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Next-gen drug-eluting stents, novel drug polymer
conjugates and neurostimulation for severe
headaches are featured in this edition of
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Elixir Medical
Specialty area(s): Interventional
cardiology
Based in: Sunnyvale, California, US
Founded in: 2005
No. of employees: 35
Total investment received to date:
$85m
Investors: Invus Group and
Elixir founder
When Johnson & Johnson, the first to
enter the drug-eluting stent market with
Cypher, buckled under the pressure of
increased competition and bowed out
of the DES arena in June 2011, it struck
a clear message of just how heated
the marketplace has become. The DES
business continues to be dominated
by big medtech players such as Abbott,
Boston Scientific and Medtronic, but
there are also a multitude of smaller
firms looking to carve a slice of the pie
for themselves.
Elixir Medical is one such company
and CEO Motasim Sirhan plans to
bring to the interventional cardiology
market one of the “broadest portfolios
to address the various clinical needs of
the patients”.
The firm was founded in 2005 and
has already begun commercialising in
Europe, the Middle East and in Asia
its novolimus-eluting stent platform
DESyne. The device consists of a
cobalt chromium stent with Elixir’s
Formula X drug/polymer coating
Elixir’s DESolve resorbable stent
technology. This proprietary coating
technology not only allows for thin
struts and a very low polymer load
(as compared to Abbott’s Xience V
and Medtronic’s Resolute), the use of
novolimus as the eluted drug enables
DESyne to have the lowest drug dose
of any DES currently available on the
market, according to Mr Sirhan.
Novolimus, a novel m-tor inhibitor
compound developed by Elixir, is an
active metabolite of sirolimus, the
drug that was used in J&J’s Cypher
DES and which has a well-established
safety profile, explains Mr Sirhan. But
novolimus has the added features
of being able to better penetrate the
tissue and on a more consistent basis,
which means the stent coating can
be loaded with a lower drug dose,
explains the CEO.
DESyne gained its CE mark approval
in 2011 based on data from a clinical
trial which compared the stent with
Medtronic’s Endeavor zotarolimuseluting stent. Zotarolimus is an m-tor
inhibitor and analogue of sirolimus.
Elixir chose to pit DESyne against
Endeavor because, at the time the
company was looking at the market,
there was significant concern over
stent thrombosis. “Endeavor was
considered to be the safest DES so
we felt if we were able to establish
superiority on clinical efficacy and noninferiority on safety, we would have an
excellent platform that would be widely
accepted,” Mr Sirhan tells Clinica.
Not only did DESyne demonstrate
non-inferiority and superiority to
Endeavor on the primary endpoint
of in-stent late lumen loss at nine
months, Elixir’s device outperformed
Medtronic’s in the long-term, followup data. At three years, the measure
of major adverse events for DESyne
was exceptionally low and essentially
unchanged through 1, 2 and 3 years,
while this measure for Endeavor
increased yearly with a trend towards
statistical significance. In addition,
clinically indicated target lesion
revascularisation rates at three years
were significantly lower in favour of
DESyne as compared to Endeavor.
“That is one of the key
differentiating factors of our stents
compared to other products; you see
www.clinica.co.uk
Sirhan, adding that the firm is “excited
with the exceptional results at two-year
follow up”.
Taking another step further from
biodegradable coatings, Elixir has in
its pipeline a fully resorbable scaffold
platform, DESolve. The device sports
the same novolimus coating as DESyne
BD, but the entire scaffold is designed
to dissolve in about one year. Mr Sirhan
believes the scaffold design of DESolve
has other differentiating features
including its ability to better conform
to the patient’s anatomy. “It can selfcorrect to better appose the vessel wall
and over-expand without fracture. It
can also be manufactured in wide size
ranges,” he says.
DESolve has presented data from
first-in-man clinical trial and also
completed enrolment for a pivotal,
multi-centre clinical trial of DESolve
and will present the dat a at Late
Breaking Trial Session at EuroPCR
2013 in Paris in May.
Mr Sirhan says he anticipates CE
mark for DESolve in 2013; Elixir would
be the second company to bring
to market a fully resorbable stent.
their results deteriorating year after
year, while we have maintained our
exceptional safety and efficacy results
from nine months through three years,”
says Mr Sirhan.
Elixir is currently selling DESyne
through distributors and, in line with
its mission to provide the “broadest
portfolio”, the product is available in a
wide range of sizes. The company is
evaluating a hybrid commercialisation
model for some countries in Europe
and Mr Sirhan says he would
“welcome opportunities for strategic
partnerships that make sense to Elixir”.
Next-gen DESs
Elixir is also poised to launch this year
DESyne BD, its novolimus-eluting stent
which has a coating that biodegrades
in about six months, leaving behind a
bare metal surface. The product was
approved for CE marking in August last
year, based on six-month data from
a clinical trial that compared DESyne
BD against Medtronic’s Endeavor. “At
six months, the same superiority over
Endeavor was also established with
DESyne BD as with DESyne,” says Mr
Abbott currently has the monopoly in
this market, gained when its Absorb
bioresorbable stent was CE marked in
2011. In terms of Elixir’s US strategy
for DESolve, as well as for DESyne and
DESyne BD, the firm is pursuing an FDA
approval to conduct an investigational
device exemption clinical trial.
Mr Sirhan believes that there is
“incredible opportunity” for innovation
to reinvigorate the cardiology industry
and it would be down to products like
DESolve and Absorb that galvanise a
new wave of growth in the market.
“The coronary stent market is
valued at $5bn on an annual basis;
as with many industries, you reach
a certain maturity and it needs to
strive for innovation to take it to the
next level and this innovation is the
bioresorbable scaffold technology. We
believe it will take the market from
$5bn to $10bn.”
Motasim Sirhan, CEO.
Tel: +1 408 636 2000
Elixir Medical. 870 Hermosa Drive,
Sunnyvale, CA 94085, US.
www.elixirmedical.com
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