bioheart news - Startup California

Vol. 2 • No.1
888.BIOHEART
(246.4327)
BIOHEART NEWS
www.bioheartinc.com
F I R S T E V E R P E R C U TA N E O U S C A S E C O M P L E T E D
First Percutaneous Endovascular Case of Heart
Muscle Regeneration Completed with Bioheart’s
MyoCellTM Product
ROTTERDAM, Netherlands and WESTON, Fla., May 25th, 2001
a team completed the first ever non-surgical endovascular case
to augment heart function by injecting cultured autologous
myoblasts (primarily immature muscle cells cultured from a
biopsy of the patient’s thigh muscle) to a damaged area of a 78
year old female patient’s heart.
“If this cell therapy lives up to its promise in clinical trials, we will
look back to this first endovascular human Myogenesis case the
way we look back to the first balloon angioplasty performed by
Andreas Gruntzig, M.D. This may be one of the most
significant developments in the history of treating heart
disease patients.” said Patrick Serruys, M.D., Ph.D. Professor
of Interventional Cardiology, Erasmus University and Head of
Interventional Dept. at the Thorax Center, Rotterdam.
This team, led by Professor Patrick Serruys, consisted of Peter
Smits, M.D., Ph.D., Clinical Director of Dept. of Interventional
Cardiology of the Thorax Center of Rotterdam, Dr. Warren
Sherman and Dr. Kumar Ravi of the Beth Israel Hospital of New
York, all interventional cardiologists.
Bioheart Has Two ISO Certified Contract Cell
Culturing Facilities Up and Running – One in Europe
and One in the USA
In order to serve our clinical trials in Europe and the USA Bioheart
has sponsored the establishment of two production lines at two
contract facilities, one in Belgium and the other on the east coast
of the United States. These facilities are working towards full
cGMP compliance, and are ISO 9001 certified. Cell culturing
processes were developed internally by Bioheart personnel.
Bioheart Makes Substantial Investments to Increase
Cell Culturing Capacity for Up Coming Year
In anticipation of expanding our number of clinical trial sites over
the course of the next year, Bioheart has made substantial
investments to increase our ISO/cGMP compliant cell culturing
capacity including acquisition of; additional space, incubators,
roller bottles, centrifuges, cold storage space, clean air and
water systems.
Management Principles . . . . . . . . . . . . . . . . . . . . . . 2
Clinical & Pre-Clinical Studies . . . . . . . . . . . . . . . 3-5
Corporate Development
“It is a very exciting development for Bioheart, Inc. as well as
patients suffering the debilitating effects of myocardial infarction
and congestive heart failure.” said Michael Brown, M.D., Ph.D.,
Chief Scientific Officer and Vice President of Clinical Affairs,
Bioheart, Inc. Weston, Florida. Special thanks to Doris Taylor,
Ph.D. for her pre-clinical work leading to this first ever clinical case.
Bioheart Wins Award. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Finance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
New Additions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Other News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
* Refer to forward looking statement.
Progress Update. . . . . . . . . . . . . . . . . . . . Back Page
Upcoming Conferences. . . . . . . . . . . . . . . . . . . . . . 7
WHAT IS INSIDE...
“Worldwide, enormous numbers of patients are affected by
heart attacks or other processes that weaken the heart muscle.
In the United States alone, nearly 5 million patients experience
heart failure from these kinds of problems and, to date, the
possibilities for strengthening the heart have been very limited.
Cell therapy may offer a level of improvement in quality of life for
these patients that, short of full heart transplantation, is
unprecedented. We are now taking the initial steps to determine
just how beneficial this therapy may be, and it is a very exciting
prospect.” Dr. Warren Sherman, Director of the Cardiac
Catheterization Laboratory at Beth Israel Medical Center, NY
stated after the successful procedure.
First Bioheart Physician Training Course, Cáceres, Spain, May, 2001
Left to Right: Markus Bork, Lab Manager, Warren Sherman, M.D.,
Patrick Chuinard, Patrick Serruys, M.D., Mike Lee, Kumar Ravi, M.D.,
Prof. Christoph Nienaber, Jim Greene, Miguel Fernandez
Vol. 2 • No.1
MANAGEMENT PRINCIPLES
BIOHEART NEWS
BIOHEART MANAGEMENT PRINCIPLES
1.
We are committed to World Class consistent quality in our products and services.
2.
