Kraton Seeking Approval for BIAXAMTM as a Self-Sterilizing Sulfonated Polymer
Kraton Corporation (NYSE: KRA) is pursuing regulatory approval for its novel sulfonated polymer technology, BIAXAM, which claims to disinfect surfaces by inactivating 99.99% of SARS-CoV-2 and other pathogens. Developed as part of its polymer product line, BIAXAM aims for EPA approval and potential applications on PPE and high-contact surfaces. Tested in BSL-4 laboratories, the technology is patent-pending and could address the urgent need for long-lasting disinfectants. Kraton is also exploring partnerships for its commercial launch.
- Demonstrated efficacy of BIAXAM against 99.99% of SARS-CoV-2.
- Potential for diverse applications including PPE and high-contact surfaces.
- Strong support from reputable testing organizations.
- Pending regulatory approval from the EPA may delay market entry.
- BIAXAM cannot currently be marketed as a disinfectant until approved.
HOUSTON, Sept. 9, 2020 /PRNewswire/ -- Kraton Corporation (NYSE: KRA), a leading global producer of specialty polymers and high-value biobased products derived from pine wood pulping co-products, is seeking regulatory approval for BIAXAM, a novel sulfonated polymer technology with long-lasting self-disinfecting properties that has been demonstrated in studies to quickly inactivate up to
Kraton developed the BIAXAM technology as part of its sulfonated polymer product line and plans to expand product testing and seek regulatory approval for use as a durable, long-lasting disinfectant from the United States Environmental Protection Agency (EPA). In parallel, Kraton is pursuing registrations and/or approval with appropriate regulatory agencies in countries outside the U.S.
The efficacy of Kraton's BIAXAM technology has been thoroughly studied by renowned organizations, including Boston University's National Emerging Infectious Diseases Laboratories (NEIDL), North Carolina State University, University of Texas Medical Branch (UTMB) at Galveston, and Syngene International Ltd. The testing performed at the UTMB and Boston University BSL-4 laboratories has demonstrated BIAXAM to be effective against SARS-CoV-2 and other microbes1.
Depending on the regulatory approval process or certification requirements by country, Kraton believes that BIAXAM could be used as a coating on personal protective equipment (PPE) such as face shields, as well as a variety of high-contact surfaces such as door handles, elevator buttons, public transportation surfaces, cellphone cases, etc. Additionally, it could be used as a replaceable peel-and-stick film for a broad range of applications including medical, textiles, building and construction, and packaging.
"BIAXAM offers rapid and long-lasting performance, unlike current disinfectant offerings that are only effective immediately or require periodic treatment or re-application," said Dr. Vijay Mhetar, Kraton's Senior Vice President and Chief Technology Officer. "Currently there are no EPA approved long-lasting disinfectants2, so this technology is truly extraordinary. We believe the EPA would approve BIAXAM for the U.S. market and allow us to market the solution due to the novel anti-microbial properties it has demonstrated."
Dr. Mhetar continued, "as COVID-19 virus can remain stable on a variety of substrates for an extended period, in some cases as many as seven days, there is an urgent need for long lasting disinfectant. Once approved, Kraton's BIAXAM polymer technology can play a vital role in mitigating exposure to infectious pathogens, including SARS-COV-2."
The BIAXAM technology is patent-pending and will be commercially available shortly. For the U.S. market, until EPA approval is obtained, BIAXAM cannot be sold, marketed or distributed as components of products that kill or repel or claim to kill or repel microbes such as virus, bacteria or mold.
"We've been developing this technology for some time for other applications, but the recent pandemic has led to an urgent and high demand for anti-microbial materials," said Kevin M. Fogarty, Kraton's President and Chief Executive Officer. "We are excited about the possibility of bringing this innovation to market. We are currently conducting discussions with a number of possible development partners to explore potential applications in the U.S. and other regions worldwide."
For more information, please contact us at kraton.biaxam.com.
1MRSA, Xenotropic Murine Leukemia virus, PI-3, vancomycin-resistant Enterococcus faecium, carbapenem-resistant Acinetobacter baumannii, influenza A virus, Staphylococcus aureus, Escherichia coli, Staphylococcus albus, Escherichia coli, Rhizoctonia solani, Fusarium oxysporum, and Aspergillus niger black mold.
2United States Environmental Protection Agency. (2020, July 7). Trump EPA Research Studying the Effectiveness of Longer-Lasting Disinfectants.
ABOUT KRATON
Kraton Corporation (NYSE "KRA") is a leading global producer of specialty polymers and high-value performance products derived from renewable resources. Kraton's polymers are used in a wide range of applications, including adhesives, coatings, consumer and personal care products, sealants and lubricants, medical, packaging, automotive, paving and roofing products. As the largest global provider in the pine chemicals industry, Kraton's pine-based specialty products are sold into adhesive, road and construction and tire markets, and it produces and sells a broad range of performance chemicals into markets that include fuel additives, oilfield chemicals, coatings, metalworking fluids and lubricants, inks and mining. Kraton offers its products to a diverse customer base in numerous countries worldwide. Kraton, BIAXAM, the Kraton logo and design are all trademarks of Kraton Corporation or its subsidiaries or affiliates
FORWARD LOOKING STATEMENTS
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are often characterized by the use of words such as "hopes," "believes," "estimates," "expects," "projects," "may," "could", "would" "intends," "plans" or "anticipates," or by discussions of strategy, plans or intentions. The statements in this press release that are not historical statements, including statements regarding Kraton's expectations of the role that BIAXAM can play in mitigating exposure to infectious pathogens, the effectiveness of BIAXAM, expectations about the possibility of bringing BIAXAM to market (including receipt of regulatory approvals or the timing thereof) and expectations regarding the potential applications and development partner opportunities are forward-looking statements. There is no assurance that any planned corporate activity, scientific research or study, regulatory approval, developing, marketing, licensing, or selling of products, patent application, allowance or consumer study, to the extent pursued, will be successful or will succeed as currently planned or expected. There is no assurance that any of BIAXAM's postulated uses, benefits, or advantages will in fact be realized in any manner or in any part. No statement herein has been evaluated by the EPA or the Food and Drug Administration (FDA).
All forward-looking statements in this press release are made based on management's current expectations and estimates, which involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed in forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those expressed in forward-looking statements is contained in Kraton's most recently filed annual report on Form 10-K, quarterly reports on Form 10-Q and in other filings made by Kraton with the U.S. Securities and Exchange Commission, and include, but are not limited to, risks related to: Kraton's ability to continue the technological innovation and successful commercial introduction of new products (which depends on obtaining regulatory approval); early stage products performing as currently expected; Kraton's ability to protect its intellectual property and other proprietary information; Kraton's ability to repay or re-finance its indebtedness; Kraton's reliance on third parties for the provision of significant operating and other services; the impact of extraordinary events, including health epidemics of pandemics such as COVID-19 (including governmental and regulatory actions relating thereto); natural disasters and other weather conditions and terrorist attacks; conditions in the global economy and capital markets; fluctuations in raw material costs; limitations in the availability of raw materials; competition in Kraton's end-use markets; fluctuations in global tariffs and logistics costs; and other factors of which we are currently unaware or deem immaterial. Readers are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements contained herein speak only as of the date of this press release, and we assume no obligation to publicly update or revise such forward-looking statements in light of new information or future events.
For Investor Information:
H. Gene Shiels
Email: gene.shiels@kraton.com
For Media and General Inquiries:
Vaneese Bell
Email: biaxaminnovation@kraton.com
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SOURCE Kraton Corporation
FAQ
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