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Advanced Medical Isotope Corp. (ADMD)

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Advanced Medical Isotope Corporation
 

The strategic market sector of Advanced Medical Isotope Corporation (AMI) is isotope applications.  Currently, the Company is engaged in the development of RadioGel™, a Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.

The company is engaging the FDA for permission to use RadioGel™ for the treatment of advanced basal and squamous cell skin cancers. The IsoPet Solutions division of AMI is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. AMI is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel™ to private animal clinics.

The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGel™ in other countries.

What is RadioGel™?

RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor.  This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area.

RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days.  This compares favorably to other available treatment options requiring up to 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.

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. Yttrium-90 beta-emissions travel only a short distance and have 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.

August 2016, 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 anticipates submittal (direct De Novo) for FDA clearance for full commercialization in the U.S. (see latest company press releases for continual updates on this evolving process).

Are there other markets for RadioGel™? 

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.

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.

Press Releases since 2017 Change in Management & Directors

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 FDA Approval
Mar 7, 2017,  AMIC's New CEO Releases Shareholder Letter Detailing Launch of Veterinary Oncology Division with Radiogel
Mar 23, 2017,  Update on Feline Cancer Treatment and Improvement to Financial Structure
Jul 6, 2017,  AMI Requests Pre-Submission Meeting with FDA
Jul 11, 2017,  ADMD Makes Significant Improvement to its RadioGel(TM) Brachytherapy Product
Jul 27, 2017,  ADMD to Host Shareholder Update Webcast with Live Q&A
Aug 2, 2017,  Advanced Medical Isotope Corp. Announces Results of Shareholder Meeting, Welcomes Two New Members of the Board of Directors
Sep 14, 2017,  Advanced Medical Isotope Corporation has its first discussions with private animal consortiums to utilize RadioGel™


Independent Analyst Research and Price Target

Sep 7, 2017, Van Leeuwenhoek Research Increases Valuation of ADMD to USD $35-$55 million USD or $0.66 - $1.00 per share

Presentation from President & CEO, Dr. Mike Korenko! 

Aug 1, 2017,  LINK HERE


STOCK SYMBOL: OTCQB: ADMD

COMPANY WEBSITE
FACEBOOK
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UPDATED 8/24/2017

