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MyoCell®
The
human heart does not have cells that naturally repair or replace
damaged heart muscle. Accordingly, the human body cannot, without
medical assistance, repopulate regions of scar tissue within
the heart with functioning muscle. MyoCell is a clinical therapy
designed to improve cardiac function by populating regions of
scar tissue within a patient's heart with myoblasts derived from
a biopsy of a patient's thigh muscle. Myoblasts are precursors
to muscle cells that have the capacity to fuse with other myoblasts
or with damaged muscle fibers to regenerate skeletal muscle.
When injected into scar tissue within the heart wall, myoblasts
have been shown to be capable of engrafting in the damaged tissue
and differentiating into mature skeletal muscle cells. In a number
of clinical and animal studies, the engrafted skeletal muscle
cells have been shown to express various proteins that are important
components of contractile function. By using myoblasts obtained
from a patient's own body, we believe MyoCell is able to avoid
certain challenges currently faced by other cell based clinical
therapies intended to be used for the treatment of chronic heart
damage including tissue rejection and instances of the cells
differentiating into cells other than muscle.
Our
clinical research to date suggests that MyoCell may improve the
contractile function of the heart. However, we have not yet been
able to demonstrate a mechanism of action. The engrafted skeletal
muscle tissues are not believed to be coupled with the surrounding
heart muscle by the same chemicals that allow heart muscle cells
to contract simultaneously. The theories regarding why contractile
function may improve include:
-
the
engrafted muscle tissue can contract in unison with the
other muscles in the heart by stretching or by the channeling
of electric currents;
-
the
myoblasts acquire certain characteristics of heart muscle
or fuse with them; and/or
-
the
injected myoblasts release various proteins that indirectly
result in a limit on further scar tissue formation.
As
part of the MyoCell therapy, a general surgeon removes approximately
five to ten grams of thigh muscle tissue from the patient utilizing
local anesthesia, typically on an outpatient basis. The muscle
tissue is then express-shipped to a cell culturing site. At
the cell culturing site, our proprietary techniques are used
to isolate and remove myoblasts from the muscle tissue. We
typically produce enough cells to treat a patient within approximately
21 days of his or her biopsy. Such production time is expected
to continue to decrease as we continue to refine our cell culturing
processes. After the cells are subjected to a variety of tests,
the cultured cells are packaged in injectate media and express
shipped to the interventional cardiologist. Within four days
of packaging, the cultured myoblasts are injected via catheter
directly into the scar tissue of the patient's heart. The injection
process takes on average about one hour and can be performed
with or without general anesthesia. Following treatment, patients
generally remain in the hospital for approximately 48- 72 hours
for monitoring.
The
MyoCell injection process is a minimally invasive procedure
which presents less risk and considerably less trauma to a
patient than conventional (open) heart surgery. Patients are
able to walk immediately following the injection process and
require significantly less time in the hospital compared with
surgically treated patients. In the 70 patients who have received
MyoCell injections delivered via percutaneous catheter, only
two minor procedure-related events (2.9%) have been reported.
In both cases, however, no complications resulted from the
event, with the patients in each case remaining asymptomatic
at all times during and after the procedure.
We
use a number of proprietary processes to create therapeutic
quantities of myoblasts from a patient's thigh muscle biopsy.
We have developed and/or licensed what we believe are proprietary
or patented techniques to:
-
transport
muscle tissue and cultured cells;
-
disassociate
muscle tissue with manual and chemical processes;
-
separate
myoblasts from other muscle cells;
-
culture
and grow myoblasts;
-
identify
a cell population with the propensity to engraft, proliferate
and adapt to the cardiac environment, including areas of
scar tissue; and
-
maintain
and test the cell quality and purity.
We
have also developed and/or licensed a number of proprietary
and/or patented processes related to the injection of myoblasts
into damaged heart muscle, including the following:
-
package
the cultured cells in a manner that facilitates shipping
and use by the physician administering MyoCell;
-
methods
of using MyoCath;
-
the
use of an injectate media that assists in the engraftment
of myoblasts;
-
cell
injection techniques utilizing contrast media to assist
in the cell injection process; and
-
cell
injection protocols related to the number and location
of injections.
Assuming
we secure regulatory approval of MyoCell for the treatment
of all NYHA Class II and NYHA Class III patients, we believe
MyoCell will provide a treatment alternative for the millions
of NYHA Class II and NYHA Class III patients in the United
States and Europe who either do not qualify for or have access
to heart transplant therapy. Furthermore, we anticipate that
the time incurred and cost of identifying patients qualified
to receive MyoCell as well as the cost of MyoCell, including
any ICD, drug and bi-ventricular pacer therapies that are simultaneously
prescribed, if any, will be less expensive than the current
cost of heart transplant therapy. Moreover, MyoCell is less
invasive than a heart transplant and is not subject to the
tissue rejection and immune system suppression issues associated
with heart transplants.
