Rhythio Medical’s soft, conductive hydrogel technology transforms traditional defibrillation into a new class of injectable bioelectronic therapy

Rhythio Medical, a medical device company pioneering injectable bioelectronic therapies, today announced that its Injectable Electrode System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation recognizes the potential of Rhythio’s technology to transform cardiac rhythm management by enabling painless, imperceptible defibrillation and pacing through a minimally invasive approach.

Unlike traditional metal leads or shocking coils, Rhythio’s proprietary Injectable Electrode Gel is itself the electrode—a soft, conductive hydrogel that can be delivered through a needle directly to the target tissue. Once injected, the gel forms a stable electrical interface that integrates seamlessly with existing implantable cardioverter defibrillators (ICDs) and pacemakers, converting conventional 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 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.”

“Our team’s interdisciplinary expertise in bioelectronics, materials science, and electrophysiology has made it possible to fundamentally reimagine what defibrillation can feel like,” said Dr. Mehdi Razavi, Clinical Co-Founder of Rhythio Medical and Director of Electrophysiology Clinical Research and Innovations at the Texas Heart Institute. “For the first time, we have the potential to deliver life-saving defibrillation and pacing that patients don’t have to fear. 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.”

The FDA’s Breakthrough Devices Program is designed to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. This designation grants Rhythio prioritized FDA engagement and review, enabling more efficient clinical and regulatory collaboration.

As a leader in biomaterials innovation, Dr. Elizabeth Cosgriff-Hernandez, Co-Founder of Rhythio Medical, emphasized the materials-driven foundation of the company’s approach. “The ability to transform a cardiac vein into a flexible hydrogel electrode enables electrical stimulation with a depth and precision far beyond current pacing technologies, directly targeting the source of electrical dysfunction in the heart,” said Dr. Cosgriff-Hernandez. “Achieving this required the design of a hydrogel electrode with an unprecedented combination of conductivity, safety, durability, and minimally invasive delivery. This breakthrough establishes a new paradigm for bioelectronic therapies that merge advanced materials with cardiac rhythm management.”

Rhythio Medical is advancing preclinical development of its Injectable Electrode System in collaboration with leading academic and clinical partners and is preparing for first-in-human studies.

About Rhythio Medical

Rhythio Medical is an early-stage medical device company developing next-generation injectable bioelectronic therapies to improve patient outcomes in cardiac rhythm management. Its patented Injectable Electrode Gel seamlessly interfaces with current implantable cardiac devices to enable painless defibrillation and pacing. Recognized by the U.S. FDA with Breakthrough Device Designation, Rhythio is accelerating development and clinical translation to deliver safer, more tolerable cardiac care.

https://www.rhythiomedical.com/

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