CBRN Burn and Blast Medical Countermeasures Program

The Philips Lumify handheld ultrasound received another 510(k) clearance in February 2021. Clinically, B-lines are lung ultrasound artifacts detectable in patients with a variety of pulmonary conditions and diseases such as pneumonia, pulmonary edema, lung contusion, and acute respiratory distress syndrome (ARDS). This 510(k) under the Philips-BARDA contract adds an algorithm to the platform for automatic detection and counting of B-lines from lung ultrasound images and extends the use of Lumify for evaluation of ‘lungs’ as part of the indications for use statement.

BARDA’s work with Philips on B-lines continues with a clinical trial currently enrolling COVID-19 patients to assess effectiveness of the approved B-lines feature algorithm specifically in COVID-19 patients. This trial will enable Philips to train the B-lines algorithm on a COVID-19 dataset to assess B-line severity in COVID-19 patients.

AVITA Medical’s RECELL^® System is a point-of-care care regenerative technology used to treat thermal burns. RECELL was approved the by U.S. Food and Drug Administration in September 2018. This breakthrough technology ended a 21 year hiatus in product innovation and development in the area of burn care and autograft sparing products.

The RECELL System combines a small autograft with an enzyme solution to create Spray-On Skin™. This process is rapid and applied during surgery. In many cases, the process can eliminate the need to harvest autografts from a patient. The RECELL System is used by trained healthcare professionals to treat burns seen frequently in our nation’s burn centers. Since approval, the RECELL system is increasingly becoming integrated into routine care and will help build emergency preparedness in the event of a mass casualty incident.

After successful development and clinical trials, the Accuro^® XV will be an ultrasound based, radiation free, rapid fracture detection device. Designed as a device capable of computer-aided 3D imaging, it will enable decision-assist capability for fracture triage.  By automating image acquisition and interpretation, Accuro XV will support just-in-time training that will help optimize user success in clinical evaluations and bolster adoption in hospital and emergency room settings.

The Accuro XV device has the potential to reduce the bottleneck in delivery of care by fast-tracking care for the large number of low severity, simple fractures and sprains, which could reduce the number of patients being unnecessarily referred for X-rays for preliminary diagnosis and free up imaging and physician resources.

NovoSorb^® BTM is a synthetic, biodegradable and biocompatible device designed to facilitate the dermis to grow within a patented polyurethane matrix. Once BTM integrates into a healing wound, its overlying sealing membrane is removed, leaving a fully vascularized dermis ready for definitive closure using a method of the physician's discretion such as with a split-thickness skin graft.

The investigation device exemption (IDE) pivotal trial is a multi-center, randomized, adaptive-design to compare the safety and effectiveness of NovoSorb^® BTM to standard of care (SOC) in patients with severe full thickness burn injuries. The study was approved by the US Food and Drug Administration (FDA) in November 2020.

StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen) will provide burn surgeons with a new biologic treatment to reduce or eliminate autografting in adults with deep-partial thickness burns. Clinical trials of StrataGraft demonstrated autograft sparing and durable wound closure at three months and a safety profile comparable to that of autografts. StrataGraft was granted FDA approval in October 2021 after a multi-year partnership with BARDA.  This success highlights the value of public-private partnerships to drive medical countermeasures from bench to bedside.