Volcano Corporation teams with Paieon Inc. and GE Healthcare to develop cath lab system with fully integrated IVUS capabilities

Rancho Cordova 17 October 2005Volcano Corporation and Paieon Inc. have reached agreement to jointly develop products allowing in-the-cath-lab combination of X-ray angiography in both 2D and 3D views with intravascular ultrasound - grayscale and VH IVUS. The Volcano/Paieon system is expected to allow physicians and their staff to quickly assess regions of the coronary tree and, for the first time, simultaneously visualize both the patency of the arterial lumen and the presence, quantity and type of coronary atherosclerotic plaques. In addition, Volcano and GE Healthcare have signed a significant development and collaboration agreement that is intended to bring an industry-first imaging capability to cardiac catheterization labs around the world. Under terms of the agreement, GE and Volcano will collaborate to develop a state-of-the-art digital cardiovascular imaging system with fully integrated intravascular ultrasound imaging (IVUS) capabilities.

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With the new composite coronary imaging technology, Volcano and Paieon will fuse the images and information from angiograms and ultrasound, and make the product fast, simple and readily available to research centres and community hospitals alike. Volcano plans to offer the angio/IVUS image fusion system as an option for installation and use on its new and existing installed base of InVision Gold (IVG) IVUS imaging consoles. The ability to retrofit Volcano's large installed base of IVGs with this state-of-the-art software option should speed its proliferation into clinical practice.

Prototypes of the Volcano/Paieon image fusion system - pending submission to FDA - were on display and available for demonstration in Volcano's exhibition booth at the 17th Annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington DC. The addition of this novel IVUS/Angio fusion system, plus the previously announced Revolution 45 MHz IVUS Imaging Catheter and commercial release of advanced Version 1.4 of VH IVUS software, further demonstrates Volcano's commitment to innovation in the field of intravascular imaging.

The Volcano/Paieon image fusion system will allow the user to quickly create a virtual 3D reconstruction of segments of the coronary tree using Paieon's patented 3D imaging technology which takes two 2D X-Ray angiograms and creates a three-dimensional reconstructed model of the segments of interest.

In less than two minutes, a catheter-based intravascular ultrasound assessment can then be performed and the images co-registered (synchronized) with the images from the 3D Angio reconstruction. Moments later, the interventional cardiologist and his/her team is then provided with a roadmap of the lumen size, shape, obstructive lesion length, etc. along with a comprehensive map of the quantity and location of any here-to-for unseen (on angio) atherosclerotic plaques along the length of the vessel of interest. Additional steps using Volcano's proprietary plaque characterization technology, VH IVUS, will allow further refinement of lumen and vessel borders and sizes and a detailed analysis of the composition of the atherosclerotic plaque.

According to Martin B. Leon, MD, Chairman of the Cardiovascular Research Foundation and the Associate Director of the Center for Interventional Vascular Therapy (CIVT) at Columbia University Medical Center, New York City, access to this newly available information should help with routine interventions in a number of ways.

"First, by having ready access to Paieon's 3D reconstructed images, more precise measures of obstructive lesion length should be possible and a better understanding of the location, shape and orientation of lesions should be attainable. By adding and co-registering the grayscale and VH intravascular ultrasound images, we gain important additional information about luminal integrity, size and shape, and the presence, quantity and composition of the plaque. Assuming this can be done quickly with modest training, this combination of technologies should allow state-of-the-art stent placement to be performed by a wide array of institutions. It may also allow for a reduction in the amount of radiation exposure to patients and medical personnel via reduction in the number of X-ray angio views performed." Dr. Leon continued: "With the availability of drug eluting stents, we are performing increasingly complex interventions. With this added complexity comes the need for more, better information on the location and morphology of lesions. The products anticipated from this Volcano/Paieon partnership have the potential to significantly improve patient care."

"Furthermore", Dr. Leon added, "as we continue our research into the future treatment of angiographically silent or insignificant vulnerable plaques, this type of easy-to-access composite coronary imaging technology from Volcano and Paieon will be absolutely essential. Without a rapid, reliable way to synchronize our findings on X-ray angiography with the essential information from IVUS, it is difficult to see how we would guide any therapeutic intervention in a non-obstructive plaque."

Scott Huennekens, President and CEO, Volcano Corporation commented: "We are extremely excited to collaborate with Paieon Inc. in this effort. We are convinced that by providing the interventionalist with quick, easy access to complete 3D coronary images, which includes information from both the contrast-enhanced X-ray angiogram along with the plaque localization and characterization information from our VH IVUS system, we will be contributing significantly to stent placement optimization and the advancement in the understanding of coronary artery disease. We see this as the foundation for the cath lab of the future and believe it may eventually set a new standard of visualization for stent placement. This new approach should not only improve and expedite routine stent placement, but also provide information for future research activities into disease progression and vulnerable plaques in the coronary and peripheral arteries."

Scott Huennekens continued: "We have over 1300 active IVUS consoles in use around the world. These customers have invested time and money into those consoles and, whenever possible, we invest the resources during our development process to allow older systems to be compatible with new software options, so as to remain state-of-the-art. We consistently receive feedback from our customers that they appreciate this long-term, partnership approach to our business."

Omer Barlev, CEO Paieon Inc., stated: "We regard the collaboration with Volcano as an important strategic step on our road to expansion and growth, thus fitting into our visionary plan. Volcano, being a leader in its field, has an impressive installed base which can significantly increase our market presence and exposure, helping us to become the Gold Standard of 3D visualization in the cath lab. Paieon envisions the co-operation with Volcano as an exceptional opportunity for integrating two different types of technologies and capabilities into one synergetic system greatly facilitating the workflow of interventional cardiologists."

