Caliber Imaging & Diagnostics, Inc., a medical device company, develops, manufactures, markets, and sells point-of-care cellular imaging systems. The company’s patented and FDA-cleared VivaScope technology provides physicians with real-time images of the epidermis and superficial dermis of the skin, as well as other epithelial tissues at a cellular level that can be interpreted by the physician at the bedside and/or transferred to a pathologist on VivaNet, its HIPAA-compliant private telepathology network for remote diagnosis. The company’s core products are FDA 510(k) cleared for clinical use and has regulatory approvals in most major markets. Its technology is already in use by physicians and researchers at major academic hospitals, and by pharmaceutical and cosmetic companies across the globe. The company’s devices allow these researchers to study the efficacy of new products, test ingredients, validate claims and determine safety. The technology is protected by 78 issued or pending patents worldwide. The company’s proprietary platform imaging technology has been the subject of approximately 350 independently sponsored studies or publications spanning various clinical and research fields. Its in-vivo products are suitable for applications in which a traditional biopsy is counterproductive, such as validating the diagnosis of benign lesions (thus, reducing unnecessary biopsies), monitoring noninvasive therapies and determining product efficacy. The company’s product portfolio consists of various in-vivo and ex-vivo imaging systems, as well as a telepathology system, covering various applications. The company’s VivaScope in-vivo devices, the VivaScope 3000 (handheld device) and the VivaScope 1500, use confocal cellular imaging to create a layer-by-layer scan of living tissue, with a >0.2mm imaging depth. Its in-vivo imagers are FDA 510(k) cleared with an intended use 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’s VivaScope ex-vivo device, the VivaScope 2500, uses confocal imaging to produce electro-optically enlarged images of unstained and unsectioned excised surgical tissue without the laborious tissue preparation procedures required to prepare the microscope slides used in traditional pathologic examination of tissue. As a Class I medical device, the VivaScope 2500 is exempt from 510(k) clearance. The company’s VivaNet telepathology server transfers images from the point of capture at a physician’s office or operating room to another physician, pathologist or other diagnostic reader for near real-time diagnosis and reporting. Its VivaLAN product is a telepathology system, which retains all patient data within the customer’s facility. As Class I medical devices, its VivaNet and VivaLAN systems are exempt from 510(k) clearance. Sales and Marketing Managed care organizations and integrated health networks that the company intends to target include UnitedHealth Group Inc.; Cigna Health Group; WellPoint, Inc.; Coventry Health Care, Inc.; Kaiser Foundation Health Plan and Hospitals; Health Net, Inc.; Humana Inc.; HealthSpring, Inc.; and Aetna Inc. The skin care product research and development companies to whom the company has shipped a VivaScope system and/or that it intends to target include Allergan, Inc.; Arch Chemicals, Inc.; Ashland Inc.; Avon Products Inc.; BASF SE; Bayer AG; Beiersdorf AG; Clariant International AG; Colgate-Palmolive Co.; E.I. du Pont de Nemours and Co.; Eastman Chemical Company; Genentech, Inc.; Genzyme; GlaxoSmithKline PLC; Janson Beckett Cosmeceuticals; Johnson & Johnson; Kao Corporation; Kimberly Clark Corporation; L’Oreal SA; McNeil PPC, Inc.; Medicis Pharmaceutical Corporation; Merck & Co Inc.; Neutrogena; Ortho Dermatologics; Pfizer Incorporated; Proctor & Gamble Company; Revlon, Inc.; Roche Holding Limited; Royal DSM NV; Sanofi-Aventis; Schick Manufacturing, Inc.; SkinMedica Incorporated; The Body Shop International; The Estee Lauder Companies Inc.; and Unilev
lucid inc (LCDX:OTC US)
50 Methodist Hill Drive
Rochester, NY 14623
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