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Just an observation, but noteworthy none the less, if you have been and you are longer term RDGL.....
The stock began it's undeterred MARCH Northward back in MARCH of this year. MARCH 1st the stock opened at 0.0524 and ended the month with a 0.07225 share price. Since then there has been no looking back. The stock has been stably trading at or near 4 year highs for a few months now all the while doing so at a more consistence base than years prior and with more shares out in the market than years prior (The last time RDGL traded anywhere NEAR OR ABOVE .20 cents was in January 2021 when it traded above .20 cents no more than 3 days, then fell back below .07 cents in a matter of a just a few) For those serious long term investors who have been accumulating shares a little along. Well I would have to reasonable assume that they are ecstatic with the current PPS and the way it's been trading along with the potential for bigger gains yet to be realized in the not so distant future upon FDA approval!
https://www.clinicaltrialsarena.com/news/vivos-eyes-human-trials-for-radiation-treatment-gel-with-ide-submission/?cf-view
https://tradersque.com/vivos-inc-announces-ide-submission-for-radiogel/
That Mayo Clinic IRB approval is required post FDA approval of VIVOS IDE is no news. The Mayo clinic has been working with Vivos for years and both parties are aware of this important requirement. In anticipation of Vivos IDE submittal to the FDA, the Mayo Clinic medical personnel who'll be directly involved in the proposed clinical trials were trained up and this fact is part of the IDE application. The prep training wouldn't have happened in the first place without prior Mayo Clinic authorization. With that being said, feel free to reach whatever conclusions from there. IMO, based on the above mentioned facts, the logical conclusion shouldn't be so mysterious or too difficult to discern by anyone who has been following this for a while. Still, to each their own. GLTA
Bahahaha you are funny.
Yeah yeah buddy
Mayo has prepped to do this procedure
Perhaps some of Jimmie come lately s and ones that really haven't been oaying attention do some DD concerning the last 6 to 8 months
I work at a hospital… bureaucracy comes with “we meet once a month” “paper pushers” lol
Actually I doubt it will take much time at all
Considering that Mayo has been an integral asset through the entire submission process . They've had plenty of time to prepare for the IDE approval event
Well, glad I took my own advice and checked out for 11 days. Seems I only missed hair pulling. Wish they had held article till next wed/thur into what I expect to be heavy traffic.
Also irb could take a little time (it's hosp bureaucracy). It is another validation of efficacy though. I should say "when it's signed off on". It's a symbolic vote of confidence. Especially for an outfit as small as this.
Time to move 🚀
RDGL I've been lurking for several weeks now and like what I see.....safe to come back into the water after today's fiasco....
Agreed. Posting is usually a complete waste of time imo. We know what we own in RDGL$. GLTA.
So much for all of our collective price forecasts! Looks like the market won't reward this ticker with higher share price until approval.
I don't like it, but it is what it is.
Other brachytherapy devices uses beads thats been placed next to the tumor.. the danger of that is it travel in the body to other places and can do damage to healthy organs. Another brachytherapies uses catheters or tubes thats been put intra-arterial and dosing the radio isotope straight to the tumor through guiding the tubes/catheter through the blood vessels that’s feeding the tumor and releasing the isotope to the tumor.. very difficult approach. Dangers of this treatment is overdosing, under dosing or damaging the blood vessels or leakage to other organs..
RadioGel distinguishes it self from others because it can be placed by a needle trough the skin or operation and injections straight to the tumor
Excellent manners he has! Very pleasant.
No, he’s one of the best veteran posters on here ….
You’re showing your “newbie” colors here.
And with that, welcome to the board still
We already know where this stands and what needs to be done.
Excellent questions.
Unfortunately I don't have an answer to any of them.
Hopefully someone does.
Nah I'm not flipping out skate
.lmao
🙄 I want it to succeed as much as you do but you are constantly getting angry when someone states the facts. I'm not inventing anything just pasting excerpts from articles approved by the company and FDA website. You're flipping out for no reason.
Or JHU. IRB is very easy to submit. I’m assured all the relevant questions and concerns answered for the FDA application apply.
200k on the bid at 17 cents on e trade
Chumly get lost w the bullshit lollpl
Almost all of us here have been here for a very long time . What's required and how it's going to move forward is already known
So take the newby bullshit and not waste anymore or your time or anyone else's
My thoughts are to wonder how the RDGL device is being treated by the FDA?
In other words Brachytherapy is not some new device... it has a decades long history.
Y90 is not a new radioisotope for cancer treatment... it has a long history as well.
The gel is an original formulation and the Y90 is far more pure than currently approved bead brachytherapy solutions.
Is FDA approving this as a new device? A new formulation for an already approved device? A human safety improvement from category 3 to 2 (more safe) for an existing device use justified by the Breakthrough Device Designation?
The answers could significantly affect/shorten the typical timeline here, no?
Discuss /explain if anyone here is up on all that stuff please?
