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Advanced Medical Isotope Corp. (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

July 11, 2016  Advanced Medical Isotope Partners with Versant Medical Physics and Radiation Safety
July 19, 2016  Advanced Medical Isotope Corporation Provides Intellectual Property Update
Oct 6, 2016  Advanced Medical Isotope Corporation Announces Treatment of First Household


OTCBQ: ADMD

UPDATED 10/6/2016

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

 
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ADMD
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ADMDD News: Quarterly Report (10-q) 11/21/2016 03:39:10 PM
ADMDD News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 11/15/2016 02:26:05 PM
ADMDD News: Current Report Filing (8-k) 10/17/2016 06:16:43 AM
PostSubject
#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
#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
#62359   You and me understand this, but some people trubach 12/07/16 06:03:25 PM
#62358   Just like being Waco for the WPRA ladies CatfishHunter 12/07/16 05:50:58 PM
#62357   I hate chasing, I preffer load at the trubach 12/07/16 05:13:03 PM
#62356   Sat on the bench all day at 12. CatfishHunter 12/07/16 05:10:39 PM
#62355   Nice close. People are getting mad because they trubach 12/07/16 04:22:29 PM
#62354   Radiogel should be called Scamicgel DreDiZzlE 12/07/16 03:28:17 PM
#62353   SAME_OLD_STORY_FOR_YEARS_NOW_NOTHING_BUT_LIES_NO_PLAN_FOR_FDA_APPROVAL_EVER_JUST_COLLECTING_MONEY TickTalker 12/07/16 03:12:38 PM
#62352   Looks like hook line and sinker in the DreDiZzlE 12/07/16 02:00:38 PM
#62351   Looking great, highers lows everyday now trubach 12/07/16 01:48:13 PM
#62350   Very nice trubach 12/07/16 12:55:22 PM
#62349   American bulls buy signal generated https://www.americanbulls.com/m/SignalPage.a Eltp 12/07/16 11:56:19 AM
#62348   ADMD bullish 0.138 stocktrademan 12/07/16 11:44:20 AM
#62347   This is gearing up for Triathlon. WALLnut 12/07/16 10:56:57 AM
#62346   failed attempts at manipulation past few sessions IdeasPS 12/07/16 10:49:01 AM
#62345   Yes, good stuff. WALLnut 12/07/16 10:39:04 AM
#62344   Very nice find. Thank you for sharing it trubach 12/07/16 08:38:46 AM
#62343   Nice find, Equities.com is one of my favorite Eltp 12/07/16 07:52:14 AM
#62342   Article https://www.equities.com/news/advanced-medical-isotope-s-radiogel-admd- oduking 12/07/16 07:22:56 AM
#62341   Today .125 lowest. In abfew days people will trubach 12/06/16 01:16:38 PM
#62340   Soon 20 cents will be a higher low Eltp 12/06/16 01:11:36 PM
#62339   Highest lows everyday now... trubach 12/06/16 01:08:56 PM
#62338   I'm working on it. WALLnut 12/06/16 12:42:21 PM
#62337   I hope you guys scooped cheap shares today trubach 12/06/16 12:32:49 PM
#62336   That's how the stock market works in general, Eltp 12/06/16 12:03:03 PM
#62334   Another great opportunity for now to get cheap shares trubach 12/06/16 10:59:12 AM
#62333   Nothing wrong with that, don't you see Eltp 12/06/16 07:25:01 AM
#62332   LOL WALLnut 12/06/16 03:36:08 AM
#62331   Last week would have been a good time... WALLnut 12/06/16 03:35:18 AM
#62330   Hopefully we can see 90 this time as trubach 12/06/16 12:41:25 AM
#62329   Still a good time, but soon will be trubach 12/06/16 12:35:58 AM
#62328   How many times you need to see the CatfishHunter 12/05/16 11:16:04 PM
#62327   how is this late? this is extremely close grande_cebolla 12/05/16 11:05:59 PM
#62326   Looks like ya came to the barn dance CatfishHunter 12/05/16 11:02:33 PM
#62325   Hmmmmm, i just need to figure out when grande_cebolla 12/05/16 10:21:47 PM
#62324   My is little bit higher around .105 cause trubach 12/05/16 06:21:45 PM
#62323   Dead? AMI is alive and well. WALLnut 12/05/16 06:20:53 PM
#62322   Or coming over the next ridge and spotting mathew633 12/05/16 06:14:19 PM
#62321   Yup. And will somehow try and claim we microcaptrdr24 12/05/16 05:54:59 PM
#62320   Always count on your own DD and the Eltp 12/05/16 05:48:04 PM
#62319   Is that .1613 a misprint? From the way Miamifl 12/05/16 05:28:09 PM
#62318   Looks so good here. Only regretting why I trubach 12/05/16 05:13:09 PM
#62317   Looks like we finally got thru the weak CatfishHunter 12/05/16 05:07:27 PM
#62316   Knowing them they will be talking about going WALLnut 12/05/16 04:37:52 PM
#62315   They still could on board before its really trubach 12/05/16 04:35:57 PM
#62314   And they missed the Trip boat. WALLnut 12/05/16 04:35:17 PM
#62313   True that trubach 12/05/16 03:59:50 PM
#62312   Our little AMIC board will soon open lots Eltp 12/05/16 03:58:53 PM
#62311   annnnnnnnnd, the bears suddenly get quiet. notofthisworld 12/05/16 03:57:47 PM
#62310   Looking great so far trubach 12/05/16 03:56:35 PM
#62309   Nice looking Monday here in ADMD land! JayBPee 12/05/16 03:55:55 PM
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