• Telix granted approval in Canda
  • EBR Systems halt trading, pending a manufacturing change announcement

 

Telix Pharma (ASX: TLX) announced that Health Canada has approved lead product Illuccix for use in staging and re-staging prostate cancer and localising tumour tissue in recurrent prostate cancer.

Illucix is a kit for the preparation of gallium (68Ga) gozetotide, a positron emission tomography (PET) agent used in the diagnostic imaging of men with prostate cancer.

It was granted a TGA approval in early November, making it the first commercially approved PSMA-PET imaging agent available in Australia.

Health Canada is the third regulatory body worldwide to approve Illuccix, which is also commercially available in the United States.

Illuccix will be made available in Canada to physicians and eligible patients through Telix’s partner, ISOLOGIC, whose distribution network services 265 hospitals and clinics nationwide.

According to the Canadian Cancer Society, prostate cancer is the most common cancer and the third-leading cause of death from cancer among Canadian men.

More than 24,000 men in Canada are estimated to be diagnosed with prostate cancer this year, and 4,600 will die from the condition.

“PSMA PET imaging has been one of the most important developments in prostate cancer detection in recent years, and we are very pleased that we can now bring this important diagnostic imaging agent to physicians and their patients across Canada,” said Kevin Richardson, CEO Telix Americas.

Telix share price today:

 


 

EBR keeps market in suspense

Pacemaker specialist EBR Systems (ASX:EBR) has asked for its shares to be temporarily suspended this morning, pending an announcement on a potential manufacturing change to its product.

EBR has been working on a new kind of “leadless” pacemaker system called WiSE, and has the backing of major US funds.

This proprietary WiSE technology was designed to eliminate the need for a lead to the left ventricle in Cardiac Resynchronization Therapy (CRT), and the associated complications.

EBR aims to expand this technology into other applications in the $11 billion cardiac rhythm management market.

The US FDA has agreed for EBR to include these leadless pacemakers as a co-implant in the company’s pivotal SOLVE-CRT IDE clinical trial.

EBR says today’s announcement is not expected to affect the results or completion date of the SOLVE study, which remains on track for H1, 2023.

 

EBR Systems share price today:

 

 

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