KENNEWICK, WA/ ACCESSWIRE / April 22, 2016 / Advanced Medical Isotope Corporation (or "AMI") (ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications provides a progress update on product development, manufacturing and commercialization efforts.
AMI Founder, CEO and Chairman James C. Katzaroff stated "We have been rapidly progressing in the product development for the human and veterinary markets. AMI anticipates shipping product within the next 30 days to Washington State University for a study that is actively recruiting companion cats for the treatment of feline sarcoma. AMI is the commercialization partner under a $250,000 grant awarded to Washington State University by Washington State's Life Sciences Discovery Fund for this study. We are very pleased with the progress to date and are excited to provide our product for the initial treatments in companion animals".
In August 2015, AMI announced a partnership with IsoTherapeutics Group, LLC to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel(TM) device. Following the successful completion of the first stage of tech transfer, manufacturing and in vitro testing in late 2015, AMI and IsoTherapeutics Group have been focusing on additional in vitro and in vivo testing. This testing has resulted in robust and repeatable manufacturing processes that IsoTherapeutics Group is executing to supply product.
In connection with the efforts related to our Y-90 RadioGel(TM) device, product will also be manufactured for the purposes of further product characterization testing, in vivo studies and data collection to support our imminent FDA filing. AMI is preparing for in vivo testing of the product in pancreatic tumors lines to evaluate the bio-distribution and therapeutic effect. AMI continues to generate data and benchmarks the FDA requires in order to grant final clearance for marketing the device in the United States. AMI intends to seek classification and clearance as a class II medical device through a de novo application.
The Y-90 RadioGel(TM) device is one of several Y-90 brachytherapy products in development by AMI that may provide a safer, quicker and less expensive treatment to certain cancers including tumors deemed inoperable. Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. AMI 's mission employs in vivo delivery systems to aid medical practitioners and medical researchers in the treatment of diseases such as cancer, and the Y-90 brachytherapy products show excellent promise for this purpose.
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage radiation oncology focused medical device company engaged in the development of yttrium-90 based brachytherapy devices for the treatment of non resectable tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area. The Company intends to outsource material aspects of manufacturing, distribution, sales and marketing for its products in the United States and to enter into licensing arrangements outside of the United States, though the Company will evaluate its alternatives before finalizing its plans. For more information, please visit our website, www.isotopeworld.com.
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, the Company'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.
Advanced Medical Isotope Corporation
James C. Katzaroff, CEO
1021 N Kellogg
Kennewick WA 99336
Circadian Group IR
SOURCE: Advanced Medical Isotope Corporation