REG - AOTI, Inc. - Real-world study of AOTI’s TWO2® therapy

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RNS Number : 9951B  AOTI, Inc.  27 April 2026

27 April 2026

 

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

 

Large real-world study in 3,126 patients demonstrates superior durable healing
of chronic wounds with AOTI's Topical Wound Oxygen (TWO(2)(®)) therapy

 

Study published in Journal of Vascular Surgery-Vascular Insights shows 64.8%
overall complete healing rate and only 2.7% reoccurrence for chronic lower
extremity wounds

 

AOTI, INC. (AIM: AOTI), a medical technology group focused on delivering
outcomes-based care at home, by more durable healing of wounds and the
prevention of amputations, announces findings from a large newly published
multicentre retrospective cohort study in the Journal of Vascular
Surgery-Vascular Insights (JVS-VI)(1) evaluating the effectiveness of Topical
Wound Oxygen (TWO(2)(®)) therapy in the treatment of chronic lower extremity
wounds.

 

The study demonstrated a high rate of complete durable healing utilising
AOTI's intermittent TWO(2)(®) therapy as an adjunct to standard of care in
hard-to-heal wounds that had failed to heal with other advanced wound care for
an average of 7 months. It encompassed 3,126 patients with broad wound types,
including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), arterial
ulcers and atypical wounds, building on previously published randomised
clinical trial data and real-world evidence as to the therapy's efficacy in
healing DFUs.

 

Key findings:

•     Treatment of chronic lower extremity wounds in a complex, comorbid
patient population with TWO(2)(®) therapy resulted in superior and more
durable complete wound healing outcomes, compared with those reported in
population-based real-world studies(2).

•     The primary outcome of complete wound healing was achieved in
64.8% (n = 2,027) of patients, in a mean time of 4.2 months, despite a mean
pre-treatment wound age of 7 months.

•     The need for retreatment due to wound recurrence was only 2.7%
(n=54), over a mean follow up time of 13.9 months.

•     TWO(2)(®) therapy significantly reduced the rates of
hospitalisations and amputations for this high-risk patient population when
compared with historical norms(3) reporting only 3.7% (n=115) and 6.1% (n=191)
respectively.

 

 

Dr. Mike Griffiths, Chief Executive Officer & President of AOTI, said:
"This large real-world study demonstrated significantly improved durable
healing and lower wound recurrence with the use of TWO(2)(®) therapy in
complex comorbid patient populations. These results build on our growing body
of robust randomised controlled trial and real-world evidence validating the
role our unique therapy plays in improving patient outcomes in a meaningful
way. In addition, multiple published peer-reviewed studies have highlighted
the cost saving potential of using TWO(2)(®) as an adjunctive at home
treatment for lower extremity wounds(4). Given the significant and increasing
global burden of chronic wounds, we believe broader adoption of TWO(2)(®)
therapy would deliver meaningful clinical and economic benefits to healthcare
systems."

 

(1) (Joann M. Lohr, et al. Retrospective Review of 3126 Patients with Chronic
Lower Extremity Wounds Treated with Intermittent Topical Oxygen Therapy)
(JVS-Vascular Insights, 2026, 100404, ISSN
2949-9127: )(https://doi.org/10.1016/j.jvsvi.2026.100404
(https://doi.org/10.1016/j.jvsvi.2026.100404) )(.)

( )

(2 Healing rates in the US Wound Registry (USWR) (included 62,964 DFUs and
97,420 VLUs, treated with both standard and advanced therapies). DFUs 45% in
mean time of 20 weeks; VLUs 57% in mean time of 16 weeks. USWR data represents
a less medically complex patient population to that examined in this study
because it includes patients who healed without the need for advanced wound
therapies.)

(3) (In an earlier published real-world DFU study, 54.1% of patients that did
not receive TWO2 therapy were Hospitalised and 41.4% had Amputations over 12
months. Yellin, et al. Reduced Hospitalizations and Amputations in Patients
with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound
Oxygen Therapy: Real-World Outcomes. Advances in Wound Care.
2022;11(12):657-665. doi:)(10.1089/wound.2021.0118
(https://doi.org/10.1089/wound.2021.0118) )

(4) (Marion Kerr, Daisy Wild, Michael Edmonds, Andrew J.M. Boulton, Cost
effectiveness of topical wound oxygen therapy for chronic diabetic foot
ulcers, Journal of Diabetes and its Complications, Volume 39, Issue 5, 2025,
10901. )(https://doi.org/10.1016/j.jdiacomp.2025.109016
(https://doi.org/10.1016/j.jdiacomp.2025.109016) )(.)

( )

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 Joint Broker)

 Dr. Christopher Golden, James Steel                 +44 (0)20 7418 8900

 Panmure Liberum Limited (Joint Broker)              +44 (0)20 3100 2000

 Emma Earl, Will Goode, Mark Rogers

 Rupert Dearden

 FTI Consulting (Financial PR & IR)                  +44 (0)20 3727 1000

 Ben Atwell, Simon Conway,                           AOTI@fitconsulting.com (mailto:AOTI@fitconsulting.com)

 Natalie Garland-Collins

 

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. TWO(2)(®) therapy has
also recently received positive coverage recommendations from the Federal
Joint Committee (G-BA) in Germany and National Institute for Health and Care
Excellence (NICE) in the United Kingdom. Also see www.aotinc.net
(http://www.aotinc.net)

 

 

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