Download Cardio Vascular Division Overview_SMIT

- Overview -
Next Generation
Ventricular Assist Devices
presented to
Society for Medical Innovation and Technology
11-14 May 2006
Pebble Beach, Monterey, CA, USA
Jeffrey L. Helfer
Introduction
Cardiovascular disease is the number one cause of death in the U.S.
Approximately 1 million deaths per year in the United States alone.
Nearly 2500 Americans die of CVD each day, an average of 1 death every 35 seconds.
It is directly responsible for nearly twice as many deaths per year as ALL types of cancer.
Cardiovascular disease is the most expensive disease in the U.S.
Anticipated $403 billion in 2006 due to health expenditures and lost productivity.
By comparison, the estimated cost of all cancers in 2004 was $190 billion, and
in 1999 HIV infections totaled $29 billion.
Existing treatments are woefully inadequate
2 •
- Briefly -
Types of Heart Failure
Acute
Heart Failure
Quick onset usually closely
preceding clinical
presentation
Example: Myocardial
infarction (MI) with
revascularization at less
than ~ 6 hours after onset
of symptoms
Acute-On-Chronic
Heart Failure
Longstanding cardiac
dysfunction who suffer
recent de-compensation
Example: Longstanding
cardiomyopathy with the
onset of atrial fibrillation.
Surgery to correct the disease may
result in worsened cardiac function
Example: Mitral regurgitation with the
onset of atrial fibrillation.
Chronic
Heart Failure
Heart failure developed
over a long period of time
Example: Serial MIs have
turned large portions of the
heart into scar tissue which
does not contract and which
impairs the function of
remaining myocardium
Biophan’s product provides the
potential for superior Rx across the
full range heart failure conditions
3 •
- Briefly -
Infarct Expansion in Ventricle
LV Before Infarct
LV After Infarct
During acute MI, the initial loss of contractile tissues adversely affects
workload and wall stress on the remaining viable myocardium, providing a
“substrate” for progressive ventricular enlargement.
4 •
Infarct Expansion in LV - continued
5 •
- Briefly -
Relative Risk for Death in MI Survivors
For each 25-mL increment in
end-systolic volume, the risk
for death increased
exponentially over that of
other survivors of myocardial
infarction with preserved left
ventricular volume.
White HD, Norris RM, Brown MA, et al.: Left
ventricular end-systolic volume as the major
determinant of survival after recovery from
myocardial infarction. Circulation 1987, 76: 44–51.
Factors that influence ventricular remodeling after MI can be modified
to improve clinical outcome.
Limiting the extent of ventricular remodeling in asymptomatic patients after MI can
be considered as preventive therapy for symptomatic congestive heart failure.
6 •
Current Ventricular Assist
Device (“VAD”) Technology
Benefits
Systolic support of a single ventricle
Increase coronary perfusion and oxygen
delivery via increased systemic pressure
Patient mobility
Problems
Perforates the heart and great vessels
High risk of patient complications due to
clotting and stroke, bleeding, and
infection
Average procedure cost: $205,8001
[1] Oz. M., Annetine, C., Miller L. et al., Left Ventricular Assist Devices as
permanent Heart Failure Therapy: The price of progress, Annals of
Surgery. 238(4): 577-83, October 2003.
7 •
Limited applications at specialized
transplant and cardiac centers
Validation of the VAD Market
Ventricular Assist Devices or “VADs” have already been shown to be
superior to medical management for the treatment of heart failure.
Survival rate (%)
REMATCH patient survival data
100.0%
80.0%
60.0%
40.0%
20.0%
0.0%
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31
Month
OMM Patients
The huge investment in VAD
technologies continues to be
a great indication of the
potential of this market despite serious short term
and long term complications,
LVAD Patients
While the therapeutic benefit of VADs is exciting,
complications severely restrict their use
8 •
Market Potential
Analysts project VAD sales to grow from $400M1 (2003) to $7.2B1
(2009) based upon existing VAD technologies and their (limited)
indications for use.
The total addressable VAD market is much larger than this –
potentially as large as $25 billion for devices alone.
Realization of this potential requires a product with significant
improvements in device safety, efficacy, cost, and ease of use as
well as additional diagnostic and therapeutic capabilities.
1. According to ABN-AMRO, Morgan Stanley and S.G. Cowan’s senior medical device industry securities analysts .
9 •
The Paradigm Shift
Energize the best known blood pump – the native human heart!
 Single use, fluid-driven heart assist device
called the “MYO-VAD” and proprietary Drive Unit
 MYO-VAD composed of a dynamic outer shell
and flexible inner diaphragm – fits the heart like
a glove and avoids surgical trauma
 Vacuum delivered to MYO-VAD inner cavity
provides non-traumatic means of heart attachment
 Drive Unit generates forces to power the inner
diaphragm and actuate the myocardium
 System generates normal hemodynamics
without cardiac trauma
 Small chest incision allows device positioning
on the heart
Prototypes have
already been used
to save human lives
10 •
 Chest can be closed to provide temporary or
extended support
 Scientific term: Direct Mechanical Ventricular
Actuation (“DMVA”)
The Product
Benefits
Non-blood contact promises to provide very low risk
of patient complications and more rapid recovery
Systolic and diastolic support to both ventricles.
