FDA approves AVITA’s RECELL GO System

Wound care medical company, AVITA Medical ASX:AVH), surged +13% this morning after receiving an FDA approval for its latest product, the RECELL GO System.

The RECELL GO system basically harvests a small sample of a patient’s skin cells, typically taken from a healthy area of skin. These cells are then processed to create a suspension of Spray-On Skin Cells.

By using less donor skin, patients experience reduced pain and faster closure, with enhanced aesthetic results at the donor site, with fewer procedures needed for complete wound closure.

This simplifies the tasks for medical professionals, making their workflow smoother and more efficient, while also guaranteeing the best possible yield and viability of cells.

CEO Jim Corbett believes this FDA approval will revolutionise wound care, making treatment more accessible and effective.

“FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” said Corbett.

“By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology.”

The RECELL GO system will launch in top burn treatment centres in the US initially, with plans for broader availability in the future.


Telix’s shares jump after sharing positive trial results

Telix Pharmaceuticals (ASX:TLX) jumped 10% this morning after sharing more positive results from the ProstACT SELECT trial.

This trial is testing TLX591, a therapy for metastatic castrate-resistant prostate cancer (mCRPC) that targets PSMA-positive tumours.

The study looks at how well TLX591 works by comparing PET scans with treatment doses.

So far, the study shows TLX591 could help patients live longer without their cancer getting worse.

The latest data reveals a median radiographic progression-free survival (rPFS) of 8.8 months, indicating promising potential for TLX591 in treating this patient group.

The trial involved 23 patients with progressive mCRPC who received two intravenous infusions of TLX591, spaced 14 days apart.

Patients in the trial have varying disease burdens, with some having already undergone two prior lines of therapy.


EZZ enters new lucrative Asian markets

Meanwhile, EZZ Life Science (ASX:EZZ) has entered into a significant sales agreement with Pinehills (Hong Kong) Limited, spanning five years.

Under the terms, Pinehills has committed to procuring EZZ-branded products worth at least $15 million within the initial 12-month period.

Over the duration of the agreement, the annual purchase volumes are set to escalate by a minimum of 10% each year.

EZZ says the deal represents a strategic move for EZZ, as it will facilitate the expansion of its product distribution into key markets such as China, Vietnam, and other Southeast Asian markets.

This expansion into new territories presents significant growth opportunities for EZZ.


PharmAust has a new CEO and CSO

And finally, PharmAust (ASX:PAA) has made key changes to its leadership team, reappointing Dr Michael Thurn as managing director and CEO, and welcoming Dr Nicky Wallis as chief scientific officer.

Dr Wallis, a neuroscientist with extensive global experience, will lead the evaluation of monepantel for potential use in treating neurodegenerative diseases.

These appointments mark a significant shift for the company as it aims to become a global leader in this field.