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Mediscience Technologys Molecular Optical Biopsy through
fluorescence imaging provides the ability to detect cancer and pre-cancer at a molecular
level and gives the Company a leading advantage on the competition
Medical Equipment and Supplies
Mediscience Technology Corporation
1235 Folkestone Way
Cherry Hill, NJ 08034
President and COO
Interview conducted by:
Lynn Fosse, Senior Editor
June 2, 2005
Michael Engelhart, COO and President of Mediscinece Technology Corp. has a 20 year history
of building companys. Prior to joining Mediscinece Technology, Inc., Mr.
Engelhart acted in the capacity of a strategic advisor to several public and private
companies including KN Energy, Reeves International, Consolidated Edison and Vitabiotics.
Mr. Engelhart developed experience and expertise in the areas of strategic
planning, business development, operational turnaround and sales & marketing.
Mediscience Technology Corporation is engaged in the design and development of diagnostic
medical devices that detect cancer and pre-cancer using light induced native tissue
fluorescence spectroscopy (the "Technology") to distinguish between malignant
and normal or benign tissue. Mediscience has successfully conducted both preclinical and
clinical evaluations, which support the value of our proprietary technology, a
breakthrough in the screening and diagnostics of cervical, esophageal, oral, colon and
breast cancer. The technology is non-invasive and delivers immediate results, with
enhanced diagnostic sensitivity and specificity.
Three prototype products employing the company's technology for cancer diagnosis have been
developed. They include the cancer detection (CD) CD Scan, CD Ratiometer, and CD Map.
Using lamp light, these devices provide a broad spectrum of safe, scanning excitation
light wavelengths to ensure that the appropriate target tissue molecules fluoresce
sufficiently to provide maximum diagnostic sensitivity. A fiberoptic probe is attached to
each device: the transmission of the optical excitation signal to retrieve the native
Medisciences CD instruments embody extensive versatility and a broad range of
potential alternative applications depending on the preferred configuration of the
fiberoptic probe. For example, the fiberoptic probe can be configured as a convenient hand
held probe for easy-to-access areas such as the oral cavity or the skin surface. The
optical fiber can be fed down the working channel of: rigid or flexible endoscopesfor
assessment of the upper or lower GI tract, cystoscopes for study of the urinary tract,
colposcopes for gynecological evaluation, laparoscopes for evaluation of internal organs,
core biopsy needles to optically assess breast tumors or other deep tissue tumors, such as
sometimes occur in the pancreas, liver or prostate.
Engelhart, what attracted you to Mediscience?
Mr. Engelhart: I was amazed that there was a technology
that was non-invasive and used Fluorescence Imaging with high spatial resolution that
could detect small foci of malignant cells and define margins of tumors and that there was
no commercial application in the marketplace; it seemed like a major breakthrough.
this a new concept?
Mr. Engelhart: The concept has been around for quite
some time. There have been a number of groups that have tried to commercialize or advance
the technology, so it is not new technology, yet I think it is a technology that is
finally being recognized as being valuable both in terms of patient outcome and medical
you give us an idea of how it works?
Mr. Engelhart: The Fluorescence Technique utilizes both emission and excitation
spectroscopy. Through the technique we are able to see thickening of mucosa layers,
increase in DNA and Nucleic Acids, Increase in cell metabolism and inflammaton/infection;
all of which are changes in tissue properties resulting from carcinogenesis.
what point would you be using this?
Mr. Engelhart: We have developed a non-invasive medical
device with no need to remove tissues, no toxic dyes that delivers real-time results at
point of care in less than one minute. Our technology is sensitive to structural and
molecular changes enabling the detection of cancerous and pre-cancerous lesions prior to
visual indication of tumor. We have accuracy of + 90% using pathology as the gold
standard and can integrate into existing diagnostic instruments.
are you in the development process?
Mr. Engelhart: We completed our prototype and have
submitted pre-IDE application to the FDA for monitoring molecular change in the
is the timeframe from there?
Mr. Engelhart: We would like to be in clinical early in
2005 and could be cleared by the end of 2005.
you tell us about the procedure for the device?
Mr. Engelhart: The OB/GYN, during a cervical exam, uses
a probe. The probe is inserted into the cervix and when it is inserted, the tissue is
excited and the physician note change at molecular level in real time and be in a position
to take a specific PAP smear for pathology analysis.
