THE SOTERIA CARDIAC PLATFORM

DISTRUPTIVE, GROUND-BREAKING DIAGNOSTIC TECHNOLOGY

HISTORY OF THE SOTERIA PLATFORM

The inventor, Dr. Jeffrey Raines, has spent his entire career devoted to research of coronary artery disease, the cause of 50% of the deaths in the US, and the development of diagnostic tools that can be utilized in conjunction with the disease.

While Soteria Medical, LLC, the medical device company that developed the Soteria Cardiac Platform and owns the rights to the Platform, was formed in 2012, the entire career of the inventor have led to the development of the Platform in it's current form

After receiving his medical degree from Harvard, the inventor, Dr. Jeffrey Raines received his PhD in engineering from MIT in 1972. His thesis title was Diagnosis and Analysis of Arteriosclerosis in the Lower Limbs from the Arterial Pressure Pulse. This work led to the development of the Pulse Volume Recorder ( PVR) that became the primary device for the diagnosis of peripheral vascular disease and in development of vascular diagnostic laboratories around the world.

During the timeframe from 1972-1989, through extensive research, it was determined that up to 70% of patients that have a myocardial infarction have NO reduction in blood flow to the heart muscle and that blood flow was not reduced until at least 60% of the arterial cross-sectional area had been obstructed by atherosclerotic disease. Work done Dr. Jay Cohn, a highly respected cardiologist at the University of Minnesota published a paper ( Arterial Compliance to stratify Cardiovascular Risk: More Precision in Therapeutic Decision Making) that beganto shift the focus of attention in cardiovascular disease prevention and treatment to the arterial wall.

Working from that tenant, Dr. Raines was able to secure funding to extend the design of the original PulseVolume Recorder to accurately and noninvasively measure arterial compliance in the lower extremity. Dr. Raines realized the need to devise an accurate method to measure local arterial volume and developed an automated and internally calibrated system controlled by a small microprocessor. He developed a device that could be used in a clinical setting to obtain accurate arterial compliance measurements in the lower extremity. This device is now called the Soterogram. Key to the Soterogram are the results that were obtained through clinical trials that are used with the algorithms to create the Soterogram score.

THE CLINICAL TRIALS

The trials were conducted by Impressive team of medical professionals. Dr. Raines and number prominent cardiovascular investigators conducted clinical trials in close conjunction with the FDA. This team received funding for two major clinical studies. The team included:

Dr. Raines-University of Miami
W. Virgil Brown, MD-Emory University
David Herrington, MD-Bowman Gray School of Medicine
Lori Mosca, MD, PhD-Columbia University
JHC Reiber, MD, PhD- University of Leiden and University of Groningen, The Netherlands.


Description Of The Trials

The two studies were as follows:

Precision Study

The first study was called the Precision Study and was carried out in the 6 academic medical centers listed above. This study involved 418 subjects, equally divided between males and females between 20 and 80 years of age. These subjects all had documented low cardiovascular risk. This was defined as absence of smoking, hypertension, diabetes, elevated blood lipids, obesity, and cardiovascular pharmacy. In addition to a detailed examination, each subject underwent two Soterograms. This data has become the reference population for the Soterogram.

Accuracy Study

The second study was the Accuracy Study and was carried out in the 4 US-based medical centers listed above. This study involved 343 subjects, equally divided between males and females between 35 and 79 years of age with four levels of cardiovascular risk: low risk, moderate risk, equivalent coronary artery disease, and documented coronary artery disease.
Each subject underwent four Soterograms, thoracic and abdominal aortic Magnetic Resonance Imaging (MRI) to define cardiovascular atherosclerosis, clinical laboratory, and stress ECG/Echocardiogram. This data was used to define atherosclerotic burden as a function of Soterogram findings.

Results Of The Trials

Upon completion of the Precision and Accuracy Studies, the team began publishing results.

The following publications resulted from the studies.

Initial Publications

The initial publications from the referenced studies focused on comparing Compliance Data as obtained from the Soterogram with known cardiovascular risk factors. These publications included those listed below with the specific reference to the publication shown at the bottom of this document in the Bibliography.

Standard cardiovascular risk factors Coronary artery disease as determined by cardiac catheterization Atherosclerotic Burden Framingham coronary artery risk assessment Aortic wall thickness and conventional risk factors Comparison of Compliance with most known risk factors on a strict statistical basis

Second Tier Publications

The second tier of publications involved a comparison of compliance measurements in specific clinical settings. One study selected high-risk cardiovascular patients and treated them aggressively with Simvastatin; a lipid-lowering statin agent

Another study determined the accuracy andoperational mechanics of the Soteria ABIgram with conventional Ankle/Arm Index methods andthe SP-10 Standard established by the FDA.

In another study, compliance was used to predictcardiovascular exercise tolerance in individuals without known coronary artery disease.

