Avita Medical Initiates Legal Proceedings to Cancel Renovacare Patent
May 10 2017 - 9:05PM
Business Wire
Avita Medical Limited (ASX:AVH; OTCQX:AVMXY), a regenerative
medicine company focused on the treatment of wounds and skin
defects, has filed an Inter Partes Review (IPR) petition against US
Patent No. 9,610,430 (the ‘430 patent) owned by Renovacare Sciences
Corp., as Avita holds that all claims in the ‘430 patent are
unpatentable and should be cancelled.
Avita filed the IPR challenge with the US Patent Trial and
Appeal Board (PTAB), which has accepted the petition and will now
decide whether the case should come to trial. The IPR process
allows a petitioner to challenge the validity of a patent by
looking at prior art consisting of patents and printed
publications. Avita’s IPR petition has been assigned the Review
Number IPR2017‐01243.
“We believe we have presented a very strong rationale to the
PTAB as to why this patent should never have been issued, and thus,
we respectfully request that all claims in the ‘430 patent should
be cancelled,” said Avita CEO Adam Kelliher. “Avita is a pioneer in
the regenerative medicine arena, and we are very protective of our
intellectual property rights.”
ABOUT AVITA MEDICAL LIMITED
Avita’s patented and proprietary collection and application
technology provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. Our medical
devices work by preparing a Regenerative Epithelial Suspension
(RES™), an autologous suspension comprised of the patients’
own skin cells and wound healing factors that are necessary to
regenerate natural healthy skin. This is then applied to the area
to be treated.
In all countries outside of Europe, our portfolio is marketed
under the ReCell® brand to promote skin healing in a wide
range of applications including burns, chronic wounds and
aesthetics.
ReCell® is TGA‐registered in Australia, and CFDA‐cleared in
China. In the United States, ReCell® is an investigational
device limited by federal law to investigational and compassionate
use.
In Europe, our portfolio of medical device products received
CE-mark approval as three tailored product presentations, with
three individual brand names. ReCell® is designed for the
treatment of burns and plastic reconstructive procedures;
ReGenerCell™ has been formulated for chronic wounds including leg
and foot ulcers; and ReNovaCell™ is tailored for aesthetic
applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These
forward-looking statements generally can 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,”
other words of similar meaning and the use of future dates.
Forward-looking statements in this letter include, but are not
limited to, statements concerning, among other things, our ongoing
clinical trials and product development activities, regulatory
approval of our products, the potential for future growth in our
business, and our ability to achieve our key strategic, operational
and financial goal. Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Each
forward-looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement.
Applicable risks and uncertainties include, among others, the
timing of regulatory approvals of our products; physician
acceptance, endorsement, and use of our products; failure to
achieve the anticipated benefits from approval of our products; the
effect of regulatory actions; product liability claims; risks
associated with international operations and expansion; and other
business effects, including the effects of industry, economic or
political conditions outside of the company’s control. Investors
should not place considerable reliance on the forward-looking
statements contained in this letter. Investors are encouraged to
read our publicly available filings for a discussion of these and
other risks and uncertainties. The forward-looking statements in
this letter speak only as of the date of this release, and we
undertake no obligation to update or revise any of these
statements.
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Avita Medical LtdAdam KelliherChief Executive
OfficerPhone: +44 020 8947 9804akelliher@avitamedical.comorTim
RooneyChief Financial OfficerPhone: + 1 (661)
367-9170trooney@avitamedical.comorAustraliaMonsoon
CommunicationsSarah KemterPhone: +61 (0)3 9620 3333Mobile: +61
(0)407 162 530sarahk@monsoon.com.auorUSAWestwicke
PartnersJamar IsmailPhone: +1 (415)
513-1282jamar.ismail@westwicke.com
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