LEONHARDT – Cal

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Cal-X Stars
Innovation and Business Accelerator
FOCUSED on Launching Great Cardiovascular and
Social Good Impact Companies
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.
Leonhardt Ventures’
Cal-X Stars Business Accelerator, Inc.
Presenter: Howard J. Leonhardt, Founder, CEO
1531 6th Street, Unit 401, Santa Monica, CA 90401
Office Direct 310 310 2534
 Elevator Pitch = All star team with over $14 billion in previous exits is
launching an unprecedented portfolio of breakthrough technologies
focused in two clear areas (1) cardiovascular and (2) social good impact.
Cardio disruptive technologies include the first stem cell recruiting heart
pacemaker, the first biological pacemaker, two revolutionary heart
pumps, the first implantable stem cell pump, the first stem cell therapies
for heart failure treatment, the first wireless energy device for directing
stem therapies non-invasively and the first stem cell recruiting women’s
bra. The social good impact portfolio is anchored by The California Stock
Exchange – the first conscious capitalism stock exchange duly designed
to aide life science and other growth cos to bridge the gap from friends
and family financing to a NASDAQ or NYSE IPO.
 One of a kind stand out technologies driven by proven team.
 FOCUSED on the launch process where the greatest equity is
available at the least cost = best FOCUS for investors.
Unmatched on two fronts
 Cardio - Heart failure is the leading economic drain on
the U.S. healthcare system today. Our technologies are
destined to cut these costs by more than one half. 50
million people are set to die from heart failure this
decade. We expect to save more than 30 million lives.
NO other technology rebuilds scarred heart with living
cells like ours does, the way hearts are built in the first
place. The combined R&D pipelines of Medtronic, St.
Jude, Boston Scientific and J&J do not come close to
match our pioneering patented portfolio in this space.
 Social good impact – The California Stock Exchange, the
first conscious capitalism stock exchange, is not just a
stock exchange it is the leading engine of innovation and
job creation and re-boots U.S. economic leadership for
this century. 23 million new U.S. jobs on the way, not just
any jobs but jobs people love! About to prove that doing
good is not just good for good sake but is good business.
For the people that believe in this they now have a home
marketplace.
Current Pains to the Customers
 Heart Failure = Leading economic drain on U.S.
healthcare system. 50 million about to die in next
3-5 years worldwide without a better solution. No
current therapy addresses underlying problem of
recovering heart scar tissue post heart attack.
 Social good impact financing = NYSE, NASDAQ,
VCs, Formal Angel Groups all fail to meet the
financing needs of life science and other social
good impact cos. years 3 to 9. It takes 9 years for
a good co these days to get to a NASDAQ IPO
up from 3 in the early 1980’s. Most life science
and other social good startups run out of seed
financing by about year 3. VCs and angel
groups increasingly want to see revenues before
investing. The FDA approval process has
lengthened to more than 5 years to get approval
for any major new breakthrough technology.
Our Solutions
 Heart Failure = We are the only ones that have
developed and patented a reliable way to convert
heart scar tissue into new living pumping muscle
which allows heart failure patients to recover.
 We are leaders in muscle stem cells, SDF-1,
electrical stimulation, nutrient hydrogel, implantable
stem cell pumps, wireless energy for growth factor
release and stem cell recruitment and
differentiation, perfusion improving heart pumps.
We are the only ones with the complete solution.
We pre-treat the scar, treat the scar with stem cell
transplantation creating new contractile muscle
and post treat the area to maintain and build on
original muscle growth. No one else comes close to
a complete solution. Where others are tapping out
at 53 meters improvement in a patient’s exercise
capacity we are expecting over 200 meters
improvement, or better.
Our Solutions
 Social Good Impact Financing – A new stock
exchange with new rules…
 Holistic analysis of companies including
innovation culture, R&D pipeline, morale, sense
of vision and purpose, long term commitment.
 No day trading.
