Pulsenmore Ltd. (PLSM) reports that its home fertility ultrasound system, Pulsenmore FC, has been registered with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing the product to be marketed in the United Kingdom and Northern Ireland. This follows recent European registration under the Medical Device Regulation (MDR).
Pulsenmore FC enables women undergoing IVF and fertility preservation treatments to perform vaginal ultrasound scans at home with remote professional guidance, potentially reducing repeated clinic visits. The UK fertility market is described as significant, and Pulsenmore states its intention to expand Pulsenmore FC into additional countries with substantial IVF and fertility preservation activity.
Pulsenmore Ltd. (PLSM) reports completion of CE European registration under the European Medical Device Regulation for Pulsenmore FC, a home ultrasound system for monitoring follicular development and endometrial thickness during IVF and fertility preservation treatments. This is the company’s second product authorized in Europe and its first move beyond prenatal monitoring into fertility care, broadening its home ultrasound platform across women’s health. Registration now allows marketing and sales of Pulsenmore FC across European markets, targeting frequent ultrasound monitoring needs in assisted reproduction.
Pulsenmore Ltd. (PLSM) has filed a post-effective amendment to its Form F-1 to update the prospectus and financial information for a previously declared-effective resale registration tied to a June 2026 private placement. The amended prospectus covers the resale by a single selling shareholder of up to 2,239,500 ordinary shares, all issuable upon exercise of outstanding warrants, with no new securities being registered.
The shares consist of 677,000 from pre-funded warrants and 1,562,500 from ordinary warrants. Pulsenmore will not receive cash from any resale, but could receive up to $7.5 million in gross proceeds if all warrants are exercised for cash at their stated exercise prices. The filing highlights potential dilution and stock overhang from warrant exercises and provides extensive risk disclosures, including volatility in PLSM’s share price and significant geopolitical risks associated with operating in Israel.
Pulsenmore Ltd. (PLSM) reported interim IFRS results for the six months ended June 30, 2026, alongside a strategic financing and several commercial and R&D milestones. Revenue rose to NIS 6.1 million (about $2.0 million), up roughly 53% year on year, driven mainly by higher Pulsenmore ES sales to Clalit and initial Pulsenmore FC revenue.
Gross profit increased to NIS 2.2 million, while operating loss was broadly flat at NIS 20.8 million. Net loss widened to NIS 35.1 million (about $11.8 million), largely due to NIS 14.3 million in net financial expenses tied to the June 2026 private placement of pre-funded and ordinary warrants, which are accounted for as liabilities and remeasured at fair value.
Pulsenmore ended June 2026 with NIS 43.6 million in cash and NIS 26.2 million in short-term deposits, plus gross proceeds of NIS 22.5 million from the private placement, and believes this liquidity should fund operations for at least 12 months. The company also disclosed a new Clalit addendum with a $9 million five‑year minimum purchase commitment after an 18‑month pilot, new U.S. partnerships including Ouma Health, and NIS‑denominated grants from the Israel Innovation Authority, while noting ongoing regional security risks that it currently assesses as having no material impact on the financial statements.
Pulsenmore Ltd. (PLSM) reported that its home-use ultrasound technology will be integrated into the Lis Maternity and Women’s Hospital at Ichilov, a major Israeli women’s and maternity care center, expanding the use of at-home pregnancy monitoring.
The addition of Lis strengthens Pulsenmore’s presence in central Israel and broadens access to its hybrid care model, which combines hospital or clinic monitoring with certain ultrasound scans performed at home for eligible patients under medical guidance. Pulsenmore’s activities in Israel now span three integration models: a nationwide service with Clalit Health Services, a Hospital at Home model used in several hospitals, and a hybrid model for high-risk pregnancies that mixes hospital-based and at-home examinations.
The company states that these models are designed to let pregnant women continue part of their monitoring in a home environment while remaining under their care team’s supervision, which may be particularly valuable for women requiring frequent monitoring who live far from medical centers. Pulsenmore also reiterates standard forward-looking statement cautions regarding the commercial potential and operational and regulatory risks around its expansion.
Pulsenmore Ltd. reported that the Israel Innovation Authority approved a $1.27 million grant for its SmartScan AI research and development program. Over the past month, total approved AI grants for Pulsenmore reached approximately $1.6 million, supporting two programs with a combined R&D scope of about $3.12 million.
The 12‑month SmartScan AI program aims to develop AI-powered, real-time guidance for home ultrasound, reducing dependence on user skill and enabling clinicians to handle a higher volume of remote examinations. Development will leverage data from more than 250,000 clinical scans and focus on fast, on-device processing using Edge AI.
Pulsenmore Ltd. reports that shareholders held the 2026 Annual General Meeting of Shareholders on August 6, 2026. At this meeting, shareholders approved all six proposals that were presented, each in accordance with the required majority.
The approved proposals correspond to those described in the Notice of Annual General Meeting of Shareholders dated July 1, 2026, which had been furnished to the U.S. Securities and Exchange Commission as an exhibit to a prior Form 6-K.
Pulsenmore Ltd. has filed a resale prospectus covering up to 3,125,000 ordinary shares for sale by a single selling shareholder. These shares are issuable upon exercise of warrants sold in a June 2026 private placement, including 1,562,500 shares from pre-funded warrants and 1,562,500 shares from ordinary warrants.
The company will not receive proceeds from any resale of shares, but could receive up to approximately $7.5 million if all warrants are exercised for cash. Ordinary shares outstanding were 6,502,844 as of July 1, 2026. The filing highlights potential dilution, share price volatility, and significant geopolitical risks tied to operating from Israel, alongside Pulsenmore’s commercialization of its home ultrasound devices (ES, FC, MC) in multiple international markets.
Pulsenmore Ltd. reports that it 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 project supports development and clinical validation of AI applications that improve workflow efficiency and scalability of Pulsenmore’s home ultrasound platform for pregnant women. The platform connects a home-use ultrasound device to a smartphone, transmitting scans for physician review, and has been used in more than 250,000 home ultrasound scans with partners including Clalit Health Services and other organizations worldwide.
New AI tools are intended to automatically identify key ultrasound parameters and present findings to physicians, aiming to reduce review time, speed results, and expand clinician capacity. Pulsenmore will collaborate with Beilinson Hospital on development and clinical validation of these AI applications within the government-backed regulatory framework.