LUCK FAVORS THE PERSISTENT. THIS SIMPLE TRUTH IS A FUNDAMENTAL CORNERSTONE OF SUCCESSFUL COMPANY BUILDING.
3.
Monday through Friday is one quick blurred together workday. Saturday and Sunday are two long rest
days. Saturday is for reading. We never work Sundays. We promote work-life balance.
4.
Our success depends on our ability to quickly bring to bear the talents of people and bits of organizations
dispersed around the globe. Positive spirit and communication are the keys.
5.
Speed and agility are two of our most important strategic assets. We cannot be weighed down with large overhead and bureaucracy. We have flexibility to adjust quickly to changing market needs and to shift resources
and focus to what really needs to get done at any particular time.
6.
We believe in continuous improvement. Never is something perfect right from the beginning. We improve our
products and our organization a little bit everyday. We use feedback from the “real world” market to drive
improvement. We WORK at improvement.
7.
We operate lean with a small flexible staff focused on customers and products. WE DO MORE WITH
LESS! We reduce wasted time. We are bootstrappers stretching every dollar out.
8.
We believe in gaining widespread early feedback on new designs early in the development process. Lots of
prototypes, lots of tries, evaluated comprehensively. Innovation is work!
9.
No internal functional barriers. We want everyone involved in doing what needs to get done when it needs to
get done.
10. Work simplification. Do not over complicate tasks. Get to the heart of the matter and get it done NOW.
Keep things simple.
11. We are committed to developing export sales to the 96% of the world’s population that lives outside of the
U.S.A. Profits from export sales fuel R&D and U.S. Clinicals.
12. We believe superior customer service and responsiveness are critical to sustaining our success.
Employees that exhibit the attitude “This would be a great business if it weren’t for the damn customers and their
irritating demands,” must be corrected to the awareness that our customers pay our bills. The only people called
“boss” in our organization are the customers.
13. We believe continuous organizational learning is a key asset of our company. We read everything we can
get our hands on! We uncover every stone. We hunger for knowledge.
14. Networking with others allows us to develop and get our products to market quicker.
15. We are passionate and compassionate about what we are doing. We care! We believe in what we are doing!
16. Every member is a co-stakeholder in the business.
17. Work should be made fun at times to relieve tension. You must have fun, that’s an order.
18. Weekly responsibilities and goals are clearly defined in our Monday Morning Meetings.
19. We have a bias for speed and action. Analysis and reflection are all well and good, but we are nowhere without implementation – and it had better be fast and right.
20. Our work environment is one of honesty, integrity and mutual respect.
Howard J. Leonhardt
Chairman & CEO
Bioheart, Inc.
2
Vol. 2 • No.1
CLINICAL & PRE-CLINICAL STUDIES
BIOHEART NEWS
CLINICAL & PRE-CLINICAL STUDIES
Bioheart Initiates Human Clinical Trials in the
Netherlands
After 18 months of preparation the first ever sole therapy
percutaneous trial for myogenesis was launched utilizing
Bioheart’s MyocellTM product at the Thorax Centre in Rotterdam,
The Netherlands. The team led by Professor Patrick Serruys and
Dr. Peter Smits included Dr. Warren Sherman and Dr. Kumar Ravi
of the Beth Israel New York. The team prepared for the trial by
undertaking numerous animal studies with various prototypes of
endoventricular delivery systems. The team helped refine the
design of the delivery systems and develop the test and clinical
protocols working with Bioheart’s engineers and clinical affairs
staff. The preparation paid off with a successful first case May
25th, 2001. This first Phase I/II trial looks primarily at safety but
also assesses functional improvement.
Bioheart Initiates Human Clinical Trials in Germany
Two I.R.B.s have given authorization to begin clinical trials for
Myogenesis utilizing Bioheart’s MyocellTM technology and
Bioheart’s SR-200 MyocathTM cell delivery system. The
currently initiated sites include the University of Rostock with
Professor C. Nienaber and the Heart Center Hospital in
Siegburg, Germany with Prof. Eberhard Grube. This is part of a
30 patient Phase I/II trial sponsored by Bioheart.
Bioheart to Initiate Clinical Trial in India
Dr. Kumar Ravi, who participated in the historical first
endovascular myogenesis case in Europe has taken a two year
leave of absence from Beth Israel Medical Center NY to serve
as Principal Investigator for Bioheart’s clinical trials in India.
