Advanced Cardiac Therapeutics Completes Successful First in Man

SANTA CLARA, Calif., Jan. 25, 2016 /PRNewswire/ -- Advanced Cardiac Therapeutics, Inc. ("ACT"), a developer and manufacturer of a proprietary and unique open-irrigated radio frequency ("RF") ablation technology, announced today that its technology has been successfully used to treat 12 patients suffering from Atrial Fibrillation ("AFIB") in Prague, Czech Republic.  The ACT first-in-man study was designed to evaluate the safety and effectiveness of the ACT system.  The patients were treated by the study's principal investigator, Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital.

According to Dr. Reddy, "What is truly extraordinary about the ACT technology is its ability to leverage temperature sensing to ablate efficiently, with ablation times that are reduced by over 50%. This technology provides a level of feedback to the operator that is greater than anything currently on the market and, accordingly, the system has the potential to change the way electrophysiologists perform RF ablation for a host of arrhythmias, including AFIB."

ACT's CEO, Duke Rohlen, commented, "The ACT system that was successfully used in humans last week validated its potential to completely redefine open-irrigated RF ablation technology."  The ACT technology combines a state of the art generator with a novel temperature-sensing, low flow catheter that incorporates multiple sensors into a diamond heat shunting, high resolution tip configuration.  The technology is the first in the world to combine and leverage four unique capabilities:

• A temperature controlled open-irrigated ablation capability that controls RF power delivery. The ability to control RF delivery allows an electrophysiologist achieve and maintain therapeutic tissue temperature targets for a wide clinical range of contact force values;
• A combination of (1) low, yet clinically effective, irrigation flow rates, and (2) an internal diamond network, provide heat shunting capabilities to keep the electrode-tissue interface within a safe range of temperatures;
• A contact indicator technology that computes and displays the magnitude of the tip electrode coupling to the tissue in the RF frequency spectrum, independent of the contact force; and
• A high-resolution electrogram ("EGM") recording and pacing capability of the tip electrode, which enables discreet localized cardiac-signal recording to differentiate tissue types, substrate morphologies, and guide lesion formation via localized EGM amplitude attenuation.

The ACT first-in-man experience demonstrated that these four system features work in harmony to optimally control lesion formation, reduce ablation times and reduce infused fluid volumes.  For the 12 patients, the safety end points were met and 100% acute success was achieved.  In addition, the average "RF-on-time" per patient was 24 minutes and 49 seconds, the average ablation application duration was 17.1 seconds and, on average, these patients received only 406 ml of irrigation fluid during the entire Pulmonary Vein Isolation procedure.

About Advanced Cardiac Therapeutics, Inc.
Advanced Cardiac Therapeutics, Inc. is a pre-commercial, medical device company that designs and manufactures a catheter-based system for the treatment of patients with AFIB.  AFIB is characterized by an irregular, often rapid heart rate that commonly causes poor systemic blood flow. The Company's mission is to dramatically improve the treatment of AFIB through the introduction of products based on its proprietary catheter and generator system.  ACT's technology is the only system in the world to leverage feedback from four unique capabilities:  temperature sensing, low irrigation flow rates, high resolution EGM attenuation and contact sensing.  The ACT system is not currently approved for commercial use.  For more information, please contact Whitney Gilmour at wgilmour@actmed.net. www.actmed.net