Enhanced myocardial perfusion
Normal pulsatile flow
Support of all size hearts in nearly all acute and
chronic disease states (including long-term support)
A “healing environment” with means to effectively
deliver multiple therapies directly to the heart
Simple installation (~3 min’s) and removal
Anticipated total procedure cost: $60,000
Likely to be available at nearly every
community and rural hospital
11 •
Current Limitations
Not yet FDA approved
Thoracotomy (Minimally invasive delivery anticipated)
Not yet fully implantable (anticipated)
A Rx for Acute Heart Failure
1. Technically simple, rapid installation & broad availability at virtually
every hospital.
2. Potential for significantly improved outcomes
A. Enhanced reperfusion (including therapeutic agents into the myocardium)
limits the ischemic process.
B. Likely to be utilized much earlier in the treatment process due to
ease of installation/removal and reduced rate of complications
3. Complete support even to a fully asystolic heart
(biventricular support with active systolic emptying and diastolic filling).
4. Pulsatile flow (proven to be important for the recovery of vital organs).
5. Likely to reduce side effects due to absence of anti-coagulation drugs.
6. Low total procedure cost.
7. Integrated diagnostic capabilities.
12 •
- Briefly Cell & Gene Therapy
Cell therapy with skeletal myoblasts or stem cells promises to be a novel
treatment for ischemic cardiomyopathy. When implanted into myocardium,
myoblasts and stem cells appear to proliferate and differentiate into myotubes
with the capability of forming functional muscle fibers.
With increased understanding of the molecular pathogenesis of heart failure,
investigators have also begun to explore the potential of gene therapy to
rescue failing myocardium
- however Initial clinical data are on myoblast transplantation by direct intraoperative
injection which requires cardioplegic arrest and increases the risk of VA.
Percutaneous repair provides very limited dosimetry.
13 •
A Potentially Superior Delivery Platform
Localization
1. Direct delivery of agents to the heart on a continuous basis
2. Optimal topical concentrations that cannot be achieved,
maintained or even tolerated systemically
3. Enhanced transfer rates to cells or across cell membranes
(the normal mechanism for delivering agents/signals to cells)
Supportive Microenvironment
4. Delivery of nutrients to the localized cells
14 •
A Rx for Chronic Heart Failure
1. Full implantability very likely (84 days use already demonstrated)
2. High potential for recovery of normal cardiac function via multiple therapies:
a. Immediate pumping support offloads mechanical stress on the heart and maladaptive response
b. Adaptive constraint maintains low mechanical stress
c. Enhanced cell/gene therapy capability
d. Mechanical “training” of the weakened heart
Nearly certain to promote re-remodeling – not just prevent further remodeling.
3. Treats multiple chronic HF conditions, including diastolic and RV failure.
4. Little or no potential for short-term or long-term complications.
5. Easily removed once the patient has recovered.
High potential for many CHF hearts to recover allowing removal of the
MYO-VAD, an outcome superior even to complication-free transplantation
15 •
Clinical Results
1. Supported 45-year old for 2 days following massive myocardial infarction
with no damage to the heart.
2. Supported 71-year old for 2 days following heart surgery
with no damage to the heart or by-pass grafts.
3. Supported 56-year old for 2-1/2 days as bridge to successful transplantation
with no damage to native heart.
4. Supported 18-year old for 7-1/2 days until heart healed from a viral myocarditis
with no damage to the heart.
5. Supported 44-year old for 84 days with normal neurologic function
with no damage to the heart.
In addition to human studies, over 700 animal experiments have been conducted to
develop and patent the means to safely and effectively support human hearts while
simultaneously providing a wide array of additional operational, diagnostic, and
therapeutic capabilities.
16 •
Anticipated Indications for Use
Indication
Bridge-to-Recovery
(Implantation time ≤ 7 days)
2002
Market
Addressable
Market
$23M
$1,200 M
Provides short-term support while the heart heals from moderate
injury. A very important and growing market.
Acute Resuscitation
(Implantation time ≤ 24 hours)
Expanded market
-
$1,100 M
$52M
$200 M
Important rapid recovery during cardiac emergencies and maintaining
cardiac output for short periods of time.
Bridge-to-Transplant (Implantation time ≤ 12 months)
Keeps patients alive until a new heart is available.
Destination Therapy (Implantation time ~ 5 years)
Expanded market
-
Permanent support. Huge potential for MYOTECH since other current
design VAD problems severely limit usage.
Therapeutic Recovery (Implantation time up to 6 months)
-
$10,000 M
New market
$14,000 M
Longer-term support from serious disease or injury. The potential for many
hearts to recover, allowing device removal.
$75M
17 •
$26,500 M
Product Demonstration
Video
Courtesy of Anatomical Travel
18 •
The Results !
19 •