Many cardiac arrhythmias are episodic and only detectable after continuously monitoring the heart’s rhythm for several days or weeks. In particular, atrial arrhythmias can be a diagnostic challenge due to the difficulty in clearly visualizing the P wave on an ECG. The two main monitoring options are either Holter monitors, which capture high-quality signals but are highly uncomfortable, or patch monitors, which can be worn more comfortably but that provide a lower-quality signal.
Bardy Diagnostics hopes to bridge the gap. The company’s Carnation Ambulatory Monitor (CAM) Patch is a non-invasive, ambulatory cardiac monitor and arrhythmia detection device that can record every heart beat for up to 14 days. The device is worn over the sternum, creating an aVF-like lead optimized to capture the P-wave and the QRS complex. The device’s accuracy has been demonstrated in multiple clinical studies published in the American Heart Journal.
We asked Ken Nelson, Chief Commercial Officer, more about BardyDx and what significance it has for arrhythmia detection.
Cici Zhou, Medgadget: Tell me about the founding of BardyDx. What was the inspiration behind the idea and the focus on P-wave specificity?
Ken Nelson: Lorene Faye Bardy was the beloved late wife of founder Dr. Gust Bardy; she had a rare heart rhythm disorder lasting for about 27 years. She wore ten external and two implantable cardiac monitors but none of them could specifically identify her rhythm disorder. The technology that was available at the time simply wasn’t sensitive enough. She was seen by world-renowned electrophysiologists, and none of them were able to record and visualize her P wave (the part of the ECG that relates to the electrical activity of the atrium) so doctors couldn’t identify what type of specific arrhythmia she had.
Unfortunately, Lorene passed away at the age of 52. One year to the day of her death, Bardy Diagnostics was founded with the single vision of enabling the highest fidelity rhythm strips with the most diagnostically-accurate and patient-friendly cardiac monitors in the industry.
Medgadget: Is CAM covered by most insurances? Are there any current barriers to patient use?
Nelson: Cardiac monitoring is already done routinely in patient care and, as a result, there is already established reimbursement for this type of diagnostics. The CAM Patch is covered by a majority of commercial payors, with the exception of Medicaid, which only covers the 48-Hour CAM Patch.
Medgadget: At what stage is the company today?
Nelson: We are a commercial stage company with over 150+ employees, and proud to be the fastest growing company in the cardiac monitoring space. Our corporate headquarters is located in Seattle, WA, with monitoring centers in Houston, TX and New Providence, NJ. In addition to having FDA 510K clearance for our 48-Hour, 7-Day and 14-Day CAM products here in the US, we also have Health Canada clearance for the 7- and 14-Day patches, and CE Mark for the 48-Hour and 7-Day patches for Europe.
Medgadget: What are some of the biggest challenges facing the team?
Nelson: BardyDx’s biggest challenge is continuing to scale the company to meet the increasing demand of cardiac monitoring using the CAM Patch. The industry-leading technology, coupled with the drastic improvements to patient compliance, has greatly accelerated the adoption of the product.
Medgadget: Looking to the next five years, what are the biggest goals for BardyDx?
Nelson: Become the standard of care in cardiac monitoring and expand our portfolio of the most diagnostically-accurate cardiac and vital signs monitors on the market.
Product page: Carnation Ambulatory Monitor