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Advanced Medical Isotope Corporation (ADMD)

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Advanced Medical Isotope Corporation (AMI)
 

is a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications.  AMI's focus is on transitioning to full operations upon receipt of FDA clearance for its patented Y-90 brachytherapy product, RadioGel

 

What is Brachytherapy?
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 believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers.  The 2013 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer and 31,000 liver cancer.

What is RadioGel™?
The Y-90 RadioGel™ device is a brachytherapy device comprising highly insoluble Y-90 particles delivered by needle injection using a water-polymer composite for high-dose treatment of non-resectable solid tumors that cannot be treated effectively by any other means. It is designed for maximum safety: to deliver a high, pure-beta radiation dose to target (tumor) tissue, with comparatively small-to-negligible radiation doses to adjacent normal tissues, and with negligible radiation dose to any major organ or tissue in the body.

Two key design characteristics of the Y-90 RadioGel™ device that influence safety and efficacy are (1) the ability to place Y-90 particles directly into tumor tissue via injection and (2) yttrium-90 containment within the tumor after injection.

Advanced Medical Isotope Corporation has obtained an exclusive license to eight (8) patents related to the Y-90 RadioGel™ device technology for use in high-dose radiation therapy. The license was granted by *Battelle pursuant to an option between Battelle and AMI announced in February 2011. The Agreement grants AMI an exclusive license to make, have made, use and sell the Y-90 RadioGel™ device

Yttrium-90 is a well-established medical isotope with many applications in cancer treatment. The combination of insoluble Yttrium-90 particles and the polymer gel carrier offers physicians an opportunity to deliver a safe, effective treatment option at a low cost.

What are the advantages of RadioGel™?

Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, AMI believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:

•Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.

•Half Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.

•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, AMI’s Y-90 RadioGel™ device is designed to be administered in a minimally invasive procedure with small-gauge needles.

•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. AMI’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.

•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and have long half-lives. AMI’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. The Yttrium-90 beta-emissions travel only a short distance and has a short half life of 2.7 days.

•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.

What is the market for RadioGel™?
Reliable sources estimate that annual sales of brachytherapy products exceed $2 billion, about half of which are in the United States. The size of the U.S. brachytherapy market for prostate cancer brachytherapy is somewhere between $90 million and $130 million per year. The market for liver and breast cancer combined is comparable.

What are the steps for FDA clearance?

AMI met at the FDA offices to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and AMI 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.

In August, AMI 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. 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. Upon completion of these studies AMI anticiptes submittal (direct de novo) for FDA clearance in 2016 for full commercialization in the U.S.

Are there other markets for RadioGel™? 

On March 15th, 2016, AMI announced the formation of a new, wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market.

The IsoPet Solutions division will focus on bringing AMI’s yttrium-90 brachytherapy products to veterinary oncologists to treat dogs and cats suffering from tumor cancers. There are over 150 million pet dogs and cats, with over 1/3 of the households in the US owning at least one dog, and just under 1/3 owning at least one cat.  IsoPet Solutions is establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance. The division will also provide product awareness and education to veterinary oncologists. AMI expects the initial treatments to be coordinated through the Chair of the Company’s Veterinary Medicine Advisory Board, Dr. Alice Villalobos and anticipate offering RedioGel™ for vet treatments in early Spring 2016.

