Advanced Medical Isotope Corp. (OTCMKTS:ADMD) has seen a recent surge in price and volume after the Company announced forward progress towards seeking FDA clearance for the X-90 RadioGel™ Device
ADMD has a long history of big moves running from $0.0001 to $0.0065 earlier this year; this is one of those Companies that knows how to market itself and has quickly attracted a loyal shareholder base that believes this one goes much higher.
Advanced Medical Isotope Corp. (OTCMKTS:ADMD) is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and 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. Annual sales of brachytherapy products exceed $1 billion, about half of which are in the United States. 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.
Earlier this year ADMD 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.
AMIC selected IsoTherapeutics Group as its lead collaboration partner after a long search. 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.
One of several Y-90 brachytherapy products in development by AMIC is the The Y-90 RadioGel™ device that may provide a safer, quicker and less expensive treatment to certain cancers, including tumors deemed inoperable. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion.
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According to AMIC It is estimated that the U.S. market represents approximately half of the global market. AMIC believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers with its Y-90 product suite. A new study published in the British Journal of Cancer claims 1 in 2 men and women will be diagnosed with a cancer at some point in their lives. AMIC’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.
On November 17 ADMD announced its progress in seeking FDA clearance for marketing of its lead product, the Y-90 RadioGel™ device. CEO Jim Katzaroff and the lead scientific and medical advisory team from AMIC met at the FDA offices last week to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and AMIC team are working closely in order to obtain all appropriate data and benchmarks the FDA requires in order to proceed with providing final clearance for marketing the device in the United States. AMIC intends to seek classification and clearance as a class II medical device through a de novo application.
In August, AMIC announced a partnership 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. AMIC is pleased to announce that IsoTherapeutics has 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, commenced last Friday.
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Currently trading at a $3 million market valuation ADMD has minimal assets, rising short term debt and no revenues to date. But this is an exciting story developing in small caps; The Company is focused on obtaining regulatory clearance by the FDA of the Y-90 RadioGel(TM) device and working hard to restructure their debt. The Company also knows how to market itself and has quickly attracted a loyal shareholder base that believes this one goes much higher. We will be updating on ADMD when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with ADMD.
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Disclosure: we hold no position in ADMD either long or short and we have not been compensated for this article