NovaBay Pharmaceuticals

Last updated
NovaBay Pharmaceuticals, Inc.
Type Public
AMEX:  NBY
Russell Microcap Index component
Founded2000
FounderRon Najafi
Headquarters
United States  OOjs UI icon edit-ltr-progressive.svg
Key people
Mark Sieczkarek, M.B.A., CEO and Chairman of BOD
John (“Jack”) McGovern, CFO
Tom Paulson, M.B.A., Strategic Planning
Lewis J. Stuart, M.B.A., Chief Commercial Officer (CCO)
Glenn Moro, VP, Marketing Avenova
Justin M. Hall, Esq, Senior Vice President, General Counsel
Greg Miller, Director, Strategic Sales
Website novabay.com

NovaBay Pharmaceuticals, Inc. is an Emeryville, California based clinical-stage biopharmaceutical company, focused on developing novel, fast-acting, synthetic anti-infectives compounds. These compounds are designed to mimic the body's defense system against infection. The company is currently focused on products for the eye care market. Major products include Avenova, cleared by FDA for lid and lash cleansing as part of a regimen for Blepharitis. [1] and NeutroPhase, used in treatment of Necrotizing Fasciitis [2] [3]

Contents

History

NovaBay Pharmaceuticals, Inc. was founded by Ron Najafi, an organic chemist who had previously worked for several pharmaceutical, chemical, and biotech companies in the U.S. Najafi became intrigued by HOCl, hypochlorous acid, an antimicrobial substance produced by White Blood Cells while investigating the chemical reaction of White Blood Cells during oxidative burst cycle. HOCl and other chlorine-containing chemicals fight invading microbes. These natural substances rapidly oxidize the cell walls of bacteria and the protein coats of viruses, rendering them inactive.

Najafi started NovaBay Pharmaceuticals in 2000 to create a stable version of HOCl. [4] [ citation needed ] Najafi, chemistry Nobel laureate Herbert C. Brown, and Purdue University Professor Dale Margerum recruited Dr. Lu Wang to NovaBay, where she is now Director of Product Development. She was able to develop the stable version of pure hypochlorous acid, without bleach impurities, which became NovaBay's first product, NeutroPhase [5] [6] [7] [8] and cleared by the Food and Drug Administration in 2010.

The product successfully treats a variety of chronic non-healing wounds without the use of standard antibiotics. NovaBay announced two new products named CelleRx™ for Plastic Surgery and i-Lid™ Cleanser (Now Avenova) that was cleared by FDA for lid and lash cleansing as part of a regimen for Blepharitis. [9]

Corporate Governance

As of April 1,2016, the members of the board of directors of NovaBay Pharmaceuticals were: Mark Sieczkarek, Paul E. Freiman, Paul Li, Gail Maderis, Yonghao (Carl) Ma, Todd Zavodnick, Mijia (Bob) Wu and Xiaoyan (Henry) Liu.

Products

Products on the market

Avenova (formerly known as i-Lid Cleanser) [10] NeutroPhase [11] CelleRx, for Plastic Surgery

Products under development

NovaBay developed a method for making a stable pure form of hypochlorous acid (HOCl), a substance produced by the immune system as an effective first defense against microbial invaders. The company calls their proprietary formulation Neutrox. The company's chemists also created a related family of compounds which the company calls Aganocides.

The company is currently developing compounds with anti-bacterial and anti-viral action. Potential applications include flesh-eating disease, problems related to in-dwelling urinary catheters, and common eye conditions. Compounds are also being developed for the veterinary market. [12]

Related Research Articles

<span class="mw-page-title-main">Chlorine</span> Chemical element, symbol Cl and atomic number 17

Chlorine is a chemical element with the symbol Cl and atomic number 17. The second-lightest of the halogens, it appears between fluorine and bromine in the periodic table and its properties are mostly intermediate between them. Chlorine is a yellow-green gas at room temperature. It is an extremely reactive element and a strong oxidising agent: among the elements, it has the highest electron affinity and the third-highest electronegativity on the revised Pauling scale, behind only oxygen and fluorine.

<span class="mw-page-title-main">Cosmetics</span> Substances applied to the body to change appearance or fragrance

Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect the body or skin. Cosmetics designed to enhance or alter one's appearance (makeup) can be used to conceal blemishes, enhance one's natural features, add color to a person's face, or change the appearance of the face entirely to resemble a different person, creature or object. Due to the harsh ingredients in makeup products, individuals with acne-prone skin are more likely to suffer from breakouts. Cosmetics can also be designed to add fragrance to the body.

