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EP MedSystems, Inc. (NASDAQ (SC): EPMD)
75 Route 73 North, Bldg. D
West Berlin, NJ 08091
EP MedSystems, Inc., incorporated in January 1993, develops, manufactures and markets a line of products for the cardiac electrophysiology market used to diagnose, monitor and treat irregular heartbeats known as arrhythmias. The Company's product offerings include the EP-WorkMate electrophysiology work station; the EP-3 Stimulator; diagnostic electrophysiology catheters; the ALERT System, including the ALERT Companion and ALERT internal cardioversion catheters, and the ViewMate intracardiac ultrasound catheter system and related disposable supplies, including its one-piece catheter. Its leading product is the EP-WorkMate, a computerized electrophysiology workstation that monitors, displays and stores cardiac electrical activity and arrhythmia data.
EP-WorkMate and EP-3 Stimulator
The EP-WorkMate offers, among other features, display and storage of up to 192 intracardiac signals; real-time analysis, including graphical and quantitative display of such data; a single keyboard for all operations, and integration capacity with the Company's own proprietary products, such as the EP-3 Stimulator, and other technologies and systems. The EP-WorkMate consists of a Dual Pentium III processor with integral proprietary software, a proprietary signal-conditioning unit, two or three 21-inch high-resolution color monitors, an optical disk drive for data storage, a custom keyboard, catheter and catheter interface module and a laser printer. In addition, each EP-WorkMate has an internal modem to provide a direct link between the purchaser and EP Med, facilitating field software support. The EP-WorkMate is differentiated from competing products by its seamless integration with the EP-3 Stimulator; its storage capacity of up to 192 intracardiac signals; its ability to process and simultaneously display both real-time and historical electrophysiology activity, and its software based on a menu-driven, point-and-click interface.
The Company's EP-3 Stimulator is a computerized electrical pulse signal generator and processor that, when integrated with the EP-WorkMate, is used to stimulate the heart with electrical impulses in order to locate electrical disturbances or arrhythmias. It features automatic synchronization and rate controls, as well as the same user interface as the EP-WorkMate. The EP-3 Stimulator can be sold as a stand-alone electrophysiology stimulator or it can be integrated with the EP-WorkMate. During 2002, the EP-WorkMate and EP-3 Stimulator accounted for approximately 81% of the Company's total sales revenues.
ALERT System
On November 27, 2002, the Company received Pre-Market Approval from the United States Food and Drug Administration (FDA) to sell the ALERT System in the United States. The ALERT System was developed in an effort to provide a more effective and less traumatic method of converting atrial fibrillation to normal heart rhythm than traditional therapies, such as drugs and external cardioversion.
The ALERT System represents a new approach to electrical cardioversion known as low-energy internal cardioversion, which uses a patented electrode catheter to deliver measured, variable, low-energy bi-phasic electrical impulses directly to the inside of the heart to convert atrial fibrillation to normal heart rhythm. The ALERT System is comprised of a single-use proprietary electrode catheter with two separate electrode arrays (the ALERT Catheter) and an external energy source (the ALERT Companion).
The advantage of the ALERT System over traditional drug therapies is the elimination of harmful side effects associated with many such drugs. The trauma associated with the high-energy external cardioversion necessitating general anesthesia makes low-energy internal cardioversion a common-sense alternative, assuming similar or better results. The Company's clinical trials of 156 patients demonstrated that the ALERT Systems was effective in 76% of patients, as compared to external cardioversion in only 67% of patients.
Catheter Products
The Company markets a line of diagnostic electrophysiology catheters for stimulation and sensing of electrical signals during electrophysiology studies. Its diagnostic catheters are similar to others sold within the industry, with the exception of the one-piece catheter design, which offers the physician unique recording capabilities. EP MedSystems offers numerous electrode/curve configurations of catheters.
The Company has developed a new electrode manufacturing process using long-length electrodes for cardioversion and ablation procedures. This process, known as SilverFlex, is a patented technology that provides electrode flexibility and a lightweight catheter. Due to development evolution, the product uses platinum instead of silver. It was determined that EP MedSystems would expand capabilities of the catheter to provide diagnostic and therapeutic functionality for use with its ALERT product line. EP MedSystems is collecting clinical data and evaluating the benefits of incorporating SilverFlex technology in its catheters.
Ultrasound Products
EP MedSystems has identified intracardiac ultrasound imaging as a necessary adjunct to the advanced treatment of cardiac arrhythmias, especially for the treatment of atrial fibrillation and ventricular tachycardias. It is developing an intracardiac ultrasound product line, which includes the ViewMate ultrasound imaging console and Viewflex intracardiac imaging catheters. These products offer high-resolution, real-time ultrasound capability designed to improve a physician's or clinician's ability to view the inside of the chambers and anatomic structure of the heart safely and accurately, without the need to expose patients or physicians or clinicians, themselves to repeated X-ray radiation. The increased visualization is a result of having the catheter inside the heart itself thereby having cardiac features in the near field or its area of highest image resolution and detail. By manipulating the catheter tip and its phased array ultrasound crystal the physician or clinician will be able to visualize not only the entire heart but also to direct the wedge-shaped ultrasound beam at specific areas of interest. Additionally, the Company's color capability will allow verification of heart valve patency and blood flow direction and amount. The Company's ultrasound products are not approved for sale.
