PULSE BIOSCIENCES, INC. 8-K

What Happened

• On March 12, 2026, Pulse Biosciences announced first patient enrollments in an investigator‑sponsored, multicenter prospective feasibility study evaluating its Vybrance™ Percutaneous Electrode System for papillary thyroid microcarcinoma (small, slow‑growing thyroid cancer).
• The initial procedures were completed at Sarasota Memorial Health Care System (first patient treated by Dr. Ralph P. Tufano) and The University of Texas MD Anderson Cancer Center (two cases by PI Dr. Victoria Banuchi). The study will enroll a total of 30 patients and targets tumors under 1.5 cm.

Key Details

• Study start announced: March 12, 2026 (press release attached as Exhibit 99.1).
• Planned enrollment: 30 patients in a multicenter, prospective feasibility study.
• Device: Vybrance Percutaneous Electrode System used with the nPulse™ Console; uses Nanosecond Pulsed Field Ablation™ (nsPFA™) for precise, nonthermal tissue removal.
• Regulatory status: Vybrance previously received FDA 510(k) clearance for soft tissue ablation and is being evaluated under an Investigational Device Exemption (IDE) for thyroid applications.
• Funding: Study is funded in part by Pulse Biosciences.

Why It Matters

• This is an early clinical step toward a potential thyroid‑cancer indication for Pulse’s Vybrance system. Positive feasibility results could support further clinical development and possible future regulatory approvals specific to thyroid tumors.
• For investors, the announcement signals active clinical progress, expanded investigational use under an IDE, and collaboration with reputable clinical sites (Sarasota Memorial and MD Anderson); however, this is an early feasibility study with a small planned sample size (30 patients), so outcomes and timelines remain uncertain.