Spectral AI, Inc. (Nasdaq: MDAI) today announced that it has signed a Memorandum of Understanding (“MOU”) with global medical device company and burn wound therapy leader PolyNovo Limited (“PolyNovo”) under which the companies will collaborate to assist Spectral AI in a potential limited deployment of its DeepView System for burn indication in Australia.
Under the MOU, PolyNovo will support Spectral AI’s application to the Australian Special Access Scheme (SAS) with an ultimate goal of allowing Spectral AI to deploy up to two DeepView Systems at the Royal Adelaide Hospital and The Alfred Hospital in Melbourne to lay the groundwork for the Company’s eventual commercial roll-out based on clinician evaluations and experiences.
The SAS was introduced by Australia's Therapeutics Goods Administration in recognition that there are circumstances where patients need access to certain medicines, medical devices, or biologics that are not already included in the Australian Register of Goods.
Spectral AI’s DeepView™ System is a predictive device that offers clinicians an immediate and objective assessment of a burn wound’s healing potential prior to treatment or other medical intervention. The image processing algorithm employed by the DeepView™ System utilizes multispectral imaging that is trained and tested against a proprietary database of more than 340 billion clinically validated data points. The DeepView™ System is non-invasive and cart-based, allowing for exceptional mobility within the healthcare setting.
PolyNovo develops and sells patented, bioabsorbable, synthetic, polymer technology used to reconstruct complex wounds, including deep dermal and full‐thickness burns, and aid the body in generating new tissue. PolyNovo’s FDA-approved NovoSorb® BTM (Biodegradable Temporising Matrix) and NovoSorb® MTX product portfolio is available in 37 countries around the world.
“PolyNovo’s innovative therapies have proven to be life changing and it is one of the world’s most respected providers of burn treatment solutions,” said Peter M. Carslon, Chief Executive Officer of Spectral AI. “Understanding when it is appropriate to apply these therapies is paramount to realizing improved patient outcomes. We believe that the Day One wound healing assessment provided by the DeepView™ System empowers clinicians with the knowledge to make an informed and rapid diagnosis when time is of the essence. We are honored to work with an established market leader as we take these initial steps to familiarize clinicians in Australia with Spectral AI’s technology, support their life-saving work, and help to elevate the level of patient care.”