AspenBio Pharma is an emerging biomedical diagnostic company dedicated to the development of AppyScore™, a test that is designed to help emergency physicians manage the large numbers of patients who enter emergency departments each year complaining of abdominal pain, many of whom are suspected of having acute appendicitis but are at low risk for the disease. The company is focused on obtaining U.S. FDA clearance and the European "CE Mark" for this test.
AspenBio recently reached out to shareholders, asking them to approve changing its name to Venaxis, Inc. The company had previously addressed the potential for a name change as part of its strategic rebranding in line with its focus on AppyScore. Also part of the corporate re-alignment AspenBio seeks to attain, the company further asked for shareholder approval on an increase in the number of shares available under its equity plan.
"We believe 'Venaxis' is more reflective of our current business," said Steve Lundy, President and CEO of AspenBio. "The name is a combination of 'Vena' and 'Axis'. Vena is Latin for vein, which ties to our product, a blood-based in vitro diagnostic test that is entering a pivotal study. Axis conveys the idea of a central or principal structure, which lends the proposed Company name strength and agility. We are focused on the future and we believe Venaxis provides an important foundation to build a long-lasting brand in the diagnostics sector."
In addition to these proposed measures, AspenBio also provided its shareholders and the broader investment community with an update on its clinical business activities. Part of this announcement focused on the company's plan to initiate a pivotal study during the fourth quarter of 2012. The study will pertain to its blood-based appendicitis test. The decision to move ahead with the study came after a productive meeting was held with the U.S. Food and Drug Administration (FDA). While seeking approval in the U.S., AspenBio plans to obtain CE Mark before the end of the year and introduce the product in Europe shortly after.
"We are very pleased with the recent progress we have made in executing on our key development objectives," said Steve Lundy, President and CEO of AspenBio. "Most importantly, after meeting with the FDA, we plan to initiate our pivotal study in the U.S. during the fourth quarter. We are currently modifying the study protocol in accordance with the FDA's constructive feedback, and we continue to engage hospitals across the U.S. for participation in our study. In parallel, we are preparing to launch the product in Europe once we obtain a CE Mark, which we anticipate receiving during the fourth quarter."
For more information on AspenBio Pharma, visit www.aspenbiopharma.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html