Truthsocial
10時間前
RDGL SUPERIOR Vivos Inc's RadioGel® competes with established Y-90 therapies like TheraSphere (glass microspheres) and SIR-Spheres (resin microspheres) by targeting a fundamentally different clinical niche: direct intratumoral injection versus intra-arterial infusion.
RDGL SUPERIOR
1. Distinct Mechanism of Action: Interstitial vs. Vascular
The primary competitive advantage of RadioGel is its delivery method, which bypasses the vascular system entirely.
RadioGel (Interstitial Brachytherapy): Administered via direct injection into the solid tumor mass. The liquid hydrogel perfuses the tumor tissue, warms to body temperature, and solidifies within seconds, locking the Y-90 particles in place. This creates a "radiation depot" that emits beta radiation locally while the gel biodegrades over ~2 months.
TheraSphere & SIR-Spheres (Radioembolization): Administered via catheter into the hepatic artery feeding the tumor. These microspheres lodge in the tumor's blood vessels.
TheraSphere: Uses high-activity glass microspheres (fewer particles, lower embolic effect).
SIR-Spheres: Uses lower-activity resin microspheres (more particles, higher embolic effect).
2. Competitive Advantages of RadioGel
RadioGel addresses specific limitations inherent to vascular radioembolization:
Tumor Confinement & Safety: Because RadioGel solidifies instantly upon injection, it prevents the migration of radioactive particles. In contrast, vascular therapies carry a risk of non-target embolization (particles flowing to healthy lungs or GI tract), requiring complex pre-procedure mapping (angiography) to prevent off-target damage. Search data indicates RadioGel achieves a therapeutic ratio of 1000:1 or higher for target vs. non-target tissue.
Applicability to Non-Vascular Tumors: TheraSphere and SIR-Spheres are primarily indicated for liver tumors (HCC and metastatic colorectal cancer) due to the liver's unique blood supply. RadioGel can theoretically treat any accessible solid tumor (e.g., pancreatic, lung, sarcomas, lymph nodes) regardless of its blood supply, as it does not rely on arterial delivery.
Procedure Simplicity: RadioGel eliminates the need for interventional radiology suites and complex catheterization. It can potentially be administered in an outpatient setting using CT or ultrasound guidance, reducing procedural costs and complexity compared to the specialized infrastructure required for SIRT (Selective Internal Radiation Therapy).
3. Clinical Differentiation
Current Status: While TheraSphere and SIR-Spheres are FDA-approved and commercially established for liver cancer, RadioGel is currently in clinical trials (IDE approved July 2026 for US trials; ongoing human demonstrations in India).
Early Efficacy Signals: Early data from Vivos's India trials (2025–2026) reported >80% tumor reduction in some cases with zero adverse events, highlighting the potential for high efficacy without the "post-embolization syndrome" (pain, nausea, fatigue) often seen with vascular blockade therapies like SIR-Spheres.
RadioGel vs TheraSphere SIR-Spheres mechanism comparison
Let's go ISOPET now and RDGL now
Truthsocial
10時間前
Current Status and Next Steps
Vivos Inc. received FDA Investigational Device Exemption (IDE) approval for its RadioGel study on July 6, 2026. This clearance allows the company to initiate its first-in-human feasibility study at Mayo Clinic in Jacksonville, Florida. However, the study cannot commence until the Mayo Clinic IRB grants its own approval.
According to the company's July 6 announcement, Vivos Inc. plans to promptly submit the treatment protocol to the Mayo Clinic IRB now that FDA conditions have been incorporated into the study design. CEO Mike Korenko stated that the team is "focused on initiating the study and working closely with our clinical partners."
Vivos Inc RadioGel Mayo Clinic trial
Estimated Approval Timeline
The Mayo Clinic IRB typically requires four to six weeks to review and approve new research protocols from the date of submission. Given that today is July 11, 2026 (five days after FDA approval), and assuming Vivos Inc. submits the protocol immediately:
Earliest expected approval: Mid-August 2026 (approximately 4 weeks from submission)
Latest expected approval: Mid-September 2026 (approximately 6 weeks from submission)
The actual timeline may vary depending on:
The speed of Vivos Inc.'s protocol submission
Whether the IRB requests additional clarifications or modifications
The complexity of the study design for non-resectable papillary thyroid carcinoma treatment
Mayo Clinic IRB submission requirements
Study Details
Once approved, the feasibility study will:
Enroll an initial five patients with non-resectable papillary thyroid carcinoma
Evaluate the safety and feasibility of RadioGel, a yttrium-90-based injectable hydrogel
Help shape subsequent pivotal trials based on results
This U.S. study runs parallel to ongoing clinical trials in India, where 10 patients have already been successfully treated with no adverse events reported.
