• The US FDA has completed inspection of Cyclopharm’s facility
  • Next Science says XPERIENCE reduces knee inflammation
  • Anteris takes one step further toward receiving FDA approval


Cyclopharm confident of FDA timeline after inspection

Cyclopharm (ASX: CYC) advised that the US FDA has completed site inspection of the company’s manufacturing facility at Kingsgrove, NSW, which took place between 31 July and 8 August.

While the inspection report will require further internal FDA review before it is final, Cyclopharm said it was pleased about how things went.

The company is also confident that its FDA goal review date of 29 September remains on track.

Cyclopharm believes the FDA approval will create an initial addressable market in the US of around US$180 million per annum in the diagnosis of Pulmonary Embolism (PE).

This estimate does not include the exponentially larger potential for Technegas’ application for Beyond PE indications, including the diagnosis and management of chronic obstructive pulmonary disease, lung cancer, asthma and long Covid.

Technegas is an ultra-fine dispersion of radioactive labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,700 degrees Celsius.

“Technegas will be regulated in the United States as combination product. The inspection covered both the drug and device elements of Technegas,” said Cyclopharm CEO James McBrayer.


Next Science says XPERIENCE reduces inflammation

Next Science (ASX:NXS) says a knee study has found potential anti-inflammatory benefit for XPERIENCE, the company’s advanced surgical irrigation solution.

Dr Andrew B. Wickline has released the findings of a pilot study which demonstrated 54% lower inflammation within 14 days compared to the common reference standard.

The study was a 60-patient double-arm study incorporating Dr Wickline’s current strategies to reduce inflammation.

The first group of patients received a 3-minute sterile dilute iodine lavage (current industry standard); the second group received Next Science’s XPERIENCE.

The study concluded that using XPERIENCE resulted in 5-degree increase in range of motion, and a 10%-20% improvement in pain score.

Next Science says the findings are encouraging, and warrant a further multi-centre study with a larger patient cohort and additional surgeons.


Anteris takes one more step toward FDA approval

Anteris Technologies (ASX:AVR) reported that its DurAVR Transcatheter Heart Valve (THV) was used to successfully treat patients as part of the DurAVR THV Early Feasibility Study (EFS or the Study) in the US.

The EFS is an essential step towards receiving FDA approval in the US and potential commercialisation.

“The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis,” said Dr Azeem Latib, who performed the first group of procedures.


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