AspenBio Pharma, Inc. Enhances Product Development & Manufacturing Capabilities in Preparation for Clinical Trial and Commercialization of AppyScore™
Published: Aug 02, 2012
CASTLE ROCK, Colo., Aug. 1, 2012 /PRNewswire/ -- AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, announced that Lyndal Hesterberg, Ph.D., has agreed to lead the Company's AppyScore product development. Dr. Hesterberg brings to AspenBio more than 30 years of experience in the medical diagnostic and biotechnology industry with a diverse background in research, product development and clinical and regulatory successes, including 510(k) submissions. His specific experience includes development of multiplexed IVDMIA "multiple-marker" diagnostic products.
Steve Lundy, President and CEO of AspenBio, commented, "Adding Lyndal to the AspenBio team infuses the company with a proven, experienced medical diagnostic executive who has built a career bringing technologies from bench to bedside. His expertise, particularly in scaling product development for clinical and commercial purposes, will be invaluable as AspenBio prepares to initiate a clinical trial of AppyScore in the third quarter of 2012, targets EU commercialization in the fourth quarter, and seeks FDA clearance and builds towards potential US commercialization in 2013."
Dr. Hesterberg has been a consultant with AspenBio since January 2012 during which time he has played a key role in R&D, product development and clinical and regulatory matters for AppyScore. Prior to joining AspenBio, Dr. Hesterberg served as Chief Technology Officer of Crescendo Bioscience, Inc., a molecular diagnostics laboratory focused on rheumatology. As CTO, Dr. Hesterberg was responsible for the rapid development of multiplexed IVDMIA products.
An entrepreneur as well as a senior operating executive, Dr. Hesterberg founded BaroFold, Inc. in 2003, serving as the company's president and CEO until 2008. In addition to Crescendo and BaroFold, Dr. Hesterberg's career is highlighted by high-ranking directorial and operational positions with SomaLogic, Inc.; Thermo BioStar, Inc.; Amgen, Inc.; and Syngene Products and Research, Inc.
Dr. Hesterberg holds a doctorate in biochemistry from St. Louis University and a bachelors of science, biochemistry from the University of Illinois. He completed his post-doctoral fellow at the Max Planck Institute for Biophysical Chemistry.
About AspenBio Pharma
AspenBio Pharma, Inc. is an in vitro diagnostic company focused on the clinical development and commercialization of its lead product, AppyScore. AppyScore is a unique blood-based test designed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative treatment planning. AppyScore is initially being developed for pediatric, adolescent and young adult patients with abdominal pain as this population is at the highest risk for appendicitis as well having the highest risk of long-term health effects associated with CT imaging. For more information, visit www.aspenbiopharma.com.
This press release includes "forward-looking statements" of AspenBio Pharma, Inc. ("AspenBio") as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that AspenBio believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors AspenBio believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of AspenBio. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for AppyScore required for FDA submission, obtain FDA clearance or approval, complete and obtain CE Mark, cost effectively manufacture and generate revenues from AppyScore, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, AspenBio does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in AspenBio's recent filings with the SEC, including its Final Prospectus filed on June 20, 2012.
SOURCE AspenBio Pharma, Inc.