We intend to focus on delivery of customized cardiovascular therapies to patients in need and to physicians as a tool for the care of their patients. We will emphasize research & development, manufacturing (assembly of components), marketing and customer service. Direct unfiltered feedback from customers will be the driving force of product and service improvement. Components for systems will be acquired by outsourcing to allow our team to focus on the highest value added portion of our products.

We hope to leverage our technology and customer relationships through the establishment of collaborations with researchers, component suppliers and heart and vascular care centers. Potential partnerships and relationships include:

• Source for skeletal muscle cells and methods to differentiate them to heart muscle cells.
• Source for stroma cells (bone marrow derived) to differentiate to heart muscle cells.
• Source for embryonic stem cell cultivation and differentiation to heart muscle cells. (Stem Cell Labs, Inc.) is committed to developing internal processes for embryonic stem cell culturing and differentiation.
• Source for Nitric Oxide Synthase for promotion of healthy blood vessels.
• Source for pyruvate.
• Source for V2 vasopressin for improving heart muscle function.
• Source for aspirin.
• Source for growth factors, both fibroblast (FGF) and vascular endothelial growth factors.
• Source for articulating guide catheter component for myocardial implant delivery system.
• Source for specialized needle as component of myocardial implant delivery system.
• Partnerships including co-promotion campaigns with major heart and vascular care centers.

Core Technologies

• Myocardial implant delivery systems.
• System to carry discovered links between single nucleotide polymorphisms and customized therapies from concept to market application.
• Various genetic tests.
• Stem cell differentiation through collaborations with various scientists.
• Cellular pellets comprised of multiple components.
• Interactive internet heart health care home page.
• Health products direct to consumer retailing (aspirin).

Business Strategy for Bioheart Genotyping, Inc.

Focus on a few cardiovascular and heart disease related genetic tests that are directly linked to therapies for preventing the disease. We do not plan to offer a genetic test that is not linked to a positive therapeutic solution.

We believe our competitors who are focusing on processing speed and creating large reports with 30,000 SNP's identified per patient, are providing information overload which is not useful and practical. We are focused on clinical utilization and simplicity. We intend to help existing cardiovascular and heart care centers to adopt genetic mapping into their armentarium of tools for fighting cardiovascular and heart disease by limiting the information to a few very useful reports. Tests applicable to a large population of people linked to therapeutic plan changes that can effectively decrease the risk of cardiovascular and heart disease.

• PLa2 Test"
• Iron Sensitivity Test"
• Salt Sensitivity Test"
• HDL Cholesterol Gene Test"
• Apolipoprotein E Gene Test"

Click Here to go to our Genotype Test Panel Info Page

Business Strategy For Bioheart Health Plans, a Division of Bioheart, Inc.

Create a Whole New Category of Healthcare Delivery - "The Heart Health Person" who visits a person's home to provide advice on heart healthy nutrition and to share knowledge about various developments within the field. These representatives will be able to reach registered nutritionists and physicians by phone to answer any questions that they cannot answer themselves. We believe a key to our success will be a very personalized approach designed to deliver customized healthcare in cooperation with leading heart and cardiovascular care centers. Reaching out to get people to actively participate in their own heart healthcare. We plan to go out to rural farms, homes and businesses to meet person to person. You could say that we are depending on the ability of attractive young and "healthy" Bioheart representatives, wearing a standardized and distinctive Bioheart smock to sweet talk older folks into engaging in their own heart health care with a very personalized approach.

To Establish Our Internet Home Page as a Heart Health Community and Shopping Mall with Multiple Stores - We will create a community of people including patient's, physicians, biologists, nutritionists, engineers and other healthcare providers with a shared interest in heart health. Our stores will offer heart health books, nutritional supplement products, customized diets, genetic mapping tests, aspirin and other over-the-counter products, prescription pharmaceuticals and heart healthy foods. We will offer these products and services in cooperation with existing firms in the field.

Proposed Health Care Products - We will develop or acquire a series of proposed genetic tests that are linked to a customized therapy designed to prevent cardiovascular and heart disease. We will develop a "Heart Shake", a "Heart Pop", and a "Heart Bar" and "Heart Soup" in cooperation with experienced beverage and food companies. The company intends to spend a substantial part of its marketing budget establishing the Heart Shake" brand and the PLa2 Test".

Proposed Genetic Tests:

• PLa2 Test"
• Iron Sensitivity Test"
• Salt Sensitivity Test"
• HDL Cholesterol Gene Test"
• Apolipoprotein E Gene Test"

Proposed Food Products:

• Heart Shake"
• Heart Pop"
• Heart Bar"
• Heart Soup"

Strategy for Myocardial Implant Systems

Bioheart MicroImplants, Inc. is focused on development of a myocardial implant system comprised a multi-components. Below is a partial listing of components of our system.

Delivery System:

1. Specialized needle assembly for depositing myocardial implant into heart muscle wall.
2. Articulating guide catheter for positioning needle assembly.

