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
TWO2 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
(TWO2®) Therapy with their patients' care.
The TWO2® 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
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,
Natalie Garland-Collins, Alex
Davis
|
+44 (0)20 3727 1000
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
(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