We
believe there is still a large population of patients exhibiting
symptoms consistent with NYHA Class II and NYHA Class III heart
failure that is seeking an effective or more effective therapy
for chronic heart damage than ICDs, bi-ventricular pacers and
drug therapies. We hope to demonstrate that MyoCell is complementary
to various therapies using ICDs, bi-ventricular pacers and
drugs. In the MYOHEART and SEISMIC Trials, enrolled patients
are required to have an ICD and to be on optimal drug therapy
to be included in the study. While we do not require patients
to have previously received a bi-ventricular pacer to participate
in our clinical trials, we plan to accept patients in our MARVEL
Trial who have had prior placement of a bi-ventricular pacer.
We are hopeful that the results of our future clinical trials
will demonstrate that MyoCell is complementary to existing
therapies for treating heart damage.
MyoCath
and MyoCath II
We
believe MyoCath has the potential to be approved for commercial
use with MyoCell and warrants testing for other commercial applications
as well. MyoCath is a disposable endoventricular catheter used
for the delivery of biologic solutions to a targeted treatment
site within the myocardium, the inner wall of the heart. MyoCath
provides for multiple injections to a pre-determined needle insertion
depth with a single core needle of 25 gauge diameter that can
be advanced and retracted from the tip of the catheter. MyoCath
is intended for use with commercially available Becton-Dickinson
1 milliliter and 3 milliliter syringes. Although we hope to prove
that MyoCell can be administered with a variety of different
catheters, MyoCath has been specifically designed to be used
for the delivery of MyoCell and has been used as the delivery
mechanism in the majority of our clinical trials to date.
We
are developing MyoCath II, a second generation catheter. MyoCath
provides a modified injection needle which has a closed tip and
side holes that result in multidirectional cell injection rather
than injection solely from the tip of the needle. We are seeking
to determine whether MyoCath II will increase the bioretention
of the cells injected in the heart and disperse the cells more
efficiently throughout the scar tissue. We commenced animal studies
of MyoCath II in the third quarter of 2007. Tricardia, LLC has
granted us a sublicenseable license to certain patents and patent
applications covering the modified injection needle we intend
to use as part of MyoCath II, which license is exclusive with
respect to products developed under these patents for the delivery
of therapeutic compositions to the heart.
It
is our hope that MyoCath and/or MyoCath II will prove to be more
cost effective than, and as safe and effective as, other catheters
at delivering MyoCell. Although MyoCath and MyoCath II have been
designed for use with MyoCell, we believe that there are a number
of other clinical therapies to treat heart disease currently
in development by other companies that could be delivered via
MyoCath and/or MyoCath II including, gene, protein, cytokine
and growth factor therapies. Three clinical trials have been
initiated by biopharmaceutical companies and other institutions
utilizing MyoCath to deliver growth factors in an effort to increase
blood supply to a damaged heart.
TGI 1200 Adipose-Tissue
Processing System and Bioheart Acute Cell Therapy
We
are seeking to develop Bioheart Acute Cell Therapy, a patient
derived cell therapy for the treatment of acute MI. Unlike MyoCell,
which is intended to be used to treat severe heart damage months
or even years after a heart attack, Bioheart Acute Cell Therapy
is being designed to be used for the treatment of muscle damage
immediately following a heart attack. We hope to demonstrate
that the injection of endothelial progenitor and stem cells derived
from fat tissue by the TGI 1200 is a safe and effective means
of limiting or reversing some of the effects of acute MI and
preventing or slowing a patient's progression from MI to CHF.
Fat tissue is an abundant and readily available source of endothelial
progenitor and stem cells and is easily extractable from a patient
using minimally invasive techniques. If approved, we intend to
market the Bioheart Acute Cell Therapy primarily to interventional
cardiologists.
We
have secured the exclusive, worldwide right to sell or lease
to medical practitioners and related healthcare entities the
following items for the treatment of acute MI:
-
TGI
1200 and certain disposable products used in conjunction
with the TGI 1200, or the TGI Licensed Products;
-
the
processes that use the TGI Licensed Products, or the TGI
Licensed Processes; and
-
the
cells derived using the TGI Licensed Products and/or TGI
Licensed Processes.
