hospitalization and death (HFH/D) event rates for New York Heart Failure (NYHA) class III patients. The results expand on the 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 on May 20th 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 robust foundation of clinical evidence supporting the use of Cordella, the 12-month SIRONA 2 data further validates the benefit of PA pressure-guided therapy to improve patient outcomes for NYHA class III patients," stated Prof.  Aßmus. "Cordella's comprehensive approach consists of PA pressure data plus non-invasive data, including blood pressure, weight, and heart rate, which enables my team to efficiently titrate key HF medications remotely and help patients feel better. By actively monitoring the trended health data, we can bring down the PA pressures to avoid acute HF hospitalizations which delivers meaningful benefits to our overall health system and to patient lives."

The Cordella solution is the first and only patient management platform to provide both critical PA pressure data with an implanted sensor, and noninvasive vitals for comprehensive clinical management delivered in the patient's home. The easy-to-use devices securely transmit a patient's daily health status for trended insights that support optimal dosing of guideline-directed medical therapy (GDMT) across all types of heart failure. The patient-friendly system engages the patient and allows them to view their trended health data which has been shown in clinical evaluation to support healthy lifestyle choices. The streamlined workflow enhances current clinical practice, providing a scalable solution that enables new treatment standards to reduce and prevent HF congestion.

SIRONA 2 is an open-label, single-arm trial of 70 European patients that met its primary endpoints for safety and accuracy with the previously reported 90-day results. The 12-month results extended both the strong safety profile, with no PA sensor failures and no additional device/system-related complications (DSRC=1.3%), as well as accurate PA pressure measurement, with good agreement with the gold standard fluid-filled reference catheter (Swan Ganz). The recent results also met secondary endpoints for validated patient quality-of-life metrics and demonstrated low event rates for HF Hospitalization / Death (HFH/D) as indicated below.

12-Month SIRONA 2 Key Findings

• Significant improvement in patient quality-of-life metrics, including NYHA classification over 12 months (p<0.0001) and 6-minute walk test distance at both 3 months (p=0.005) and 12 months (p=0.02)
• Low event rates for HF Hospitalization/Death and only 5 deaths (7.1%) at 12 months
• Cumulative hazard rate for HFH (0.27) and HFH/D (0.33)
• 78.6% reduction in HFH rate in the year following implant compared to the year prior
• Consistently high patient compliance with daily submissions of heath data - 95% at 12 months

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

About Endotronix

Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF).  The comprehensive Cordella 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 which directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice, and supports guideline-based care across the entire HF continuum. Learn more 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 U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

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

SOURCE Endotronix, Inc.