Pulsenmore (PLSM) has completed registration of its Pulsenmore FC home fertility ultrasound system with the UK MHRA, allowing marketing across the United Kingdom and Northern Ireland.
Pulsenmore FC supports women undergoing IVF and fertility preservation by enabling self‑performed vaginal ultrasound scans at home, with remote professional guidance, to monitor follicular development and endometrial thickness. The UK fertility market includes about 53,000 IVF patients and more than 100,000 fertility and storage cycles in 2024. This is Pulsenmore's second product in international markets and extends the company's platform from pregnancy monitoring into the broader women's health and fertility segment, with plans to expand Pulsenmore FC into additional countries.
Pulsenmore (PLSM) has completed CE European registration under the Medical Device Regulation for Pulsenmore FC, a home ultrasound system for monitoring follicular development and endometrial thickness during IVF and fertility preservation treatments, as of September 8, 2026.
This is the company’s second product authorized in Europe and its first move beyond prenatal monitoring into fertility care. Pulsenmore FC combines a self-use ultrasound transducer with a dedicated app to support remotely guided scans, aiming to shift part of intensive clinic-based monitoring into patients’ homes. A clinical study at Rabin Medical Center showed high agreement between home and in-clinic scans and high satisfaction among patients and staff. European MDR registration now allows marketing and sales across European markets.
Pulsenmore (NASDAQ/TASE: PLSM) reported H1 2026 revenues of NIS 6.1 million (≈$2.0 million), up 53% year over year, with gross profit rising 53% to NIS 2.2 million. Operating expenses increased 4% to NIS 23 million, keeping operating loss broadly flat at NIS 20.8 million.
Net financial expenses climbed to NIS 14.3 million, driving total comprehensive loss to NIS 35 million (up 51%). The company raised NIS 22.5 million (≈$7.5 million) in a private placement and ended June 30, 2026 with NIS 70 million (≈$23.4 million) in cash, cash equivalents, and short-term deposits. Operationally, Pulsenmore launched U.S. commercialization following FDA authorization, signed its first U.S. provider agreements, sold about 4,265 devices, secured ES Tera regulatory clearances, expanded partnerships in Israel and the U.S., and obtained NIS 5 million (≈$1.67 million) in AI grants.
Pulsenmore (NASDAQ/TASE: PLSM) plans to release its financial results and business highlights for the six months ended June 30, 2026 on August 31, 2026 at 8:30 a.m. Eastern Time. The company will host a webcast the same day to review results, business developments, and recent progress, with a replay available on its investor relations website.
Pulsenmore (NASDAQ: PLSM) announced an expansion of its home ultrasound activities in Israel through integration of its technology at Lis Maternity and Women's Hospital at Ichilov, a major women's and maternity care center. Lis joins other Israeli medical centers that use Pulsenmore devices as part of pregnancy monitoring pathways.
The company now operates three models in Israel: a nationwide service with remote medical interpretation via Clalit Health Services; a Hospital at Home model used in several hospitals; and a hybrid model for high-risk pregnancies that combines in-hospital monitoring with at-home ultrasound scans under medical guidance.
Pulsenmore (NASDAQ: PLSM; TASE: PLSM) received a new $1.27 million grant from the Israel Innovation Authority to fund its 12‑month SmartScan AI home-ultrasound R&D program. According to Pulsenmore, this brings total AI grants approved over the past month to about $1.6 million, supporting two programs with a combined scope of roughly $3.12 million.
SmartScan AI aims to use AI-powered real-time ultrasound analysis and dynamic guidance to help pregnant women independently perform home scans, reducing operator dependency and improving image quality. Development is expected to leverage data from more than 250,000 clinical scans and optimize models for fast, on-device Edge AI processing. The program targets applications in fetal monitoring, late-pregnancy visual feedback on fetal head position during pushing preparation, and ultrasound monitoring in fertility treatment. The new grant follows Pulsenmore’s July 2026 selection for a joint Israel Innovation Authority–Ministry of Health AI program focused on clinical workflow efficiency.
Pulsenmore (NASDAQ: PLSM; TASE: PLSM) has been selected for Israel’s Healthcare AI Regulatory Sandbox Program, established by the Israel Innovation Authority and the Ministry of Health, to lead a $1 million AI development project. The company will receive IIA funding to develop and clinically validate AI applications that improve workflow efficiency and scalability of its connected home ultrasound platform for pregnancy care.
Pulsenmore reports over 250,000 home ultrasound scans performed to date, creating a large real‑world prenatal dataset for AI training. The project includes collaboration with Beilinson Hospital, part of Clalit Health Services, to develop and clinically validate the new AI applications.
Pulsenmore (NASDAQ: PLSM) priced a $7.5 million private placement with a single healthcare-focused institutional investor. The deal covers 1,562,500 ordinary shares (or pre-funded warrants) plus warrants for 1,562,500 shares at a combined purchase price of $4.80, above the Nasdaq Minimum Price.
Warrants are immediately exercisable at $4.80 for five years. Closing is expected on or about June 26, 2026. Net proceeds are earmarked for marketing, commercialization, working capital and general corporate purposes.
Pulsenmore (NASDAQ: PLSM) announced a strategic partnership with Ouma Health to integrate its FDA-authorized home ultrasound platform into Ouma’s virtual maternity care model across the United States.
The collaboration targets underserved communities and maternal care deserts, aiming to extend prenatal ultrasound monitoring into patients’ homes and support future expansion with healthcare systems and payers.
Pulsenmore (NASDAQ: PLSM) reported full-year 2025 revenue of $12.5 million, a 374% increase versus 2024, driven largely by a $9.6 million one-time settlement with GE. Net loss improved to $5.0 million from $10.0 million in 2024. Total liquid assets were $21.7 million (including $7.0 million cash) as of Dec 31, 2025.
Key operational milestones include FDA clearance for remote-use prenatal ultrasound in the U.S., MDR/CE certification for the Pulsenmore Early-Screening pregnancy product in Europe, and initial U.S. commercial programs. Management will host a webcast today, March 30, 2026, at 8:30am ET to discuss results and business update.