Latest Press Releases

Jun 24, 2015 Advanced Medical Isotope Corporation Provides Commercialization and Strategic Plan  Update
Aug 28, 2015 Advanced Medical Isotope Corporation Announces Collaboration with IsoTherapeutics Group, LLC
Oct 7, 2015 Advanced Medical Isotope Corporation Completes Substantial Capital Restructuring Activities and Continues Product Development
Nov 17, 2015 Advanced Medical Isotope Corporation Reports Progress Towards Seeking FDA Clearance for the Y-90 RadioGel™ Device
Feb 1, 2016 Advanced Medical Isotope Corporation Featured in World Council on Isotopes Newsletter
Feb 16, 2016 Advanced Medical Isotope Corporation To Present at the SeeThruEquity & The Brewer Group 2nd Annual Investors Conference Feb 22nd, 2016
Feb 18, 2016  Advanced Medical Isotope Corporation CEO announces, "We Are the Next Generation"
March 1, 2016 Advanced Medical Isotope Corporation Appoints Dr. Ludwig E. Feinendegen to the Medical Advisory Board
March 14, 2016 Advanced Medical Isotope Corporation Appoints Dr. Alice Villalobos Chair of the Veterinary Medicine Advisory Board
March 15, 2016 Advanced Medical Isotope Corporation Launches IsoPet Solutions to focus on Veterinary Market
March 22, 2016 SeeThruEquity Initiates Coverage of Advanced Medical Isotope Corporation with Target Price of $.02
March 28, 2016 Advanced Medical Isotope Corporation Appoints Dr. Albert S. Denittis to the Medical Advisory Board

!! MOST RECENT NEWS !!
April 12, 2016 A New Audio Interview with Advanced Medical Isotope Corporation with SmallCapVoice.com
April 22, 2016 Advanced Medical Isotope Announces FDA Resubmission Progress; Stands Ready to Ship First Batch of  RadioGel for Veterinary Division
April 27, 2016 Dr. Albert S. DeNittis and Advance Medical Isoptope Founder CEO and Chairman, James C. Katzaroff, are Featured in a New Audio Interview at SmallCapVoice.com.
May 26, 2016 Advanced Medical Isotope Corporation Announces Participation in Upcoming Investment Conferences
June 3, 2016  Advanced Medical Isotope Corporation to Present at the LD Micro Invitational


