Bardy

Market position

BardyDx competes in ambulatory cardiac monitoring against Holter systems, other extended-wear ECG patches such as the Zio patch, and mobile cardiac telemetry, and positions itself on atrial signal clarity, publishing head-to-head comparative studies against each of those modalities. It has described the CAM as the industry's only P-wave centric ambulatory cardiac patch monitor.

The stated differentiator is preservation of the P-wave and overall ECG signal clarity, in contrast to conventional ECG engineering that the founder characterizes as over-processing the heart's electrical signal. Additional differentiators cited are the lightweight, wire-free, chest-centered hourglass patch design intended to support compliance including in pediatric patients, human technician-based analysis rather than purely algorithmic interpretation, and a proprietary full-disclosure report format delivered in under 48 hours on average.

Technology

The CAM Patch is a non-invasive, single-channel, sternally placed ECG patch monitor built around what the company terms P-wave centric recording: rather than heavily processing the ECG signal, the design aims to preserve atrial signal quality so that P-waves remain visible for arrhythmia interpretation. The hourglass-shaped, adhesive form factor is intended for comfort and compliance in adults and children over 10 kg. Data is uploaded via BDx download software to a cloud portal (BDxCONNECT), where human ECG technicians analyze recordings and generate the multi-view CAM Report. The company has also pursued development programs in augmented intelligence and visualization technologies.

Go-to-market

The company sells through a direct sales organization, with website request-a-demo and sales inquiry forms, provider-facing clinical study and reimbursement resources, and patient support hotlines. It expanded its sales force and monitoring services using Series B proceeds. Awards from SXSW's Impact Pediatric Health Competition, the Children's National Health System Pediatric Medical Device Innovation Competition and the Fierce Innovation Life Sciences Awards have been used as third-party validation.

Cardiologists, electrophysiologists and other healthcare professionals, hospital and clinic EP labs and institutions ordering ambulatory ECG monitoring, and the patients they prescribe monitors to, including adults and children weighing more than 10 kg.

Geography

United States. Corporate offices are at 220 120th Avenue NE, Suite 100, Bellevue, Washington, with BDx Solutions locations in Houston, Texas; New Providence, New Jersey; and Milpitas, California. The company was headquartered in Seattle at the time of its 2019 Series B, and provides patient materials in English and Spanish.

History

Founded in 2013 in the Seattle area, the company commercialized the Carnation Ambulatory Monitor and built out the BDxCONNECT portal and CAM Report analysis service. Comparative clinical studies were published in the American Heart Journal in 2017 and 2019 and in Heart Rhythm O2 in 2021. It received industry and pediatric device innovation awards in 2018 and 2019 and raised a $35.5 million Series B in April 2019 led by River Cities Capital Funds. The company's current web presence identifies BardyDx, Bardy Diagnostics and CAM as trademarks of Baxter International Inc. or its subsidiaries and directs careers and corporate information to Baxter.

Risks & controversies

The CAM Patch is a prescription-only regulated medical device, so its commercialization depends on regulatory clearance conditions, adherence to labeled instructions for use, and coding and reimbursement policies for ambulatory ECG monitoring. The company operates in a category with established competing modalities including Holter monitors, other ECG patches and mobile cardiac telemetry.