HEART TRONICS INC.

HEART TRONICS INC.

Previous company name
SIGNALIFE, INC.
Name change date
6/10/2009
Company Overview
Signalife Inc., with headquarters located at Greenville, California, is engaged in the research, development, and marketing of medical devices in the United States. The company was incorporated in January 1987 and is formerly known as Recom Managed Systems. The company is publicly traded on the American Stock Exchange under the ticker symbol . Signalife Inc. is a subsidiary of ARC Finance Group, LLC, an investment and financial advisory firm.
Signalife Inc. offers Fidelity 100 Monitor System, Fidelity 200 Event Recording System, Cardiac Vest and Intracardiac Monitor. The Fidelity 100 Monitor System is a 12-lead heart monitoring system which includes a patient module that wirelessly transmits the electrocardiogram (ECG) to a data collection device (such as laptop). Fidelity 100 offers signal yields accuracy that allows improved physician interpretation, stable baseline, and greater accuracy of the ECG measurements for physician interpretation. It also offers the physician the unique ability to monitor a patient in real time, mark events of interest, and perform further evaluation. The Fidelity 200 Event Recording System is a non-prescription over-the-counter event recording system. Cardiac Vest is a lightweight, close-fitting vest or undergarment made of stretchable material in which the electrodes are stitched into the fabric. Intracardiac Monitor applies its proprietary physiological signal acquisition and amplification technology to read intracardiac signals procured from intracardiac catheter products.
Signalife aims to improve and extend the lives of all people through the revolutionary signal processing technology incorporated in its medical device products. The company markets its product at Laurel Canyon, California, USA.
Business Summary
Heart Tronics Inc, formerly Signalife Inc., is a medical device company engaged in the research, development and marketing of medical devices that monitor and measure physiological signals, intended to detect diseases that affect an individual’s health. The Company’s initial product, the Signalife Fidelity 100 Monitor System or (Fidelity 100), is a heart monitoring system that uses Signalife’s own signal acquisition technology to obtain, amplify and process physiological signals associated with a patient’s cardiovascular system. The Fidelity 100 is approved by the United States Food and Drug Administration (FDA), and can be used for resting, ambulatory and stress testing, as well as monitoring during surgical procedures and 911 transportation. The Company also has several products in the development stage that operate using the same signal acquisition technology employed in the Fidelity 100.
Description and history
Heart Tronics Inc, formerly Signalife Inc., incorporated on January 19, 1987, is a medical device company engaged in the research, development and marketing of medical devices that monitor and measure physiological signals, intended to detect diseases that affect an individual’s health. The Company’s initial product, the Signalife Fidelity 100 Monitor System or (Fidelity 100), is a heart monitoring system that uses Signalife’s own signal acquisition technology to obtain, amplify and process physiological signals associated with a patient’s cardiovascular system. The Fidelity 100 is approved by the United States Food and Drug Administration (FDA), and can be used for resting, ambulatory and stress testing, as well as monitoring during surgical procedures and 911 transportation. The Company also has several products in the development stage that operate using the same signal acquisition technology employed in the Fidelity 100. In February 2008, the Company announced that it has established a division focused on developing, acquiring and/or testing therapies capable of treating cardiovascular disease.

Fidelity 100 Monitor System

The Fidelity 100 is marketed as an integrated system containing three components: the Model 100 Patient Module, electrode lead sets, and a laptop computer that operates using the Company’s own software. This product has received FDA clearance as a class II medical device. In operation, the Model 100 Patient Module collects, processes and amplifies electrocardiogram (ECG) signals from that patient through a set of 10 electrodes that are certified to work with the system. This signal data is then wirelessly transmitted to the laptop computer using Bluetooth technology. The signals are then displayed on the computer’s monitor. These results can also be stored or printed for later or further analysis by the cardiologist.

The Model 100 Patient Module is the core component of the system. It is a digital battery-powered compact device (approximately 4 x 3.5 x 1.5 inches in size and 5.5 ounces in weight) that allows a patient’s heart to be continuously monitored over a period of 24 to 48 hours. The Model 100 Patient Module contains both the Company’s own patented amplification technology, which acquires, processes and amplifies ECG signals; and Bluetooth technology that allows the obtained signals to be wirelessly transmitted to the laptop computer. The Model 100 Patient Module complies with all applicable performance, safety, environmental and regulatory standards. The device also complies with ANSI/AAMI EC-11 and EC-13 ECG standards to the extent they relate to non-diagnostic features and alarm functions for stationary (non-ambulatory) ECG devices.

