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17011 Beach Blvd., Suite 900 Huntington Beach, CA 92647

Bus. (714) 841.2670

www.itechmedical.com
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QMCI
Impact Medical Solutions, Inc. (OTCBB:IMSU)

Impact Medical Solutions-(d/b/a/ iTech Medical, Inc.) (OTCBB: IMSU) is a medical technology company whose primary focus is on the research and commercial development of healthcare information systems and technologies. To date, the Company has focused on the development of a proprietary platform called Muscle Pattern Recognition (MPR).

The MPR System analyzes patterns of muscle recruitment and provides detailed physiological information on muscle function that can assist in the diagnosis and treatment of back and neck injuries and illness.

As one of the largest muti-billion dollar industry sectors, back pain is one of the most common and significant musculoskeletal problems in the world. In North America alone, the annual direct and indirect cost of diagnosing and treating back injuries is estimated to be between $50 and $100 billion.

In fact, back injuries are the leading cause of disability in North America and the European Union (EU) for people younger than 45 years of age, and the most expensive health care problem for those in the 20 to 50 year-old age group.

To be commercially successful in this lucrative market, Impact Medical Solutions has established a series of goals, which include the following:

  • Complete the independent clinical study to establish the medical and scientific credibility required for broad acceptance of the MPR System;
  • Develop an awareness of MPR with physicians, employers, insurance companies, HMOs and other potential users of the MPR System;
  • Develop a template for consistent usage patterns of the MPR System in key reference accounts;
  • Form relationships with key strategic partners with access to insurers, self insured employers and other health care organizations that could use the MPR System;
  • Establish MPR in selected key reference accounts in geographic markets throughout North America, creating a delivery system to perform the tests as and where needed; and,
  • Form corporate alliances for the development, sales and marketing of the MPR System in a number of important foreign markets.

The Company is looking to develop a broad product pipeline of commercially successful medical products as they explore other potential clinical applications that meet all of the following criteria just as their first product -- the MPR System already does:

  • Products that have large market opportunities;
  • Products that can be protected by intellectual property laws, and;
  • Products that address unmet clinical needs.

Impact Medical Solutions is currently in the process of an independent clinical trial of the MPR System at a number of North American sites. Successful completion of this trial in later 2009 will lead directly to all filings with the appropriate regulatory agencies and the commercialization of the MPR System in North America and the European Union (EU).

Initial discussions with potential sales, marketing and distribution partners are already underway, as are discussions with potential users of the system.

Pilot Clinical Trial Update of MPR System

On April 23, 2009, Impact Medical Solutions, Inc. (OTCBB: IMSU, FWB: 0IM), provided an update on its pilot clinical trial for the Company's proprietary information technology platform, Muscle Pattern Recognition (MPR).

“The MPR technology will be the first quantitative tool developed for assisting in the diagnosis of the presence or absence of a musculoskeletal dysfunction (sprain/strain injuries) in a patient population,” stated Dr. Alan Goldman, Vice President, Clinical and Medical Affairs for Impact Medical Solutions.

“The availability of such an evaluation tool to a healthcare provider for patients with soft tissue, non-surgical neck or back complaints will substantially improve the accuracy of diagnosis, rehabilitation and case management decisions,” added Goldman.

The Company announced that it had recruited its 150th trial subject since the trial was first announced in February 2009.

“We are ahead of schedule as far as testing is concerned and we're pleased to report that the MPR System is performing at or above our expectations, and our expectations are high,” said Wayne Cockburn, President and CEO at Impact Medical Solutions.

”There is currently a two to three week waiting list to get into our trial and we anticipate this trend to continue. We are planning on opening a second test site in Southern California within the next several weeks and a third site in Michigan during the summer. We expect the results of this pilot trial will be used in our submission to the FDA later this year,” Cockburn adds.

The pilot clinical trial is currently being conducted at the Utah Spine and Joint Center in Salt Lake City, Utah and the total trial is expected to involve several hundred subjects, many of whom are experiencing chronic back pain.

About Alan Goldman, M.D.

Dr. Goldman joined Impact Medical Solutions as VP of Clinical and Medical Affairs in 2003.

Prior to that, Dr. Goldman was a practicing Board Certified neurologist for 27 years and an Associate Clinical Professor of Neurology at the University of California (Irvine). He served as a neurology consultant to numerous insurers and served for four years on the Medical Advisory Board of Blue Cross.

His Workers' Compensation appointments include Independent Medical Examiner for the State of California in 1990, Qualified Medical Evaluator, State of California in 1991 and Agreed Medical Evaluator, State of California in 1992. Dr. Goldman is a member of the American Academy of Neurology, the California Medical Association, the Utah Medical Association and a Past-President of the Orange County Neurological Society (Los Angeles, CA).

