Medical Software Business Plan

AgaMatrix will develop a set of software products that provides critically needed diagnostic functionality to current and next-generation medical biosensors. Optimized for computational efficiency, they are designed to be easily incorporated into a number of leading biosensor platforms. All products that we develop will be powered by our core DSP algorithms with certain features configured and optimized for the relevant applications. Our algorithms will be delivered in a format that is convenient and useful to our customers; as such, each AgaMatrix Product Suite will consist of a core DSP engine supplemented with integration tools, application-specific expansion modules, and professional services. Since our initial product focus is OEM technology, we will work closely with our customers and partners in the development and deployment of our products. The core DSP algorithms will be encoded as a platform technology in modular components that can be rapidly configured as needed for various customers’ applications.

Initially, we are marketing one product for the glucose biosensor market and one product for the hospital POC market:

Suite Name: AccuMatrix

• Target Customer: Smaller Home Glucose Biosensor Manufacturers
• Why Needed: These customers need a method of suppressing interference from other known chemicals in the blood (vitamin C, Tylenol, and uric acid) that can react at the biosensor and give erroneous readings. They need to be able to suppress these interferences without the use of chemical mediators or expensive membranes.

Suite Name: PosiMatrix

• Target Customer: Hospital Point-of-Care Manufacturers
• Why Needed: These customers need a method of alerting the user when unknown chemicals in the blood interfere with the biosensor and give false positives. E.g., the FDA regularly approves new anesthetic gases that are used in surgery; however, the POC makers cannot keep up with these new “unknown” chemicals that may be present in the patient’s blood and can interfere with the device. For one POC maker, it is “medically imperative” for them to avoid reporting false readings; thus, they need a method of identifying when the reading is corrupted by unknown chemical interference so that they may indicate to the user that the reading is not valid.

The core DSP algorithm engine contains all the needed functionality. Using a Configuration Tool, we can rapidly integrate the appropriate Data Modules that are appropriate for the target customer. These Modules contain a library of information that is needed to configure and optimize the core algorithms for the chemicals that are relevant to the customer’s device. Once configured, the algorithms will be delivered in the appropriate software or ASIC-design version for the target device and can be deployed with our Integration Tools by our Professional Services Deployment Team or by the customer’s engineering team. The basic components of each AgaMatrix Suite will include the following:

Core Engine
Core DSP technology software and firmware code base will consist of a major portion of the algorithms that AgaMatrix develops. These algorithms will be activated as needed for each customer’s requirements by the Configuration Tools.

Data Modules
These are libraries that contain empirical data needed to optimize the core DSP engine for the detection of different chemicals in various operating environments. The Configuration Tools will in part use the data from these Data Modules to customize the software for customers’ various products. We will initially offer the following 2 modules:

• Blood Glucose Data Module: Library of empirical information of the standard chemicals that are commonly encountered in blood glucose measurements. This data is used to optimize the core algorithms for detection of glucose and suppression of common interfering chemicals.
• Point-of-Care Data Module(s): Library of empirical information of the standard chemicals that are commonly encountered in various blood chemistry measurements routinely performed by point-of-care devices. This data is used to optimize the core algorithms for detection of each of the relevant chemicals and suppression of common interfering chemicals.

As market and customer needs dictate, future offerings will include the following Modules:

• Implantables Data Module: Library of empirical information on quantities that are relevant to implantable glucose sensors. This data is used to optimize the core algorithms to correct for sensor deterioration (fouling) effects and suppress signals from interfering chemicals while boosting the signal from glucose.
• Immunoassay Data Module(s): Library of empirical information of the standard chemicals that are commonly encountered in relevant immunoassays. Immunoassay Data Modules will be developed for each immunoassay that is of interest to the customer. This data is used to optimize the core algorithms for detection of the relevant chemicals for the given immunoassay.

Configuration Tools
Configuration tools are the front-end interface of the software. This set of tools will allow for the rapid optimization and configuration of the core algorithms for various functionalities and chemicals. These tools are used to select which Data Modules and algorithms are needed for the customer’s application and generate the end product, which can be delivered either as software/firmware for the target device or be delivered in the form of an ASIC design.

Code Integration Tools
This set of tools facilitates the integration and customization of software and firmware code base into customers’ products. These tools may be used by our Professional Services Deployment Team when integrating the product into the customers’ end-device, or they may be used by the customer’s in-house engineering teams themselves. Initially, we will include:

• Software Integration Tools: Tools that facilitate the integration of our technology onto microprocessor-based devices.
• Firmware Integration Tools: Tools that facilitate the integration of our technology onto firmware-based devices.

Technology and Development Tutorials
These are in-depth, easy-to-use online tutorials consisting of scientific and engineering guides to help quickly bring a development and integration team up to speed on AgaMatrix’s DSP technology. The tutorials will consist of code examples, customization, and integration tutorials.

Professional Support Services Package
A set of professional services, including software/firmware development and QA/QC testing, designed to assist in supporting the use and maintenance of the AgaMatrix Product Suites for customers and partners.

Based on initial discussions with potential customers, we believe that we can deliver our product in a format that will be readily usable by their development and integration teams. We will use established processes analogous to those used in the deployment of enterprise software solutions where a Deployment Team will assist the customer in the integration of our product into their devices, as indicated by the professional services component of our product offering.