BioLeonhardt Executive Summary

About BioLeonhardt

BioLeonhardt was formed in 2012 to focus on heart regeneration utilizing the combination of (1) bioelectric signaling, (2) micro infusion pump delivery and a (3) mixed stem cell based composition for heart regeneration.

The core BioLeonhardt team has been working on heart regeneration since the 1980’s. Dr. Race Kao and Dr. George Magovern two research collaborators published their first muscle stem cell heart regeneration study in 1989 in The Physiologist. In 1992 Howard J. Leonhardt BioLeonhardt founder filed his first of a series of patents for cardiovascular catheters including a 1995 first patent for delivering stem cells in the heart and cardiovascular tissues. In 1994 Dr. Stuart Williams a BioLeonhardt founding member filed his first patents for harvesting cells from adipose tissue and applying them to therapeutic purposes. Dr. Doris Taylor co-Chair of our Scientific Advisory Board published myoblast based heart regeneration study in 1998 in Nature Medicine. The same year Dr. Jorge Genovese a BioLeonhardt founding member published his first paper on heart regeneration in Cell and Molecular Biology. In 1999 the team working with Dr. Shinichi Kanno published their first paper on bioelectric based regeneration in 1999 in CIRCULATION a Journal of the American Heart Association. In 2000 Howard Leonhardt began filing a series of patents for mixed composition, repeat delivery and bioelectric stimulation supported heart regeneration. He has since filed more than 100 related patent claims. The Leonhardt team lead heart regeneration studies in dogs in 2000 with Dr. Dan Burhoff and Dr. Warren Sherman at Columbia University that led to the historic first ever non-surgical muscle stem cell repair of a human heart in May 2001 in The Netherlands with Dr. Patrick Serruys, Dr. Pieter Smits, Dr. Warren Sherman and Dr. Doris Taylor. This lead to Pilot FIM, Phase I, Phase II and Phase II/III published studies in JACC, EuroIntervention and The American Heart Journal. A repeat injection study was completed in 2011 with Dr. Felipe Prosper in Spain in large animals and was published in the European Heart Journal. Phase II/III double blinded, randomized, placebo control interim results with just one session delivery of immature myoblasts with an endoventricular delivery catheter demonstrated 84% of treated patients improved while only 16% worsened. 69% of control and placebo patients worsened. Treated patients improved 91.7 meters in six minute walk while control and placebo patients worsened minus 4 meters decline. The Leonhardt team led studies at Cleveland Clinic with Dr. Marc Penn and the University of Florida with Dr. Barry Byrne that demonstrated a nearly doubling of cardiac improvement by adding SDF-1 to immature myoblast injections in treating infected and failing animal hearts.

The team is currently undertaking lab and animal studies of its combination therapy at the University of Utah and other locations and plans to enter clinical trials in late 2019.

The BioLeonhardt research team is on a path through careful studies to attempt to prove out that a combination of bioelectric signaling + repeat slow infusion deliveries of a mixed stem cell and growth factors composition will provide superior heart recovery results to a single one time injection session of stem cells all alone with no support factors.

The BioLeonhardt therapeutic regime is divided into three distinct protocols for treatment.

1. Pre-treat myocardial scar = growing a blood vessel network and creating a myogenic milieu.
2. Myocardial scar treatment = growing new contractile muscle in scar tissue.
3. Post-treatment maintenance = managing inflammation, maintaining beat to reduce arrhythmia risk, fibrosis reduction, blood pressure management.

BioLeonhardt is headquartered in Los Angeles California and has a satellite lab in Utah via its affiliation with Leonhardt’s Launchpads Utah.

BioLeonhardt has a Scientific Advisory Board comprised of over 35 leading clinicians and scientists – https://calxstars.com/scientific-advisory-board/

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

 

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