- Go $RDGL
Mayo is waiting for FDA approval.. They want to start asap !! Vivos has already send the clinic trial protocols to the IRB gatekeepers for comments in anticipation of fda approval.. everything is prepared.. just waiting on fda green light
It is not done yet. https://tradersque.com/vivos-inc-announces-ide-submission-for-radiogel/
Collaboration with Mayo Clinic
In anticipation of FDA approval, Vivos Inc. is collaborating with the Mayo Clinic to prepare the necessary documentation for submission to their Institutional Review Board (IRB). This partnership aims to facilitate the initiation of clinical trials at Mayo Clinic, leveraging their extensive expertise in oncology and clinical research.
Dont listen to lost and lollipop
This information has been posted at nauseum...take your FUD and .
The FUDSTERS are trying like cockroaches
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-institutional-review-boards-irb
Mayo is waiting for FDA APPROVAL of course you know that or not
MAYO IS READY TO GO
FULL STOP
Mayo clinics IRB has been with Dr Korenko and rdgl throughout this process so we are good to go
Mayo has completed the practice protocol with dummies....
Now we go live ....imo
In that case, I would expect Mayo to assist, as someone else said.
The opposite: Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study.
That is for a non-significant risk device such as contact lenses. That doesn't apply here imo...anyone else on the board have any thoughts?
That’s through the Mayo Clinic so nothing to worry about there.
The Mayo Clinic has been extremely proactive with Radiogel.
Pretty sure they also need an IRB approval prior to starting trials. https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
Great information, thank you!
Mammoth! For all the fudsters asking whether the fda got the submission or not. I believe we will be accepted via non response. That sets phase 1 trials to begin as early as 7/30/24 although 8/1/24 for the first patient works too!
Nice article in a website for the medical device industry (versus the many AI generated investor rag articles that have been coming out). Looks to me like they got more meaningful quotes from Korenko.. Apologies if this was already posted. Note it says that funding of startup and early-stage companies through investments made by venture capital firm has increased by about 550% from $63m in 2017 to $408m in 2023. I wouldn't mind a partnership to get some of our funding to stabilize price, but I don't think Korenko will go that route.
https://www.medicaldevice-network.com/news/vivos-eyes-human-trials-for-radiation-treatment-gel-with-ide-submission/
Ahh, this quote below I'm pretty sure I saw posted before that put the recent buyouts of companies like Vivos at a low of $1.4 billion to a high of $4.1 billion. Nice morning reading to remind me to hold my shares!
Big pharma has made plays for the space in the past year too, with Eli Lilly, Novartis and Bristol Myers Squibb signing deals ranging from $1.4bn to $4.1bn to acquire radiopharma specialists.
Been reading about the BDD more this morning. Getting that designation was certainly a boon for the company. Recall the path Vivos anticpates taking is to apply for a De Novo marketing authorization. I cannot find anything about IDE submission of devices that qualify as BDDs. I'm beginning to think that is because that first step is a relative non-issue.
The increase of breakthrough device designations has allowed more products to get to the commercial market in a shorter amount of time. Under the breakthrough device program, the average time for review of a 510(k) clearance decreased by more than 50%, down from 270 days to 155 days. Similarly, the breakthrough device program has decreased time to grant for a De Novo marketing authorization by 68 days, a decrease of more than 25%.
An update from our Vivos Inc. CEO, Dr. Korenko regarding the IDE application. The FDA has acknowledged they have received the application. It is under interactive review. #Cancer #CancerJourney #CancerAwareness @RadioGel @IsoPet $RDGL pic.twitter.com/8uzgmiFlVb
— Vivos Inc. (@VivosIncUSA) July 9, 2024
For those with L2 (.... and I'm hoping that's everyone...lol) the Pre-Market action just prior to the open tells the story. ....as in yes, I agree with you this AM
Obviously MMs control the PPS down
MM talk is all BS.. this is just people don’t know what they are holding and getting nervous.. All i can say the approval chances is like 95% thanks to the EFS program.. they did everything the FDA asked for so be prepared for a slingshot to the stratosphere when the news drops..
Added 0.168 here.
The production cost is lowered by the years to $ 6000
I Just saw double rainbows, which is a great indicator that, it will be a great day today.
Grab them while you can….
And the FUDSTERS forgot to mention the treatment is covered by Pet insurance...they knew this
It's their way of getting people to sell into their FUD
Added 16s in what's wildly moronic stock price and market cap for the company
How paranoid do you have to be to think that there are only three people on the internet? All I did was post an article explaining why the treatment is not as popular. So weird…. But ok
just grabbed 5,000 more at .165
ridiculous
The plan with IsoPet is to get more clinics throughout the US so the travel distance will be considerably shorter.. the issue was people didn’t wanted to travel a long distance with their pets.. And by having more clinics they can increase the animal patients and lower the cost at the same time..
The production cost is lowered by the years to $ 6000
If 2 dogs could be treated with the same production preparation than the cost is about 50% of what would be otherwise, and if you could treat 3 animals ( doesn’t has to be in the same clinic ) at the same time the cost goes way down..
The plan is to schedule multiple animal patients that can be treated at the same time ! Not necessarily in the same clinic but important is the treatment is all on the same day so they can do one production run and separately send them to the different clinics
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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.
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
Presentation(s) from CEO & President, Dr. Mike Korenko.
2017 - LINK HERE
STOCK SYMBOL: OTC: RDGL
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