First MyocellTM Physician Training Course completed
in Spain
Pat Chuinard, Bioheart’s Vice President of Physician Relations,
John Geis, President of Bioheart International and James
Greene, Bioheart’s Vice President of Physician Relations for
Europe, and Markus Bork, Clinical Specialist, organized our first
physician training seminar for myogenesis at the Research
Center in Cáceres, Spain. Attendance included Professor
C. Nienaber from Rostock, Dr. Patrick Serruys and Dr. Peter
Smits from Rotterdam, Dr. Kumar Ravi and Dr. Warren Sherman
from Beth Israel and Mount Sinai Hospitals in NY and a number
of other researchers. Each attendee had the opportunity to
inject labeled mixtures into damaged myocardial tissue in
beating animal hearts using Bioheart’s SR-200 MyocathTM cell
delivery system.
Bioheart Completes GLP Tumorgenecity, Arrythmia
and Biodistribution Studies for MyocellTM Product
Bioheart designed and sponsored over the course of the last 24
months a series of GLP animal studies of our MyocellTM product
focused on safety including tumorgenicity, biodistribution,
inflammation, migration, bioretention and arrythmias. This test
data was instrumental in gaining permission to enter human
clinical trials last spring in Europe. This data is an integral part
of our IND application being assembled for the FDA.
Bioheart Sponsors First Ever Pre-Clinical Heart
Failure Reversal Study Utilizing Direct Injection of
Myoblasts
Dan Burkhoff, M.D., Ph.D. of Columbia University utilized timed
coronary injections of glass microspheres to create a heart
failure model in large animals. These hearts were treated with
cultured autologous myoblasts. Results will be presented at the
upcoming Cell Transplantation Meeting Oct. 16-17th, 2001 in
Keystone, Colorado and at the American Heart Association
annual meeting Nov. 12-14th, 2001.
Bioheart Completes 1st Round of Bioretention
Studies Comparing Epicardial to Endocardial
Injection Techniques
Bioheart has sponsored a series of non-GLP and GLP
pre-clinical studies documenting bioretention (ability to deliver
and retain cells in myocardium) at a number of institutions
including; Mount Sinai Miami, Florida International University,
University of Arizona, Thorax Centre, East Tennessee State
University, Medical Education Research Institute (MERI), Mass
General, Cáceres Spain and the Washington Hospital Center.
Techniques have included labeling cells with radioactive tags,
fluorescent dyes and beads, and with contrast. Some studies
have included injecting human myoblasts into pig myocardium
and then staining for the human cells present in the
myocardium. The conclusion from these studies is that
epicardial and endocardial injection techniques provide
substantially equivalent bioretention and biodistribution results.
Ray Chiu, M.D. and Team at McGill University
Complete Bioheart Sponsored Pre-Clinical Study of
Bone Marrow Derived Stem Cells – Study Concludes
Stem Cells Injected into Scar Tissue Do Not Form
Muscle Like Myoblasts
Bioheart sponsored an important pre-clinical study at McGill
University which looked carefully at the use of mesenchymal
stem cells derived from bone marrow on damaged myocardial
tissue. The same group had previously conducted the same
study using autologous myoblasts. The conclusion from these
two studies were that myoblasts create new muscle in scar
tissue and mesenchymal stem cells create more fibrotic tissue
or fat (not muscle) when injected into scar tissue. All cell types
injected serve to loosen the scar tissue improving the relaxing
phase of the heart cycle (diastolic) but only myoblasts in various
studies have found to improve contraction (systolic) function in
the previously damaged area.
Bioheart’s Cell Delivery Catheter Validated in Over a
Dozen Pre-Clinical Animal and Bench Evaluations
First time users of Bioheart’s SR-200 MyocathTM delivery
catheter have reported the ability to consistently hit
pre-determined myocardial injection targets on their first
attempted use. Evaluation tests and controlled pre-clinical tests
of our catheter delivery systems have been conducted at a
number of institutions including: Medical Education Research
Institute (with human myoblasts into pig myocardium),
University of Arizona, University of California at Los Angeles,
University of Southern California, University of California at
continued on page 4
3
Vol. 2 • No.1
CLINICAL & PRE-CLINICAL STUDIES
BIOHEART NEWS
C L I N I C A L & P R E - C L I N I C A L S T U D I E S ( C O N T. )
San Francisco, Mass General Hospital, Thorax Centre
Rotterdam, Cáceres Research Center Spain, Washington
Hospital Center, Arizona Heart Institute and various private labs.
