Tivic Health Systems, Inc. (Nasdaq: TIVC) has unveiled promising new data demonstrating that personalizing non-invasive vagus nerve stimulation (ncVNS) parameters can optimize therapeutic impact on the autonomic nervous system. The findings, presented at the Sixth Bioelectronic Medicine Summit in March, support the company's strategy to develop highly personalized neuromodulation devices for treating inflammatory, cardiac, and neurologic disorders.
The research, conducted in collaboration with The Feinstein Institute of Medicine, revealed that personalized stimulation approaches yield significantly better results than standardized protocols. According to the data, no single stimulation frequency produced universally dominant effects on heart rate variability (HRV), highlighting the necessity for individualized treatment parameters.
"We continue to build a defensible position for our next generation VNS technology," said Blake Gurfein, Tivic's Chief Scientific Officer. "This patent protects key learnings from our VNS optimization study, which is advancing the science of vagus nerve interventions. In fact, we believe we are moving the needle on what will become the state-of-the art treatment approach."
Significant Autonomic Nervous System Effects
The study results showed remarkable improvements in autonomic function. In 60% of participants, raw HRV nearly doubled on average following ncVNS stimulation. Even more impressive, normalized HRV increased 2.67 times post-stimulation, suggesting strong activation of vagal tone and improved autonomic balance.
These findings are particularly significant because HRV is a well-established biomarker of parasympathetic nervous system activity, which plays a crucial role in regulating inflammation and other physiological processes. By demonstrating substantial improvements in this metric, Tivic's approach shows promise for conditions where autonomic dysfunction contributes to disease pathology.
Expanding Intellectual Property Portfolio
To protect its innovations, Tivic Health has filed a new patent application (No. 63,801,058) entitled "Vagus Nerve Stimulation System" with the United States Patent and Trademark Office. This patent expands claims around the company's technology that personalizes stimulation parameters and electrode positioning to enhance efficacy.
Jennifer Ernst, Tivic CEO, emphasized the importance of this intellectual property strategy: "As we continue to advance our VNS program, protecting our proprietary and intellectual property is critical. Tivic's diversified portfolio of bioelectronic VNS and biologic immunotherapies represent a unique breadth of treatments to address health issues where immune system dysregulation is a significant underlying factor."
Advantages Over Current Treatment Options
The company's approach offers several potential advantages over existing vagus nerve stimulation technologies, which often require surgical implantation or deliver inconsistent results. By personalizing stimulation parameters for each patient, Tivic aims to deliver more reliable therapeutic effects in a non-invasive form factor.
This personalization strategy addresses a key limitation of current neuromodulation approaches, which typically apply standardized stimulation protocols across diverse patient populations. The data presented by Tivic suggests that such one-size-fits-all approaches may be suboptimal for many patients.
Broader Therapeutic Portfolio
Tivic Health's vagus nerve stimulation program is part of a diversified therapeutic approach that includes both bioelectronic and biologic treatments. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™, has received Fast Track and Orphan Drug designation from the FDA for treating acute radiation syndrome (ARS).
The company has already achieved commercial success with ClearUP™, an FDA-approved device that treats sinus pain and pressure. This established market presence provides Tivic with revenue while it advances its more ambitious neuromodulation technologies.
Future Directions
The ongoing collaboration with the Feinstein Institute of Bioelectronic Medicine aims to further advance high-precision vagus nerve stimulation in a non-invasive form factor. As research progresses, Tivic Health is positioned to potentially redefine treatment approaches for conditions where immune system dysregulation plays a significant role.
With its expanding intellectual property portfolio and promising clinical data, Tivic Health represents an emerging player in the growing field of bioelectronic medicine, where electrical stimulation of neural circuits is used to modulate physiological processes and treat disease.
