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IVDiagnostics |
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January 28, 2013 Issue |
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The Most Powerful Name In Corporate News and Information |
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With their IVD CTC Assay that Accurately Measures Circulating Tumor Cells (CTCs) in vivo Without Taking Blood, IVDiagnostics of Offering the Medical Community a New Paradigm for the Diagnosis, Monitoring and Treatment of Metastatic Disease |
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The
Company’s mission is to provide oncologists and pathologists with better
diagnostics tools for monitoring blood borne diseases such as metastatic
cancer. IVDiagnostics first product is the IVD CTC assay which accurately
measures circulating tumor cells (CTCs) which are known to be the way solid
tumors metastasize to other parts of the body. By monitoring CTCs,
physicians will know the baseline CTC count on patients, and use the IVD CTC
assay on a regular basis to determine effectiveness or ineffectiveness of
therapy.
Frank Szczepanski is a
veteran entrepreneur, technologist and innovator. He has played key roles
for nine startups in the past 20 years which led to the creation of many new
applications, the generation of over $1 billion in product revenue, and the
creation of leading edge technology. Mr. Szczepanski co-founded IVDiagnostics, a biomedical technology company based in Indiana that has a passion for developing novel solutions for monitoring blood borne diseases and creating innovative molecular diagnostic products. IVDiagnostics is on track to become a leader in monitoring circulating tumor cells (CTCs) – a new form of “liquid biopsy”. |
Crown Point, Indiana 46307
Print Version |
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 28, 2013
CEOCFO: Mr. Szczepanski, what was the basic concept for IVDiagnostics and where are you today? Mr. Szczepanski: The basic concept for the company was leading-edge technology for blood borne diseases. Where we are today is that we have created a device that allows us to do that in vivo without taking blood.
CEOCFO: Would you tell us more about the device, what will it be replacing or what it would be doing that is not available today?
Mr. Szczepanski:
Today, if you are a woman who goes in for her post mammogram procedure, you
would generally have an MRI, CT scan or PET scan if they thought that you
had cancer. Or if you were a male, going in for prostate cancer diagnosis
you probably would have a biopsy done and then a pathologist would determine
if there was anything cancerous. If the tissue sample was suspicious, the
clinician would probably do a CT scan or a PET scan. After surgical removal
of the tumor, how do you know if therapies are truly effective? Cancer cells
are more prevalent than those found by image of a solid tumor. Oncologists
need to be able to track the microscopic cancer cells that are generally in
the range of two to thirty microns in size and cannot be picked up by
imaging technology. Therefore, it is not that the imaging technology would
be replaced but our technology would complement it. Secondly, the type of
blood tests that are prescribed called cancer assays do not specifically
measure circulating tumor cells. They look for particular types of antigens
or proteins, so they are indirect measurements and can reflect high false
positives and in some cases false negatives related to CTCs (circulating
tumor cells). Most cancer assays are not effective in determining whether or
not the therapy is working. CEOCFO: What is happening that is allowing you to measure? Mr. Szczepanski: We create nano particles that actually attach to the surface of the cancer cells. We have a conjugate that includes florescence which binds on the cancer cell surface, so we have a way to excite that florescent conjugate so that a signal is emitted and we can pick up the signal through the surface of the skin without penetrating the skin as the cancer cells move past a peripheral point such as a vein on the back of your hand or your arm. As the blood keeps flowing we are picking up signals from the cells because we are exciting them with a custom laser and with the way we design our probe, we pick up that data and convert those signals into information that is held in an online database. If you look at our technology, it is the combination of biology, chemistry, physics, mathematics, and IT engineered into a comprehensive solution that allows us to go beyond the thought process of “Gee I always have to take a blood sample to know what CTCs are in the blood.”
CEOCFO: Where is IVDiagnostics in the development and commercialization process? Mr. Szczepanski: We are at a point where we have developed the assay where it works in vitro. It is the same conjugate that we would apply in vivo, so we have done studies with human patients already with a regional hospital partner and have independently validated that at a large central laboratory. Therefore, we know that the conjugate works. It is then a matter of setting up your FDA trials so that you can actually show that you have enough data to make it worthy to have a product enter the market. We have actually planned a pilot trial initially using the conjugate in vitro, meaning with cancer patient blood samples. That will end up being the predicate or the comparator for when we do our pivotal trial with the device utilizing the same conjugate. In other words, there is not good comparator in the market right now, so we are setting up our own comparative predicate.
