Ann: BlastX approved by TGA for sale in Australia, page-3

Meep Meep!

Highlights

• BlastXTM antimicrobial wound gel cleared by the Therapeutic Goods Administration for sale in Australia

• Commercial sales in Australia to commence in June 2021

Sydney, Australia 27 May 2021, Next Science Limited (ASX:NXS) (Next Science / Company) is delighted to announce that BlastXTM antimicrobial wound gel has been cleared by the Therapeutic Goods Administration (TGA).

This TGA clearance allows Next Science to sell BlastXTM in Australia for use as a hydrogel wound dressing on all open wounds.
The product has shown excellent efficacy on non-healing wounds such as diabetic foot ulcers, pressure sores, venous leg ulcers and non-healing surgical wounds for example for patients who have undergone a caesarian section operation.

First sales in Australia are expected to commence in June 2021 directly from Next Science.

As previously announced, Next Science regained the global distribution rights to BlastXTM from 3M in April 2021.
BlastXTM has been sold in the United States since 2017 under an FDA 510(k) clearance.
The product has also been cleared for sale in the European Union and the UK under a CE Mark clearance received in December 2020.

BlastXTM is an antimicrobial wound gel based on Next Science's patented, non-toxic, biofilm-disrupting XbioTM technology. BlastXTM deconstructs the bacterial biofilm; the gel envelops and eliminates the bacteria and then defends from recolonisation while maintaining a moist wound environment conducive to healing.
The product is ideal for the treatment of non-healing wounds such as diabetic foot ulcers, bed sores (pressure ulcers) and venous leg ulcers as well as preventing infections in acute wounds from trauma and surgical incision sites.

BlastXTM can be used in hospital, pre-hospital and clinic environments as well as home care.

Chronic wounds such as ulcers continue to be a major health issue for patients across the global community.
They are very difficult to treat, increase pain and suffering, cause a decline in quality of life, increase mortality and add considerable costs to healthcare systems and individuals.



In a study conducted independently by Dr. Randall Wolcott at the South West Regional Wound Care Center in Lubbock Texas, USA and published in 2015, it was shown that combining Next Science's BlastXTM with custom antibiotics increased the extent of chronic wound closures by 40% in 4 weeks based on a 45 patient, four week, prospective, randomised, controlled trial compared with customised antibiotic treatment alone1.

Figure 1 BlastX comparison with customised antibiotics

* Defined as 50% wound closure in 4 weeks

Next Science's Managing Director, Judith Mitchell, commented: “I am delighted that we can offer this proven product to healthcare professionals and patients in Australia as we continue to pursue our mission to heal patients and save lives worldwide by reducing the impacts of biofilms on human health.”

Approved and authorised for release by Next Science's Managing Director.