Dr. Marty Leon, Dr. Warren Sherman, Dr. Kumar Ravi, Dr.
Randall Lee, Dr. Nabil Dib, Dr. Ron Waksman, and Dr. Patrick
Serruys have been instrumental in providing feedback on our
initial prototype designs. Functionality studies are planned at
U.C.S.F. and Duke University using contrast enhanced MRI for
evaluation. In vitro tests have been completed on the product at
various labs including Bioheart’s own laboratories.
Bioheart & Biosense Sponsor Endoventricular
Functional Improvement Feasibility Study at Arizona
Heart Institute, Including Evaluation of the Acuson
AcuNav Ultrasound Catheter
Dr. Edward Diethrich of the Arizona Heart Institute was one of the
first members to join Bioheart’s research team back in 1999. He
and his colleague Dr. Nabil Dib have conducted a series of animal
experiments documenting the ability to deliver myoblasts to
damaged myocardium and to effect functional improvement. The
myocardial functional performance before and after the injections
have been documented by ultrasound and electro-magnetic
mapping. In one of the experiments, even a low dose of myoblasts,
were shown to effect a positive functional improvement within 8
weeks of the injections. The Acuson AcuNav was found to provide
excellent visualization of the left ventricle.
Bioheart Completes Pre-Clinical Study of Myoblasts
transfected with eNOS at Cleveland Clinic with Dr.
Stephen Ellis
Bioheart sponsored a 6 month pre-clinical study in small animals
at the Cleveland Clinic examining the effects of myoblasts
transvected with eNOS using a virus carrier in vitro. Attempts
were made to remove all traces of the transvection virus prior to
implantation. The team concluded that additional studies are
required to fully determine the effects of eNOS on myoblast
engraftment. Previous studies in Europe demonstrated the
ability of eNOS to promote the formation of longer, larger
diameter and more functional coronary arteries to feed muscle.
Sam Ahn, M.D. Leads Program to Utilize Bioheart’s
MyocellTM Myogenesis Product with Robotic Surgery
and Minimally Invasive Thorocoscopic Instruments
Dr. Sam Ahn has assigned to Bioheart a series of patent
pending designs for thorocoscopic and minimally invasive
delivery of cells to myocardial tissue. Dr. Ahn has participated in
nearly one dozen animal experiments documenting the
performance of various prototype delivery systems being
developed by the Bioheart R&D team. These studies have
included a careful evaluation of a corkscrew tip needle design as
well as the use of thorocoscopic scopes to visual the
myocardium with only 5mm ports in the chest wall.
Race Kao, Ph.D. and George Magovern, M.D. Receive
Rewards in Recognition of their Historic First Ever Case
of Heart Muscle Regeneration in Animals in 1988
At a Bioheart sponsored dinner held in conjunction with the
Society of Thoracic Surgeons Meeting. Race Kao, Ph.D. and
George Magovern, M.D. received recognition for their historic
first ever case of heart muscle regeneration using myogenic cells
in animals, which was completed in 1988 and published in 1989
(The Physiologist: Vol 32, No. 4, August 1989 – Also Published in
The FASEB Journal Vol. 65, No. 6, Circulation Vol. 84, No. 4,
Journal of Cellular Biochemistry 20th Annual Mtg Supplement
15C). Dr. Kao and Dr. Magovern are regarded as the founding
fathers of cellular based heart muscle regeneration based on
this pioneering work. Their work has served as inspiration for the
dozens of scientists continuing this research today more than 13
years later.
Dr. Charles Murry’s Lab Presents Initial Data on
Ability to Control In situ Myoblast Proliferation with
Drugs at Remodeling and Progression of Heart
Failure Meeting July 14th, 2001 in Minneapolis
Marsha Whitney, Ph.D., working in Dr. Murry’s lab led a study to
control myoblast proliferation by the creation of a chimeric
receptor composed of modified FK506 binding protein (F36V)
fused with fibroblast growth factor receptor-1 (FGFR-1)
cytoplasmic domain. Mouse myoblasts were transvected with the
construct and treated with AP20187, a dimeric F36V ligand, to
induce receptor dimerization. Transfected myoblasts proliferated
in direct response to dimerizer administration. The team
hypothesizes from these cell culture study results that in vivo
administration of AP20187 following myoblast grafting may allow
control over graft size and ultimately improve cardiac function.
