Friday August 3, 2012 0 comments
CASTLE ROCK - AspenBio Pharma Inc. (Nasdaq: APPY) has added medical diagnostic and biotechnology veteran Dr. Lyndal Hesterberg to lead the company's AppyScore product development, the company announced.
Dr. Hesterberg brings to AspenBio more than 30 years of experience with a diverse background in research, product development and clinical and regulatory successes, including 510(k) submissions.
Hesterberg's specific experience includes development of multiplexed IVDMIA "multiple marker" diagnostic products, the company said.
AppyScore is AspenBio's lead product and is a blood-based test designed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative treatment planning.
The product is initially being developed for pediatric, adolescent and young adult patients with abdominal pain who are the population at greatest risk for appendicitis as well as having the highest risk for long-term health effects associated with CT imaging.
"Adding Lyndal to the AspenBio team infuses the company with a proven, experienced biomedical diagnostic executive who has built a career bringing technologies from bench to bedside," said Steve Lundy, AspenBio president and CEO.
"His expertise, particularly in scaling product development for clinical and commercial purposes, will be invaluable as AspenBio prepares to initiate a clinical trial of ApplyScore in the third quarter of 2012, targets EU commercialization in the fourth quarter and seeks FDA clearance and builds toward U.S. commercialization in 2013."
Dr. Hesterberg has been a consultant with AspenBio since January, during which time he has played a key role in R&D, product development and clinical and regulatory matters for AppyScore, the company said.
Prior to joining AspenBio, Hesterberg served as chief technology officer for Crescendo Bioscience Inc., a molecular diagnostics lab focused on rheumatology. He founded BaroFold Inc. in 2003, serving as the company's president and CEO until 2008.
For more information, visit www.aspenbiopharma.com.