Triple Amputation From Flesh-Eating Disease in the United Kingdom Highlights Importance of NovaBay’s NeutroPhase Wound Cleanser

By March 28, 2014

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY). The Daily Mirror, a British newspaper, recently reported the tragic story of a father who lost both legs, an arm and half of his face to deadly flesh-eating bacteria. Alex Lewis, 34, went to bed with what he thought was a common cold, but had to be rushed to the hospital hours later in toxic shock. Doctors were barely able to save his life—and the treatment required three emergency amputations.

Lewis’  tragic story highlights the urgent need for more effective treatments against life-threatening flesh-eating disease—and NovaBay believes that its NeutroPhase®* Skin and Wound Cleanser, used as adjunct therapy for the disease, offers a major improvement. “We hope to prevent patients like Lewis from having to lose their limbs from this terrible disease,” says Ron Najafi, Ph.D., CEO of NovaBay.

Dr. John Crew, Vascular Surgeon and Medical Director of the Advanced Wound Care Center at Seton Medical Center in Daly City, California, has developed a procedure in which dangerous wounds, like Lewis’, are treated with systemic antibiotics and also irrigated with NeutroPhase while being vacuumed using negative pressure wound therapy (NPWT).

Dr. Crew has now treated more than a dozen patients with flesh-eating disease (or necrotizing fasciitis) with this approach. Mortality from flesh-eating disease can be as high as 80% without aggressive treatment. Even with the current standard of care, about 20% of victims still die—and many more, like Alex Lewis, lose hands, arms or legs. But none of patients Dr. Crew has treated with the new approach has died or even lost a limb. “Now for the first time we can stop the progress of this terrible disease,” says Dr. Crew.

In a recent issue of the peer-reviewed journal WOUNDS, for instance, Dr. Crew described the case of a woman named Lori Madsen. A few days after scraping her elbow in a parking lot fall, Madsen, then 51, collapsed in the hospital with a raging Streptococcus infection. Her blood pressure dropped so low it was unreadable. But Dr. Crew’s treatment regimen of IV antibiotics and irrigation with NeutroPhase brought the infection—and the cascade of tissue damage triggered by the bacteria—under control. The wound healed completely. “He saved my arm and my life,” says Madsen.

Dr. Crew will describe not only Madsen’s case, but also the successful treatment of other patients. For instance, Dr. Crew cured restaurant manager Michael Meillon, 55, of an infection that was eating away Meillon’s groin area, causing his kidneys to fail and threatening his life. In another case, bacteria and bacterial toxins had eaten away all the skin on the lower leg of Jared Hamilton. But Dr. Crew’s treatment with NeutroPhase and NPWT saved Hamilton’s leg. “NeutroPhase is making history,” said Dr. Najafi. “We were happy to see Jared in NovaBay’s headquarters offices alive and smiling.”

NovaBay’s key innovation was creating a stable, 0.01% pure version of hypochlorous acid in saline (with no bleach impurities, which is often present in Dakin and Dakin-like solution). NovaBay’s innovation is a natural substance produced by the immune system as a first defense against microbial invaders. The version, which became NovaBay’s NeutroPhase product, has been cleared by the Food & Drug Administration as a wound cleanser through the FDA’s 510(k) process. In a recent peer-reviewed study, NeutroPhase achieved better results in lab tests than 18 other commercial wound cleansing products, killing bacteria in less than a minute. Lab tests also show that NeutroPhase is effective at neutralizing the toxins that eat away tissue.

It’s difficult to say whether or not Alex Lewis’ legs and arms could have been saved by the new NeutroPhase-based treatment, says Dr. Crew. “But I’m committed to using this promising approach to minimize or even prevent the losses that other patients might otherwise suffer from this disease,” says Dr. Crew.

About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing topical non-antibiotic anti-microbial products.

*About NeutroPhase®
NeutroPhase® is a 510(k)-cleared wound cleanser and is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material, including: microorganisms and debris from wounds; cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin; as well as moistening absorbent wound dressings. It is also intended for moistening and debriding acute and chronic dermal lesions, such as: Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, as well as grafted and donor sites.

NeutroPhase is a 0.01% pure hypochlorous acid in saline (with no bleach impurities, which is often present in Dakin and Dakin-like solution). In in vitro laboratory models, NeutroPhase has shown to be fast-acting against bacteria, biofilm and toxins. Statements regarding necrotizing fasciitis and flesh-eating bacteria have not been reviewed by the FDA. More information on NeutroPhase and how to purchase it at: www.neutrophase.com.

Forward-looking Statements
This release contains forward-looking statements and opinions, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the effectiveness of NovaBay’s products against bacteria and ‘flesh-eating disease’. The words “suggest”, “believe”, and “will” are intended to identify these forward-looking statements.  Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company’s product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company’s intellectual property or trade secrets, the company’s ability to obtain additional financing as necessary and unanticipated research and development and other costs. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

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NovaBay Pharmaceuticals Contacts
Thomas J. Paulson  
Chief Financial Officer
510-899-8809
Contact Thomas Paulson

Ana Kapor
Director, Investor Relations and Corporate Communications
NovaBay Pharmaceuticals, Inc.
510-899-8889
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