The results have been published on-line ahead of print in J Biol
Chem (Whitney ML, Otto KG, Blau CA, Reinecke H, Murry CE.
Control of myoblast proliferation with a synthetic ligand. J Biol
Chem. 2001 Aug 13 [epub ahead of print]).
Dr. Taheri Completes Pre-Clinical Study with 22
Animals Examining the Effect of Bypassing
Omentum Blood Supply to Cell/Skeletal Muscle
Fragment Treated Region of Myocardium – Data to
Be Presented at Upcoming Meetings
This 22 animal study concluded that cell engraftment, survival
and functionality were improved with blood supply diverted from
the omentum to the treated area of myocardium with
conventional by-pass techniques.
Professor Menasche’s Team Publishes Pre-Clinical
Dose Escalation Study – Myoblasts for Heart Muscle
Regeneration
In a landmark paper published in Annuals of Thoracic Surgery
2001;71:844-51 an independent team of biologists and clinicians
from France lead by Jean-Thomas Vilquin, Ph.D. and Professor
Philippe Menasche demonstrated in small animals with ligation
created infarctions the ability to effect left ventricular functional
improvement over a wide range of post infarct ejection fractions,
including the sickest hearts provided that they are injected with
continued on page 5
4
Vol. 2 • No.1
CLINICAL & PRE-CLINICAL STUDIES
BIOHEART NEWS
C L I N I C A L & P R E - C L I N I C A L S T U D I E S ( C O N T. )
a sufficiently high number of cells. An important finding of this
study is that the functional outcome after transplantation was
linearly related to the number of injected myoblasts.
Data from Dr. Charles Murry’s, Dr. Race Kao’s and Dr.
Randall Lee’s Labs Confirm Ability of Myoblasts to
Form Electrical Connections with Cardiomyocytes In
Vitro
In The Journal of Cell Biology, Volume 149, Number 3, May 1,
2000 Dr. Murry’s Lab from the University of Washington
published a landmark paper proving that under in vitro conditions
cardiomyocytes can form electromechancial junctions with some
skeletal myotubes in coculture and induce their synchronous
contraction via gap junctions. Work continues at a number of
labs worldwide to prove out the ability of myotubes, myoblasts or
satellite cells to perform similarly in vivo.
Scientific Advisory Board and Consultants*
Doris Taylor, Ph.D.*
Phillipe Menasche, M.D., Ph.D.*
Ray Chiu, M.D., Ph.D.*
Pascal Goldschmidt, M.D., FACC
Edward Diethrich, M.D.
Daniel Burkhoff, M.D., Ph.D.
Barry Katzen, M.D.*
Stuart Williams, Ph.D.*
Syde A. Taheri, M.D.
Zvonimir Krajcer, M.D.
Stephen Ramee, M.D.
James Margolis, M.D.
Randall Lee, M.D., Ph.D.*
Charles Murry, M.D., Ph.D.*
Sam Ahn, M.D.*
Stephen G. Ellis, M.D.*
Martin B. Leon, M.D.
Race L. Kao, Ph.D.*
Juan C. Chachques, M.D.,Ph.D.
George J. Magovern, M.D.
Gregory Fontana, M.D.
Richard Heuser, M.D.
Tim Henry, M.D.
Warren Sherman, M.D.
Kumar Ravi, M.D.
Board of Directors and Board Consultants*
New Round of Functionality (dose) and Contrast
Media Compatibility Studies to be Launched at
UCSF with Dr. Randall Lee and Duke with Dr. Pascal
Goldschmidt and Doris Taylor, Ph.D.
Howard J. Leonhardt
Doris Taylor, Ph.D.
John L Babitt, Jr., CPA
Mark Maciejewski
Samuel S. Ahn, M.D.
Bruce C. Carson
Kirk Essenmacher, M.D.
Robert Lashinski*
As we move closer to pivotal studies in humans which will
determine our final therapeutic dosage of myoblasts, we seek to
understand better the relationship between the number of
injections, the angle of the injections and the volume of injections
with demonstrated functional improvement. In addition we also
seek to document the effects of commonly used contrast agents
on cell viability in function, with the intention to be able to let
cardiologists know if it is acceptable to make contrast injections
during the myogenesis procedures to gain a better view of the
myocardium and injection sites. These studies in progress are
designed to answer these two important questions.
