April 7, 2023 (Burlington, VT) – Biocogniv Inc, a leading innovator in digital diagnostics, has announced today that the US Food and Drug Administration (FDA) has granted their Sepsis aiMarker™ a Breakthrough Device Designation. The company’s cloud-based digital diagnostic tool aims to help hospital providers identify patients with sepsis, or at increased risk of developing sepsis, up to 72 hours in advance using only routine laboratory tests and vitals collected at the time of presentation to the emergency department (ED). This Breakthrough Designation affirms the company's belief in the potential of Sepsis aiMarker™ to significantly improve outcomes for patients at risk of sepsis.
The FDA Breakthrough Designation is a coveted recognition that accelerates the review of medical devices with the potential to offer significant advantages over existing options for patients with life-threatening or debilitating conditions. Only a small percentage of medical devices ever receive this prestigious designation.
In addition to accelerated FDA review, devices with Breakthrough Designation enjoy a streamlined pathway to enhanced inpatient reimbursement, via the Centers for Medicare & Medicaid Services' (CMS) New Technology Add-on Payment (NTAP) program. NTAP offers additional reimbursement to hospitals for adopting novel technologies that demonstrate substantial clinical improvement over current standard of care. By law, the CMS NTAP program accepts FDA Breakthrough Designation as evidence of clinical usefulness and novelty, the most difficult criteria medical devices need to pass in order to qualify for the program, and nearly 100% of medical devices with a Breakthrough Designation are accepted into the program.
To receive the FDA Breakthrough Designation, Biocogniv submitted real world evidence (RWE) data demonstrating not only the diagnostic performance of its Sepsis aiMarker™, but also its clinical utility. For example, as early as in the first 3 hours of presentation to the ED, the device was able to flag nearly 80% of patient encounters that subsequently developed severe sepsis and yet did not satisfy one of the classic signs of sepsis at the time of prediction – the so-called Systemic Inflammatory Response Syndrome (SIRS) criteria. Similarly, in that same time window, the product was able to flag over 70% of encounters that received a late sepsis intervention, i.e. more than 3 hours after the time of prediction. For a condition where every hour of delay in recognition and intervention is associated with substantial increases in mortality, these numbers reviewed by FDA point to the potential for the product to save numerous lives.
Artur Adib, PhD, CEO of Biocogniv, stated, “We are honored to receive this prestigious Breakthrough Designation from the FDA. This recognition highlights the potential of our Sepsis aiMarker™ to dramatically impact sepsis diagnosis and management, ultimately improving patient outcomes and reducing the burden on healthcare systems. In view of FDA’s recent guidance on the regulation of clinical decision support software, this designation is a significant milestone for the company. We look forward to continuing our work with the Agency to get this important product in the hands of hospital providers.”
About Biocogniv Inc
Biocogniv Inc is the world’s first digital diagnostic company tackling time-critical conditions using artificial intelligence on top of laboratory data. The company’s software platform, clinOS™, is already connected to multiple hospital systems across the US, processing thousands of laboratory tests per day, and its pipeline of aiMarkers™ includes diagnostic and predictive tools for sepsis, acute kidney injury, GI bleed, and others. For more information, please visit http://www.biocogniv.com.