Spectral MD Holdings Ltd (AIM:SMD) has highlighted its strong cash position in its audited results for the year ended 31 December 2022, with cash on hand of US$14.2mln at the year-end (2021: US$16.1mln)
The predictive analytics company, with proprietary AI algorithms and optical technology for faster and more accurate treatment decisions in wound care, also saw its R&D revenue rise by 67% to US$25.4mln (2021: US$15.2mln) funding its Burn indication development as well as the development of handheld prototype DeepView SnapShot.
In the results statement, Wensheng Fan, chief executive officer of Spectral MD, commented: "We are pleased with the rate of progress and development made in 2022 and have delivered strong operational results for both our Burn and DFU indications. Spectral MD also exceeded financial expectations during the period through effective cost management. Importantly, this will allow the company to increase investment in 2023 to drive forwards our commercialization strategy for DFU.
"Our immediate strategy remains focused on commercialization planning activities. We are in regular communication with BARDA to further develop our infrastructure readiness for a federal-level commercial contract and look forward to building upon our strong momentum, whilst continuing to collaborate with BARDA and our clinical partners to scale and advance our transformative technology."
Among the company's operational highlights in full-year 2022, its US Burn Indication was supported by BARDA (Biomedical Advanced Research and Development Authority) and it was awarded an US$8.2mln contract expansion to accelerate the commercialization pathway for DeepView.
The company saw its Burn Image Assessment Study (BIAS) findings reinforce DeepView's value proposition and clinical need showing that in 31% of healing wounds Emergency Department (ED) physicians incorrectly selected immediate referral to a burn center or surgery, while in 74% of non-healing wounds ED physicians failed to select immediate referral or surgery.
Adult enrollment in Burn AI training study was also completed in 2022, and since the year-end, pediatric enrollment in Burn AI training study has been completed in February 2023.
A federal contract opportunity has also been initiated for Spectral MD's Health and Human Services Burn Wound Imaging technology since the year-end, and the company has responded with a proposal and will be evaluated for contract fulfillment.
DeepView AI-3D has also been developed to capture millimetric-level wound size measurement accuracy with single image acquisition without requiring external reference markers for seamless integration into the clinical workflow.
For its Diabetic Foot Ulcer (DFU) Indication, the company said its clinical study is on track to complete enrollment by end of Q2 2023 to support DeepView AI-DFU FDA regulatory submission in 2023. Since the 2022 year-end, Spectral MD has reported successful interim results showing AI diagnostic accuracy improvement from 81% to 86%.
The company noted that its US clinical study is on track with additional sites being incorporated in Q1 2023, providing data to support FDA and UKCA regulatory submissions, and it has initiated an EU clinical study with the Royal College of Surgeons in Ireland to be conducted at Connolly Hospital in Dublin.
During the year, Spectral MD strengthened its senior leadership team with four key appointments: Niko Pagoulatos, chief operating officer; Christine Marks, VP Marketing & Commercialization; Vince Capone, general counsel & company secretary; and Mary Regan, VP of Clinical Affairs.
The company also won the Best Technology Award at the European Mediscience Awards in June 2022.