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Micro Stimulator

The BioLeonhardt Micro Stimulator + Stem Cell Micro Pump combination device is the first ever designed to deliver 100% regeneration of a failing heart reliably 100% of the time.

The BioLeonhardt Micro Stimulator + Stem Cell Micro Pump is implanted in the patients abdomen for 36 months with a pacing infusion lead with a corkscrew tip directed to the center of the patients heart scar tissue.  The micro pump is re-filled cardio angiogenic and cardio myogenic cocktail compositions once a week with slow timed infusion delivery to the heart scar tissue programmed.

We have patented a device that delivers precise bioelectrical signals to tissues, just like the brain does, that communicates with the DNA of cells in those tissues to program those cells to release specific proteins for specific purposes in the exact location they are needed and at the exact time they are needed.  We have signals for recruiting stem cells to any location = SDF-1, for growing new blood vessels = VEGF, for growing muscle = Follistatin, for repairing damaged DNA = IGF-1 and for increasing elasticity of tissues = Tropoelastin as well as others such as HGF, eNOS, RANKL, Anti-VEGF and Anti-Cell Division signals.   We also have signals for controlling the differentiation of stem cells into specific tissues such as muscle, breast tissue, brain neuron cells, liver, eye, kidney, lungs or pancreas.    We have complimented this patented regeneration micro stimulator technology with a patented stem cell and growth factor micro pump that can be refilled once a day, once a week or once a month as chosen for programmed timed infusions of cells and growth factors to the organ being regenerated.  We believe the combination of the regeneration stimulator and the stem cell micro pump together is the first product ever developed that can deliver total organ regeneration on a reliable consistent basis. 

The micro stimulator runs through 10 programmed signals that cause the stimulated tissues of the heart to release specific proteins for specific purposes.  The first and most important is the SDF-1 signal for recruiting repairative stem cells to the heart.  The Follistatin signal promotes muscle repair.  The eNOS and VEGF signals improve blood supply to the heart.  The insulin growth factor IGF-1 signal greatly enhances heart regeneration.  The hepatocyte growth factor HGF signal helps in three ways – aides creation of a new blood supply, supports regeneration and most importantly reduces risk of irregulator heart beats know as arrhythmias.  Activin and epidermal growth factor signals support regeneration.  Tropoelastin is a special signal that increase elasticity of previous stiffened scar tissues and keeps that tissue elastic for years to follow.  A differentiation signal converts recruited stem cells to beating pumping pumping new muscle tissue within the scar and the final signal of the micro stimulation program ensures the newly created muscle beats in synchrony with the rest of the heart.  

 

The end result by design is a fully regenerated and healthy heart at the end of the 36 month treatment cycle.

 

1.  SDF-1 (stem cell homing signal).

2.  Follistatin (muscle regeneration signal).

3.  eNOS and VEGF (blood flow improvement signals).

4.  Tropoelastin (increases elasticity of treated tissues).

5.  IGF-1 (DNA repair)

6.  HGF (regeneration promotor and arrhythmia protection).

7.  Activin (regeneration promotor).

8.  EGF (regeneration promotor).

9.  Stem cell differentiation into beating pumping muscle.

10.  Synchronization heart beat signal. 

 

Warning:  Available for investigational use only.   Not yet proven to be safe and effective from double blinded, randomized, placebo controlled trials. 

 

BioLeonhardt www.bioleonhardt.com is a Leonhardt Ventures Co. incubating within the Cal-X Stars Business Accelerator, Inc. in Santa Monica, CA and Leonhardt’s Launchpads Utah in Salt Lake City.   Leonhardt Ventures first introduce electrical stimulation devices for improving blood flow in the 1980’s working closely with Dr. Robert O. Becker the author of the best selling book The Body Electric.  Leonhardt associated research team members Dr. Race Kao and Dr. George Magovern completed the first regeneration of an damaged animal heart in 1988 published in The Physiologist.  In 1991 Leonhardt research collaborator Dr. Stuart Williams began filing a series of patents for harvesting stem cells and endothelial progenitor cells from adipose (fat) tissue.  In 1993 Howard Leonhardt filed the first of a series of patents for stem cell delivery systems – the PRO-CELL.  In 1998 Leonhardt research collaborator Dr. Doris Taylor published a landmark paper in Nature Medicine documenting the ability of muscle stem cells to create new muscle in heart scar tissue.  In 2000 Howard Leonhardt began filing a series of patents utilizing bioelectric stimulation to control specific protein releases supporting tissue and organ regeneration working with Dr. Juan Chachques and Dr. Jorge Genovese.   A Leonhardt led team co-led by Dr. Patrick Serruys in Rotterdam, The Netherlands completed the first-in-man non-surgical repair of a failing human heart in May 2001.   Since then more than 400 patients worldwide have been treated with muscle stem cell treatments in various clinical trials.  One Leonhardt led and sponsored Phase II/III clinical trial demonstrated 95.7 meters improvement in exercise capacity 6 minute walk over placebo with just one single session of muscle stem injections in hear scar tissue.  The new protocol with the micro infusion pump calls for this dosing once per week for 432 weeks in a row supported by a multitude of supporting growth factors, micro stimulation signals, matrixes and nutrient hydrogels.  Leonhardt help lead with Dr. Felipe Prosper and Dr. Jesus Herreros in Spain a large animal study published in the European Heart Journal in 2011 demonstrating that repeat injections of muscle stem cells provided dramatically better cardiac functional improvement and reduction of nearby fibrosis than just a single session of deliveries.  Leonhardt worked with Dr. Marc Penn and Dr. Stephen Ellis at Cleveland Clinic to study the improvements to heart regeneration derived from SDF-1 and eNOS.  

 

All this accumulated knowledge since the 1980’s has led to the latest generation BioLeonhardt heart regeneration protocol with 10 micro stimulation signals and micro infused compositions made up over of 15 individual components and cell types.   We believe this product represents a giant leap forward in treating heart attack recovery and heart failure.  Translational studies are being launched this year.