Advanced Medical Isotope Corporation Files 510(k) Pre-Market Notification for FDA Clearance of Yttrium-90 RadioGel(TM) Brachytherapy Product
KENNEWICK, Wash., Nov. 3, 2013 (GLOBE NEWSWIRE) -- Advanced Medical Isotope Corporation ("AMIC") (OTCBB:ADMD), a company engaged in the development, production and distribution of medical isotopes, today announced that it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Food, Drug and Cosmetic Act for its Yttrium-90 RadioGel™ patented brachytherapy cancer product.
Pursuant to Section 510(k), the FDA has 90 days in which to clear the device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the Company would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.
The Company intends to file FDA pre-market notifications for two related Yttrium-90 "Y-90" brachytherapy products promptly after receiving either clearance from the FDA for the Y-90 RadioGel™ device, or any comments from the FDA to its application.
Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. Among the cancers for which brachytherapy is often selected as a treatment are prostate, liver, breast, head and neck cancerous tumors. AMIC's products may also offer treatment options for certain pancreatic cancers.
In the United States, annual sales of brachytherapy products for prostate cancer exceed $160 million. Once it receives FDA clearance, AMIC intends to begin marketing efforts in the United States for its Y-90 RadioGel™ device with a focus on prostate cancer. Thereafter, AMIC intends to offer the device for other cancers. In addition, AMIC intends to seek opportunities to license its products for worldwide sales. Sales outside of the United States will be subject to the applicable local regulatory approvals.
Based on comparisons of the indications for use, design, materials, and functionality, AMIC believes the Y-90 RadioGel™ brachytherapy device is substantially equivalent to predicate devices previously granted clearance by the FDA, as referenced in the 510(k) application. The discussion in this press release is subject to the more complete disclosures and analyses set forth in its 510(k) application.
The composition and uses of AMIC's brachytherapy products are protected by a series of exclusive patent licenses from the Battelle Memorial Institute and the University of Utah.
The three Y-90 brachytherapy devices developed by AMIC are:
- Y-90 RadioGel™ – combined insoluble Y-90 microspheres and a polymer carrier that is injected directly into the tumor;
- Y-90 Fast-Resorbable Polymer Seeds – intended as a safer, more effective and less expensive alternative to existing metal and glass seeds used in other brachytherapy devices;
- Y-90 Polymer Topical Paste – intended as a supplemental treatment to be applied into a surgical incision to kill residual tumor cells.
As noted above, the 510(k) application filed by AMIC pertains only to the Y-90 RadioGel™ device.
AMIC's analyses support an expectation that its brachytherapy products will achieve a higher therapeutic index than existing brachytherapy products, while reducing collateral damage to healthy tissue due to the shorter penetration distance, shorter half-life and other attributes of the device as compared to brachytherapy devices that use isotopes emitting gamma radiation. These features also reduce the risk of radiation exposure to the patient, family members and medical personnel involved in manufacturing and injecting the device. The AMIC Y-90 RadioGel™ device uses a biodegradable carrier with FDA approved components which leaves no metal or glass in the patient.
AMIC anticipates that these features will permit it to reduce the cost of manufacturing, compared to existing brachytherapy products. AMIC intends to pass along a portion of any savings to its customers, permitting medical practice groups, hospitals, insurers and patients to share in the anticipated cost benefit.
Initially, the Company likely will seek to outsource material aspects of manufacturing, distribution, sales and marketing in the United States. Outside of the United States, the Company likely will enter into licensing arrangements. The Company will evaluate its alternatives before finalizing its plans.
The anticipated introduction of the Yttrium-90 products will mark AMIC's transition from a development-stage company to an operating company. AMIC CEO Jim Katzaroff commented: "Once AMIC receives clearance from the FDA for its Y-90 RadioGel™ brachytherapy device, we will commence operations with a product that will help save lives and that we believe offers therapeutic benefits, reduced risk of radiation exposure for healthy tissue and a lower cost of manufacturing. The introduction of these products would begin a new era for AMIC."
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (OTCBB:ADMD) is a company engaged in the production and distribution of medical isotopes for advanced diagnostic and non-surgical therapeutic application. AMIC's goal is to empower physicians, medical researchers, and ultimately patients by providing them with essential medical isotopes that, until recently, have not been feasible or economical, in an effort to detect and cure human disease. For more information, please visit our website, www.isotopeworld.com
The Advanced Medical Isotope Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5139
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, AMIC's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
CONTACT: Advanced Medical Isotope Corporation
James C. Katzaroff
(509) 736-4000
6208 W. Okanogan Ave.
Kennewick, WA 99336
Source: Globe Newswire (November 3, 2013 - 7:22 PM EST)
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