AVITA Medical Announces Exclusive Distribution Agreement with Stedical Scientific
January 10 2024 - 4:01PM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a
commercial-stage regenerative medicine company focused on
first-in-class devices and autologous cellular therapies for skin
restoration, today announced it has entered into an exclusive
multi-year distribution agreement with Stedical Scientific, Inc. to
commercialize PermeaDerm® Biosynthetic Wound Matrix in the United
States. PermeaDerm is cleared by the Food and Drug Administration
as a transparent matrix for use in the treatment of a variety of
wound types until healing is achieved.
Under the terms of the agreement, AVITA Medical will hold the
exclusive rights to market, sell, and distribute PermeaDerm
products, including any future enhancements or modifications,
within the United States. The initial term is for five years, with
the option to renew for an additional five years, contingent upon
meeting certain minimums. The Company expects the gross margin from
the sale of PermeaDerm to be 50% of the average sales price.
“Our partnership with Stedical Scientific is an important step
in expanding our portfolio and addressing the unmet needs of our
patients,” said Jim Corbett, Chief Executive Officer of AVITA
Medical. “AVITA Medical and Stedical Scientific are ideal partners
given the complementary nature of our products, the overlap of call
points, and the strength of our footprint and sales force. We
anticipate these synergies will allow us to effectively leverage
our established commercial presence, enhancing the integration of
PermeaDerm into our portfolio. This strategic collaboration
underscores our commitment to delivering innovative solutions and
improving outcomes for those we serve.”
PermeaDerm is a biosynthetic matrix that facilitates wound
healing while also providing a high level of permeability and
biocompatibility. For burn or wound procedures treated with
Spray-On Skin™ Cells from the RECELL® System, PermeaDerm can be
applied to further aid in healing. PermeaDerm is eligible for
reimbursement in the U.S. across inpatient and outpatient
settings.
“We are thrilled to mark this important growth milestone with
AVITA Medical, who shares our goal of treating millions of patients
suffering from a broad spectrum of wounds,” said Lin Sun, Chairman
of Stedical Scientific. “AVITA Medical has an established presence
in the U.S. wound care market, further validating the clinical and
commercial value of PermeaDerm. This collaboration will expand our
reach to more patients, physicians, and hospitals with a compelling
portfolio of solutions that improve care and surgical performance.
We look forward to a long and successful partnership.”
About AVITA Medical, Inc.AVITA Medical® is a
commercial-stage regenerative medicine company transforming the
standard of care for skin restoration with innovative devices and
autologous cellular therapies. At the forefront of our platform is
the RECELL® System, approved by the Food and Drug Administration
for the treatment of thermal burn wounds and full-thickness skin
defects, and for repigmentation of stable depigmented vitiligo
lesions. RECELL harnesses the regenerative properties of a
patient’s own skin to create Spray-On Skin™ Cells, delivering a
transformative solution at the point-of-care. RECELL enables
improved clinical outcomes. This breakthrough technology serves as
the catalyst for a new treatment paradigm enabling improved
clinical outcomes.
In international markets, our products are approved under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, full-thickness skin defects, and
vitiligo. The RECELL System is TGA-registered in Australia,
received CE-mark approval in Europe and has PMDA approval in
Japan.
To learn more, visit www.avitamedical.com.
About Stedical Scientific, Inc.Stedical
Scientific, Inc. is an innovative tissue engineering and
regenerative medicine company that develops, manufactures and sells
cutting-edge products delivered from a proprietary biosynthetic
technology platform for the treatment of acute and chronic wounds,
burns, as well as for plastic and reconstructive surgery. Stedical
Scientific’s mission is to expand its portfolios of disruptive
innovations and to serve millions of people around the globe.
Stedical Scientific has brought extraordinary clinical experience
to patients through its signature product, PermeaDerm®,
revolutionizing wound care.
Stedical Scientific’s growth strategy, in addition to marketing
products in the U.S., is to expand extensively in the international
market, while committed to substantially improving patient and
clinician experiences through breakthrough technologies and
changing the course of human health.
To learn more, visit www.stedical.com.
Forward-Looking Statements Statements in this
press release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are subject to significant risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Forward-looking statements generally may be identified by the use
of words such as “anticipate,” “expect,” “intend,” “could,” “may,”
“will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,”
“target,” “project,” “continue,” “outlook,” “guidance,” “future,”
and similar words or expressions, and the use of future dates.
Forward-looking statements in this press release include, but are
not limited to, statements concerning, among other things, our
partnership with Stedical Scientific, and the anticipated benefits
and financial impact of the partnership. These statements are made
as of the date of this release, and the Company undertakes no
obligation to publicly update or revise any of these statements,
except as required by law. For additional information and other
important factors that may cause actual results to differ
materially from forward-looking statements, please see the “Risk
Factors” section of the Company’s latest Annual Report on Form 10-K
and other publicly available filings for a discussion of these and
other risks and uncertainties.
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
Investor & Media Contact:
Jessica Ekeberg
Phone +1-661-904-9269
investor@avitamedical.com
media@avitamedical.com
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