Greater than 2-fold predictive value (p=0.001) for heart attack, stroke, and death
Significant unmet need in balancing the risks and benefits of antithrombotic treatment in patients with acute coronary syndrome (ACS)
Supports trend in individualized antiplatelet therapy
PHILADELPHIA, PA / ACCESSWIRE / October 21, 2024 / Prolocor, Inc., a healthcare startup developing the innovative diagnostic Prolocor pFCG® test that identifies patients at higher and lower risk of thrombotic events (heart attack, stroke, and death), announced today the publication of results from the confirmatory 800 patient ACS trial titled: Fc?RIIa: A Marker of Cardiovascular Risk after Myocardial Infarction in the prestigious Journal of the American College of Cardiology (JACC).The trial was conducted in 25 sites across the United States.
Dr. David Schneider, Prolocor Co-Founder and Chief Scientific Officer said, "I would like to thank the investigators and patients for their participation in this important study. The Prolocor pFCG® test is poised to become a critical tool for clinical decision making in ACS patients."
The trial was a prospective, multicenter non-interventional cohort study. The primary objective of the study was to determine whether the Prolocor pFCG® test, which quantifies the expression of Fc?RIIa on the platelet surface, predicts risk of heart attack, stroke and death. Patients with a high pFCG had a significantly higher risk of an event than those in the low-risk group a hazard ratio of 2.09 (1.34-3.26;) p = 0.001.
Dr Deepak L. Bhatt, the Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, stated, "We need tools to enable better risk stratification and treatment of ACS patients. A simple blood test that assists in decisions regarding intensity and duration of antiplatelet therapy would be extremely useful if it subsequently leads to better patient outcomes."
"We have now studied Prolocor pFCG® in nearly 1,000 ACS patients, with consistent results," said CEO and Co-founder Dr. Pete DiBattiste. "We at Prolocor understand the challenges clinicians face in treating this patient population and are working closely with our cardiology colleagues to provide them with this additional tool to support their clinical decision."
Additional information regarding the Prolocor pFCG® test and our clinical development program are available at Prolocor.com.
ABOUT PROLOCOR, INC.
Founded by a team that deeply understands thrombosis and cardiovascular disease, Prolocor is building its strategy around platelet Fc?RIIa and embarking on a journey to commercialize an innovative precision diagnostic test that quantifies Fc?RIIa 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 STATEMENTS
This 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.
CONTACT
ray.russo@prolocor.com
SOURCE: Prolocor Inc.
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