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Vivos Inc. (OTC: RDGL)

The strategic market sector of Vivos Inc. (formerly Advanced Medical Isotope Corporation) is therapeutic 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 RadioGel™ Veterinary Solutions division of Vivos is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. Vivos 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, Vivos 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, Vivos’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. Vivos’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. Vivos’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 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.  Vivos 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.

Are there other markets for RadioGel™? 

March 15th, 2016, Vivos Inc. announced the formation of a new, wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market. In August 2017 the subsidiary was changed and made into a separate operating division inside the Company.

The IsoPet™ Veterinary Solutions division will focus on bringing RadioGel™ 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. Initial treatments are to be coordinated through the Chair of the Company’s Veterinary Medicine Advisory Board, Dr. Alice Villalobos.

CEO and President Dr. Mike Korenko stated: “IsoPet Solutions allows specific resources to focus on the use of our RadioGel™ Yttrium-90 brachytherapy products in the veterinary space. We believe that RadioGel™ is positioned to build a significant presence in the cancer treatment tool-kit of veterinary oncologists.”

Dr. Alice stated: "I am quite excited at the opportunity to work with RadioGel's™ team to integrate their products into the cancer treatments of companion animals. Cancer affects 50% of dogs over age ten and one in four dogs under age ten. For many years, we have been searching for a useable and effective agent such as RadioGel™ Y-90 brachytherapy devices that can be delivered into tumors on an outpatient basis. I believe that veterinary oncologists around the globe will finally have an ideal product line for the treatment of accessible and inoperable tumors."

What are the steps for FDA clearance?

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



Press Releases 2018 ( Change in Company name and trading symbol • Jan 2, 2018)
Jan 2, 2018,  Advanced Medical Isotope Corporation (ADMD) Announces Corporate Name Change to Vivos Inc., and Ticker Symbol Change to RDGL
 



Press Releases 2017 ( Change in Management & Directors Dec 2016)

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™ 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(s) from CEO & President, Dr. Mike Korenko.