A Patented Medical Information System

Impact Medical Solutions, Inc. acquired the patented medical information system called Muscle Pattern Recognition (”MPR“) from MPR Health Systems, Inc. in 2003.

The Company believes that the capabilities of the MPR System addresses an unmet market need for an objective, evidence-based test that can be used by physicians and other health care professionals to better assess and manage patients with impaired musculoskeletal function.

Further, Impact Medical Solutions has developed the MPR System to support the cost-containment and risk management goals of insurers, workers compensation carriers, self-insured employers and managed care providers by providing objective information to help control health care costs associated with back and neck injuries.

Huge Market Need

It is estimated that 1/3 of all disability costs in the United States are due to back disorders, with approximately 80% of adults seeking care at some time for low back pain.

For most patients, the cause or causes of persistent back pain remain poorly understood.

Although imaging procedures, including computerized tomography (CT) and magnetic resonance imaging (MRI), are able to accurately define structural anomalies, the correlation of these anatomic findings with physiology, back pain, and other clinical complaints is imprecise.

Key Market Trends

Several trends have expanded the market for better solutions to diagnosing back problems:

  • increased employer and payor aggressiveness in quantifying and seeking ways to reduce the economic toll of back injuries, one of the largest segments of health care costs;
  • growing awareness of the need for objective information in medical-legal injury litigation;
  • need for measuring patient treatment effectiveness and managing patients to successful outcomes;
  • increased health care purchaser and provider attention to injury prevention; and
  • increased patient awareness of treatment alternatives.

The Company is targeting the convergence of these trends, which they believe has magnified the large business opportunity to provide clinically proven tools to reduce the costs and improve the outcomes of patients with back pain.

Target Markets for MPR

The target markets for MPR are large and include the following:

  • Primary care physicians, who initially treat the majority of patients with back pain;
  • Specialists including neurologists, orthopedic surgeons, physical medicine and rehabilitation physicians (PM&R) and occupational medicine practitioners (occmed);
  • The employer market;
  • The Workers’ Compensation market;
  • Health Maintenance Organizations (HMOs); and,
  • Insurance companies.
Product Offerings

The MPR System
The MPR System is a clinical tool that performs a biomechanical and mathematical analysis of muscle function. Test results are based on the simultaneous measurement of surface electromyography (sEMG), signals produced by specific back and neck muscles during the execution of distinct body movements (an MPR Test).  A patient's readings are digitized and processed by a proprietary data analysis system that generates graphic images of recognizable muscle activity patterns.  A computer-assisted comparison of a patient's patterns with those produced by normal subjects is then provided in a report that forms the basis of the clinical evaluation.

The MPR System consists of three components:

  • MPR Data Acquisition Device;
  • MPR Data Analysis System; and
  • MPR Report

The MPR Data Acquisition Device
The MPR Data Acquisition Device consists of a commercially available laptop computer system and a recording system equipped with a set of signal amplifiers. The amplifiers are attached to customized skin-surface electrodes that pick up the electrical signals produced by the underlying muscles. The recording system and signal amplifiers are purchased from one of several suppliers in the market place.

The Data Acquisition Device is controlled by proprietary data collection software developed and owned by IMS.  The software prompts and guides the Technician (operator) in performing the required data collection tasks; it assists patient and operator in the execution of body movements by providing visual and audio prompts; and it provides a real-time graphical display of muscle activity.  The MPR Technician is therefore assisted in completing successfully and reliably the data collection process, and is further guided in archiving and transmitting the data for clinical analysis.

The MPR Data Analysis System
The data collected during each MPR Test is transmitted electronically to a central location (application server) for processing by our computerized Data Analysis System.  Proprietary analytical software, also developed and owned by IMS, is used to assess the quality of the MPR data and to derive a number of complex measures which characterize the patient’s muscle recruitment patterns. These measures are then compared to their respective equivalent derivations from a normative database of non-injured and pain-free subjects.  The results of the analysis are presented in an MPR Report, which is electronically transmitted to the referring health care provider.

The MPR Report
The MPR Report provides the health care provider with findings that help to classify the patient as normal or with a graded level of muscle dysfunction (abnormal).  The MPR Report includes graphic, statistical and narrative representations of each muscle group’s recruitment patterns as compared to normative patterns and provides critical information about the muscle groups examined.

MPR - based Clinical Evaluation

The MPR Report and a health care provider clinical examination would form the basis of an MPR - based evaluation. At the discretion of the referring health care provider, patients may be retested to measure the progress of treatment and assist in making a decision for discharge. We believe several other critical questions are implicitly addressed when a patient is retested to ascertain if additional treatment is advisable.

