Jr. Oil & Gas CEI
Jr. Oil & Gas GNF
Jr. Oil & Gas
BEY
Jr.
Oil & Gas XPL
Jr. Oil & Gas
ATH
Oil Sands ATH
Light Sweet Crude XPL
Solar Energy CSKH
Renewable Energy CSKH
Wood Pellet VRD
Biofuels VRD
Wind Energy JUHL
Wind Energy SENY
Clean Technology SENY
Clean
Technology SYMX
Jr. Gold GNMT
Jr. Gold MII
Jr. Gold CCD
Jr. Gold AA
Jr. Gold WCX
Jr. Gold ICX
Jr. Gold RCZ
Jr. Gold EXA
Jr. Gold FDN
Jr. Gold MAO
Jr.
Gold EVG
Jr. Gold RYMM
Jr. Gold LAT
Niobium QRE
Base Metals ORT
Precious Metals LMR
Precious Metals SOP
Precious Metals Extraction RYMM
Lithium LMR
Lithium PL
Silver ELS
Jr. Exploration YLL
Jr. Exploration BKI
Paraguay Exploration LAT
Drug Development Concert
Drug Development CNDO
Drug Development NWBO
Drug Development WNDM
Drug Development APRI
Drug Development BPAX
Drug
Development VICL
Drug Development LLTP
Drug Development
BPTH
Radiation Therapy ISR
Medical Device COO
Medical Device CTTC
Medical Device ISR
Medical Device ABAX
Medical Device CSDT
Health & Wellness LQD
Health & Wellness WELL
Women's Health BPAX
Cancer Detection CSDT
Business Banks BKSC
Business Bank HBOS
Business Banks
AMBZ
Insurance ALTE
Insurance SYA
Insurance-GWC
Insurance MIG
Multifamily Lender WD
Commercial Banks ECBE
Commercial Banks AUNB
Commercial Banks EMPK
Business Development WELL
Brokerage
Services GFIG
REIT TWO
REIT BDN
Energy Conservation AURT
Safety Management Solutions MTPR
Security & Protection GRDH
Digital Media Distribution System YOO
Technology ATCH
Technology SITO
Technology CPSH
Technology ESP
Technology SPA
Technology ANDR
Advanced Power DPW
Semiconducto LGL
Building Materials IBTGF
Fire Resistant Materials IBTGF
Business Services INV
Business Services PMFI
Business Services AUXO
Business Services VSST
Business
Services NSSI
Business
Services GMT
Business Services ITEX
Business Services QIS
Retail BILB
|
James
V. Snider, Ph.D., President
James joined Critical
Diagnostics as President in 2005, shortly after the company's formation. He
has extensive experience in product development and operations in both
startup and large companies. Prior to joining Critical Diagnostics, James
was the Executive Vice President of Business & Operations for IntelligentMD,
an early-stage medical device company that focuses on the essential elements
of disease diagnostics and therapeutic intervention. Previously, he spent
eight years in a series of marketing and product development positions at
Applied Biosystems (ABI). James holds a B.S. in chemistry from Grand Valley
State University and a Ph.D. in chemistry from the University of South
Carolina.
Company Profile:
www.criticaldiagnostics.com
Critical Diagnostics helps
physicians optimize patient care in cardiovascular diseases, such as heart
failure. Our high sensitivity Presage® ST2 Assay measures the level of
soluble ST2 in blood, identifying patients at increased risk of morbidity
and mortality. ST2 has been evaluated in multiple clinical studies, now
spanning more than 30,000 subjects.
ST2 signals the presence of adverse cardiac remodeling and fibrosis, which
occurs in response to myocardial infarction (MI), ischemia, or worsening
heart failure. Remodeling and fibrosis can also contribute to the
development of future adverse events, such as secondary MI or sudden cardiac
death (SCD), and to progression of heart failure.
The Presage ST2 Assay helps clinicians assess patient prognosis in order to
better personalize their care. By selecting the most appropriate treatments
and interventions for each patient, a physician can maximize the clinical
benefit from increasingly limited healthcare resources.
Interview
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 4,
2012
CEOCFO: Dr.
Snider, would you give us a brief overview of Critical Diagnostics?
Dr. Snider:
Critical Diagnostics is an early stage company that was formed to develop a
test for the cardiac biomarker protein called ST2, which has been shown to
be useful in providing prognostic and risk stratification information for
patients with cardiovascular diseases particularly heart failure. Critical
Diagnostics was formed to develop an in vitro diagnostic test, a laboratory
based test for this product; move that through the clinical regulatory
process and commercialize it. We have received regulatory approval both in
Europe and the US to market this test for clinical use.
CEOCFO:
Would you tell us about ST2 and why it is so important to be able to do the
assessment?