 No short trading.
 Emphasis on promoting local investing.
 Greater transparency.
 Less volatility.
 A place where doing well by doing good will
become the norm rather than the exception.
Market & Strategy
 Heart Failure Market
 50 million patients and growing.
 Current cost > $150,000 ea annually to care for.
 We will cut this cost by more than one half.
 Cost to produce $5000. Reimbursement $58,000+
 We will create, make and sell. Our primary
strategy is to win the prime time podium at the
major cardio meetings by winning support of the
opinion leaders. We have done it before and
can do this again.
Market & Strategy
 The California Stock Exchange
 Over 1 million great U.S. social good impact and life science seeking
better financing options.
 Over 1 billion potential investors worldwide that believe that the better
future is… one where companies that treat people and their
communities well win and take their investors along on this win.
 The current cost of an NASDAQ IPO is $2.3 to $4.8 million. We will cut
this range down to $40,000 to $450,000.
 Investors are on a roller coaster ride on Wall Street with the over
emphasis on short term quarterly net profits at all costs including
cutting R&D and people. We will get them off this roller coaster.
 The current financing systems favor men owned enterprises over
women owned 95:5. We will end this gender gap and gain the
support of 50% of the world’s population in the process.
 We will prove with solid data that treating people and communities
well with a product with a true sense of purpose is not just good for
good sake, but is good business. Companies with this conscious
capitalism model will attract the most talented members. This will
foster innovation and superior customer service. This leads to happier
repeat customers which leads to more reliable steady returns for
investors. For the people that believe in these principles this will be
their home marketplace. We will attract a whole new class of investors
in the marketplace.
Competition
 Heart Failure
• In-direct = Medtronic, Boston Scientific, St. Jude with pacers =
only 16 meters improvement.
• In-direct = HeartWare, Thoratec, Cardiac Assist, Abiomed with
mechanical artificial heart pumps – they do nothing to repair
problem they only allow pts to live temporarily with problem.
Low quality of life.
• In-direct = All CHF drug manufacturers. $8 billion is spent ea yr
on these drugs. Their performance is minus 4 meters decline
in exercise capacity.
• Direct = Mesoblast, Cytori, Aastrom, NeoStem, Cardio-3, Osiris,
Capricor. None of these cell types can grow new contractile
muscle in scar tissue. All of them are one dimensional
incomplete solutions. Their best result is 53 meters
improvement as a group. Osiris with allogeneic bone marrow
comes in a 10 meters.
• We have achieved 95.7 meters improvement already in
Phase III trials and animal data indicates we should be to over
200 meters with SDF-1 and repeat delivery alone and we are
adding many more enhancements with the new generation
of developments.
Competition Table
Improve
Scar Tissue
Repair
FDA Sales
Medtronic
16 mtrs
No
Y
$3 bil.
St. Jude
16 mtrs
No
Y
$2 bil.
Boston
Scientific
16 mtrs
No
Y
$2 bil.
CHF Drugs
-4 mters
No
Y
$8 bil.
Mesoblast
53 mtrs
No
N
Valuation
$2 billion
Capricor
53 mtrs
No
N
?
Osiris
10 mtrs
No
N
?
Cytori Therap.
53 mtrs
No
N
Valuation
$500 mil.
NeoStem
?
No
N
?
Cardio-3
53 mtrs
No
N
Valuation
$300 mil.
LEONHARDT –
Cal-X Stars
*200
mtrs
YES!
N
*$6 bil.
* = projected
Competition Table
Holistic
Analysis
Clear
Branding
Min.
IPO
Total IPO
Cost
NYSE
No
No
$1 bil.
$5 mil.
NASDAQ
No
No
$100
mil.
$2.3 to
$4.8 mil.
OTC Markets
No
No
?
?
BATS
No
No
?
?
TSX Venture
No
No
?
?
Cal-X
Yes
Yes
$8 mil.
