What is TOL? Is it FDA approved? Where is it available?

1. What is Targeted Osmotic Lysis (TOL)?

Targeted Osmotic Lysis is an investigational cancer therapy that combines a cardiac glycoside drug (digoxin) with a pulsed electric field generated by a coaxial ring device.

Advanced solid tumor cells over-express voltage-gated sodium channels (VGSCs) at 10 to 50 times the density of normal cells. The drug blocks the sodium pumps. The pulsed field opens the over-expressed channels. Sodium floods the cancer cell. Water follows. The cell ruptures. Normal cells, with low VGSC density, take in only modest sodium and water, tolerate the exposure, and return to baseline when the drug clears.

Full mechanism walk-through at fixcancer.org/procedure. The mechanism visualization is at /.

2. Is TOL FDA approved?

No. TOL is investigational under 21 CFR Part 312. It has not been reviewed or approved by the U.S. Food and Drug Administration for the treatment of cancer.

United States access is limited to three pathways.

• Authorized clinical trials. Trials are registered at ClinicalTrials.gov.
• Expanded access (21 CFR 312 Subpart I). Patients with serious or life-threatening disease and no comparable alternative may qualify. Requires sponsor agreement, FDA authorization, IRB review, and informed consent.
• Right to Try Act of 2018 (Pub. L. 115-176). Patients with life-threatening conditions may access therapies that have completed Phase 1 and remain in active development. Eligibility is determined by the treating physician and the sponsor.

3. Where is TOL available today?

TOL is delivered at international partner facilities operating under their local regulatory framework.

• Mexico. CORE Medical, Tijuana. Under COFEPRIS oversight. coremedical.mx
• Honduras. Partner facility in Roatan.
• Australia. Therapeutic Goods Administration Special Access Scheme.
• United States. Clinical trial enrollment, expanded access, or Right to Try.

Jurisdiction selection depends on regulatory pathway, urgency, and the patient's clinical situation. The intake team makes the introduction after eligibility is confirmed.

4. What cancers does TOL treat?

TOL targets advanced solid tumor cancers that over-express voltage-gated sodium channels.

Eligible tumor types

• Breast (including triple-negative)
• Prostate (including castration-resistant)
• Colorectal (including KRAS-mutant)
• Lung (non-small cell)
• Ovarian
• Pancreatic
• Gastric and esophageal
• Melanoma
• Cervical squamous cell carcinoma
• Cutaneous squamous cell carcinoma

Not eligible

• Hematologic malignancies
• Bone marrow primary cancers

Eligibility is confirmed by a tumor biopsy with VGSC immunohistochemistry assay, not by tumor type alone.

5. What does a TOL treatment look like?

1. Drug load (~6 days, at home). Daily oral digoxin to reach steady-state therapeutic blood level.
2. Session one (~120 minutes). Patient enters the coaxial ring chamber. Awake. No sedation. No surgical preparation. Pulsed electric field for the session duration.
3. Session two (next day, ~120 minutes). Same protocol.
4. Post-treatment. Follow-up biopsy and imaging per protocol.
5. Cycle interval. Two to three weeks. Subsequent cycles per clinician judgment.

The full treatment protocol is at fixcancer.org/procedure.

6. How much does TOL cost?

FixCancer.org does not quote a price. Treatment cost is set by the partner clinic and disclosed in a written engagement letter after clinical eligibility is confirmed.

• The eligibility review costs nothing.
• The partner clinic prices in writing. No bundled marketing-page headline. No surprises.
• FixCancer.org receives no referral fees. Not from lenders, life-settlement providers, insurance specialists, or partner clinics.

Funding pathways including PPO out-of-country reimbursement, medical loans, life settlement and Living Benefit Loan, US/Canada/Australia/UK retirement-account access, and crowdfunding are documented at /financial-resources.

7. How is TOL different from chemo, radiation, or surgery?

• Not chemotherapy. No DNA-damaging agent. No cytotoxic effect on dividing normal cells.
• Not radiation. No ionizing beam. No radiation dose record.
• Not surgery. No cutting. No resection.
• Not thermal ablation. The device generates no heat.
• Not immunotherapy. Mechanism does not depend on the patient's immune response to the tumor.

Side-by-side clinical comparison vs. integrative wellness clinics and off-label immunotherapy clinics is at /why-fixcancers.

8. Is there published evidence?

Yes. Thirteen peer-reviewed publications and the foundational LSU patent are catalogued at /literature, with PubMed Central links and DOIs.

Highlight papers

• Mechanism foundation: Oncotarget 2018, Cancers 2020, Biomedicines 2022, Cancers 2022.
• Human emergency-use case reports: Current Oncology 2021 (cervical SCC), Annals of Oncology Case Reports 2025 (melanoma, cutaneous SCC).
• Veterinary safety: Case Reports in Vet Medicine 2022, AJVR February 2025 Beagle safety study.
• Independent reviews: Biomarker Research July 2024 (Liu et al. VGSC review), IEEE Transactions on Plasma Science 2024 (Ma et al. device engineering).

9. What are the side effects?

Reported side effects from the published case experience.

• Warmth, tingling, or "pins and needles" sensation in the tumor area during stimulation.
• Erythema and serous fluid leakage from visible lesions as the tumor lyses.
• Cardiac glycoside-related effects in the standard digoxin therapeutic range (nausea, visual disturbance, arrhythmia risk).
• Risk of tumor lysis syndrome when a large tumor mass is rapidly destroyed. Managed with hydration and allopurinol prophylaxis.

TOL does not produce the systemic toxicity, hair loss, or severe nausea associated with chemotherapy.

10. How do I get started?

Submit the intake form at /#consult or email [email protected]. Include the patient name, primary tumor type, current stage, and a brief treatment history.

The clinical team reviews and responds within three to five business days with a written eligibility assessment. No payment is required for the eligibility review.