CEOCFO: Has the medical community started to pay attention or is it still too early? Mr. Szczepanski: We have people locally that run facilities, local centers such as Cancer Health Treatment Centers, as well as doctors positioned in different regional hospitals that actually want to use the product to keep track of their patients’ health. There is that objective question of whether the medication is working. “Are we (the physician) recording actual CTC measurements over the course of two to three month period? Can we stop your treatment, increase dosage or vice versa? Are your (the patient’s) CTC counts going up, if so you likely know the therapy needs to be changed or the dosage is wrong. The clinicians definitely want to use us.
CEOCFO: Does IVDiagnostics have sufficient funding to get you through the next steps? Mr. Szczepanski: We are currently in the process of a Series-A round in order to be able to cover the cost the next two trials, so this run will raise a little over $5 million, the majority of which will be used to cover the trials. We are not there yet, we do need the help and support of not only current investors but also new investors. We have registered that Series-A and it falls under the guidance of a private offering. We have a private placement memorandum available that was put together by an attorney from New York who actually specializes in PPMs. We have all the information available to provide the prospective investor whether it is an individual, an angel group or a strategic partner that is interested in potentially acquiring marketing rights to our products. Thus, the Series-A preferred opportunity is here now.
CEOCFO: How did the idea and the pieces all come together? Mr. Szczepanski: Initially you start out with a concept and then you think of how you can make this concept work. How you can change the paradigm of treatment of diagnosis so that you have a way of still keeping an initial sample to diagnose things like genetic predispositions for different types of treatment or mutations on those genes so clinicians know what treatment should be given that patient. That is part of the direction for creating a molecular platform. Along the way we have added additional scientists and consultants as part of the team who have particular niches. We have for example a research scientist that we brought over from North Carolina to work with us, whose specialty is development of aptamers. We have a physicist who is a consultant to us whose specialty is developing medical devices that are unique and different. Then, my background is in complex systems integration so it is just a matter of bringing in the right talent and team.
CEOCFO: Why should investor pay attention to IVDiagnostics today? Mr. Szczepanski: We are changing the paradigm of how you actually manage cancer patients. The focus is on metastatic cancers, which is important to note because we have been doing this research and development for four years on circulating tumor cells, and these cases are approximately 99% of the causes of metastatic cancer. What this means is that a patient will successfully have a solid tumor removed and be given their normal protocol treatment such as radiation, chemo, hormonal therapy, and they will be released and go home. Then all of a sudden they wonder why six or twelve months down the road, from coming back again. This will offer a unique way to protect your family and friends who have cancer. We can say we have a monitoring vehicle whether it is done once a month or once every time during treatment where you can using minimally invasive techniques, determine precisely what is happening in your body without having to continually do biopsies which would never be prescribed anyway. You never hear: “let us do another biopsy every month”. What we are all about is a nontoxic way of doing molecular analysis, and with the fact that we are using aptamers means that we can create specific tests for specific types of metastatic cancer. The other reason investors are interested in us, is they want a superior return on investment. Our business plan illustrates that early investors will enjoy a ten times their return on investment. From a clinical perspective, we have a unique product that can change the paradigm of how you track effectiveness or an effectiveness of therapy. From an investor perspective, we have a beautiful way for those investors to make a difference in the lives of their family and friends and make a very good investment. Overall, we are helping to change the whole cost structure. From an insurance perspective, insurance companies will like our approach as well because we can eliminate some of those complementary tests, which can be very costly whether it is a CT scan, bone scan or PET scan. Those imaging test are not able to find metastatic cancer cells anyway because they can only capture images down to one millimeter in size solid tumor and then they miss what is really happening in the bloodstream. These are the primary reasons why you should consider investing in IVDiagnostics.
CEOCFO: Final thoughts?
Mr. Szczepanski:
I will tell you the story of why we formed this company. My wife Carol got
her first occurrence of breast cancer 23 years ago. The paradigm of
treatment has not changed in 25 years; we are still using the same methods
of diagnosis. Clinicians still provide treatment the same way and still miss
the signs of recurrence. About seventeen years went by and then in 2007 she
had her second occurrence. That is about the time that I started to look for
an alternative. There has to be a better way of being able to help cancer
patients and change this current paradigm of diagnosis and treatment. We
formed the company in the spring of 2008. Then two years went by and in 2009
she had her third recurrence with the cancer metastasized to her bone and
liver. I personally, have an incentive to make sure that this works. My wife
has been the inspiration for why we keep pushing forward even in tough
economic times. |
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“The medical community needs a new paradigm for the diagnosis, monitoring and treatment of metastatic disease – IVDiagnostics offers a novel in vivo platform for assisting clinicians in determining effectiveness or ineffectiveness of therapy.” - Frank Szczepanski |
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