AVACEN Medical (AVACEN) announced partnering with Morulaa HealthTech of Chennai, India to introduce its AVACEN 100, Class II medical device, in India. Initial focus will be to reduce the number of limb amputations resulting from foot ulcers, a common complication associated with diabetes.
According to the Diabetic Foot Society in India, every year 200,000 diabetic patients in India undergo amputations of a leg for inadequately treated diabetic foot ulcers. This has a devastating impact on those who suffer from the amputation and their personal support systems. In addition, it imposes a large economic burden on public and private healthcare providers.
AVACEN recently received CE (Conformité Européenne) Mark approval to market the AVACEN 100 to the European Union’s 28 member countries to increase microcirculation during treatment. AVACEN believes this is the first time a medical device has been approved for improving whole-body microcirculation – the vascular link whereby tissue and single cells are supplied with oxygen and nutrients, and toxins are carried away. Adequate microcirculation is critical to supporting the wound-healing process.
The AVACEN 100 uses an entirely new concept to increase microcirculation. It noninvasively and safely infuses heat into the circulatory system forcing the body to dilate peripheral capillaries to radiate off this excess heat.
AVACEN Medical CEO Thomas Muehlbauer described the AVACEN 100 as “the only medical device on the market today able to provide non-invasive, whole-body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for rapid healing of foot ulcers from the inside.” Muehlbauer added, “With over 1 million safe treatments, we frequently hear reports of rapid wound healing, especially after surgery. Recently our device was credited with saving the limb of a patient at a major university hospital who was given a 1 to 2% chance of retaining the limb by the attending physician. Closer to home, my diabetic mother would only have one leg if it wasn’t for our device. That makes this product launch in India very personal.”
India has 70 million diabetics. Health experts warn that India is on track to reach 120 million cases, or nearly 10 percent of the population, in the next eight years. That would put it on par with the United States, which counts 9.3 percent of the population as diabetic, or China, where 11 percent of the population—or 109 million—have been diagnosed, according to the International Diabetes Federation.