MiMedx Group Inc (MDXG)

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9:02AM MiMedx Group crossover study is published in the Journal of Wound Care (MDXG) 5.94 : Patients enrolled in this "crossover" study had been randomized to receive standard care in the DFU clinical trial that compared treatment with EpiFix to the standard of care. In that RCT, the overall healing rate with application of EpiFix was shown to be 77% and 92% after 4 and 6 weeks of treatment, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. At completion of the RCT, patients that did not heal with standard care were then offered treatment with EpiFix.

Wounds had been present for an average of over 21 weeks when treatment with EpiFix was initiated. When reporting outcomes at the predetermined study intervals of 4, 6 and 12 weeks, 55% of the patients achieved complete healing within 4 weeks, 64% within 6 weeks, and 91% within 12 weeks. Although 12 weeks was the predetermined study interval, the 91% complete healing outcome was actually achieved in 9 weeks.


from the study...

Discussion
This is the ?rst randomised controlled trial in the USA comparing standard of care versus standard of care plus advanced
therapy using a dehydrated human amniotic membrane product (EpiFix) in patients with a long-standing diabetic ulcer.
Patients in the study sample treated with EpiFix had significantly greater rates of healing and healed in a more rapid
fashion than those patients receiving standard of care alone.

Human amniotic membrane has been scienti?cally studied
to examine how it contributes to the healing process in
wounds. Amniotic membrane is composed principally of
three types of material: structural collagen and extracellular
matrix, biologically active cells and a large number of
important regenerative molecules (21). Collagen types IV,
V and VII provide an important substrate, which is not only
important for the structural integrity of the membrane but
also facilitates wound healing and cellular ingrowth. There
is clear evidence that many of these molecules interact with
one another in a highly complex milieu of bioregulation
that requires the presence of membranes, individual growth
factors and interactions that upregulate and downregulate the
various regenerative processes of healing (22).

Human amniotic membrane has been found to have a
number of characteristics that make it uniquely suited to
wound healing. For example, previous studies have shown
that amniotic membrane:

• provides a matrix for cellular migration and proliferation (15),
• promotes increased healing and enhancement of the
wound healing process (23),
• is non immunogenic (24),
• reduces in?ammation (25),
• reduces scar tissue (26),
• has antibacterial properties (27,)
• reduces pain at the site of application (29,30),
• provides a natural biological barrier (29,31),
• contains a number of essential growth factors and
cytokines (32).

Overall, amniotic membrane has potential uses in a variety
of other wound healing applications in addition to cutaneous
wounds including applications in periodontology, otorhinolaryngology and general surgery. The material appears to be
safe in its overall use and contributes signi?cantly to the
regeneration of various soft tissues (31,33,34).

Models of cost-effectiveness in wound care have been
postulated and developed by a number of authors. Data from
registries often are used to calculate the health care claims
costs of wound care, and are expressed in terms of cost
to heal, hospitalisation costs or overall medical care costs
(13,35). While health economists focus on these tangible
costs of wound management, the true economic analyses also
develop from productivity, quality of life and related issues
as well (36). In order for an advanced therapy such as EpiFix
to be seen as an acceptable treatment option it must be
clinically ef?cacious, operationally ef?cient for the clinician,
improve the patients’ quality of life and be cost-effective. A
treatment that reduces healing time while requiring minimal
dressing changes with a low need for reapplication meets these
requirements.

Dehydrated amniotic membrane material is operationally
ef?cient in that it can be transported and stored at room
temperature for long periods of time up to 5 years, thus
minimising the need for complex policies for receiving
and storing the material. In addition, the added expense of
subzero refrigeration or short storage life that often leads
to wasted product is no longer a consideration or expense.
Handling characteristics of the EpiFix material permit easy
retrieval and use and minimise time for application, allowing
for more ef?cient utilisation of the clinicians’ time and effort.
The material can be provided in a number of different sizes,
minimising the amount of waste when used on varying size
ulcers and at various stages in healing.

In this study, the overall comparison of the standard of care
with the standard of care plus dehydrated amniotic membrane
allograft re?ected an unprecedented ability of the material to
assist in the resolution of diabetic neurotrophic ulcers. The use
of the EpiFix material obviated at least six dressing changes
by the patient per week and any associated home health care
visits. The EpiFix material, placed on an every other week
regimen, aggressively closed the wounds under consideration
in a far shorter time than standard wound treatment. Therefore,
as the allograft material is placed less frequently, and the
wounds heal more quickly than alternative therapies, the
potential for reduced cumulative as well as episode costs can
be assumed.

https://docs.google.com/viewer?url=http%3A%2F%2Fmimedx.com%2Fimages%2Fpdf%2FIWJ_Zelen_RCT_June_2013.pdf
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