Diabetes affects over 25 million Americans and is the leading cause of kidney failure, blindness, and non-accident-related leg and foot amputations. The last two of these problems result from progressive neuropathy, or specifically the degeneration of nerves starting with those in the extremities. Patients with diabetic neuropathy often lose sensation in their feet, making it difficult for them to detect abnormal levels of pressure on their heels and thus putting them at risk for developing ulcers and infections that may lead to amputations.
This is the problem that Orpyx, an innovative medical technology company based in Canada, hopes to solve. The company aims to release its first product, the SurroSense Rx, later this year. In brief, the system comprises a special shoe insert with embedded pressure sensors and a transmitter that sends alerts to a watch display (and eventually smart phone) to let the patient know when they need to relieve pressure on their heels. We had the opportunity to speak with Orpyx founder, Dr. Breanne Everett, about the company and its plans.
Shiv Gaglani, Medgadget: What is the primary problem you are trying to solve at Orpyx? How have others tried solving this problem?
Dr. Breanne Everett: Orpyx’s primary intention is to address the world’s growing epidemic of diabetes and its associated complications, most notably, lack of circulation, numbness, infection and ulcers in the feet, or ‘diabetic peripheral neuropathy.’ The diabetic foot ulcer is one of the most devastating complications of diabetes, occurring in upwards of 15% of all diabetic patients. Development of vascular and nerve-related complications, including lack of sensory feedback in the feet and failure of the wound healing process, leaves the diabetic patient unaware that serious complications are developing. Diabetic foot ulcers and amputations cost the U.S. health system an estimated $29 billion in 2007.
The current gold standard care for treatment of the diabetic foot includes primary prevention via diabetes education, traditional orthotics, reactionary wound care and wound control. Economics aside, this is an outdated approach applying principles of “sick” care, not preventative “health” care that Orpyx solutions offer. Orpyx’s technologies address both a North American and global market that is currently untouched by any comparable device. Orpyx will be starting pre-sales this summer, with its initial SurroSense Rx product launch this November.
“Work to create a “sensory substitute” can and will make an enormous difference in preventing diabetes-related amputations. It is this promise for prevention that is so very exciting and potentially game-changing.”
– Dr. David G. Armstrong, DPM, MD, PhD; Professor of Surgery and Director, Southern Arizona Limb Salvage Alliance, University of Arizona College of Medicine; Senior Scientific Collaborator, Orpyx Medical Technologies
Medgadget: Where did you get the idea for the SurroGait and SurroSense products?
Dr. Everett: In my experience as a resident in Plastic & Reconstructive Surgery, I realized that we really don’t have a good way to address neuropathic complications. We are able to offer patients insoles, proper fitting footwear, and education about their problem. And then we tell them to take pressure off their ulcers. This advice only goes so far, because these patients oftentimes can’t feel when they are putting pressure on these wounds, so they progress and fail to heal. I envisioned a simple system that would enable the patient/provider to know when pressure thresholds had been met (as otherwise, that sensing capability is often not there).
At the same time, I had developed a keen interest in the area of sensory substitution systems. A system, the Brainport, had been developed for blind patients to enable restoration of site. The device is comprised of a set of glasses that takes in visual information by a camera affixed to a set of glasses. That information is then translated into an electrotactile stimulus that is felt on the tongue. With time, the user is able to interpret that tactile cue as visual feedback. What is really interesting with this system is that over time, this translation becomes second nature. It happens instantaneously. At the same time, fMRI studies have been able to show that with use, these patients start to “rewire” their brains. He or she will start “feeling” their tongue (seeing) through the occipital lobe—the part of the brain that is used to process vision, and is constitutively inactive in the non-sighted patient.
I thought this phenomenon of rewiring the brain, or neuroplasticity, was fascinating and had direct implications in the world of diabetic neuropathy, where many of the associated complications stem from a lack of sensory feedback. Based on this inspiration, I came up with the idea for the SurroGait Rx.
Medgadget: Both products wirelessly transmit to a watch. Are you currently working on syncing to a smart phone?
Dr. Everett: We are currently developing an iPhone/Android App for the first product, the SurroSense Rx. This will be available for the commercial launch of this product (late 2012). We will do the same for the SurroGait Rx.
Medgadget: You mention on your website that there are potential athletic applications. Can you please elaborate?
Dr. Everett: Outside of healthcare, our products have extensive applications in athletic monitoring and optimization. Beyond our Medical Division, we are establishing a consumer electronics division (CED) to address these potential users.
Devices that help athletes to improve performance using real-time wireless feedback systems will be in high demand. The SurroSense Rx would have far-reaching potential for growth in this space, most notably as a live performance diagnostic tool to track and provide feedback regarding plantar pressure for athletes. Areas that have been identified as being particularly apt for vertical growth include running, golf, and hockey. Orpyx has access to the technology required to integrate additional functionality into an athletic device such as: heart rate monitoring, accelerometry, calorie counting, and activity tracking.
We have an established relationship with the Running Injury Clinic (Directed by Dr. Reed Ferber) to develop athletic profiles for our devices.
We are currently in the process of exploring these market verticals and developing a strategic approach to developing our consumer electronics division.
Medgadget: The SurroGait takes the system one step further and provides biofeedback to one’s back. Do you have any data as to whether this will lead to plastic rearrangement in the somatosensory cortex?
Dr. Everett: There is ample literature to suggest neuroplastic rearrangement for other sensory substitution systems (including the Brainport and Braille). We will be testing out this hypothesis with our device and associated gait biomechanics and fMRI studies in the early New Year in conjunction with Dr. Cory Toth (Dept of Clinical Neuroscience, University of Calgary).
Medgadget: The product page says that there are 8 force sensors that sample at a rate of 4 Hz. How did you decide on this, as opposed to other arrangements? For example, there are hundreds of deep pressure mechanoreceptors (e.g. Pacinian corpuscles) in the foot that sample at a rate of 250 Hz. Also, are there any plans on incorporating information besides pressure; e.g. temperature?
Dr. Everett: Our device is not intended to directly capture and relay what a normal foot, rich in Pacinian corpuscles, would capture. Rather, it is intended to provide a simple real-time map of pressure seen on the foot. Its alert function is based on what we know of capillary pressure and tissue perfusion. The device is designed to measure when and for how long capillary pressure has been exceeded at discrete points on the foot (I.e. For how long blood supply to the soft tissues in that area has been compromised). We know that 60% of neuropathic ulcers have pressure as the primary etiologic factor in their development. Certainly, there are other factors that play into this (temperature, shear, peripheral vascular disease to name a few). Over time, we are looking to diversify our products by incorporating other sensing abilities to improve the diagnostic capabilities of the device.
Medgadget: How did you choose the name “Orpyx”?
Dr. Everett: Orpyx is an anagram of the word “proxy”–representing the sensory substitution component of what we are doing. In our first product, the back is serving as a proxy for the feet, through a process of rearranging collectd plantar information. This rearrangement is similar to the process of creating the anagram.
Beyond this, “Or” stands as a root for “orthotics” or “orthosis.” The word pyx describes a box that was used (in antiquity) to carry the eucharist to sick people who were unable to make it to church. This concept of helping the ill also has parallels to what we are doing.
For more information, visit the Orpyx website and watch the video below: