NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and BioStem Technologies, Inc. (OTC: BSEM) announce an agreement under which NovaBay has been granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces.
Amniotic Tissue Allograft provides a protective environment or covering for repair of the cornea and conjunctiva, helping ocular surface to return to a healthier state. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eyecare brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.
Placentally derived human amniotic membrane is a potent source of pro-healing growth factors and anti-inflammatory cytokines. Amniotic allografts have successfully been used in regenerative medicine for over a century and dehydrated human amniotic membrane continues to be widely used as an ophthalmic covering. Avenova Allograft is the only optic allograft manufactured using BioStem Technologies’ patented six-step BioREtain® process that preserves the natural integrity of the placental tissue. This new NovaBay-branded product will compete in the global ophthalmology amniotic membrane market estimated at $403.6 million in 2022, and is expected to grow at 9.8% per year between 2023-2030.
“Avenova Allograft is a differentiated, high-quality product making it an ideal extension of our eyecare franchise,” said Justin Hall, CEO and General Counsel of NovaBay. “We look forward to launching Avenova Allograft in the coming weeks and making this valuable solution available for the eyecare professionals who specialize in treating dry eye.”
“Avenova Allograft is an ultra-thin, ultra-light structural tissue allograft composed of the amnion layer of the placental membrane. Our proprietary six-step BioREtain manufacturing process preserves the natural components of the tissue critical to the wound healing process and creates a product that is high-quality, versatile, and is applicable to a wide variety of topical ophthalmic covering applications. It is easy to use, and has no harsh chemicals or cryopreservants,” said Jason Matuszewski, CEO of BioStem Technologies. “Our company has an unwavering commitment to innovation, developing superior processes and delivering high-quality products. We manufacture products that change lives!”
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.
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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