The
TGI 1200 system is a compact, fully automated cell isolation
system for the rapid processing of patient-derived fat tissue
to separate, isolate and produce large yields of endothelial
progenitor cells and stem cells. The fat tissue is extracted
from the patient using a minor liposuction-like procedure and
processed using the TGI 1200. We anticipate that the TGI 1200
system will produce stem cells from adipose tissue within two
hours.
We
have developed a proposed pathway for seeking regulatory approval
of Bioheart Acute Cell Therapy. Preclinical studies involving
pigs testing the safety and efficacy of Bioheart Acute Cell Therapy
commenced in the first quarter of 2007 at Indiana University
and were completed in the fourth quarter of 2007. Assuming favorable
preclinical test results and provided that Tissue Genesis completes
its Device Master File for the TGI 1200 in the second quarter
of 2008, we anticipate submitting to the FDA an IND with respect
to Bioheart Acute Cell Therapy in the third quarter of 2008.
Provided we secure FDA approval of the Phase I protocol set forth
in the IND in the third quarter of 2008, we anticipate commencing
Phase I trials of Bioheart Acute Cell Therapy in that quarter.
Until
the TGI 1200 is readily available for research and clinical applications,
we have been manually isolating and separating endothelial progenitor
and stem cells from fat tissue using Tissue Genesis' TGI 100
Wound Dressing Kit and its related manual cell isolation techniques.
We are currently in the process of negotiating a research agreement
with Indiana University. To date, we have provided training as
well as the TGI 100 Wound Dressing Kits and catheters to Indiana
University for use in connection with these preclinical studies.
Tissue
Genesis has finalized the design of the TGI 1200 and has completed
validation studies demonstrating that the TGI 1200 produces a
pulpy composition comparable to the TGI 100. It is our understanding
that the TGI 1200 is now available for research and clinical
applications. Tissue Genesis has informed us that it anticipates
filing for 510(k) approval in the third quarter of 2008. Tissue
Genesis has informed us that it has entered into an agreement
for the manufacture of the TGI 1200. Upon approval of our IND
application for Bioheart Acute Cell Therapy, we anticipate that
we will seek cost reimbursement for supplying TGI 1200 and the
related disposable kits for use in connection with our clinical
trials of Bioheart Acute Cell Therapy.
MyoCell® SDF-1
Our
MyoCell SDF-1 product candidate, which has recently completed
preclinical testing, is intended to be an improvement to MyoCell.
In February 2006, we signed a patent licensing agreement with
the Cleveland Clinic of Cleveland, Ohio which gave us exclusive
license rights to pending patent applications in connection with
MyoCell SDF-1. We expect this collaboration to give us access
to the extensive underlying animal studies supporting the patent
applications. In addition, in connection with our establishment
of this relationship with the Cleveland Clinic, Dr. Marc Penn,
the Medical Director of the Cardiac IntensiveCare Unit at the
Cleveland Clinic and a staff cardiologist in the Departments
of Cardiovascular Medicine and Cell Biology, joined our Scientific
Advisory Board.
We
anticipate that MyoCell SDF-1 will be similar to MyoCell, except
that the myoblast cells to be injected will be modified prior
to injection by an adenovirus vector or a non-viral vector so
that they will release extra quantities of the SDF-1 protein,
which expresses angiogenic factors. Following injury which results
in inadequate blood flow to the heart, such as a heart attack,
the human body naturally increases the level of SDF-1 protein
in the heart. By modifying the myoblasts to express SDF-1 prior
to injection, we are seeking to increase the SDF-1 protein levels
present in the heart. We are seeking to demonstrate that the
presence of additional quantities of SDF-1 protein released by
the myoblasts will stimulate the recruitment of the patient's
existing stem cells to the cell transplanted area and, thereafter,
the recruited stem cells will assist in the tissue repair and
blood vessel formation process. Preclinical animal studies showed
a definite improvement of cardiac function when the myoblasts
were modified to express SDF-1 protein prior to injection as
compared to when the myoblasts were injected without modification.
We
filed an IND application in May 2007 for Phase I clinical trials
of MyoCell SDF-1 and received comments from the FDA in August
and December 2007. Assuming FDA approval of the protocol for
a Phase I Trial of MyoCell SDF-1 in the second quarter of 2008
and our receipt of certain grants which we have applied for,
we hope to begin enrolling patients in the Phase I Trial during
such quarter.
