MARIETTA, Ga., Aug. 30, 2016
/PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading
regenerative medicine company utilizing human amniotic tissue and
patent-protected processes to develop and market advanced products
and therapies for the Wound Care, Surgical, Orthopedic, Spine,
Sports Medicine, Ophthalmic, and Dental sectors of healthcare,
provided an update today on the status of key clinical trials.
Plantar Fasciitis Investigational New Drug ("IND") Study
Receives FDA Approval for Protocol Amendment Reducing Follow-up
Requirements by One Year
Pursuant to the Company's agreement with the Food and Drug
Administration ("FDA") to pursue a Biologics License Application
("BLA") with the Company's AmnioFix® Injectable product, MiMedx
entered a Phase IIB Randomized Control Trial ("RCT") for the
treatment of plantar fasciitis in August, 2014. The FDA
approved the clinical study protocol which targets 146 subjects at
up to 20 clinical sites. The study has met a very significant
milestone. In the initial protocol, a 24-month follow-up blood draw
was requested by the Agency in order to determine if the micronized
dHACM injection elicited an immune response in patients. An
amendment was submitted to the FDA based on generated data
requesting a protocol amendment to remove the 24-month follow-up
requirement for this clinical trial. Because of the excellent
safety profile and the lack of immunogenic response seen in the
study patients thus far, the FDA has agreed that two year data is
NOT needed and reduced the requirement to one year. This is a
major milestone for this study.
Parker H. "Pete" Petit, Chairman and CEO, said, "At present, 109
of the 146 patients have been consented and 103 randomized in the
plantar fasciitis study, in a total of 13 sites, and the study
should be fully enrolled by the end of the year. In
terms of cost, the total expenditure for this study is projected to
be slightly over $2 million, a large
portion of which has already been expensed since the inception of
the study in late 2014."
BLA/PMA Compliant Chronic Wound Clinical Trials Near
Completion
Bill Taylor, President and COO,
stated, "In anticipation of additional needs for future regulatory
and/or reimbursement purposes, we have had two large, multi-center
chronic wound studies under way since 2014. One study is for
diabetic foot ulcers ("DFUs") and the other is for venous leg
ulcers ("VLUs"). These large studies follow the multiple clinical
trials with EpiFix® concluded over the years, including the
published 100 patient comparative effectiveness trial against a
competitive product, and complete the DFU and VLU clinical trials
for EpiFix. As with the comparative effectiveness study, the
two studies that are underway follow the 2006 FDA Guidance for
Industry-Chronic Cutaneous Ulcer and Burn Wounds. This is the
guidance document that outlines clinical trial design for Premarket
Approval ("PMA") and BLA products."
The multi-center DFU study was designed to have in excess of 10
sites and a target enrollment of 130 patients. This study
currently has 12 sites enrolling patients, with 105 enrolled to
date. The Company expects to complete enrollment by the end
of this year. This study has been ongoing since 2014. The
total cost of the study is expected to be less than $2 million, and a large portion of this estimated
$2 million has already been expensed
by the Company.
The multi-center VLU study targeted in excess of 10 sites and
120 patients. At present, 11 sites have enrolled 123
patients. MiMedx expects that this study will conclude
enrollment shortly, and will be completed by the end of this
year. This study is also expected to cost under $2 million. As with the other two studies
mentioned above, a large portion of the cost of this study has
already been expensed.
Investments in Clinical Trials Position MiMedx Favorably for
Any Outcome from FDA Industry Meeting
Petit commented, "We expect the industry meetings that the FDA
is holding on September 8, 12 and
13, 2016 to be very enlightening and productive relative to
questions that have arisen over the last several years on amniotic
membrane and other tissue allografts. We will be extending a
thank you to the FDA for the approach it is now taking to these two
meetings. Including industry, physicians, scientists and patients
in the deliberations will be very beneficial. Regardless of how
these discussions are perceived, we believe MiMedx is the best
positioned organization to fulfill further regulatory requirements
in the future, if they are mandated. As a matter of fact, we
have already incurred much of the expenses to do so. In addition,
we are now past the half way point in patient enrollment for our
IND/BLA study for our micronized allograft, and we expect
completion of patient enrollment near the end of 2016."
