Prolocor Announces the Publication of Two Important New Analyses from a Recently Completed Clinical Study

In JACC: Advances, high platelet FcɣRIIa (pFCG) identified patients at greater risk of multiple, recurrent cardiovascular events.In Catheterization and Cardiovascular Interventions, the pFCG test refined clinical risk assessment, adding prognostic value beyond established clinical risk factors. PHILADELPHIA, PA / ACCESS Newswire / July 20, 2026 / Prolocor, Inc., a healthcare company developing the innovative diagnostic Prolocor pFCG™ test to identify patients at risk of thrombotic events, today announced the publication of two analyses from a recently completed clinical study of the pFCG test. The first, "Increased Platelet FcɣRIIa Identifies Patients at Greater Risk of Multiple Cardiovascular Events After Myocardial Infarction," was published in JACC: Advances, a journal of the American College of Cardiology. The second, "Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial Infarction," was published in Catheterization and Cardiovascular Interventions. Together, these two peer-reviewed papers-drawn from the same prospective, multicenter trial-demonstrate that quantifying platelet FcɣRIIa (pFCG) sharpens risk assessment after myocardial infarction (MI).The new JACC: Advances analysis evaluated 765 patients hospitalized with type 1 MI who were enrolled in Prolocor's prospective, noninterventional multicenter trial (NCT05175261) and followed for an average of 21 months. Each patient had at least two established clinical risk factors (age ≥ 65 years, multivessel coronary artery disease, prior MI, chronic kidney disease, or diabetes mellitus). Investigators quantified pFCG and tracked both ischemic events (MI, stroke, and death; n = 158) and clinically significant bleeding events (BARC 2, 3, and 5; n = 74). High pFCG identified patients at greater risk of not only a first ischemic event but also additional, recurrent events. A second observation is that the association of the pFCG test with bleeding is largely driven by patients who have both MI and bleeding. "These data show that the pFCG test does more than flag who is at risk after a heart attack-it identifies the patients most likely to suffer repeated ischemic events," said David J. Schneider, MD, FACC, FAHA, Prolocor Co-Founder and Chief Scientific Officer and the study's lead author. "Taken together with our companion publication, these findings strengthen the case that measuring platelet FcɣRIIa can help clinicians identify ischemic risk that can be weighed against bleeding risk when individualizing antiplatelet therapy.""Recurrent events are where much of the morbidity and cost after myocardial infarction concentrate, and yet they remain difficult to predict at the bedside," said C. Michael Gibson, MD, of the Baim Institute for Clinical Research and Harvard Medical School, Boston. "A biomarker that identifies patients prone to multiple ischemic events-without simply selecting for those who will bleed-could meaningfully sharpen how we tailor antithrombotic therapy, and these results warrant testing in a prospective, treatment-guiding trial."Key Findings: Increased Platelet FcɣRIIa Identifies Patients at Greater Risk of Multiple Cardiovascular Events After Myocardial InfarctionPublished in JACC: Advances (2026)Predicts recurrent events: Patients with high pFCG had a significantly greater risk of both an initial ischemic endpoint and additional ischemic endpoints (HR: 2.70; 95% CI: 1.82-4.02; P < 0.0001).Risk that persists across the year: Among the 47 patients with two or more ischemic events, recurrent events were distributed across the follow-up period rather than clustering immediately after the index event.An ischemia-selective signal: High pFCG was not significantly associated with bleeding alone (HR: 1.39; 95% CI: 0.63-3.06; P = 0.412). A net clinical event analysis of any ischemic or bleeding event yielded an HR of 1.86 (95% CI: 1.40-2.46; P < 0.0001), a result driven by ischemic risk.Key Findings: Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial InfarctionPublished in Catheterization and Cardiovascular Interventions (2026)Clinical risk gradient: A greater number of clinical risk factors was associated with progressively higher one-year risk of the composite of MI, stroke, and death-10.2% with 2 risk factors, 14.4% with 3 risk factors, and 35.6% with 4 or 5 risk factors (P < 0.001 for trend).Added value of the pFCG test: Across all clinical risk cohorts, the pFCG test separated patients into higher- and lower-risk groups (P = 0.001), demonstrating prognostic value independent of clinical risk factors.Magnitude of risk discrimination: The absolute risk difference in patients with high versus low pFCG ranged from 7.5% to 16.5%.Potential to guide therapy: Among 749 patients across 25 U.S. centers-all with at least two clinical risk factors-the authors concluded that the pFCG test may be a useful tool to balance the risk of ischemic events against the risk of bleeding when defining a treatment strategy after MI."Two peer-reviewed publications in leading cardiology journals, drawn from the same rigorous multicenter study, reinforce the consistency and strength of the pFCG signal," said Peter DiBattiste, MD, Prolocor's Chief Executive Officer. "Identifying patients at risk of recurrent events is exactly where a precision diagnostic can change care, and it underscores why we're focused on generating the evidence that matters most to clinicians and patients."The study was supported by Prolocor, Inc. and is registered at ClinicalTrials.gov (NCT05175261). The full articles are available atJACC: Advances and Catheterization and Cardiovascular Interventions.About Prolocor, Inc.Founded by a team that deeply understands thrombosis and cardiovascular disease, Prolocor is building its strategy around platelet FcɣRIIa and embarking on a journey to commercialize an innovative precision diagnostic test that quantifies FcɣRIIa on the surface of platelets. For more information on Prolocor, please visit the company's website at www.prolocor.com and follow us on LinkedIn.Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although Prolocor's management believes that the expectations reflected in such forward-looking statements are reasonable, forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Prolocor, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, among other things, Prolocor's planned level of revenues and capital expenditures, Prolocor's available cash and its ability to obtain additional funding, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities regarding whether and when to approve any device or application that may be filed for any such product candidates and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Prolocor's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, and risks associated with intellectual property. Other than as required by applicable law, Prolocor does not undertake any obligation to update or revise any forward-looking information or statements.Contactray.russo@prolocor.comSOURCE: Prolocor IncView the original press release on ACCESS Newswire

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