# Pulsenmore Ltd.

> Clarifo company profile — qualitative business description generated from
> the company's filings. Financial statements, charts and ratios are
> available on Clarifo (https://www.clarifo.com/fi/companies/Pulsenmore Ltd.).

## Overview

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.

## Products & services

• Home-use ultrasound devices for remote patient scanning
• Prenatal self-scan and telehealth-guided imaging
• IVF and fertility monitoring ultrasound solutions
• Portable ultrasound technology for pulmonary and cardiac monitoring
• Clinical development and regulatory support for new indications

- **Prenatal home ultrasound** (55%) — Pulsenmore ES and related products used by expectant mothers for remote prenatal imaging and telehealth guidance.
- **Fertility and gynecology ultrasound** (10%) — Pulsenmore FC for ovarian follicle and endometrial self-examination in fertility care.
- **Clinical development programs** (5%) — Next-generation portable ultrasound products such as Pulsenmore MC under development for new medical uses.
- **Medical device commercialization** (15%) — Regulatory, marketing, and sales activities supporting adoption of the company’s ultrasound platforms.
- **Clinical research and evaluation** (15%) — Product supply and study support for clinical research and feasibility work in additional territories.

- Home-use ultrasound devices for remote patient scanning
- Prenatal self-scan and telehealth-guided imaging
- IVF and fertility monitoring ultrasound solutions
- Portable ultrasound technology for pulmonary and cardiac monitoring
- Clinical development and regulatory support for new indications

## Customers

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** (primary) — Buy home-use prenatal ultrasound workflows to extend monitoring beyond the clinic and improve continuity of care.
- **Expectant mothers** (primary) — Use Pulsenmore ES for self-scans and telehealth-guided prenatal imaging at home.
- **IVF and fertility clinics** (secondary) — Use Pulsenmore FC for ovarian follicle and endometrial self-examination in fertility treatment.
- **Clinical research partners** (secondary) — Evaluate the company’s devices in studies and feasibility trials for new medical applications.
- **Healthcare systems and telemedicine providers** (secondary) — Adopt connected imaging tools that support remote monitoring and reduce in-clinic dependence.

- Obstetric and maternal-care providers using remote prenatal imaging
- Expectant mothers performing self-scans at home under supervision
- IVF and fertility clinics monitoring follicles and endometrium
- Healthcare systems adopting telehealth-connected imaging workflows
- Clinical researchers evaluating new ultrasound indications

## Geography

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.

- **Israel** (35%) — Headquarters location and initial commercialization market for FC.
- **United States** (20%) — Approved market for Pulsenmore ES and key expansion geography.
- **Europe** (20%) — Approved market for Pulsenmore ES.
- **Other international markets** (25%) — Includes Australia, Brazil, Colombia, and research territories.

- Headquartered in Omer, Israel, with principal executive offices there
- Pulsenmore ES approved in the United States and several overseas markets
- Europe is a core commercialization region for the home ultrasound platform
- Israel is the first market for Pulsenmore FC commercialization
- Research use in additional territories supports future expansion

## Strategy

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 ultrasound** (short-term) — Prenatal care is the company’s most established use case and the anchor for broader adoption.
- **Expand fertility care applications** (medium-term) — Fertility monitoring broadens the addressable market and uses the same remote-imaging platform.
- **Develop new clinical indications** (medium-term) — Additional uses in pulmonary and cardiac monitoring can increase platform utility over time.
- **Secure market access and evidence** (long-term) — Medical device adoption depends on regulatory clearance, clinician acceptance, and clinical validation.

- Expand home ultrasound from prenatal care into adjacent indications
- Build clinical evidence to support adoption and reimbursement
- Pursue regulatory approvals market by market
- Commercialize Pulsenmore ES and expand Pulsenmore FC
- Advance Pulsenmore MC through feasibility trials

## Risks

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.

- **Regulatory approval risk** [high] — Each product and market requires device clearance or approval before sale.
- **Clinical adoption risk** [high] — Providers and patients must trust remote self-scanning and telehealth workflows.
- **Product development risk** [medium] — New indications such as Pulsenmore MC remain in early-stage development.
- **Reimbursement and market-access risk** [high] — Commercial traction can be limited if payers and providers do not support home imaging workflows.
- **International execution risk** [medium] — Operating across multiple countries creates differing standards, approvals, and support requirements.

- Regulatory approvals may be delayed or restricted by country
- Clinical adoption depends on proof of safety and utility
- Reimbursement and procurement acceptance may be uneven
- Development risk is high for new indications like Pulsenmore MC
- International expansion adds compliance and commercialization complexity

## Accounting

Pulsenmore is a development-stage medical device company, so judgment around capitalization, clinical development costs, and product-stage classification can materially affect reported results. The company also notes that estimates and assumptions are significant, which is typical when product commercialization is still evolving and fair-value or liability classifications may change. Because it reports in NIS but presents convenience translations into USD, currency translation is another factor investors should keep in mind when comparing periods.

- **Management estimates and assumptions** — Can change expense timing and balance-sheet values
- **Warrant classification** — May create mark-to-market income statement volatility
- **Foreign currency translation** — Creates FX-related comparability issues across periods
- **Development-stage accounting** — Affects operating expense recognition and asset values

- Significant estimates and judgments affect reported assets and expenses
- Development-stage costs may depend on capitalization versus expensing
- Warrants can be classified as financial liabilities and remeasured
- Foreign-currency translation affects USD presentation of NIS results
- Clinical-stage product accounting may shift as programs advance

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*Last updated: 2026-09-28T12:13:45.083824+00:00*
