Pulsenmore Expands Its Fertility Platform into the UK

MHRA registration for Pulsenmore FC opens the UK fertility monitoring market and broadens the company’s women’s health platform beyond pregnancy.

Rhea-AI Summary

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.

Positive

• MHRA registration enables marketing of Pulsenmore FC throughout the UK and Northern Ireland
• Pulsenmore FC targets a UK market with 100,000+ annual fertility and storage cycles (2024)
• Pulsenmore now has two home ultrasound products in international markets
• Expansion from pregnancy monitoring into the broader women’s health and fertility market

Negative

• None.

Market Context

PLSM’s 0% pre-publication 24-hour price change provided no observed reaction to compare with this UK...

Analysis

PLSM’s 0% pre-publication 24-hour price change provided no observed reaction to compare with this UK registration; the Sep 8 European registration of the same Pulsenmore FC program had a 0.41% 24-hour move.

Key Figures

UK market authorization: MHRA registration Fertility treatment cycles: more than 100,000 cycles IVF patients: approximately 53,000 patients +2 more

UK market authorization

MHRA registration

Pulsenmore FC marketing in the United Kingdom and Northern Ireland

Fertility treatment cycles

more than 100,000 cycles

UK HFEA-licensed clinics in 2024

IVF patients

approximately 53,000 patients

UK IVF patients in 2024

IVF births

around 21,400 babies

UK births through IVF in 2024

Share of UK births

3.2%

Share attributed to IVF births in 2024

Historical Context

1 past event · Latest: Sep 08

1 event

1. Sep 08

   European registration

   24h Move

   +0.4%

   Earlier European registration established Pulsenmore FC’s fertility-market regulatory progression

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

ivf, follicular development, endometrial thickness, medical device regulation

4 terms

ivf medical

"women undergoing IVF and fertility preservation treatments"

In vitro fertilization (IVF) is a medical procedure that helps people conceive by combining an egg and sperm outside the body to create embryos, which are then placed in the uterus. It matters to investors because IVF creates a distinct market for fertility clinics, specialized drugs, lab equipment and diagnostic services; demand and profitability are shaped by demographics, technology advances, regulation and insurance coverage, so shifts in any of those areas can affect companies tied to this service.

follicular development medical

"monitor follicular development and endometrial thickness"

Follicular development is the biological process in which ovarian follicles — tiny fluid-filled sacs that each contain an immature egg — grow and mature under hormonal signals until one or more become ready for ovulation. It matters to investors because many reproductive-health drugs, fertility treatments, and endocrine therapies are designed to influence this process; changes in follicular development are common efficacy and safety endpoints in clinical trials and can drive regulatory and commercial outcomes.

endometrial thickness medical

"monitor follicular development and endometrial thickness"

Endometrial thickness is the measurement of the lining of the uterus, usually taken by transvaginal ultrasound and reported in millimeters. It is a clinical indicator used in fertility care, hormone therapy and gynecological drug trials; like measuring the thickness of a carpet to judge readiness, it helps regulators and investors gauge treatment effects, trial endpoints, market size for therapies, and potential safety or efficacy signals.

medical device regulation regulatory

"European registration under the Medical Device Regulation (MDR)"

Rules and processes governments require for making, testing, approving, and monitoring medical devices so they are safe and work as intended. Think of it like a building code and inspection process for devices: meeting these rules can be costly and slow but opens markets and reduces the risk of recalls and legal trouble, while failure to comply can cut revenue, delay product launches, or cause fines—issues investors watch closely.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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MHRA registration allows Pulsenmore FC to be marketed across the United Kingdom and Northern Ireland, extending the Company's home ultrasound platform into the UK fertility market where more than 100,000 IVF and fertility treatment cycles were performed in 2024.

OMER, Israel, Sept. 17, 2026 /PRNewswire/ -- Pulsenmore (NASDAQ: PLSM) (TASE: PLSM), a healthcare technology company developing self-use ultrasound solutions for remote care, today announced that it has completed the registration of Pulsenmore FC with the MHRA, the UK regulatory authority responsible for medical devices. The registration enables the Company to market the system in the United Kingdom and Northern Ireland, and follows the recent completion of the system's European registration under the Medical Device Regulation (MDR).

Pulsenmore FC is a home ultrasound system for women undergoing IVF and fertility preservation treatments. The system enables patients to perform vaginal ultrasound scans themselves from home to monitor follicular development and endometrial thickness, with remote professional guidance, as part of a treatment pathway managed by the fertility care team. By moving part of ultrasound monitoring from the clinic to the home, the system can reduce the need for repeated clinic visits and allow patients to better integrate monitoring into their daily lives.

