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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.

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
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

!! MOST RECENT NEWS !!
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 
Jan 11, 2017  AMIC's New CEO Issues Letter to Shareholders

Independant Analyst Research and Price Target
Feb 6, 2017  Van Leeuwenoek Research Increases Valuation of ADMD .78 - $1.57 Per Share

 


OTCBQ: ADMD

DOWNLOAD 2016 COMPANY PRESENTION

COMPANY WEBSITE           FACEBOOK          TWITTER
UPDATED 2/6/2017

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
#62930  Sticky Note I know this was talked about but I Popeye 01/23/17 07:55:30 PM
#62793  Sticky Note Advanced Medical Isotope's CEO Issues Letter to Shareholders WALLnut 01/11/17 10:30:05 AM
#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
#63155   Advanced Medical Isotope's CEO Releases Shareholder Letter Outlining Popeye 02/18/17 12:41:24 PM
#63154   FDA says in plain english DENOVO WONT WORK DreDiZzlE 02/18/17 11:43:04 AM
#63151   FDA SAY NONONONONONONO on DeNovo. #scAMIC TickTalker 02/17/17 03:34:40 PM
#63149   For sure and we aren't going anywhere until Eltp 02/17/17 08:16:58 AM
#63148   No worries.... we are on the same team JayBPee 02/17/17 08:16:09 AM
#63147   Np, i guess I misunderstood Eltp 02/17/17 08:15:34 AM
#63146   I was just agreeing with ya. Guess JayBPee 02/17/17 08:14:47 AM
#63145   That post should be addressed to F.L not Eltp 02/17/17 08:11:55 AM
#63144   I like your posts.... sounds like you know JayBPee 02/17/17 07:40:07 AM
#63141   It's not over til the Fat Lady sings. WALLnut 02/17/17 06:31:08 AM
#63140   Sounds like your beef is with that pile CatfishHunter 02/16/17 08:45:42 PM
#63139   I won't wish for anyone to die fat Eltp 02/16/17 08:10:23 PM
#63138   Guessing who buys correctly wins the $$$ Fat Lady 02/16/17 06:57:44 PM
#63137   Only way radio gel gets made - Caldwell Fat Lady 02/16/17 06:55:44 PM
#63136   DynAMIC! WALLnut 02/16/17 02:30:53 PM
#63135   Well - don't get too caught up in Popeye 02/16/17 12:18:39 PM
#63134   Another decade of doing absolutely nothing! Radiogel is DreDiZzlE 02/16/17 11:57:23 AM
#63133   Thanks TC, buford78 02/15/17 04:56:16 PM
#63132   Best and most accurate, insightful post in some Chief Slapaho 02/15/17 04:04:24 PM
#63131   Lol I am not touching this with your Tcsxyz 02/15/17 02:18:47 PM
#63130   Looking like CDEL is walking this little doggy CatfishHunter 02/15/17 01:20:19 PM
#63129   Shouldn't take long at all for Korenko to CatfishHunter 02/14/17 10:04:48 PM
#63128   Haha, I talk to him all the time. Eltp 02/14/17 09:26:43 PM
#63126   I'm all relaxed and understand that new CEO Eltp 02/14/17 08:22:12 PM
#63124   Confidence and positive sentiment about the new management Eltp 02/14/17 07:27:41 PM
#63123   Okay.. I'm in again SOON. chakalalaBoom 02/14/17 07:18:19 PM
#63122   If we get some major pet or FDA WALLnut 02/14/17 03:03:46 PM
#63121   I don't know if he's loading or not. buford78 02/14/17 02:21:15 PM
#63120   He could come back in and be a Boot Hill 02/14/17 12:57:51 PM
#63119   Tc is loading his boat? WALLnut 02/14/17 12:38:40 PM
#63118   TC is to busy loading at the moment buford78 02/14/17 12:23:48 PM
#63117   I don't have PM. WALLnut 02/14/17 11:33:23 AM
#63115   Can you post the brochure? WALLnut 02/14/17 11:25:56 AM
#63114   WOW! This is good stuff. WALLnut 02/14/17 10:58:04 AM
#63113   Glad to see you still around these parts JayBPee 02/14/17 10:52:06 AM
#63112   Man, sounds like the new CEO has a JayBPee 02/14/17 10:49:15 AM
#63111   Spot on Bro, no fluff but real plan Eltp 02/14/17 10:47:13 AM
#63110   Definitely no fluff in that PR. How Boot Hill 02/14/17 10:46:36 AM
#63109   Korenko, a straight up legit cowboy CEO with CatfishHunter 02/14/17 10:46:12 AM
#63108   Finally!! A CEO that's doing something. Boot Hill 02/14/17 10:43:25 AM
#63107   Just got off the phone with my buddy Eltp 02/14/17 10:36:02 AM
#63106   Here is the man http://www.hoganlovells.com/en-US/john-smith Eltp 02/14/17 10:27:21 AM
#63105   See who we hired and retained to engage Eltp 02/14/17 10:26:08 AM
#63104   Here we go TCXYZ, http://finance.yahoo.com/news/advanced-medical-isotopes-ceo-re Eltp 02/14/17 10:23:49 AM
#63103   Same here lol Eltp 02/14/17 08:03:14 AM
#63102   Dam dude....that sounds awesome. WALLnut 02/14/17 08:01:39 AM
#63101   Very true! WALLnut 02/14/17 07:45:02 AM
#63100   I'm counting on Korenko's last 2 months and Eltp 02/14/17 07:44:47 AM
#63099   It needs action taken. ADMD PRs have gotten Tcsxyz 02/14/17 05:27:02 AM
#63098   Korenko be like Jess Lockwood taking Pearl Harbor CatfishHunter 02/13/17 09:07:54 PM
PostSubject