Wound care. It may not sound scary, but it is lethal. Described as, “a rising scourge” and “a major and snowballing threat to public health and the economy” in the scientific journal Wound Repair and Regeneration, a recent study found 28% of patients with chronic wounds died within a 2 year span. There is no cure for chronic wounds. Even though current treatments are invasive and don’t work effectively, wound care is a $25 billion global market growing at 10% per year. Chronic wounds, including pressure ulcers and diabetic foot ulcers, are open wounds on the skin’s surface which have not healed in six months. 6 million people in the U.S. and 20 million in the developed world have them. An article in scientific journal Wounds described $50 billion as being a “conservative estimate” of the cost of caring for chronic wounds.
A proven cure, the Bioelectrical Signal Therapy (BST) device, is already approved and set to launch in several countries. Thankfully for the U.S., E-QURE Corp.’s patented BST device is set to be evaluated in a pivotal U.S. FDA trial beginning this quarter. Boosting the body’s natural electromagnetic healing process, the BST device closes and heals chronic wounds. Investors should take note.
Skyrocketing rates of chronic wounds create a growing burden on the healthcare system. The most expensive complication following surgery is wound infections because they are a major source of bacteria and drive infection rates in hospitals, according to Johns Hopkins School of Medicine, as reported in the Wall Street Journal. An aging population, greater numbers of diabetics, stroke, and heart disease patients are increasing incidence. Patients who have dementia or are bedridden due to bodily injuries are very vulnerable to pressure ulcers.
Actor Christopher Reeve, Superman of the 1978 – 1983 superhero movie franchise, succumbed to an infected pressure ulcer. Although he had spinal cord injury, it was the pressure ulcer caused by laying on a surface 24/7 that killed him. Foot ulcers are like kryptonite for diabetics, 25% of whom will get a diabetic foot ulcer and lose a limb as a result.
Current standard of care when wounds don’t heal via conventional methods like bandages, antibiotics and topical treatments include alternative therapies like bioengineered skin, pressurized concentrated oxygen,
negative pressure delivered via a section pump, and electrical stimulation. It is this last one: electrical stimulation that has proven to be an effective cure and E-QURE is the only company to offer this patented technology in the U.S. Electrotherapy isn’t even on the wound care market segment graph because it’s not commercially available in the U.S. – yet.
The U.S. National Institutes of Health (NIH) endorsed the technology, stating electrical stimulation “appears to be the most effective on healing recalcitrant Stage III and IV pressure ulcers.” A large number of peer reviewed scientific articles provide a wealth of data on this.
No FDA approved electrical stimulation device exists, making E-QUR’s FDA trial for the BST critical to the wellbeing of patients and to the U.S. healthcare system. Moreover, the few electrical stimulation devices that are approved in Europe are invasive and therefore cannot close and completely heal a wound.
Patented Electrical Current of Healing
Human cells carry electrical currents. One specific naturally occurring electrical current heals wounds. It’s called the “current of injury.” Wounds fail to heal and become chronic when this specific signal becomes too weak. E-QUR’s ‘secret sauce’ is their patented technology’s ability to mimic this current of injury.
Non-invasive electrodes are placed 3-5 centimeters away from opposing sides of a wound. The BST sends the patented healing current, which goes from one electrode across the wound to the other, allowing full and complete healing, without any part of the device entering the wound.
Magic may come to mind but this is solid science. Validated in multiple clinical trials, data show BST treated wounds had 5 times the closure rate as compared to placebo.
Best for the patient and the healthcare system, BST is painless and easy to use. The treatment can be given at home, the clinic, or a in hospital for just 30 minutes, 3 times per day, over the course of 45 to 60 days. Standard of care methods require in-hospital treatment for up to 23 hours per day.
U.S. FDA Trial Set to Begin
By far the largest single market in the world, the U.S. healthcare system could benefit greatly from the BST. Accordingly, the U.S. FDA has granted E-QURE an Investigational Device Exemption. A pivotal multi-center, double-blind, placebo controlled, randomized registration trial for the BST will commence this quarter under a Premarket Approval pathway. 90 patients with Stage III and IV ulcers, the hardest to treat will be enrolled. The primary endpoint is complete wound closure in 60 days for BST treated patients versus those treated with a placebo device. Top line results are expected in Q3 2018, with potential market launch in 2019.