In January 2003, the Company filed an application with the European Notified Body for regulatory approval to affix the CE Mark to allow sale of the product in the European Community. EP MedSystems expects to file a 510(K) for approval to sell the system in the United States in the second quarter 2003.
The Company's primary competitors in the production of catheters and disposable accessories are C.R. Bard Inc., EP Technologies, Inc., Medtronic, Inc., Biosense Webster, Inc. and Daig Corporation. In the computerized electrophysiology workstation and electrophysiology stimulator market, the Company's main competitors are Marquette-Prucka and C.R. Bard Inc.
| Company Type |
Public (NASDAQ (SC): EPMD) |
| Fiscal Year-End |
December |
| Employees |
85 |
Sector:
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Healthcare |
| Industry: |
Medical Equipment & Supplies |
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CEO and Chariman:
David A. Jenkins |
David A. Jenkins is the CEO and currently Chairman of our Board of Directors. Mr. Jenkins served as Chief Executive Officer of EP Med since its inception in 1993 until August 2002. He served as President from inception through August 2001, and he has served as a director since our inception and our Chairman since 1995. From 1988 to 1993, Mr. Jenkins served as the Chief Executive Officer and then Chairman of the Board of Directors of Arrhythmia Research Technology, Inc., a publicly held company engaged in the sale and distribution of electrophysiology products. He also serves as President and a director of Transneuronix, Inc., a privately held company. |
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CFO and Secretary:
Matthew C. Hill |
Matthew C. Hill was our Controller from August 2002 to March 2003. In March 2003, Mr. Hill was appointed as our Chief Financial Officer. Mr. Hill came to EP Med from the international accounting and auditing firm of Grant Thornton LLP where he held various positions up to the level of senior manager. He has over 11 years of experience in finance and accounting. |
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Vice President-Operations and Engineering:
Byrd, C. Bryan |
C. Bryan Byrd is the Vice President, Engineering and Operations of EP Med. Mr. Byrd joined EP Med in April 1993 to oversee software development for new products. Prior to joining EP Med, Mr. Byrd co-founded and served as the Director of Engineering for BioPhysical Interface Corp. from 1989 to 1993 where he was responsible for developing automated computerized monitoring equipment for pacemaker and open heart operating rooms and follow-up clinics. Prior to his involvement with BioPhysical Interface Corp., Mr. Byrd was employed by Mt. Sinai Medical Center in Miami Beach, Florida as a clinical software engineer. |
NOMINATINGCOMMITTEE CHARTER
Adopted by the Board of Directors of EP MedSystems, Inc.
Purpose
The purpose of the Nominating Committee (the "Committee") of the board of directors (the "Board") of EP MedSystems (the "Company") is to identify individuals qualified to serve as members of the Board of the Company, and recommend nominees for election as directors of the Company,(1).
Composition
The Committee shall be composed of two(2) or more directors, as determined by the board of directors, each of whom shall satisfy the requirements of Nasdaq.(3)
Responsibilities
The Committee is charged by the Board with the responsibility to:
- Identify and evaluate individuals, including individuals proposed by stockholders, qualified to serve as members of the Board, recommend for determination by the independent directors of the Company nominees for election as directors of the Company at the next annual or special meeting of stockholders at which directors are to be elected, and identify, evaluate and recommend to the Board individuals to fill any vacancies or newly created directorships that may occur between such meetings(4).
- Oversee/Conduct an annual evaluation of the performance of the Board, including individual members of the Board, and discuss the evaluation with the full Board.
- Provide minutes of Committee meetings to the Board, and report to the Board on any significant matters arising from the Committee's work.
- Perform such other duties and responsibilities as may be assigned to the Committee by the Board.
Authority
By adopting this Charter, the Board delegates to the Committee full authority in its discretion to:
- Perform each of the responsibilities of the Committee described above.
- Delegate such of its authority and responsibilities as the Committee deems proper to members of the Committee or a subcommittee.(5)
- Appoint a chair of the Committee, unless a chair is designated by the Board.
- Engage and terminate search firms, independent counsel and other advisers as the Committee determines necessary to carry out its responsibilities, and approve the fees and other terms of retention of any such search firms, independent counsel and other advisers.
- Cause the officers of the Company to provide such funding as the Committee shall determine to be appropriate for payment of compensation to any search firm or other advisers engaged by the Committee.
(1)Since the Nasdaq rules refer to the nomination of directors, this probably is limited to nominating a slate of directors at a meeting of stockholders, and not to filling vacancies on the board.
(5)A committee of three or more members provides more flexibility in terms of membership. See footnote 4 below.
(3)Nasdaq Rule 4350(c)(4) contemplates that the nominating committee will consist solely of independent directors, but provides that if the nominating committee is comprised of at least three members a single non independent director, who is not an officer, employee or family member, may serve for up to two years under an "exceptional and limited circumstances" exception.
(4)See footnote 2 above regarding filling vacancies. Under the laws of some states (e.g., California), committees are not authorized to fill vacancies on the board.
(5)Consideration should be given as to whether such a committee has authority to delegate any of its authority and responsibilities to its members or a subcommittee, particularly those responsibilities that involve the exercise of judgment as distinguished from ministerial acts.
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