Based in Kennewick, WA, AMI is a late stage radiation oncology focused medical device company. AMI is engaged primarily in the development of brachytherapy devices for therapeutic applications for the treatment of cancer. Brachytherapy, which is the process of using radiation to destroy cancerous tumors by placing a radioactive isotope inside or next to the treatment area, represents a growing portion of the multi-billion-dollar market for medical radioisotopes. Indeed, the global market for brachytherapy is expected to grow from $680mn in 2013 to reach $2.4Bn by 2030, according to MEDraysintell Report. AMI's lead product candidate is the Y-90 RadioGel™ device, which represents a novel approach to the therapeutic use of yttrium-90 to treat tumors. AMI management is currently focused on achieving regulatory clearance to market the Y-90 RadioGel™ device in the United States, and believes that it will represent a significant move forward in brachytherapy devices given that it has been optimized for safety, efficiency and scale.
"We see several potential catalysts ahead for AMI in 2016 on both the corporate and clinical development fronts. In the US, the company is in the process of pursuing FDA clearance for Y-90 brachytherapy products via a class 2 medical device regulatory pathway. After having its petition for the Y-90 RadioGel™ device to be classified as a de novo class 2 medical device declined by the FDA last summer, AMI management has listened to the agency's feedback and has partnered with IsoTherapeutics Group, a third-party radiopharmaceutical R&D company, to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel™ device. AMI announced in November that the company had completed the first stage of the project, comprised of tech transfer, manufacturing and in vitro testing. The next stage, comprised of additional in vitro and in vivo testing, is in process. If AMI is successful in getting the Y-90 RadioGel™ device cleared for sale in the US by the FDA, this would represent a significant milestone for the company and a key accomplishment for AMI management. Following regulatory clearance, we would expect management to move forward aggressively with the signing of manufacturing and distribution agreements. Outside of the US, pending successful new fundraising activities, we expect AMI to pursue a partner-based strategy. We expect the AMI management to seek out experienced strategic partners and pursue licensing agreements, which we have assumed would include license fees and royalties on products sold, with different partners in each major geography in which the company is able to gain regulatory clearance to market its products," commented Ajay Tandon, CEO of SeeThruEquity.
"On the corporate development front, AMI has put forth ambitious plans for the next 12-24 months. The company recently engaged a leading investment bank and is currently in the process of raising capital. Management indicated in a presentation at SeeThruEquity Annual Innovations Investor Conference (co-hosted by the Brewer Group) on February 22 2016 in Miami, FL, that it was also pursuing an uplisting to a national exchange. In order to accomplish this, the company is likely to need to raise $5mn -$10mn of capital, which, in conjunction with a conversion of debt to equity, may enable the company to meet the minimum shareholder's equity requirements for such a move. If AMI is successful in uplisting to the NASDAQ or NYSE MKT, the move would likely improve share liquidity, expand the company's potential investor base, and make shares available to institutions unable to invest in OTC companies. Along these lines, we would also expect AMI to pursue reverse split / share consolidation to ensure that the company meets minimum bid requirements. AMI has approximately 2Bn shares of stock outstanding, and an additional potential dilution of 1.8 billion common shares from 1.8Bn shares of convertible preferred stock. In January, AMI also announced that it had engaged Circadian Group, an investor relations group that specializes in working with small capitalization growth companies, primarily in the healthcare and technology sectors. The move should assist AMI as it pursues these corporate aims throughout the year. We are initiating coverage with a 12-month price target of $0.02 per share."
