ADONA MEDICAL COMPLETES ENROLLMENT IN FIRST-IN-HUMAN TRIAL FOR NOVEL INTERATRIAL SHUNT FOR PATIENTS WITH HEART FAILURE

• 10 patients enrolled with 100% implantation success
• Adona's adjustable interatrial shunt is designed so it can be modified post-implantation to provide a more adaptive and personalized lifetime approach to heart failure management

LOS GATOS, Calif., June 17, 2025 /PRNewswire/ -- Adona Medical, a Shifamed portfolio company that is developing one of the world's first combined therapeutic/diagnostic cardiovascular implants, announced today the completion of enrollment in the ATHENS-HF first-in-human study. The company's chronically-adjustable interatrial shunt with integrated bi-atrial pressure monitoring was successfully implanted in 10 patients with heart failure with 100% procedural success. All patients had their shunt diameters successfully adapted both larger and smaller relative to an initial configuration, with the impact of shunt size on the acute effects of the therapy noted.

"A 'one-size-fits-all' technology may not be an optimal approach for all patients because heart failure is a diverse and evolving condition. The ideal shunting solution would enable adaptive flow rates and provide hemodynamic feedback so that the shunt device could be adjusted to optimize therapy based on the patient's needs, similar to calibrating for optimal medical therapy," shared Gregg W. Stone, MD, FACC, MSCAI, Mount Sinai Heart Health System and Co-Principal Investigator for the ATHENS-HF study. "The Adona interatrial shunt is designed to allow for tailored hemodynamic modulation in response to feedback from the integrated pressure sensors and the patient's changing clinical status, offering promise to a broad patient population."

The ATHENS-HF study enrolled patients with both preserved and reduced ejection fraction heart failure. The majority of patients have reached the 90-day follow-up timepoint following their original procedure, and as planned have undergone successful additional treatments to alter the shunt size several months after the initial implantation. There have been no major procedural complications or site-reported major adverse cardiovascular and neurovascular events (MACNE) in the entire cohort to date. The company anticipates presenting primary endpoint data from ATHENS-HF later this year.

"During the initial cases, I have seen firsthand that the Adona shunt can be safely and reliably deployed, and that the bi-atrial sensors provide important insights into the hemodynamic condition of the patient and the immediate impact of the shunting therapy," said Gagan Singh, MD, MS, Clinical Cardiovascular Research Unit Director, University of California Davis Health, and Clinical Advisor and Proctor for ATHENS-HF. "Additionally, the early clinical experience preliminarily indicates the shunt diameter can be adjusted smaller or larger post-implantation, allowing for treatment tailored to patient-specific needs."

The Adona device features a shunt with an adjustable flow channel size, offering the potential for more individualized treatment compared to current shunt technologies with a single, fixed flow passage geometry. In addition, the Adona device features integrated sensors designed to capture pressure readings from both the left and right atria multiple times per day without requiring patient interaction. These daily readings hold promise to provide physicians with a more complete understanding of a patient's hemodynamic status and could augment shunt therapy by enabling more informed and proactive medical management.

"Completing enrollment in our first-in-human study ahead of schedule marks a pivotal milestone that highlights our team's ability to execute upon our ambitious mission," stated Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. "The strong early results are a clear indicator that we're building a platform that has the potential to transform heart failure management. We are well-positioned for our next phases, with a plan to advance our clinical program with the evaluation of next-generation devices later this year."

About Adona Medical, Inc.
Adona Medical, a privately held portfolio company of Shifamed, LLC, is a clinical stage medical technology company developing next-generation interatrial shunting and remote patient monitoring solutions for patients with advanced heart failure. The Adona shunt is an investigational device and is not approved for use in the U.S. or anywhere in the world. To learn more, please visit www.adonamed.com.

About Shifamed, LLC
Founded by serial entrepreneur Amr Salahieh, Shifamed is a highly specialized medical innovation hub focused on developing solutions that forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

MEDIA CONTACT:
Jennie Kim
SPRIG Consulting, LLC
jennie@sprigconsulting.com

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SOURCE Adona Medical