XPhyto Pursues Potential Application of its Oral Dissolvable Biosensor Inflammation Test for Buprenorphine-related Dental Disease
XPhyto Therapeutics Corp. (CSE:XPHY, OTCQB:XPHYF) has identified a significant market opportunity for its oral dissolvable biosensor screening tests for oral inflammation, particularly concerning dental issues linked to buprenorphine medications used for opioid use disorder. The FDA has acknowledged serious dental problems associated with these drugs and continues to recommend their use. XPhyto's biosensor product is designed for simple, low-cost detection of inflammation and has already been registered for marketing in Europe. The global buprenorphine market is projected to exceed USD $10.9 billion by 2027.
- XPhyto's oral dissolvable biosensor has gained EU registration for marketing, enhancing market presence.
- The potential market for buprenorphine-related oral health products aligns with a forecasted USD $10.9 billion market by 2027.
- The reliance on FDA warnings may affect the perceived safety of buprenorphine, potentially impacting sales.
- Commercialization efforts are contingent on successful clinical evaluations, which remain pending.
VANCOUVER, BC and UTTENWEILER, GERMANY / ACCESSWIRE / July 15, 2022 / XPhyto Therapeutics Corp. (CSE:XPHY),(OTCQB:XPHYF), (FSE:4XT) ("XPhyto" or the "Company") is pleased to report a significant potential market opportunity for its oral dissolvable ("ODF") biosensor screening tests for oral inflammation. Certain buprenorphine medicines prescribed to treat opioid use disorder ("OUD") and pain have been recently associated with numerous serious oral health problems requiring medical intervention. Buprenorphine is a medication approved by the U.S. Food and Drug Administration (the "FDA") to treat OUD as a medication-assisted treatment (MAT). The number of US adolescent and adult individuals with OUD in 2019 was estimated between 6.7-7.6 million. XPhyto is investigating the potential application of one or more of its ODF biosensor screening tests for oral inflammation to detect buprenorphine-related dental problems.
This year, the FDA issued a Drug Safety Communication ("DSC") titled "FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain." The DSC notes that the dental problems include "tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues." Notwithstanding the seriousness of the side-effects, the FDA is recommending the continued use of these medications as the benefits outweigh the risks and oral care can assist. The global buprenorphine market is expected to surpass USD
XPhyto's proprietary ODF biosensor development portfolio includes multiple oral health products, including for the detection of stomatitis, periodontitis, and periimplantitis. The Company's first ODF biosensor screening product is for general oral inflammation. Positive detection of the causative inflammatory agents results in an enzymatic release of a bitter compound in the user's mouth, with no medical training, analytical equipment or power supply required. The oral inflammation biosensor is designed to function as a simple, low-cost, and self-administered screening test to identify users for follow-up medical testing. The Company's oral dissolvable inflammation screening test was EU registered in late 2021 and is currently licensed for marketing and sale in Europe.
The Company is currently investigating the potential application of one or more of its oral health biosensor screening tests for the detection of buprenorphine-related dental problems. Requirements for clinical evaluation for the purpose of commercial registration and/or approval will be released once established. The company expects to provide further updates on its oral health and infectious disease screening test programs in the coming weeks.
XPhyto's pipeline of biosensor screening products for inflammatory, bacterial and viral infectious diseases includes stomatitis, periimplantitis, periodontitis, group A strep, influenza A, and covid-19. This suite of biosensor products positions the Company within the global biosensor and oral health markets which are expected to reach US
About XPhyto Therapeutics Corp.
XPhyto Therapeutics Corp. is a diversified bioscience accelerator focused on next-generation drug formulation, diagnostic, and new active pharmaceutical ingredient investment opportunities, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and manufacture, standardization, and evaluation of psychedelic compounds for the treatment of neurological conditions. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
XPhyto Therapeutics Corp.
Hugh Rogers, CEO and Director
Email: info@xphyto.com
Phone: +1 780-818-6422
Forward-Looking Statements
This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law ("forward-looking statements"). Forward-looking statements are frequently characterized by words such as "develop", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "propose" and other similar words, or statements that certain events or conditions "may" or "will" occur, and in this release include the statement regarding the Company's goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements, including: that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company's control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this news release.
SOURCE: XPhyto Therapeutics Corp.
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