$40K to
$450K
Management Team
 We have built an all star team of over 40 proven industry
veterans with over $14 billion in exits in the cardiovascular
space alone. Our scientific advisory board, research and
clinical investigation teams includes over 70 world leaders in
the space. Our cGMP manufacturing team has over 30 years
experience.
 Howard J. Leonhardt, Chairman & CEO – 21 U.S. patents. Has
brought more than five cardio products to market leadership
positions. Over 200,000 patients have been treated with
Leonhardt inventions to date. His TALENT thoracic stent graft
captured 70% world market share before being sold to
Medtronic.
 Alex Richardson – CEO Core Manufacturing – 30 years
experience in electronics and medical device cos primarily
with Alfed Mann companies.
 Jeremy Koff – VP Business Development – 20+ years in product
launch experience primarily with Alfred Mann companies.
 Alan Remen – 30 years operational management experience
in technology companies.
 Dr. William Abraham – Chairman Scientific Advisory Board –
Chief of Heart Failure at OSU. PI of the MIRACLE trial that
launched the $9 billion CRT/ICD era of heart failure treatment.
Financial Projections
2015
2016
2017
2018
2019
Revenues
$117.7
$204.6
$337.4
$154.2
$227,699
Expenses
$14,500
$701.3
$722.9
$745.1
$767.7
Net
($14,382)
$(496.7)
($385.5)
($590.9)
$227,231
Above table is in 000’s.
Note – These are breakthrough first ever products un-tested in markets. Markets are
big – really big. This is very very difficult to predict. We are focused on addressing
great market needs with far superior products.
Brief History Review
 Leonhardt Ventures founded in 1982.
 1982-85 – Built cardic cath labs around the world – AGMC + IMA.
 1986 – Introduced private label line of cardio balloon catheters, oxygenators and
heart valves – World Medical Corp. – PolyCath, DMG and Labcor.
 1987 - $3.2 million in sales, $200K net profit – World Medical. Richard Spencer
former President of Cordis Corp. joins.
 1988 – Dr. Race Kao and Dr. George Magovern team members complete first
case of muscle stem repair of damaged heart muscle in dogs and publish in The
Physiologist. – Bioheart MyoCell.
 1988 – Patented line of polyurethane balloon cardiovascular catheters and
launched World Medical Manufacturing Corp. – PolyCath.
 1989 – Developed first stem cell delivery catheter Pro-Cell, later patented and sold
to Medtronic.
 1990 – FDA 510K authorization to market received. Captured world leading market
share for polyurethane cardiovascular balloon catheters. Supplied Cordis Corp.,
Nippon Zeon and later Novoste.
 1990 – Team member Wendell King successfully completes and patents the first
biological pacemaker – BioPace.
 1990 – Team member Dr. Stu Williams patent endothelial cell procurement device
and cell sodding of grafts – EndoCell.
 1991 – Developed and patented PENSIL intravascular lung catheter working with
Penn State University.
Brief History in Review
 1991 – Developed blood vessel patch that led to first prototype of TALENT (Taheri-Leonhardt) stent
graft for aortic aneurysm repair – 5 patents. Later captured 70% of world market share and sold to
Medtronic.
 1992 – Developed vibrational energy device to prevent plaque formation in arteries – CoroStim.
 1992 – Radiation delivery catheter developed and patented for restenosis prevention after stenting
or balloon angioplasty.
 1993 – Leonhardt and Greenan invent, patent and develop first percutaneous heart valve –
ValveStent. Later sold to Medtronic.
 1995 – Leonhardt led team complete first ever percutaneous repair of an aortic aneurysm in
Melbourne, Australia with Dr. Ken Thomson and Dr. Peter Field.
 1997 – Leonhardt and Taheri patent improved biological pacemaker.
 1998 – World Medical Mfg. Corp. reaches $9.2 million in sales with $1 million net profit and merges
with Arterial Vascular Engineering, Inc. of Santa Rosa, California. November of 1998 Medtronic
acquires combined companies for $4.3 billion.
