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September 18, 2013

Intrinsic Imaging Undergoes Extensive Quality Audit — Receives Zero Observations

Complete compliance with ISO 9001:2008 and ISO 13485 — zero observations or recommendations.

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Boston, MA / San Antonio, TX — September 18, 2013 — Intrinsic Imaging, LLC, a medical imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that it recently underwent an extensive International Organization for Standardization (ISO) audit by the British Standards Institution (BSI). At the conclusion of the audit, Intrinsic Imaging was found to be in complete compliance with all ISO 9001:2008 and ISO 13485 quality requirements and received zero observations or recommendations.

This successful ISO audit is the latest quality achievement for Intrinsic Imaging. Over the last year, Intrinsic Imaging also underwent an extensive routine audit by the Food and Drug Administration (FDA), and was found to be in complete compliance with all federal regulations and received zero 483 observations from the agency.

Intrinsic Imaging's quality management system is ISO 9001:2008 and ISO 13485:2003 certified and registered specifically for the provision of medical imaging core lab services to pharmaceutical, biotechnology, contract research and medical device organizations conducting clinical trials. Its ISO certifications demonstrate the company's ability to provide imaging core lab services that consistently meet customer and regulatory requirements.

About Intrinsic Imaging, LLC

Intrinsic Imaging is a full-service medical imaging core lab providing comprehensive services in support of Phase I-IV clinical trials and Class I, II, III medical device trials. Intrinsic Imaging is also a world leader in conducting Artificial Intelligence studies. With its team of more than 750 board-certified and fellowship-trained physicians, Intrinsic Imaging’s team has sub-specialization in all therapeutic areas, including Cardiovascular, Central Nervous System, Gastroenterology, Musculoskeletal, Oncology and Ophthalmology. Certified by the British Standards Institution (BSI), Intrinsic Imaging is the only company in the world to hold five ISO certifications specifically for providing imaging core lab services on clinical trials. For more information, please visit www.IntrinsicImaging.com.

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