Company Strategy - Medical Diagnostic Device Development
Compact Photonic Explorer (CPE) A smallscale spectroscopic diagnostic “pill” designed to detect optical molecular signatures of cancer inside the digestive tract of the human body.
CD-Ratiometer (CD-R) A medical device based upon optical spectroscopy without removing tissue from the body. Using patented algorithms, the CD-R will enable the OB/GYN to determine malignant, dysplastic and benign tissues of the Cervix.
Mediscience Technology Corporation has invested over $25 million in the development of noninvasive medical diagnostic devices that utilize ultraviolet light to detect the presence of cancer in human tissue. The company benefits from a separately funded research agreement with the City University of New York covering medical and non-medical applications of photonics which has generated over 26 patents, including "Stokes-Shift Fluorescence Spectroscopy" for the detection of disease and physiological state of specimen; as well as exclusive US and worldwide license rights, prototype instruments, and seminal in-vitro and in-vivo preclinical and clinical data.
In addition to the fundamental technology for all of its products, which stems from its licensing agreements with the City University of New York, Mediscience also has a collaborative arrangement with Infotonics Technology Center, a collaborative, industry-led Microsystems R&D center. The Center is a consortium which includes Corning, Xerox, and Eastman Kodak; the State of New York; Federal Government agencies; and eighteen universities domiciled in New York State. Its goal is to create high technology businesses from its position as a world leader in photonics and microsystems innovation and commercialization. The center will commercialize Mediscience's Compact Photonic Explorer. (described below).
The company believes that all known competitors have a limited intellectual property position relative to itself. Furthermore, all use less sensitive technologies based on diffuse reflectance or on tissue excitation at wavelengths that do not optimally interrogate key native fluorescence (the basis for the company's technology).
Basis for Technology
The onset of carcinogenesis causes molecular and structural change in tissue which can be observed through differences in the fluorescence spectra between benign, precancerous, and cancerous tissue when the tissue is excited by ultraviolet light. This is the basis for Mediscience's non invasive optical biopsy technology utilized in its diagnostic instruments. Successful preclinical and clinical evaluations support the devices' real time results, sensitivity, and specificity.
Initial Products
Two cancer detection instruments developed by Mediscience render tissue removal unnecessary, produce real time results at the time of the procedure, detect cancerous and pre-cancerous lesions before any visual indication of tumor occurs, and have over a 90% accuracy rate.
They are:
The CD-Ratiometer determines malignant, dysplastic, and benign tissue in the cervix through optical spectroscopy. without removing tissue from the body. It is a diagnostic tool for point of tissue characterization of the cervix based upon the measurement of key fluorescence ratios. The CD Ratiometer has been perfected by a five person research team at the City University of New York (MTC shareholder). A six month pilot study utilizing the CD Ratiometer is about to commence.(FDA filing Jan 5, 2006). This will be followed by a pivotal study which should be completed within another 12-18 months.
The Compact Photonic Explorer is an ingestible pill that detects optical signatures of cancer as it courses through the gastrointestinal tract (US Patent IP MTC owned). The Compact Photonic Explorer utilizes ultraviolet light to remotely monitor the health of human tissue. The procedure is a noninvasive biopsy determined through spectroscopy. Infotonics, Mediscience's collaboration nano-technology partner (MTC shareholder), on this project, estimates that it will have a production prototype of the Compact Photonic Explorer, within 12-18 months. The Center has the capability to ramp up to pre-commercial pilot production of thousands of devices.
Since the CD Ratiometer is essentially non-invasive in nature and does not cause physiological changes in tissue, it is reasonable to believe that the clinical studies should not be unnecessarily delayed because they will be replicating the highly accurate in-vitro and in vivo results already achieved.
In the case of the Compact Photonic Pill, the outer definition of the device is essentially similar to the Camera Pill currently being marketed by Givens (symbol GIVN) for taking pictures of the gastrointestinal tract. Mediscience has at its disposal the intellectual and fabricating capabilities in the area of Photonics of Infotonics Technology Center to miniaturize and create a production prototype which they estimate will be completed in 12-18 months. No great "leaps of technology" are required. The task of clinical trials will be to confirm the inclusion in the Compact Photonic Explorer of already proven technology to identify abnormal tissue in the gastrointestinal tract.
Exit Strategy
After a long gestation phase, Mediscience is now in a position to capitalize with a high degree of predictability on its broad based technology platform. Well defined programs for the Compact Photonic Pill and the CD Ratiometer make many options available for an exit strategy within a short period of time. These include:
A public offering with listing on a major exchange.
Licensing agreement with a major pharmaceutical/medical device company.
Marketing agreement with a company that has distribution capability to be served by Mediscience products
Acquisition by potential competitor or one with complimentary products.
The next phase of funding is intended to complete the pilot study for the CD Ratiomenter and see the Compact Photonic Pill through to a production prototype. As previously stated, these events should occur within a period of 18 months.
The pilot study for the CD Ratiometer will be completed within six months subsequent to funding. This is a significant milestone within the 18 month time frame mentioned above since it will trigger a pivotal study which should take an additional 12-18 months. As previously mentioned, the Infotonics Technology Center has expressed its confidence in delivering a production prototype of the Compact Photonic Pill with 12-18 months.
