ASX Health Wrap: Resonance gains ground, with sights set on FDA approval for LiverSmart
Health & Biotech
Health & Biotech
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Here are the biggest ASX healthcare plays in early trade, Wednesday October 13.
The medical imaging company released an update on its LiverSmart device, which is now undergoing “final quality and verification checks” before RHT submits it for approval by the US Food & Drug Administration (FDA) in “the coming weeks”.
The aim of the LiverSmart platform is to remove the need for multiple MRI appointments, by combining two of the company’s products — FerriSmart and HepaFatAI — into a “single multi-parametric MRI session”.
Both FerriSmart and HepaFatAI have been cleared by regulators, and Resonance said FDA clearance for LiverSmart “is expected to take approximately 45 days from submission, or longer if the FDA have queries”.
RHT managing director Mitchell Wells said LiverSmart is an evolution of its existing technology suite that will deliver a more comprehensive liver analysis while removing the need for multiple appointments.
The company added that it’s also investigating whether LiverSmart may be eligible for two new United States (Category III) Current Procedural Technology (CPT) codes which will become active on January 1.
Within the US health system, CPT codes start at Category III and are upgraded to Category I if there’s sufficient reporting, “at which point they become permanent and reimbursable”, Resonance said.
If approved, US hospitals and MRI centres will be able to apply the codes when LiverSmart is used for clinical purposes — a key element in demonstrating a clinical need for the service.
That in turn opens a pathway to “widespread payer and insurer reimbursement” for LiverSmart in the US market, the company said.
Shares in RHT were up by around 8% in morning trade to 9.4c.
PAR has released top line results from the pre-clinical study of its pentosan polysulfate sodium (PPS) treatment in the influenza model of acute respiratory distress syndrome (ARDS).
The results showed that PPS treatment reduced lung inflammation, improved oxygen saturation and reduced weight loss compared to standard treatment.
PAR’s goal is to commercialise PPS as a late-stage treatment of pain associated with musculoskeletal disorders due to various factors such as injury or ageing.
The study on mice showed “statistically significant reductions in the levels of complement 3a, a marker of tissue damage in the lung”, as well as other inflammatory biomarkers in mice affected with influenza, PAR said.
The next step for PAR is to validate these findings on the pathway to a possible clinical trial.
The pre-clinical results “suggest that PPS may have a role to play in the acute and chronic phases” for people with ARDS, Paradigm CEO Paul Rennie said.
Shares in Paradigm edged higher to around $1.90 in morning trade.
Shares in the clinical stage oncology company rose by ~9% in morning trade following the release of its October investor presentation.
The company provided some detailed analysis of OmniCAR — its platform solution for companies developing CAR-T cell therapies targeting more effective detection of cancer antigens.
Prescient’s goal for the platform is to target “huge market opportunities” for the improved treatment of HER2+ (ovarian, breast and gastric) cancers.
Shares in the PTX have climbed by more than 200% since January 1.