From their 10K. Yesterday's news stated they have the 501k FDA approval to sell the EchoCath!
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The Company's Products and Technology
The following is a description of the Company's products and proposed products utilizing the Company's proprietary technologies.
EchoFlow EchoCath is engaged in ongoing research and development of the EchoFlow technology. The Company has commercialized its first product incorporating the
EchoFlow technology, the BVM-1, which is intended to provide data on the blood flow through internal vessels during intra-operative procedures. Other applications include
small sensors that can be mounted onto blood vessels or within the walls of a graft, and that provide crucial data on the flow of blood, have wide applicability, including for
feedback control of pacemakers and implantable defibrillators. EchoFlow sensors can be disposable products and will connect to an electronics module.
The Company has successfully performed bench tests on EchoFlow sensors, and has conducted pre-clinical testing on EchoFlow at Mount Sinai Hospital in 1997 and at the
University of Louisville in April 1998. In March 1998, at the national conference of the Society of Clinical Vascular Surgeons ("SCVS") in San Diego, California, EchoCath
demonstrated the EchoFlow system using a sensor, one-quarter the size of a postage stamp, that when laid directly on or over a blood vessel, provides the quantitative blood flow
measurements required by a vascular surgeon. At the SCVS conference, the pre-clinical results from employing an EchoFlow prototype instrument to measure blood flow were
also presented. (Portions of this presentation were published in American Journal of Surgery in August 1998, authored by Dr. M. Skladany and associates). Continued product
definition took place at the Annual Meeting of the Society of Vascular Surgeons (SVS) in June 1998. (Professor William Abbott of Harvard Medical School, a member of
EchoCath's Medical Advisory Board, was President of the SVS).
The Company applied for 510(k) clearance to market its first EchoFlow product, the BVM-1 Blood Velocity Meter for inter-operative use in February 1999. It received
clearance on September 23, 1999. The initial device is being marketed to vascular surgeons for intra-operative measurements and potentially for intensive care monitoring of
circulatory status. The initial commercial units of this product have been placed in 10 demonstration sites, and one unit has been sold.
The Company intends to develop, manufacture and market additional EchoFlow products that utilize its EchoFlow technology. Planned products include monitoring systems that
will measure blood flow in the circulatory system, utilizing sensors on the skin above a blood vessel, or placed directly on the vessel following surgery, or, carried on a catheter,
inside the blood stream. As the status of the circulatory system is crucial, the Company believes such products have significant potential uses, but widespread acceptance of
these products will depend on numerous factors. The commercialization of other applications of the EchoFlow product will depend on the Company's ability to obtain additional
financing through joint ventures, licensing agreements or other collaborative arrangements or otherwise. The Company cannot predict, when, if ever, such products will be
successfully developed or available for commercial sale.
EchoMark The Company's EchoMark system electronically marks and displays the position of non-metallic objects, such as catheters within the body on existing ultrasound
imaging screens, eliminating the need to use X-ray to confirm the position of such objects. The Company has developed a catheter utilizing the EchoMark technology to diagnose
fallopian tube blockage (the "EchoMark Salpingography Catheter"). The EchoMark Salpingography Catheter consists of a disposable catheter to which is attached a proprietary
sensor connected by wire to a reusable catheter system interface (the "EchoMark CSI"). The EchoMark CSI, for which the Company received FDA market clearance in 1992,
provides the interface between the Company's EchoMark products and most commercially available ultrasound imaging systems. On the EchoMark Salpingography Catheter,
the sensor captures ultrasound signals and relays them
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back to the EchoMark CSI, which in turn displays the position of the sensor on the ultrasound-imaging screen. The Company believes that the EchoMark Salpingography
Catheter may expand the use of ultrasound for diagnosing and treating infertility problems in women because of the desire to avoid X-rays in such patients and the desire to
reduce procedure time. The Company intends to enter into joint venture, licensing or other collaborative arrangements to market and sell the EchoMark Salpingography
Catheters. To date, the Company has been unsuccessful in securing an agreement with a joint venture partner or licensee or any other arrangement.
