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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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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
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
#64237   has your one legged sister ever entered into microcaptrdr24 04/22/17 06:44:23 PM
#64233   Shorting regulations and expediting Fda approval is what Eltp 04/22/17 10:45:56 AM
#64232   Mucho Deniro spent on Pets, http://www.americanpetproducts.org/press_industrytre Eltp 04/22/17 10:38:06 AM
#64231   I'm so bored of this board but I'm Popeye 04/22/17 10:10:23 AM
#64230   It is indeed at the moment. Chief Slapaho 04/21/17 11:19:50 PM
#64228   Add ADMD to your collection. Its going to WALLnut 04/21/17 08:25:43 PM
#64227   I have seen some market cap from $100 Eltp 04/21/17 07:52:03 PM
#64226   I never said they were 2 months away microcaptrdr24 04/21/17 05:47:28 PM
#64225   Does this look like a stock that is tilltom 04/21/17 05:25:24 PM
#64223   Do you see anyone rushing out to buy tilltom 04/21/17 03:26:08 PM
#64222   Exactly! Chief Slapaho 04/21/17 03:23:09 PM
#64221   Sorry, you have claimed many times in your Chief Slapaho 04/21/17 03:22:36 PM
#64220   you made the claim they're different....you had your microcaptrdr24 04/21/17 03:02:03 PM
#64219   Forget about it. It will be in testing tilltom 04/21/17 03:01:14 PM
#64218   Not at all. Are you a vet or Chief Slapaho 04/21/17 02:54:28 PM
#64214   I am however intelligent enough microcaptrdr24 04/21/17 02:26:40 PM
#64213   ROTFLMAO "A vet I know well"- is he a microcaptrdr24 04/21/17 02:25:40 PM
#64211   I am not your son. I am however Chief Slapaho 04/21/17 02:06:00 PM
#64208   I am getting a little dizzy reading some budwallstfox 04/20/17 07:50:34 PM
#64207   I like triple trips better $3.33. budwallstfox 04/20/17 07:09:34 PM
#64206   I think we need a new shareholder letter. budwallstfox 04/20/17 07:05:00 PM
#64205   It will be years in testing before approved tilltom 04/20/17 04:34:06 PM
#64204   You are using the street logic but scientific Eltp 04/20/17 02:16:42 PM
#64203   Because they're treating different species. Humans are not Chief Slapaho 04/20/17 01:55:04 PM
#64202   Why would the formula be different in Vet Eltp 04/20/17 01:25:09 PM
#64201   Not true. Not the exact same formula or Chief Slapaho 04/20/17 12:56:30 PM
#64200   AMIC will be going nuclear on pet division WALLnut 04/20/17 10:16:43 AM
#64198   Agreed. That was already established on this Boot Hill 04/20/17 09:06:52 AM
#64197   nice post...pretty black and white that FDA approval microcaptrdr24 04/20/17 08:07:29 AM
#64195   We only have one product for both Vet Eltp 04/19/17 07:59:52 PM
#64194   LOL this reminds me of the presidential debates. clsace 04/19/17 04:57:06 PM
#64193   Wrong. Radiogel is not a Veterinary device. Isotope tilltom 04/19/17 04:53:14 PM
#64192   Wrong, link below can educate you https://www.fda.gov/animalveterinary/resources Eltp 04/19/17 04:09:25 PM
#64191   Wrong. The company does not get to set tilltom 04/19/17 04:00:35 PM
#64190   Wrong. FDA has a Veterinary medicine center that tilltom 04/19/17 03:58:23 PM
#64189   What company wouldn't do any product testing and CatfishHunter 04/19/17 02:13:18 PM
#64188   WRONG......I just provided the link from FDA that microcaptrdr24 04/19/17 02:02:29 PM
#64187   WRONG. What do you think the 3 Universities tilltom 04/19/17 01:48:46 PM
#64186   An animal device does not go through a microcaptrdr24 04/19/17 01:40:32 PM
#64185   Risks of Animal Drugs Marketed as Animal Devices microcaptrdr24 04/19/17 01:39:17 PM
#64184   provide a link that says med devices need microcaptrdr24 04/19/17 01:35:07 PM
#64183   Check it out for yourself. FDA center for tilltom 04/19/17 01:26:39 PM
#64182   correct, part of the vet standards says clearly microcaptrdr24 04/19/17 01:19:26 PM
#64181   since it's a medical device there is no microcaptrdr24 04/19/17 01:18:09 PM
#64179   You're wrong otherwise Post links or proof for Popeye 04/19/17 01:13:10 PM
#64178   Vet use has their own standards for approval. tilltom 04/19/17 12:50:39 PM
#64177   This is certainly not a pretty picture for Chief Slapaho 04/19/17 12:50:09 PM
#64176   I hope so. I'd like more shares! Popeye 04/19/17 12:27:35 PM
#64175   VERY wishful thinking at best. Only 2.8 ticks Chief Slapaho 04/19/17 12:23:43 PM
#64173   That is a point that true investors have JayBPee 04/19/17 09:45:38 AM
PostSubject