<span class="mw-page-title-main">Sodium hypochlorite</span> Chemical compound (known in solution as bleach)

Sodium hypochlorite, commonly known in a dilute solution as (chlorine) bleach, is an inorganic chemical compound with the formula NaOCl, consisting of a sodium cation and a hypochlorite anion. It may also be viewed as the sodium salt of hypochlorous acid. The anhydrous compound is unstable and may decompose explosively. It can be crystallized as a pentahydrate NaOCl·5H
2
O
, a pale greenish-yellow solid which is not explosive and is stable if kept refrigerated.

<span class="mw-page-title-main">Gangrene</span> Type of tissue death by a lack of blood supply

Gangrene is a type of tissue death caused by a lack of blood supply. Symptoms may include a change in skin color to red or black, numbness, swelling, pain, skin breakdown, and coolness. The feet and hands are most commonly affected. If the gangrene is caused by an infectious agent, it may present with a fever or sepsis.

<span class="mw-page-title-main">Necrotizing fasciitis</span> Infection that results in the death of the bodys soft tissue

Necrotizing fasciitis (NF), also known as flesh-eating disease, is a bacterial infection that results in the death of parts of the body's soft tissue. It is a severe disease of sudden onset that spreads rapidly. Symptoms usually include red or purple skin in the affected area, severe pain, fever, and vomiting. The most commonly affected areas are the limbs and perineum.

<span class="mw-page-title-main">Hypochlorous acid</span> Chemical compound

Hypochlorous acid is an acid that forms when chlorine dissolves in water, and itself partially dissociates, forming hypochlorite, ClO. HClO and ClO are oxidizers, and the primary disinfection agents of chlorine solutions. HClO cannot be isolated from these solutions due to rapid equilibration with its precursor, chlorine.

<span class="mw-page-title-main">Blepharitis</span> Medical condition of the eyelid

Blepharitis, sometimes known as "granulated eyelids," is one of the most common ocular conditions characterized by inflammation, scaling, reddening, and crusting of the eyelid. This condition may also cause swelling, burning, itching, or a grainy sensation when introducing foreign objects or substances to the eye. Although blepharitis by itself is not sight-threatening, it can lead to permanent alterations of the eyelid margin. The primary cause is bacteria and inflammation from congested meibomian oil glands at the base of each eyelash. Other conditions may give rise to blepharitis, whether they be infectious or noninfectious, including, but not limited to, bacterial infections or allergies.

<span class="mw-page-title-main">Eyelash</span> Facial feature

An eyelash is one of the hairs that grows at the edges of the eyelids. The lashes grow outwards in up to six layers on the edges of the upper and lower eyelids. Eyelashes protect the eye from debris, dust, and small particles and perform some of the same functions as whiskers do on a cat or a mouse in the sense that they are sensitive to being touched, thus providing a warning that an object is near the eye. The eyelid margin from which lashes grow is among the most sensitive parts of the human body, with many nerve endings enveloping the lashes, giving it sensitivity to light touch, enabling it to trigger the blink reflex when touched.

<span class="mw-page-title-main">Stye</span> Medical condition

A stye, also known as a hordeolum, is a bacterial infection of an oil gland in the eyelid. This results in a red tender bump at the edge of the eyelid. The outside or the inside of the eyelid can be affected.

Dakin's solution is a dilute solution of sodium hypochlorite and other stabilizing ingredients, traditionally used as an antiseptic, e.g. to cleanse wounds in order to prevent infection. The preparation was for a time called also Carrel–Dakin solution or Carrel–Dakin fluid.

<span class="mw-page-title-main">Amcinonide</span> Chemical compound

Amcinonide is a topical glucocorticoid used to treat itching, redness and swelling associated with several dermatologic conditions such as atopic dermatitis and allergic contact dermatitis. Amcinonide can also be classified as a multi-functional small molecule corticosteroid, which has been approved by the FDA and is currently marketed as an ointment, lotion, or cream. It acts as both a transcription factor for responses to glucocorticoids and modulator for other transcription factors while also regulating phospholipase A2 activity.

Personal care products are consumer products which are applied on various external parts of the body such as skin, hair, nails, lips, external genital and anal areas, as well as teeth and mucous membrane of the oral cavity, in order to make them clean, protect them from harmful germs and keep them in good condition. They promote personal hygiene and overall health, well-being and appearance of those body parts. Toiletries form a narrower category of personal care products which are used for basic hygiene and cleanliness as a part of a daily routine. Cosmetic products, in contrast, are used for personal grooming and beautification. Pharmaceutical products are not considered personal care products.

Aflibercept, sold under the brand names Eylea among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals and is approved in the United States and the European Union.