Bioheart, Inc. Headquarters in Weston, Florida
1/4 of the top floor.
C O R P O R AT E D E V E L O P M E N T S
OTHER NEWS
Bioheart Forms Spin-Off BioPace, Inc. and Names
Mark Maciejewski President.
In order to capitalize on our intellectual
property estate in biological pacing
(U.S. Patents 5,103,821 & 5,543,318)
without distracting from our focus on developing myogenesis,
Bioheart’s board of directors authorized the formation of a spin off
company that has been established in Minneapolis, MN the
epicenter of the cardiac rhythm industry worldwide. Mark
Maciejewski with over 21 years experience in the medical
technology industry was named President of this new company. Mr.
Maciejewski was formerly founder and CEO of Angioguard, Inc.
now a unit of Johnson & Johnson and served as an executive, often
a founding member, of several other companies such as InStent,
American Medical Systems, Palamar Medical and Angiosonics. He
received his B.S. from the University of Dayton and an M.B.A. from
St. Thomas University in St. Paul, Minnesota.
BIOPACE
American Heart Association List of Top 10 Advances
of 2000 Highlights Immature Muscle Cell Therapy for
the Heart as No. 3 Advance, Researchers Hope New
Human Clinical Data Moves Myogenesis Position to
No. 1 in 2001
1. Cracking human genetic code.
2. Discovery of genetic basis of lung disease.
3. Using immature muscle cells from elsewhere in the body
to inject new life into failing hearts.
4. Gene therapy to keep coronary arteries clear.
5. Gene therapy to slow rapidly beating hearts (a trial
fibrillation).
6. ACE inhibitors to reduce risk of stroke.
7. High resolution MRI for coronary artery imaging.
8. Dietary approaches to reduce sodium intake.
9. AHA’s new low cholesterol, low fat diet.
10. Improved response to cardiac emergencies with portable
defibrillators.
continued on page 6
5
Vol. 2 • No.1
CORPORATE DEVELOPMENTS
BIOHEART NEWS
C O R P O R AT E D E V E L O P M E N T S
OTHER NEWS (CONT.)
Bioheart’s Scientific Advisory Board Unanimously
Vote NOT to use Electro-Mechanical Mapping During
Myogenesis Procedures
After extensive evaluation and substantial input from numerous
investigators Bioheart has decided not to recommend
electro-magnetic mapping as part of myogenesis procedures.
The general consensus was that electro-magnetic mapping was
too time consuming and too costly to justify the slight benefit
provided by a colorized map of the myocardium. In addition the
team was concerned that the 30 minutes to 2 hours of catheter
manipulation required to make a complete map introduces
increased risk of thrombolitic events.
BIOHEART WINS S. FLORIDA’S TECHNOLOGY AWARD!
Bioheart, Inc. was named winner of 2001 Technology Award in
the Shooting Stars category. This annual award is sponsored by
a number of companies and organizations including The S.
Florida Business Journal and Deloitte Touche. Over 250,000
companies were candidates for the award. The award trophy
was given out at a luncheon at the Pier 66 Hotel in
Ft. Lauderdale with about 350 in attendance. Howard
Leonhardt, Bioheart’s CEO, thanked their “Best and Brightest”
team in an acceptance speech.
NEW ADDITIONS
James Margolis, M.D., Dr. Richard Heuser, M.D.,
F.A.C.D., F.A.C.P. and Tim Henry, M.D. join Bioheart
Scientific Advisory Board
FINANCE
Bioheart Receives Financing from Tyco Ventures
Unit of Tyco International – Tyco Ranked No. 1
Performing Company of the Year by Business Week
Bioheart announced earlier this year a
substantial investment from Tyco
Ventures a unit of Tyco International (see
press release on web site for additional information). Tyco
International was voted by Businessweek as the No. 1
performing company of 2001. Connected with this investment
Tyco has been granted a board seat on Bioheart’s Board of
Directors.
James Margolis, M.D. is Director of Cardiovascular Research
and Education at the Miami Heart Institute, Miami, Florida.
Dr. Richard Heuser is currently the Director of Research and a
practicing cardiologist at St. Luke’s Medical Center, Phoenix,
Arizona. In 1997 Dr. Heuser established the Phoenix Heart
Center.
Tim Henry is the Assistant Professor of Medicine at the
University of Minnesota and has been Director of Interventional
Cardiology at Hennepin County Medical Center for ten years.
