PLSMNasdaqSurgical & Medical Instruments & ApparatusUS GAAP · USD

Pulsenmore Ltd.

Pulsenmore Ltd. develops portable, home-use ultrasound solutions that connect patients with healthcare providers remotely. Its products are designed for non-invasive self-scanning and telehealth-supported imaging, with an initial focus on maternal health and women’s care, and development work extending into other clinical monitoring applications.

Liiketoiminta

Osuus liikevaihdosta
Prenatal home ultrasound55 %

Pulsenmore ES and related products used by expectant mothers for remote prenatal imaging and telehealth guidance.

Fertility and gynecology ultrasound10 %

Pulsenmore FC for ovarian follicle and endometrial self-examination in fertility care.

Clinical development programs5 %

Next-generation portable ultrasound products such as Pulsenmore MC under development for new medical uses.

Medical device commercialization15 %

Regulatory, marketing, and sales activities supporting adoption of the company’s ultrasound platforms.

Clinical research and evaluation15 %

Product supply and study support for clinical research and feasibility work in additional territories.

Asiakkaat

The company sells into healthcare workflows rather than consumer retail, so its buyers include providers, telehealth-enabled care programs, and fertility practices that want to extend imaging beyond the clinic. End users are patients, especially expectant mothers and women in fertility care, who perform scans at home under medical supervision. As new indications develop, the customer base can also include clinical research institutions and health systems evaluating remote monitoring tools.

Obstetrics and maternal care providers

Buy home-use prenatal ultrasound workflows to extend monitoring beyond the clinic and improve continuity of care.

Expectant mothers

Use Pulsenmore ES for self-scans and telehealth-guided prenatal imaging at home.

IVF and fertility clinics

Use Pulsenmore FC for ovarian follicle and endometrial self-examination in fertility treatment.

Clinical research partners

Evaluate the company’s devices in studies and feasibility trials for new medical applications.

Healthcare systems and telemedicine providers

Adopt connected imaging tools that support remote monitoring and reduce in-clinic dependence.

Strategia

Pulsenmore’s strategy centers on making ultrasound available at home while preserving clinician oversight through telemedicine connectivity. It is expanding from prenatal care into fertility and other remote monitoring uses, while building evidence, regulatory approvals, and market access for each new indication. The company’s competitive position depends on turning a specialized medical workflow into a repeatable platform that can be adopted by providers across countries.

Commercialize home prenatal ultrasoundLyhyt aikaväli

Prenatal care is the company’s most established use case and the anchor for broader adoption.

Expand fertility care applicationsKeskipitkä aikaväli

Fertility monitoring broadens the addressable market and uses the same remote-imaging platform.

Develop new clinical indicationsKeskipitkä aikaväli

Additional uses in pulmonary and cardiac monitoring can increase platform utility over time.

Secure market access and evidencePitkä aikaväli

Medical device adoption depends on regulatory clearance, clinician acceptance, and clinical validation.

Maantiede

Pulsenmore is headquartered in Israel, with its principal office in Omer, and its commercial footprint extends across multiple approved markets. The Pulsenmore ES is approved in the United States, Europe, Switzerland, Australia, Brazil, Colombia, and Israel, while Pulsenmore FC is approved in Israel and used in other territories for research. This makes regulatory approvals and market access central to where the company can sell and deploy its products.

Riskit

The business depends on successful regulatory approvals, clinical evidence, and physician adoption for each product and country, so commercialization risk is concentrated in execution rather than manufacturing scale. As a medical device company focused on new usage models, it also faces development risk, reimbursement uncertainty, and the possibility that telehealth-linked home scanning proves harder to standardize than clinic-based imaging. International expansion adds country-specific approval, market-access, and operational complexity.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Regulatory approval risk1Clinical adoption risk2Reimbursement and market-access risk3Product development risk4International execution risk5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Regulatory approval riskVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Each product and market requires device clearance or approval before sale.

    KohdistuuUnited StatesEuropeBrazilAustraliaOther markets
  2. Clinical adoption riskVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Providers and patients must trust remote self-scanning and telehealth workflows.

    Kohdistuu: Prenatal care and fertility workflows

  3. Reimbursement and market-access riskVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Commercial traction can be limited if payers and providers do not support home imaging workflows.

    Kohdistuu: Healthcare systems and telehealth channels

  4. Product development riskVaikutus: KeskitasoTodennäköisyys: Korkea

    New indications such as Pulsenmore MC remain in early-stage development.

    Kohdistuu: Pulsenmore MC and future pipeline products

  5. International execution riskVaikutus: KeskitasoTodennäköisyys: Korkea

    Operating across multiple countries creates differing standards, approvals, and support requirements.

    KohdistuuUnited StatesEuropeIsraelOther territories

Kirjanpito

Harkinnanvaraiset erät
Management estimates and assumptions

The company states that significant judgments affect reported assets, liabilities, income, and expenses.

Vaikutus: Can change expense timing and balance-sheet values

Warrant classification

New issued warrants and pre-funded warrants are classified as financial liabilities.

Vaikutus: May create mark-to-market income statement volatility

Foreign currency translation

Interim financials are reported in NIS and translated into USD for convenience.

Vaikutus: Creates FX-related comparability issues across periods

Development-stage accounting

Clinical feasibility trials and product development require judgment on cost treatment.

Vaikutus: Affects operating expense recognition and asset values

Julkisesti listattuja yhtiöitä, joilla on samankaltainen liiketoiminta.

Päivitetty: 28.9.2026

Pulsenmore Ltd. (Nasdaq) – Surgical & Medical Instruments & Apparat | Analyysi – Clarifo