Finally, in this series compliance measurement levels were compared to triglyceride-rich lipoproteins in healthy men and women

Conclusion

The Soterogram™ is:

• 14% more predictive than ANY tests that look at traditional cardiovascular risk factors.
• 45% more predictive when used in combination with traditional risk factors.
• False Negatives are reduced in males from 60% to 27% and from 30% to 23% in females.

DR. JEFFREY K. RAINES

Dr. Jeffrey K. RainesDr. Raines has a long and illustrious career devoted to the development of diagnostic tools that could help in the diagnosis of coronary artery and cardiovascular disease.

Below is a summary of his career:

Higher Education


Clemson University BSME (Mechanical Engineering / Pre-Medicine)

June 1965

University of Florida MME (Mechanical Engineering / Fluid Mechanics)

June 1967

Harvard Medical School / MIT NIH Training Fellowship [1F01GM48295]

PhD Degree Awarded June 1972

Certifications


Fellow (FACC) American College of Cardiology Inducted December 29, 1975 (Active 1975-1978)

Clinical Engineering Board of Examiners for Clinical Engineering March 23, 1976

Associate Member American College of Radiology Inducted July 1, 1983 (Active 1983-1990)

Clinical Engineer (#090) International Certification Commission Clinical Engineering and Biomedical Technology April 16, 1984

Registered Vascular Technologist (RVT) [#57079] American Registry of Diagnostic Medical Sonographers Year Certified (1998)

Advanced Practice Sonographer (APS) [#042237] Society of Diagnostic Medical Sonography New Category (2004)

Academic Career


Harvard Medical School Massachusetts Institute of Technology (MIT)

Massachusetts General Hospital (MGH) Fellow-in-Training (NIH) [1F01GM48295] 1968 - 1972

Harvard Medical School

Assistant Professor of Surgery 1972 - 1977

University of Miami

Graduate Faculty 1977 - Present

University of Miami

Department of Surgery (Division Chief - Research) Division of Vascular Surgery Associate Professor 1977 - 2004 Retirement (Emeritus Professor)

University of Miami

Department of Epidemiology and Public Health (Secondary) Associate Professor 1988 - 1995

Harvard Medical School / Massachusetts General Hospital Surgical Society

Inductee: 2008

Hospital Affiliations


Massachusetts General Hospital (MGH) Founding Director, Clinical Vascular Laboratory Director, Vascular Surgical Laboratory 1972 - 1977

Miami Heart Institute 1977 - 1988
Jackson Memorial Hospital 1988 - Retirement Technical Director

UM/JMH Comprehensive Vascular Laboratory 2000 - Retirement

Non-Academic Employers


Miami Heart Institute

Research Director and Director, Clinical Vascular Laboratory Responsible for all institution research activities (130employees); Responsible for all clinical services in the Vascular Laboratory including interpretation of reports (employees) 1977 - 1988

Miami Vein Center

Director, Vascular Laboratory and Research Director
Responsible for all center research activities; Responsible for all clinical services in the Vascular Laboratory 2004 - 03-02-10

Raines Medical Consulting

President
03-01-10 - Present

Soteria Medical, LLC

President and CEO 03-01-12 - Present

THE SOTEROGRAM™

The Soterogram™ is possibly the most important test you can prescribe for your patient.


The Soteria Cardiac™ Platform performs a number of different tests but the flagship test is the Soterogram ™.The Soterogram ™ is based on the following tenet. It is highly important to identify early, the specific presence and degree of atherosclerosis in patients. Using blood pressure cuffs and sophisticated algorithims the Soterogram compares the patient's results to those gathered in FDA approved clinical trials to produce the following:

Soterogram™ Score


This is a numeric age which compares the patient's arteries to those of individuals in the clinical trials with no coronary artery disease. Over time we expect the Soterogram Score to be as widely known as the patient's blood pressure.

Arterial Elasticity


The Soterogramalgorithims provide the most accurate measurement of arterial elasticity.

Generalized Atheroscleric Burden


Using peripheral arterial measurements the Soterogram is able to predict the presence and degree of genralized atherosclerosis.
The Soterogram™ is designed to identify coronary artery disease in individuals without known risk factors or symptoms. By doiing this, physicians can then change the disease trajectory of individuals in these individuals . It is also effective in the identification of the extent of cardiovascular disease in individuals with risk factors and sumptoms and when conducted on a regular basis, the progress in managing the disease.

The Soterogram™, Effective If Precribed Regularly For Patients 30 Years Of Age And Older


Extensive studies have been conducted to determine the age when atherosclerosis begins. Most experts point to an in-depth population-based study performed at Emory University as one of the most conclusive studies regarding this important question. This study (Pathobiological Determinants of Atherosclerosis in Youth - PDAY Study) began in 1985 and has been active now for over 30 years. The major results which are still expanding, are highlighted in the table below which was published in 2008.

VIEW A DEMONSTRATION OF THE
SOTERIA CARDIAC PLATFORM