Elixir Medical Corporation

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CLINICA's Hot Pick of the Month | Elixir Medical

APRIL 2013  |  View original article (PDF)

Next-gen drug-eluting stents, novel drug polymer conjugates and neurostimulation for severe headaches are featured in this edition of Medtech Ventures

Specialty area: Interventionalcardiology
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 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-torinhibitor 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 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 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. 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