20-F: Pulsenmore narrows loss, wins US FDA nod

Pulsenmore cut 2025 losses on a GE settlement, secured FDA clearance for its home-use prenatal ultrasound, and deepened ties with Israel’s Clalit while preparing a U.S. launch.

Summary

• Revenue totaled NIS 40.0m (US$12.5m), including NIS 30.5m (US$9.6m) one-time revenue from an August 6, 2025 settlement with GE Precision/GE Healthcare; product/service revenue was NIS 9.48m (US$3.0m).
• Cost of revenues was NIS 6.34m (US$2.0m); gross profit was NIS 33.68m (US$10.6m) due to the settlement; underlying product gross profit approximated NIS 3.14m.
• R&D NIS 17.35m (US$5.44m), Sales & Marketing NIS 11.82m (US$3.70m), G&A NIS 16.68m (US$5.23m).
• Operating loss improved to NIS 12.16m (US$3.81m); net loss narrowed to NIS 15.85m (US$4.97m) from NIS 36.74m in 2024.
• Cash and cash equivalents NIS 21.60m (US$6.77m) and short-term deposits NIS 47.53m (US$14.90m) at Dec 31, 2025; management believes cash is sufficient for >12 months.
• FDA de novo clearance (Class II) for Pulsenmore ES received October 31, 2025 for acquisition of ultrasound images allowing fetal heart rate determination.
• EU MDR Quality Management System certificate received August 26, 2025, authorizing CE-marked ES (Class IIa) marketing in Europe.
• Clalit ES agreement (Oct 28, 2024) covers at least 25,000 units over up to 60 months; 6,915 ES units supplied to Clalit in 2025 (7,148 in 2024). Sheba hospital received 110 units in 2025.
• Clalit FC addendum (Jan 21, 2026): 18-month pilot with direct-to-patient sales; thereafter a 5-year term with a minimum 2,000 FC units per year and right to return up to 1,000 units; pilot pricing applies.
• Nasdaq listing effective January 21, 2026 (ticker: PLSM); 1-for-8 reverse split effective December 28, 2025; 6,502,844 shares outstanding as of Dec 31, 2025 and March 15, 2026.

Sentiment

Score: 6

Explanation: StockSavvy.ai views the FDA clearance, EU MDR certificate, and GE settlement as strategic positives offset by low core revenue, customer concentration, and a deferred FC ramp; overall moderately positive but execution-dependent.

Positives

• Net loss reduced to NIS 15.85m (US$4.97m) from NIS 36.74m in 2024, aided by GE settlement.
• FDA de novo clearance (Oct 31, 2025) positions Pulsenmore ES for U.S. commercialization.
• EU MDR quality certificate (Aug 26, 2025) supports European sales.
• GE settlement (Aug 6, 2025) delivered NIS 30.5m (US$9.6m) revenue, canceled disputed orders with cash received, and removed remaining exclusivity constraints in key markets.
• Strong liquidity: NIS 69.1m (US$21.7m) in cash and deposits at year-end 2025; runway >12 months.
• Clalit ES framework: at least 25,000 units over 5 years; steady Israeli demand (6,915 units supplied in 2025).
• Clalit FC addendum extends FC engagement to 5 years post-pilot with a 2,000-unit annual minimum and returns flexibility.
• Initial commercial beachheads emerging in the U.S. (Center for Fetal Medicine agreement Jan 29, 2026; TLC Perinatal Feb 2026) and Australia (GCUH MOU; 100 units supplied).

Negatives

• Core product revenue remains modest at NIS 9.48m (US$3.0m); 2025 gross profit largely from one-time settlement revenue.
• Revenue concentration: ~Israel-only operations with heavy reliance on Clalit; international sales still nascent.
• GE distribution order cancellation in 2023 underscores channel execution risks; future GE orders not obligated under amended terms.
• Operating expenses (R&D, S&M, G&A) remain high relative to current sales scale; continued net losses.
• FX headwinds in 2025 from a stronger NIS increased USD cost base.
• Purchases under the FC addendum begin only after an 18-month pilot, deferring revenue ramp.

Risks

• Dependence on Clalit Health Services for ES sales and on future FC purchases; any reduction or change in terms could materially impact revenue.
• Need for additional capital to expand commercialization and R&D; potential dilution and/or restrictive debt covenants if financing is raised.
• Regulatory risk across multiple jurisdictions; ongoing compliance with FDA, EU MDR and other regimes required for market access.
• Supply-chain reliance on limited and sole suppliers and subcontractors; disruptions can delay production and increase costs.
• Cybersecurity, privacy (HIPAA/GDPR) and AI/ML-related compliance risks; potential fines or reputational harm from incidents.
• Geopolitical instability in Israel and the region (active conflicts, mobilizations) could disrupt operations, supply chains, and personnel availability.
• Market acceptance risk versus incumbent cart-based ultrasound and handheld POCUS competitors; pricing pressures possible.
• Nasdaq continued listing risks and share price volatility; new delisting criteria introduced in 2026 could apply.

