A Diagnostics & Imaging Week

Cambridge Heart (Bedford, Massachusetts) said it has amended its sales and marketing agreement with St. Jude Medical (St. Paul, Minnesota).

St. Jude's sales force now will be able to market Cambridge Heart's HearTwave II Microvolt T-Wave Alternans (MTWA) test to North American primary care and internal medicine physicians. In addition, Cambridge Heart's sales force now will have the ability to support St. Jude Medical's field sales force in all physician markets in North America.

Under the original agreement, signed in March, the cardiology and electrophysiology markets were to be targeted by St. Jude Medical's field force, and Cambridge Heart's representatives addressed the internal medicine and primary care markets.

"The amendment reflects the growing synergistic partnership between our two field sales forces and highlights the benefits of employing a strategic joint approach. Many patients at high risk for sudden cardiac death are in the care of internal medicine and primary care physicians, and the importance of addressing this population has been recognized increasingly by the CRM industry," said Robert Khederian, interim CEO and chairman of Cambridge Heart.

"Expanding the collaborative partnership provides us with an opportunity to penetrate the internal medicine and primary care markets more efficiently. Our two sales forces have worked very well together over the last few months, and by jointly addressing all markets, we can increase awareness for sudden cardiac death and enhance the adoption of MTWA as an effective tool for identifying high-risk patients."

Cambridge Heart said there are no other changes to the agreement, and the company's guidance for 2007 remains $14-$16 million in revenue. Apart from expanding the markets in which Cambridge Heart and St. Jude Medical may work together, the amended agreement retains substantially the same material terms as the original agreement, as outlined in the Form 8-K Cambridge Heart filed with the Securities and Exchange Commission on March 27.

Cambridge Heart's MTWA test measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person's electrocardiogram, the company said. This pattern of fluctuations is called T-wave Alternans. These tiny variations in the electrocardiogram, measured at one millionth of a volt accuracy, are measured most commonly during a sub-maximal exercise stress test in the physician's office or hospital outpatient setting. Extensive clinical research has shown patients with a positive or non-negative MTWA test are at increased risk for sudden cardiac death (SCD), while those who test negative are at reduced risk, the company noted.

Cambridge Heart develops products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest.

In other agreements:

• CompleWare (North Liberty, Iowa), VIDA Diagnostics (Coralville, Iowa) and the University of Iowa (Iowa City) reported that they will collaborate in providing software and services to manage radiological images for clinical drug trials. The software would give pharmaceutical companies the opportunity to use just one software application to collect clinical research data.

"This is an exciting opportunity that allows pharmaceutical companies to collect, analyze, manage and report all clinical research data using only one software application," said John Weiler, MD, CompleWare president. "Companies performing clinical research want all data to be integrated. We call this interoperability."

CompleWare offers products and services to manage clinical research studies, with customers worldwide. The University of Iowa, Department of Radiology, specializes in development of imaging protocols and quantitative central review. VIDA, which produces software based on technology developed at the University of Iowa, provides the ability to automate review of lung X-ray images using advanced software.

Edwin van Beek, MD, professor of radiology, said, "We will work together to provide unique radiological services to the pharmaceutical industry." We can significantly enhance the information we obtain from imaging studies."

• Luna Innovations (Roanoke, Virginia) said that it has entered into an IP licensing, development, and supply agreement with Intuitive Surgical (Sunnyvale, California). Luna will develop and supply its fiber optic-based shape sensing and position tracking system for integration into Intuitive Surgical's products, which includes the da Vinci surgical system.

"This agreement with Intuitive Surgical expands our presence within the medical devices market and further demonstrates the strength of our business model focused on the commercialization of our proprietary technologies and intellectual property. Our technology, partnered with the world leader in medical robotics, will help surgeons precisely guide and control surgical tools during robotically assisted procedures," stated Kent Murphy, Luna's CEO/chairman. "It's truly rewarding to know that Luna's technology will be assisting in complex minimally invasive surgery helping to ensure the best outcome for patients."

Luna's shape sensing and position tracking system promises to provide real-time position measurements to help surgeons navigate through the body. The system consists of software, instrumentation and disposable optical sensing fiber. Luna's technology is designed to provide the user with an accurate, direct and continuous measurement of device location with no adverse effect from line of sight limitations and without introducing electrical signals or radiation into the body.