FOR IMMEDIATE RELEASE
Reven Announces Coronavirus Treatment Acceleration Program (CTAP) Submission to the FDA
Golden, Colorado, Friday, April 3, 2020 3:00pm MDT – Reven, LLC, a biopharmaceutical company that is developing its flagship product Rejuveinix (RJX) for patients with vascular and metabolic related health conditions, announced today that it has submitted a proposal to the FDA to consider RJX as an adjunctive therapy for patients affected by COVID-19.
Peter Lange, Chief Executive Officer, stated, “The urgent need to address the COVID-19 pandemic appears to demand our immediate initiative. Reven’s preparation of white papers to draw parallels from our Phase I data to cardiovascular signals has led us to realize RJX’s potential contribution to the COVID-19 crisis.” More specifically, Reven’s RJX product is aimed at calming the Cytokine storm inherent in COVID-19 patients which if unresolved, often leads to death.
Reven’s scientific team recognizes that many cytokine and inflammation signals can be considered as common to both fibrotic response in cardiovascular disease and viral induced inflammation leading to fibrotic pulmonary and cardiac complications. These measures of immune pro- and anti-inflammatory balance appear to also affect resilience when the body is affected by viral agents.
“We are confident that our approach can make a meaningful contribution to CTAP in this time of urgent need,” added Brian Denomme, Chief Operating Officer.
About Cardiovascular Disease
Cardiovascular disease (CVD) is a class of diseases that involve the heart or blood vessels. Cardiovascular disease includes coronary artery diseases such as angina and myocardial infarction. Other CVDs include stroke, heart failure, rheumatic heart disease, cardiomyopathy, heart arrhythmia, congenital heart disease and more. Cardiovascular diseases are the leading cause of death globally, of which coronary artery disease and stroke account for 80% of CVD deaths in males and 75% of CVD deaths in females. In the United States, 11% of people between 20 and 40 have CVD, while 37% between 40 and 60, 71% of people between 60 and 80, and 85% of people over 80 have CVD.
About Reven, LLC
Reven, LLC is a Golden, Colorado based biopharmaceutical company. Reven’s vision is to make a difference in the world by making its products accessible to everyone suffering the effects of vascular and metabolic related diseases. Reven is committed to being the premier, research-intensive biopharmaceutical company that advances the health and well-being of people around the world. It’s primary product, RJX, targets patients suffering from vascular and metabolic related diseases as well as specific patient populations suffering PAD and other cardiovascular related medical conditions.
This announcement may contain forward-looking statements. These statements are based on Reven management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those indicated or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with our ability to continue to operate as a going concern; our ability to raise sufficient additional funds to continue operations and to conduct clinical trials of RJX in the United States and elsewhere; our ability to enlist clinical trial sites and enroll patients; the risk that the FDA stops RJX early as a result of the occurrence of certain safety events or does not approve an expansion of RJX; obtaining and maintaining regulatory approvals required to market and sell our products; the possibility that future clinical trials will not be successful or confirm earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; intellectual-property risk; risks related to assumptions regarding the size of the available market; the benefits of our products; product pricing; timing of product launches; future financial results; and other factors. Given these uncertainties, one should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events or otherwise, unless we are required to do so by law.
Contact: Vincent Vanderbent
Director of Corporate Communications
600 Corporate Circle, Suite D
Golden, CO 80401, USA