Leo ai says
Let's go ISOPET now and RDGL now
Nytoncva
1日前
He may have already raised a chunk this past week, obviously not 9M, but anyone know what volume the first day was? Yesterday was less than average at only 700k. That really felt like dilution on day 1. Even with the poor PR, in this market environment I really would have expected more strength. I haven’t been monitoring the OS closely and it’s not always updated real time. Right now apparently 493,964,360.
chereb19
1日前
This post is a good reminder that confidence and accuracy aren't the same thing. You predicted the FDA wouldn't "give the green light." The FDA subsequently approved the IDE to begin the human feasibility study. It's perfectly reasonable to remain skeptical, but it's also reasonable to acknowledge when a prediction doesn't match the outcome.
This is why absolute statements are risky. "I just don't see how the FDA will give the green light..." sounded definitive at the time. The FDA reached a different conclusion. Maybe next time dial back the certainty and dial up the evidence.
Much of this post consists of hypotheses about manufacturing, polymer behavior and regulatory thinking. Those are valid areas for discussion, but they should not be confused with established regulatory findings. The subsequent IDE approval demonstrates that the FDA's assessment differed from the one predicted here.
Looking back, the key takeaway is straightforward. The prediction was that the FDA would not authorize human investigation. The documented outcome was IDE approval for an Early Feasibility Study. Whatever one's investment view, it's helpful to distinguish between speculation and what ultimately occurred.
chereb19
1日前
Every time you're wrong, you don't revisit your thesis—you just invent a new one. First it was "they'll never get an IDE." Then it became "it's only an EFS IDE." Now it's dilution, patents and OTC. The conclusion never changes; only the excuse does.
You're throwing everything at the wall hoping something sticks. "Junk science." "Patent expiration." "Competition." "No market." "Bad management." Yet despite years of predicting the FDA would never authorize human studies, here we are. Maybe it's time to admit your crystal ball needs recalibrating.
The post conflates scientific, commercial and financial issues into a single conclusion. Those are separate questions. Financing needs do not establish scientific validity, just as regulatory progress does not guarantee commercial success.
Your statement that the device "can only treat papillary thyroid cancer" is simply inaccurate. The current IDE authorizes an Early Feasibility Study in that indication. That does not define the potential scope of the technology or every future indication.
It's remarkable how every milestone is dismissed the moment it's achieved. If the FDA had rejected the application, you'd have called it proof the science was dead. The FDA authorizes the study, and suddenly the approval "doesn't count." That's not objective analysis—it's a script. No matter what happens, the ending is written before the first page.
CatfishHunter
1日前
The IDE approval isn’t “fluff” — it’s FDA clearance to start first-in-human trials at Mayo Clinic for a Breakthrough Device. That’s a real regulatory milestone after addressing prior feedback, incorporating IsoPet safety data (200+ cases, strong profile) and India human results.
Yes, dilution risk exists in OTC biotech, and execution/funding will be critical. But calling it “junk science” ignores Breakthrough designation, preclinical/vet data, and the platform’s potential beyond one narrow indication (EFS is an entry point for solid tumors).
Management has advanced regulatory, manufacturing, and vet commercialization (IsoPet). Patent/competition/economic challenges are real for any early device, but de-risking via EFS data is exactly how these programs move forward.
This isn’t “skyrocket tomorrow” but with IDE approval it went from high-risk/high-reward to lower risk with concrete next steps (IRB finalization, enrollment, data). Trade the volatility if that’s your style, but the fundamentals improved with this approval. Always DYOR and manage risk.
Musical Shares
2日前
First, it was "when we get the IDE approval this will skyrocket." Now, "look at all the catalysts coming."
It's always the pink sheet phrase "buying shares at this level is a gift." This is the OTC. The people who understand this ticker know how to trade it. And that's exactly what happened. And will continue to happen. This is not even worth 8 cents a share at this point in time. It's overpriced.
Look at all the new bag holders from this EFS IDE press release. And this was supposed to be the big one!
What will happen, just like every other OTC biotech, is a continuous amount of fluff PRs to keep this going.
The amount of money they need to raise through dilution will be terrible. I'm skeptical at the funding that's going to take place here.
The problems that have already been laid out here include patent expiration, tough competition, and little economic incentive to produce the medical device given the costs associated with scaling and actual patient demand. People forget that this is for the indication papillary thyroid cancer. So, this medical device can only treat that condition.
