8-K
DAXOR CORP (DXR)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) January 2, 2024
DaxorCorporation
(Exact name of registrant as specified in its charter)
| New<br> York | 811-22684 | 13-2682108 |
|---|---|---|
| (State<br> or other jurisdiction | (Commission | (IRS<br> Employer |
| of<br> incorporation) | File<br> Number) | Identification<br> No.) |
| 109<br> Meco Lane, Oak Ridge, TN | 37830 | |
| --- | --- | |
| (Address<br> of principal executive offices) | (Zip<br> Code) |
212-330-8500
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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock $0.01 par value | DXR | Nasdaq |
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. ☐
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Item8.01 – Other Events
On January 2, 2024 Daxor Corporation announced it has submitted its next-generation blood volume analyzer - Daxor BVA - to the U.S. Food and Drug Administration (FDA) via the 510(k)/CLIA-waiver dual submission pathway. Potential clearance is expected during the first half of 2024. The Company’s mission is to advance healthcare by enabling optimal fluid management. The press release issued is attached to this filing as Exhibit 99.1
Item9.01 Exhibits
(d) Exhibits. The following exhibit is filed with this Current Report on Form 8-K:
| No. | Description |
|---|---|
| 99.1 | Press<br> release dated January 2, 2024 – Daxor Corporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
| DAXOR CORPORATION | ||
|---|---|---|
| (Registrant) | ||
| Date:<br> January 2, 2024 | By: | /s/ Robert J. Michel |
| Name: | Robert<br> J. Michel | |
| Title: | Chief<br> Financial Officer |
Exhibit99.1
DaxorCorporation Submits Dual 510(k)/CLIA-waiver Application to the FDA for Its Advanced Next-Generation Blood Volume Analyzer
TheNew BVA System is Designed to be Significantly Faster, Simpler and Give Results at the Bedside
OakRidge, TN – January 2, 2024 -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces it has submitted its next-generation blood volume analyzer - Daxor BVA - to the U.S. Food and Drug Administration (FDA) via the 510(k)/CLIA-waiver dual submission pathway. Potential clearance is expected during the first half of 2024. The Company’s mission is to advance healthcare by enabling optimal fluid management.
The new Daxor BVA device directly quantifies the intravascular blood, red blood cell and plasma volume, providing clinicians with actionable information to achieve optimal fluid management for their patients. Compared to the current Daxor BVA-100 system, the new Daxor BVA is designed to be three times faster, simpler to operate, completely portable, and capable of performing bedside analysis, making it easier for healthcare providers to integrate this innovative diagnostic into their clinical workflow.
“Today marks a long-anticipated and momentous milestone in our continued commitment to our customers, patients, and to achieving our vision of optimal blood volume for all,” said Michael Feldschuh, Daxor’s CEO and President. “Funded under contract by the U.S. Department of Defense, our next-generation analyzer will deliver a level of speed, access, and accuracy to blood volume management that can significantly improve care and outcomes in medicine.”
AboutDaxor Corporation
Daxor Corporation (Nasdaq: DXR), is the global leader in blood volume measurement technology focused on blood volume testing innovation. We developed and market the BVA-100^®^ (Blood Volume Analyzer), the only diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. Over 65,000+ tests have been performed at leading hospital centers across the U.S., enhancing hospital performance metrics in a broad range of surgical and medical conditions, including significantly reducing mortality and readmissions in heart failure and critical care. Daxor has several ongoing trials in the areas of heart failure treatment with support from the NIH and is under contract developing analyzers to improve combat casualty care with the U.S. Department of Defense. Daxor’s mission is to advance healthcare by enabling optimal fluid management with blood volume analysis. Daxor’s vision is optimal blood volume for all. For more information, please visit our website at Daxor.com. Sign up to receive news on Daxor’s innovative technology HERE.
Forward-LookingStatements
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 risk 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.
InvestorRelations Contact:
Bret Shapiro
Sr. Managing Partner, CORE IR
1-516-222-2560
brets@coreir.com