VIDA Diagnostics Gains FDA Approval for Software

Monday, December 1, 2008

University of Iowa News Release

VIDA Diagnostics Inc., a University of Iowa Research Foundation licensee and UI Technology Innovation Center business incubator tenant, announced today that its primary product, Pulmonary Workstation 2.0 (PW2), has obtained FDA 510(k) clearance for sale.

PW2 is the first commercial release of lung image analysis software from VIDA and comprises a comprehensive approach to quantitative, repeatable lung measurements including the industry's first so-approved automatic lobe density and airway system measurement functions.

"We are privileged to be given the opportunity to make our leading PW2 application available to assist in the evaluation of millions of chronic obstructive pulmonary disease (COPD) and emphysema patients throughout the U.S.," said John Garber, VIDA CEO. "Since these diseases often affect specific regions of the lung, the ability to individually and objectively measure each of the five lobes and 25 major airways should fast become an invaluable complement to existing systemic measures like pulmonary function tests."

"The University of Iowa congratulates VIDA on this important milestone," said Tom Sharpe, associate vice president for economic development at the UI. "We are proud of VIDA's accomplishments as well as the unique medical imaging center of excellence at the university that was the early innovator of this important technology. And we're pleased that the infrastructure we have developed at UI to support early stage technology companies has contributed to VIDA's success."

VIDA's PW2 takes the complex information from a CT (computed tomography) scan of the lung and converts it into useful 3D images and measurements that are easily viewed by the practicing pulmonologist at the point of patient service, or by the radiologist in the radiology department. For the first time, airway, lung, and lobe measurement tools are combined in the comprehensive PW2 software application. Other lung products from VIDA will be available shortly.

"PW2 has set the standard for lung image analysis in the pulmonary research community, with installations at 27 top research sites and has been used to process over 10,000 CT scans in the last three years," Garber said.

"The capabilities of PW2, shown to be helpful in the clinical research environment, can now be extended into the broader clinical practice," said Geoff McLennan, VIDA co-founder and professor of medicine and radiology at UI. "This bench-to-bedside research and development, undertaken at the University of Iowa, can therefore now be made available to the wider national and international community of medical practitioners and to the people they serve, the patients."

"We are very pleased to see that our research efforts, originally supported through basic, and then translational research grants from the National Institutes of Health, have now made their way all the way through the FDA vetting process and will begin to serve the clinical community," said Eric Hoffman, UI professor of biomedical engineering, nursing and radiology, and a co-founder of VIDA.

VIDA Diagnostics was founded in 2004 by four UI faculty members: Hoffman and McLennan; Joseph Reinhardt, associate professor of biomedical engineering; and Milan Sonka, professor of electrical and computer engineering.

The National Institutes of Health have awarded four Small Business Innovation Research grants to VIDA in the past five years. VIDA Diagnostics has also received funding from the Iowa First Capital Fund II via Corridor Management Co. The UI investigators also received a UI Battelle Award for the development of their core research platform. For more information about VIDA Diagnostics visit http://www.vidadiagnostics.com.

The UI Research Foundation and Technology Innovation Center are part of the IOWA Centers for Enterprise, which integrates existing economic development activities at the UI, offers a comprehensive program that promotes economic development and technology transfer, provides assistance to Iowa startups and existing Iowa businesses and communities, and helps the state of Iowa develop a creative, entrepreneurial workforce. IOWA Centers for Enterprise optimizes the flow of university intellectual property into opportunities for licensing, commercialization and business development. For more information visit http://enterprise.uiowa.edu.

STORY SOURCE: University of Iowa News Services, 300 Plaza Centre One, Suite 371, Iowa City, Iowa 52242-2500

MEDIA CONTACTS: John Garber, VIDA Diagnostics, 319-335-4740, johngarber@vidadiagnostics.com; Thomas Sharpe, UI vice president for economic development, 319-335-3899, thomas-sharpe@uiowa.edu; David Pedersen, University of Iowa Health Science Relations, 319-335-8032, david-pedersen@uiowa.edu; George McCrory, University News Services, 319-384-0012, george-mccrory@uiowa.edu