The UK represents a significant and growing market for fertility treatment. According to the Human Fertilisation and Embryology Authority (HFEA), the UK's independent regulator of fertility treatment, approximately 53,000 patients underwent IVF in 2024, with more than 100,000 fertility treatment and storage cycles performed at HFEA-licensed clinics. Around 21,400 babies were born through IVF in 2024, accounting for 3.2% of all UK births.

Pulsenmore FC is Pulsenmore's second product to reach international markets, following the Company's home ultrasound system for pregnancy monitoring, and marks the Company's expansion from pregnancy monitoring into the broader women's health market.

Dr. Elazar Sonnenschein, Founder and CEO of Pulsenmore, said:

"Following our recent European registration, our entry into the UK opens another significant market for Pulsenmore in fertility care. This is an important step toward turning the technology we have developed into a care model that can be implemented in fertility clinics across different markets. Fertility treatment currently requires patients to adapt a significant part of their daily lives around monitoring. We want to reverse that equation, enabling part of the monitoring process to fit into the patient's life, while keeping the clinical team at the center of care. We intend to expand the use of Pulsenmore FC into additional countries with a significant number of IVF and fertility preservation cycles."

About Pulsenmore
Pulsenmore Ltd. (NASDAQ: PLSM) (TASE: PLSM) is a healthcare technology company focused on transforming women's healthcare through remote ultrasound and telemedicine solutions. The Company develops patient-operated ultrasound systems that enable remote clinical assessment and monitoring, with applications across pregnancy and fertility care.

Forward-Looking Statements

This press release contains forward-looking statements. In particular, statements using words such as "may," "seek," "will," "consider," "likely," "assume," "estimate," "expect," "anticipate," "intend," "believe," "contemplate," "do not believe," "aim," "goal," "due," "predict," "plan," "project," "continue," "potential," "positioned," "guidance," "objective," "outlook," "trends," "future," "could," "would," "should," "target," "on track" or their negatives or variations, and similar terminology and words of similar import, generally involve future or forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding the commercialization of Pulsenmore FC in the United Kingdom and other markets; the potential benefits of the Company's technology and remote monitoring platform; the Company's plans to expand into additional countries and markets; and the potential size, growth and opportunities of the fertility care market. Forward-looking statements reflect Pulsenmore's current views, plans, or expectations with respect to future events or financial performance. They are inherently subject to significant business, economic, competitive, and other risks, uncertainties, and contingencies. Forward-looking statements are based on Pulsenmore's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, but not limited to, the following: the Company's lack of operating history; the Company's current and future capital requirements and the Company's belief that its existing cash will be sufficient to fund its operations for more than one year from the date that the financial statements are issued; the Company's ability to manufacture, market and sell its products and to generate revenues; the Company's ability to maintain its relationships with key partners and grow relationships with new partners; the Company's ability to maintain or protect the validity of its U.S. and other patents and other intellectual property; the Company's ability to launch and penetrate markets in new locations and new market segments; the Company's ability to retain key executive members and hire additional personnel; the Company's ability to maintain and expand intellectual property rights; interpretations of current laws and the passages of future laws; the Company's ability to achieve greater regulatory compliance needed in existing and new markets; the Company's ability to achieve key performance milestones in its planned operational testing; the Company's ability to establish adequate sales, marketing and distribution channels; security, political and economic instability in the Middle East that could harm its business; and acceptance of the Company's business model by investors. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the SEC, including, but not limited to, the risks, uncertainties and other factors included in the Company's Annual Report on Form 20-F, filed with the SEC on March 30, 2026. The inclusion of forward-looking statements in this or any other communication should not be considered as a representation by Pulsenmore or any other person that current plans or expectations will be achieved. Forward-looking statements speak only as of the date on which they are made, and Pulsenmore undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as otherwise required by law.

Investor Contact:

Miri Segal-Scharia
MS-IR LLC
msegal@ms-ir.com

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SOURCE Pulsenmore Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Pulsenmore FC and who is it intended for?

Pulsenmore FC is a home ultrasound system designed for women undergoing IVF and fertility preservation treatments. It enables patients to perform vaginal ultrasound scans themselves from home to monitor follicular development and endometrial thickness, as part of a treatment pathway managed by their fertility care team.

How is Pulsenmore FC used in the fertility treatment pathway?

The system allows patients to conduct vaginal ultrasound scans at home with remote professional guidance, while the fertility clinic team remains at the center of care. By shifting part of monitoring from the clinic to the home, the company says it can reduce repeated clinic visits and help patients integrate monitoring into their daily lives.

What prior regulatory milestone did Pulsenmore FC achieve before the UK registration?

Before completing MHRA registration in the UK, Pulsenmore FC obtained European registration under the Medical Device Regulation (MDR), supporting its availability in European markets.