A-Fem Medical (OTC Bulletin Board: AFEM), announced today it has promoted Dr. Paul Mueggler to the new position of Vice President of Clinical and Regulatory Affairs. Dr. Mueggler’s promotion recognizes the contribution he has made to the clinical validation of A-FEM’s core PadKit technology, and his demonstrated ability to guide the Company through the regulatory approval process.
Dr. Mueggler served as Director of Clinical Affairs for the Company since April of 1997. From August 1989 to January 1994, Dr. Mueggler served as director of clinical and technical operations for OXIS Corporation, a diagnostic company. From April 1984 to August 1989, he served as assistant professor and chief, toxicology section for the Department of Clinical Pathology of the School of Medicine at Oregon Health Sciences University.
The PadKit(R) Sample Collection System is a totally new approach for diagnosing a variety of woman’s health conditions and diseases with a non-invasive self-collected sample obtained in the privacy of her own home.
“Dr. Mueggler brings decades of directly related experience to our cervical cancer diagnostic development efforts,” stated William Fleming, vice chairman for A-FEM. "We believe that PadKit’s encouraging clinical results to date warrant our focusing top talent to prepare for commercialization.”
The PadKit(R) is the first planned diagnostic application of the company's proprietary interlabial pad (“ILP”) product. The PadKit(R) contains an ILP to collect a vaginal pool sample, which includes exfoliated cervical and endometrial cells, as well as other vaginal secretions of diagnostic interest. Clinical studies conducted to date continue to support our vision of a women’s health panel derived this non-invasive self-collected sample.
The Company expects the PadKit(R) to be a cost effective alternative to the invasive cervical scrape for Pap smears, to the intrusive vaginal swab for STD’s, potentially hazardous venipuncture (blood draws) or unpleasant urine samples. With the recent addition of U.S. and U.K. patents, the technology for both the method and apparatus used for collecting vaginal fluid and exfoliated vaginal cells is more broadly protected.
Currently over 50 million Pap tests are performed annually to test for cervical cancer at a cost of more than $1 billion per year. Although significant improvements have been made in the area of Pap test sample preparation and reading, no consistent sample collection method has been developed. The PadKit(R) will allow a woman to collect a sample in the privacy of her own home, which would be analyzed by a lab and the results provided to the physician prior to a patient's office visit. This would allow appropriate procedures, such as a confirming smear, colposcopy, biopsy or other procedure, to be scheduled during the actual visit. Samples may also be used for repeated testing and/or additional testing, and may be stored for further testing at a later date.
A-Fem Medical Corporation is a medical technology company with multiple product platforms targeting unmet women's health needs. A-Fem has developed three proprietary business lines: the inSync(R) miniform ILP, Rapid*Sense(R) diagnostic products and the PadKit(R) Sample Collection System. A-Fem currently markets the inSync(R) miniform as an alternative to tampons, pads and liners for light flow protection. The Company is developing diagnostic products using its proprietary Rapid*Sense(R) technology. The PadKit(R), currently in clinical trials, utilizes an ILP as a non-invasive sample collection method for use in screening for certain cancers and diseases. For more information, visit A-Fem's website at www.afem.com.
This document may contain forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended) that involve risks and uncertainties. Actual results could differ materially from those projected in the forward looking statements as a results of a number of factors, including those disclosed in the company’s reports filed with the Securities Exchange Commission including the Annual Report on form 10K for the year ended 12/31/98.