REG - AOTI, Inc. - CMS Topical Oxygen Therapy coverage review

AotiAnnouncement

11/11/2024 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20241111:nRSK6763La&default-theme=true

RNS Number : 6763L  AOTI, Inc.  11 November 2024

11 November 2024

 

 

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

 

CMS commences formal review for Topical Oxygen Therapy coverage

 

AOTI, INC. (AIM: AOTI), a medical technology group focussed on the durable
healing of wounds and prevention of amputations, is pleased to note that the
Centers for Medicare and Medicaid Services (CMS), through its Durable Medical
Equipment (DME) Medicare Administrative Contractors (MACs), has scheduled a
public Contractor Advisory Committee (CAC) meeting. The CAC meeting on 11
December 2024 will convene subject matter experts to consider revising the
Oxygen and Oxygen Equipment Local Coverage Determination (LCD) to include
language indicating that Topical Oxygen is reasonable and necessary for wound
healing therapy.

 

The specialty focused CAC meeting is to discuss the scientific evidence
underlying the requested LCD and to provide a formal mechanism for healthcare
professionals to be informed of the evidence used in developing the LCD and
promote communications between the DME MACs and the healthcare community.
During the meeting, the CAC members will be asked to discuss the clinical
literature related to the LCD reconsideration request and to score a series of
key questions that will help guide CMS in drafting their proposed LCD
revision. The DME MACs will then publish the proposed LCD and generally have
up to 365 calendar days from the publication date to finalise the process.

 

Dr. Mike Griffiths, Chief Executive Officer and President of AOTI, INC.,
commented: "Following the specialist led coverage reconsideration request made
in mid-2023, we are delighted that CMS has decided to initiate their coverage
review of topical oxygen therapy. Such coverage, if achieved, would provide
significant additional momentum to accelerate our business trajectory above
what we have outlined previously, and provide us with access to the c.65
million Americans covered by Medicare (the Government-funded healthcare
insurance scheme for citizens 65 years of age and over).

 

"Our unique topical wound oxygen (TWO(2)(®)) therapy has revolutionised
chronic wound healing, by providing significant reductions in wound related
reoccurrence, hospitalisations and amputations(1,2). AOTI is proud to continue
its efforts to expand the access of these benefits to all patients,
predominately applied in their homes, thereby driving meaningful improvements
in access-to-care for those who need it most."

 

1. Multinational, Multicenter, 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. Robert G.
Frykberg et al, Diabetics Care 2020; 43:616-624.
https://doi.org/10.2337/dc19-0476 (https://doi.org/10.2337/dc19-0476)

 

2. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot
Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy:
Real-World Outcomes; Jessica Izhakoff Yellin, et al; Advances in Wound Care
2022; http://doi.org/10.1089/wound.2021.0118
(http://doi.org/10.1089/wound.2021.0118)

 

 

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)

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCQKKBDNBDBCDD