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HyperMed receives 510K approval to market its second-generation device, OxyVu™-2 for use in determining oxygenation levels in tissue for patients with potential circulatory compromise

Burlington, MA – January 25, 2008 – HyperMed has just received U.S. Food and Drug Administration (FDA) approval to legally market its second-generation diagnostic device, the OxyVu™-2. The non-invasive OxyVu™-2 Hyperspectral Tissue Oxygenation Measurement System (HTCOM) is immediately available to provide healthcare professionals with a highly useful tissue image map which reports quantitative values of oxyhemoglobin (HT-Oxy), deoxyhemoglobin (HT-Deoxy) and oxygen saturation (HT-Sat).

Richard Lifsitz, Chief Operating Officer of HyperMed, commented that "We are excited to introduce our second-generation product to the physician community. Many of the new features and functions have been added based upon extensive feedback from physicians on the original device." Mr. Lifsitz further observed: "We extend our appreciation to the National Institute of Health, the Juvenile Diabetes Research Foundation, the US Army, NASA and the American Diabetes Association for their efforts in funding the original research behind the OxyVu™ technology. These institutions and our collaborators at many other of the country's leading academic research hospitals deserve much gratitude from us here at HyperMed for providing the foundation for our commercial launch and also from the patient population who will greatly benefit from this product. We would also like to extend our gratitude to our investors, Greenwich Biotech Partners, for their financial and strategic assistance in bringing the second-generation device to market." "HyperMed's OxyVu™-2 technology provides physicians the opportunity to significantly reduce complications associated with diabetic foot ulcers and peripheral arterial disease, which today cost the United States medical system over $15 billion annually", added Mr. Lifsitz.

The OxyVu™-2 enables the efficient collection of data from over a million points, producing a two-dimensional map of the state of tissue oxygenation, essential to assess the "Oxygen Anatomy™." Medical professionals that benefit from HyperMed's OxyVu™-2 include vascular surgeons, foot and ankle surgeons, plastic surgeons, podiatrists, endocrinologists, orthopedists and wound healing professionals.

A Broad Range of Hyperspectral Applications

Hyperspectral Technology (HT) has been used previously by the military and more recently has been applied to the study of physiologic and pathologic changes in animal and human tissue. This technology now provides previously unavailable diagnostic information in medical applications. In addition to studies of patients with diabetic foot ulcers and peripheral vascular disease, HyperMed has conducted research in the areas of shock, breast cancer and endoscopy. HyperMed is at the forefront of these technological advancements, with 8 issued and 18 pending and provisional patents.

About HyperMed, Inc.

HyperMed is the leader in applying hyperspectral analysis to medical applications and has presented at numerous national and international meetings, including Advanced Technology Applications for Combat Casualty Care, the American College of Foot and Ankle Surgeons, the American Diabetes Association, the American Heart Association, the American Association for the Surgery of Trauma, the Diabetic Foot Conference, the Symposium for Advanced Wound Care and the World Congress of Cardiothoracic Surgery. HyperMed's research is published in numerous journals, including Cancer Biology and Therapy, The Journal of Trauma, The Lancet and Diabetes Care. HyperMed’s technology is now commercially available to address diabetic foot ulcers and peripheral arterial disease in the form of OxyVu™-2. For more information about HyperMed, Inc. and the OxyVu™ system please visit the company's website at www.hypermed-inc.com.

Press Contacts:

HyperMed, Inc.
Richard Lifsitz
Chief Operating Officer
781-229-5900
rlifsitz@hypermed-inc.com


 
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