Rhythio Medical Wins FDA Breakthrough Nod for Injectable Electrode Tech

Rhythio Medical, a company pioneering injectable bioelectronic therapies, has earned U.S. Food and Drug Administration breakthrough device status for its Injectable Electrode System.

The breakthrough nod recognizes Rhythio’s technology as a possible solution to transform cardiac rhythm management with painless, imperceptible defibrillation and pacing through a minimally invasive approach.

The company’s Injectable Electrode Gel, unlike metal leads or shocking coils, is itself the electrode. It’s a soft, conductive hydrogel that can be administered with a needle directly into the target tissue. Once injected, the gel forms a stable electrical interface that integrates with existing implantable cardioverter defibrillators (ICDs) and pacemakers, converting high-voltage shocks into gentle, patient-friendly therapies.

“This Breakthrough Device Designation highlights the FDA’s recognition of our technology’s potential to redefine how lifesaving cardiac therapies are delivered,” said Rhythio founder and CEO, Allison Post, Ph.D. “For decades, defibrillation has been synonymous with pain. Rhythio’s injectable system is designed to make these therapies imperceptible—transforming the patient experience and expanding access to treatment.”

Dr. Mehdi Razavi, clinical co-founder of Rhythio Medical and Director of Electrophysiology Clinical Research and Innovations at the Texas Heart Institute said its team’s expertise in bioelectronics, materials science, and electrophysiology made it possible to fundamentally reimagine what defibrillation can feel like.

“For the first time, we have the potential to deliver life-saving defibrillation and pacing that patients don’t have to fear,” said Dr. Razavi. “Traditional shocks can be painful and traumatic, sometimes so much so that patients delay or disable therapy. Rhythio’s technology is designed to eliminate that barrier, creating a new standard of care that is both effective and humane. Our goal is to restore rhythm without pain, and to transform the patient experience from one of fear to one of confidence.”

Dr. Elizabeth Cosgriff-Hernandez, co-founder of Rhythio Medical emphasized the company’s materials-driven foundation. She said transforming a cardiac vein into a flexible hydrogel electrode allows electrical stimulation with depth and precision beyond current pacing technologies, directly targeting the source of the heart’s electrical dysfunction.

“Achieving this required the design of a hydrogel electrode with an unprecedented combination of conductivity, safety, durability, and minimally invasive delivery,” Dr. Cosgriff-Hernandez said. This breakthrough establishes a new paradigm for bioelectronic therapies that merge advanced materials with cardiac rhythm management.”

The company is currently advancing preclinical development in collaboration with leading academic and clinical partners and preparing for first-in-human studies.