Svelte Medical Systems and ASAHI INTECC Announce Manufacturing and Co-Branding Agreements

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Svelte Medical Systems and ASAHI INTECC Announce Manufacturing and Co-Branding Agreements

February 12, 2015

NEW PROVIDENCE, N.J. and Tokyo, Japan – Svelte Medical Systems, Inc., a privately held company engaged in the development of highly deliverable balloon-expandable stents, and ASAHI INTECC CO., LTD. (Securities Code 7747, Second Section, Tokyo and Nagoya Stock Exchange) today announced Svelte and ASAHI INTECC USA, INC., a subsidiary company of ASAHI INTECC CO., LTD., executed formal agreements relating to the manufacture and co-branding of the Svelte drug-eluting coronary stent fixed wire Integrated Delivery System (IDS). The collaboration will feature ASAHI’s latest ACTONE™ wire technology in the design, development and supply of core wire and coil assemblies for the Svelte IDS.

The Svelte IDS is designed to optimize transradial (through the wrist) interventions (TRI) and the ‘slender’ approach to Percutaneous Coronary Intervention (PCI). With the lowest-crimped stent profile on the market, the Svelte IDS allows physicians to downsize catheter sizes used during procedures. In Japan and parts of Europe, TRI is the default interventional strategy. In the U.S., the number of TRI procedures is growing rapidly, increasing from less than 5 percent of procedures in 2007 to more than 25 percent today. Svelte is working with regulatory authorities to secure approval to conduct pivotal studies with the IDS in Japan and the US and expects the IDS to be commercially available in Europe in 2015.

“Our collaboration with ASAHI INTECC takes our fixed wire stent program to the next level at a time when global support for TRI procedures and the ‘slender approach’ is growing rapidly, especially in the U.S.,” said Jack Darby, President and CEO of Svelte Medical Systems. “The Svelte fixed wire IDS represents the first change in coronary stent delivery since the advent of the rapid exchange catheter. By leveraging our innovations with world-class ASAHI INTECC expertise and wire technology, we will create a truly unique drug-eluting coronary stent platform which enhances patient outcomes while minimizing costs to the healthcare system.”

“Svelte Medical Systems has a unique and promising drug-eluting coronary stent platform,” said Masahiko Miyata, president and chief executive officer, ASAHI INTECC CO., LTD. “With the unique fusion of Asahi advanced wire technology and components and novel Svelte technology, this partnership should improve procedure outcomes worldwide.”

ASAHI INTECC CO., LTD. specializes in wire drawing, wire forming, torque transmission and coating processes for percutaneous transluminal coronary angioplasty (PTCA) guidewires.

About ASAHI INTECC CO., LTD.

ASAHI INTECC CO., LTD. develops, manufactures and sells original brand guidewires and catheters used in less invasive cardiovascular, peripheral vascular, abdominal vascular and neurovascular procedures, as well as original equipment manufacturer (OEM) products and medical components. The original brand PTCA guidewires have top market share in Japan. In the industrial device field, ASAHI INTECC CO., LTD. supplies ultrafine stainless wire rope used in a wide range of applications such as office automation equipment and automobiles. ASAHI INTECC CO., LTD. identifies its mission as continuing to provide the world market with its “Only One” technology and “Number One” product for less invasive procedures to improve patients’ quality of life.

About Svelte Medical Systems

Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

For additional information please contact Jack Darby, President and CEO, Svelte Medical Systems, Inc., via e-mail jdarby@sveltemedical.com or phone 908-264-2012.