Outstanding Shares 51,200,000
Preffered Series A     4,000,000

 
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PostSubject
#65430  Sticky Note Radiogel, Radiogel for Vet will be a major obesestupidmouse 08/05/17 07:15:12 PM
#65067  Sticky Note News out, significant improvement on the manufacturing process Eltp 07/11/17 08:49:02 AM
#63480  Sticky Note interesting eh ????? if no profit then what mick 03/05/17 12:12:44 PM
#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
#66136   Hey Happy Slappy!! WALLnut 09/22/17 04:32:05 PM
#66135   Good to see you here boot, three days Eltp 09/22/17 04:18:33 PM
#66134   Awesome close. Green 3 Days in a row Popeye 09/22/17 04:02:45 PM
#66133   Restructuring the management team but especially resolving some JayBPee 09/22/17 02:38:31 PM
#66132   Hey, just poking around today. Looks like there Boot Hill 09/22/17 01:52:23 PM
#66131   Chief....please tell me this is not true. WALLnut 09/22/17 01:27:29 PM
#66130   Sorry - just proving you’re wrong. There were Popeye 09/22/17 01:15:20 PM
#66128   Yes there was and I made a lot Popeye 09/22/17 12:38:31 PM
#66127   There were no such gains in the ticker, Chief Slapaho 09/22/17 12:25:30 PM
#66126   even better....last 3 times it was in trips microcaptrdr24 09/22/17 11:49:33 AM
#66125   Damn straight it's mediocre news. Chief Slapaho 09/22/17 11:48:48 AM
#66124   Looks more like the trip 7 potential cancer Chief Slapaho 09/22/17 11:47:35 AM
#66123   Looks like the 7 cent cancer cure that microcaptrdr24 09/21/17 10:28:02 PM
#66120   Every rocket begins with 1 screw and bolt, Popeye 09/21/17 12:41:21 PM
#66119   Just filling the AMIC tank with intelligent fuel. WALLnut 09/21/17 12:29:43 PM
#66118   This is an announcement with little or no Chief Slapaho 09/21/17 12:23:49 PM
#66117   Anything connected associated with the Mayo Clinic, I Miamifl 09/21/17 10:42:59 AM
#66116   Dam straight it's good news. WALLnut 09/21/17 09:06:05 AM
#66115   Saaaaweet!!!!! I love it!! Korenko is making great Popeye 09/21/17 08:52:31 AM
#66114   Great news indeed Eltp 09/21/17 08:31:57 AM
#66113   Mayo Clinic Doctor Joins Advanced Medical Isotope Corporation's WALLnut 09/21/17 07:57:21 AM
#66112   Anyone else see ALRT?? That'll be chump change chiflow 09/20/17 01:32:29 PM
#66111   Monster bid on 69s. WALLnut 09/20/17 12:51:51 PM
#66110   Sweet! I see that. Lots of support coming Popeye 09/20/17 12:50:12 PM
#66109   Looks like time to bounce back, bid bid Eltp 09/20/17 12:47:30 PM
#66108   Hear the sound of the S-1 that was microcaptrdr24 09/20/17 03:03:46 AM
#66107   They can't give the garbage away. Next stop tilltom 09/19/17 03:55:22 PM
#66106   I agree. It's very encouraging. Good thing 4 Popeye 09/19/17 01:25:51 PM
#66105   No its not! WALLnut 09/19/17 01:24:35 PM
#66104   According to the company's press release, both consortiums Chief Slapaho 09/19/17 12:39:43 PM
#66103   We'll have to see then, won't we. Chief Slapaho 09/19/17 12:35:54 PM
#66102   ADMD Holds First Talks With Private Animal Consortiums Popeye 09/19/17 12:29:25 PM
#66101   It will be bankrupt in 4 months. Hear tilltom 09/19/17 12:07:18 PM
#66100   In due time we all will be compensated. WALLnut 09/19/17 10:11:40 AM
#66099   I see it as a very viable revenue microcaptrdr24 09/19/17 12:32:13 AM
#66098   Here is the data and research report http://nebula.wsimg.com/4428bdde9198e981707 Eltp 09/18/17 08:21:05 PM
#66097   Korenko is setting a benchmark for real CEO Eltp 09/18/17 05:47:14 PM
#66096   Looks like new employment agreement for both Korenko Eltp 09/18/17 05:39:00 PM
#66095   Now this I totally agaree with. WALLnut 09/18/17 02:56:46 PM
#66094   Happy Monday everyone! Another week closer to Radiogel Popeye 09/18/17 02:21:32 PM
#66093   Agreed!! Chop Chop gobble gobble gulp gulp.... WALLnut 09/18/17 01:47:39 PM
#66092   Agreed. Chief Slapaho 09/18/17 01:33:21 PM
#66091   Everyone knows this is years away if ever tilltom 09/18/17 01:32:43 PM
#66090   Works for what? One feline? No one knows Chief Slapaho 09/18/17 01:12:19 PM
#66089   Incorrect!! WSU has stated by AMI's CEO that Radiogel WALLnut 09/18/17 01:02:54 PM
#66088   Incorrect assumption. Radiogel treatments are still not proven, Chief Slapaho 09/18/17 12:34:10 PM
#66087   Well, that is your area, not mine. I Chief Slapaho 09/18/17 12:29:52 PM
#66085   Its on the doorstep of bankruptcy. Doubt this tilltom 09/18/17 09:28:20 AM
#66084   Lmfao. The comparison that was made to vision microcaptrdr24 09/18/17 03:23:16 AM
#66083   Spot on, you don't need insurance or payment Eltp 09/17/17 06:45:45 PM
PostSubject