 1999 – TALENT stent graft captures 70% of world market share for thoracic aortic aneurysm repair
and 35% of AAA market. Eventually peripheral division sales built around this product line grow to
$800 million annually by 2009.
 1999 – TALENT stent graft positive results for treating aortic dissections for the first time are published
in THE NEW ENGLAND JOURNAL OF MEDICINE - Nienaber CA, Fattori R, Lund G, et al. Nonsurgical
reconstruction of thoracic aortic dissection by stent-graft placement. N Engl J Med. 1999;340:15391545.
 1999 – Leonhardt launches Bioheart, Inc. the first company dedicated to stem cell repair of
damaged heart muscle.
 2000 – Bioheart launches in U.S. market first ever cardiovascular genetic test – Pla2 – currently over
$200 million in annual sales with various producers.
 2001 - Leonhardt founded Bioheart led team completes historic first ever clinical case of stem cell
repair of damaged heart tissue with Dr. Patrick Serruys, Dr. P. Smits, Dr. Warren Sherman, Dr. Doris
Taylor and Dr. Kumar Ravi.
Brief History in Review
 2000 - Leonhardt launches Leonhardt Vineyards in California.
 2002 – Leonhardt, Chachques and Kanno being filing series of landmark
patents later issued for utilizing electrical stimulation to recruit and
differentiated stem cells into useful tissues – regeneration. 3 pioneering
patents with dozens of claims are eventually issued with more pending.
 2007 – Leonhardt resigns as CEO of Bioheart. Bioheart stock price
remained above $7 per share during entire 9 year tenure as CEO. $85
million in capital was raised. 33 patents issued or acquired. MyoCell
completed Phase II/III clinical trial with success.
 2008 – Bioheart completes IPO under CEO Bill Pinon.
 2008 – Bioheart announces by press release formal plans to divest its noncore assets and Leonhardt takes on assignment as CTO to find homes for
each technology to be developed.
 2010 – Bioheart published Phase III clinical trial results demonstrating 95.7
meters improvement over placebo.
 2011 – The California Stock Exchange plans are formally announced.
Soon there-after INC. Magazine, Forbes, UpStart Business Journal,
Northbay Biz, Crowdfund Insider, Startup California, The Press Democrat,
Impact, Caypen, TCA, It’s Just Good Business, CBS Radio, The California
Womens Conference and others cover the story of the development of
the first conscious capitalism stock exchange.
Brief History Review
 2011 – MyoStim Pacers and BioPace are officially spun out of Bioheart
to be incubated in California by Leonhardt Ventures and Airspeed
Equity and are later enrolled into the Cal-X Stars Innovation and
Business Accelerator in 2012.
 2011 – Leonhardt renews research collaboration with Dr. Eric Duckers
and Dr. Pieter Doevendans in The Netherlands for research
collaboration on Bioheart, BioLeonhardt, MyoStim Pacers and BioPace.
 2012 – The Cal-X Stars Innovation & Business Accelerator is launched.
 2012 – Stem Cell Bra is the first Cal-X Stars new product development.
A patent application is filed and the company is launched with Dr.
Joel Aronowitz from Cedars Sinai UCLA.
 2012 - Leonhardt travels to Germany to structure conditional
agreement with Cardiogbridge for U.S. rights and investment
opportunity in the Reitan heart pump on a catheter.
 2013 – Cal-X Stars Business Accelerator has 28 portfolio companies or
innovations enrolled for acceleration services and launches first
funding round. 14 cardiovascular and 14 social good impact. 33
member Scientific Advisory Board of world opinion leaders is
assembled. Business team of over 40 is signed up.
 2013 – Working with the team at Core Manufacturing the Leonhardt
team develops the first stem cell pump, implantable heart sensor and
wireless energy devices for directing stem cell therapies non-invasively.
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