Mediscience Technology Corporation is engaged in the design and development of diagnostic medical devices that detect cancer using light induced native tissue fluorescence spectroscopy (the "Technology") to distinguish between malignant and normal or benign tissue.
We have 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, and colon cancer.
Our technology will have substantial commercial appeal due to its non-invasive character, its delivery of immediate results, and its enhanced diagnostic sensitivity and specificity.
Method of Detection
Animal and human tissue contains molecules that fluoresce naturally when excited by light at UV and visible wavelengths. Given that the molecular and/or structural makeup of tissue changes as it becomes cancerous, our medical devices detect a shift in the resulting native tissue fluorescence spectrum: an immediate, hands-on distinction between normal, pre-cancerous and cancerous tissue.
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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.
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.
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.
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.
Optical Biopsy Approach
Optical Biopsy is a novel approach based on optical spectroscopy used to diagnose the state of human tissue without removing it from the body.
The onset of carcinogenesis causes molecular and structural change in tissue. These molecular and structural changes can be observed through the differences in the fluorescence spectra between benign, precancerous and cancerous tissue. Mediscience has characterized the fluorescence signatures of normal and malignant tissue from multiple organs through its patented algorithms that distinguish malignant tissue from normal tissue.
Compact Photonic Explorer
Ingestible Pill Camera with fluorescence Spectroscopy IP
Sensitivity and Specificity
1988 through 1998
Mr. Peter Katevatis, Chairman and CEO of Mediscience Technology, identified medical optics as a high potential area.
To pursue potential opportunities in this arena of technology, Mediscience Technology acquired Laser Diagnostics Instruments (LDI) and its seminal photonics patent, Method and Apparatus for Detecting Cancerous Tissue Using Visible Luminescence, from Dr. Robert Alfano.
Under the guidance of Mr. Katevatis, the company entered into a long-term research relationship with the City University of New York and Dr. Alfano (Distinguished professor of Science and Engineering, and director New York State Center for Advanced Technology for Ultra fast Materials and Lasers).
1988 through 1998
Mediscience Technology funded research at the City University, generating over 30 patents in the areas of tissue spectroscopy and optical imaging with applications in cancer detection.
The company also partnered with and/or conducted research at leading medical institutions including the National Cancer Institute (NCI), Memorial-Sloan Kettering Cancer Center, New York Hospital Cornell Medical Center, Yale University Department of OBGYN, and others. Its technology was validated in both pre-clinical and clinical testing, progressing to a focus on commercialization.
1998 through 2003
A research team, headed by Dr. Robert R. Alfano, at City College's Institute for Ultrafast Spectroscopy and Lasers (IUSL), developed a significantly more sensitive technique than conventional fluorescence Spectroscopy to detect cancerous bio-molecules and structures.
Named Stokes Shift Emission Spectroscopy, this method evolves from seminal work performed at the IUSL for the past two decades. Dr. Alfano affirmed, "this revolutionary breakthrough will make optical biopsy the new medical frontier for cancer diagnosis and other medical applications."
Mediscience Technology enters into a project agreement for the development of cancer detection and diagnosis devices with the Research Foundation of the City University of New York.
As stated in a dramatic news release dated May 2, 2004:
" … this Project Agreement provides the Company with a clear path in its intent to commercialize the CD Ratiometer for detecting and diagnosing cancers of the cervix, mouth, esophagus and gastro intestinal tract and other potential applications that are compatible with current state of the art computer hardware and operating systems.We expect to have a completed device by November 30, 2004".
RF-CUNY completes production of the improved CD-Ratiometer instrument(s). Mediscience Technology seeks approval by the United States Food and Drug Administration (FDA) for marketing in the U.S.
RF-CUNY successfully applies its research and development to deliver an updated CD-Ratiometer, as well as associated technology for use in Mediscience Optical Biopsy, including the testing of the Mediscience CD-Ratiometer on ex vivo human tissue specimens.
Under the specific terms of the project agreement, Mediscience Technology is granted an exclusive world-wide license, with the right to grant sublicenses, to manufacture, use, or sell all patented imaging product technology for molecular detection of cancer and physiological change.