HyperMed Imaging Announces Cardiology Group as Early Adopter For Its New HyperView Product

October 30, 2017 / Memphis, TN

HyperMed Imaging, Inc. announced today that Mid-South Heart Center, PC in Jackson, TN is the first interventional cardiology facility in the United States to acquire the newly available HyperView™ Imaging System.

The HyperView System is FDA cleared, and it represents a new standard of performance when assessing tissue oxygenation and perfusion in patients with potential circulatory compromise.  The HyperView is a fast, handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient and without the need for injectable contrast. The system uses proprietary technology to capture colorcoded images containing data that provides the clinician critical information such as oxyhemoglobin levels (Oxy), deoxyhemoglobin levels (Deoxy) and oxygen saturation (O2Sat) in superficial tissue.  Such information may assist clinicians when determining if a patient has adequate blood perfusion to heal a wound or maintain healthy tissue.  Understanding both arterial and venous sufficiency in the surface tissue may enable clinicians to make more informed decisions regarding when to intervene.  The HyperView system also helps document perfusion levels before and after vascular interventional procedures such as: peripheral bypass, stent placement, or balloon angioplasty.

Dr. Tommy Miller and Dr. Louis Cunningham at the Mid-South Heart Center commented, “As interventional cardiologist we often treat patients suffering from complications of peripheral vascular disease.  For example, diabetic foot ulcer patients that need increased blood perfusion to heal a wound or patients suffering from leg pain as a result of arterial occlusions or venous insufficiency.  We evaluated the HyperView product and found significant value in documenting tissue perfusion levels before and after interventional procedures.  HyperView enables new insight by providing an image and quantitative data to document changes in micro-vascular performance in the tissue capillary bed after a vascular interventional procedure.  While angiograms can provide confirmation of success in large vessel intervention, it cannot image the micro-vascular response to the procedure and that is a key factor in understanding if the procedure will ultimately be successful.”

HyperMed’s President and CEO Mark Darty stated, “Mid-South Heart Center shares HyperMed’s passion to use the best available technology and to strive for better patient outcomes.  We appreciate the insight they provided our team during product evaluation and are pleased with their decision to adopt the product in their clinical practice.  This is an example of the strong interest we have seen for the new HyperView system by clinicians performing interventional vascular procedures.  HyperView provides new and useful information that fills a gap in current diagnostic devices.  By providing information on arterial and venous sufficiency in the surface tissue, HyperView helps confirm success of procedures meant to increase perfusion.”

HyperMed Imaging, Inc. is a privately owned medical device company located in Memphis, TN.  HyperMed pioneered the use of hyperspectral imaging for assessment of tissue oximetry and HyperMed’s core technology has over 10 years of established clinical efficacy.  With over 50 issued patents and more than 50 additional patents pending worldwide, HyperMed is the market leader in hyperspectral medical imaging.

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

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

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HyperMed Imaging Announces Sales Availability for Its New HyperView Product

October 16, 2017 / Memphis, TN

HyperMed Imaging, Inc. announced today that the company is now offering for sale its new HyperView™ Imaging System to customers in the United States.  Customers are invited to contact the company for more information.  HyperMed will be present at the Symposium on Advanced Wound Care (SAWC) in Las Vegas, NV on October 20 – 22, 2017 where product demonstrations will be available at exhibit booth #443.

The HyperView System is FDA cleared, and it represents a new standard of performance when assessing tissue oxygenation and perfusion in patients with potential circulatory compromise.  The HyperView is a fast, handheld, battery operated, non-invasive and portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient and without the need for injectable contrast. The system uses proprietary technology to capture color-coded images containing data that provides the clinician critical information such as oxyhemoglobin levels (Oxy), deoxyhemoglobin levels (Deoxy) and oxygen saturation (O2Sat) in superficial tissue.  Such information may assist clinicians when determining if a patient has adequate blood perfusion to heal a wound or maintain healthy tissue.  Understanding both arterial and venous sufficiency in the surface tissue may enable clinicians to make more informed decisions regarding when to intervene.  The HyperView system also helps document perfusion levels before and after vascular interventional procedures such as: peripheral bypass, stent placement, or balloon angioplasty.

HyperMed’s Vice President of Sales, Annette Plishka, commented, “We are pleased to offer the new HyperView system to our customers in the USA.  There are many important applications for this exciting new diagnostic imaging device in wound care, vascular intervention and reconstructive surgery.”  HyperMed’s President and CEO, Mark Darty added, “Early market feedback from customers has confirmed that HyperView is a game changer.  It is a product poised to impact a number of important market segments.  The low cost, speed, portability, ease of use and high-quality data and imagery provide clinicians a new class of tool to rapidly assess perfusion and locate ischemic tissue.  This information helps caregivers better understand potential circulatory compromise and allow more informed treatment of complications of vascular disease and diabetes.”

HyperMed Imaging, Inc. is a privately owned medical device company located in Memphis, TN.  HyperMed pioneered the use of hyperspectral imaging for assessment of tissue oximetry and HyperMed’s core technology has over 10 years of established clinical efficacy.  With over 50 issued patents and more than 50 additional patents pending worldwide, HyperMed is the market leader in hyperspectral medical imaging.

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

HyperMed and HyperView are trademarks of HyperMed Imaging, Inc.

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

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HyperMed Imaging, Inc. Receives FDA Clearance for Its New HyperView™ Product

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

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HyperMed Imaging, Inc. Receives UL Certification for New Product

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.

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HyperMed Imaging, Inc. Relocates Offices to Memphis, TN

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.

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HyperMed Imaging, Inc. Secures New Financing

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.

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HyperMed Imaging, Inc. Hires New CEO

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.

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HyperMed’s new tissue oximetry device called HyperView™ is FDA 510(k) cleared.
HyperMed, HyperView, OxyVu™-1 and the company logo are trademarks of HyperMed Imaging, Inc.