VOTIS Subdermal Imaging Technologies, Ltd. announced today that it has licensed an imaging technology from Columbia University. The technology is being used to develop a suite of medical devices to help people with peripheral artery disease, or PAD, to receive an accurate assessment of their condition. In this way PAD patients can receive crucial treatment early, even before they have symptoms. This knowledge will help physicians delay or eliminate the need for debilitating amputation.
The license grants to VOTIS exclusive worldwide rights in and to the intellectual property being licensed, for all medical imaging purposes, including telemedicine. The license includes rights to 10 issued U.S. patents as well as other patents issued and pending worldwide. Terms of the license were not disclosed.
A wound in the foot of a healthy person heals naturally, in part because blood carries oxygen to the site of the wound and helps it heal. In a person with diabetes, lack of blood flow or lack of oxygen in the blood may prevent or slow wound healing. This lack of blood flow or oxygen in the lower extremities, caused by a narrowing of the peripheral arteries in the legs, is PAD.
More than 200 million people have PAD worldwide and this patient population is increasing rapidly.
An estimated 2 million people in the U.S. suffer from the most severe state of PAD, critical limb-threatening ischemia, or CLTI (also called chronic limb ischemia, or CLI). In Europe, about 3 million people have the condition. Globally, there are more than 20 million CLTI-sufferers. Hospitalization for CLTI is common with up to 60 percent of patients re-admitted within six months. Within one year following diagnosis nearly one quarter of people with CLTI are dead, and nearly one quarter have had a lower limb amputated. Mortality exceeds 50 percent within five years.
Diabetic foot ulcers, or DFUs, develop in up to one-third of people with diabetes, and over half of DFUs will develop an infection. Of these, one-sixth will require an amputation. Five-year mortality for DFU is nearly one-third.
While earlier detection with treatment reduces amputations and disabilities and improves patient quality of life, a major difficulty in treating CLTI is the failure to make an early diagnosis.
“We are proud to be able to utilize this new technology for such an important purpose,” said Merrill Weber, the Chief Executive Officer and President of the VOTIS. “Peripheral artery disease, or PAD, is a huge and growing problem around the world, and unfortunately there is no good way to identify it before symptoms appear. It is especially hard to monitor disease progression in people with diabetes. At VOTIS, we are using this technology to accompany the PAD patient throughout the patient journey, every step of the way.
The technology, called vascular optical tomographic imaging, or VOTI, was developed under the leadership of Andreas Hielscher, who until recently led the Biophotonics and Optical Radiology Laboratory as professor of biomedical engineering, radiology, and electrical engineering at the Fu Foundation School of Engineering and Applied Sciences at Columbia University in New York City. This summer, Dr. Hielscher was appointed professor and chair of the newly formed Department of Biomedical Engineering at the New York University Tandon School of Engineering, also in New York City.
“The VOTI technology is able to identify problems with blood flow and oxygenation deep within the tissue of the foot,” Dr. Hielscher explained. “The technology uses infrared and near infrared light to measure the scattering and absorption of the light. With this information, oxyhemoglobin, deoxyhemoglobin, and total oxygen saturation can be analyzed. The VOTI technology represents a breakthrough because it penetrates deep below the surface of the foot and can identify the precise areas of the foot where there are problems. With this information the treating physician can more accurately develop a therapeutic plan to help preserve the patient’s foot.”
Dr. Hielscher’s assessment is echoed by Danielle Bajakian, MD, FACS, professor of vascular surgery and the director of the critical limb ischemia program at the Columbia University Medical Center. “When a patient may have critical limb ischemia (CLI), we really need to evaluate the patient. Not every patient who has narrowing of the arteries needs to be treated. If I find a wound that’s not healing, it may look fine with ultrasound. But with VOTIS I may be able to see decreased perfusion in the foot, which allows patients to get an intervention they desperately need that I did not pick up on another test.” She added, “What I feel is the potential benefit of this device over many of the others being developed to serve this purpose is that this allows us to determine more than skin perfusion. We’re also able to go into the deep tissues of the foot and leg to determine what the circulation is there, and that’s really what I think its true value is.”
For Brian Glenville, MD, FRCS, executive chairman of VOTIS, the most important attributes of VOTIS are the depth of the examination and its operator-independent nature. “Physicians will tell you that examination of the foot in this vascular setting is extremely limited,” he said. “You can have a patient with severe diabetes, severe vascular disease, and the skin might be perfectly intact. It might be ulcerated. It might appear to have good capillary perfusion or poor capillary perfusion. You might be able to feel a pulse, you might not be able feel a pulse. But it is extremely difficult to do a clinical examination of how the foot actually is, using one’s clinical skills. What’s special about VOTIS is the depth of examination. This is the key. If you are looking at an arteriography, it will tell you where the vessels are, and where there are any anomalies of supply and so on. But it won’t actually tell you what the tissue perfusion is.”
He added, “Many other techniques are so operator dependent, and you can get whatever results you want. This is operator independent. It produces the same result whoever does the examination. And that’s why we believe it stands to be an extremely useful diagnostic tool.”
“Over the past few years we have gotten to know Merrill and the team at VOTIS,” said Jerry Kokoshka, associate director of Columbia Technology Ventures. “We agree with his vision for use of the VOTI technology. VOTIS plans to build small and inexpensive devices that utilize the cloud and artificial intelligence machine learning. This strategy, to make the VOTIS devices inexpensive yet powerful tools, will enable them to be used not only in developed countries but also in other areas of the world — such as India and the Arab world — where diabetes and PAD are widespread.”
Simply put, as David G. Armstrong, DPM, MD, PhD, Professor of Surgery at Keck School of Medicine of University of Southern California, is fond of saying, “You can’t manage what you can’t measure.” With VOTIS, for the first time clinicians will be able to measure the location and severity of PAD and CLI deep within the foot. With that knowledge, it is expected that they will be able to help patients keep their feet.
Both Drs. Bajakian and Armstrong are members of VOTIS’s scientific advisory board.