Efficient, Cost-Competitive, Faster Patient Monitoring
HyperMed Imaging has come a long way from being a medical device startup to an emerging commercial enterprise. HyperMed Imaging was the first to commercialize a hyperspectral imaging device, OxyVuTM, which was cleared by FDA in 2006 and has been in service for over 10 years, producing positive research results. The company’s guiding principle has been to invent, develop, and commercialize new technology and products that can help improve the lives of diabetic and vascular disease patients by providing better access to valuable diagnostics. The company is driven by the motto of uncovering vascular issues earlier in the disease process, thus helping to deliver more proactive patient care. Darty, who has served as the CEO of the company for the last seven years, says, “Our product can be used to assess vascular performance which is related to tissue health; applications include wound care, vascular intervention and plastic and reconstructive surgery. The goal is to improve clinical outcomes while lowering cost of care compared to other more expensive and invasive diagnostics.”
By helping diagnose peripheral vascular issues early on, HyperMed Imaging aims to lower the cost of care over the life cycle of diabetic and vascular disease patients. “The key is to identify perfusion deficiency early in the disease process before the patient progresses to non-healing wounds and amputation,” asserts Darty. As such, the company’s flagship product called HyperViewTM is designed to rapidly image superficial tissue to uncover perfusion issues, facilitating proactive screening and lower life-cycle cost of care. The handheld, portable and battery-operated device captures the image and data in less than one second, and the full diagnostic process is typically completed in less than 5 minutes. This is a breakthrough in that it allows millions of patients to be screened on the front lines, thus uncovering vascular issues that would otherwise go unnoticed until the patients suffered from complications.
Darty recalls an instance where one of their early customers, an interventional cardiologist used the product to improve clinical practice efficiency. Because HyperView is portable, fast and provides quantitative data on perfusion, it allowed the clinical practice to proactively screen more patients than otherwise would have been possible with older technology such as Ankle Brachial Index and TcPO2 devices.
HyperView, a self-contained imaging and analysis system, leverages HyperMed Imaging’s patented visible light hyperspectral imaging technology to rapidly assess microcirculatory performance in superficial tissue by imaging the key biomarkers of interest for tissue health; oxygenated hemoglobin and deoxygenated hemoglobin. HyperView is optimized for efficiency, mobility, and ease of use with a built-in touchscreen display and diagnostic software tools, which allow clinicians to image the patient and quickly complete the diagnostic process. The HyperView system comes standard with a point-and-shoot diagnostic camera which incorporates a patented and unique spectrometer, as well as a docking station to recharge the camera battery and connect the device to a computer for image downloads (computer software included with system purchase).
The company’s patented visible light spectral imager allows clinicians to differentiate light absorption between oxygenated hemoglobin and deoxygenated hemoglobin. HyperView provides a unique image of the patient’s skin, and the clinician can select regions of interest. Presented as color-coded images, the results contain quantitative data that depict levels of oxyhemoglobin and deoxyhemoglobin, as well as oxygen saturation values. The built-in software tools allow clinicians to analyze various areas within the image corresponding to locations on the skin surface. Images and associated analysis results are electronically stored in an industry-standard format for medical images (DICOM). “HyperMed’s patented visible light spectral imaging technology only penetrates a few millimeters to assess perfusion in the capillary bed and thus avoids potential loss of accuracy associated with near infrared imaging systems that also sample deeper veins and arteries. It is ideal for assessing tissue viability levels. Such is important for clinicians to determine when to intervene to improve blood flow to enable better wound healing. It is also useful for plastic reconstructive surgery to determine flap and tissue viability,” explains Darty.
HyperMed’s patented visible light spectral imaging technology only penetrates a few millimeters to assess perfusion in the capillary bed and thus avoids potential loss of accuracy associated with near infrared imaging systems that also sample deeper veins and arteries
HyperMed Imaging’s technology has no contact with the patient and is more affordable than competing imaging systems that require injectable contrast. Unlike competitors in the market who use near-infrared light, HyperView’s visible light penetrates a few millimeters into the skin, thus sampling bulk blood molecules in only the capillary bed of the tissue without sampling the deeper veins and arteries in the image. This allows clinicians to receive an accurate diagnostic indication of perfusion levels in tissue.
Consistent with its commitment to provide innovative solutions for superficial tissue oximetry applications, HyperMed Imaging’s new HyperView product recently won a 2018 Medical Design Excellence Award. HyperView is FDA cleared and European CE Marked and HyperMed Imaging is an ISO13485 certified medical device provider. “We continue to remain the leader in the field and foster innovation. Our company has over 60 issued patents and over 40 pending worldwide,” says Darty. HyperMed Imaging is growing both in the U.S. and abroad. Signing major distribution partners in several countries, the company continues to expand rapidly. After a successful product launch in the U.S. and Europe, HyperMed Imaging is geared up for the development of its next-generation technology and has several other products in the pipeline. “We will attend over 15 major tradeshows and conferences worldwide this year, and we are sponsoring several important events,” Darty concludes.