Symetis

Symetis

September 26, 2013 02:00 ET

Symetis and Endoluminal Sciences Enter Into a License Agreement to Develop 3rd Generation TAVI

- Symetis' ACURATE TAVI™ to incorporate Endoluminal Sciences' active anti-paravalvular leak technology

- Complements Symetis' ZeroLeak™ initiative

ECUBLENS, SWITZERLAND--(Marketwired - Sept. 26, 2013) - Symetis Inc., a privately-owned Swiss company focusing on transcatheter aortic valve implantation (TAVI) systems announces today that it has entered into a license agreement with Endoluminal Sciences (Sydney, Australia) to gain rights to their active anti-paravalvular leak technology for the TAVI field.

Endoluminal Sciences has developed a unique solution to actively reduce paravalvular leak (PVL) based upon the company's proprietary swelling polymer and membrane technology. Symetis will incorporate this technology into both the ACURATE TA™ and ACURATE TF™ product lines with the goal of continuing to reduce PVL in patients undergoing TAVI procedures.

Since the publication of Kodali et al. in 2011, reduction of PVL has been identified as the main challenge to unleashing the full potential of the TAVI market. Several companies in the TAVI market already have programs to partially address this challenge using various passive solutions. This includes Symetis' "Self-Sealing" technology that has been designed into the ACURATE TAVI™ products and has contributed to strong clinical results.

Symetis' Self-Sealing design has demonstrated clear efficacy in both clinical and real world procedures. Results from Symetis' 250 patients SAVI registry showed that approximately 97% of patients who were implanted with an ACURATE TA valve had no relevant paravalvular leak (PVL ≤1).

By combining its Self-Sealing TAVI design with Endoluminal Sciences' active anti-PVL technology, Symetis is establishing its ZeroLeak™ vision: offering superior clinical outcomes by eliminating relevant PVL for all patients, while maintaining the ACURATE reputation for uncomplicated valve delivery.

Dr. Raj Makkar, MD (Cedars Sinai, Los Angeles), a member of Endoluminal Sciences' clinical advisory team commented: "Reducing paravalvular leak is critical for long-term success of TAVI. Endoluminal Sciences' active anti-paravalvular leak technology is a novel solution to this problem."

Ashish Mitra, CEO & Founder of Endoluminal Sciences expressed, "We are very excited to partner with Symetis and to be part of the foundation of a unique 3rd generation of TAVI devices that will improve patient outcomes. The outstanding ACURATE TAVI™ products together with the Endoluminal Sciences' active anti-PVL technology will prove to be a winning combination."

Stéphane Delaloye, VP R&D at Symetis added: "Our initial in-vitro evaluation confirmed that Endoluminal Sciences' sealing technology has the potential to address PVL in the most challenging calcification patterns. Mounting this novel technology onto our ACURATE TAVI™ platform will allow us to further reduce PVL for the benefit of all patients."

About the ACURATE TA™ & ACURATE TF™

The commercially available, self-expanding ACURATE TA™ has a unique and intelligent design featuring a two-step single operator deployment technique. The most important differentiator is the "self-seating and self-sealing" architecture combined with outstanding ease-of-use throughout the procedure. This contributes to optimal positioning of the valve and promotes sealing, hence reduces paravalvular leak. The ACURATE TA™ is available in three sizes (S, M, L) to treat patients with aortic annulus diameters from 21mm to 27mm.

ACURATE TF™, Symetis' transfemoral TAVI system, is based on the same self-seating, self-sealing design and stepped deployment concept of ACURATE TA™ and currently is under clinical investigation to obtain CE mark by end 2013. ACURATE TF™ is composed of a porcine pericardial tissue valve sutured within a self-expanding nitinol stent covered by a pericardial skirt on the interior and exterior of the device. ACURATE TF™ will be available in four sizes (XS, S, M, L) and its Delivery System boasts an 18F outer diameter.

For more information on ACURATE TA™ and ACURATE TF™, please see www.pcronline.com/redirect/2013-EuroPCR-Symetis/.

About Symetis

Symetis Inc. is a privately-owned Swiss company developing innovative, minimally invasive heart valve replacement solutions (www.symetis.com). The company's products, ACURATE TA™ and ACURATE TF™, are based on proprietary geometry and delivery technologies and are well positioned to target the estimated $2 billion TAVI market. Based in Lausanne, the company is financed by leading European venture capital firms, including Truffle Capital, Novartis Venture Fund, Wellington Partners, Aravis Venture, Vinci Capital, Banexi Ventures, Endeavour Vision, NBGI Ventures and BiomedInvest.

About Endoluminal Sciences

Endoluminal Sciences is a Sydney, Australia-based, venture capital-backed company committed to the development of novel, platform technologies to dramatically enhance the clinical performance of endovascular prostheses. While its novel technologies are foreseen to have applications in a range of vascular disease states, the immediate focus is the transcatheter treatment of structural heart disease. The company is financed by GBS Venture Partners, Australia's leading healthcare venture capital firm, and Reidsdale Investments.

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