REG - AOTI, Inc. - US FDA 510(k) Clearance of NEXATM NPWT System

AotiAnnouncement

29/07/2024 07:00

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RNS Number : 1385Y  AOTI, Inc.  29 July 2024

29 July 2024

 

 

AOTI, INC. (the "Company" or "Group" or "AOTI")

 

AOTI announces US FDA 510(k) Clearance of NEXA(TM) NPWT System for use in the
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

 

AOTI, INC., a medical technology group with a mission to help all people with
chronic conditions get back to living their lives to the fullest, through the
durable healing of wounds and prevention of amputations, is pleased to
announce that the US FDA has issued 510(k) Clearance (K241515) for the
Company's NEXA(TM) Negative Pressure Wound Therapy (NPWT) System to include
its use 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 this unique 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 NEXA(TM) 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. The NEXA(TM) 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 TWO(2)(®) therapy system is already the global market-leader in
the topical oxygen wound therapy segment and the Company recently acquired the
complementary NEXA(TM) 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.(1)

 

Dr. Mike Griffiths, Chief Executive Officer and President of AOTI, INC.
commented: "I am delighted that the FDA has granted clearance for our NEXA(TM)
NPWT device such that it can now be marketed for use in the home care setting
too, bringing it in line with the approvals we already have in international
markets. We continue to believe that the NEXA(TM) NPWT System offers
significant capabilities, in a more cost-effective platform, to transition
patients more effectively from hospital to the community and reduce the risk
of subsequent re-admission due to complications with their wounds. I would
like to thank the entire team at AOTI for all their hard work and diligence in
providing a thorough submission to the Agency such that this important
clearance was received so expeditiously."

 

AOTI recently raised net proceeds of £13.5 million (c.$17.5 million) through
an initial public offering ("IPO") on the AIM market on 18 June 2024.

 

1. SmartTRAK 2021 WW Advanced Wound Care Market; and Market Watch Hyperbaric
Oxygen Therapy (HBOT) Market Size 2023

END

 

 AOTI, INC.

 Dr. Mike Griffiths, Chief Executive Officer   +44 (0)20 3727 1000

 Jayesh Pankhania, Chief Financial Officer     ir@aotinc.net (mailto:ir@aotinc.net)

 Peel Hunt LLP (Nominated Adviser and Broker)

 Dr. Christopher Golden, Patrick Birkholm      +44 (0)20 7418 8900

 FTI Consulting (Financial PR & IR)

 Ben Atwell, Simon Conway, Alex Davis          +44 (0)20 3727 1000

                                               AdvancedOxygenTherapy@fticonsulting.com
                                               (mailto:AdvancedOxygenTherapy@fticonsulting.com)

 

 

ABOUT AOTI, INC.

 

AOTI, INC. was founded in 2006 and is based in Oceanside, California, US and
Galway, Ireland, providing innovative solutions to resolve severe and chronic
wounds worldwide. Its products reduce healthcare costs and improve the quality
of life for patients with these debilitating conditions. The Company's
patented non-invasive Topical Wound Oxygen (TWO(2)(®)) therapy has
demonstrated in differentiating, robust, double-blinded randomised controlled
trials (RCT) and real-world evidence (RWE) studies to more-durably reduce the
recurrence of Diabetic Foot Ulcers (DFUs), resulting in an unprecedented 88
per cent reduction in hospitalisations and 71 per cent reduction in
amputations over 12 months. TWO(2)(®  )therapy can be administered by the
patient at home, improving access to care and enhancing treatment compliance.
TWO(2)(®) therapy has received regulatory clearance from the US (FDA), Europe
(CE Mark), UK (MHRA), Health Canada, the Chinese National Medical Products
Administration, Australia (TGA) and in Saudi Arabia. Also see www.aotinc.net
(http://www.aotinc.net)

 

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