SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 15, 2020
|(Exact name of registrant as specified in its charter)|
|(State or other jurisdiction||(Commission||(IRS Employer|
|of incorporation)||File Number)||Identification No.)|
|350 5th Avenue, New York New York||10118|
|(Address of principal executive offices)||(Zip Code)|
|Registrant’s telephone number, including area code|
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
|[ ]||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|[ ]||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|[ ]||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|[ ]||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:|
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock $0.01 par value||DXR||NYSE AMERICAN|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Potential persons who are to respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number.
Item 8.01 – Other Events
On July 15, 2020 Daxor Corporation issued a press release announcing the initiation of first-of-its-kind multicenter BVA-100 study in hospitalized patients with COVID-19. The press release issued is attached to this filing as Exhibit 99.1.
Item 9.01 Exhibits
(d) Exhibits. The following exhibit is filed with this Current Report on Form 8-K:
|99.1||Press release dated July 15, 2020 - Daxor Announces Initiation of First-of-Its-Kind Multicenter BVA-100; Study in Hospitalized Patients With COVID-19|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
|Date: July 15, 2020||By:||/s/ Robert J. Michel|
|Name:||Robert J. Michel|
|Title:||Chief Financial Officer|
Daxor Announces Initiation of First-of-It’s-Kind Multicenter BVA-100® Study in Hospitalized Patients with COVID-19
COVID-19 Investigation Commences at NYU Langone Health with Daxor’s Blood Volume Analysis Technology
NEW YORK, July 15, 2020 — Daxor Corporation (NYSE MKT: DXR), an investment company with innovative medical instrumentation and biotechnology operations focused on blood volume measurement, today announced the initiation of a multicenter prospective study utilizing Daxor’s BVA-100 (Blood Volume Analyzer, “BVA”) technology in hospitalized COVID-19 patients. NYU Langone Health in New York City is the first site to enroll patients under the leadership of Jan Bakker, MD, PhD.
“Institutions have been using and collecting data on the BVA-guided care of COVID-19 patients since the onset of the pandemic,” said Michael Feldschuh, CEO and President of Daxor Corporation. “A multicenter trial is essential to understanding COVID-based volume derangements. We are encouraged by the initial application of the BVA to improve care and outcomes and are confident that the BVA will continue to help physicians detect and manage the significant underlying volume derangements suffered by COVID patients in the ICU.”
Jonathan Feldschuh, Chief Scientific Officer of Daxor, stated, “Accurate volume assessment allows for individualized care, ensuring circulatory integrity and optimal tissue perfusion. Our BVA technology provides clinicians with precise volume measurement superior to commonly used indirect estimates. The BVA also offers insights into patients’ capillary leak rate, which has been shown to be an early prognostic indicator in critically ill patients. In addition, the use of the blood volume to optimize treatment has been shown to improve outcomes in other clinical settings. We expect to announce additional study sites in the coming weeks.”
Daxor’s FDA-cleared diagnostic instrument used in critical care can help guide treatment, as the BVA-100 measures patients’ blood, plasma and red cell volume and calculates the ideal blood volume that the patient should have, with statistics showing deviations from the patient-specific ideal. The BVA is the only test that provides a unique measure of capillary permeability via its albumin tracer, an important insight into COVID-19 pathophysiology. This study aims to show the implications of COVID as an endothelial disease utilizing this measure.
In a randomized control trial (RCT) published in 2011 in the journal Shock, patients at a Level-1 trauma center ICU suffering predominantly from ARDS/sepsis/septic shock/hemorrhagic shock who received BVA-guided care showed significant benefits including a 66% lower mortality rate (P<0.03), reducing mortality from 24% to 8%. Analysis showed 44% of BVA test results led to a change in treatment strategy (P=0.004) that care teams would not have performed absent the data from the BVA volume status measure.
About Daxor Corporation
Daxor Corporation (NYSE: DXR) is an innovative medical instrumentation and biotechnology company focused on blood volume measurement. We developed and market the BVA-100® (Blood Volume Analyzer), the first diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. The BVA technology has the potential to improve hospital performance metrics in a broad range of surgical and medical conditions, including heart failure and critical care, by informing treatment strategies, resulting in significantly improved patient outcomes. Our mission is to partner with clinicians to incorporate BVA technology into standard clinical practice and improve the quality of life for patients. For more information, please visit our website at Daxor.com.
Certain statements in this release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the impact of hiring sales staff and expansion of our distribution channels. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, FDA regulatory actions, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and additional other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Daxor does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
|Investor Relations Contact:|
|Sr. Managing Partner, CORE IR|