AOTI announces FDA clearance of NEXATM NPWT system for use in home care setting

Extension to Indications for Use follows submission of results from a human factors study evaluating the safe and effective use of the device in the home care setting.

The labelling for the device now includes the extended indications of ‘for use in acute, extended and home care settings …’ In the US, the initial target market for the System has been long term care. This new clearance will allow for marketing of the system across all care sites, including into the expanding home care setting. The home care setting indication already exists in the international approvals for the device.

The NEXATM NPWT System was developed to provide clinically proven negative pressure therapy for patients with chronic or acute wounds, with a simpler, more portable and affordable device. AOTI says the NEXATM NPWT System is differentiated from other systems on the market as it is the only multi-week disposable NPWT system that delivers the performance of traditional NPWT, at a lower cost.

AOTI markets two product families in the US and International markets. Its proprietary TWO2 therapy system is already a leader in the topical oxygen wound therapy segment according to the company, which recently acquired the complementary NEXATM NPWT platform to add to this offering. The total advanced wound care market segment that the Group’s products address is estimated to be 12 billion USD says AOTI.

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