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Leonhardt’s Launchpads Update

Innovation and startup accelerator focused on applying bioelectrics and biologics to organ regeneration and recovery.

What is special?

  • Total organ regeneration with combination of bioelectrics and biologics.
  • Many ailments treated successfully with non-invasive bioelectric stimulation alone.
  • Non-toxic bioelectric cancer therapy customized based on tumor read.
  • Controlled regenerative protein expressions by specific precise bioelectric signaling sequences = instructions to coax a body to repair itself.
  • Patented stem cell homing signals.
  • Patent pending Klotho anti-aging protein expression. Perhaps most powerful anti-aging protein.
  • Patent pending tropoelastin elasticity expression. Turns elasticity switch turned off at puberty back on.
  • Patent pending follistatin expression for muscle regeneration.
  • Patent pending real time inflammation management.
  • Patent pending bioelectric blood pressure management.
  • Patent pending bioelectric breast tissue augmentation.
  • Patented method to straighten teeth in 2/3rds less time and keep them straight.
  • Patent pending bioelectric erectile dysfunction treatment.
  • Superior circulatory assist device.
  • Technology to help people keep their own organs instead of getting transplants.

Link to Slide Deck > https://app.slidebean.com/p/u7ksTx4OXY/Accelerator-MidSized-Deck-New

Brief History
The Leonhardt team completed their first muscle stem cell repair of a large
animal heart in 1988 published in 1989. In 1991 Leonhardt developed the first
percutaneous heart valve. In 1995 the team completed the first
non-surgical repair or an aortic aneurysm without surgery in Australia.
Their first bioelectric regeneration paper was published in 1999 in Circulation.
In 2001 Leonhardt led the team that completed the historic landmark first ever
non-surgical muscle stem cell repair of a human heart in The Netherlands. They
went on to complete pilot, Phase I,Phase II and Phase II/III clinical studies at over
40 centers around the globe for heart regeneration with a single endoventricular
injection session of muscle stem cells (immature myoblasts). Data from these
studies showed 83% of treated patients improved and only 17% worsened. In
placebo and control patients more than 42% worsened. In Phase II/II double
blinded randomized studies treated pts improved 91.7 meters in 6 minute walk
compared to a minus 4 meters decline in placebo pts.

In 2008 Leonhardt’s Launchpads as an innovation lab was formed to leverage
everything the team had learned about organ regeneration since 1988
and apply it toward developing not only the next generation therapy for heart
regeneration but to explore options to use the core technology for regenerating
other organs such as liver, pancreas, kidney, aortas, skin, hair, eye vision, ear
hearing and more. The team committed to a strategy of combining bioelectric
stimulation with a re-fillable micro infusion pump and a fifteen + component
stem cell and support factors organ regeneration composition.

The core team and board has led multiple products from concept to market leadership
and exit in the past.