<span class="mw-page-title-main">Pimple</span> Type of comedo

A pimple or zit is a kind of comedo that results from excess sebum and dead skin cells getting trapped in the pores of the skin. In its aggravated state, it may evolve into a pustule or papule. Pimples can be treated by acne medications, antibiotics, and anti-inflammatories prescribed by a physician, or various over the counter remedies purchased at a pharmacy.

Avita Medical is a clinical and commercial company developing and marketing a range of respiratory and regenerative products. The first regenerative medicine product brought to the market by Avita Medical was ReCell spray-on skin for the treatment of burns. The two latest products are ReNovaCell, for Aesthetics and Plastic applications including skin trauma, and ReGenerCell for the treatment of chronic wounds. The Avita Medical regenerative product range is currently marketed in Europe, the Middle East, Africa (EMEA) and Australia.

Wound bed preparation (WBP) is a systematic approach to wound management by identifying and removing barriers to healing. The concept was originally developed in plastic surgery. During the year 2000, the concept was applied to systematizing the treatment of chronic wounds. The 2000 proposals recommended that wound management address the identifiable impediments to healing in order to achieve more successful outcomes. Three publications appeared that year that focused on the concept of managing the healing processes of a wound exudate, bioburden and devitalized tissue. Initially, emphasis was placed on debridement, moisture balance and bacterial balance as the three guiding principles of good wound care, while at the same time recognizing that the provision of care includes a vast array of patient, clinical and environmental variables.

<span class="mw-page-title-main">Water chlorination</span> Chorination of water

Water chlorination is the process of adding chlorine or chlorine compounds such as sodium hypochlorite to water. This method is used to kill bacteria, viruses and other microbes in water. In particular, chlorination is used to prevent the spread of waterborne diseases such as cholera, dysentery, and typhoid.

Brilacidin, an investigational new drug, is a polymer-based antibiotic currently in human clinical trials, and represents a new class of antibiotics called host defense protein mimetics, or HDP-mimetics, which are non-peptide synthetic small molecules modeled after host defense peptides (HDPs). HDPs, also called antimicrobial peptides, some of which are defensins, are part of the innate immune response and are common to most higher forms of life. As brilacidin is modeled after a defensin, it is also called a defensin mimetic.

<span class="mw-page-title-main">Ron Najafi</span>

Ramin (Ron) Najafi is an Iranian-American businessman and the Founder and CEO of Emery Pharma. He is the Founder and former CEO of NovaBay Pharmaceuticals.

<span class="mw-page-title-main">Meibomian gland dysfunction</span> Medical condition

Meibomian gland dysfunction is a chronic disease of the meibomian glands, which is commonly characterized by obstruction of the end of the duct that delivers the secretion produced by the glands to the eye surface, which prevents the glandular secretion from reaching the ocular surface. The dysfunction could be that the amount of secretion produced may be abnormal. Dysfunction could also be related to the quality of the meibum produced. MGD may result in evaporative dry eye, blepharitis, chalazion, unsealed lid during sleep, and meibomian gland atrophy.

References

  1. "NovaBay Avenova has a low toxicity but kills eyelid bacteria in dry eye or blepharitis patients".
  2. "Treatment of Acute Necrotizing Fasciitis Using Negative Pressure Wound Therapy and Adjunctive NeutroPhase Irrigation Under the Foam". Wounds Research. Retrieved 2019-12-11.
  3. "NNFF Names NovaBay's (NBY) NeutroPhase Its Official 'Flesh-Eating Disease' Wound Cleanser". StreetInsider.com. Retrieved 2019-12-11.
  4. "Hypochlorous Acid as a Potential Wound Care Agent Part I" (PDF).
  5. "510(k) Summary NeutroPhase® Skin and Wound Cleaner OTC" (PDF).
  6. "Hypochlorous Acid as a Potential Wound Care Agent Part II" (PDF).
  7. "NeutroPhase® in chronic non-healing wounds" (PDF).
  8. "Treatment of Acute Necrotizing Fasciitis Using Negative Pressure Wound Therapy and Adjunctive NeutroPhase Irrigation Under the Foam".[ failed verification ]
  9. "NovaBay Avenova has a low toxicity but kills eyelid bacteria in dry eye or blepharitis patients".
  10. NovaBay’s new Advanced i-Lid Cleanser has been Cleared by the FDA for Cleaning, Removing Debris and Microbes from the Skin around the Eyes, the Eyelids and Eyelashes eyelid and lash cleansing as part of a regimen for Blepharitis."
  11. Steven E. F. Brown (February 26, 2014). "NovaBay Pharmaceuticals makes deal for flesh-eating bacteria cleanser". San Francisco Business Times. Retrieved June 19, 2014.
  12. "NovaBay Pharmaceuticals and Virbac Enter Into a Collaboration and License Agreement for Animal Health". CNBC .