Implant Delivery Device Components

BMI has contracted with an ISO 9001/GMP contract manufacturing company in Connecticut for the development, testing and production of certain components of BMI's myocardial implant delivery system which has been specially designed to deliver the implants. BMI has also arranged for supply of articulating guide catheters from an ISO/9000 manufacturer in California. These catheters are already marketed in the U.S. with FDA approval for another purpose (electrophysiology mapping).

BMI's Proposed Myocardial Implant Systems. Below is a description of the various components for BMI's currently proposed microimplant systems:

Delivery System (laproscopic and/or endovascular)

    • Specialized sliding injection needle assembly with corkscrew tip for precision depositing of myocardial implants into heart muscle wall.

    • Articulating guide catheter for positioning needle assembly.

    Myocardial Implant

      • Autologous immature myoblasts from skeletal muscle, stem cells from bone marrow stromal cells and/or from embryonic stem cell culturing with a patient's own genetic material. Cardiomyocytes cultured from biopsy with Townsend method.

      • Growth factors, both fibroblast (FGF) and vascular endothelial (VEGF).

      • Nitric oxide synthase and/or Larginine for improving angiogenesis.

      • Pyruvate for improving catecholamine activity which stimulates cardiac function.

      • Angiopoiten 1 tie receptors for improving functionality of angiogenic vessels.

      • Agents for improving contraction of heart muscle.

      • Placenta and cord blood derived cellular mixtures.

      Potential Accessories

        • Monophasic action potential mapping probe at tip of guide catheter.

        • Porous biodegradable ceramic or dermal fibroblast housing.

        • Stainless steel "corkscrew" implant device.

        • Electrical or ultrasonic stimulation device for improving uptake of implant components.

        • Viral vectors for improving uptake of growth factors.

        Bioheart Microimplants, Inc. will test its various prototypes in animals to determine the optimal combination of components that most closely achieves the following goals:

          • MYOGENESIS - Regeneration of heart muscle area damaged from previous myocardial infarction.

          • Angiogenesis – the growth and development of 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.

          • Improved cardiac function (the ability of the heart to pump).

          BMI's proposed microimplant technology will involve the insertion by catheter of a number of small implants into the heart muscle, by utilizing cardiac catheter technology (including BMI's specialized sliding implant injection needle) to reach the heart through blood vessels accessed elsewhere on the body or through the patient's chest via a port hole (the Company also plans to have implants applied during open heart surgery for patients already undergoing surgery). BMI's initial experimental implant designs will be composed of various components, and are designed to facilitate heart muscle regeneration with autologous cells (cells derived from the patient's own body) and angiogenesis (growth of supplemental blood vessels to supply more blood to the heart muscle). Later prototypes and studies are planned to involve the addition of other components including (i) stem cells and other cellular tissue for regeneration of heart muscle tissue, and (ii) various growth factors and other ingredients to increase the implant's effectiveness for heart muscle regeneration and angiogenesis. However, BMI is only in the very early conceptual stages with respect to the more comprehensive types of implants, and cannot predict when prototypes or testing thereof will commence. There are also a variety of other technologies and products that BMI will be evaluating, and it is impossible to predict whether the proposed microimplants or any other technology will be BMI's first commercialized product. There can be no assurance that any products proposed by BMI will be successful in testing or will ever become available for sale or use on humans.

          Microimplant Technologies Being Developed Directly by Bioheart Microimplants, Inc. In addition to its pursuit of technology from independent sources, BMI is also in the process of developing and filing patent applications for its own related inventions, developed in house. These include the following (all in process of being filed by H. Leonhardt, CEO of Bioheart):

            a. Multi-component Cellular Pellet for Heart Muscle Regeneration, Angiogenesis and Improved Cardiac Performance

            Example:  Combining Autologous Derived Skeletal Muscle Cells with Bone Marrow Derived Stromal Cells with growth factors (FGF and VEGF), nitric oxide synthase and pyruvate.

            b. Delivery system to Inject Cellular Materials Into Myocardium

            Example:  Torqueable articulating guide catheter with slidable needle assembly movable within. Needle assembly able to inject cellular materials into heart wall. Stopper to control depth of needle penetration into heart wall.

            c. Porous degradable ceramic housing to avoid migration of cellular materials injected into heart wall and to provide time release of certain agents

            d. Utilization of Heart Tissue Biopsy to Create Micro-Environment Conducive To Differentiating Autologous Muscle Cells into Cardiomyocytes (heart muscle cells) in Lab Culture Dishes


          Bioheart, Inc.
          Cardiovascular Healthcare
          Service based on Genotyping