29 July
2024
AOTI, INC. (the "Company" or
"Group" or "AOTI")
AOTI announces US FDA 510(k)
Clearance of NEXATM 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 NEXATM 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 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. 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 the global
market-leader in the topical oxygen wound therapy segment and the
Company 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.1
Dr.
Mike Griffiths, Chief Executive Officer and President of AOTI, INC.
commented: "I am delighted that the FDA
has granted clearance for our NEXATM 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
NEXATM 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
Jayesh Pankhania, Chief Financial
Officer
|
+44 (0)20 3727 1000
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
|
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
(TWO2®) 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.
TWO2® therapy can be administered by
the patient at home, improving access to care and enhancing
treatment compliance. TWO2® 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