Highlights
- A retrospective analysis of real-world data published in the
‘International Wound Journal’ compared the wound closure times for
diabetic foot ulcers treated with either Endoform™ Natural (1150
wounds) or collagen/ORC (1072 wounds).
- The data was analyzed to evaluate the median time for wound
closure, percentage of wounds healed at 12-,24- and 36- weeks and
probability of wound closure.
- The time to wound closure was significantly faster, between 1.9
to 5.6 weeks, in the Endoform Natural group relative to the
collagen/ORC group. This represented a reduction in time to wound
closure of 11.3% to 21.4%, and increased the probability of wound
closure between 18% to 38%.
- Diabetic foot ulcers are the leading cause of non-traumatic
amputations in the United States and are estimated to cost the US
health care system $9-13 billion per annum.1,2
A new retrospective study of real-world data (‘RWD’) has shown
significantly improved wound closure times for diabetic foot ulcers
(‘DFU’) and much greater probability of wound closure in wounds
treated with Endoform™ Natural, compared to wounds treated with a
traditional collagen dressing.
Endoform Natural is manufactured and distributed by soft tissue
regeneration company Aroa Biosurgery Limited (ASX:ARX, ‘AROA or the
‘Company’). This is the first large retrospective analysis
comparing the healing efficacy of Endoform Natural to
collagen/oxidized regenerated cellulose (‘ORC’) and is the first
large clinical study comparing advanced extracellular matrix
(‘ECM’) technology to an older style reconstituted collagen
product.
The findings have been published this week in a study titled
“Retrospective Real World Comparative Effectiveness of Ovine
Forestomach Matrix and Collagen/ORC in the Management of Diabetic
Foot Ulcers” published in the ‘International Wound Journal.’
The study is online at
https://onlinelibrary.wiley.com/doi/10.1111/iwj.13670.
About the study
The retrospective study employed a data set of patients treated
in U.S.-based wound care centers for their DFUs where treatment
included either Endoform Natural or collagen/ORC. It used existing
wound data, with minimal inclusion or exclusion criteria. As such,
the study captured ‘real-world’ use of both products from 2222
qualifying DFU wounds from 1590 patients, extracted from a wider
data set of over 31,880 wounds in over 25,760 patients.
Of the 2222 qualifying wounds analyzed, 1150 wounds had been
treated with Endoform Natural and 1072 treated with collagen/ORC to
compare the median time for wound closure, percentage of wounds
healed at 12-, 24- and 36- weeks and probability of wound
closure.
Key findings
The time to wound closure for all
wounds was 1.9 weeks faster in the Endoform Natural group relative
to the collagen/ORC group. This represents a reduction in time to
wound closure of 11.3%. The percentage of all wounds closed at 12-,
24- and 36-weeks also increased in DFUs treated with Endoform
Natural compared to collagen/ORC, and differences were
statistically significant at 36-weeks. Statistical analysis showed
that the treatment of wounds with Endoform Natural increased the
probability of wound closure by up to 21%.
The research team also undertook a sub-group analysis of the
data set to look at the impact of Endoform Natural treatment on
those more challenging wounds that required more visits to the
wound care centers (‘WCC’) for intervention. For example, DFU that
received twelve or more WCC visits closed 5.3 weeks faster,
representing a 19.4% reduction in the time to wound closure.
Additionally, these more challenging wounds had a 38% increase in
the probability of closure having received Endoform Natural.
Significance of the findings
AROA CEO, Dr. Brian Ward said this study demonstrates the
potential for improvements in patient quality of life due to the
significantly reduced time to close wounds and material cost
reductions using Endoform Natural compared to traditional collagen
dressings.
“Recent research indicates that up to one-third of the half a
billion people with diabetes worldwide will develop a DFU over the
course of their lifetime3. This presents many real challenges in
treatment and quality of life for patients, family members and
clinicians, particularly as an estimated 1 in 6 patients with a DFU
will go on to require an amputation,” Dr. Ward says.
DFUs are the leading cause of non-traumatic amputations in the
United States4 and there are also significant financial burdens
associated with DFUs. A 2012 retrospective study of 7099 DFUs
reported a mean cost to achieve closure of $3927 per DFU5 and the
overall DFU related cost and burden to the U.S. health care system
alone has been estimated at $9-13 billion6,7.
