COMPANY:

miR Scientific

"miR Scientific, LLC announces the miR Sentinel™ Prostate Cancer Test is now commercially available in the United States, Puerto Rico and select international markets. miR Sentinel™ is a novel, urine-based, molecular test that analyzes small non-coding RNA using a proprietary biostatistical algorithm. The miR Sentinel™ Test assesses the risk of aggressive prostate cancer and is intended to aid in the clinical management of men >45 years of age at risk for prostate cancer." "

"miR Scientific...and Leonie Hill Capital...announced today the signing of a collaboration agreement to partner in the commercial launch of the award-winning miR Sentinel™ Prostate Cancer Test in Singapore and Southeast Asia."

"miR Scientific announced at the Puerto Rico Urologists Convention that it will open a registry of patients who wish to receive the new miR Sentinel™ Prostate Cancer Test, which the company expects will be commercially available by the end of the year."

"Data presented from a cross-validation study at the American Urological Association's (AUA) 2021 Annual Meeting confirms that the miR Sentinel® Prostate Cancer Test can detect and risk-classify prostate cancer at the molecular level with predictive accuracy of over 90%, based on a single urine sample. This validation study follows and confirms the data on more than 1,400 patients published in The Journal of Urology in September 2020."

"In a validation study with data presented at the American Urological Association’s 2021 Annual Meeting, clinician-researchers reported that a new test (miR Sentinel PCC4 Test) may be able to detect and risk-classify prostate cancer at the molecular level with predictive accuracy based on a single urine sample. The data were reported on September 12, 2021, in a late-breaking abstract...When compared with systematic core needle biopsy, results of the Sentinel (PCC4) Test validation study demonstrated a 93% concordance between the two methods of screening/detection regarding classification of clinically significant cancer. The accuracy of the classification of 'not clinically significant' cancer was 96%."

"miR Scientific, LLC…and the Puerto Rico Health Insurance Administration ('ASES') announced today the signing of a cooperation agreement aimed at evaluating the clinical and economic utility of the miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) and its potential impact in Puerto Rico…The agreement memorializes the explicit intent of deploying the Company's Sentinel™ Prostate Test commercially in Puerto Rico in an effort to alleviate the disease burden of prostate cancer on the Island."

"miR Scientific, LLC...announced today that it has received Breakthrough Device Designation by the U.S Food & Drug Administration for its miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test). FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions."

"miR Scientific, LLC…today announced that validation data for its Sentinel Prostate Test™…were published in the September issue of the Journal of Urology... The publication highlights test results based on urinary exosomes that are isolated from a single specimen of regularly passed urine. Hundreds of specifically extracted small non-coding RNAs (sncRNA) are then interrogated in a high-throughput real-time PCR–based platform and analyzed with a proprietary classification algorithm."