Our technology will be a dual component system that combines both negative pressure wound therapy and micro-nanobubble technology. With both technologies, our product will provide a steady stream of super-oxygenated fluid to irrigate and aerate the wound through a foam dressing while simultaneously acting as a vacuum to suck up all the debris, fluid, and infected tissue in and around the wound into a waste collection system. These two therapies, together, would kick-start the healing process, while preventing bacterial infection, reducing the time a patient spends in the hospital, the cost in treating their wounds, and further complications that would require surgery.
Diabetes is the leading cause of non-traumatic lower extremity amputations in the United States. A diabetic foot ulcer (DFU) is a foot affected by an ulceration that is associated with neuropathy of the lower limb in a patient with diabetes. As of 2015, 30 million people in the United States suffer from diabetes, 25% will suffer from DFUs at least once in their diabetic health life. As a result more than 7.25 million people currently suffer from diabetic foot ulcers. To treat these DFUs, the costs are really high, treatments ranging from $11000-$16000, costing the nation a grand total of $10 billion dollars in annual healthcare costs.
At a compounded annual growth rate of 4.1%, the market value is expected to reach 14 billion dollars by 2024, compared to 10 billion dollars in 2015.
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Bubtech will be focused on obtaining partners and securing its federal supply schedule with VA Health Care during clinical trials. By the end of 2020, we hope to begin sales and pre-production in the United States. The device will be marketed at medical trade fairs which is how we expect to acquire distributors and manufacturing representatives. Those distributors and manufacturing representatives will sell to vascular surgeons, plastic surgeons and wound care centers in the United States at the markup prices demonstrated.
With a power suctioned pump, the B.U.B system classifies as a FDA Class II Special Controls device. This requires that only a 510(k) premarket notification be submitted along with clinical data to satisfy all regulatory requirements before commercialization can be achieved. The clinical trials needed are projected to be completed by the beginning of 2020.