VasoActiv's Current Status

 

The company is in the premarket mode. We have secured US and international patents, FDA 510k clearance and CE labeling for our devices. Following extensive field studies for several years and four generations of prototype design, the company has completed final design and manufacturing specifications with a noted engineering firm in Dallas.

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Diabetic Foot Ulcers and Limb Salvage - Diabetic foot ulcers constitute a tremendous challenge for patients, caregivers and the health care system. Over 34 Million people in the US suffer from Diabetes (1 out of every 10 people). One-third of these individuals will develop a foot ulcer during their lifetime. The majority will require hospitalization and 20% will require amputation affecting 100,000 patients every year.

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We have contracted with the  University of Texas for a randomized prospective controlled trial for healing of diabetic foot ulcers. That study will notably include ischemic ulcers which are frequently excluded from such studies because they are extremely difficult to heal.

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We have opened discussions with Native American tribes for a series of retrospective studies on diabetic foot ulcers. Our device was invented by a Native American.

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Sepsis and Septic Shock  - We are in the early stages of a randomized controlled trial at the University of Oklahoma for improving outcomes in patients. Severe Sepsis prolongs patient stay in the ICU and the hospital by over 50%. More than $27B is spent annually on Sepsis treatment representing 40% of ICU costs.  There have been almost no advances in the treatment of sepsis for 30 years.

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