Next Science Limited (ASX:NXS) has received CE Mark approval for its BlastX antimicrobial wound gel.
This allows Next Science to apply to sell BlastX in each market in the European Union and the UK. BlastX is the second Next Science product to receive a CE Mark, with Bactisure (distributed by Zimmer Biomet globally) receiving a CE Mark in March this year.
The BlastX antimicrobial wound gel based on Next Science’s patented, non-toxic, biofilm- disrupting Xbio technology. BlastX deconstructs the bacterial biofilm, the gel envelops and eliminates the bacteria and defends from recolonisation while maintaining a moist wound environment conducive to healing.
The product is ideal for the treatment of non-healing wounds (Chronic Wounds) such as diabetic foot ulcers, bed sores (pressure ulcers) and venous leg ulcers as well as preventing infections in acute wounds and surgical wounds. Chronic Wounds continue to be a major health issue for patients in all countries in the world. They are very difficult to treat, increase pain and suffering, cause a decline in quality of life and increase mortality.
In a study conducted at the South West Regional Wound Care Centre in Lubbock Texas, USA and published in 2015, it was shown that combining Next Science’s BlastX 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 alone.
Managing Director, Judith Mitchell, said that as a collective, the Advanced Wound Care market in Europe is estimated to be valued at US$2.8 billion per annum and is growing at 4.6% per annum.
BlastX is currently sold by 3M in the US market with FDA 510(k) clearance for sale as indicated for use on patients with:
- Stage I – IV pressure ulcers
- Partial and full thickness wounds
- Diabetic foot and leg ulcers
- Post-surgical wounds
- First and second-degree burns
- Grafted and donor sites
BlastX is approved in the various markets in the European Union and UK for these same indications.
The receipt of a CE Mark approval for BlastX represents the successful conclusion of three years of work and marks a major milestone for Next Science as we pursue our mission to heal patients and save lives worldwide by reducing the impacts of biofilms on human health. The CE Mark is a minimum requirement for many other jurisdictions so we can now work on further approvals,” Ms Mitchell said.