Obtaining the depth of the melanoma lesion (Breslow thickness) is of cardinal importance in successful early diagnosis. In order to provide a vigorous link between the data sampled and the physiology of melanoma lesions BMOIC uses more comprehensive measurement data than is presently used in other methods. By obtaining a larger number of wavebands over a wider total bandwidth along with both polarizations and then applying well developed and understood tissue models to this data, the three-dimensional distribution of biological features in tissue are obtainable. Melanoma surface lesions are very easy to remove, but lesions with a depth greater than one millimeter quickly become lethal. BMOIC is able to provide depth information by making more comprehensive measurements, and then applying the company's patent pending advanced analytical algorithms to well-developed and understandable tissue models to provide quantitative measures of the spatial distribution of the biological features in the tissue.


We employ a combination of optical techniques, including tissue fluorescence and spectral imaging in various polarizations to generate maps of the distribution of tissue features from the surface to depths of up to 3 mm. We use fluorescence imaging and fluorescence anisotropy to probe collagen and elastin distribution. We also use diffuse reflectance hyperspectral imaging to quantify hemoglobin, melanin, as well as scattering properties of tissue, which can provide information about growth characteristics and cell proliferation. Additionally, imaging with different polarizations allows us to extract surface topography of the skin. It is the multimodal nature of our imaging that allows us to extract these accurate measurements that are free from the cross-talk (misestimations of skin composition, described in our scientific publications) that compromises specificity in competitor dermoscopes.


The direct linkage to underlying tissue characteristics provides the biological plausibility that many clinicians require before adopting a technology. This biological plausibility also makes our system more easily testable, using tissue phantoms and appropriate standards to verify accuracy of quantification and ongoing system performance. Skin composition mapping is currently under validation with smaller clinical trials, thus speeding our path to regulatory approval and the market.


Intellectual Property

The intellectual property of BMOIC consists of in house patents, licensed technology patents, copyrighted software and know-how. The patents are related to programmable illumination to accomplish hyperspectral imaging and multimodal imaging, tissue model reconstruction algorithms and disposable accessories for calibration in skin imaging.


Patents: Licensed patents include are primarily those developed as part of laboratory research of Dr. Farkas (PI). BMOIC also has signed a letter of intent to license for certain markets programmable illumination technology developed and patented by Tidal Photonics Inc., a company founded by Mr. MacKinnon (VP, product development). A number of other developments in the course of system design are captured in provisional patents owned by BMOIC.


The Company has a license agreement with Carnegie Mellon University ("Carnegie Mellon") under which BMOIC is the exclusive worldwide licensee of certain rights for two patents issued to Carnegie Mellon: U.S. Patent No. 5,796,512 covers an optical-imaging system with an acousto-optic-tunable filter, and U.S. Patent No. 5,841,577 covers a light microscope having an acousto-optic-tunable filter. The uses licensed to BMOIC include spectral imaging for all clinical medical applications, including endoscopy and dermoscopy. In addition, BMOIC is assignee and owns all rights to U.S. Patent No. 7,428,048 covering a non-invasive technique for the potential early detection of cancer and other abnormal tissues in the field of imaging-elastic-scattering spectroscopy.


BMOIC has filed the following two additional patents, closely linked to the implemented SkinSpect, capturing the essence and novelty of our approach:


  1. Disposable calibration end-cap for use in a dermoscope and other optical instruments (US20150018645)
  2. Method and system for characterizing tissue in three dimensions using multimode optical measurements (WO 2014121152 A1).


Applications

BMOIC's spectral-optical-imaging technology has multiple applications, end-user markets, and potential revenue streams. The company's devices are intended to harness its acousto-optic-tunable filter platform, generating revenue from unit sales, recurring items, and tangential services, including high profit margin software. BMOIC also intends to generate income from telemedicine (dermatology), device maintenance, optional feature modules, and remote terminals. The company's objective is for SkinSpectâ„¢ to become an integral part of the standard of care in melanoma detection. Additionally, BMOIC's strategy will include the potential acquisition of complementary products and technologies in the dermatological arena. SkinSpect is extensible to other kinds of skin conditions (chronic wounds, Lupus, Rubeola (Measles), Acne, Psoriasis, Rosacea, Eczema and etc.), providing dermatologists additional future revenue opportunities.