Www.myostimpacers.com 1 E NHANCING THE BODY ’ S NATURAL H EALING AND R EGENERATIVE R ESOURCES.

www.myostimpacers.com

1

ENHANCING THE BODY’S NATURAL HEALING AND REGENERATIVE

RESOURCES


Transformational IPMyoStim’s patented technology replicates and augments the body’s own natural bioelectric processes to therapeutically induce healing, regeneration, and perfusion.

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$ IPClinical

PatentsPatent #

Patent Description – of Low-Intensity Electrical Stimulation

US 6,988,004 Grows new blood vessels

US 7,341,062Repairs Myocardium by a combination of cellular based therapy and electrical stimulation

US 7,483,749 Generates the “homing’ signal to recruit Stem Cells to the site of injury


Electrical Stimuli Act on Multiple Regenerative Pathways


Market Size


Wound Healing


AFIRMArmed Forces Institute of Regenerative MedicineLimb and Digit Projects – Goal:RECRUITING CELLS FOR REGENERATIONTaking cues from salamanders that can re-grow limbs, this team is investigating mechanisms for recruiting large populations of stem cells to the site of limb and digit injury and then “instructing” these cells to form functional limb and finger tissue to replace the damaged or missing structures.


MyoStim’s Support for AFIRMProposed Mechanisms of Action for Wound Healing (MWHD-1)

1. Recruits stem cells from bone marrow, fat, muscle and circulating blood to wound site by stimulating the over expression of the stem cell homing signal protein SDF-1.

2. Multiply recruited stem cells to greater quantities at wound site.3. Increases blood flow at wound site 3X (from recruiting endothelial progenitor cells and

increased expression of VEGF).4. Decreases pain at wound sites.5. Decrease edema.6. Debrides necrotic tissue.7. Attracts neutophils and macrophages.8. Stimulates receptor sites for growth factors and growth factor expression.9. Stimulates growth of fibroblasts and granulation tissue.10. Stimulates neurite growth.11. Induces epidermal cell migration.12. Induces repair myoblast cell migration.13. Prevents post-ischemic oxygen radical mediated damage.14. Inhibits bacteria.15. Reduces number of mast cells.


Effect of electrical stimulation on chronic wound healing: a meta-analysis.Gardner SE, Frantz RA, Schmidt FL.Source Colleges of Nursing, The University of Iowa, Iowa City, IA 52242-7066, USA.

Abstract

The purpose of this meta-analysis was to quantify the effect of electrical stimulation on chronic wound healing. Fifteen studies, which included 24 electrical stimulation samples and 15 control samples, were analyzed. The average rate of healing per week was calculated for the electrical stimulation and control samples. Ninety-five percentage confidence intervals were also calculated. The samples were then grouped by type of electrical stimulation device and chronic wound and reanalyzed. Rate of healing per week was 22% for electrical stimulation samples and 9% for control samples. The net effect of electrical stimulation was 13% per week, an increase of 144% over the control rate.

http://www.ncbi.nlm.nih.gov/pubmed?term=Gardner%20SE%5BAuthor%5D&cauthor=true&cauthor_uid=10633009

http://www.ncbi.nlm.nih.gov/pubmed?term=Frantz%20RA%5BAuthor%5D&cauthor=true&cauthor_uid=10633009

http://www.ncbi.nlm.nih.gov/pubmed?term=Schmidt%20FL%5BAuthor%5D&cauthor=true&cauthor_uid=10633009


Wound Healing/Limb Salvage Device (MWHD-1)

Designed to:

Recruit stem cells to site of injury

Stimulate muscle tissue or muscle scar tissue to activate the release of angiogenic (blood vessel forming) proteins.

Form new blood vessels in ischemic or scarred areas

Enhance perfusion


MyoStim Wound Healing, Blood Flow Stimulator (MWHD-1) is designed for treating wounds secondary to peripheral limb ischemia, foot ulcers and other slow healing wounds. Electrodes are placed near the affected area, and on the blood supply routes to the affected area, and stimulation is administered over a course of physician directed treatment. An example of a treatment protocol is one (1) hour sessions for twenty-one (21) days. Our clinical study end point goals are:(1) To improve blood flow by a minimum of 30%(2) Foot ulcers healing by 70%. (3) Epidermal wound healing by 55%.(4) Dermal healing by 22%. MyoStim’s electrical stimulation therapy can be used alone or in conjunction with injections of adipose derived stem cells (Bioheart) or other angiogenic cells. It is believed that the combination of electrical stimulation and stem cell injections/infusions will be superior to either as stand alone therapies (subject to confirmation in well controlled clinical trials).

Wound Healing/Limb Salvage Device (MWHD-1)


Business ModelProvide as a FREE service to the Medical Professional

How Doctors get paid... Their office bills the patients insurance for the professional services

How MyoStim gets paid… bills the patients insurance for the technical services… The Doctor’s office is never billed……..

Who else does this? KCI Holter Monitor companies


Market Development Harbor-UCLA Medical Center Kaiser Permanente William Abraham, Ohio State University Medical Research Cooperative Research and Development Agreement (CRADA)

Veterans Medical Research Foundation DEPARTMENT OF DEFENSE BROAD AGENCY ANNOUNCEMENT for

Extramural Medical Research

FDA 510k path through collaboration with Manufacturing Partner


Product Features

Remote Programming, Monitoring & Management

Pad computer & mobile phone interfaceData transport compatible with existing

infrastructureSoftware interface to institutional data

repositories


Product Roll-out

2017

2013Limb Salvage/Wound Healing

Heart Repairing ICD

Sales / lease of devices

implantations revenue

marketing, mfg, clinical trials, distribution

Revenue

Costs

Revenue

Costs marketing, mfg., clinical trials, distribution


Cardiac Targets


Validation

“This invention could be regarded in the future as one of the most important developments in the fight to reduce

death from heart failure“

Dr. Juan Chachques, Director of Surgical and Clinical Research at

Broussais and Pompidou Hospitals in Paris, France

"This truly has the potential to be a landmark invention in the field of

heart failure treatment”

David Holmes, M.D., Chairman of Cardiology, Mayo Clinic


$ Clinical IP

MHRD-1

20m

100m

Implantable Heart Repairing Device Recruits Stem Cells to site of

injuryDifferentiates cells to heart cellsStimulates creation of new blood

vesselsStimulates heart muscle growthIncreases contraction strength of

muscleEnsures heart remains

synchronizedSignificant improvement in

patient health


Contact Information

[email protected] Remen, CEO

(858) 231-3606

http://www.myostimpacers.com/

mailto:[email protected]

Www.myostimpacers.com 1 E NHANCING THE BODY ’ S NATURAL H EALING AND R EGENERATIVE R ESOURCES.

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