MIMEDX Announces Wound & Surgical Product Pipeline Expansion via In-Licensing and Distribution Agreement with Turn Therapeutics
08 Dezembro 2022 - 10:00AM
MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a
pioneer and leader in placental biologics, today announced that it
has licensed worldwide exclusive rights to Turn Therapeutics’
proprietary antimicrobial technology platform, PermaFusion®, for
the development of future biologic products focused on wound and
surgical recovery applications.
“Today’s transaction enables a meaningful
expansion of our product development pipeline ambitions,” stated
Todd Newton, MIMEDX interim Chief Executive Officer. “This deal
allows us to bring new amniotic tissue and particulate products to
market with antimicrobial properties significantly faster,
consistent with our stated goal of ensuring that our R&D
activities are prioritized, productive and pursued with a sense of
urgency. Putting together Turn’s intellectual property with our
tissue know-how will help us leapfrog into the next generation of
biologics for our Wound & Surgical business.”
PermaFusion® is petrolatum-based, liquid-in-oil
suspension technology that involves the creation of nanodroplets
without binding agents or emulsifiers and also includes a process
to coat materials with antimicrobial-infused petrolatum. Turn’s IP
estate includes “mixing” and “coating” IP and provides protection
up to 20 years. MIMEDX expects this technology to be included in
the creation of a number of new antimicrobial biologic products for
the Wound & Surgical markets.
“For many patients suffering from acute and
chronic soft tissue defects, the risk of bioburden is significant
and can lead to numerous complications that impede their ability to
make a full recovery,” added Dr. Rohit Kashyap, MIMEDX President,
Wound & Surgical. “In acquiring the rights to PermaFusion®, I
am excited to help usher in a new generation of products for the
wound and surgical markets that combine MIMEDX’s best-in-class
placental-based allografts with antimicrobial technology that can
help reduce risks associated with healing complications, such as
surgical site infections. We look forward to building upon our
current portfolio and including this important and differentiated
feature in future products to help physicians manage bioburden in
the treatment of soft tissue defects.”
In addition to the exclusive license to Turn’s
IP, MIMEDX is acquiring the commercial rights to Turn’s particulate
collagen matrix product, FleX™ AM, contingent upon its receipt of
FDA 510(k) clearance, which is expected in 2023. FleX™ AM is an
absorbent, particulate bovine collagen powder product that
incorporates antimicrobial properties to neutralize absorbed
microbes and prevent proliferation.
Under the terms of the agreement, MIMEDX has
exclusive rights to develop future products for the wound care,
burn, and surgical fields using Turn’s IP. Turn will receive an
upfront cash payment and is entitled to future payments upon the
meeting of regulatory and product commercial milestones along with
royalties on the sales of such products.
About MIMEDXMIMEDX is a pioneer
and leader in placental biologics, developing and distributing
placental tissue allografts to help address unmet clinical needs in
multiple sectors of healthcare, including the Advanced Wound Care
market as well as in surgical recovery settings. MIMEDX is also
focused on advancing a promising late-stage pipeline opportunity
targeted at decreasing pain and improving function for patients
with knee osteoarthritis. Our products are derived from human
placental tissues and processed using our proprietary methods,
including the Company’s own PURION® process. We employ Current Good
Tissue Practices, Current Good Manufacturing Practices, and
terminal sterilization to produce our allografts. MIMEDX has
supplied over two million allografts, through both direct and
consignment shipments. For additional information, please visit
www.mimedx.com.
About Turn TherapeuticsTurn
Therapeutics is a concept-to-approval research and development
organization focused on novel, best in class products for infection
control, skin disease, and wound care. The company's proprietary
technologies are used every day by world-leading healthcare
institutions to care for a variety of skin and wound conditions.
For more information, visit www.turntherapeutics.com.
MIMEDX Safe Harbor
StatementSome of the information and statements contained
in this press release and certain oral statements made from time to
time by representatives of MIMEDX constitute "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995 that do not directly or exclusively relate to
historical facts. Forward-looking statements include statements
regarding: (i) our transaction with Turn enabling us to bring new
amniotic tissue and particulate products to market with
antimicrobial properties significantly faster and leapfrog into the
next generation of biologics for our Wound & Surgical business;
(ii) our expectation that Turn’s technology will be included in the
creation of a number of our new antimicrobial products for the
Wound & Surgical markets; and (iii) our expectation that Turn’s
FleX™ Antimicrobial Collagen Matrix product will receive FDA 510(k)
clearance in 2023. Additional forward-looking statements may be
identified by words such as "believe," "expect," "may," "plan,"
“goal,” “outlook,” "potential," "will," "preliminary," and similar
expressions, and are based on management's current beliefs and
expectations.
Forward-looking statements are subject to risks
and uncertainties, and the Company cautions investors against
placing undue reliance on such statements. Actual results may
differ materially from those set forth in the forward-looking
statements. Factors that could cause actual results to differ from
expectations include: (i) future sales are uncertain and are
affected by competition, access to customers, patient access to
healthcare providers, and many other factors; (ii) the status,
timing, results and expected results of the Company’s and Turn’s
clinical trials and planned regulatory submissions; (iii) the
results of scientific research are uncertain and may have little or
no value; (and (iv) we may alter the timing and amount of planned
expenditures for research and development based on the results of
clinical trials and other regulatory developments. The Company
describes additional risks and uncertainties in the Risk Factors
section of its most recent annual report and quarterly reports
filed with the Securities and Exchange Commission. Any
forward-looking statements speak only as of the date of this press
release and the Company assumes no obligation to update any
forward-looking statement.
Contact:Matt NotarianniInvestor
Relations470-304-7291mnotarianni@mimedx.com
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