CEOCFOinterviews: How is
this more specific than a pap smear and how would it work in conjunction?
Mr. Engelhart: Our molecular technology looks at
aromatic amino acids, structural proteins, NADH, flavins and porphyrins and that allows us
to create sensitivity and specificity, and therefore the ability to potentially be taking
a PAP sampling in an area of concern, so we believe that the rate of accuracy in terms of
finding pre-cancerous and cancerous cells will be enhanced.
is the clinical trial procedure on devices?
Mr. Engelhart: Once in clinical trials, it should take
approximately one hundred twenty days to collect the data. Our device is a non-toxic and
non-invasive and believe it can potentially be cleared by the end of 2005.
CEOCFOinterviews: If the
testing goes well, how do you get people to sit up and take notice?
Mr. Engelhart: We are designing a marketing awareness
campaign that will target both OB/GYNs and the patient population. We will
communicate to all of our constituents that, here is a new way to have greater sensitivity
and specificity of potentially diagnosing cervical cancer and pre-cancer far earlier than
is done today; and all in real time during your annual exam.
is it that you will actually be selling to physicians?
Mr. Engelhart: We will be selling a complete unit
consisting of a dual channel detector with algorithms based on intensity ratios, multiple
wavelength pairs with fast data acquisition (<2 sec/ratio) and a probe.
did you decide to make cervical cancer the first in the process?
Mr. Engelhart: There are over 55 million pap smears
conducted annually in the USA year and OB/GYNs are receptive to introducing new
technology that enhance patient outcomes. In addition, we have a great deal of internal
work completed in cervical cancer offering a lower risk in terms of FDA clearance and
CEOCFOinterviews: Do you
see partnerships as part of the program?
Mr. Engelhart: Yes, we see tremendous potential for
partnerships and business development opportunities. Initially, the CD Ratiometer will
lead the way in cervical, oral, colon, and esophagus cancer detection. We see
excellent potential for ex-vivo applications at point of care to measure for clear
margins. We contractually developing our proprietary Compact Photonic Explorer
(CPE) or Photonic pill camera, with Infotonics Technology Center,
www.infotonics.org (founded by Kodak, Corning and Xerox). The CPE is a remote,
self-controlled diagnostic pill to image and detect optical signatures of
cancer inside the human body. The CPE will combine multiple photonic and optical
techniques into a single device."
have a tremendous opportunity with the technology!
Mr. Engelhart: Dr. Robert Alfano and his team at City
University of New York have developed and demonstrated technology that affords Mediscience
the enviable position of leading the way in detecting pre-cancer and cancer.
reaching the general public a large component of your recognition strategy?
Mr. Engelhart: Yes, we are in the process of an
awareness campaign that will communicate our story and focus upon our advantages as a
leader in molecular imaging.
CEOCFOinterviews: Do you
have the funding you need to move ahead?
Mr. Engelhart: We are in the process and have completed
the initial phase of private placement funding, the completion of which will enable us to
fund multiple commercialization applications.
about competition for other devices to enhance cervical cancer detection?
Mr. Engelhart: There are a number of competitors that
are developing new technologies to detect various cancers. We believe that our
intellectual properties portfolio coupled with commercializing our first device will keep
us in the lead and provide a long term competitive advantage.
CEOCFOinterviews: Is the
investment community responding well to your ideas?
Mr. Engelhart: They are just beginning to find our
about us. We are in the process of developing a communication program for investors
that should create a clear and sustainable awareness. We made a number of statements
during 2004 and created a great deal of credibility by delivering and that is beginning to
attract recognition. On October 1st, Smith Barney analyst Peter Bye in a
research report concerning Given Imaging (GIVN) on page 20 cited Mediscience as a
potential future competitor of Given in pill camera devices.
else should potential investors know about Mediscience that is apparent to them as they
look on the surface?
Mr. Engelhart: The exceptional relationship with the
City University of New York and and Dr. Robert Alfano is a driving force in the continued
development of our product matrix. We have some of the greatest minds in the field
investing their time in developing detection devices."
CEOCFOinterviews: Finally, can you address all your
opportunities without losing focus of your main objective?
Mr. Engelhart: Yes, with Dr. Alfano conducting day to
day R&D, we are able to focus on commercialization, sales, marketing and business
development. We are very confident both with our technical and business model execution
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