Adona Medical Initiates First-In-Human Study With Its Novel Interatrial Shunt for Patients With Heart Failure

• Initial cases conducted in the Republic of Georgia with support from leading U.S. cardiologists
   
• Adjustable interatrial shunt with integrated bi-atrial pressure monitoring aims to deliver a more personalized lifetime approach to heart failure management

Adona Medical News

LOS GATOS, Calif. -- Adona Medical, a Shifamed portfolio company that aims to deliver advanced solutions for heart failure, announced the successful first-in-human use of its novel interatrial shunt in patients with heart failure. The initial cases were performed by George Khabeishvili, MD, at Tbilisi Heart and Vascular Clinic in the Republic of Georgia, and supported by US heart failure experts Gagan Singh, MD, MS, and Edris Aman, MD.

The initial cases of Adona Medical's adjustable interatrial shunt for heart failure were conducted in the Republic of Georgia led by Dr. George Khabeishvili and supported by US experts Dr. Gagan Singh, Dr. Edris Aman and the Adona Medical team.

"I am incredibly excited to be involved in the initial procedures for this groundbreaking technology. The Adona implant represents the next-generation of shunt technology, designed for dynamic interatrial flow that can be modified based on patient-specific hemodynamic needs," said Dr. Singh, Clinical Cardiovascular Research Unit Director, University of California at Davis. "Heart failure is not a static condition but requires lifetime management. The combination of adjustable shunt size and atrial pressure measurement represents a huge leap forward in device therapy solutions."

The Adona device includes a shunt that features a flow channel with an adjustable geometry that can be made larger or smaller post-implantation via the use of a proprietary induction catheter. This configurability holds the potential for more individualized treatments compared to current shunt technologies which feature a flow passage with one fixed 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 medical management.

"Success with the initial clinical cases represents a significant milestone in our mission to offer improved solutions for the management of heart failure. We're now one step closer to validating the potential benefits that the Adona technologies may offer to a vulnerable and suffering patient population," said Brian Fahey, Co-Founder and Chief Executive Officer of Adona Medical. "This was an enormous team effort, and I'd like to thank all of the Adona employees for their many contributions and our clinical collaborators for providing the valuable insights that have guided our incredible journey." 

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.

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