REG - AOTI, Inc. - Enrolment Commences for VLU Clinical Trial

AotiAnnouncement

16/12/2024 07:00

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RNS Number : 1938Q  AOTI, Inc.  16 December 2024

16 December 2024

 

 

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

 

Patient Enrolment Commences for VLU Clinical Trial of TWO(2) therapy

 

AOTI, INC. (AIM: AOTI), a medical technology group focussed on the durable
healing of wounds and prevention of amputations, has commenced enrolling
patients in the USA for a multi-national, prospective, randomized,
double-blinded, placebo-controlled trial to evaluate Topical Wound Oxygen
(TWO(2)) therapy in the treatment of chronic Venous Leg Ulcers (VLUs) (the
VaLUe trial). This 212 patient study is intended to demonstrate the complete
durable healing efficacy of TWO(2) for this ulcer type using a similar study
design to the award-winning Frykberg et al. clinical trial for diabetic foot
ulcers.(1)

 

VLUs are painful, chronic leg sores caused by venous hypertension and
resultant tissue swelling (edema) and damage. They are the leading cause of
wounds on the leg and represent a significant burden on patients, caregivers,
healthcare systems and related economies. VLUs afflict approximately 2% of the
world's population, with 60% progressing onto a chronic nonhealing wound.(2)
VLUs have extremely high rates of recidivism, with the recurrence of the
ulcers that heal reported as high as 75%. With this cycle of poor healing and
re-ulceration, patients can suffer for decades leading to poor quality of life
and a significant financial burden on the healthcare systems.(3)

 

AOTI's multi-modality TWO(2) therapy is the only topical oxygen approach that
combines both cyclical non-contact compression with higher partial pressure
oxygen delivery around the limb and wound. This cyclical pressure pattern
mimics a healthy body's calf pump, as well as the pressure applied by
conventional compression dressing (CCD), the only currently accepted VLU
treatment option. Additionally, as TWO(2) therapy can be applied by the
patient at home over their existing CCDs, it does not require additional
health resources, which greatly improves patient compliance and access to
care.

 

An earlier 132 patient, vascular surgeon-led, controlled cohort study
demonstrated the significant durable healing potential of TWO(2) therapy in
refractory VLU when compared to CCD, reporting a 76% vs 46% complete healing
efficacy at 12 weeks (p <0.0001), and substantial reductions in VLU
recurrence over three years, 6% vs 47% (p <0.0001).(4) A recent
late-breaking abstract, presented at the prestigious VEITH symposium, which
explored the real-world efficacy of TWO(2) therapy in treating 2,088 patients
with wounds of varying etiologies and an average of 13.5 months duration,
showed overall that 76% reached complete healing within an average of 4.4
months of treatment with TWO2, with a subset of 193 refectory VLUs reaching
72% complete healing within an average of 4.6 months of TWO(2) therapy, and
demonstrating only 0.5% recurrence.(5)

 

Dr. Mike Griffiths, Chief Executive Officer and President of AOTI, INC.,
commented: "We know from earlier studies and our treatment of hundreds of VLU
patients at home daily that TWO(2) therapy has dramatic durable healing
benefits in VLUs, which are estimated to afflict as many 6 million people in
the USA alone. VLU patients are sometimes forgotten due to limited effective
treatment options, but the disease inflicts enormous pain and suffering, in
many cases for decades, with considerable associated economic burden. TWO2 has
outstanding evidence to support its use to heal Diabetic Foot Ulcers (DFU)
more durably and the VaLUe study which will be conducted by leading vascular
surgeons from across the USA and Europe, is designed to establish a similar
level of evidence in healing VLUs."

 

1. Frykberg et al., A multinational, multi-center, randomized, double-blinded,
placebo-controlled trial to evaluate the efficacy of cyclical Topical Wound
Oxygen (TWO2) therapy in the treatment of chronic diabetic foot ulcers: the
TWO2 study; Diabetes Care 2020; 43: 616 - 624.

 

2. Venous leg ulcers. Nelson EA, Adderley U. 2016, BMJ Clin Evid., Vol.
2016:1902.

 

3. Prevalence and incidence of venous leg ulcers-a protocol for a systematic
review. Probst, S et al. 2021, Systematic reviews vol. 10,1 148. 12 May. 2021,
doi:10.1186/s13643-021-01697-3, Vol. 10, p. 148.

4. Technical and clinical outcome of topical wound oxygen in comparison to
conventional compression dressings in the management of refractory nonhealing
venous ulcers. Tawfick WA, Sultan S. 2013, Vasc Endovascular Surg., Vol.
47(1).

 

5. Compression, Oxygen, and Humidification - Improves Venous Would Healing and
Reduces Venous Ulcer Recurrence. J. Lohr. VEITH Symposium 2024;
https://www.veithsymposium.org/current/abstracts/vei/1255.pdf
(https://www.veithsymposium.org/current/abstracts/vei/1255.pdf)

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,                     +44 (0)20 3727 1000

 Natalie Garland-Collins, Alex Davis           AOTI@fticonsulting.com (mailto:AOTI@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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