Judy Brown Joins Bioheart as Executive Director of
Logistics
Bioheart Receives Financing from Guidant
Corporation – leader in heart failure technologies
In June following the Paris
Course on Revascularization
and the completion of the first
ever percutaneous case of myogenesis with Bioheart’s
MyocellTM product, Guidant and Bioheart announced an
investment received by Bioheart, from Guidant Corp. Guidant
Corp. is the world’s leading producer of coronary stents used by
cardiologists and stands as the second leading medical
technology company in terms of total revenues. Guidant has
received an observational seat on Biohearts Board.
Bioheart Receives Financing From Ascent Private
Equity
Ascent Venture Capital based in Minneapolis and New York
manages over $25 million in funds specializing in medical
technology. Ascent is known for investing in emerging
cardiology oriented companies with multiply rounds of capital
contributions as the companies reach important milestones.
Please go to www.bioheartinc.com for full copies of
press releases.
6
Ms. Brown was formerly Director of Clinical Affairs at Medtronic
World Medical and prior to that was Manager of Clinical
Research at the Miami Cardiac and Vascular Institute in Miami,
Florida. Ms. Brown has a B.S. in Biology from Russell Sage
University, Albany, NY.
FACILITIES
Bioheart Launches Cell Delivery Catheter
Production Facility in Santa Rosa, California Passes
first CA Food and Drug Administration Inspection.
In July our cell delivery
catheter production facility
and clean environment area
passed it’s first ever state
F.D.A. inspection audit. The
facility is committed to
operating under strict cGMP
and ISO 9001 Quality
Assurance Systems. Bioheart has as it’s first management
principle a commitment to World Class Quality in all our
products and services.
Vol. 2 • No.1
UPCOMING CONFERENCES
BIOHEART NEWS
EXHIBIT BOOTH
AT N E X T C O N F E R E N C E S
ESC / TCT / AHA
UPCOMING CONFERENCES
September 1 - 5, 2001 - ESC (European Society of Cardiology), Stockholm,
Sweden. Visit us at our booth #1696.
September 11 - 16, 2001 - TCT (Transcatheter Cardiovascular Therapeutics)
Frontiers in Interventional Cardiology, Washington, DC. Bioheart Plenary Session #3
on Intramyocardial Therapeutics September 13, 11:30 a.m. in the Main Arena. Visit
us at our booth #724.
November 12 - 14, 2001 - AHA (American Heart Association), Anaheim, CA.
Scientific Sessions run November 11 - 14.
CONFERENCE PLANS THIS YEAR
Enrollment Completed in 200 Patient Bioheart
Sponsored Clinical Study of Pla2 Test at Lennox Hill
– Results to be Presented at Annual TCT Meeting
Look for Our Booth and Live Case* at TCT
*Pending availability of cells.
Invitations to ESC and TCT Meetings
Transcatheter Cardiovascular Therapeutics
September 11 - 16, 2001 • Washington, DC
at
Visit us 6
169
Booth #
Invites You To A
FOCUS SESSION
at
Visit us 4
72
Booth #
On
Invites You To
“Advances in Catheter Based Treatment
for Ischaemic Heart Disease”
TCT PLENARY SESSION #3
Chaired by: PROF. DR. MED. PATRICK W. SERRUYS,
Erasmus University, The Thorax Center, Rotterdam, The Netherlands
“Intramyocardial Therapeutics”
On
September 13, 2001 • 11:30 a.m.
European Society of Cardiology Meeting
Main Arena - TCT
September 3, 2001 • 11:00 a.m. - 12:30 p.m.
Room K1; Green Zone
I. Novel Approaches to Cardiac Regeneration: Preclinical Basis for Myoblast
Transplantation.
By DORIS A. TAYLOR, PH.D., Associate Professor of Medicine in Cardiology, Duke
University Medical Center
Stockholm, Sweden
I. First Human Catheter Based Myoblast Transplantation:
Clinical Update - Bioheart, Inc. “MyoCellTM” Interim Study Results.
By PROFESSOR DR. MED. PATRICK W. SERRUYS, Erasmus University,
The Thorax Center, Rotterdam, The Netherlands
11:30 a.m. - 11:45 a.m.
II. Arrival of Cardiac Regeneration: First In-Man Results.
By PROFESSOR PHILIPPE MENASCHE, M.D., Professor of Surgery,
Bichat Hospital, Paris, France
11:45 a.m. - 12:00 p.m.
