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Vivos Inc. (RDGL)

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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



UPDATED 8/24/2017

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

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#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
#47440  Sticky Note The only topic to be discussed here is ADMD IH Dan (Retired) 09/27/15 02:45:52 PM
#67947   Why would he do that, I thought he Eltp 04/20/18 02:02:45 PM
#67946   Jim K.just sold a hundred shares. So WALLnut 04/20/18 12:25:37 PM
#67945   I disagree entirely. It is the ticker's fault. Chief Slapaho 04/20/18 11:02:56 AM
#67944   ???? You guys were saying? LOL gonetopot 04/20/18 10:06:30 AM
#67943   Obviously Eltp 04/20/18 09:39:39 AM
#67942   Hasn't really started yet. Grace period lets most tilltom 04/20/18 09:36:07 AM
#67941   Looks like the Bonus shares given to debt Eltp 04/20/18 09:14:06 AM
#67940   Exactly, it's s matter of time. This is Tcsxyz 04/19/18 07:29:24 PM
#67939   FDA is recommending approval of one CBD product clsace 04/19/18 05:33:56 PM
#67938   FDA is recommending CBD now for treatments? It's Tcsxyz 04/19/18 04:20:45 PM
#67937   This ticker will not survive or thrive IMO. Chief Slapaho 04/19/18 12:28:18 PM
#67936   You're BS talk don't make this investor walk. WALLnut 04/18/18 08:00:02 PM
#67935   Just don't see why anyone would be buying Tcsxyz 04/18/18 06:45:09 PM
#67934   I guess I can revise to giving our Chief Slapaho 04/18/18 04:57:52 PM
#67931   Sure did ... gave 'em our 2-cents' worth Chief Slapaho 04/17/18 11:17:39 AM
#67929   Correction!!! You'll probably be "smart" enough to buy WALLnut 04/16/18 12:39:39 PM
#67928   Yeah! I’m still here too! I’ll probably be Miamifl 04/16/18 11:53:18 AM
#67927   We tried to warn em Tcsxyz 04/16/18 10:44:03 AM
#67926   Without a miracle this POS could see trips tilltom 04/16/18 10:24:24 AM
#67925   It's the only two of anything on this Tcsxyz 04/16/18 09:06:14 AM
#67923   Thanks, TCS, for giving this your "2 cents" Chief Slapaho 04/15/18 12:25:32 PM
#67922   How what is spun? The deals are done Tcsxyz 04/13/18 06:20:20 PM
#67921   Down to .19 now. Not looking good, no Chief Slapaho 04/13/18 04:32:38 PM
#67920   The answer is here today, Read the ending,  WALLnut 04/13/18 10:04:29 AM
#67919   Stock not a company, like I said Tcsxyz 04/11/18 11:59:04 AM
#67918   Brooksda! Yea it's been a while for you Tcsxyz 04/10/18 06:47:21 PM
#67917   Oh my. Haven't been here in years. A Brooksda 04/10/18 03:09:49 PM
#67916   Titanic's most prized treasures are being discovered of WALLnut 04/09/18 08:56:30 PM
#67915   The boat is unloading ... and sinking fast. Chief Slapaho 04/09/18 07:11:44 PM
#67914   I said it would touch 2s in two Tcsxyz 04/09/18 04:52:38 PM
#67913   Notice how quiet the board is now. What tilltom 04/09/18 03:48:14 PM
#67911 mick 04/07/18 10:42:26 AM
#67910   I can't believe anyone is buying this dumpster Tcsxyz 04/06/18 02:29:16 PM
#67909   Several peeps here have been telling you this tilltom 04/05/18 09:49:04 AM
#67908   I don’t think there is money for payroll, Eltp 04/04/18 08:48:32 PM
#67907   In the filing it states equestrians and canines Tcsxyz 04/04/18 07:22:51 PM
#67906   Good question? Washington and Colorado Universities were CatfishHunter 04/04/18 01:56:08 PM
#67905   I just read in the 10k that testing obfisher 04/04/18 01:29:17 PM
#67904   I believe they had the same wording in Eltp 04/04/18 07:48:04 AM
#67903   Catfish we already know. In their own words Tcsxyz 04/03/18 10:05:42 AM
#67902   We should know in few weeks if Korenko CatfishHunter 04/03/18 09:28:36 AM
#67900   If that gives you comfort and think that's Tcsxyz 04/03/18 05:42:43 AM
#67899   Still alive and will survive. WALLnut 04/03/18 04:39:45 AM
#67898   Haha! Spot on Bro. WALLnut 04/03/18 04:37:37 AM
#67897   Exactly, only debt that could be in default Eltp 04/03/18 12:03:54 AM
#67896   Butter it however you want, it's dogshit and Tcsxyz 04/02/18 08:07:45 PM
#67895   Deficit and debt do not mean the same thing. Popeye 04/02/18 08:04:38 PM
#67894   The debt is the main reason it can't tilltom 04/02/18 07:17:23 PM
#67893   Debt is not the problem, inability to raise Eltp 04/02/18 06:55:02 PM
#67892   That deficit is HUGE. They're never going to Chief Slapaho 04/02/18 06:36:24 PM