SUPER BRIEF HISTORY Leonhardt Ventures founded in 1982. Has since raised $145 million that has been invested in the development of over 28 innovations and companies. 21 direct Leonhardt patents and over 70 acquired or licensed patents or technologies. 1982-1985 – Built dozens of cardiac cath labs & ICUs around the world. 1986-1994 – Developed world leadership in polyurethane balloon cardiovascular catheters. 1995-1998 – Developed world leadership in stent grafts and percutaneous heart valves. 1999 – 2008 – Developed world clinical leadership in stem cell repair of damaged heart muscle. 2009 – Launched Leonhardt’s Launchpads Life Science Incubator. 2008 to 2012 – Developed world leadership in the development of electrical stimulation for stem cell therapies. 2012 – Launched Cal-X Stars Innovation & Business Accelerator.
SUPER BRIEF HISTORY Major Exits Leonhardt Ventures and Core Manufacturing Team Pacesetter Systems $1 billion > Siemans/St. Jude AVE $4.3 billion > Medtronic (via WorldMed merger) Minimed $4.3 billion > Medtronic Advanced Bionics $800 million > Medtronic World Medical Mfg. Corp. $70 million > AVE Bioheart $60 million > IPO 2008 (stock price down since) Note – We in no way attempt to claim full credit.
Market = 50 million+ people in heart failure. $40 billion + Magnitude Problem = 25 million about to die in next 5 years with current therapies. Current Pain = No other therapy regenerates scar tissue back to muscle.`
Cost to Produce = $3000 Sell price = $29,000 Gross Profit = $26,000 per unit Reimbursement = $58,000 for procedure = to CRT Pacer, less than LVADs Total Annual Sales = $9 billion
Proven Team – The Leonhardt and Core Manufacturing teams have had more than $15 billion in exits in this space already. Track Record = Pacemakers, Insulin Pump, Cardio Catheters, Stent Graft, Intravascular Lung Catheter, Pain Pump, Percuntaneous Heart Valve, Heart Pumps, Stem Cell Therapies, Stem Cell Recruiting Heart Pacer, Biological Pacers, Wireless sensors.
MYOBLAST ENGRAFTMENT POST- TRANSPLANTATION Contractile muscle tissue growing in the scarred portion of the heart following treatment with myoblast injections. Human Heart, Proof of Concept * Hagege et al., Viability and Differentiation of Autologous Skeletal Myoblast Grafts in Ischemic Cardiomyopathy, Lancet, Vol. 361, 2003: 491-492
Scar tissue following heart attack Injection of skeletal myoblasts into scar tissue using deflecting-tip catheter Cell manufacturing following thigh muscle biopsy 1 3 2
BIO-LEONHARDT METHOD Pre-Treat Scar 1. Micro-RNAs (helps converts scar to muscle). 2. Nutrient hydrogel 3. Electrical stimulation via MyoStim Pacers of San Diego, California (produced at Core Manufacturing in Los Angeles). 4. Growth factor infusion ie; VEGF, SDF-1, HGF 5. Granulocyte colony stimulating factor. 6. Endothelial progenitor cells derived from adipose tissue. Treat Scar 1. TANAKA cardiac progenitor cells derived from skeletal muscle as developed in Japan 2. Cardiac stem cells delivered at rim edge of scar. 3. SDF-1 via Ono Pharmaceuticals in Japan. 4. Nutrient hydrogel 5. Electrical stimulation from MyoStim Pacers San Diego. 6. Injection of iPS cells with MicroRNAs. 7. Cardiobridge or Procyrion implantable pump to allow heart to rest during healing process. Post Treat Scar 1. Repeat injections of all of the above. 2. Continued electrical stimulation. 3. Continued delivery of nutrient hydrogel and growth factors.
(1) The Kanno program stimulates angiogenesis (new blood vessel growth). (2) The Chachques-Leonhardt program recruits stem cells to injured heart tissue areas and proliferates them (includes resident cardiomyocytes). (3) The Leonhardt-Chachques program differentiates recruited and/or injected stem cells to beating heart muscle. (4) The Leonhardt program senses arrhythmia's-fibrillation and delivers a low voltage pulse to restart a patient's heart back to a normal beat. (5) The final program is a standard synchronization-pacing program.
STIMULATION OF ANGIOGENESIS Capillary density in rat TA muscles. Number of capillaries was counted in at least 8 different fields, and capillary density was obtained by calculation of capillary/muscle fiber area.