Bad economic outlook. Junk science. Inexperienced management. OTC ticker.
Always take profits.
CatfishHunter
2日前
Your $9 raise with 200M shares puts the share price at $.045 per share if my math is correct. The current Reg A offering is at $0.08. I expect the SP will higher after start of EFS and positive 30 day report, which may lead to a higher offering price, but at a minimum, it should remain at $.08 and MK won’t need to raise the full $9M all at once. So total shares sold should be should be around 100M if not less, depending on share price and if MK amends and raises the SP in the offering accordingly.
Mayo Clinic will definitely add legitimacy to Radiogel, but MK and Vivos Team need to do their part and properly market and have a reach out program to bring more attention and awareness to serious investors and not leave the marketing to their current “Client Relations Manager”.
CatfishHunter
2日前
EFS IDE Approval Is Meaningful Progress, Not “Junk Science”
FDA approval of the Feasibility IDE (announced July 6, 2026) for the first-in-human study at Mayo Clinic isn’t trivial. The agency reviewed the submission (including preclinical, veterinary IsoPet data, and India human experience) and determined there was sufficient safety justification to proceed in patients with non-resectable papillary thyroid carcinoma. Prior IDE feedback loops were addressed. This isn’t a rubber stamp — it’s the outcome of the EFS pathway designed exactly for innovative devices like this. Many programs advance past IDE but face challenges later; that’s why the staged approach (EFS ➡️ pivotal via supplement) exists. Strong 30-day (and longer) safety/feasibility data from this small cohort will directly inform the next steps.
Data Foundation Is Broader Than Just Rabbits
• Veterinary IsoPet: Hundreds of cases with real-world use, strong safety profile (no radiation-associated adverse effects in normal tissues per histopathology).
• India human work: Multiple patients treated with safety endpoints met (PET-confirmed retention, no complications reported in updates).
• Preclinical: Extensive animal work supporting targeted delivery and tumor ablation.
Yes, human data in the U.S. is the key next step, and the EFS is designed to generate exactly that (containment, dosimetry, degradation, ablation signals). It’s not starting from zero.
Funding, Manufacturing & Logistics
• Funding: They have a qualified $75M Reg A+ (raised ~$2.2M recently) and a stated $9M need over 36 months for FDA/trials/manufacturing/clinics. This is disclosed in SEC filings. Dilution is a risk all early companies face, but they’re executing on the capital plan.
• Manufacturing & Y-90: Valid point on logistics (short half-life, radiation handling). However, they already hold a Washington State radioactive materials license for IsoPet production and have been advancing manufacturing (new sterilization processes noted in filings). It’s challenging (as with any Y-90 program, including established players), but not insurmountable — the EFS will help validate scalability.
• Patents & Economics: Vivos has issued patents (e.g., recent U.S. Patent No. 12,521,452 mentioned in updates) protecting key aspects of the PrecisionGel platform. Economics will depend on clinical success, reimbursement, and adoption — too early to declare “no sustained profits.” Competitors exist in radiation oncology, but a direct intratumoral gel has differentiation potential (targeted vs. systemic or bead-based approaches).
Price Action
Short-term ticker movement after news is noisy and often driven by traders, low volume, and Reg A overhang. Many in this space see “sell the news” followed by consolidation until the next data catalysts. The long-term value is tied to clinical results, not daily price.
Musical Shares
2日前
All this ticker has right now is an EFS IDE. I will admit I am a little surprised it didn't get rejected but not so much that it still can't be junk science. This has gotten passed the IDE before with others but failed in the clinicals.
This has a long way to go. They still need major funding, extensive clinical trials, and manufacturing suitability in the end.
They still need to show a tandem of containment, tumor ablation, degradation decline, and dosimetry on multiple levels in humans. And that is rather different than rabbits. They still need to show, in the end, consistent manufacturing on a medical grade level. Y-90 has no shelf life. The logistics are on a whole different level than other medicinal compounds. I've shown numerous times how difficult for companies like Boston Scientific to do it. This is nothing more than a worthless, poorly ran "company."
The patent is public domain. The economics are not there anymore for sustained profits in the short or long term. And there are competitors on top of that.
Look at the ticker price. It's only staying steady now for about a penny and half above pre-PR news. Should tell you a lot.
See you all in a couple of years.
CatfishHunter
2日前
If the initial 30-day safety and feasibility data from the EFS is very strong (clean safety profile, good gel retention/dosimetry on imaging, no major adverse events, and clear feasibility signals), Vivos could transition reasonably quickly to a pivotal study — potentially within 3–9 months of the 30-day readout, though 6–12 months is more typical in practice for a device like this.