Dr. Snider:
ST2 is a protein that is expressed both as a cell surface receptor as well
as a soluble form. On the surface of cardiac cells, cardiomyocytes, when
those cells are subjected to injury or illness, that receptor responds to a
signal through an interleukin called interleukin 33. If that signal is
blocked when those cells are subjected to an injury or illness and do not
get that positive signal from interleukin 33, then those cells move into
apoptosis, necrosis and eventually fibrosis and remodeling. Cardiac
remodeling results in impaired cardiac function, which is by definition
heart failure. Soluble ST2, which is the protein that we measure, blocks
that signal of interleukin 33 to the receptor. Soluble ST2 is a different
gene product of the ST2 receptor gene and is expressed at higher
concentrations in patients who are progressing toward worsening disease. The
biology of their cardiac tissue is such that for some reason it goes into a
deterioration mode rather than a recovery mode. Soluble ST2 initiates a
series of cellular events that lead toward increasing fibrosis, cardiac
remodeling and impaired cardiac function. If left unchecked ultimately
leading to the patient’s death. In the clinical contextmeasuring ST2
identifies patients that are beginning this process. If you can identify
those patients then the physician has the opportunity to intervene earlier
and more effectively with appropriate therapeutics or device treatments to
reduce disease progression.
CEOCFO: Is there a test for it now that
you would be replacing or is this a new area?
Dr. Snider:
There are other cardiac biomarker tests but this is a new area. This is the
first clinical test for this marker, ST2, that has ever been available.
CEOCFO: What would be the indication?
Why would a physician decide to test with your array?
Dr. Snider:
This is not a diagnostic test. This is a test for assessing the prognosis or
the risk stratification of patients that have disease, such as in the
context of managing patients with heart failure. Our current indication for
use, as defined by the FDA, is for use as an aid in risk stratification of
patients with chronic heart failure. This is a population of patients that
doctors are already treating and the Census of heart failure patients in the
US is approximately 6 million. It is approximately twice that in Europe. The
challenge is that when patients are being treated, they are being treated
primarily for their symptoms, not necessarily for the biology of their
disease. If their symptoms change, it is usually a reflection of a
biological change that was happening some time previously. What ST2 provides
is that indication that the biology of the patient is changing prior to
their symptoms changing. For instance, before a patient with heart failure
becomes decompensated. That patient may show up in the emergency room or
clinic for treatment, because he or she is in distress or a patient that is
in early stages of disease, but does not have a compromised ejection
fraction so the ejection fraction not decreased. Therefore, remodeling is
not yet visible by echocardiography. ST2 can identify which patients are
progressing down that pathway. So, it can be used as an early indicator of
patients that should be monitored more closely for a potential change in
their status or to introduce treatment to delay the progression of the
disease.
CEOCFO: Would this eventually become
something standard to use for cardio patients?
Dr. Snider:
Yes, risk stratification of patients with heart failure is an accepted
clinical practice. And research projects that are currently in place, both
in the US and Europe, are being evaluated to better ascertain the
appropriate medical response to this assessment of risk. The objectives of
these projects include establishing what the optimum frequency is of testing
is and what treatment implementation or therapeutic changes should be made
to these patients and their care. This clinical adjustment is expected to
result in a delay in the patients’ progression of disease, keep them out of
the hospital and improve their quality of life.
CEOCFO: What is the product that
Critical Diagnostics will be bringing to the market; is it a device with a
razor/razor blade component?
Dr. Snider:
It is a laboratory test, a kit that can be performed in any standard medical
laboratory.
CEOCFO: Will expense be a factor?
Dr. Snider:
Certainly, it is not free, but we priced it very fairly and reflective other
tests in the category. In vitro diagnostic tests run anywhere from commodity
tests that are just a few dollars per test. For example, there is troponin,
which is right now reimbursed at around $10, and then there are natriuretic
peptides, such as BNP and NT-proBNP, which are reimbursed at $49. We do not
yet have an analyte specific reimbursement code for ST2 so we priced it at
$26.00.
CEOCFO: Critical Diagnostics has named
some distributors at Asia Pacific; would you tell us about that?
Dr. Snider:
Since receiving clearance from the FDA, we have been working globally. In
the US, we work directly. We also have relationships with some of the
reference testing laboratory companies, such as ARUP Laboratories in Salt
Lake City. The test has been available through them first as a research use
test and now as the FDA cleared test. We are establishing agreements with
additional reference testing laboratories companies in the US. We are also
selling directly with our own sales and marketing force in the US.
Internationally, we are leveraging with experts in individual countries;
some in Europe as well as in Asia. In Asia, we have engaged exclusive
distribution and marketing agreements with companies right now in China,
Korea, and in Indonesia. We are working on final stages of agreements with
the companies in several other Asian countries. By the end of this year, we
expect that we will have six or seven countries, with the major Asian
countries represented and moving forward.
CEOCFO: Development is a costly process;
is Critical Diagnostics funded to get to commercialization?
