The Resonance Health Ltd (ASX: RHT) share price rocketed more than 16% today before closing 5% higher.
The booming share price moves come after the company emerged from a trading halt late this morning. This follows the release of an announcement on its medical device.
What did Resonance Health report to send its shares higher?
In a late morning ASX release, Resonance Health announced that it has received Australian Therapeutic Goods Administration (TGA) approval for its HepaFat-AI device. The device provides fully automated artificial intelligence software to assesses liver fat.
With the TGA approval, Resonance Health can now supply its device across Australia. The company had already received clearance from the United States Food & Drug Administration (FDA) in early December.
HepaFat-AI automatically analyses magnetic resonance imaging (MRI) data. Subsequently, this data assesses liver fat in patients to give physicians a new tool in assessing patients with confirmed or suspected fatty liver disease.
According to Resonance Health, doctors can use the device to monitor patients for a number of issues. This will include patients in weight loss programs and screening the livers of live donors for transplant suitability. Additionally, the device will monitor patients who have or are believed to have non-alcoholic fatty liver disease (NAFLD) or the more serious subtype, non-alcoholic steatohepatitis (NASH).
Resonance Health reports that "NAFLD affects up to 2.3 billion people, a figure expected to grow year-on-year. Of these, about 470 million people (or 20%) will develop NASH". NASH can lead to serious health consequences, including liver failure.
The company plans to market the device to radiologists and physicians involved in the routine clinical diagnosis and management of patients with confirmed or suspected fatty liver disease. However, it also sees a market with pharmaceutical companies engaged in NASH drug development.
Resonance Health says its work in machine learning to develop assistance tools for the medical sector is continuing.
Share price snapshot
Over the past 12 months, Resonance Health shares are up 2.5%. That compares to a 1% loss on the All Ordinaries Index (ASX: XAO).
Year-to-date, the Resonance Health share price is down 10.8%.