Future Outlook

Focus shifts to U.S. commercialization following FDA de novo clearance, with initial provider agreements signed in early 2026 and continued expansion in Europe and Australia. The Clalit FC 18‑month pilot precedes a five‑year term with a 2,000‑unit annual minimum. Management plans to invest in manufacturing capacity, product enhancements, and additional regulatory submissions while acknowledging potential future capital needs.

Management Comments

• Management believes existing cash resources will fund operations for more than one year from the financial statements’ issuance date.
• Strategy prioritizes U.S. market entry for ES after FDA clearance while maintaining Israeli momentum and building European and APAC channels.
• The GE settlement simplifies channel strategy, removes exclusivity constraints, and resolves outstanding disputes without repayment of the $1m component advance.

Industry Context

StockSavvy.ai notes the home-use ultrasound niche remains emerging versus handheld clinician-operated POCUS systems (e.g., Butterfly iQ+, GE Vscan, Clarius). Pulsenmore’s self-scan ES targets hybrid prenatal care and telehealth, aligning with trends in maternal access gaps and hospital capacity constraints. FDA clearance differentiates Pulsenmore among consumer-facing prenatal imaging tools, though scaling adoption and reimbursement remain key hurdles.

Comparison to Industry Standards

• Butterfly Network (BFLY) has focused on clinician-operated handheld POCUS with broader installed base and higher revenue scale; Pulsenmore’s ES is a self-scan home device with early U.S. entry in late 2025—product-market fit and payer pathways are distinct.
• GE HealthCare’s Vscan Air competes in clinician POCUS; Pulsenmore’s GE settlement removes legacy channel complications but also eliminates guaranteed bulk orders, shifting Pulsenmore to direct/provider channels.
• Clarius wireless probes price in the low-thousands for clinicians; Pulsenmore targets approximately US$1,000 per pregnancy for single-patient prenatal solutions with recurring software/monitoring components for clinicians.
• Compared with hospital cart-based ultrasound (>US$45–100k), Pulsenmore’s home device aims to reduce visit burden and enable hybrid prenatal models; validation and reimbursement evidence will drive parity with best-in-class outcomes.

Management Changes

Corporate Governance

Legal Proceedings

• No material legal or regulatory proceedings disclosed.

Related Party Transactions

• Consultancy agreement with D.L.L.D. Consulting Ltd. (wholly owned by the CEO) for management services; fees include monthly management, social benefits, and vehicle/accommodation allowances.
• Patent services from Luzzatto & Luzzatto (principals are shareholders); payments in 2025: NIS 1.047m (US$0.33m), 2024: NIS 0.605m, 2023: NIS 0.483m.

Stakeholder Impact

• Shareholders: Reverse split and Nasdaq listing may improve marketability; underlying profitability still pending commercialization scale.
• Customers/Patients: FDA clearance enables U.S. access to home prenatal scans; Clalit FC pilot introduces direct-to-patient IVF follicle monitoring.
• Suppliers/Subcontractors: Continued reliance on limited sources; long-lead components managed with partners; any disruption could affect deliveries.
• Employees: Israel security situation recognized; business continuity plan includes cloud ERP and alternative production site in South Korea.
• Creditors/Investors: Settlement resolved GE exposure; contract liabilities reduced; liquidity adequate for >12 months.

Next Steps

• Execute U.S. ES commercialization with early provider partners (agreements signed Jan–Feb 2026).
• Run the 18-month FC pilot via Beilinson NEXT, then transition to a five-year term with a 2,000-unit annual minimum.
• Grow European and APAC distribution following EU MDR certificate and Australia center-of-excellence MOU.
• Scale manufacturing and consider alternative site readiness in South Korea for business continuity.
• Pursue additional clinical evidence and regulatory submissions (e.g., remote BPP capabilities).

Key Dates

Recommendation

FDA clearance, EU MDR certification, and the Clalit/GE developments are strategically positive, but core revenue remains small, customer concentration is high, and the FC program’s revenue is deferred by an 18‑month pilot. Maintain Hold pending evidence of U.S. uptake and recurring revenue traction.

Keywords

Pulsenmore, home ultrasound, prenatal care, FDA de novo clearance, Clalit Health Services, GE Healthcare settlement, EU MDR, IVF follicle monitoring, telehealth, NASDAQ listing, reverse split, Israel healthcare, point-of-care ultrasound, Butterfly Network, Vscan, Sheba Medical Center, Beilinson NEXT, GCUH Australia