The company’s atrial fibrillation product impacts the diagnosis and treatment of atrial fibrillation (AF). This condition is significantly under-diagnosed and when left undetected can lead to significant increased risks of stroke and cardiovascular disease. The Company’s AF Patch product will be inexpensive (COGS less than $20/unit) and easy to use. Current technologies are cumbersome for the patient, and expensive both because of the hardware used and the need for trained technician overview. The earlier detection and treatment will also reduce the expensive costs associated with acute care of strokes and cardio vascular disease resulting from untreated patients. The licensed, proprietary algorithms used by the company allow automated screening with accuracy equivalent to that of trained technicians. Cardiac Insight was founded in 2008. In June 2010, angel investors provide an initial funding investment of $200,000 combined with an executed a technology license with the University of Washington for an atrial fibrillation detection algorithm. An additional $1.2M has been raised from private investors and $235,000 of previous development has come from grants/gifts (WRF, CAC, STTR). The company received FDA 510(k) clearance for its ECG patch device (record only, 24 hours) in May, 2013. Additional capital will be used to develop the commercial version of the atrial fibrillation product and pursue strategies for the development of two additional markets.
The simple Patch type product can improve the diagnosis and treatment of atrial fibrillation. The product utilizes a highly accurate algorithm with 100% sensitivity. The device is designed for low power, battery operated applications and can be wearable for up to 7 days. The device will allow data to be directly downloaded with automatic report generation in a physician’s office; eliminating the need to send the device to a third-party service center that is standard practice today. In conjunction with a partner, the Company will also develop a 48-hour sleep apnea screening device similar in form factor to the atrial fibrillation device. Finally, the Company will license its implantable algorithm to reduce inappropriate shocks from ICD devices.