OTCBQ: ADMD

UPDATED 6/3/2016

Outstanding Shares 1,950,180,595
Authorized Shares     2,000,000,000

 
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#60262  Sticky Note This stock is bigger than the company. If Tcsxyz 07/27/16 08:25:42 PM
#59994  Sticky Note Addition of Dr Fisher is HUGE news microcaptrdr24 07/11/16 08:48:58 AM
#56879  Sticky Note GREAT POST! THIS EXACTLY WHY MANY LONGS Boot Hill 04/07/16 05:55:51 PM
#55396  Sticky Note Veterinary Market! Major Due Diligence! Why Revenue will nike242 03/16/16 10:52:22 AM
#52957  Sticky Note $ADMD recent news/filings mick 01/18/16 02:36:15 PM
#47440  Sticky Note The only topic to be discussed here is ADMD IH Admin [Dan] 09/27/15 02:45:52 PM
#61128   True enough. Chief Slapaho 09/24/16 01:30:57 PM
#61127   LOL.....No, ADMD is broke. The LA is broken. kheath39 09/24/16 10:16:07 AM
#61126   LOL...Its broke? WALLnut 09/24/16 08:48:23 AM
#61125   LOL...I know right. Its kinda like buying kheath39 09/24/16 01:00:22 AM
#61124   Yes, they sure do. Especially when you have Chief Slapaho 09/23/16 10:44:53 PM
#61123   So reading posts from earlier make it a fact? WALLnut 09/23/16 06:35:54 PM
#61122   Then you haven't been reading posts from earlier Chief Slapaho 09/23/16 03:29:40 PM
#61121   Then you haven't been reading posts from earlier Chief Slapaho 09/23/16 03:29:39 PM
#61120   I'm not questioning if Circadian was hired by WALLnut 09/23/16 02:47:11 PM
#61119   MAAAAAANNNNNNNY people know this is going to fail kheath39 09/23/16 02:43:07 PM
#61118   You can wait all you want. Those on Chief Slapaho 09/23/16 02:35:12 PM
#61117   FACT! I don't need to show you anything. Chief Slapaho 09/23/16 02:34:32 PM
#61116   Circadian turned a frog into a prince to DreDiZzlE 09/23/16 02:19:25 PM
#61115   Umm still waiting!! WALLnut 09/23/16 02:01:39 PM
#61114   Link please! WALLnut 09/23/16 01:43:44 PM
#61113   FACT! Circadian was absolutely hired to pump the stock Chief Slapaho 09/23/16 01:28:35 PM
#61112   Wrong!! WALLnut 09/23/16 01:21:50 PM
#61111   Or more likely, sell and wait for the Chief Slapaho 09/23/16 01:06:51 PM
#61109   Reverse splits for the most part are risky. WALLnut 09/23/16 12:46:36 PM
#61107   Thank you so much wallnut for being constructive.... I topgunbcn 09/23/16 12:12:14 PM
#61106   Each needs to draw their own conclusion on WALLnut 09/23/16 12:02:28 PM
#61104   You didn't sell anything from the already 3 HMONNY 09/23/16 11:32:27 AM
#61103   Ok....hold until it reaches .0005....make no money. DR. EVIL 09/23/16 10:55:55 AM
#61102   Sorry but your recommendation has not any foundation, topgunbcn 09/23/16 10:51:38 AM
#61101   Sell while u r still up!!! DR. EVIL 09/23/16 10:45:35 AM
#61100   Hi all! I am a little bit scared about topgunbcn 09/23/16 10:40:29 AM
#61099   Smart!! WALLnut 09/23/16 08:40:36 AM
#61098   I'm still here :). Just playing other tickers Popeye 09/22/16 09:55:29 PM
#61097   Hey Popeye, thought you died, good to see Miamifl 09/22/16 08:17:43 PM
#61096   Thanks, sometimes a few beers helps to bring Monroe1 09/22/16 07:26:58 PM
#61095   I made $9k today!!! Toot toot! Popeye 09/22/16 06:53:00 PM
#61091   Delisted. Chief Slapaho 09/22/16 01:37:55 PM
#61089   Don't have 2100 posts. WALLnut 09/22/16 01:32:09 PM
#61088   AMIC desperately hanging on and clinging to .002. Chief Slapaho 09/22/16 01:27:50 PM
#61086   SFO$!!! COPPER BABY YEAH!! I AM AN OTCTRADER GOD!!! DR. EVIL 09/22/16 01:24:53 PM
#61084   You'll be waiting a long time before that Chief Slapaho 09/22/16 01:24:40 PM
#61082   That's to bad. WALLnut 09/22/16 01:23:21 PM
#61080   scAMIC scAMIC scAMIC pump dump pump ! $#/!&!&$*@&!^^ Jim CatsAREoff DreDiZzlE 09/22/16 01:17:15 PM
#61077   "ADMD is a huge POS" Chief Slapaho 09/22/16 01:15:10 PM
#61075   It's definitely worth the wait. WALLnut 09/22/16 01:13:27 PM
#61074   Nothing to 'watch and learn' about, except that Chief Slapaho 09/22/16 01:11:18 PM
#61073   The prop-ups only indicate to me this puppy WALLnut 09/22/16 01:08:43 PM
#61072   Now it's five years???? The line has always Chief Slapaho 09/22/16 01:05:08 PM
#61068   Great post! Popeye 09/22/16 08:58:28 AM
#61067   I love this post...it is dead nuts spot on. WALLnut 09/22/16 08:42:37 AM
#61066   I am more of a believer in the JayBPee 09/22/16 08:32:51 AM
#61065   Excellent post Popeye. Good to see you're JayBPee 09/22/16 08:29:57 AM
#61064   The caliber of the leadership outweighs even the Monroe1 09/22/16 01:39:06 AM
#61062   There is extreme criticism because we've been consistently Chief Slapaho 09/21/16 10:18:22 PM
#61061   Funny that there's such extreme criticism daily for Popeye 09/21/16 09:53:41 PM
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