NovaBay Pharmaceuticals Announces Publication of Novel Surgical Procedure for Life Threatening Wounds and Flesh Eating Bacteria

New Procedure Utilizes Adjunctive NeutroPhase® Therapy

Paper in the Medical Journal WOUNDS Describes First Successful Procedure that Removes Toxins from Wounds with Less Invasive Debridement and Avoids Possible Amputation

NovaBay^® Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced the publication of a scientific paper by Dr. John R. Crew of Seton Medical Center, Daly City, California, describing the first use of adjunctive NeutroPhase^®* irrigation therapy in conjunction with Negative Pressure Wound Therapy (NPWT) to successfully manage the severely-infected wound in the arm of a patient with life-threatening ‘flesh-eating’ disease.

“This is a whole different way to manage the life-threatening wounds and flesh-eating infections” said Dr. John R. Crew, MD, FACS, Vascular Surgeon, Medical Director, Advanced Wound Care Center, Seton Medical Center in Daly City, California, and lead author of the case study in WOUNDS. “I think this will supplant the current method of treatment and significantly improve the outcome for the patients.”

Added Jacqueline Roemmele, Executive Director of the National Necrotizing Fasciitis Foundation, “This is a very exciting new approach that we hope can make a major difference in saving limbs and life.”

‘Flesh-eating’ disease, also known as necrotizing fasciitis or toxic inflammatory cellulitis, is a neglected (orphan) disease striking up to 1,500 Americans every year according to the Centers for Disease Control although many physicians believe the figure is higher. It typically starts just as a small, seemingly innocuous cut or scrape that gets infected by bacteria. Normally, the infection can be easily fought off by the body’s own immune system or with antibiotics.

But in a small percentage of infections, something goes terribly wrong. The bacteria can hide from the immune system and from antibiotics and spread under the skin, producing toxins and enzymes that destroy cells. Meanwhile, the immune system, attempting to fight the bacteria and clean up the damage, produces chemicals that also can kill normal cells. Together, these toxins cause excruciating pain, dangerously low blood pressure, confusion, high fever, and severe dehydration. Victims can quickly lose an arm or a leg—or potentially, their lives. Even with emergency treatment with antibiotics, about 20% of patients die. Without treatment, mortality climbs to 70%.

But Dr. John Crew thought there must be a better way to fight the disease. For several years, he had been experimenting with a novel product, called NeutroPhase, from NovaBay. NeutroPhase is a 0.01% pure hypochlorous acid in saline with no bleach impurities, unlike other Dakin and Dakin-like solutions. Natural hypochlorous acid (HOCl) is produced by white blood cells. In extensive in-vitro testing, NeutroPhase kills bacteria in seconds and has the ability to neutralize toxins generated by flesh eating bacteria. NovaBay found a way to make pure HOCl in saline shelf-stable. “We believed that NeutroPhase would be useful as a safe skin and wound cleanser,” said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay.

The new study by Dr. Crew and colleagues showed that NeutroPhase irrigation therapy and NPWT can be used for severe flesh eating and wound infections. For example, when 51-year-old Lori Madsen fell in a parking lot, she scraped her left elbow. Three days later, she arrived at Seton Medical Center’s emergency room in toxic shock. Her blood pressure dropped so low it was unreadable. Streptococcus bacteria had gotten under her skin and started a cascade of devastation that was eating away her tissue. “She almost lost her arm and her life,” says Dr. Crew.

Dr. Crew and his team cut away the dead tissue on part of Madsen’s arm—a process called radical surgical debridement—and bathed and irrigated the wound with NeutroPhase. They also irrigated another part of the damaged area with just the NeutroPhase solution, without doing surgery. Meanwhile, bacterial cultures taken from the wound, somewhat surprisingly, were negative, showing that the initial antibiotics Madsen had taken had killed the strep bacteria. The threat to Madsen’s arm and life was coming from the toxins that were still present, chewing up tissue in the wound.

Video: The use of adjunctive NeutroPhase^® irrigation therapy in conjunction with Negative Pressure Wound Therapy (NPWT) to successfully manage the severely-infected wound in the arm of a patient with life-threatening ‘flesh-eating’ disease. http://www.youtube.com/watch?v=_qqb3oRKK-w&feature=youtu.be

Cleansing with the NeutroPhase solution worked. Within a few days, Madsen was able to go home from the hospital. Within a few weeks, the wound had fully healed. Surprisingly, it didn’t seem to matter whether or not the doctors surgically removed the dead tissue. “Notably, the elbow area that was not surgically debrided, and treated with the irrigation solution alone, healed rapidly and without scarring,” Dr. Crew and his co-authors, Randell Varilla, RN, MS, Thomas Allandale Rocas III, RN, BSN, Suriani Abdul Rani, MS, and Dmitri Debabov, Ph.D., report in the WOUNDS publication.

The study broke further ground when the doctors asked the question of why the treatment worked so well even though the Strep bacteria had already been apparently killed by antibiotics. Dr. Dmitri Debabov tested NeutroPhase against the toxins themselves in his laboratory at NovaBay. He discovered that the product actually breaks down the toxins in his laboratory testing. “It neutralizes all the toxins that dissolve cells,” said Dr. Crew. “This was really exciting to me as a clinician – I suddenly realized we may have a new procedure to add to the armamentarium against this deadly infection. The paper concludes: “This case illustrates and justifies the use of pure 0.01% Hypochlorous Acid, without any bleach impurities in necrotizing fasciitis.”

Additional Related Videos

CBS Eyewitness News on Lori Madsen’s story

NeutroPhase for Negative Pressure Wound Therapy

About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics^®

NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing topical non-antibiotic antimicrobial 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). FDA has not reviewed NovaBay’s data with respect to anti-toxin activity of NeutroPhase in in vitro experiments. 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 general use of antibiotics in the United States and NovaBay’s possible effect on that use. The words “potentially,” “think” and “believe” 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, 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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