AROA’s Endoform Natural is an intact ECM technology for acute
and chronic wounds that utilizes the Company’s proprietary AROA
ECM™ technology. It is a distinctly different technology to the
traditional reconstituted collagen products that have been commonly
used in the management of acute and chronic wounds. These ‘older
style’ technologies utilise collagen, isolated from animal tissues
using relatively harsh processing, which is then reconstituted into
finished wound dressings. For example, collagen/ORC is comprised of
bovine reconstituted collagen and synthetically modified cellulose.
This product typically gels on contact of the wound bed, remains in
place for 48-72 hours and requires frequent reapplications.
Pre-clinical studies have shown that the AROA ECM technology
includes over 150 different protein components that are known to
aid wound repair, stimulate blood vessel formation and attract stem
cells. It acts as a bio scaffold to aid the patient’s natural wound
healing process.
ECM-based products for wound care have largely remained
inaccessible due to their cost. They are typically rationed and
utilized as a ‘last resort’, being available only as ‘cellular or
tissue-based product’ (CTP, or ‘skin substitutes’).
Endoform Natural is the first widely accessible ECM-based
product available to wound care professionals, enabling increased
accessibility and adoption of advanced ECM technology into clinical
practice.
“This data also adds to our existing body of evidence about the
effectiveness and broad application of our AROA ECM technology
platform for healing complex wounds in compromised patients. It is
consistent with the improved outcomes that we have seen in Tela
Bio’s Ovitex BRAVO hernia study and Aroa’s previously published
Myriad studies. It is encouraging that our underpinning AROA ECM
technology and product portfolio is continuing to demonstrate
improved healing in complex wounds and soft tissue reconstruction,
often in the presence of inflammation and contamination,” Dr. Ward
says.
Authorised on behalf of the Aroa Biosurgery Board of
Directors by Brian Ward, CEO.
About Aroa Biosurgery:
Aroa Biosurgery is a soft-tissue regeneration company committed
to ‘unlocking regenerative healing for everybody’. We develop,
manufacture, sell and distribute medical and surgical products to
improve healing in complex wounds and soft tissue reconstruction.
Our products are developed from a proprietary AROA ECM™ technology
platform, a novel extracellular matrix biomaterial derived from
ovine forestomach. AROA has six patented product families selling
in the US based on its AROA ECM technology targeting chronic
wounds, hernia, soft tissue and breast reconstruction. AROA’s
products have been used in more than four million procedures to
date, with distribution into our key market of the United States
via our direct sales force and our partner TELA Bio. AROA has
regulatory approvals in 49 countries. Founded in 2008, AROA is
headquartered in Auckland, New Zealand and is listed on the
Australian Securities Exchange (ASX:ARX). www.aroabio.com/
_______________________________
1 Rice, J.B., et al., Burden of diabetic foot ulcers for
medicare and private insurers. Diabetes Care, 2014. 37(3): p.
651-8. 2 Barshes, N.R., et al., The system of care for the diabetic
foot: objectives, outcomes, and opportunities. Diabet Foot Ankle,
2013. 4. 3 Armstrong, D.G., et al., Five year mortality and direct
costs of care for people with diabetic foot complications are
comparable to cancer. J Foot Ankle Res, 2020. 13(1): p. 16. 4
Boulton, A. J. M., D. G. Armstrong, R. S. Kirsner, C. E. Attinger,
L. A. Lavery, B. A. Lipsky, J. L. Mills, Sr. and J. S. Steinberg
(2018). Diagnosis and Management of Diabetic Foot Complications.
Diagnosis and Management of Diabetic Foot
Complications. Arlington (VA). 5 Fife, C.E. and M.J. Carter,
Wound Care Outcomes and Associated Cost Among Patients Treated in
US Outpatient Wound Centers: Data From the US Wound Registry.
Wounds, 2012. 24(1): p. 10-7. 6 Rice, J.B., et al., Burden of
diabetic foot ulcers for medicare and private insurers. Diabetes
Care, 2014. 37(3): p. 651-8. 7 Barshes, N.R., et al., The system of
care for the diabetic foot: objectives, outcomes, and
opportunities. Diabet Foot Ankle, 2013. 4.
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version on businesswire.com: https://www.businesswire.com/news/home/20210810005400/en/
Investor Simon Hinsley Investor Relations shinsley@aroabio.com +
61 401 809 653
Media Australia Matthew Wright
matt@nwrcommunications.com.au +61 451 896 420
New Zealand Piet De Jong
piet.dejong@baldwinboyle.com +64 21 812 766
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