Company to Focus on 510(k) Approval Path, Accelerating Time-to-Market
Oak Ridge, TN, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation ( DXR), the global leader in blood volume measurement technology, today announces a strategic update to its regulatory approach for its novel diagnostic blood volume analyzer platform. Following productive discussions with the U.S. Food and Drug Administration (FDA), the company has decided to withdraw its current dual 510(k)/CLIA-waiver application and resubmit a focused 510(k) application.
This decision comes after considerable progress in addressing key regulatory considerations and aims to expedite the approval process, potentially bringing this innovative technology to patients sooner.
"We're excited about the positive momentum in our discussions with the FDA," said Daxor CEO and President, Michael Feldschuh. "Our team has made substantial strides in resolving critical issues, and this strategic shift allows us to capitalize on that progress. By focusing on the 510(k) pathway, we're streamlining our approach and potentially accelerating our time-to-market."
The company's decision to transition to a simple 510(k) application is based on several factors:
- Significant progress in addressing key regulatory requirements
- Identification of a small set of additional technical data needed for approval
- Opportunity to expedite the approval process by focusing on 510(k) clearance
Daxor plans to pursue a separate CLIA-waiver application subsequently, allowing for a more targeted approach to each regulatory pathway.
"This strategy aligns with our commitment to bringing innovative diagnostic solutions to healthcare providers and patients as quickly and efficiently as possible," added Dr. John L. Jefferies, Daxor's Chief Medical Officer. "We're confident that this approach will ultimately lead to a smoother approval process and faster market entry."
The company expects to submit the new 510(k) application in the coming quarter and will provide updates on its progress in the regulatory process, as appropriate.
About Daxor Corporation
Daxor Corporation ( 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-Looking Statements
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.
Investor Relations Contact:
Bret Shapiro
Sr. Managing Partner, CORE IR
1-516-222-2560
[email protected]