This is faster than starting a brand-new IDE from scratch, thanks to the EFS program’s design and FDA guidance. Here’s the realistic pathway and timeline:
Why and How the Transition Happens
• EFS Success Enables an IDE Supplement: FDA guidance explicitly allows moving from EFS to pivotal (or expanded feasibility) via a supplement/amendment to the existing IDE (no new full IDE needed). The supplement includes EFS results, updated risk analysis, the full pivotal protocol, and any device/protocol refinements. ?
• FDA Review of Supplement: Typically 30 days (similar to initial IDE clock). With strong data and prior FDA familiarity (via Breakthrough Device interactions and the EFS itself), approval (or approval with conditions) is more likely on the first cycle.
• Other Gates: Mayo IRB review/approval of the expanded protocol (can run in parallel or sequentially), site readiness for more patients, manufacturing scale-up for larger supply, and funding (via Reg A or other sources).
Estimated Timeline Example (Assuming Strong 30-Day Data)
This is a best-case but realistic scenario based on FDA EFS program practices, similar device transitions, and Vivos’ statements (EFS results will “help shape subsequent pivotal trials”). Actual timing depends on data quality, FDA feedback, IRB speed, and operational readiness.
1. EFS 30-Day Readout (˜ 1–2 months after first patient dosing): Data collected, analyzed, and internally reviewed. Strong results (e.g., confirmed targeted delivery, no UADEs, positive early signals) trigger planning for supplement.
2. Protocol Finalization & Supplement Prep (1–3 months): Vivos + Mayo investigators refine the pivotal protocol (larger N, more sites, statistical powering for safety/effectiveness). Submit IDE supplement to FDA.
3. FDA Review of Supplement (˜ 30 days): Clock starts upon submission. Strong EFS data shortens back-and-forth.
4. IRB Approval & Site Activation (1–3 months, overlapping with FDA review): Mayo (and any additional sites) approves the expanded study.
5. Pivotal Enrollment Start: Could begin as soon as 3–6 months after the 30-day EFS data in an optimistic scenario (parallel processing + fast reviews). More commonly 6–12 months to allow for full EFS maturation, manufacturing validation, and funding.
Total from EFS Start to Pivotal Ramp: Often 6–18 months overall, with strong early data compressing the back end significantly.
Supporting Factors for Vivos
• FDA Familiarity: They’ve used the Breakthrough Device/sprint process and EFS pathway — this builds goodwill and faster reviews.
• Existing Data: Preclinical, veterinary IsoPet, and India human experience provide a robust safety foundation to support expansion.
• Small EFS Design: The initial ~5-patient cohort is intentionally limited, so positive 30-day results can quickly justify scaling.
CatfishHunter
2日前
Here is a realistic hypothetical/example patient timeline for the Early Feasibility Study (EFS) of RadioGel at Mayo Clinic (non-resectable papillary thyroid carcinoma). This is not the official protocol (exact details are finalized during IRB review and not fully public), but it is modeled on:
• Standard practices for first-in-human IDE/EFS device studies (small cohort, safety/feasibility focus).
• Typical follow-up in Y-90 brachytherapy/radioembolization or intratumoral injection studies.
• Vivos’ public descriptions (emphasis on PET imaging for gel retention/dosimetry, strong safety monitoring from India/veterinary data).
Key assumptions for this example:
• Day 0 = Procedure/injection day.
• Small initial enrollment (e.g., ~5 patients).
• Primary focus: Safety (acute and longer-term radiation effects), feasibility (successful targeted delivery and retention), and early signals of tumor response.
• Assessments include clinical exams, labs, and imaging (especially Y-90 PET/CT or bremsstrahlung SPECT/CT for dosimetry and confirmation of gel placement/retention at the injection site).
• All data goes into Case Report Forms (CRFs). Safety events trigger rapid reporting to the sponsor (Vivos), Mayo IRB, and FDA as required.
Example Patient Timeline (Day 0 to 12 Months)
Pre-Procedure / Screening (˜ Day -30 to Day -1)
• Informed consent and eligibility confirmation.
• Baseline physical exam, medical history, vital signs, symptom assessment (pain, swallowing issues, etc.).
• Labs: CBC, comprehensive metabolic panel, thyroid function, tumor markers.
• Baseline imaging: CT/MRI ± PET/CT of the neck/thyroid region to characterize the tumor(s).
