NEXL will be $9.60 by 9/8/2000
(NEXL was $4.41 on 6/9/2000)
Biotech is Back. Cell Technology big business.
Bruce Cullen
sherwoodcoastsgroup.com
Always an opinion.
Companies with FDA approval are always better than those waiting for one. NEXL has a strong technical chart, not only are the technicals strong but so are the fundamentals. As expected biotech shall shed more advance on the securities markets as biotechnology shows signs of strength after a few years of dead movements. Due to recent moves in many sister companies financing should be easier to come by as well as partnerships or even mergers of this new excting overlooked sector. Longer term is the way to approach this, thus at a 100% price objective in a few months you have a great start to sell 1/2 at about 10/share and hold long term, this is my plan I use many times on stocks I purchase. (Also watching (IATV))
Bruce Cullen
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Nexell Therapeutics Receives FDA Approval On Next Generation Isolex 300i System Version 2.5 for Positive Stem Cell Selection Delivers Enhanced Performance Consistency and User Interfaces. IRVINE, Calif.--(BW HealthWire)--May 15, 2000--Nexell Therapeutics Inc. (Nasdaq:NEXL - news), one of the world's leading suppliers of therapeutic and diagnostic products based on stem cell technology, announced today that the U.S. Food and Drug Administration (FDA) has given the Company clearance to market an enhanced version of its Isolex© 300i Magnetic Cell Selection System. The ``version 2.5'' upgrade for the current commercial Isolex© 300i System, version 1.12, involves new instrument software and modifications to the instrument hardware and disposable set. The enhanced Isolex© 300i will be launched in July, 2000, at which time the process of upgrading current Isolex© 300i customers will begin. All future instrument placements will be the 2.5 version. ``We have committed, as an organization, to continuous product improvement and an aggressive pace of new product introductions,'' said L. William McIntosh, President and COO of Nexell Therapeutics. ``We are very pleased that less than one year after our first FDA approval for the Isolex© 300i System, we are able to offer our customers an enhanced version of our flagship cell selection product that keeps pace with their evolving needs.'' In preclinical data on 8 apheresis test samples submitted to the FDA, the Isolex© 300i version 2.5 produced target cell (hematopoietic stem cell) purity of 97 percent versus 92 percent for the current version and target cell yield of 67 percent versus 48 percent. In non-target cell depletion, the upgraded positive selection system produced a 4.2 log reduction in T-cells, versus 3.6 logs for version 1.12, and a 3.1 log depletion of B-cells, versus 2.9 logs. A log is a power of 10. ``By making minor adjustments to the control software and fluid flow dynamics of the Isolex© 300i instrument and disposable set, our engineers have been able to enhance the performance of positive-only cell selection,'' said Mr. McIntosh. The specific modifications to the Isolex© 300i positive selection instrument and disposable set include: new version 2.5 software that enhances operating performance and user-friendliness; the addition of a filtered wash bag for cell concentration and washing; modifications to the weight scales and solution tower; the addition of a third waste bag and a cell source bag; and other improvements to the plastic disposable set, including changes to the buffer filter, the reagent filter, and the primary magnetic separation chamber. In November, 1999, Nexell Therapeutics submitted a pre-market approval application (PMA) supplement to the FDA requesting approval of these upgrades. The Isolex© 300i System is a fully automated device for the clinical separation of various types of cells from peripheral blood. Integrating all steps of the stem cell selection process into one continuous procedure that takes about 2.5 hours, the system uses a specific anti-CD34 stem cell antibody and paramagnetic beads to target and capture CD34+ stem cells and a unique, patented peptide release system that leaves the selected cell surface virtually free of the antibodies and paramagnetic beads. Total automation of the sterile, closed-path procedure enhances consistency of the final cell product by greatly reducing the potential for contamination and errors in processing. Thus the Isolex© 300i is ideally positioned to help cell processing laboratories meet the increasing level of regulatory and quality scrutiny to which they are being subjected. A restricted device, the Isolex© 300i System is indicated for processing autologous peripheral blood progenitor cell products to obtain a CD34+ cell enriched population intended for hematopoietic reconstitution after myeloablative therapy in patients with CD34- tumors. Please refer to the Isolex© 300i System package insert for full prescribing information. Isolex© cell selection systems are currently marketed in the United States, the European Union, Canada and Eastern Europe. In the European Union, Nexell markets its most advanced Isolex© system, the 2.5 CE, which offers positive and negative selection in a single, continuous procedure. Nexell is seeking clearance to market Isolex© systems in Australia, Japan, Korea and various countries in the Mediterranean region. There are also a number of Isolex© systems currently in use in investigational protocols for gene therapy and dendritic cell therapy, engineered transplants with alternative donors and for autoimmune diseases, and depletion of specific T-cell subsets such as CD4 or CD8 cells. Nexell Therapeutics Inc. Located in Irvine, California
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Company Summary:
Nexell Therapeutics is biopharmaceutical company developing products utilizing cell separation technology in cell therapy for cancer & other life-threatening diseases. For the 3 months ended 3/31/00, revenue fell 13% to $4.8M. Net loss applicable to Common rose 30% to $9.3M. Revenues reflect restructuring of the distribution agreement with Baxter. Loss also reflects assumption of marketing and selling responsibilities for cell therapy products.
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