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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 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.

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

!! RECENT NEWS !!
April 12, 2016 A New Audio Interview with Advanced Medical Isotope Corporation with SmallCapVoice.com
April 22, 2016 AMIC 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 AMIC Announces Participation in Upcoming Investment Conferences
June 3, 2016  AMIC to Present at the LD Micro Invitational

July 11, 2016  AMIC Partners with Versant Medical Physics and Radiation Safety
July 19, 2016  AMIC Provides Intellectual Property Update
Oct 6, 2016  AMIC Announces Treatment of First HouseholdPet
Oct 18, 2016  AMIC to Attend the Veterinary Cancer Society Annual Meeting
Nov 10, 2016  AMIC Repays all Outstanding Matured Convertible Debt and Bridge Finiancing to Advance FDA Submission
Nov 30, 2016  AMIC to Present at the 9th Annual Micro Main Event
Dec 2, 2016  AMIC Wins Judgement of $527,875.74
Dec 20, 2016  Board of Directors Appoints Dr. Michael Korneko CEO and Dr. Carlton Cadwell Chairman of AMIC 
 


OTCBQ: ADMD

DOWNLOAD 2016 COMPANY PRESENTION

COMPANY WEBSITE           FACEBOOK          TWITTER
UPDATED 12/20/2016

Outstanding Shares 29,200,000
Preffered Series A     4,000,000

 
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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
#62793  Sticky Note Advanced Medical Isotope's CEO Issues Letter to Shareholders WALLnut 01/11/17 10:30:05 AM
#62551  Sticky Note Why this stock is worth 50 cents a korenkorocks 12/20/16 03:40:02 PM
#60262  Sticky Note This stock is bigger than the company. If Tcsxyz 07/27/16 08:25:42 PM
#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
#62916   sounds like $4 is your average, so .14 microcaptrdr24 01/21/17 08:14:48 PM
#62915   Finally got around to calculating my weighted average clsace 01/20/17 06:14:17 PM
#62914   Another week, two maybe, at most then. CatfishHunter 01/20/17 04:26:30 PM
#62913   like I said earlier, I think there's probably microcaptrdr24 01/20/17 04:10:38 PM
#62912   Ya clean it up, turn your back and CatfishHunter 01/20/17 04:00:36 PM
#62911   Are you saying we now have two piles WALLnut 01/20/17 03:52:28 PM
#62910   Got home and walked over to the barn, CatfishHunter 01/20/17 03:43:02 PM
#62909   Opportunity is knocking for sure. WALLnut 01/20/17 11:22:07 AM
#62908   Congrats Bro, great move Eltp 01/20/17 11:13:21 AM
#62907   I picked up 20k more as well these gimpie 01/20/17 11:08:58 AM
#62906   My friends and I are stabbing the asks Eltp 01/20/17 10:09:22 AM
#62905   100% true.....people accumulating down here will make a microcaptrdr24 01/20/17 10:05:34 AM
#62904   The news are important for sure but what's Eltp 01/20/17 09:53:32 AM
#62903   If this company can only go up in Tcsxyz 01/20/17 06:55:57 AM
#62902   ADV MEDICAL ISO (ADMD) CEO Michael K. Korenko fcdwars 01/20/17 03:06:30 AM
#62901   What we need now is a follow up wrinklesobw 01/19/17 10:40:14 PM
#62900   It's such an awkward day after the S4, Eltp 01/19/17 06:33:21 PM
#62899   Agreed. notofthisworld 01/19/17 04:29:19 PM
#62898   Maybe Our boy isn't finished buying yet. buford78 01/19/17 03:45:40 PM
#62897   Yes - all great stuff and the company Popeye 01/19/17 03:39:46 PM
#62896   You'd think so pardner, but guessin CDEL running CatfishHunter 01/19/17 03:38:56 PM
#62895   agree, cleaned up toxic debt, brought in a microcaptrdr24 01/19/17 03:11:49 PM
#62894   Just got back from auction. Lookin like CDEL CatfishHunter 01/19/17 01:29:19 PM
#62893   Great News by Korenko.....surprised the sp hasn't move more. notofthisworld 01/19/17 12:26:54 PM
#62892   HELL YEAH!!! buford78 01/19/17 11:26:55 AM
#62891   That's the difference between Korenko who runs at Eltp 01/19/17 09:26:32 AM
#62890   Can we get a Hell Yeah!! WALLnut 01/19/17 08:55:23 AM
#62889   Getting there Bro, volume will help to clear Eltp 01/19/17 08:47:05 AM
#62888   Hope to see us back in the .17s JayBPee 01/19/17 08:25:13 AM
#62887   I expect Yuuge volume today and tomorrow based Eltp 01/19/17 08:20:57 AM
#62886   Excellent news AND a good move on his JayBPee 01/19/17 08:06:52 AM
#62885   This great news!! WALLnut 01/18/17 06:42:17 PM
#62884   In the past two weeks the New CEO buford78 01/18/17 04:35:24 PM
#62883   Wow, he is very confident. Korenko rocks Eltp 01/18/17 03:35:55 PM
#62882   I agree. Strap your spurs on and Boot Hill 01/18/17 02:47:44 PM
#62881   Yee Haw! If CEO Korenko is buying CatfishHunter 01/18/17 02:46:44 PM
#62880   Whoa!! Form 4 just out. CEO is Boot Hill 01/18/17 02:34:19 PM
#62879   CDEL has to run out of feed and CatfishHunter 01/18/17 02:03:57 PM
#62878   Still a little early to tell what new WALLnut 01/18/17 10:57:36 AM
#62877   We had a shareholder update regarding Korenko's plan Eltp 01/18/17 09:50:07 AM
#62876   Another block this morning and last night after hours microcaptrdr24 01/18/17 09:44:03 AM
#62875   I know one thing, my order didn't get trubach 01/17/17 07:19:17 PM
#62874   Volume precedes price. Highest volume we've seen since chiflow 01/17/17 03:53:29 PM
#62873   The pump appears to be back on !! Toot toot DreDiZzlE 01/17/17 02:44:17 PM
#62872   Lucky that person who picked up 415k shares trubach 01/17/17 12:26:19 PM
#62871   Who ever is selling will be kicking their WALLnut 01/17/17 11:14:25 AM
#62869   I second you, almost there Eltp 01/17/17 10:36:59 AM
#62868   yes, some big blocks going off the last microcaptrdr24 01/17/17 10:34:49 AM
#62867   That's some serious volume at the opening, everyone Eltp 01/17/17 10:14:17 AM
#62866   Radiogel will be the next big medical breakthrough WALLnut 01/16/17 10:39:01 AM
PostSubject