Products in Development

The Signalife Fidelity 200 Event Recording System (Fidelity 200), which the Company refers to as the Signalife Heart Tempo Card, is a flexible credit card-sized direct-to-consumer non-prescription heart monitoring device that is intended to be used as an early-detection device by patients who desire to independently monitor their condition. The Fidelity 200 utilizes the physiological signal acquisition and amplification technology used in the Model 100 Patient Module. The system has received FDA 510(k) clearance as a class II medical device, and is in the final stage of development. The Fidelity 200 is anticipated to be sold to consumers either through retail outlets, such as drug stores, retail pharmacies, and major retail discount chains, or, in selected cases, through monitoring centers.

The Signalife Fidelity 350 Holder Monitor (Fidelity 350) is a pager-sized, two or three channel ambulatory Holter monitor that can be used to collect ECG data relating to arrhythmia and other transient heart disease while the patient carries out his or her daily activities away from the physicians’ office or hospital. The Fidelity 350 will allow up to 30 days of data to be recorded, satisfying physician needs for a more extensive database. The Fidelity 350 utilizes the Company’s own physiological signal acquisition and amplification technology used in the Model 100 Patient Module. The data collected by the Fidelity 350 is acquired, processed, amplified and stored in a computer storage chip incorporated in the system. Signalife is in the process of filing for FDA 510(k) clearance as a class II medical device for the Fidelity 350 Holter Monitor.

The Signalife Fidelity 400 Intracardiac Monitor (Fidelity 400) applies the Company’s own physiological signal acquisition and amplification technology to read intracardiac signals procured from intracardiac catheter. Signalife developed and tested a prototype version of this product at the Electrophysiology Laboratories at the Cleveland Clinic Heart Center. The Company is in the process of planning a series of clinical studies through the Cleveland Clinic for the purposes of procuring FDA 510(k) clearance of the proto-type as a class II medical device. Signalife is also designing, engineering and fabricating a prototype version of this product.

The Signalife Cardiac Vest is a lightweight, close-fitting vest or undergarment made of stretchable material in which the electrodes are stitched into the fabric. The design is planned to allow a patient to use the vest on a around-the-clock basis for extended periods of time, being removed only intermittently for showers, and the like. The purpose of the Cardiac Vest is to facilitate longer-term monitoring in ambulatory settings with either the Signalife Fidelity 100 monitor or the Signalife Fidelity 350 Holter Monitor. The Company is designing, engineering and fabricating a production version of the Signalife Cardiac Vest.

The Fidelity 1000 Module is being developed for the dual purpose of providing a data base to compare the Company’s signal quality to that of its competitors, and the longer-term objective of offering a product as a front end and add-on, which will enable Signalife competitor’s access to the Company’s front end technology and other heart monitoring devices to meet American Heart Association guidelines. The timing to design and engineer a production model and the evaluation of the necessity of procuring FDA approval for this product is under review.

The Company competes with GE Healthcare, Royal Philips Electronics, Cardiac Science, Inc., Welch Allyn, Inc., GE Healthcare, Cardiac Science, Inc, Welch Allyn, Inc., Schiller AG, Del Mar Reynolds Medical Ltd., GE Healthcare, Royal Philips Electronics, Cardiac Science, Inc, Mortara Instrument, Inc., Rozinn Electronics, Inc., CardioNet, Inc., Raytel Medical Corporation, Cardiac Telecom, Inc. and Card Guard Instromedix and Lifewatch subsidiaries.

Incorporated formerly known as Recom Managed Systems.

Business Line
Engaged in the research, development, and marketing of medical devices
Subsidiary

Advisor
ELLIOTT DAVIS LLC
IPO date
10/30/1998
US SIC Code
3845
Company Address
Suite 203
4705, Laurel Canyon Boulevard
City province or state postal code
91607, STUDIO CITY, CA
Phone: +1 818 432 4561
Fax: +1 818 432 4567
Country address: UNITED STATES OF AMERICA
Website url: www.signalife.com

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