II. Novel Approaches to Cardiac Regeneration:
Preclinical Basis for Myoblast Transplantation.
By DORIS A. TAYLOR, PH.D., Associate Professor of Medicine in
Cardiology, Duke University Medical Center, Durham, USA
III. First Human Catheter Based Myoblast Transplantation: Clinical Update Bioheart, Inc. “MyoCellTM” Interim Study Results.
By PROFESSOR DR. MED. PATRICK W. SERRUYS, University Hospital Dykzigt, Thorax
Center, Rotterdam, The Netherlands
III.Catheter and Technique of Cell Delivery
By PROFESSOR DR. MED. CHRISTOPH NIENABER, Director of Cardiology,
University Hospital, Rostock, Germany
IV. LIVE CASE DEMONSTRATION I: Bioheart, Inc. “MyoCellTM” - Catheter Based
Myoblast Transplantation.
By PROFESSOR EBERHARD GRUBE AND ASSOCIATES, Heart Center Hospital,
Siegburg, Germany.
ALSO:
Arrival of Cardiac Regeneration: First In-Man Results.
By PROFESSOR PHILIPPE MENASCHE, M.D., Professor of Surgery, Bichat
Hospital, Paris, France
V. LIVE CASE DEMONSTRATION II: Bioheart, Inc. “MyoCellTM” - Catheter Based
Myoblast Transplantation.
By ANTONIO COLOMBO, M.D., CARLO DI MARIO, M.D. AND ASSOCIATES,
Columbus Hospital, Milan, Italy.
888.BIOHEART
888.BIOHEART
(246.4327)
(246.4327)
www.bioheartinc.com
www.bioheartinc.com
7
Vol. 2 • No.1
PROGRESS UPDATE
BIOHEART NEWS
LETTER FROM THE CHAIRMAN / CEO
It has been one year since our last
newsletter August of 2000.
Bioheart and myogenesis have
come a long way over the course of
the past year. Bioheart has raised
paid in capital of over $15,000,000
including
investments
from
Guidant, Tyco Ventures, and
Ascent. Human clinical trials of our
Myocell™ myogenesis product
have been initiated in The
Netherlands and Germany. This is the first ever endovascular
myogenesis trial and the first ever sole therapy trial. On May 25,
2001 Prof. Serruys, Dr. Smits, Dr. Ravi and Dr. Sherman
completed the first ever percutaneous case of myogenesis with
our Myocell™ product. Bioheart’s Engineers and Biologists have
further developed our delivery systems and our cell culturing
processes, with production lines up and running in Europe and
the USA. Recently our delivery system production facility, 100%
Bioheart operated, in Santa Rosa, California passed it’s first
state F.D.A. inspection. We have also added numerous new
patents, and patents pending, to our portfolio of intellectual
property. We continue to attract the best and brightest scientists,
engineers, investigators and managers to help move our projects
forward. These great people put Bioheart in the position to
recently win S. Florida’s Technology Award. We continue to
believe that our team has the potential to save more lives than
any other group ever assembled before, what an
exciting time! Thanks for your continued interest and support.
Howard J. Leonhardt
Chairman & CEO
Bioheart, Inc.
BIOHEART RELEASES NEW WEB SITE
www.bioheartinc.com
For those interested in
learning more about the
on going research on
myogenesis Bioheart
has created a useful
web site. This web site
features a great volume
of
peer
reviewed
pre-clinical and clinical
abstracts that have
been published or
presented at various
meetings. The web site
also
posts
career
opportunities
with
Bioheart.
Easy access
menu to get
you anywhere
in our web site.
We now have
a search box
to help you to
get you exactly
where you
want.
Click to see
video clip of
First Live Case
* Disclaimer: Products not available for sale. Investigational only. This release contains certain forward-looking statements, which are based on management’s current expectations and are subject to uncertainties, risks and changes in circumstances, many of which involve factors or circumstances beyond Bioheart’s ability
to control. These factors, risks and uncertainties could cause actual results to differ materially from historical results or those expected, estimated or anticipated
in the forward-looking statements. Note: Effectiveness in humans not yet shown by studies.
2400 North Commerce Pkwy.
Suite 408
Weston, Florida 33326
Ph: 954.217.7259
Fx: 954.385.5340
Call Us Today!
888.BIOHEART
(246.4327)
www.bioheartinc.com