KENNEWICK, WA / CRWEPRESSRELEASE / August 28, 2015 /Advanced Medical Isotope Corporation (“AMIC”) (OTCMKTS:ADMD), a late stage development company engaged in the development of brachytherapy devices for therapeutic applications, today announced its collaboration with IsoTherapeutics Group, LLC of Angleton, TX on the preclinical development of Y-90 based brachytherapy products including AMICs Y-90 RadioGel(TM) device.
After a comprehensive search of entities capable of supporting the commercialization of its Y-90 brachytherapy products, AMIC has selected IsoTherapeutics Group as its lead collaboration partner. IsoTherapeutics Group provides research and development services, including animal studies and early stage manufacturing, for the purpose of aiding customers and collaborators in the development of radionuclide-based drug and device products.
The first project that AMIC and IsoTherapeutics will focus on is the evaluation of AMICs Y-90 RadioGel(TM) device. IsoTherapeutics is developing and will execute studies, under AMIC guidance, in the manner the FDA has requested, with the end goal of FDA clearance for the Y-90 RadioGel(TM) device. This multiple phase group of tasks has begun, with the first phase of tech transfer/development underway with anticipated completion by November 1, 2015. The next phase, which includes rigorous in vivo testing, will commence immediately thereafter. In June 2015, AMIC was notified by the FDA that the December 2014 de novo submission for the Y-90 RadioGel(TM) device was declined. All studies conducted by IsoTherapeutics will be designed with significant attention to data sets and endpoints aimed at addressing comments and questions provided by the FDA in the June 2015 de novo denial letter to support a new submission. A de novo granted by the FDA allows a Class II medical device to be marketed in the United States.
James C. Katzaroff, CEO of AMIC, stated We are delighted to be working with IsoTherapeutics Group to support the ongoing preclinical validation of the safety and efficacy of the Y-90 RadioGel(TM) device as a therapeutic agent. IsoTherapeutics expertise and facilities make them an ideal partner for AMIC.
We are pleased to offer our services to AMIC and look forward to a long and outstanding collaboration that will have a significant, positive impact on the commercialization efforts of the AMIC Y-90 brachytherapy products, stated R. Keith Frank, Ph.D., President and CEO of IsoTherapeutics Group.
AMICs primary focus continues to be obtaining regulatory clearance by the FDA of the Y-90 RadioGel(TM) device. In addition, AMIC is evaluating the requirements for regulatory approval for the Y-90 RadioGel(TM) device in Europe, Canada and Asia as well as for use in the veterinary market as additional paths toward commercial use of the device.
As part of the Companys financial capitalization plan, AMIC intends to raise the capital necessary to complete a new direct de novo FDA filing for the Y-90 RadioGel(TM) device, which todays announcement with IsoTherapeutics supports. The Company expects that its known data from previous bench and animal studies in combination with the collaboration with IsoTherapeutics on additional preclinical studies to address the FDA comments and questions will support a Class II designation and corresponding marketing clearance. There can be no assurance regarding the outcome of the Company’s regulatory, financing or commercial efforts.
About Advanced Medical Isotope Corporation
Advanced Medical Isotope Corporation (ADMD) is a late stage development company engaged in the development of brachytherapy devices for therapeutic applications. AMIC’s focus is on transitioning to full operations upon receipt of FDA clearance for its patented brachytherapy cancer products. 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.
About IsoTherapeutics Group, LLC
IsoTherapeutics Group is a radiopharmaceutical company that provides research and development services, including animal studies and early stage manufacturing for the purpose of aiding customers and collaborators in the development of radionuclide-based drug and device products. Additionally, IsoTherapeutics is developing its own technologies including CycloSam Sm-153-DOTMP for the treatment of primary and metastatic bone cancer. Current collaborators include Molecular Imaging, PerkinElmer, MD Anderson Cancer Center, University of Missouri-Columbia, Excel Diagnostics and Valco Instruments. The Company scientists, while formerly employed at The Dow Chemical Company, developed the commercial products QUADRAMET and Iotrex.
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.
Advanced Medical Isotope Corporation
James C. Katzaroff, CEO
1021 N. Kellogg St.
Kennewick, WA 99336
SOURCE: Advanced Medical Isotope Corporation