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Company Description

Contact Info

50 Methodist Hill Drive

Suite 1000

Rochester, NY 14623

United States

Phone: 585-239-9800

Fax: 585-239-9806

Caliber Imaging & Diagnostics, Inc., a medical device company, designs, manufactures, and sells non-invasive cellular imaging systems enabling physicians to image and diagnose skin disease in real time with an optical biopsy versus an invasive or surgical biopsy. Operations The company's Rapid Cell ID technology offers physicians the option to non-invasively diagnose, monitor, and follow-up the non-invasive treatment of basal cell carcinoma, and includes the capacity to visualize the margins of the disease prior to surgery, improving patient outcomes. The company has developed an integrated platform of tools, including the VivaScope 1500, VivaScope 2500, and VivaScope 3000 Rapid Cell ID Imagers along with its telepathology service that can be used by doctors, surgeons, and research laboratories. The company’s tools are in use by doctors and researchers in major academic hospitals, as well as at pharmaceutical and large cosmetic companies. The company’s telepathology server, when connected to a physician’s VivaScope imager, transfers images from a physician’s office or operating room to another physician, pathologist or other diagnostic reader for near real-time diagnosis and reporting. In addition, the telepathology server stores images and pathology reports as a part of a patient’s Health Insurance Portability and Accountability Act (HIPAA) compliant permanent, electronic, medical record increasing efficiency and reducing costs for medical institutions compared to current histology record retention processes. The company’s Rapid Cell ID technology platform consists of: In-Vivo Confocal Imagers: The VivaScope 1500 and the VivaScope 3000 (handheld device) confocal systems are cleared with an FDA 510(k) to acquire, store, retrieve, display, and transfer in-vivo images of tissue, including blood collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment. The company designed its VivaScope System to support the capture of clinical images of the patient; images of the patient’s lesions; and confocal images of the patient’s lesions that can be evaluated at the point of care or transmitted over its HIPAA compliant telepathology network to a pathologist. Ex-Vivo Confocal Imagers: The VivaScope 2500 produces electro-optically enlarged images of unstained and unsectioned excised surgical tissue for medical purposes. The VivaScope 2500 is a Class I medical device and is exempt from FDA 510(k). The company is developing the VivaScope 2500 confocal imager for the rapid imaging of tissue that has been surgically excised from the body. Telepathology: The company’s telepathology server is a Digital Imaging and Communications in Medicine (DICOM) standard compliant medical grade image server. The DICOM standard is a global technology standard for various aspects of the communication of medical images and is used in hospitals worldwide, ensuring that every hospital and medical imaging center is a potential customer. The company’s telepathology server is registered with the FDA as a Class I medical image device, which categorizes it as a radiology diagnostic device, for the storage, transfer, and retrieval of images between physicians and diagnostic readers, typically pathologists. Research and Development The company has ongoing and planned U.S. and European clinical studies, including a U.S. based multi-center trial funded by the National Cancer Institute evaluating 400 pigmented lesions suspicious for malignancy based on clinical exam; 2 planned payer-based studies to evaluate the economics of confocal imaging to set reimbursement rates within a primary care and dermatology clinical setting for the treatment of skin cancer; a European study evaluating confocal imaging over a telepathology network with clinical sites in Italy and Spain; and a U.S. based study to differentiate parathyroid gland from lymph node and other tissues, intrasurgically, without removing the parathyroid from the body. Intellectual Property Patents: The company holds 58 patents, which consist of 45 U.S. patents, 5 Australian patents, 3 Japanese patents, 3 European patents, 1 Chinese patent, and 1 Canadian patent. These patents are owned by the company, with the exception of two non-fundamental patents which are co-owned. In addition, the company has 20 additional U.S. and foreign patents pending. The company’s portfolio of issued patents includes both method and apparatus patents in areas, such as handheld imaging, imaging quality, surgical pathology, tissue stabilization, and tissue navigation. Its pending patents include pending foreign counterparts of its U.S. patents and patent applications, as well as pending U.S. patents on new technology. The company has granted limited licenses to its European intellectual property to its distribution partner in Europe. Trademarks and Domain Names: The company has obtained United States trademark registrations for the following marks: ‘VivaScope’, ‘Lucid’, ‘VivaBlock’, ‘VivaStack,’ ‘VivaCam’, ‘VivaNet’, ‘VivaCell’, ‘VivaScan’, and ‘VivaScopy’, as well as its corporate logo. Competition The company competes with Mauna Kea Technologies; FotoFinder Systems, Inc.; Mela Sciences, Inc.; Michelson Diagnostics; and Verisante. Regulation The company’s products are considered medical devices and are subject to regulation by the FDA. The Food, Drug, and Cosmetic Act and other federal and state statutes and regulations govern the research, design, development, preclinical and clinical testing, manufacturing, safety, approval or clearance, labeling, packaging, storage, record keeping, servicing, promotion, import and export, and distribution of medical devices. The advertising of its medical devices is subject to both FDA and Federal Trade Commission regulations. History The company was founded as a New York corporation in 1991. It was formerly known as Lucid, Inc. and changed its name to Caliber Imaging & Diagnostics, Inc. in 2012.

 

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