The Venture Codex

Participated · Convertible Note · Dec 2011

CardioInsight Technologies makes a non-invasive cardiac mapping system that fuses body-surface electrode recordings from a wearable vest with anatomical CT images to produce real-time, 3D maps of electrical activity. The device, called ECVUE, received CE Mark clearance in 2011 and has been used on more than 800 patients in Europe. The company says the new financing will allow it to complete ongoing clinical trials in Europe, advance product development programs and pursue regulatory clearance in the U.S. CardioInsight was formed in 2006 using technology from Case Western Reserve University. The company is not yet FDA cleared and a company representative had not provided an update on U.S. commercialization at the time of the article. Competitors in the cardiac mapping space include Boston Scientific, St. Jude Medical and Biosense Webster. CardioInsight Technologies develops the ECVUE™ advanced 3D cardiac mapping system, a non-invasive electrocardiographic mapping technology that generates 3D images of the heart’s electrical activity. The company recently obtained CE Mark certification for the ECVUE system and has completed commercial installations at three European centers: St. Mary’s Hospital (London), the Kerckhoff Clinic (Bad Nauheim) and Hopital Cardiologique du Haut-Leveque (Bordeaux). CardioInsight plans to use new capital to accelerate clinical and commercial efforts and to pursue FDA regulatory clearance. Management, led by CEO Steve Arless, is focused on demonstrating ECVUE’s value for routine arrhythmia mapping and in Cardiac Resynchronization Therapy (CRT). The company is based in Cleveland, Ohio and has begun limited commercial deployment in Europe. CardioInsight develops the ECVUE electrocardiographic mapping system, which uses an electrode vest plus CT images and software to produce 3-D, beat-by-beat maps of cardiac electrical activity. The technology is noninvasive and intended to help diagnose and guide treatment of electrical abnormalities such as arrhythmia and heart failure. The company recently received the CE Mark and said it secured first customers in England, France and Germany, and is actively fundraising to support its European launch. Regulatory filings show recent financings, indicating activity on both equity and convertible-debt fronts. The filings include $1.6 million raised in convertible debt from 14 investors since May and $7.5 million in equity raised since January 2010. CardioInsight is Cleveland-based and counts Draper Triangle Ventures, JumpStart and Case Western Reserve’s technology-transfer office among its investors. CardioInsight’s core product is an electrocardiographic mapping system that gathers electrical data from an electrode “vest” and combines it with CT images to produce beat‑by‑beat, whole‑heart 3‑D maps. The system comprises a sensor array and software to collect, analyze and integrate electrical signals with imaging to aid diagnosis and treatment of arrhythmia and other electrical abnormalities. The company planned a European launch in June 2011, a U.S. launch later in 2011, and expects a Japanese launch no earlier than 2012, subject to regulatory clearances such as a U.S. FDA 510(k). CardioInsight said it will expand hiring in anticipation of commercialization; it currently employs about 20–25 people, primarily in clinical and R&D roles, and plans to hire sales, marketing and operations staff. Financially, the company disclosed roughly $10M raised last year—including a $6M Series B in February—plus about $4M in additional funding disclosed in this article, and has raised about $12M since its 2006 founding. Investors to date include Draper Triangle (DFJ’s Pittsburgh office), JumpStart Inc., and Case Western Reserve University’s technology transfer office; the new funding includes Tokyo‑based distributor DVx and a $1M Third Frontier grant from Ohio. CardioInsight makes a blanket-like array of noninvasive sensors plus software that collects data, analyzes it and produces detailed 3-D images of cardiac electrical activity. The system is intended to help diagnose and guide treatment of electrical heart abnormalities such as arrhythmia and heart failure. The company says its technology originates from two decades of research by former Case Western Reserve researcher Yoram Rudy and was spun out in 2006. CardioInsight’s system was initially developed and tested by Charu Ramanathan and Ping Jia, and has been evaluated in animal studies and more than 75 human studies. The Cleveland company employs about 14 people and is led by chairman and CEO Steven G. Arless. Per a regulatory filing, CardioInsight has raised $5.7M in an ongoing funding round and says it hopes to raise more before the round closes; the company declined to disclose how the funds will be used until the round is closed.