January 10, 2017 / Memphis, TN

HyperMed Imaging, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s new medical imaging device called HyperView™. The HyperView product is a handheld, battery operated, portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient. The product is intended for use by physicians and healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of oxygen saturation (O2Sat), oxyhemoglobin level (Oxy), and deoxyhemoglobin level (Deoxy) in superficial tissue. The HyperView system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface. Images and data provide hyperspectral tissue oxygenation measurements for selected tissue regions. The product is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

The HyperView product produces similar data and images as HyperMed’s prior OxyVu™-1 product which has been in service in the US for many years. In comparison to OxyVu-1, the new HyperView product is smaller, faster, and more portable. There are many research publications establishing the OxyVu-1 product effectiveness in a number of key applications involving tissue oximetry. Such applications involve, among others, wound care and associated vascular complications of diabetes and peripheral vascular disease.

HyperMed’s President and CEO Mark Darty stated, “The new HyperView product represents a significant advancement in non-invasive assessment of superficial tissue oxygenation. We began years ago by first meeting with clinicians to understand their working environment and determine user requirements. The need for portability, ease of use and speed of imaging required a full custom design for the HyperView product. Our team’s effort has long been energized by a belief that the HyperView product holds great potential to positively impact the lives of millions of patients. With this new FDA clearance we are now pleased to be able to offer clinicians and patients in the US this exciting next generation imaging device.”

Dr. Aristidis Veves, Harvard Medical School Professor of Surgery and Research Director of the Microcirculation Lab at Beth Israel Deaconess Medical Center commented, “The HyperView is a new and innovative product that can provide clinicians a better understanding of surface perfusion and localized oxygen delivery in patients with potential circulatory compromise, which is important for a number of applications including limb ischemia, wound healing, and reconstructive surgery.” Dr. Veves is Chairman of HyperMed Imaging’s Scientific Advisory Board.

HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of superficial tissue oximetry with its OxyVu-1 device, first cleared by the FDA in 2006. HyperMed currently has over 30 issued patents and more than 40 additional patents pending worldwide on its hyperspectral medical imaging technology and associated products.

For more information, visit: https://www.hypermed.com/

HyperMed Imaging, Inc. is not offering for sale any medical device at this time.
HyperMed and HyperView are trademarks of HyperMed Imaging, Inc.

Contact:
Max Mortensen, PhD
VP Regulatory Compliance and Quality Assurance
1-844-HYPRMED / 1-844-497-7633

101-D073 Rev. A

May 1, 2016 / Memphis, TN

HyperMed Imaging, Inc. has received Underwriters Laboratories (UL) Certification for its new medical imaging device. HyperMed worked with UL to test and evaluate the company’s new medical device for compliance to domestic and international safety standards.

HyperMed’s CEO Mark Darty commented, “This UL certification and our recent completion of clinical validation studies have allowed our company to submit its 510(k) request for clearance to the US Food and Drug Administration. This represents a major milestone toward the goal of commercializing our next generation tissue oximetry product.”

HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of surface tissue oximetry with its OxyVu™-1 device, first cleared by the FDA in 2006. HyperMed’s new generation medical imaging device is currently pending FDA clearance. HyperMed is not selling any medical devices at this time.

February 1, 2015 / Memphis, TN

HyperMed Imaging, Inc. has relocated its headquarters from Greenwich, CT to Memphis, TN. The company made the decision based on a number of factors including improved cost of operations and availability of highly qualified medical device industry talent in the Memphis area. HyperMed’s CEO Mark Darty commented that, “The Memphis area is one of several nexus locations in the US for medical device companies and related technology. By relocating to Memphis, we positioned the company for growth as we seek to develop and launch our next generation of medical imaging devices.”

HyperMed Imaging continues to make progress toward the development of its new medical device for tissue oximetry and has recently completed preproduction prototype devices that will be utilized for development testing, clinical studies and certification activities. The company is expanding and actively hiring for a range of qualifications including product development, operations management, clinical research, regulatory compliance, and quality management systems.

HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of surface tissue oximetry with its OxyVu™-1 device, first cleared by the FDA in 2006. HyperMed’s OxyVu-1 has been successfully used across America for many years, generating substantial clinical research into the use of the technology for a number of applications involving circulatory compromise. HyperMed is not currently selling any medical device and is focusing its efforts toward a new generation of devices using its hyperspectral imaging technology.

January 1, 2014 / Greenwich, CT

HyperMed Imaging, Inc. has closed its first installment of private Series B financing with existing and new investors. Use of proceeds will include the development, testing, clinical trials and regulatory clearance activities for the company’s new medical imaging device for tissue oximetry. The company recently completed advanced research resulting in new intellectual property that will enable its next generation of product based on the company’s core technology in medical hyperspectral imaging.

HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of surface tissue oximetry with its OxyVu™-1 device, first cleared by the FDA in 2006. HyperMed’s OxyVu-1 has been successfully used across America for many years, generating substantial clinical research for use of the technology in a number of applications involving circulatory compromise. HyperMed is not currently selling any medical device and is focusing its efforts toward a new generation of devices using its hyperspectral imaging technology.

January 1, 2012 / Greenwich, CT

HyperMed Imaging, Inc. has hired Mark Darty as its new CEO. Mr. Darty is a seasoned medical device executive that brings a wealth of experience in value creation and commercialization of new and market disruptive technologies. He has held board and operations management positions in cutting edge companies ranging from startups to large, established industry leaders. During his 28-year career, he has brought emerging technologies from the drawing board to production and revenue bearing status in the medical device, consumer electronics, automotive and aerospace sectors.

Prior to joining HyperMed, Mr. Darty was Executive VP of Operations for Luminetx, an award winning medical device company specializing in vascular imaging. From 2005 through 2010, he led the company’s technical operations from inception through global commercialization. The company was listed among Red Herring’s Top 100 startups and won several awards including the Medical Design Excellence Award. When acquired, the company had sales in over 20 nations with manufacturing operations in the US and Europe. Prior to 2005, Mr. Darty held senior management and technical positions at companies such as Brother International and McDonnell Douglas (Boeing), where he led the development, commercialization and manufacturing of new technologies and products such as avionics, mobile computing equipment, imaging devices, and nanotechnology materials and devices. Mr. Darty earned a Master’s of Science in Engineering from the University of Alabama and a Bachelor’s of Science in Electrical Engineering from the University of Tennessee. He is an inventor with many patents ranging from medical devices to electronics, software and nanotechnology.

HyperMed Imaging, Inc. is a privately owned medical device company and the market leader in hyperspectral medical imaging. HyperMed pioneered the use of its novel version of hyperspectral imaging for assessment of surface tissue oximetry with its OxyVu™-1 device, first cleared by the FDA in 2006. HyperMed’s OxyVu-1 has generated substantial clinical research for the use of the technology in a number of applications involving circulatory compromise. HyperMed is now engaged in the research and development of a new generation of devices using its proprietary hyperspectral imaging technology.