BioPace
BioPace
is an autologous cell-based therapy intended to be used as a
biological pacemaker for the treatment of sino-atrial nodal dysfunction
disease, a disease in which the natural pacemaker cells of the
heart do not properly function due to electrical disturbances
in the upper chambers of the heart and which results in an abnormal
heart rhythm. The sino-atrial node is the impulse generating
tissue located in the right atrium of the heart. As part of the
BioPace therapy, cells from the sinoatrial node are removed from
the right atrium of a patient's heart and cultured in our temperature
controlled cell culturing facility. These cells are cultured
in vitro in a solution containing oxygen and nutrients. While
the cells are being cultured, we anticipate the patient will
receive an external pacemaker to pace the remaining portions
of the patient's sino-atrial node. The cultured cells are then
implanted into the myocardial tissue of the right ventricle to
provide biological pacing for the heart. We are currently establishing
a preclinical development plan for BioPace.
Allocell
We
anticipate that Allocell will be similar to MyoCell, except that
the myoblast cells to be injected will be taken from third party
donors. Like MyoCell, we hope to demonstrate that allogenic myoblasts
are a safe and effective treatment of severe heart damage. We
anticipate that Allocell may be administered in conjunction with
immunosuppressive drugs to reduce the risk of tissue rejection.
We are exploring the storage life of myoblast cells and the feasibility
of maintaining an inventory of Allocell from which interventional
cardiologists can select to perform the myoblast implantation
procedure.
We
believe our license agreement with Dr. Law and Cell Transplants
International provides us a conditionally exclusive license in
the United States to certain patents that include claims we believe
cover the use of cultured allogenic myoblast cells for the administration
to diseased muscle within the field of heart muscle repair and
angiogenesis.
We
are currently establishing a preclinical development plan for
Allocell.
Bioheart
RTX3370
 The
Bioheart Health Monitor Sends
Data Directly to Your Clinical Information System
The
Bioheart RTX3370 Health Monitor is an interactive and simple
to use device, designed specifically to improve the way of providing
healthcare to patients outside hospitals suffering from chronic
diseases such as heart failure, COPD and diabetes.
The Bioheart RTX3370 Health Monitor engages the patients through
personalized daily interactions and questionnaires while collecting
vital signs and transmitting the information directly into a database
using regular telephone lines.
Wireless and Secure
The Bioheart RTX3370 Health Monitor is a wireless gateway, which
serves as the central device for seamless and secure collection
of data from chronically ill patients. The Bioheart RTX3370 Health
Monitor collects data from a range of standard external vital sign
monitoring devices such as scales, blood pressure monitors, blood
glucose monitors and peak flow meters and transmits the data to
a HTTPs server on the Internet.
Patient
Home Use
The Bioheart RTX3370 Health Monitor is designed for home use by
the patient and contains a number of unique features that make
the device state-of-the-art for system integrators working in the
area of home monitoring, e-health and remote disease management.
Product Benefits
- Home
Care RN sets up monitor and educates patient to disease management
- Patient’s vital signs are monitored daily
- Data
is reviewed daily by an RN at the central station
- Results
faxed to Physicians PRN
- Medication
adjustments made mostly via phone.
- Instruction
on how to us monitor PRN for distress
- Nursing
visit frequency declines
- 2X/week
for 1st week
- 1X/week
and PRN for remainder of 60 day period
- Total
average visits/60 days = 9
Unique Features
- Low
cost solution
- Large
easily readable color display
- Audio
for patient interaction
- Bluetooth,
serial and IrDA interface for external vital sign monitors
Pocket ECG: Real-time Heart Monitoring
System
 Features
- Designed
for long-term, fully-automated ECG arrhythmia analysis and
long-term heart rate variability analysis.
- Monitors:
- Long-term
ST segment elevation.
- Long-term
QT interval measurements.
- ECG
for detecting arrhythmia and heart ischemia events.
- Post-ablation
long-term arrhythmia.
- QT
interval during pharmacological arrhythmia treatment.
Benefits
- Selects
and immediately sends ECG tracing intervals when an abnormal
event takes place.
- Especially
effective during the night, when the patient does not feel
any symptoms, or during daytime in asymptomatic (but potentially
dangerous) events.
- Automated
analysis saves the physicians’ time; there is no
need to analyze the long ECG tracings.
- Allows
for monitoring a larger number of patients at the same time.
- Arrhythmias
may occur rarely, therefore it is important to monitor the
patient for an extended period of time.
- Automatically
selects potentially interesting ECG fragments and send them
to monitoring system.
- CE
marked 0197 and US FDA 510(k).
Market Size:
- Millions
of patients worldwide requiring heart monitoring including post-MI
patients, post-cardiac surgery patients, etc.
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