The innovation also sparked a new startup to bring the technology to market.
A team of researchers led by a Veterans Affairs Department biomedical engineer produced a high-tech “smart bandage” that uses electrical stimulation to treat chronic wounds and can provide information about how they are healing.
The bandage, now named “Exciflex," is equipped with a chip, sensors and more, incorporating electrotherapeutic technology developed by Dr. Kath Bogie and her research colleagues in Cleveland at the VA Advanced Platform Technology Center and Case Western Reserve University.
With help from the VA Technology Transfer Program, VA’s Bogie connected with entrepreneurs who formed a new startup company—Exci Inc.—to bring the tech-boosted bandage to market.
“In all my research I am motivated by improving healthcare for veterans, particularly those who experience chronic wounds,” Bogie told Nextgov during an email conversation Thursday. “It is very exciting to see this technology coming to fruition.”
Veterans—particularly those who use wheelchairs or who’ve experienced blast injuries—face some of the highest risks for infections and chronic wounds, such as pressure ulcers or pressure injuries, she noted. The injuries can be painful and costly for patients, and those that are especially slow to heal can require a great deal of specialized care. In the U.S. pressure injuries can amount to more than $11 billion per year.
It’s understood that energy from electrical stimulation can help heal chronic wounds by reducing infection, disrupting biofilm formed from bacteria that can slow down the healing process and more. Though electricity has been studied and used in treatment approaches previously, the technology built by Bogie—who has been confronting the health care challenge intermittently for nearly 15 years—offers a little something more.
“The smart bandage can stay in place for up to seven days, so the wound environment remains stable,” VA’s release on the work reads. “That is one of the reasons why the smart bandage system is superior to a traditional wound dressing that must be removed every time the patient receives conventional electrical stimulation.”
Another crucial element is that the device can offer therapy at any time—and outside of clinic visits.
The bandage is equipped with sensors, electrodes, a power and control module and other elements. The electronics within its top half can be removed from the absorbent bandage beneath it, which can be worn for up to seven days before disposing of it. And what’s happening inside the bandage itself and the wound can be recorded. According to the release, the chip can capture data including the period of use, battery charge, as well as readings of a wound’s temperature or any disturbance across it.
Health care professionals can leverage information collected by the bandage in patients’ overall treatment. Further, the smart bandage also includes a capability—which has not yet been approved by VA for use—to sync up straight to patients’ phones and directly transmit information to their clinical care providers, enabling them to make treatment adjustments in close to real time.
“We have worked with veterans healthcare providers during development and they have provided input on the design,” Bogie noted regarding the device’s creation, adding that the team has “made design changes based on their input.”
Through the work, they received funding and what Bogie called “invaluable support” from VA to run a clinical pilot study involving veteran participants with lower extremity ischemic wounds, which accompany poor blood flow.
“The study is currently on hold due to the COVID-19 administrative hold on clinical research,” Bogie noted.
But in hopes to help bring the wound-helping device toward broader implementation more quickly, she also turned to the agency’s Technology Transfer Program, which aims to assist in the licensing and patenting of new VA-made tech tools. In the process, the bandage was included in the VA's first FedTech Startup Studio and Bogie was teamed with entrepreneurs who helped with market analysis, investor pitches, business plan creation, and beyond.
With intent to better appeal to customers down the line, the team coined the name “Exciflex” for the bandage—and the tech went on to be voted "Best Potential Startup Technology," during the event.
From there, the entrepreneurs launched the startup Exci Inc., to fully scale the bandage to market; Bogie serves as that company’s senior advisor. Now, its founders are negotiating a license agreement with VA.
Ultimately, the to-be-marketed Exciflex will “enable user-friendly monitoring and control of [electrical stimulation, or ES] wound therapy by the clinician,” Bogie explained, also reiterating that the device will deliver therapeutic ES without needing to disturb the wound dressing for up to a week.
“This will positively impact all patients, in particular, those who are receiving out-patient care because they will not need to attend the outpatient clinic so frequently,” she said.
Bogie also confirmed that the device is Bluetooth Low Energy, or BLE-enabled and that cached wound status data will be securely uploaded to a web service. Graphical wound history and trends and wound status between therapeutic ES will also be provided.
“The apps to check and manage Exciflex activity are being developed for clinician use at this time,” Bogie said. “There has not been a technology that provides real-time data on wound healing before, so we want to make it accessible to clinicians first so they can determine what is useful data.”