myostimpacers

1. Enhancing the body’s natural Healing and Regenerative Resources www.myostimpacers.com

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

3. $ Clinical IP Patents

4. Electrical Stimuli Act on Multiple Regenerative Pathways

5. Market Size

6. Wound Healing

7. Armed Forces Institute of Regenerative Medicine Limb and Digit Projects – Goal: RECRUITING CELLS FOR REGENERATION Taking 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.
 AFIRM

8. Proposed Mechanisms of Action for Wound Healing  (MWHD-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. • Multiply recruited stem cells to greater quantities at wound site. • Increases blood flow at wound site 3X (from recruiting endothelial progenitor cells and increased expression of VEGF). • Decreases pain at wound sites. • Decrease edema. • Debrides necrotic tissue. • Attracts neutophils and macrophages. • Stimulates receptor sites for growth factors and growth factor expression. • Stimulates growth of fibroblasts and granulation tissue. • Stimulates neurite growth. • Induces epidermal cell migration. • Induces repair myoblast cell migration. • Prevents post-ischemic oxygen radical mediated damage. • Inhibits bacteria. • Reduces number of mast cells.  MyoStim’s Support for AFIRM

9. Gardner SE, Frantz RA, Schmidt FL. SourceColleges 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. Effect of electrical stimulation on chronic wound healing: a meta-analysis.

10. 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

11. 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)

12. Provide 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 Business Model

13. 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 Market Development

14. Remote Programming, Monitoring & Management • Pad computer & mobile phone interface • Data transport compatible with existing infrastructure • Software interface to institutional data repositories Product Features

15. Product Roll-out • 2013 Limb Salvage/Wound Healing • Sales / lease of devices Revenue • marketing, mfg, clinical trials, distribution Costs • 2017 Heart Repairing ICD implantations revenue Revenue marketing, mfg., clinical trials, distribution Costs

16. Cardiac Targets

17. Validation "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 • “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

18. MHRD-1 $ Clinical IP Implantable Heart Repairing Device • Recruits Stem Cells to site of injury • Differentiates cells to heart cells • Stimulates creation of new blood vessels • Stimulates heart muscle growth • Increases contraction strength of muscle • Ensures heart remains synchronized • Significant improvement in patient health 20m 100m

19. www.myostimpacers.com • info@myostimpacers.com • Alan Remen, CEO(858) 231-3606 Contact Information