Paieon Inc., based in New York, and its R&D subsidiary Paieon Medical Ltd., located in Israel, is a pioneering medical imaging company in the field of Interventional Cardiology. The CardiOp-B System is the world's first commercial 3D imaging system for real time use in cardiovascular procedures. Paieon's revolutionary products enable optimal utilization of data obtained from standard vascular angiography equipment, thus enhancing the capabilities of interventional cardiologists in both diagnosis and treatment. With an increasing number of installations worldwide and through continuous clinical studies at distinguished medical and research institutions, Paieon has achieved a leadership position. The CardiOp-B System is becoming recognized as the Gold Standard System for 3D quantitative vascular analysis.

The integration of GE Healthcare's best-of-class Innova all-digital x-ray system cath lab system with Volcano's new PC-based IVUS platform, is intended to give interventional cardiologists a clear view of coronary and peripheral vessel morphology. This visualization capability is intended to assist clinicians in determining the extent of cardiovascular disease and in performing therapeutic procedures such as stent placement. This is also intended to help physicians determine the length of lesion and stent length.

"GE Healthcare continues its commitment to cardiology by bringing state-of-the-art, clinically-relevant technologies to the cath lab with this latest agreement with Volcano Corporation", stated Laura King, Global Vice President and General Manager, Interventional, Cardiology and Surgery of GE Healthcare. "GE has sought opportunities to integrate IVUS technology directly into our award-winning, industry-leading Innova systems. Until the development of Volcano's PC-based IVUS product, this leapfrog in technology has not been possible. We are excited to work with another market leader to bring clinically relevant value to the cath lab."

Scott Huennekens noted: "We have a shared philosophy with GE; success in the marketplace is founded on providing solutions that are both state-of-the-art and simple to use. Technology for technology's sake is not the answer. We are dedicated to meeting the clinical needs of our customers in a way that also simplifies their lives and makes their own cath lab operations more efficient and more cost-effective, all while allowing the physician to improve patient care. This partnership is squarely focused on those goals."

The development of this new integrated hardware and software architecture is made possible, in part, due to Volcano's latest PC-based IVUS platform that dramatically reduces the size, weight and noise of the IVUS console, allowing the unit to be easily attached to the patient table, in the control room or in other areas outside of the daily traffic pattern of the cath lab. The integrated user interface is set apart from current stand-alone systems that impose many practical limitations on the regular use of IVUS.

With more than 1200 Innova all-digital x-ray systems installed worldwide, GE and Volcano are poised to facilitate greater utilization of IVUS to further guide patient management. As the clinical relevance of IVUS has increased, particularly with the recent innovations in IVUS-based on-line tissue characterization and IVUS/angio image co-registration, so too has the market need for an integrated, easy-to-use system.

Gregg Stone, MD, professor of Medicine at Columbia University College of Physicians and Surgeons commented: "We use IVUS nearly every day in our clinical practice. We do so because IVUS gives us information about vessel morphology that you can't get anywhere else and it highlights angiographically silent or ambiguous disease that you just can't see on angiograms. We do this in spite of the fact that IVUS has historically been fairly cumbersome to use, with a stand-alone cart and stand-alone images on a remote monitor. An integrated system from Volcano and GE has the potential to increase the user-friendliness of IVUS and we would welcome such a system."

Dr. William Wijns, MD, Co-Director, Cardiovascular Centre, Aalst, Belgium, elaborated: "When you have a catheterized patient on the table, often in the midst of an acute syndrome, you need your diagnostic and therapeutic tools at the ready ... there for quick and simple implementation. Many times it is just not an option to ask the staff to roll in the IVUS, turn it on and wait for the system to boot up. We have been asking for this advance from the IVUS companies for some time now. We are thrilled that Volcano and GE have recognized the need and are investing in developing this product."

"IVUS, advanced 3D angiographic imaging techniques and non-invasive imaging technologies such as MDCT/MSCTA and MRI hold the promise of unlocking many important questions surrounding the cause and progression of coronary and peripheral artery disease. Integrating information from these modalities will permit a better understanding of this disease. The integration of IVUS with angiographic systems, as envisioned in this agreement between GE and Volcano, is an important step in making truly integrated imaging feasible and practical for a wide array of physicians", commented Robert S. Schwartz, MD, of the Minneapolis Heart Institute and Foundation.

The system will require FDA clearance in the United States and elsewhere and will be co-marketed by the GE and Volcano sales and marketing organisations in the United States, Europe, certain markets in Asia and other world markets. GE will also collaborate with Volcano to provide unparalleled cath lab design, installation and field repair/service of this new system. Current GE cath lab customers can modify existing cath lab rooms with the new integrated IVUS system. Customers will be able to contract with one vendor, GE, for their purchasing, installation and field service needs.

Prototypes of the new investigational device were on display and available for demonstration in the exhibition booths of GE Healthcare and Volcano Corporation at the 17th Annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in health care and enhancing patient care by enabling health care providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions.

GE Healthcare is a $15 billion unit of General Electric Company headquartered in the United Kingdom. Worldwide, GE Healthcare employs more than 43.000 people committed to serving health care professionals and their patients in more than 100 countries.

Volcano Corporation, formerly Volcano Therapeutics Inc., is a privately held medical device company founded in 2001. Investors and shareholders include Domain Associates, Johnson and Johnson Development Corporation, Medtronic, Ferrer, Freeman & Co. and OrbiMed Advisors.

With over 475 worldwide employees, Volcano is dedicated to providing technologies leading to optimal management of coronary artery and peripheral vascular disease. Volcano products include Intravascular Ultrasound (IVUS) systems and catheters, as well as physiology guide wires. With global distribution, Volcano is a provider of innovative therapy-enabling and therapy-guiding technologies to the interventional cardiology and peripheral vascular fields.


Leslie Versweyveld

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