PROGRESS

  • 30 startups in the accelerator – https://leonhardtventures.com/development-pipeline/
  • Heart & Cardiovascular 8 startups.
  • Brain 1 startup.
  • Cosmetic & Personal Care 7 startups.
  • Major Organ Regeneration 12 startups.
  • Cancer 1 startup.
  • 13 products at clinical stage of development.
  • 17 products at pre-clinical stage of development.
  • Data on 250 patients for bioelectric therapy.
  • 400 patent claims issued, pending, optioned or licensed.
  • Early data shows > 83% success rate and no serious adverse effects.
  • Over 30 patented or patent pending bioelectric protein expressions including SDF1, PDGF, IGF1, HGF, EGF, HIF1a, VEGF, eNOS, follistatin, tropoelastin, klotho, sonic hedgehog.
  • Full suite of real time inflammation patent claims.
  • Full suite or blood pressure management patent claims.
  • Full suite of bioelectric cancer therapy patent claims.
  • Klotho may be most powerful anti-aging protein known.
  • SDF1 and PDGF are stem cell homing proteins.
  • Full suite or angiogenic (blood vessel formation) proteins.
  • Recent Milestones
  • Published two positive MyoStim ED clinical studies and completed enrollment in a third with additional bioelectric signaling sequences.
  • Published data on 176 EyeCell patients.
  • Enrolled 37 patients in OrthodontiCell study.
  • Enrolled 12 patients in HairCell study.
  • Launched SkinStim study.
  • Launched BladderCell study.
  • Completed 23 patients in Vascustim studies.
  • Completed 15 large animals in Stem Cell Bra studies.
  • Completed TestiStim single patient pilot study.
  • PressureStim IP validated by 3 independent studies in Asia.
  • KidneyCell IP validated by independent study in Brazil.
  • CancerCell animal study launched at UCLA.
  • Filed 180 new patents claims in 2018 alone.
  • Expected Upcoming Milestones (Subject to Change)
  • Launch Second Heart Assist clinical study.
  • Launch Stem Cell Bra clinical study.
  • Launch CerebraCell clinical study.
  • Launch TestiStim full study.
  • Complete BioLeonhardt large animal study at Texas Heart Institute.
  • Complete AortaCell large animal study at U of Virginia.
  • Complete Valvublator surgical pilot study in Italy and Paraguay.
  • Launch new PressureStim study.
  • Complete new EyeCell study.
  • Launch OrthoStim study.
  • Secure BioPace NIH grant.
  • Complete DentaCell clinical studies.
  • Launch LiverCell clinical studies.
  • Launch KidneyCell new study.
  • Launch PancreaCell clinical study.
  • Launch CancerCell clinical study.
  • Exit 5 startups by early 2020.

Executive Management
Team > https://leonhardtventures.com/team/
Scientific Advisory Board > https://calxstars.com/scientific-advisory-board/

Howard J. Leonhardt
Executive Chairman & CEO
hleonhardt@secondheartinc.com
*Has brought multiple cardiovascular products to leadership since 1986.

Dr. Leslie Miller
Chief Medical Officer
lmiller@secondheartinc.com
*241 peer reviewed publications, 80+ clinical trials, former Chairman Cardiovascular Medicine U of Minnesota for over a decade.

Jeff Donofrio
Executive President
jdonofrio@secondheartinc.com
*Helped launch Cardiac Assist in USA.

Larry Stevens
Chief FDA Regulatory Compliance Advisor
lstevens@secondheartinc.com
*Over 20 years FDA Examiner device section.

Alex Richardson
Vice President Engineering & Product Development
arichardson@secondheartinc.com
*Over 30 years experience developing medical devices many serving Alfred Mann Cos.

Ken Evans
Vice President Corporate Development & Physician Relations
kevans@secondheartinc.com
*Over 30 years medical device launch experience.

Dr. Stuart K. Williams
Vice President Biologics Research
cvregen@gmail.com,
*Over 30 years regeneration research experience. Original inventor of stem cells from fat tissue.

Dr. Jorge Genovese
Vice President Bioelectric Regeneration Research
genoveseja@yahoo.com
*Over 25 years bioelectric regeneration research experience formerly at McGown Pittsburgh and U of Utah.

Jeremy Koff
Vice President Strategic Development
jeremykoff@colibripartners.com,
*25 years experience with Advanced Bionics and other startups many Alfred Mann Cos.

Dr. Brett Burton
Vice President R&D
bburton@secondheartinc.com
*PhD. Bioengineering, 7 years experience.

Market Size
$1000 billion +

Markets

  • Organ regeneration = $500 billion +
  • Bioelectric cancer treatment = $23 billion +
  • Teeth straightening = $6 billion +
  • Circulatory assist support = $5 billion+
  • Inflammation management = $9 billion+
  • Blood pressure management = $23 billion+

Valuation Comparables – Competition

  • Samumed = $12 billion.
  • Shock Wave = $1 billion million
  • Novocure = $4.3 billion
  • Abiomed = $12 to $21 billion
  • Align Tech = $31 billion