RICHLAND, WA / ACCESSWIRE / July 11, 2017 / Advanced Medical Isotope Corporation ("AMI") (OTC PINK: ADMD), a late stage radiation oncology focused medical device company today announced that a new proprietary process has been developed that significantly improves originally licensed technology on the company's Y-90 RadioGel™ device.
After five months of effort, the AMI team have finalized an improved manufacturing process for our yttrium phosphate particles. We conducted more than thirty process development runs to achieve the most cost-effective process to reproducibly give us the small particles that we desire.
Small particles perfuse further into the tumor and reduce the number of injections required for dose coverage in large tumors. In parallel, we concentrated on reducing the time and cost required for manufacturing and increasing the batch yield. As an example, one production step was reduced from 20 hours to just an hour. Product yield increased from 80% to 99.99%. The process is elegantly simple, but based on fundamental understanding of the underlying chemistry involved.
IsoTherapeutics, a key manufacturing and testing contractor, did a very professional job working with our team to explore all of the key manufacturing variables.
AMI Interim CEO and President Dr. Mike Korenko stated, "This is a significant improvement over the technology that was originally licensed to AMI from the Pacific Northwest National Laboratory. This new proprietary process is an important part of our intellectual property and will reduce our manufacturing costs to position AMI to make a profit on future sales.
The manufacturing process has now been institutionalized in a formal Standard Operating Procedure, which is needed to ensure a safe reproducible product for animal and human therapy and it is the protocol required by the Food and Drug Administration."
Dr. Korenko added, "This accomplishment required a great deal of effort and is a major step in executing our business plan, which I outlined in my first letter to Shareholders January 2017."
AMI previously created the Standard Operating Procedures for the hydrogel (RadioGel™). We are now working on the Quality Assurance and Quality Control Plans and to convert all process activities to GMP (Good Manufacturing Processes) which is a FDA requirement. This will complete the entire disciplined manufacturing process requirements.
About Advanced Medical Isotope Corporation
The strategic market sector of Advanced Medical Isotope Corporation (ADMD) is isotope applications. Currently, the company is engaged in the development of RadioGelTM, an Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.
The company is engaging the FDA for permission to use RadioGel for the treatment of advanced basal and squamous skin cancers. The IsoPet Solutions division is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. After this demonstration phase the plan is to sell RadioGelTM to the private animal clinics.
The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGelTM in other countries. For more information, please visit our websites: www.isotopeworld.com and www.isopetsolutions.com.
AMI is developing a brachytherapy and topical cancer treatment product called RadioGel™.
RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles which may be injected into a tumor. This hydrogel liquid is maintained at a temperature below body temperature but begins to gel, harden, once it is injected into the body and as the temperature increases up to body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage outside of the injected area.
RadioGel™ also has a short half-life - after 10 days only about 5% of the radiation remains; as opposed to other available options that would 50% after 10 days. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately after with no risk to any family members.
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
Dr. Michael K. Korenko, CEO
SOURCE: Advanced Medical Isotope Corporation