• EBR Systems warns of delay in FDA approval
  • Consultant says no efficacy conclusions can be drawn from Firebrick’s 2023 trial data
  • Regis Healthcare acquires Queensland aged care provider, CPSM

 

EBR warns of FDA delay

Cardiac disease specialist, EBR Systems (ASX:EBR), tumbled 11% this morning after providing a status update regarding the company’s Premarket Approval Application (PMA) to the US FDA.

EBR is developing the world’s only wireless cardiac pacing device for heart failure, and has previously announced positive results from iSOLVE-CRT, a trial assessing the safety and clinical efficacy of the WiSE CRT System.

EBR says it has submitted four out of five required modules for the PMA submission (as previously disclosed), and now expects to submit the final module in Q3 2024.

Previously, the company said it expected to receive FDA approval by the end of 2024, but now, it has postponed that target to Q1 of 2025.

The updated timeline is a result of new information from an expert consultant involved in the design verification testing required for the final module.

This testing schedule has been expanded by a short period, meaning the final module will not be able to be submitted in Q1 2024.

However, EBR expects the new testing schedule to increase the strength of the company’s PMA submission, and place EBR in a better position to receive FDA approval without further delay.

“We believe that the benefits from additional testing have the potential to demonstrate increased durability and longevity of the WiSE CRT device, resulting in a more robust PMA submission,” said John McCutcheon, EBR Systems’ president & CEO.

“Given we have already submitted four modules to date, we are confident in this updated timeline and remain well capitalised through to the initial commercialisation phase.”

 

Firebrick’s 2023 Trial data shows ‘inaccuracies’, says expert

Firebrick Pharma (ASX:FRE) rose 8% despite a setback relating to its Nasodine Nasal Spray product.

The company said it has been conducting an investigation into the results of its 2023 Phase 3 common cold trial.

Recently, the company engaged an expert in data analysis to independently review that 2023 Trial data, and for comparative purposes, the data from the first Phase 3 trial (2019 Trial).

The project scope was restricted to efficacy data from Australian sites only, as this permitted a direct comparison between the two trials.

In summary, the expert analysis concluded that the 2019 Trial placebo results conformed strongly with the human model.

However, the expert also concluded that the 2023 Trial points to inaccuracies in trial efficacy data, and no efficacy conclusions therefore can be drawn.

“The model outcomes strongly indicate major inaccuracies in the 2023 trial data, casting doubt on its reliability,” said the expert report.

“This raises significant concerns about using the 2023 data to draw conclusions about the efficacy of the active versus placebo in that trial.”

Despite this setback, Firebrick said it remains committed to the development of Nasodine for the common cold, but will now consider alternative study designs that could avoid the problems experienced in the 2023 Trial.

There are no immediate plans to repeat the 2023 Trial.

 

Regis acquires aged care provider

Meanwhile, Regis Healthcare (ASX:REG) has entered into a binding agreement to acquire CPSM, a privately-owned residential aged care provider for net consideration of $74.2 million.

CPSM owns five high quality residential aged care homes in South-East Queensland with 644 beds. The company’s FY23 operating revenue was $67 million, and underlying EBITDA was $13 million.

The purchase price represents a multiple of 5.7x FY23 underlying EBITDA or approximately $115,000 per bed.

Regis said the transaction will be funded from existing debt facilities.

 

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