
Saturday, June 21, 2025 12:32:08 AM
To those watching from the sidelines, wondering if Vivos Inc. (RDGL) and its flagship cancer-fighting technology RadioGel® are worth the investment — let me make this crystal clear:
We are now standing on the doorstep of FDA IDE (Investigational Device Exemption) submission. After years of R&D, animal studies, dosimetry testing, safety validation, radiation delivery modeling, and navigating every regulatory hurdle the FDA has thrown their way, Vivos is preparing to submit what could be the final sprint package that opens the gates to human trials.
Let that sink in:
We are potentially weeks, not years, away from the FDA greenlighting the use of RadioGel in human cancer patients.
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Why This Matters
RadioGel isn’t just another radiation therapy — it’s a precision-targeted injectable that delivers internal beta radiation directly into solid tumors using a hydrogel matrix. No systemic toxicity. No damage to surrounding healthy tissue. No side effects like you’d see with chemo or external beam radiation. It’s localized, lethal to the tumor, and safe for the patient.
This is the future of interstitial cancer therapy.
Once this treatment enters human trials under the IDE, Vivos isn’t just another speculative biotech — it becomes a first-in-class oncology device company with the ability to address cancers that current technologies cannot treat effectively.
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For the Fence-Sitters
Yes, it’s been a long road. But biotech breakthroughs don’t happen overnight. What matters is that we’re here now, at the inflection point — when all the science, safety, and data align with regulatory readiness.
And let’s be honest — once that IDE is accepted, everything changes:
Institutional eyes come in
Licensing and partnership talks intensify
Market credibility skyrockets
Valuation? Re-rated overnight
Investors ask, “What’s the upside?” I say: what’s the value of a platform that can be used across multiple tumor types, both in humans and animals, and has already shown strong efficacy in preclinical models?
Add to that the IsoPet® veterinary division, already generating clinical interest and helping animals survive aggressive tumors — validating the core science behind the gel. It’s working.
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The CEO’s Mission Is Personal
Let’s not forget: CEO Mike Korenko isn’t your typical executive padding a résumé. His goal is personal — he wants to see RadioGel save a child with brain cancer before his time is done. That’s the kind of leadership you cannot buy. That’s a mission you invest in.
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Final Thought
You don’t get many chances in the market to be early to a disruptive cancer therapy backed by real science, peer-reviewed data, animal success, and now on the verge of human trials.
The train hasn’t left the station yet — but the whistle is blowing.
I’m not just holding. I’m invested in a medical revolution.
– Long and strong on $RDGL
Know what you own, and know why you own it.
Recent RDGL News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2025 09:14:29 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/24/2025 04:47:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/10/2025 08:37:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/10/2025 05:44:35 PM
- Form 253G2 - • Edgar (US Regulatory) • 11/18/2024 08:01:15 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/13/2024 06:12:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/28/2024 08:23:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/30/2024 04:34:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 05:58:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 05:56:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/07/2024 05:26:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 01:00:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/29/2024 05:16:12 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 07/17/2024 04:15:04 AM
- Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 07/15/2024 10:02:55 AM
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