By: Dylan Sikes - AllPennyStocks.com News

Wednesday, June 5, 2013

Diabetic foot ulcers, of DFUs, are one of the most common complications of diabetes mellitus. Further, diabetic foot ulcers can be extremely resilient when treated with today’s approved therapies, often leading to osteomyelitis, or inflammation of the bone or bone marrow, or even lower limb amputations. Worse yet, the diabetes population is growing faster than any other chronic disease on the planet. The diagnosis rate has accelerated by about 8 percent annually with about 22.3 million people living in the U.S. with type 1 or type 2 diabetes in 2012, according to a March report by the American Diabetes Association. That’s up from about 17.5 million five years earlier. Diabetics run a 15 percent to 25 percent chance of developing a DFU in their lifetime. The cost of diabetes has skyrocketed because of the mushrooming population; totaling $245 billion in 2012, up 41 percent from $174 billion in 2007. With more than 100,000 diabetics having a foot amputated in 2007, the costs add-up substantially, considering costs associated with an amputation generally exceed $100,000. The average cost of just treating an infected DFU is around $20,000.

So what can be done?

Big pharma has drugs, but some can carry heavy risks. GlaxoSmithKline (NYSE:GSK) presented new information to the FDA this week on its once blockbuster diabetes drug Avandia that was blasted in 2007 for presenting elevated heart attack risks to diabetes patients taking it. Glaxo is contesting that the drug is safer than regulators thought. Glaxo is not alone with a diabetes drug potentially carrying heavy risk of collateral damage. The New York Times published an article on May 30 detailing the findings of Dr. Peter C. Butler on Merck & Co.’s (NYSE:MRK) diabetes drug Januvia that could “threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes.”

Butler’s research on rats suggested that the drugs could lead to pancreatic cancer.

Now, of course, the research could be rebuked and nothing may come of it. Point being here that diabetes is a major going concern for the health care system and the U.S. budget.

Other companies, like ALR Technologies, Inc. (OTCBB:ALRT) have FDA clearance and are commercializing remote monitoring solutions to encourage patient compliance to care plans. Clinical research has shown remote monitoring platforms are effective at lowering hemoglobin A1c levels, the gold standard measure for management of diabetes.

Kinetic Concepts, Inc., a company acquired by private equity investment group Apax Partners in 2011 for $6.3 billion, is a specialist in wound care, including its V.A.C. (Vacuum Assisted Closure) Therapy System that is indicated for DFUs. Essentially, looking like just a big boot, the system prepares the wound bed for healing, reduces edema and promotes perfusion and tissue formation, amongst other benefits.

Maneuvering down the regulatory pathway with a new therapy, Sanuwave Health, Inc. (OTCBB:SNWV) is advancing its dermaPACE® device for DFUs. The device emits focused, high-energy, acoustic shock waves to restore the body’s natural healing process. The shock waves have been shown to promote arteriogenesis (widening of blood vessels), angiogenesis (formation of new blood vessels), increase perfusion, stimulate production of growth factors and, subsequently, regeneration of skin tissue and musculoskeletal and vascular structures. The device is already being sold internationally through a CE Mark for the treatment of the skin and subcutaneous soft tissue.

First quarter revenue reported by the company in May totaled $201,234, down 16 percent from $238,540 in the year prior quarter, as sales of Sanuwave’s orthoPace dropped in Europe’s challenged economy. Net loss for the quarter grew 193 percent compared to the first quarter of 2012 to $4.24 million.

Stateside, dermaPACE is in clinical trials evaluating its efficacy in treating DFUs. Sanuwave said on Wednesday that the first patient has been enrolled and begun treatment in a supplemental Phase 3 clinical trial. The trial is slated to be conducted at up to 20 centers in the U.S. and enroll a minimum of 90 patients.

Patients will be randomized 1:1 to enter the dermaPACE arm (dermaPACE plus standard of care dressings and with offloading from a walking boot as required) or control (only standard of care dressings and with offloading from a walking boot as required). The primary endpoint is complete wound closure at 12 weeks. Time to closure, reduction in total wound surface area and volume, rates of ulcer recurrence and amputations and other safety assessments will serve as secondary endpoints.

"We expect to show, through a successful trial, that the dermaPACE device can offer significant benefits over current therapies for diabetic foot ulcers. It is a simple, comfortable, and unobtrusive treatment option,” said Joseph Chiarelli, chief executive at Sanuwave.

Shares of SNWV have exploded about 430 percent higher so far in 2013. In Wednesday trading following the news, shares are ahead by 7.4 percent at 87 cents.

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