IMX - old favorite which hit about 2x current price in the midst of all the excitement about bomb detection hits Briefing.com with news in the cancer front.
o/s about 8 million shares and
float about 5 million.
Company PR's have been criticized, but I like the fact that, they are understated, in comparison to other microcaps that we follow.
Implant Sciences Receives FDA 510-k- Premarket Approval for Its New Radiation Treatment Source
Thursday January 27, 8:01 am ET
Ytterbium-169 Source to be Used for Breast Cancer Radiation Treatments
WAKEFIELD, Mass.--(BUSINESS WIRE)--Jan. 27, 2005-- Implant Sciences Corporation (AMEX: "IMX", "IMX.WS") a developer and manufacturer of products for homeland defense, semiconductor, and medical device industries today announced it received the approval of its 510(k) premarket notification from the Food and Drug Administration ("FDA"), which allows the Company to proceed with the marketing of its new Ytterbium-169 radioactive source for the treatment of breast and other cancers. FDA approval represents a significant step in bringing the Company's radioactive source to commercialization. The Company, however, will take additional steps over the next six months before it can successfully commercialize this new product. These steps include registration of the radioactive source by the Massachusetts Radiation Control Program and receipt of a National Institute of Standards and Technology traceable calibration. In addition, the Company intends to supply the new radiation source to several radiation oncologists for a pilot clinical evaluation of the radioactive source. Several practitioners on three continents have expressed interest in performing these clinical evaluations. There can be no assurances that these steps will be achieved or that the oncologists evaluating the new radiation source will be satisfied with the results.
Breast cancer is the most common cancer in women, aside from skin cancer. According to the American Cancer Society, it is estimated that 211,240 new cases of invasive breast cancer is expected to occur among women in the United States during 2005. Breast cancer is commonly treated by either a mastectomy, which requires the complete removal of the breast, or lumpectomy. A lumpectomy is a breast conservation therapy involving the excision of a tumor followed by radiation therapy to reduce the likelihood of reoccurrence of the cancer. While the standard of care for post-lumpectomy radiation has been external beam radiation, requiring whole breast irradiation over a period of six to seven weeks, accelerated partial breast irradiation ("APBI") is gaining in popularity due to a shorter treatment time of 4 to 5 days and reduction of collateral tissue and organ damage that may be experienced by undergoing external beam radiation.
The National Cancer Institute has stated that about 40 percent of breast cancer patients who are eligible for lumpectomy still choose total mastectomy over breast conservation therapy, despite comparable long-term recurrence and survival rates. Many of these patients decline breast conserving lumpectomy because they are unable to endure the time and travel burdens imposed by six to seven weeks of traditional external beam radiation therapy.
However, the currently available radioactive sources continue to limit the accessibility of APBI to cancer patients. APBI therapy using currently available radioactive sources still require treatments to be performed in hospital facilities that have expensive shielded treatment rooms where external beam radiation is typically performed. Our new Ytterbium-169 source for APBI is administered on the tip of a wire into a lumpectomy cavity for 8 to 10 short (15 minute) periods over 4 to 5 days. In addition, the source will be sold in conjunction with a portable shielding apparatus the Company has developed (patent pending). This should permit hospitals and clinics, previously unable to offer APBI therapy due to the lack of dedicated shielded treatment rooms, to perform APBI therapy thereby potentially increasing the accessibility of APBI therapy to cancer patients eligible for lumpectomy.
Dr. Anthony J. Armini, CEO of Implant Sciences Corporation, stated "This 510(k) notification is a major step in the commercialization of this new product. We believe this product will be helpful in bringing accelerated partial breast irradiation treatment to many more hospitals, and consequently to many more patients."
About Implant Sciences
Implant Sciences, incorporated in 1984, is using its core ion technology to develop, manufacture and market products for the homeland security, semiconductor and medical device industries. The Company has developed and commercialized portable and bench-top trace element detection devices to identify explosives. The Company has also received government grants from the US Army, Navy and Air Force, and the Transportation Security Administration to adapt the Company's explosive detection technology to a wide number of security requirements. The Company continues its efforts to develop new products and applications using its Quantum Sniffer(TM) technology, including applications for the detection of explosives, narcotics and toxic materials.
Using its proprietary ion implantation and thin film coating technologies, Implant Sciences has a sophisticated production line that modifies the surface characteristics of orthopedic joint implants to reduce polyethylene wear, thereby substantially increasing the life of the implants. The Company also manufactures and markets radioactive and non-radioactive products for medical use, including radioactive seeds for treating prostate cancer that are distributed throughout the United States by its own direct sales force. In parallel with the production of these seeds, it is also developing additional brachytherapy products for the treatment of breast, eye, and other cancers.
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "expect," "should," "plan to," "potential," or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, the ability of the Company to develop effective new products and receive governmental approvals of such products, competitive factors, dependence upon third-party distributors and sales representatives, ability to attract and retain members of its advisory board, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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Contact:
Investor contact:
Aurelius Consulting Group:
Dave Gentry, (407) 644-4256
dave@aurcg.com
www.runonideas.com
or
Implant Sciences Corporation:
David C. Volpe, (508) 523-3141
dvolpe@implantsciences.com
www.implantsciences.com
or
Media contact:
The Investor Relations Group
Mike Graff or Janet Vasquez
(212) 825-3210 |
