• Avita receives US FDA approval for RECELL
  • Emyria and Antisense to progress trials
  • Beamtree has won a key contract in Canada

 

Avita Medical (ASX:AVH) announced that the US FDA has signed off on a premarket approval (PMA) for the use of its RECELL System to treat full-thickness skin defects.

The AVH share price surged by 14% on the news.

The supplementary approval expands the use of RECELL in full-thickness skin defects, such as wound injuries after traumatic avulsion (e.g., degloving), surgical excision (e.g., necrotizing soft tissue infection), or resection (e.g., skin cancer).

Avita says the grant has dramatically expanded the company’s market opportunity by at least five times.

The RECELL System was first approved in the US for the treatment of severe burns in 2018. It’s an autologous cell harvesting device that prepares, produces, and delivers a regenerative cell suspension, Spray-On Skin Cells, using a small amount of a patient’s own skin.

The Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed.

Currently, skin grafting is the standard of care for full-thickness skin defects, but significant pain, delayed healing, risk of infection, and scarring are associated with donor site wounds.

RECELL meanwhile, demonstrated that less skin from the patient is required to repair and close the wound without compromising the healing outcomes relative to convention autografting.

 

Emyria and Antisense progress clinical trials

Emyria (ASX:EMD) surged 12% this morning after being granted a Human Research Ethics Committee (HREC) approval to commence a pivotal MDMA-assisted therapy trial for Post-Traumatic Stress Disorder (PTSD).

The study will be conducted at the PAX Centre, one of Australia’s leading psychiatric services specialising in the treatment of complex trauma.

Emyria says MDMA-assisted therapy has shown promising results for patients with PTSD. The use of MDMA-based therapies to treat mental conditions has gained attention after the TGA allowed MDMA to be used on PTSD patients starting July 1.

Antisense Therapeutics (ASX:ANP) meanwhile announced a significant milestone in the development of its ATL1102 drug for Duchenne muscular dystrophy (DMD).

Recruitment has commenced in the Phase IIb trial of ATL1102 in non-ambulant boys with DMD, and the first participant has been dosed in Turkey.

 

Beamtree wins key contract in Canada

Medtech company Beamtree Holdings (ASX:BMT) has won a key contract with the Provincial Health Services Authority (PHSA) in British Columbia, Canada.

Under the deal, Beamtree’s PICQ technology will be used to review and support the enhancement of the quality of hospital data.

The revenue of the new contract is around $0.5m, all expected in the next financial year and represents the company’s first major contract in North America.

 

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