• Reporting: All baseline data entered into CRFs; eligibility confirmed.
Day 0 – Procedure Day
• Percutaneous direct needle injection of RadioGel under real-time ultrasound or CT guidance into the target tumor/lymph node.
• Immediate post-procedure monitoring for acute reactions (pain, bleeding, swelling).
• Key imaging: Y-90 PET/CT (or bremsstrahlung SPECT/CT) shortly after injection to confirm precise placement, initial dosimetry, and gel retention at the target site with minimal off-target activity.
• Discharge if stable (often same day or next day).
• Reporting: Procedure details and immediate post-procedure imaging results documented in CRFs. Any acute adverse events (AEs) reported promptly to sponsor/IRB.
Day 1
• Clinical assessment (vitals, symptom check for pain/swelling/systemic effects).
• Labs if clinically indicated.
• Reporting: Daily/early safety check entered in CRFs.
Days 3–7 (Early Acute Follow-up)
• In-person visit or phone check: Assess for local reactions (injection site), systemic symptoms, or radiation-related effects.
• Possible labs (e.g., inflammatory markers).
• Reporting: Any AEs or concerns documented and escalated if serious/unanticipated.
Day 14–30 (Critical 30-Day Safety/Feasibility Endpoint – Often a Primary Focus)
• Comprehensive in-person visit.
• Full clinical exam and symptom review.
• Labs (CBC, metabolic panel, thyroid markers).
• Key imaging: Follow-up Y-90 PET/CT or dedicated PET/CT to evaluate gel retention at the injection site, dosimetry confirmation, and early tumor response (e.g., changes in size/metabolic activity).
• Reporting: Data compiled into CRFs. Sponsor reviews safety summary. Any UADEs (unanticipated adverse device effects) must be evaluated and reported to FDA + IRBs within 10 working days. Aggregated 30-day data contributes to ongoing sponsor reports to FDA/IRB.
Month 3 (˜ Day 90)
• Clinical follow-up visit.
• Symptom assessment and physical exam.
• Labs as needed.
• Imaging: CT/MRI or PET/CT to assess tumor response (e.g., using RECIST or similar criteria) and long-term gel behavior/safety.
• Reporting: Safety and efficacy signals entered in CRFs; periodic progress summary to sponsor/IRB.
Month 6 (˜ Day 180)
• Similar clinical + lab assessment.
• Imaging follow-up (CT/MRI ± PET) to evaluate durable response, any recurrence, or late radiation effects.
• Reporting: Continued CRF documentation and safety monitoring.
Month 12 (˜ Day 365 – End of Primary Follow-up or Transition)
• Comprehensive end-of-study or long-term visit.
• Full clinical exam, symptom review, labs.
• Final imaging assessment (CT/MRI/PET) for tumor control, response durability, and any late adverse effects.
• Reporting: Complete dataset in CRFs. Sponsor prepares summaries for annual IDE reports to FDA and IRB. Individual patient data supports overall EFS conclusions (feasibility + safety profile). Patients may transition to standard care or longer-term observational follow-up.
Ongoing / As-Needed Throughout
• Regular safety monitoring (phone calls or visits) for any new symptoms.
• Immediate reporting of serious or unanticipated events.
• Sponsor (Vivos) data monitoring and potential DSMB (Data Safety Monitoring Board) reviews for the small cohort.
• Public/high-level updates: Milestone-based press releases or SEC filings (e.g., “first patient dosed,” “30-day safety data available”) — individual patient details remain confidential.
Notes on Reporting Overall:
• Real-time / Rapid: UADEs and serious AEs flow quickly from Mayo investigators ? Vivos (sponsor) ? FDA + IRB.
• Periodic: Monthly/quarterly internal reviews; annual progress reports to regulators.
• Study-Level: Aggregated safety, feasibility, and early efficacy data inform the transition to a pivotal trial via IDE supplement.
This structure balances intensive early monitoring (especially around the procedure and 30-day mark, when acute radiation/device effects are most likely) with longer-term follow-up to capture durability and late effects. Y-90 PET imaging is particularly emphasized because it directly visualizes the therapeutic isotope’s distribution and retention — a key feasibility endpoint for RadioGel.
CatfishHunter
2日前
I agree. And in my opinion, the big game changer will be the initial EFS results. New investors, especially the large/institutional type investors in my opinion, are waiting for proof of concept from a reputable institution, and that will be Mayo Clinic. The EFS can start as early as August more likely September and then once it starts, a bout 45 days later, we’ll get the initial report which I’m full of confident will be excellent given what we know about isopet and the original India study.
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