INTELLIGENT MEDICAL IMAGING, INC.

INTELLIGENT MEDICAL IMAGING, INC.

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Company Overview
Intelligent Medical Imaging Inc. (IMI), with registered head office located in Palm Beach Gardens, Florida, is engaged in the manufacture and sale of automated medical equipment for hospitals and laboratories throughout the world. The company’s main product line is an automated cell and urine analyzer, sold under the name Micro21. The product could perform many different procedures, nine of which were Food and Drug Administration (FDA) approved. Intelligent Medical Imaging was established in June 1989. It went public in 1996.
Business Summary
Intelligent Medical Imaging, Inc. (IMI) has developed and is marketing the MICRO21 system, an intelligent, automated microscope system, for diagnostic use in hospital, commercial reference and physician group-practice laboratories. The Company’s MICRO21 system is designed to automate a broad range of manual microscopic procedures, potentially enabling the laboratory to reduce costs and exposure to liabilities, enhance analytical accuracy and consistency, increase the productivity of medical technologists and improve patient care. The MICRO21 system consists of the Company’s NeuralVision software platform integrated with slide delivery, optics, video and monitor hardware subsystems. The MICRO21 system automatically scans pre-loaded slides to locate, classify, count, display and store full-color digital images of cells. Up to 100 cell images, identified and grouped by cell type, can be displayed simultaneously on a full-color screen.
Description and history
Intelligent Medical Imaging, Inc. (IMI), incorporated in 1989, has developed and is marketing the MICRO21 system, an intelligent, automated microscope system, for diagnostic use in hospital, commercial reference and physician group-practice laboratories. The Company’s MICRO21 system is designed to automate a broad range of manual microscopic procedures, potentially enabling the laboratory to reduce costs and exposure to liabilities, enhance analytical accuracy and consistency, increase the productivity of medical technologists and improve patient care.

The MICRO21 system consists of the Company’s NeuralVision software platform integrated with slide delivery, optics, video and monitor hardware subsystems. The MICRO21 system automatically scans pre-loaded slides to locate, classify, count, display and store full-color digital images of cells. Up to 100 cell images, identified and grouped by cell type, can be displayed simultaneously on a full-color screen. A pen-based, touch-sensitive screen allows a medical technologist to review, regroup and reclassify cells, and an on-line reference library can be accessed to assist in cellular analysis. By automating most of the steps associated with microscopic procedures, the MICRO21 system allows medical technologists to focus on diagnostic analysis. The Company believes that the MICRO21 system can substantially reduce review time, thereby decreasing labor costs and allowing for more efficient use of personnel.

While IMI intends to apply the MICRO21 system to a variety of diagnostic tests, the Company implemented the white blood cell (WBC) differential, including the WBC morphology, the red blood cell (RBC) morphology and the platelet estimate as the first procedure. The WBC differential is the most common clinical laboratory microscopic procedure. A WBC morphology, RBC morphology and platelet estimate are commonly performed in conjunction with, and on the same blood smear used when performing, a WBC differential. The Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the MICRO21 system for the automated location and display of nucleated blood cells (to assist medical technologists in performing WBC differentials and WBC morphological analysis); and for the display of full-screen wide-field images from a slide (to assist a medical technologist in assessing RBC morphologies and in estimating platelets).

The Company has FDA 510(k) clearances for two additional commonly performed microscope procedures: reticulocyte count and anti-nuclear antibodies (ANAs). The reticulocyte procedure, which is now implemented, measures the number of reticulocytes (immature red blood cells produced in the bone marrow) and is performed to monitor bone marrow production during the treatment of particular anemias in order to track the effectiveness of the therapies being utilized. An ANA analysis is used to identify cells associated with general connective tissue and autoimmune diseases such as arthritis, lupus and Graves disease.

The Company has FDA 510(k) clearance for the nDNA procedure, an indirect enzyme antibody test that is used for the semi-quantitative detection of nDNA antibody in human serum. This procedure is used as an aid in the diagnosis of systemic lupus erythematosus and other connective tissue disease. IMI also has FDA 510(k) clearance for the cerebrospinal fluid white blood cell differential, which is the examination of white blood cells in spinal fluid and is used to diagnose inflammation and infection of the central nervous system, including meningitis. Currently under development is a procedure for urine sediment analysis, which is broadly used to screen urinary tract and renal functions and to establish diagnosis of multiple kidney and urinary tract diseases. FDA 510(k) submission for this procedure was approved in 1998. The MICRO21 now also supports animal applications for use in veterinary, pharmaceutical and other medical research.

In December 1998 the Company’s new blood slide maker, HSM, was commercially released. The HSM fully automates the process of blood slide making/staining. The HSM was designed so that results from the hematology analyzers manufactured by Bayer and Beckman-Coulter can trigger the automatic preparation of a slide, providing the lab significant labor savings and improved operational efficiency. Once prepared, the slides can be automatically reviewed by the MICRO21, providing even greater labor savings and improved operational efficiency.

With regard to the WBC differential, the MICRO21 system competes indirectly with flow cytometers performing complete blood counts and partial WBC differentials, including flow cytometers manufactured and sold by Coulter Corporation, Abbott Laboratories and Sysmex as well as with older image-based systems. The Company is aware of one other intelligent optical system utilizing neural network software, manufactured and developed by Neuromedical Systems, Inc. The Company believes that Neuromedical’s product has been developed primarily for the Pap smear procedure. Neuromedical has notified the Company of its belief that the MICRO21 system may infringe certain patents held by Neuromedical. In addition, other companies, including NeoPath, Inc. and International Remote Imaging Systems, Inc., are marketing or may market intelligent optical systems applicable to microscopic testing procedures that compete or may compete with the MICRO21 system.

Business Line
Engaged in the manufacture and sale of automated medical equipment for hospitals and laboratories throughout the world
Subsidiary

Advisor
ERNST & YOUNG LLP
IPO date

US SIC Code
3841
Company Address
Suite 214
4360, Northlake Boulevard
City province or state postal code
33410, PALM BEACH GARDENS, FL
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Country address: UNITED STATES OF AMERICA
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