REG - AOTI, Inc. - New Medicaid states, payer coverage expansion

AotiAnnouncement

09/01/2025 07:00

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RNS Number : 6600S  AOTI, Inc.  09 January 2025

9 January 2025

 

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

 

Entering 2025 with growing momentum; update on new Medicaid states and other
payer coverage expansion

 

AOTI, INC. (AIM: AOTI), a medical technology group focused on the durable
healing of wounds and the prevention of amputations, today provides an update
on its market access and commercial expansion strategy, demonstrating that the
Group is delivering against its strategic priorities and growth drivers.

 

Market Access & Commercial Expansion - on track and momentum building

Continued investment into Market Access and strategic alignment of the
Commercial teams towards higher value segments has enabled the Group to
accelerate its plans to migrate its revenue mix away from one historically
dominated by the Veterans Administration (VA) market segment. The VA
opportunity remains significant, and the Group is well positioned to continue
its growth, having recently received a 5-year extension to its Federal Supply
Schedule contract. Management continues to expect Medicaid and other new payer
sectors to outpace growth in the VA, as expanded access is established after
the required provider registrations and billing commences.

 

Since its IPO on AIM in June 2024, the Group has made significant progress in
penetrating these higher value segments, including commercial payers, through
beginning to gain access to the Workers' Compensation, Long-Term Acute Care
and Skilled Nursing Facilities sectors, in addition to further Medicaid
states.

 

The Group is now billing in all six of the Medicaid states outlined at IPO
(Arizona, Massachusetts, New Jersey, New York, Tennessee, Virginia), up from
three at the time of the IPO. The typical timeframe to become a provider and
open a Medicaid state remains around nine months, with a further nine months
commonly needed to establish billing in the state.

 

New provider registrations were achieved in three new states in 2024, in line
with the 2-3 expected per year, bringing the total to nine Medicaid states
opened to date. These three new states are expected to contribute to revenue
in FY25, and the Group is advanced in the stages for access in a further six
states presently.

 

·      Combined Medicaid run rate (excluding New York) now exceeds $2
million per month (up from $0.8 million at the end of May 2024, as disclosed
in the Company's Admission Document) through increasing penetration and
billing in new states

 

·      Expanded direct sales team headcount to 85 in line with
expectations. As previously guided, the new sales rep pay-back period is
around 6-9 months, and the Group remains focused on hiring experienced reps to
drive sustainable growth

 

Increased Payer Appreciation of Highly Evidenced TWO(2) therapy Benefits

This increasing level of interest from payers stems from a growing awareness
of the clinical, health economic, and health equity benefits that are
obtainable by incorporating the Group's proprietary Topical Wound Oxygen
(TWO(2)(®)) Therapy with their patients' care. The TWO(2)(®) therapy system
has global regulatory clearance including in the US (FDA) and Europe (CE
Mark). It has been used to treat >20,000 patients to date, and has been
demonstrated in pivotal clinical trials to reduce the recurrence of diabetic
foot ulcers (DFUs)(1) six-fold versus standard-of-care, leading to a 71%
reduction in diabetes-related amputations and 88% reduction in
hospitalisations. The Company also offers an innovative disposable Negative
Pressure Wound Therapy (NPWT) device, the NEXA™ System.

 

Dr. Mike Griffiths, Chief Executive Officer & President of AOTI,
commented: "2024 was an important transitional year for the Group with
significant continued emphasis on market access activities and positioning our
commercial teams to drive further expansion both in the US and
internationally. I am delighted to see so many of our strategic initiatives
coming to fruition as we make inroads into the multi-billion dollar Advanced
Wound Care market. We enter 2025 with significant momentum: more sales
channels for our products, a wider group of payers underpinning our business
model and confidence in delivering continued strong growth over the medium
term and beyond."

 

The Company expects to announce a financial trading update for FY24 in
mid-February 2025 and its Full Year financial results to 31 December 2024 in
April 2025.

 

1. DFUs frequently result in hospitalisations in diabetics and are the leading
cause of morbidity and lower extremity amputations in the diabetic population.
In the US, DFUs have a similar five-year mortality risk (at 30.5 per cent) as
all-cause cancer, and in the US alone, the annual cost of diabetic foot care
is c.$79 billion, which is comparable to the c.$80 billion annual cost spent
for all cancer treatments.

 

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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