Dr. Snider:
Yes. The investment group that I worked with, that actually founded the
company, Carrot Capital Healthcare Ventures, has been extremely committed to
the development and success of the company. We have managed the company very
conservatively through this development cycle; minimizing our investment,
maximizing our return. We have kept the company very small with a modest
internal deployment force, leveraging significantly on resources that we
could obtain through subcontracting and through OEM. Our manufacturing has
been through OEM. Going forward, because we were so conservative in the
development cycle, they are very comfortable with the additional investment
necessary to move into commercialization and through the marketing efforts
that we are in process of executing. The revenue stream will offset a
significant amount of our expenses going forward.
CEOCFO: What is the potential market?
Dr. Snider:
The best thing that we can do is benchmark to the most comparable existing
test, the natriuretic peptides. Right now worldwide, the natriuretic peptide
tests market, the combination of BNP and NT-proBNP, is approximately $800
million. The clinical evidence that we have developed with ST2 is in the
context of patients with heart failure, which is the dominant use of the
natriuretic peptides. A significant amount of that business is in patient
management, which is exactly where ST2 should be used. We believe that the
opportunity for the Presage ST2 Assay is equal to, if not greater than the
current market for the natriuretic peptides.
CEOCFO: Why should investors pay
attention to Critical Diagnostics today?
Dr. Snider:
What differentiates the Critical Diagnostics product is that ST2 is
completely unique in the product. We already touched on the point that there
is not a product that it is replacing. It is a new clinical opportunity, a
new clinical value to the market for managing patients and making treatment
decisions for patients with cardiovascular diseases, heart failure as well
as other cardiovascular diseases. Therefore, it is a completely new
opportunity in the market space with very high clinical value. Critical
Diagnostics has exclusivity of intellectual property around the clinical
uses of this biomarker. We also have the proprietary reagents and components
of the test, so the test that is approved for clinical use can only be
produced with materials that we own and under our intellectual property.
Right now as a company, we are completely unencumbered by relationships with
any other partners. We have not entered into any licensing agreements for
instance with a major company in the IVD industry. We are certainly open to
discussions for partnership arrangements with large IVD companies, but we
have not yet entered into any of those agreements. Therefore, we have
complete latitude to consider any opportunity or structure that somebody
might be willing to present. Our investment group is extremely committed to
the success of the company and to this product. This test is comparable to
any of the other high success products such as the natriuretic peptides. The
experts in the field, the key opinion leaders that we work with, fully
believe that this test is potentially more valuable than the natriuretic
peptides, which are established and have proven value in managing patients
with cardiovascular diseases.
disclaimers
Any reproduction or further distribution of this
article without the express written consent of CEOCFOinterviews.com is prohibited. |
Healthcare
Cardio
(Privately Held)
Critical Diagnostics
3030 Bunker Hill St., Suite 117A
San Diego, CA 92109
Phone: 877-700-1250
www.criticaldiagnostics.com
Critical Diagnostics
Print Version
Medical Diagnostic Companies, Critical Diagnostics (Privately Held), CEO
Interviews 2012, diagnosing cardiovascular diseases, heart failure, Presage
ST2 Assay, Recent CEO Interviews, identifying patients at increased risk of
morbidity, adverse cardiac remodeling and fibrosis, myocardial infarction
(MI), ischemia, diagnosing heart failure, Companies looking for venture
capital, Angel Investors, private companies looking for investors,
healthcare companies seeking investors, biotech companies needing investment
capital, More
Headlines.....
With A
Platform Technology That Improves Survival Time, Lacks The Toxicity Of
Current Chemotherapeutic Drugs And May Be Applicable To Any Cancer,
Immunotherapy Company, Northwest Biotherapeutics, Inc. Is Well
Positioned for a Breakthrough In This Exciting New Field
(NWBO-OTCBB)
Biotonix
Is Using Their Postural Technology And Soon Orthotics To Address The Health
And Wellness Market, With Their BioPrint™ For The Health Market , Their
FitPrint™ For The Fitness Market And Their New GolfPrint™ For Evaluating The
Posture Of Golfers – For The Sports Market, All High Potential Markets
Individually
(BTX-TSX-V)
With An Acquisition Allowing
Them To Enter Into The Area Of Traditional Pharmaceuticals, But Remain
Focused On Stem Cell Therapy And Services With Their Expansion Into China,
NeoStem, Inc. Has Become A More Global Company With Greater
Growth Potential Being In The Right Place At The Right Time
(NBS-AMEX)
Bio-Solutions Corp.
Is Focused On Two Large Market Areas With Their NutraAnimal™ Organic Feed
Supplement For The Poultry Industry And Their GreenEx™ Biological
Insecticide To Help Combat Mosquitoes That Carry Deadly Diseases Such As
Malaria
(BISU-OTC: BB)
With People Investing More On
Their Health And To Reduce Their Stress, Simulated Environment
Concepts, Inc. Is In The Right Place At The Right Time With Their
SpaCapsule® Product Line For The Health And Fitness Industry, Designed To
Decrease The Stress Level For Individuals And Businesses In A Busy World
(SMEV-OTCPK)
|