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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  AMIC's 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
Feb 14, 2017  AMIC's CEO Releases Shareholder Letter Outlining New Streamlined Path to FDA Submission
Feb 28, 2017  AMIC's New CEO Releases Shareholder Letter Announcing and Discussing their Cancer Indication Selection to pursue for FDA Approval
Mar 7, 2017  AMIC's New CEO Releases Shareholder Letter Detailing Launch of Veterinary Oncology Division with Radiogel 


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 3/7/2017

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

 
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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
#63735  Sticky Note ISO Pet near term catalysts: microcaptrdr24 03/16/17 09:13:02 AM
#63480  Sticky Note interesting eh ????? if no profit then what mick 03/05/17 12:12:44 PM
#63359  Sticky Note Focus on this! The good stuff really JayBPee 03/02/17 10:01:05 AM
#62930  Sticky Note I know this was talked about but I Popeye 01/23/17 07:55:30 PM
#60262  Sticky Note This stock is bigger than the company. If Tcsxyz 07/27/16 08:25:42 PM
#47440  Sticky Note The only topic to be discussed here is ADMD IH Admin [Dan] 09/27/15 02:45:52 PM
#63960   You can't say b@$her but the b@$hers can Popeye 03/29/17 06:53:00 PM
#63959   I have no plans to sell my shares JayBPee 03/29/17 03:56:50 PM
#63958   I wonder if admd collected it's money from budwallstfox 03/29/17 02:10:55 PM
#63957   Sorry sometimes I don't read the rules. I budwallstfox 03/29/17 01:58:48 PM
#63956   Can someone tell me if investor hub removes budwallstfox 03/29/17 01:27:13 PM
#63954   Means nobody selling. It either breaks to the Popeye 03/29/17 12:08:16 PM
#63953   Volume is showing zero today. Not a good Chief Slapaho 03/29/17 12:03:29 PM
#63952   What progress? Talk is cheap and worth nothing tilltom 03/29/17 11:52:28 AM
#63951   Soon we will see few million shares bids Eltp 03/29/17 10:44:53 AM
#63950   Wrong again, Korenko wasn't on the board a Eltp 03/29/17 10:40:09 AM
#63949   Korenko is "still" cleaning up Jim's trashed mess. WALLnut 03/29/17 10:34:50 AM
#63947   Yup, complete nonsense and if fda is equipped Eltp 03/29/17 10:29:05 AM
#63946   Few thousands are not an issue, lots of Eltp 03/29/17 10:26:17 AM
#63945   the million share buyer is back so looks microcaptrdr24 03/29/17 10:26:15 AM
#63944   Doesn't answer the question. Look at the balance Tcsxyz 03/29/17 10:25:09 AM
#63943   Katzaroff knew about John Smith over a year Eltp 03/29/17 10:25:07 AM
#63942   FYI, I recommended the legal approach with this Eltp 03/29/17 10:17:43 AM
#63941   Don't fool yourself. No one does anything here Tcsxyz 03/29/17 10:10:29 AM
#63940   Because if you have been in this stock Tcsxyz 03/29/17 10:01:48 AM
#63939   I think buying 700k shares in the open budwallstfox 03/29/17 09:53:20 AM
#63938   How's it an assumption after reading the progress Eltp 03/29/17 09:51:03 AM
#63937   No, they are not actually. However assuming things Tcsxyz 03/29/17 09:49:10 AM
#63936   When your new sheriff actually does something besides tilltom 03/29/17 09:34:27 AM
#63935   Tc, Your post here is old school. WALLnut 03/29/17 09:26:47 AM
#63933   Still fighting the good fight here?! This is Brooksda 03/29/17 04:31:39 AM
#63932   All are assumptions and made up thoughts, we Eltp 03/29/17 12:10:27 AM
#63931   Of course you have been. I guess the Tcsxyz 03/29/17 12:05:47 AM
#63930   I been involved in FDA submissions in the Eltp 03/28/17 10:20:44 PM
#63929   Sorry my friend. You must not be familiar Popeye 03/28/17 10:02:05 PM
#63928   Popeye, It matters not one fraction the way ADMD Tcsxyz 03/28/17 09:55:50 PM
#63927   Well if we been saying it for years.....we WALLnut 03/28/17 01:41:13 PM
#63925   I'll be there with ya partner, sitting CatfishHunter 03/28/17 01:14:46 PM
#63924   You've been saying months away for the last tilltom 03/28/17 01:14:06 PM
#63923   Nope. Months. Watch and learn! See ya from Popeye 03/28/17 12:34:31 PM
#63922   Hope so. Been too busy to be Boot Hill 03/28/17 12:31:01 PM
#63921   Spot on! WALLnut 03/28/17 12:28:46 PM
#63920   Hey, guys. Been slowly adding some shares Boot Hill 03/28/17 12:23:03 PM
#63918   Trips will happen here. Just a blip in Chief Slapaho 03/28/17 12:14:56 PM
#63916   The time is near for what? Neither the tilltom 03/28/17 11:40:45 AM
#63915   100k support on 13's. The time is near! Popeye 03/28/17 11:33:09 AM
#63914   Sorry duplicate post. budwallstfox 03/28/17 11:28:41 AM
#63913   Someone seems to be buying this morning. Hope budwallstfox 03/28/17 11:28:39 AM
#63912   "Come get your trips" microcaptrdr24 03/28/17 11:17:00 AM
#63911   Jim failed Radiogel. Not the other way around. WALLnut 03/28/17 06:17:50 AM
#63910   From my understanding FDA shot down admd because budwallstfox 03/27/17 04:33:05 PM
#63909   Wrong amigo. It was not properly submitted to Popeye 03/27/17 04:14:08 PM
#63908   Radiogel is something that has already failed. ....its DreDiZzlE 03/27/17 02:56:50 PM
#63907   The days of buying cheap share is fast approaching. WALLnut 03/27/17 02:52:56 PM
#63906   Wouldn't be surprised to see a 133 share CatfishHunter 03/27/17 02:25:03 PM
#63905   agree, and now it's attracting other buyers...bid grew microcaptrdr24 03/27/17 02:18:15 PM
PostSubject