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China's FDA Cleares NovaBay's NeutroPhase Skin And Wound Cleanser For Sale Throughout Mainland China By NovaBay's Partner, China Pioneer Pharma

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NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on the development and commercialization of its non-antibiotic anti-infective products, and China Pioneer Pharma Holdings, Limited (HK Stock Code: 01345), a leading marketer of branded pharmaceutical products and medical devices in China, today announced that China's Food and Drug Administration has cleared NovaBay's NeutroPhase® Skin and Wound Cleanser for sale throughout mainland China. NovaBay will be shipping NeutroPhase to China in the fourth quarter of 2014 to support Pioneer's launch of the product in early 2015.

Chronic non-healing wounds, such as venous stasis ulcers, diabetic ulcers, and pressure ulcers are serious unmet medical needs that affect a patient's morbidity and mortality. NovaBay's FDA cleared NeutroPhase has shown remarkable properties in the management of these categories of wounds. As cited in a paper published in the peer-reviewed International Journal of Burns and Trauma, “Patients showed a profound improvement and marked accelerated rates of wound healing using NeutroPhase® with and without NPWT (negative pressure wound therapy). NeutroPhase® was non-toxic to living tissues.”

“The clearance of NeutroPhase in China will help Chinese doctors address major unmet medical needs,” said Paul Li (Mr. Li Xinzhou), Chairman, Executive Director and Chief Executive Officer of Pioneer Pharma. “In China, we are experiencing a ‘catastrophic' epidemic of diabetes. According to estimates provided by the International Diabetes Federation and the American Medical Association, there are approximately 100 million Chinese already suffering from this condition and its chronic side effects such as diabetic ulcers and other chronic wounds—and their numbers are increasing.”

“At the same time, China has the highest number of reported cases of necrotizing fasciitis, or ‘flesh-eating' disease of any nation in the world,” Li added. “NeutroPhase will help with both problems.”

NeutroPhase offers new treatment options for both the chronic wounds of diabetes patients and for deadly flesh-eating disease. NovaBay's NeutroPhase contains a substance produced naturally by the immune system as a first defense against microbial invaders. Laboratory tests show that NeutroPhase not only kills bacteria that infect wounds and cause necrotizing fasciitis, it also neutralizes toxins produced by both bacteria and the immune system that impede healing and destroy healthy tissue. Those properties enable NeutroPhase to address acute infections and thereby help promote the healing of chronic wounds.

Physicians like Dr. John Crew, director of the Advanced Wound Care Center at Seton Medical Center in Daly City, Calif, already routinely manage diabetic ulcers with NeutroPhase to assist healing. Dr. Crew has also developed a method of irrigating flesh-eating wounds with NeutroPhase that has been remarkably successful in saving the lives and limbs of victims of this life-threatening disease, as Crew and NovaBay researchers reported in the journal WOUNDS.

“China is a significant market for NovaBay's NeutroPhase. The China FDA approval gives us access to this important market. Pioneer Pharma is a major distributor in the region and is NovaBay's largest single shareholder. We believe that NeutroPhase can bring a major improvement in medical care in China and the quality of these patients' lives,” said Dr. Ron Najafi, Chairman and CEO of NovaBay. Similar to this healthcare crisis in China, the American Diabetes Association estimates that 29 million Americans suffer from diabetes.

As part of the partnership deal between NovaBay and Pioneer Pharma, the marketing clearance of NeutroPhase by the Chinese Food & Drug Administration triggers a milestone payment of $625,000 to NovaBay from Pioneer.

Posted-In: News FDA Press Releases


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