2017 -  LINK HERE



STOCK SYMBOL: OTC: RDGL

COMPANY WEBSITE
FACEBOOK
TWITTER

UPDATED 8/24/2017

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

 
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#68627  Sticky Note https://www.slideshare.net/RedChip/advanced-medical-isotope-corp-presentation-83 boomer 07/17/18 02:04:50 PM
#68588  Sticky Note $RDGL:Most Recent SC13D=5.116 Million shares avrg. .01 Sibware 07/17/18 01:00:02 PM
#65430  Sticky Note Radiogel, Radiogel for Vet will be a major obesestupidmouse 08/05/17 07:15:12 PM
#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
#69417   Old news under advanced medical isotope sharkey1 07/20/18 03:43:08 AM
#69416   Yesterday as well about 8mil. ARCA medic79 07/20/18 02:43:17 AM
#69415   I see a significant run coming based on The raging bull 07/20/18 02:14:54 AM
#69414   What strikes me is the similarity between animals The raging bull 07/20/18 02:11:53 AM
#69413   Insanity rules. There hasn't even been a chart Milo1 07/20/18 01:02:34 AM
#69412   The Company recently obtained clarification from the FDA PENNIEStoSTACKS 07/20/18 01:00:52 AM
#69411   Lots of buying at the close. The market Milo1 07/20/18 12:58:59 AM
#69410   Sending Private messages insulting me does not improve Milo1 07/20/18 12:54:54 AM
#69409   No, you look. Do your own DD. Milo1 07/20/18 12:51:27 AM
#69408   That’s been my dilemma as well, I don’t angelo2112 07/20/18 12:23:43 AM
#69407   You look https://google2.fda.gov/search?q=IsoPet+&client=FDAgov&site=FDAgov&lr=& PENNIEStoSTACKS 07/20/18 12:17:32 AM
#69406   It's on their website. Look for pete's sake! Milo1 07/20/18 12:15:22 AM
#69405   "IsoPet just recently approved by FDA" Can someone PENNIEStoSTACKS 07/19/18 11:55:37 PM
#69404   Oh clay trader..lol Another chart analysis. Traders here Hey Ray 07/19/18 10:54:12 PM
#69403   This is real interesting about skin cancer in Fireindahole101 07/19/18 10:07:25 PM
#69402   immediate revenues from IsoPet just recently approved Natural Trader 07/19/18 09:50:25 PM
#69401   Exactly, think that may be worth a little Fireindahole101 07/19/18 09:44:22 PM
#69400   they found the cure for skin cancer in Natural Trader 07/19/18 09:39:59 PM
#69399   Correct. VCA won’t be upstaged by a local West Coast Snapper 07/19/18 09:30:11 PM
#69398   That would be fantastic. Get PR of actual CatfishHunter 07/19/18 09:28:52 PM
#69397   They have found a cure for skin cancer. Fireindahole101 07/19/18 09:27:26 PM
#69396   J, I can answer that question. Never. :-) dandream 07/19/18 09:22:41 PM
#69395   They should generate revenue in the fall from West Coast Snapper 07/19/18 09:20:56 PM
#69394   Ya, they missed that goal and several others. CatfishHunter 07/19/18 09:03:02 PM
#69393   The presentation says revs in spring 2018 Luckysevens 07/19/18 08:48:42 PM
#69392   I expect an extension of filling like last Eltp 07/19/18 08:28:27 PM
#69391   Just wait for the next financials due mid-august. CatfishHunter 07/19/18 08:25:58 PM
#69390   Please make a video, it’s good to see Eltp 07/19/18 08:20:44 PM
#69389   Gap .0068 - .0073? $tockaddict 07/19/18 08:06:26 PM
#69388   Can’t track down the karate kid tho lolz Luckysevens 07/19/18 07:57:20 PM
#69387   Greg dona owns a million dollar apt by Luckysevens 07/19/18 07:56:30 PM
#69386   There won't be. He's probably covered his short Fireindahole101 07/19/18 07:30:14 PM
#69385   Agree with your comment lowfloatmaster 07/19/18 07:28:39 PM
#69384   An asian d filer is always good news https://www.prosek.com/unboxed-thoughts/a VortMax 07/19/18 07:14:14 PM
#69383   Depends if your playing the right patterns or tylerotc 07/19/18 06:28:16 PM
#69382   Lol, there isn't even a video. Milo1 07/19/18 06:23:57 PM
#69381   "The Company is also engaging the FDA for Chief Slapaho 07/19/18 06:23:14 PM
#69380   dude, this is the OTC.. most stocks dont Jambo 07/19/18 06:16:37 PM
#69379   Clay, does a stock ever go up the Johnstonj27 07/19/18 05:37:15 PM
#69378   Was just someone that had a inside drop Johnstonj27 07/19/18 05:29:39 PM
#69377   Clay make us a chart wearing a tin Stabbakilla 07/19/18 05:17:47 PM
#69376   RDGL in high level discussions with VCA for West Coast Snapper 07/19/18 05:13:52 PM
#69375   When you figure out how you do it crazyLuck 07/19/18 04:24:28 PM
#69374   no kidding! quite impressive if I may say ClayTrader 07/19/18 04:23:06 PM
#69373   Amazing new powers you've developed there! crazyLuck 07/19/18 04:21:56 PM
#69372   Okay, thanks :) Legster1969 07/19/18 04:20:59 PM
#69371   "The Company recently obtained clarification from the FDA Milo1 07/19/18 04:17:58 PM
#69370   $RDGL In Late Profitted In again Heavier Leaving LionsPride 07/19/18 04:15:34 PM
#69369   Clay, the sad part is if we all Stabbakilla 07/19/18 04:15:04 PM
#69368   The ironic part is, people who "claimed to ClayTrader 07/19/18 04:12:54 PM
PostSubject