Pulsenmore's Transformative 2025 Paves Way for Home Ultrasound Revolution

OMER, Israel – March 30, 2026 – Home ultrasound pioneer Pulsenmore Ltd. (NASDAQ: PLSM) has declared 2025 a "transformative year," punctuated by landmark regulatory approvals in the U.S. and Europe and a dramatic financial turnaround. The company reported a 374% surge in annual revenue and halved its net loss, positioning it to accelerate the rollout of its novel remote prenatal care technology.

However, a closer look at the financial results reveals a complex picture. While the headline numbers are impressive, the company's performance was significantly bolstered by a one-time settlement, placing intense focus on its ability to convert recent regulatory victories into sustained, long-term commercial success in the burgeoning maternal health tech market.

In a statement, CEO and Founder Dr. Elazar Sonnenschein emphasized the shift from regulatory milestones to market execution. "Following our FDA De Novo authorization and Nasdaq listing, we focused on scaling our U.S. infrastructure, expanding clinical partnerships, and strengthening our operational capabilities to support long-term growth," he said.

A Financial Picture Sharpened by Settlement

Pulsenmore's full-year 2025 financial report showcased total revenues of $12.5 million, a massive leap from the $2.6 million recorded in 2024. This growth was instrumental in cutting the company's net loss in half, from $10 million in 2024 to $5 million in 2025.

The primary driver of this revenue spike was a $9.6 million one-time payment from a settlement agreement with GE Precision Healthcare LLC (GEHC). This agreement resolved all outstanding disputes between the two companies. When this one-time contribution is excluded, Pulsenmore's core operational revenue for 2025 stands at approximately $2.9 million. This figure represents a more modest, though still positive, year-over-year growth of about 11.5% from its core business operations.

The settlement significantly improved the company's bottom line and gross margin, which soared to 84% in 2025 from 37% the previous year. It also fortified the company's balance sheet, leaving it with $21.7 million in total liquid assets as of year-end. This financial cushion is critical as Pulsenmore ramps up spending on its commercial expansion. Operating expenses grew to $14.4 million in 2025, up from $12.6 million in 2024, reflecting strategic investments in building out its U.S. infrastructure and forging new clinical partnerships.

Unlocking Global Markets with Key Regulatory Wins

Beyond the financial headlines, 2025 was defined by two monumental regulatory achievements that unlocked the world's largest healthcare markets for Pulsenmore's technology.

In a major breakthrough for the U.S. market, the company secured FDA De Novo marketing authorization for its Pulsenmore ES system. This decision was a landmark, creating a new regulatory category for home-use, clinician-guided prenatal ultrasound. The device, which pairs with a smartphone, allows expectant mothers to perform scans from the comfort of their homes. An application guides the user through the process, and the resulting video clips are securely transmitted to a clinician for review. The FDA's clearance was supported by a multi-center trial at leading U.S. institutions, including Mount Sinai and Brigham and Women's Hospital.

Crucially, the Pulsenmore ES is designed to complement, not replace, traditional in-clinic care. Its use requires a physician's prescription and is intended to enhance existing prenatal workflows, offering a new tool for remote monitoring and triage.

Across the Atlantic, Pulsenmore also received Medical Device Regulation (MDR) Conformité Européenne (CE) Certification. This certification authorizes the commercial sale of its Early-Screening (ES) product across the European Union for single-fetus pregnancies starting at 14 weeks of gestation, providing another massive market for the company to target.

From Clearance to Clinic: The U.S. Rollout Begins

With regulatory hurdles cleared, Pulsenmore has quickly moved to commercial execution, launching its initial programs in the United States. The company is strategically partnering with maternal-fetal medicine (MFM) specialists, who manage high-risk pregnancies and are often early adopters of innovative technologies that can improve patient outcomes.

In late January 2026, Pulsenmore announced its first U.S. commercial partnership with the Center for Fetal Medicine & Women's Ultrasound (CFFM) in Los Angeles. The center, which manages around 1,500 pregnancies annually, will integrate the Pulsenmore ES to provide remote monitoring and potentially reduce unnecessary in-clinic visits for its patients.

Shortly after, a second partnership was announced with TLC Perinatal PA, an MFM practice in Maryland that handles approximately 2,000 pregnancies a year. TLC Perinatal plans to incorporate the home ultrasound system into a hybrid care model, blending telehealth with scheduled in-person appointments.

These initial rollouts are a critical test of the technology's real-world integration into U.S. clinical workflows. They also represent a tangible step toward addressing significant gaps in care. According to experts, approximately 35% of U.S. counties are considered "maternity care deserts," with limited or no access to obstetric services. Technologies like Pulsenmore's offer a potential solution to bridge these geographical and capacity barriers.

Pioneering a New Era in Maternal Health

Pulsenmore is entering a dynamic and competitive maternal health tech landscape. While companies like Nuvo Group and Bloomlife offer remote monitoring through wearable devices, Pulsenmore's status as the first FDA-cleared home ultrasound device gives it a unique and powerful market position.

The technology aligns with a broader shift in healthcare toward patient-centric, remote-first solutions. For expectant mothers, particularly those in high-risk categories or living in rural areas, the ability to perform a clinician-directed scan at home offers unprecedented convenience and can help alleviate anxiety between appointments. For healthcare systems, it presents an opportunity for greater efficiency, improved patient triage, and the ability to extend care beyond the clinic's walls.

"We are seeing encouraging validation from providers and health systems who recognize the value of remote, clinician-directed ultrasound as part of modern prenatal care," Dr. Sonnenschein noted in the company's announcement.

As Pulsenmore moves into 2026, its focus is squarely on building commercial momentum from its foundational achievements. The company's ability to scale its U.S. partnerships, secure insurance reimbursement, and demonstrate clear value to both patients and providers will determine if its "transformative year" was a prelude to a true revolution in prenatal care.