NEXATM NPWT program has been approved by the FDA, according to AOTI.

AOTI, INC. has announced that the FDA has issued 510 ( k ) Clearance ( K241515 ) for the Company’s NEXATM Negative Pressure Wound Therapy ( NPWT ) System to include its use in the home care setting.

Long-term care was the first target market for the System, but the system now has extended indications for” for use in severe, extended, and house care settings.” This new certification will enable the system to be promoted across all treatment locations, including the advancing apartment care setting. The device’s worldwide approvals now contain the indicator for “home care setting.”

With a less expensive, more convenient, and more accessible device, the NEXATM NPWT System was created to offer patients with chronic or severe wounds scientifically proven negative pressure therapy. The NEXATM NPWT System, according to AOTI, is unique among other available multi-week throw-away NPWT systems because it is the only one with lower prices and the same functionality as standard NPWT.

In both domestic and international markets, AOTI sells two solution families. The organization, which lately acquired the companion NEXATM NPWT platform to complement its offering, claims that its proprietary TWO2 therapy system is now a leader in the dermal oxygen wound therapy market. According to AOTI, the Group’s products address a business section containing 12 billion USD of sophisticated wound care.

Dr. Mike Griffiths, president and CEO of AOTI, INC., expressed his delight that the FDA has granted clearance for the company’s NEXATM NPWT machine, bringing it in line with the international approvals we now have.

We continue to think that the NEXATM NPWT System has the ability to move patients more effectively from the doctor to the area and lower the chance of re-admission as a result of wound complications. I want to thank the whole AOTI team for their hard work and diligence in getting this crucial clearing so quickly.

AOTI recently raised net proceeds of 13.5 million GBP ( 17.5 million USD ) through an initial public offering (” IPO” ) on the AIM market on 18 June 2024.