"It is well known that the FDA is reviewing its HCT/p 361
regulations and Draft Guidance documents, and considering
potentially further modifications of the regulations. By
early 2017, MiMedx will have completed a total of three large
multi-center clinical trials for EpiFix on chronic wounds that will
meet the FDA's 2006 Guidance Document for Phase III clinical trials
of chronic wounds. The FDA typically only requests two such
studies in BLA programs, so we are extremely well positioned for
any potential changes in regulations related to HCT/ps and their
use in chronic wounds. Also, MiMedx has already spent the
majority of the dollars needed for those clinical trials. Should
the FDA update its regulations such that our EpiFix product line
would need a BLA after a suitable transition period, or frankly, if
we decide to voluntarily request a BLA for a specific indication
for use, we feel that the data we will have from these three large
clinical trials should be sufficient to meet the FDA's clinical
trials requirement for a BLA. Therefore, we believe that
MiMedx is in the leadership position in this area, no matter which
direction the FDA takes relative to updating its Draft Guidance
documents and regulations," added Taylor.
Petit commented, "In the event that the FDA Draft Guidance
Document on Homologous Use is finalized exactly as published in the
draft documents, we would disagree that the science supports such a
result; however, we will comply with the new regulations. If
we don't appeal or otherwise contest the changes, we will simply
change our marketing material to match the examples in the Draft
Guidance. If that happens, I expect that we will immediately
begin to enter the process for a BLA. We expect that the
clinical data that we will have from our three Phase III level
studies will meet the study requirements for a BLA for chronic
wounds. The two remaining studies should be complete and
submitted for publication early next year."
Shareholder Call
MiMedx management will host a live broadcast of its conference
call to discuss the clinical studies highlighted in this press
release. In light of the upcoming Labor
Day holiday, the conference call will be held on
Wednesday, September 7, 2016,
beginning at 10:30 a.m. eastern
time. A listen-only simulcast of the MiMedx Group
conference call will be available on-line at the Company's website
at www.mimedx.com. A 30-day on-line replay will be available
approximately one hour following the conclusion of the live
broadcast. The replay can also be found on the Company's website at
www.mimedx.com.
About MiMedx
MiMedx® is an integrated developer, processor and marketer of
patent protected and proprietary regenerative biomaterial products
and bioimplants processed from human amniotic membrane and other
birth tissues and human skin and bone. "Innovations in
Regenerative Biomaterials" is the framework behind our
mission to give physicians products and tissues to help the body
heal itself. The MiMedx allograft product families include
our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands;
Amniotic Fluid family with OrthoFlo brand; Umbilical family with
EpiCord™ and AmnioCord™ brands; Placental Collagen family with
CollaFix™ and AmnioFill™ brands; Bone family with Physio® brand;
and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and
EpiBurn are our tissue technologies processed from human amniotic
membrane; OrthoFlo is an amniotic fluid derived allograft;
EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio
is a unique bone grafting material comprised of 100% bone tissue
with no added carrier; AlloBurn is a skin product derived from
human skin designed for the treatment of burns; and CollaFix,
our next brand we plan to commercialize, is our collagen fiber
technology, developed with our patented cross-linking polymers,
designed to mimic the natural composition, structure and mechanical
properties of musculoskeletal tissues in order to augment their
repair.
We process the human amniotic membrane utilizing our proprietary
PURION® Process, to produce a safe and effective implant. MiMedx is
the leading supplier of amniotic tissue, having supplied over
600,000 allografts to date for application in the Wound Care, Burn,
Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental
sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time
or that express management's beliefs, expectations or hopes. Such
statements are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to the Company's belief that it is the
best positioned organization to fulfill further regulatory
requirements in the future, if they are mandated by the FDA;
that MiMedx is in a leadership position related to clinical trial
requirements for BLAs, no matter which direction the FDA takes
relative to updating its guidance documents; that in the event the
FDA finalizes its Draft Guidance on Homologous Use in its current
state, the Company will immediately begin to enter the process for
a BLA, so as to claim wound healing; that the Company expects that
the clinical data it will have from its three Phase III level
studies will meet the study requirements for a BLA for chronic
wounds, and that the two remaining studies should be complete and
submitted for publication early next year. Among the risks and
uncertainties that could cause actual results to differ materially
from those indicated by such forward-looking statements include
that the FDA may impose regulations that are not anticipated by the
Company, that the data the Company will have from its three large
clinical trials may not be sufficient to meet the FDA's clinical
trials requirements for a BLA or that the requirements may change,
that the Company may not be able to enter the process for a BLA so
as to claim wound healing should this become necessary, that the
two remaining Phase III level studies may not be completed on
schedule and may not be ready for publication early next year or
may not ultimately be accepted for publication, and the risk
factors detailed from time to time in the Company's periodic
Securities and Exchange Commission filings, including, without
limitation, its 10-K filing for the fiscal year ended December 31, 2015 and its most recent 10Q filing.
By making these forward-looking statements, the Company does not
undertake to update them in any manner except as may be required by
the Company's disclosure obligations in filings it makes with the
Securities and Exchange Commission under the federal securities
laws.
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SOURCE MiMedx Group, Inc.