Pairing intelligent, “clinically aware” expert algorithms that automate medical decision-support analytics with unobtrusive but sophisticated body-worn biosensors can lower the costs and complexity of cardiac rhythm diagnosis and enable exciting new telehealth capabilities for clinicians and their patients. The added challenge with this game-changing technology, however, is to keep data access and patient care squarely in the hands of medical professionals and healthcare institutions, as opposed to third-party service companies that may seek to monetize collected biometric data. One company, Cardiac Insight, is uniquely at the forefront of driving clinician-centric solutions -- disrupting what is currently an outsourced, service-based ECG data industry but no longer needs to be.
Cardiac Insight, a leading US digital healthcare innovation company based in Bellevue, WA, has developed medical-grade, body-worn sensor technology and automated cardiac analysis solutions through its propriety algorithms and software platforms. Each of Cardiac Insight’s highly differentiated products addresses the growing global market demand for accurate, high throughput cardiac arrhythmia diagnosis. These abnormal rhythms include Atrial Fibrillation, a cardiac arrhythmia that is more common in older populations that can significantly increase the risks of stroke, heart failure and mortality, as well as a spectrum of cardiac rhythm disorders that can lead to Sudden Cardiac Death (SCD), particularly in young athletes.
Cardiac Insight’s flagship product, the Cardea SOLO System™ is a single-use, wearable ECG Sensor paired with the company’s proprietary PC-based automated software analysis system. Cardea SOLO Analysis Software operates on Windows® based PCs that are commonly used in medical settings. Cardea SOLO is the only FDA-cleared, 7-day ambulatory ECG monitoring system that enables clinicians to perform complete, automated ECG analysis of over 15 significant cardiac arrhythmias, including Atrial Fibrillation, right in the office or clinic setting, producing a draft analysis and report ready for physician review at the point of care in only five minutes.
As a clinician “self-serve” solution, by using Cardea SOLO, physicians have immediate access to, and ownership of all ECG data. Contrast this to the lost finances, time and workflow disruption of what is currently often done today – outsourcing long-term ECG monitoring to ECG service-centers. The lightweight and unobtrusive Cardea SOLO Sensor design allows patients to wear the SOLO Sensor comfortably for just over a week while going about their usual activities, including brief showers and moderate exercise. Studies have shown that longer ECG recording duration can result in a 25% higher diagnostic yield than traditional wired Holter ECG monitors that are typically worn only 1-2 days. Further, Cardea SOLO advanced analysis software produces comprehensive test reports immediately, making available to clinicians a concise summary as well as every recorded ECG beat. Medical teams and their patients no longer need to wait weeks or even months to determine test results and initiate the patient’s treatment plan.
“We seek to do more than incrementally improve cardiac detection to enable faster time-to-treatment, ” Mr Brad Harlow, Cardiac Insight CEO said. “We bring to market complete and novel solutions that address challenging unmet needs.”
The ingenious solutions developed by Cardiac Insight focus on achieving early detection to reduce or avoid potentially devastating cardiac and vascular events that are the complications of common and growing heart rate and rhythm disorders worldwide, including increased risks of stroke, heart failure and SCD (Sudden Cardiac Death).
The Cardea 20/20 ECG System is the only diagnostic 12-lead ECG system designed to identify cardiac conditions associated with the leading medical cause of death in athletic youth: sudden cardiac arrest or SCA. Traditional ECG interpretation systems, when used on athletes and youth for routine heart screenings, can produce false positive rates as high as 25%, whereas the Cardea 20/20 ECG algorithm has lowered this figure to less than 2%.
“The tragic occurrence of sudden cardiac death in our athletic and high school-aged youth can be reduced, and even prevented, with the use of our purposefully designed technology as part of a comprehensive athlete health physical exam that includes ECG screening,” Mr Harlow said. “It is one of Cardiac Insight’s greatest developments to help address this unmet need in our communities, supported by tireless athlete healthcare advocates, volunteer organizations and dedicated medical professionals.”
As with all technology, success relies on innovators remaining flexible and adapting to the current climate. The Cardiac Insight team is continuously identifying ways to improve.
“There are well over 30 million people affected by serious cardiac rhythm disorders such as Atrial Fibrillation worldwide,” Mr Harlow said. “That number is constantly growing and is expected to triple by 2050. Medical teams no longer have the time to rely on third parties to read long-term ECG results. With Cardea SOLO™, clinicians can obtain in-office analysis and get to a diagnosis quickly and in a cost-effective manner.”
Cardiac Insight is a post-revenue company led by an experienced team of industry leaders, boasting a robust product pipeline with multiple channel partners and multiple exit pathways. Cardiac Insight has raised $35M raised to-date and is currently involved in a Series D-1 financing round to support further growth. Fueled by its ongoing recurring Cardea SOLO Sensor sales model, its growing customer base and positive clinical pathway, Cardiac Insight is expanding its global salesforce and marketing reach. The team aims to accelerate research and development to leverage more growth opportunities in adjacent and international markets.