NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company commercializing and developing novel approaches for the global eye care market, including revolutionary non-antibiotic antimicrobial products, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its novel intelli-Case with hydrogen peroxide solutions.
More than 24 million Americans now disinfect their contact lenses with a disinfection system to prevent potentially serious infections. But only about 2 million use the gold standard disinfection solution, hydrogen peroxide. That’s because hydrogen peroxide can be tricky to use. Too low a concentration and it doesn’t fully disinfect lenses; too high, and it can irritate the eye. Getting the concentration right is challenging because hydrogen peroxide degrades over time. Many ophthalmologists and optometrists favor the disinfection and lens material compatibility peroxide systems provide, yet side effects associated with misuse and non-compliance minimize peroxide system use.
“The intelli-Case is a highly innovative, extremely easy-to-use device for the millions of Americans who wear contact lenses and want to use the best disinfection system,” said Ron Najafi, Ph.D., NovaBay’s President and CEO. “We believe that intelli-Case can revolutionize contact lens care by making the peroxide disinfection system as simple as using multipurpose solutions. Following the launch of Avenova, intelli-Case is the second in a series of cutting-edge products being developed by NovaBay that target unmet needs in the eye care market and demonstrates our strong commitment to innovation.”
The intelli-Case monitors the neutralization of hydrogen peroxide during the disinfection cycle with sophisticated microprocessor electronics embedded in the cap of what otherwise looks like a standard peroxide lens case. The high-tech cap has three LED lights labeled UNSAFE, BUSY and READY. Lenses are placed into the case with hydrogen peroxide solution. The green light (READY) blinks when lenses are safe to insert into the eyes and continues to blink green until contact lenses are removed from the case.
“The intelli-Case can be co-packaged with a hydrogen peroxide disinfection/cleaning solution and we are actively seeking a partnership with a hydrogen peroxide manufacturer,” added Dr. Najafi. “Replacing the standard case that is typically boxed with hydrogen peroxide solutions with the intelli-Case will make for a highly differentiated product offering that we believe will be warmly welcomed by both eye care professionals and contact lens wearers.”
“Poor contact lens hygiene is a major risk factor for a range of eye complications,” explained David Stroman, Ph.D., NovaBay’s Senior Vice President for Ophthalmology. “Americans make more than a million visits each year to emergency rooms, clinics or their eye care professionals with contact lens-related issues. Patients often report irritation and/or red eye after insertion of their contact lenses, when the hydrogen peroxide solution has not been adequately neutralized. Failure to properly disinfect is a well-documented cause of contact lens-related infections. The intelli-Case is designed to ensure the adequacy of the peroxide disinfection cycle and that the contact lenses are safe for insertion into the eyes.
“The intelli-Case provides real-time information to the user through solution monitoring and blinking LED lights, indicating that their lenses can be safely placed into their eyes,” said Dr. Stroman. “The intelli-Case removes the guesswork.”
“The advantages of peroxide are well known, but compliance has remained a problem for many patients,” said Art Epstein, OD, FAAO, FABCO, FBCLA, DPNAP, a recognized authority on contact lens complications. “What I most like about intelli-Case is that it leverages high-tech, real-time analytics to foster improved patient compliance. From what I’ve seen, it can make a tremendous difference even for the compliance-challenged patients. I am really excited about this technology.”
Steven J. Lichtenstein, MD, FAAP, FACS, FAAO, a leading pediatric ophthalmologist, stated, “The responses I’m getting from patients who have tested the intelli-Case are very positive. For instance, one individual reported that intelli-Case was easy to use and loved the fact that each morning she could safely put her lenses in her eyes without worrying about them burning. Like many other contact wearers, she has experienced severe pain from residual hydrogen peroxide that can occur with other peroxide disinfecting solutions. I plan to move my contact lens patients from multipurpose solutions (MPS) to intelli-Case as soon as possible.”
NovaBay management will host an investment community conference call, which will feature key opinion leaders in both ophthalmology and optometry and a discussion of its commercialization strategy, as well as to answer questions. The call will be held on Tuesday, June 9, 2015, at 12:00 p.m. noon Eastern time (9:00 a.m. Pacific time). Shareholders and other interested parties may participate in the conference call by dialing 866-880-4999 from within the U.S. or 702-495-1913 from outside the U.S. and entering the conference identification number 57071355. The live call also will be available at www.novabay.com.
A replay of the call will be available beginning two hours after its completion through June 23, 2015 at 11:59 a.m. Eastern time by dialing 855-859-2056 from within the U.S. or 404-537-3406 from outside the U.S. and entering the conference identification number 57071355. The call will also be archived at www.novabay.com.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a biopharmaceutical company focusing commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global, topical anti-infective market with its two distinct product categories: the NEUTROX™ Family of Products, including AVENOVA™ for the eye care market and NEUTROPHASE® for wound care,, and CELLERX® for the aesthetic dermatology market, cleared by the FDA as a 510(k) medical device; and its AGANOCIDE® compounds, led by AURICLOSENE™.
NovaBay is partnered in the U.S. and around the globe with: PBE, Inc. (USA), IHT, Inc. (USA), Galderma (France), Virbac (France), China Pioneer Pharma (China and Southeast Asia), Shin Poong Pharmaceuticals (South Korea), Biopharm (North African and Middle East), Sarmedic Ltd (Israel) and Alpha Pharma LLC (Ukraine).
NovaBay has received FDA-clearance of its intelli-Case, a highly innovative, easy-to-use device for use with hydrogen peroxide disinfection solutions with soft and Rigid Gas Permeable (RGP) contact lenses.
This release contains forward-looking statements and opinions regarding the commercial potential of intelli-Case, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. The words “believe” and “will” are intended to identify the 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 the future commercialization and market acceptance of intelli-Case. Other risks relating to NovaBay and its products, 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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From the Company
Thomas J. Paulson
Chief Financial Officer
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