EndoQuest Robotics will advance its system to clinical trials following the IDE award. Image credit: Jeppe Gustafsson / Shutterstock.

AOTI’s NEXA Negative Pressure Wound Therapy (NPWT) system has been granted 510(k) clearance to extend its indications of use by the US Food and Drug Administration (FDA).

Following the FDA clearance, the label of the Ireland-headquartered device company’s NPWT system will read for use in acute, extended and home care settings, enabling it to be marketed for care sites including home care settings in the US.

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The home care setting indication already exists in the international approvals for the device.

The FDA 510(k) clearance of AOTI’s NPWT system was based on the submission of results from a human factors study that evaluated the safe and effective use of the device in the home care setting.

NEXA NPWT was developed to provide negative pressure therapy for patients with chronic or acute wounds in the form of a more portable and affordable device.

According to AOTI, the system is currently the only multi-week disposable NPWT system that delivers the performance of traditional NPWT systems at a lower cost.

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AOTI debuted on the AIM market, a sub-market of the London Stock Exchange, in June 2024 with a market cap of £140m, and raised £35.1m via its initial public offering (IPO).

According to GlobalData’s Market Size & Growth database, the global NPWT market was worth around $2.8bn in 2023. Growing at a CAGR of 2.7%, it is projected to reach a valuation of around $3.89bn by 2033.

GlobalData’s Product Pipeline database indicates that there are 13 NPWT devices in various stages of development globally.

Elsewhere in NPWT, Smith+Nephew launched its RENASYS EDGE NPWT system in the US in April 2024 with the aim to improve home-based care for patients with chronic wounds, including ulcers.

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