NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) announces the commercial launch of Avenova Allograft to eyecare professionals across the U.S. through its physician-dispensed channel. This prescription product is the only optic allograft manufactured using BioStem Technologies, Inc.’s (OTC: BSEM) proprietary process and is intended for use as a protective covering during the repair of ocular surfaces.
The product launch follows a previously announced agreement under which NovaBay was granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft under the Avenova brand. The Avenova Allograft will compete in the global ophthalmology amniotic membrane market estimated at $403.6 million in 2022, which is expected to grow at 9.8% per year between 2023-2030.
“Avenova Allograft is a valuable addition to our high-quality, differentiated eyecare franchise and allows us to provide another solution for the professionals who specialize in treating eye conditions,” said Justin Hall, CEO and General Counsel of NovaBay. “We have fostered strong relationships with eyecare professionals nationwide including thousands of optometrists and ophthalmologists who recommend, prescribe, and sell Avenova-branded products every day. Sales in our physician-dispensed channel continue to grow, providing us with a terrific platform to launch this innovative product.”
The Avenova Allograft provides a protective environment or covering for repair of the cornea and conjunctiva, helping ocular surface to return to a healthier state. Using its patented six-step BioREtain® process that preserves the natural integrity of the placental tissue, BioStem Technologies will be responsible for manufacturing, packaging, shipping and regulatory compliance. The product consists only of the amnion layer of the placental membrane and measures between 20-50 microns thick, making it ideal for delicate ophthalmic applications. Avenova Allograft is available in 8mm, 10mm and 12mm diameter sizes.
NovaBay’s commercial launch of Avenova Allograft includes outreach programs aimed at educating eyecare specialists on both the clinical benefits of the product, as well as the process for Medicare reimbursement. Clinics can order Avenova Allograft now directly on Avenova.com.
“We are excited to partner with NovaBay, which shares our commitment to commercializing innovative, best-in-class products that improve people’s quality of life,” said Jason Matuszewski, CEO of BioStem Technologies. “This relationship allows us to capitalize on NovaBay’s well-established relationships in the eyecare sector as we focus on additional market opportunities for tissue allograft products.”
In addition to the new allograft product, NovaBay’s Avenova suite of products include Avenova antimicrobial lid and lash spray, specially designed dry wipes, lubricating eye drops, a warm eye compress, oral supplements and the i-Chek mirror to monitor physical eyelid health.
About NovaBay Pharmaceuticals, Inc.:
NovaBay Pharmaceuticals, Inc. develops and sells scientifically created and clinically proven eyecare, skincare and wound care products. NovaBay’s leading product Avenova® Antimicrobial Lid & Lash Solution is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to consumers through online distribution channels such as Amazon. DERMAdoctor® offers more than 30 dermatologist-developed skincare products through the DERMAdoctor website, well-known traditional and digital beauty retailers, and international distributors. NovaBay also manufactures and sells effective, yet gentle and non-irritating wound care products. The PhaseOne® brand is distributed through commercial partners in the U.S. for professional use only, and the NeutroPhase® brand is distributed in China by China Pioneer Pharma Holdings, Limited. More information about NovaBay is available here.
About BioStem Technologies, Inc. is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioRetain® processing method. BioRetain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (AATB). These systems and procedures are established per current Good Tissue Practices (cGTP) and current Good Manufacturing Processes (cGMP). Its portfolio of quality brands includes VENDAJE®, VENDAJE® AC and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Fla. More information about BioStem Technologies is available here.
NovaBay Pharmaceuticals Forward-Looking Statements
Except for historical information herein, matters set forth in this press release may be forward looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial progress and future financial performance of NovaBay Pharmaceuticals, Inc. This release contains forward-looking statements that are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding our business strategies, current partnerships, marketing efforts, and any future revenue that may result from such partnerships and related marketing initiatives, as well as generally the Company’s expected future financial results. These 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 size of the potential market for our products, the possibility that the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, and revenues will not be sufficient to meet the Company’s cash needs. Other risks relating to NovaBay’s business, 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-Q/K filings and Registration Statement on Form S-1 filing 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.
BioStem Technologies Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
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