Healthcare Industry News:   XTENT  

Devices Interventional Cardiology

 News Release - March 13, 2006

Xtent CUSTOM I Trial Shows Zero Restenosis at Four Months

Principal Investigator Presents Mid-Term Results at ACC

ATLANTA, GA and MENLO PARK, CA--(Healthcare Sales & Marketing Network)--Mar 13, 2006 -- Xtent, Inc., developer of next-generation drug-eluting stent (DES) systems, today announced four-month follow up results from its CUSTOM I trial, designed to demonstrate the XTENT system's ability to customize stent length in situ to accurately match diseased coronary artery lesions. All 30 patients are alive and well, and there was zero percent restenosis.

Professor Eberhard Grube, Chief of Cardiology at the Heart Center Siegburg in Siegburg, Germany, and principal investigator for the multi-center CUSTOM I trial, presented these and other data at a late-breaking clinical trial session during the American College of Cardiology annual meeting in Atlanta. The trial completed enrollment in July 2005.

"The interim results with the XTENT DES system are very encouraging and strongly support the feasibility and safety of in situ stent customization," said Professor Grube. "We saw no target vessel failure or stent thromboses despite the long lesions treated and the small average vessel diameters (2.6mm)."

The objective of the CUSTOM I trial is to demonstrate the safety of in situ stent-length customization in 30 consecutive patients treated using the Xtent® system to place custom-length stents coated with Biolimus A9(TM) and a bioerodable polymer. The four-month endpoints were: angiographic late loss, the difference between interior vessel diameter measured immediately post-procedure and at four months; and neointimal tissue volume, an indicator of restenosis of the treated artery that is measured with intravascular ultrasound (IVUS).

Additional results presented by Dr. Grube further reinforced the success of the XTENT approach, including no change in MACE (major adverse cardiac events) since the 30-day data presented at TCT, and late loss comparable to other Biolimus A9 trials such as Biosensors' STEALTH trial and Devax's AXXESS PLUS trial.

"The IVUS results demonstrated the potency of Biolimus A9 in preventing neointimal growth," said Peter Fitzgerald, MD, PhD, director, Cardiovascular Core Analysis Lab, Stanford University Medical Center. "This data takes a significant step forward in establishing the viability of Xtent's customizable stent system as a platform to address the treatment of complex disease."

"We're thrilled with these four-month results from our CUSTOM I first-in-man trial," said XTENT president and CEO Greg Casciaro. "The largest and fastest-growing segment of the $5 billion DES market is patients with complex disease. We are very pleased with the level of enthusiasm that our investigators have shared from their experience in the CUSTOM I trial. This excitement has now been corroborated from an additional five centers treating patients in our ongoing CUSTOM II trial. This trial is evaluating the safety and efficacy of the XTENT DES System in a patient population even more representative of the real world -- patients with longer lesions, multiple lesions and multi-vessel disease."

About Xtent

Xtent is a privately held developer of next-generation drug-eluting stent (DES) systems designed for the treatment of real-world patients, those with complex, multi-vessel, and multi-lesion coronary and peripheral vascular disease. Although the field of interventional cardiology is today dominated by large companies such as Boston Scientific and Johnson & Johnson, the field has seen many technological breakthroughs that have changed market leadership. XTENT is bringing on the next revolution in interventional cardiology, the move from fixed length, single-lesion devices to custom length, multiple-lesion treatment systems.

Xtent's customizable DES systems are designed to enable the customized treatment of multiple lesions of varying lengths in one or more vessels in a single catheter intervention. Having completed its CUSTOM I clinical trial, the company is now enrolling patients in the expanded CUSTOM II trial in multiple European centers. Market approvals for the XTENT DES system are expected in Europe in 2007 and in the US in 2009.

Based in Menlo Park, California, XTENT is funded by leading venture capital firms including Advanced Technology Ventures, Latterell Venture Partners, Morgenthaler Ventures, and Split Rock Partners, co-manager of St. Paul Venture Capital.

Source: Xtent

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