The Los Angeles medical device startup is developing a wrist-worn system designed to reduce recurring heart rhythm problems after catheter ablation.
StimCardio Medical has closed an oversubscribed $30 million Series A led by Metis MedTech, the family office of medical technology entrepreneur John Slump.
The financing, announced October 29, includes participation from Catalyst Health Ventures, strategic corporate investors and other new and existing backers.
The Los Angeles-based company is developing Rhyvive, an investigational wearable designed to deliver non-invasive neuromodulation therapy to patients with atrial fibrillation.
Unlike conventional smartwatches that primarily detect irregular heart rhythms, StimCardio is developing technology intended to influence the physiological mechanisms involved in those rhythms.
The financing will support a pivotal clinical study and preparations for a regulatory submission to the US Food and Drug Administration.
A Wearable Designed to Deliver Therapy
Atrial fibrillation is one of the most common cardiac rhythm disorders, affecting millions of people worldwide.
Patients can experience irregular heartbeats and face elevated risks of complications, including stroke.
Catheter ablation is an established treatment, but recurrence after the procedure remains a significant clinical challenge.
StimCardio is developing Rhyvive as a complementary treatment.
The wrist-worn device combines physiological monitoring with electrical stimulation of the median nerve, aiming to influence pathways in the autonomic nervous system associated with cardiac rhythm regulation.
Its intended advantage is allowing treatment to continue outside the hospital, potentially extending therapy into patients' everyday lives.
The product is not intended to replace catheter ablation or existing treatments.
Early Clinical Results
StimCardio has conducted a randomized, double-blind, sham-controlled pilot study called NeuroPulse.
The study evaluated non-invasive median nerve stimulation in patients following catheter ablation.
According to results disclosed by the company, 90% of patients receiving active stimulation were free from atrial arrhythmias at six months after a 60-day blanking period, compared with 80.8% in the sham group.
These are preliminary clinical findings, not proof that the technology will produce the same results in larger patient populations.
The company plans to conduct NeuroPulse 2, a pivotal clinical study intended to generate further evidence of safety and efficacy.
StimCardio is also preparing for a potential FDA De Novo submission.
Rhyvive remains investigational and has not received FDA clearance or marketing authorization.
Building a New Category of Medical Devices
StimCardio was founded by Amos Ziv, who serves as chief scientific officer, and Tsahi Holand, its chief technology officer.
The company is led by CEO Amir Soltanianzadeh, who previously founded medical device startup Spine Align before moving into healthcare venture investing.
Its approach combines biomedical engineering, physiological monitoring and neuromodulation.
That combination could potentially open a new category of wearable therapeutic devices, but clinical adoption will depend on evidence beyond early feasibility studies.
The Commercial Challenge
StimCardio will need to demonstrate that Rhyvive provides meaningful clinical benefits, secure regulatory authorization and establish how physicians and healthcare providers would adopt the device.
Reimbursement and patient adherence could also become important commercial challenges.
Unlike consumer wearables, a medical therapy requires clinical validation and a clear regulatory pathway before broad commercialization.
The $30 million financing will help StimCardio advance that process.
Its next major milestone is not commercial scale or revenue growth, but a pivotal trial capable of determining whether non-invasive neuromodulation can reliably improve outcomes for patients with atrial fibrillation.
Sources: PR Newswire · Clinical research · Team