For example:

  • Is the patient's muscle recruitment pattern now within the range of normal?
  • If not, have the patient’s recruitment patterns improved through treatment?
  • Should the payer continue to fund further (or alternative) treatment?

These critical questions address issues of rehabilitation, short and long term disability, and the ability of a person to return to work.

Manufacturing and Service

Impact Medical Solutions uses commercially available data recording equipment and disposable electrodes from Thought Technology Ltd., an unaffiliated biofeedback and psycho-physiological instrument manufacturer based in Montreal, Canada.  Thought Technology maintains all relevant manufacturing facility registrations and Quality System certifications (ISO 13485) for the sEMG/ECG equipment and disposables used in the MPR System, and is in full compliance with FDA, Health Canada and European (CE Marking) requirements.

IMS currently performs the final assembly of the MPR Data Acquisition Device, which includes software installation, system configuration, and final system testing.  The MPR software is produced and released by IMS and is currently responsible for first-line service, including software support. Individual equipment is serviced by their corresponding manufacturers.

The MPR Data Analysis System (central application server and related software) is configured, maintained, and operated by Impact Medical Solutions.

Executive Officers / Directors

Wayne Cockburn,President & CEO, Director

Mr. Cockburn joined Impact Medical Solutions in September 2003. Prior to IMS, Mr. Cockburn was President at MPR Health Systems from January 2002 until September 2003 and Executive Vice President from January 2000 until January 2002. From January 1995 to December 1999, Mr. Cockburn was Vice President, Business Development for Lorus Therapeutics, a public biotechnology company. Mr. Cockburn’s background includes strategic planning, corporate finance, corporate partnering, corporate governance and mergers and acquisitions. Mr. Cockburn has served on the board of directors of several private and public companies and currently serves on the boards of IMSU, MPR Health Systems, Inc., Litewave Corporation and Red Juggernaut, Inc. Mr. Cockburn also acts as a business mentor with the Canadian Youth Business Foundation (CYBF).

Alan J. Goldman, M.D. - Vice President, Clinical and Medical Affairs

Dr. Goldman joined IMS in September 2003. Prior to joining IMS, Dr. Goldman was a practicing Board Certified neurologist for over 27 years and an Associate Clinical Professor of Neurology at the University of California (Irvine). Through his practice, Dr. Goldman attained extensive experience with work-related injuries. He served as a neurology consultant to numerous insurers and served for four years on the Medical Advisory Board of Blue Cross. Dr. Goldman serves as an expert witness in Workers’ Compensation and general liability litigation matters and was recently appointed as a Medical Panel Chairperson for the State of Utah Labor Commission. His Workers Compensation appointments include Independent Medical Examiner for the State of California in 1990, Qualified Medical Evaluator, State of California in 1991 and Agreed Medical Evaluator, State of California in 1992. Dr. Goldman is also a member of the American Academy of Neurology, the California Medical Association, the Utah Medical Association and a Past-President of the Orange County Neurological Society.

At IMSU, Dr. Goldman is responsible for all the clinical and medical affairs of the Company. In addition to being a key member of the management team, Dr. Goldman also serves as Chairman of the Company's Medical Advisory Board.

Steeve Asselin - Vice President, Research and Development

Prior to joining IMS in September 2003, Mr. Asselin was the Director of the Biomechanics Lab at HealthSouth Inc. from September 2000 to December 2002. Mr. Asselin was responsible for the development of the Biomechanics Lab at HealthSouth to enhance and support the clinical programs and services of the company. From May 1994 until September 1999, Mr. Asselin was Research Coordinator at Spinex Medical Technologies. From February 1992 until March 1994, Mr. Asselin was Director, Clinical and Spinoscopy Affairs with a physician group in Boston, Mass. Prior to that, Mr. Asselin was a Research Assistant at Spinex Medical Technologies from September 1989 until February 1992. Mr. Asselin is coauthor of six scientific publications dealing with back injuries and back function and author and/or coauthor of approximately 30 scientific abstracts.

Patricia Colvin - Director of Operations and Financial Controller

Ms. Colvin joined IMS in September 2003 and is responsible for Operations and Human Resources for the Company. Ms. Colvin is also responsible for Quality Control for the Muscle Pattern Recognition technology, including the development and implementation of policies and procedures for software development, hardware assembly, material outsourcing and training and certification of Technicians and Trainers. Prior to joining IMS, Ms. Colvin was Director of Operations and Human Resources at MPR Health Systems from February 1997 until August 2003.


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