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Executive Summary

BioLeonhardt –       www.bioleonhardt.com  – The world’s first 6 component heart failure treatment therapy combining;  micro RNAs, SDF-1, muscle stem cells, iPS or cardiac stem cells, nutrient hydrogel and electrical stimulation.

Elevator Pitch:   The first implantable stem cell/growth factor pump + microcurrent regeneration stimulator designed to regenerate 100% of damaged heart muscle 100% of the time.   First device to fight for limb salvage with a progressive aggressive protocol.

Problem:  No other therapy completely converts heart scar tissue back to beating pump muscle reliably.   No other therapy utilizes multiple therapies for limb salvage.

Solution:  The BioLeonhardt device is implanted in the abdomen with an infusion pacing lead directed to the center of the heart scar tissue.  The device is re-fillable and programmable.

Stage of Development:  Completed muscle stem cell clinical trials separate through Phase II.  Completed repeat injection studies in pigs.  Completed SDF-1 studies in small animals.  Completed microcurrent studies for diabetic foot ulcers Phase II in Europe.  Preparing for first combination devices studies in large animals and then clinical later this year.

Forecasted Sales Year 1 = $300 million, Year 2 $800 million, Year 3 $2 billion, Year 4 $4 billion, Year 5 $5 billion

Management Team:  Howard Leonhardt CEO,  Dr. Stuart Williams VP Research, Dr. Nic Chronos VP Clinical, Dr. Jorge Genoves VP Electrical Stimulation, Jeff Donofrio VP Sales Heart, Tom Newman VP Sales Peripheral, Brian Hardy Director of Marketing, Sofia Yepes Office Manager

Lead Scientists:  Dr. William Abraham, Chief of Heart Failure Ohio State, Dr. Barry Greenberg Chief of Heart Failure UCSD San Diego,   Dr. Eric Duckers Utrecht University

 

Executive Summary                                                                                             BioLeonhardt

 

BioLeonhardt is focused on the development and sales of implantable stem cell pumps for directing stem cell regeneration and healing.   The company has developed and patented two product lines:

 

  1.      The BioLeonhardt Stem Cell Pump for heart muscle regeneration and repair.
  2.      The BioLeonhardt Stem Cell Pump for treating critical limb ischemia and diabetic foot ulcers – Peripheral Vascular.
  • Both models available with 2ml or 20ml chambers and with or without electrical stimulation option.

 

The company expects to receive FDA 510K clearance and CE Mark to sell its devices into the peripheral vascular market late spring of 2015.   The expected cost is $4500 in low volume, $800 in high volume, and expected sell price is $7500.

 

The BioLeonhardt Stem Cell Pump for Heart Muscle Regeneration is expected to receive Category B designation permitting reimbursement of $27,000 per device entered into clinical trials.  The heart repairing stem cell pump costs $7000 to produce in low volume, $1200 in high volume, with an expected sell price of $27,000 to $70,000 each.

 

 

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.  Other therapies with one single time deliver do not provide a complete solution.   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 = The BioLeonhardt stem cell pump delivers stem cells, growth factors, micro RNAs, nutrient hydrogels and other agents directly into patients heart scar tissue over time and converts those cells to new beating pumping muscle with a vibrant blood supply thus 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 = Delivers stem cells + growth factors directly to wound site and stimulates the over expression of the stem cell homing signal protein SDF-1 which is also a powerful arteriogenic agen.
2.  Multiples recruited and delivered stem cells to greater quantities at wound site.
3.  Increases blood flow at wound site 3X (from delivering and recruiting endothelial progenitor cells and increased expression of VEGF).
4.  Decreases pain at wound sites.

 

Strategy  –   1. Add to current estate of patents.   2.  Get to $30 million in annual sales for peripheral product.  3.  Get to $2 million in annual sales selling to research labs and vet clinics.   4.  Get Phase II data on heart stem cell pump in over 100 patients published – all cases reimbursed during trials.   5.  Auction company off to highest bidder on May 11th, 2018.

Building patent position claims 1.  Delivers and recruits 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.  11.  Multi-stage muscle building program – A. Pre-treat scar.  B.  Treat scar.  C.  Post implantation treat scar.  D.  Repeat.

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.

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Competition – Heart = Drugs minus 4 meters decline, Standard CRT pacers 16 meters, Stem Cells = 53 meters, LVADs = Temporary, BioLeonhardt *200 meters+.  Peripheral = Dressings, Bypass, Stenting, Ballooning, Stem Cell Injections, Drugs