The Company has also developed the EchoMark Electrophysiology Catheter (the "EchoMark Electrophysiology Catheter") which consists of a conventional electrophysiology
catheter augmented by a piezo plastic covered brass sensor connected by wire to the EchoMark CSI. The sensor captures ultrasound signals and relays them back to the
EchoMark CSI, which in turn displays the position of the sensor in the image of the cardiac structures on the ultrasound-imaging screen. The Company believes that the
EchoMark Electrophysiology Catheter will increase the speed and ease the diagnosis of arrhythmias in the heart. The Company received FDA clearance in May 1995 to market
the EchoMark Electrophysiology Catheter to diagnose defective conductive pathways in the heart. In February 1997, the Company entered into a license agreement with EP
MedSystems Inc., a New Jersey corporation ("EP MedSystems"), for this use of this technology. On March 31, 1998, EP MedSystems announced the successful use of
EchoMark in connection with guiding electrophysiology devices under ultrasound imaging. See "Collaborative Agreements".
Additional products that the Company has developed utilizing the EchoMark technology are an EchoMark peripheral angioplasty catheter (the "EchoMark PTA Catheter") and
EchoMark guidewire (the "EchoMark Guidewire"). The Company received marketing clearance from the FDA under a 510(k) pre-market notification for the EchoMark PTA
Catheter in 1992 and the EchoMark Guidewire in 1993. The Company previously experienced resistance from the medical community when it attempted to introduce the
EchoMark PTA Catheter in 1993 because of the conflict over the administration of such procedures between different medical specialties. The Company is continuing to
explore means of introducing the EchoMark PTA Catheter to be utilized in the actual performance of peripheral angioplasty under ultrasound guidance.
Currently, the EchoMark CSI may be used with the systems of Acuson, Inc., Advanced Technology Laboratories, Inc. ("ATL"), Hewlett-Packard Inc., Siemens Medical
Systems Inc., Toshiba and other ultrasound systems. The Company will seek to enter into additional joint venture, licensing or other collaborative arrangements for the
distribution, marketing sale and/or use of the Company's proprietary EchoMark technology.
ColorMark The Company has developed a product (the "ColorMark Clip") utilizing the ColorMark technology. The ColorMark Clip consists of a disposable clip and a
non-disposable drive box. The clip is mounted on the needle or other interventional device and the drive box produces a voltage, which is transmitted to a piezo ceramic slab
mounted in the clip. The voltage generates vibrations, which in turn allows the device to appear in color on the ultrasound-imaging screen, which permits clinicians to more
effectively guide needles during therapeutic and diagnostic procedures. The ColorMark Clip is compatible with a wide variety of needles and guidewires and can operate with
most currently available color ultrasound systems. The Company has received market clearance from the FDA for the ColorMark Clip for needle placements. The Company
believes that with the ColorMark Clip, needle biopsies and vascular access procedures are more accurate and faster for clinicians to administer.
The Company may develop and commercialize additional products utilizing the ColorMark technology to address specialized procedures such as laparoscopic instrument
guidance. Such products are expected to be subject to regulatory approval by the FDA and comparable foreign agencies or state health departments prior to marketing and are
expected to require additional financing to commercialize.
The ColorMark technology was licensed by the Company to Medtronic (in conjunction with the license for EchoMark) for guidance of pacemaker lead implantation and this
license agreement has terminated, except for a continuing right of last refusal, which will end in 2002. The ColorMark technology has also been licensed to Medtronic MICS
Division for cardiac surgery applications, and to EP MedSystems for guided placement of electrophysiology catheters. Critical Care Concepts, Inc., presently holds an option to
purchase a license agreement from the Company for the use of ColorMark technology for soft tissue biopsies and cancer therapy guidance; that option will expire on December
30, 2000.
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The Company will seek to enter into additional joint venture, licensing or other collaborative agreements for, among other things, the distribution, marketing, sale and/or use of the
Company's proprietary ColorMark technology.
EchoEye The Company is engaged in the research and development of products incorporating the EchoEye technology which, if successfully developed, would allow clinicians
to view tissues and organs inside the body in three-dimensional real-time and provide forward-looking images and guidance for minimally invasive ultrasound guided procedures.
The Company has successfully performed preclinical testing on the EchoEye technology. The EchoEye technology has been licensed to EP MedSystems for its use in
electrophysiology procedures. Medtronic received an option from the Company to license the use of EchoEye in cardiac surgery. This option has expired. See -"Collaborative
Agreements." |
