Adona Medical Announces Completion of First-in-Human ATHENS-HF Trial with 100% Implant Success for Its Adjustable Atrial Shunt

Adona MedicalAnnouncement of Its Atrial Shunt DeviceAdonaCompletion of FIM (ATHENS-HF) clinical study enrollment.

ATHENS-HF Study Enrolls Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) and Heart Failure with Reduced Ejection Fraction (HFrEF). The majority of patients have completed the 90-day follow-up time point after the original procedure and, as planned, successfully received additional treatment months later to adjust the shunt size.

Preliminary Research Data

• AdonaSuccessfully implanted into10 HeartsIn patients with heart failure, the success rate of the surgery reached 100%.

• The diameter of the shunt was successfully adjusted both upwards and downwards from the initial configuration in all patients, and the impact of shunt size on the treatment efficacy during the acute phase was observed.

• To date, no major surgical complications or major adverse cardiovascular and cerebrovascular events (MACNE) reported by the research center have occurred in the entire cohort.

PI Evaluation

"One-size-fits-all technology may not be the best choice for all patients, as heart failure is a diverse and constantly evolving condition. The ideal shunt solution should provide adaptive flow rates and hemodynamic feedback, allowing the shunt device to be adjusted according to patient needs to optimize treatment—similar to how medications are fine-tuned for optimal effect. The Adona Shunt is designed to deliver tailored hemodynamic adjustments based on feedback from integrated pressure sensors and the patient’s evolving clinical status, offering hope to a broad range of patients."

---Gregg W. Stone  Mount Sinai Heart Health System

Expert Evaluation

"In the initial cases, I personally witnessed that the Adona shunt can be safely and reliably implanted, and the dual-atrial sensor provides crucial insights into the patient's hemodynamic status as well as the immediate effects of shunt therapy. Moreover, early clinical experience preliminarily suggests that the shunt diameter can be adjusted to increase or decrease post-implantation, allowing for personalized treatment tailored to the specific needs of each patient."

---Gagan Singh  University of California Davis Health

Executive Evaluation

"Completing patient enrollment for our first-in-human study ahead of schedule is a key milestone, highlighting our team's ability to execute this ambitious mission. Strong early results clearly indicate that we are building a platform with the potential to transform heart failure management. We are well-prepared for the next phase and plan to evaluate the next-generation device later this year to advance our clinical program."

---Brian Fahey  Co-founder and CEO of Adona Medical

Adona MedicalIt is a very unique atrial shunt, which can personalize the adjustment of channel size based on patient monitoring data.Compared with the current shunt technology that adopts a single fixed-size flow channel,AdonaTo achieve personalized treatment. In addition, Adona integrates sensors designed to capture left and right atrial pressure readings multiple times a day without requiring any action from the patient. These daily readings are expected to provide doctors with more comprehensive information about the patient’s hemodynamic status and enhance the effectiveness of shunt therapy by enabling more informed and proactive medical management.

AdonaMainly composed of Bi-Atrial Pressure Sensors, Adjustable Shunt Lumen, and ePTFE Encased Anchor.

• Bi-Atrial Pressure Sensors

Can monitor the pressure in the left and right atria

• Adjustable Shunt Lumen

• ePTFE Encased Anchor

Using biocompatibilityePTFEMaterials Accelerate Healthy Tissue Response

When the directional flow is too large and the channel needs to be narrowed, Adona Medical's dedicated development is used.AdonaThe innovative catheter Adona Magnetic Catheter. Adona Magnetic Catheter transfers energy through non-contact induction toAdonaUpward, thereby restoring the channel to its nominal dimensions.