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UNIONDALE, NY - ProPhase Labs, Inc. (NASDAQ:PRPH), a micro-cap biotech company currently valued at $11.7 million, announced Tuesday that the United States Patent and Trademark Office has issued U.S. Patent No. 12379378-B2 for its biomarker-based systems to assess progression risk in Barrett’s esophagus and esophageal adenocarcinoma. According to InvestingPro data, the company operates with a significant debt burden but analysts anticipate sales growth of 215% in the current fiscal year.
The patent issuance follows the company’s June 17 announcement validating its BE-Smart molecular diagnostic test, which achieved greater than 95% technical success rate in detecting the patented panel of biomarkers. The test is compatible with both esophageal brush cytology and forceps biopsies.
The patent, originally filed in December 2023, covers methods for assessing risk by detecting key biomarkers including ISG15, LTF, CNDP2, DAD1, SET, UBE2N, S100P, and GPI, which form the foundation of the BE-Smart test platform.
"This achievement solidifies our leadership in medical innovation and brings us one step closer to transforming early detection and treatment strategies for this serious condition," said Ted Karkus, Chief Executive Officer of ProPhase Labs, in the press release.
According to the company, brush biopsies can capture a broader epithelial cell population, while forceps biopsies provide targeted tissue sampling. By working with both methods, the BE-Smart test aims to enhance early detection and risk stratification in patients with GERD, Barrett’s esophagus, and other distal esophageal disorders.
The patent also enables potential novel treatment approaches, including methods for inhibiting cancer cell proliferation and migration and enhancing tumor susceptibility to cytotoxic therapies.
ProPhase Labs is a biotech, genomics and consumer products company that develops diagnostic tests and operates a direct-to-consumer platform for dietary supplements. The company faces some financial challenges, with a gross profit margin of just 7.46% and its stock currently trading at $0.28, near its 52-week low of $0.22. For deeper insights into PRPH’s financial health and growth prospects, InvestingPro subscribers have access to over 10 additional ProTips and comprehensive financial metrics.
In other recent news, ProPhase Labs has secured $3 million in private placement financing through senior secured convertible notes, which are accompanied by warrants to purchase common stock. The notes come with a 20% original issue discount and are secured by company and subsidiary assets. Additionally, ProPhase Labs is exploring a reverse merger with a digital asset-focused company, aiming to complement its current operations. The company has also approved a strategic initiative to acquire and hold digital assets, including Bitcoin, as part of a diversified treasury strategy.
Moreover, ProPhase Labs has received a 180-day extension from Nasdaq to comply with the minimum $1.00 bid price requirement, giving the company until December 22, 2025, to meet this listing condition. In governance news, Carolina Abenante has been appointed as an independent director to the Board of Directors, filling an existing vacancy and serving on several committees. ProPhase Labs has also formed a Clinical Science Advisory Board to advance the clinical adoption of its BE-Smart™ molecular test for esophageal disease. This test is designed to improve the accuracy of endoscopies and potentially reduce healthcare costs.
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