Executive Summary MyoStim Pacers, Inc.
MyoStim Pacers, Inc. is focused on the development and sales of microcurrent devices for directing stem cell regeneration and healing. The company has developed and patented two product lines:
- MyoStim Heart Repairing Pacemaker for heart muscle regeneration and repair.
- MyoStim Microcurrent Stimulator for treating critical limb ischemia and diabetic foot ulcers – Peripheral Vascular.
The company has FDA 510K clearance and CE Mark to sell its devices into the peripheral vascular market. The stimulator sells for $7500 each with a cost of $4500 in low volume and expected cost of $800 in high volume.
The MyoStim Heart Repairing Pacemaker is expected to receive Category B designation permitting reimbursement of $27,000 per device entered into clinical trials. The heart repairing pacemaker costs $3000 in low volume with expected cost of $800 in high volume.
Problem – Heart = More than 50 million people worldwide suffer of heart failure. 50% of them will die within 3-5 years of diagnosis with current treatments. No other therapy effectively recovers post heart attack scar tissue back to beating pumping muscle. Peripheral Vascular = Over 100 million people worldwide suffer of peripheral artery or venous disease due to lack of blood flow in the legs. The lack of blood flow creates painful and dangerous open wound leg and foot ulcers that often lead to leg amputation and death. No other therapy reliably renews blood flow in legs to the feet to heal ulcers on a sustainable basis.
Solution – Heart = MyoStim’s device recruits stem cells with a homing signal to a patients heart scar tissue and converts those cells to new beating pumping muscle curing permanently the damaged heart. Peripheral Vascular = MyoStim’s device causes tissues to release angiogenic growth factors which grow new blood vessels and heals ulcers.
Mechanisms of Action:
Primary = 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. Multiples 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. Decreases 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.
Strategy - 1. Add to current estate of 3 pioneering patents. 2. Get to $30 million in annual sales for peripheral product. 3. Get Phase II data on heart stimulator in over 100 patients published – all cases reimbursed during trials. 4. Auction company off to highest bidder on May 11th, 2018.
Pioneering Patent Claims = Electrical signals to… 1. Recruit stem cells to specific location. 2. Multiple stem cells on demand. 3. Multiple resident cardiomyocytes. 4. Cause tissues to release blood vessel growing proteins ie; SDF-1, VEGF, MCP-3. 5. Differentiate stem cells to muscle. 6. Ensure new muscle beats in synchrony with host heart. 7. Accelerate rapidly healing of wounds. 8. Reduces infection risk. 9. Reduces pain. 10. Recovers defibrillating heart with rapid low voltage pulses.
Management Team – Solid experience in bringing multiple cardiovascular concepts to market leadership since the early 1980’s. 10 focused executives on management team. Over 70 business mentors and board members. Over 35 opinion leader Scientific Advisory Board Members.
_________________________________________________________________________________________________________Business Model = Sell direct in the USA to physicians and hospitals. Sell through distributors overseas. Get opinion leaders to present data at major meetings. Attend over 20 cardiovascular meetings a year with showcase. Publish data.
Competition - Heart = Drugs minus 4 meters decline, Standard CRT pacers 16 meters, Stem Cells = 53 meters, LVADs = Temporary, MyoStim *200 meters. Peripheral = Dressings, Bypass, Stenting, Ballooning, Stem Cell Injections, Drugs