Myocardial Implant:

1. Differentiated stem cells, autologous from skeletal muscle, from bone marrow stroma cells and from embryonic stem cell culturing with a patientís own genetic material.
2. Growth factors both fibroblast and vascular endothelial.
3. Pyruvate for improving catecholamine activity which stimulates cardiac function.
4. V2 Vaspressin for improving contraction of heart muscle.
5. Nitric oxide synthase for improving angiogenesis.
6. Placenta and cord blood derived cellular mixtures.

Accessories:

1. Porous biodegradable ceramic housing.
2. Stainless steel corkscrew.
3. Electrical stimulation device for improving uptake of growth factors.
4. Viral vectors for improving uptake of growth factors.
5. Electroporation device for improving uptake of all injected cells.
6. Ultrasonic device for improving uptake of all injected cells.

Bioheart MicroImplants, Inc. will test in animals to determine the optimal combination that most closely achieves the following goals:

• Angiogenesis Ė a network of collateral blood vessels to feed the heart muscle which are healthy and perform their function as close as possible to the performance of native coronary arteries.
• Stimulation of cardiac function (the ability of the heart to pump).
• Regeneration of heart muscle area damage from previous myocardial infarction.

Our Product Development Programs

In the table below under the heading development status, the terms research, preclinical, early clinicals, advanced clinicals and limited release and full release are used as follows:

• Research indicates that studies are being conducted in animal models or biochemical or cell culture systems in order to identify a product candidate;

• Preclinical indicates that products candidates are being tested for potency, pharmacology, and/or toxicology in animal models or biochemical or cell culture systems; and

• Early clinicals indicates that we are in early stage testing in humans for safety, pharmcologic profile and preliminary indications of efficacy in a limited patient population. This would be classically defined as Phase I investigational study.

• Advanced clincals indicates that we have passed through the Phase I studies and are moving onto Phase II or III studies focusing more on efficacy than previous studies which focused primarily on safety.

• Limited release indicates the product candidate has been release to a limited market segment.

• Full release indicates that a product is commercially available in the prime markets the company intends to serve.
  

Click Here to go to our Genotype Test Panel Info Page

Myocardial Microimplant, uses a combination of cells in a pellet form to regenerate heart muscle, stimulate angiogenesis (growth of new blood vessels) and improve cardiac function (the ability of the heart to pump). The cellular pellet is delivered to the heart muscle with a catheter based system by endoluminal, laproscopic or open surgical means. Components of the cellular pellet may include; differentiated stem cells (heart muscle cells-cardiomyocytes), growth factors (FGF and VEGF), pyruvate, nitric oxide synthase (NOS) and V2 Vasopressin and a biodegradable or radiopaque scaffolding. Components of the delivery system include an articulating guide catheter and a central needle assembly for insertion of the cellular pellet into the heart muscle. Accessories include an electrical, vibrational or ultrasonic stimulation system to improve uptake of injecting materials into host tissue. BACK

PLa2 Test", is a genetic test able to identify presence of the PL a2 polymorphism (a point mutation) of DNA. Studies at Johns Hopkins and Ohio State University have linked the presence of this polymorphism with the effectiveness of aspirin in preventing myocardial infarction. Approximately 20-50% of the population in North America has the PL a2 polymorphism and can effectively reduce their risk of myocardial infarction with aspirin therapy. The other 50-80% of people should consider another anti-platelet therapy such a Plavix" Clopidigrel or ticlopidine. The company believes all people at risk of a heart attack or stroke should have this test, including all patients undergoing bypass surgery, angioplasty or coronary stenting. BACK

Iron Sensitivity Test" is a genetic test able to identify presence of the hemachromatosis gene. This gene has been linked through studies to iron intake and heart disease. Hemachromatosis is a disease which allows too much iron to be absorbed from food. Utrecht University published a study of 12,239 women. Those who had just one copy of the hemochromatosis gene had double the risk of dying from heart disease or stroke, this data was confirmed by a similar study at the University of Kuopio in Finland. One in ten Americans have at least one copy of this gene. BACK

Salt Sensitivity Test", is a genetic test able to identify presence of variants of the HSD 11B2 gene (Allele A7/A7) which contribute to enhanced blood pressure response to salt. The prevalence of salt sensitivity was 35% in subjects with the allele A7/A7. Elevated blood pressure is a leading underlying cause of many forms of cardiovascular and heart disease. BACK

HDL Cholesterol Gene Test", is a genetic test under development designed to identify presence of the ATP- binding cassette transporter gene (ABC1). This gene regulates a protein that is crucial for intracellular cholesterol transport. HDL helps rid the body of artery clogging cholesterol. About half of heart disease patients have low HDL levels. BACK

Apolipoprotein E Test", is a genetic test under development designed to identify presence of the apoE polymorphism and the apoE e4/3 allele. Apolipoprotein E (apoE) is one of the genetic determinants of serum cholesterol values. The apoE e4 allele has been associated with advanced coronary heart disease and atherosclerosis of the aorta.

In men who are early middle age (<53 years) the apoE e4 allele is a significant genetic risk factor for coronary atherosclerosis. In older age other known risk factors of coronary heart disease play a more important role than the apoE polymorphisms. Men <53 years old with the apoE e4/3 genotype showed 61% larger total antherosclerotic lesion area in their right coronary artery and 26% larger area in left anterior descending artery than did men with the e3/3. BACK

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