Calgary, Alberta-based Kent Imaging Inc. has unveiled its FDA-approved Kd203, a hand-held, multispectral imaging device for measuring wound and tissue oxygenation. Directly imaging oxygen perfusion provides more accurate diagnosis than existing technologies, Kent Imaging's CEO Pierre Lemire told BioWorld MedTech, which will also lead to more effective treatment planning and patient monitoring.
"This is a huge milestone for the company," Lemire said. "The wound market has been underserved in terms of imaging technology and what this device will do is give surgeons insights about what's happening in the wound they haven't had before."
Launched earlier this month at the Symposium on Advanced Wound Care in Las Vegas, the Kd203 measures the percentage of hemoglobin carrying oxygen along the smaller blood vessels and veins to the wound site. This is distinct from pulse oximetry, for example, which measures oxygenation of the larger carrier vessels and will tell you if your heart and lungs are okay, Kent Chief Science Officer Michael Sowa told BioWorld MedTech. "But it won't tell you how well surrounding tissues are oxygenated."
Kd203's closest competitor, however, is transcutaneous oxygen pressure monitoring or TcP02, the current gold standard for perfusion quantification in surrounding wound tissue. TcP02 involves measuring oxygenation through the skin via placement of electrodes around the periphery of the wound. Problem: that physical contact won't allow you to measure oxygenation within the wound bed itself.
"You also have to infer the oxygenation of the wound from the measurement of oxygen you receive around the periphery of the wound," said Sowa. "We measure that wound bed directly and in an imaging format."
The Kd203 camera uses lasers to locate areas of the wound to be imaged and determines the ratio of oxygenated to deoxygenated hemoglobin. "Once the ratio of oxygenation dips below 40 percent we suggest clinicians really pay attention to that area," said Lemire. Being aware of low oxygenation ratios also helps surgeons prepare the patient's treatment plan, he said.
"That's why when we say 'wounds' we also mean acute wounds that would be surgical, so that you could even use this inter-operatively during post-op reconstruction.
No more wasting time
Equally important to the patient's treatment plan, added Lemire, is the speed of the technology: no more waiting for placement and heating up of electrodes on the skin to measure perfusion. Instead, Kd203 imaging takes less than a second. "Our device is about the same level of complexity and time invested as taking a digital picture with a camera or your phone. So we don't disrupt workflow, you take your image and move on."
"Because the imaging is quite simple to do and takes very little time, you can also follow up on the ward as the patient recovers, especially if you saw something immediately suspicious in the immediate post-op image, he said"
Surgeons and wound care specialists will also be pleased with the Kd203's near instant calibration prior to its use, said Lemire. Hospitals, meantime, will be happy eliminating second surgeries that occur because surgeons are unable to adequately measure poor tissue oxygenation. At US$26,000, the Kd203 is also less expensive than traditional technologies, Lemire said, "because there are no disposables and dyes. It doesn't cost anything to operate the device."
Perfusion in the marketplace
Developed over 10 years through private and public sector investments, the object now is to expand its adoption in other markets for which it is cleared, for example, imaging of burn wounds, while eventually penetrating markets in Europe and Australia as well. Sowa calls the Kd203 "the next step in perfusion imaging."
"Whether it's a chronic wound, acute injury or following surgical intervention, we give physicians the first line of defense to determine if the tissue has a chance to survive and remain viable."