ASX Health Stocks: Singular Health pulling out all the stops to make first US sale
Health & Biotech
Health & Biotech
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Medtech company Singular Health (ASX:SHG) announced the appointment of Kelyniam Global, a US-based patient-specific medical device manufacturer, as its US-based agent.
This is a key appointment and an important pre-requisite to satisfy the final regulatory requirement, prior to Singular Health making sales in the US.
Singular believes that Kelyniam is very well positioned to both provide continual feedback on the 3Dicom Surgical software and AI cranial implant tool.
The 3Dicom Viewer was developed as a cross-platform application which allows end-users to interact with standard 2D medical images such as MRI and CT scans in 3D.
It was designed for use by medical practitioners of all specialities, including radiologists and dentists, for the diagnostic viewing of Digital Imaging and Communication in Medicine (DICOM) scans.
Plus, it was developed for a post-COVID clinical environment, and features telehealth functionality with in-built remote control, VoIP calling, and text chat for remote collaboration.
Singular also announced that CG1 Solutions, a Florida-based medical IT consulting services company providing solutions to US hospitals, has joined the recently formed 3Dicom Partner Program.
CG1 Solutions will be marketing both the non-diagnostic and diagnostic 3Dicom software offerings to their existing customer base, and conducting joint marketing activities with Singular Health at upcoming tradeshows and conferences.
These key appointments follow presentations by Singular Health’s COO, James Hill, and Dr Guan Tay, executive director of Research and Innovation, in various conferences earlier this year.
The appointment of a US-based agent is required by the FDA for all foreign entities, to act as the in-country point of contact and liaison on regulatory filings, product updates and other requirements, prior to making sales in the US market.
The FDA510(k) review process involves an initial 90-day review period, which can be extended should the FDA have additional questions or discussions arising from the dossier.
Firebrick Pharma (ASX:FRE) announced that it has received an RDTI (R&D Tax Incentive) payment of $1,081,266 for eligible R&D expenditure incurred in 2021/22.
The incentive payment relates to the $2.2 million in reported R&D costs in the FY22 year, primarily associated with the company’s two ongoing clinical trials.
Firebrick is currently conducting a Phase 3 trial of Nasodine Nasal Spray as a treatment for the common cold, and a Phase 2 trial of Nasodine in COVID-19.
“We welcome the valuable injection of non-dilutive funds from the R&D tax incentive,” said Dr Peter Molloy, executive chairman of Firebrick.
“With most of the ongoing trial activity occurring before 30 June 2023, we expect our R&D tax receipt for the coming year to be larger.”