Management to Host Webcast today at 8:30 am ET to discuss Results and Provide Business Update
OMER, Israel, Aug. 31, 2026 /PRNewswire/ -- Pulsenmore Ltd. $(PLSM)$ (TASE: PLSM), a leading innovator in remote maternal-fetal healthcare and home ultrasound solutions, presents the key operational, commercial, regulatory, and technological achievements as well as financial updates for the six month period ended June 30, 2026.
During the first half of 2026, Pulsenmore advanced its commercialization efforts in the United States following FDA marketing authorization for its home ultrasound platform, while continuing to advance product development, regulatory approvals, prepare for manufacturing and pursue strategic collaborations.
H1 2026 Highlights
Commercial & Business Development
-- The Company officially launched its U.S. commercial activities following
FDA market authorization and showcased its platform at the Society for
Maternal-Fetal Medicine (SMFM) Pregnancy Meeting in Las Vegas in February
2026.
-- The Company signed its first U.S. commercial agreements with:
-- The Center for Fetal Maternal Ultrasound (CFFM) in Los Angeles,
California
-- TLC Perinatal Care in Silver Spring, Maryland
-- The Company completed its first provider onboarding in the United States
at the end of January 2026.
-- The Company recorded its first U.S. home ultrasound patient scan during
February 2026.
-- Pulsenmore's U.S. e-commerce platform officially opened for online orders
in April 2026.
-- The Company expanded discussions with digital health and maternal-care
organizations regarding potential collaborations intended to support
broader access to virtual obstetric care.
-- In June 2026, the Company announced a strategic partnership with Ouma
Health to expand access to remote prenatal care across the U.S. The
collaboration aims to deliver transformative care for the most
underserved patients including those living in maternity deserts and
underserved communities and establish insights and experience to support
future expansion opportunities with healthcare systems, maternity care
providers, and payer organizations seeking innovative approaches for
maternal health delivery.
-- In August 2026, the Company announced that its home ultrasound technology
will be integrated at Lis Maternity and Women's Hospital at Ichilov,
expanding the ability to incorporate at-home ultrasound scans as part of
pregnancy monitoring.
Strategic Partnerships & Healthcare Expansion
-- Pulsenmore signed an addendum to its agreement with Clalit Health
Services, regarding its Pulsenmore FC (follicles monitoring) product,
strengthening its collaboration in Israel.
Product Development & Technology
-- The Company supported FDA and AMAR submissions for the ES Tera product
line (compatible for both iOS and Android devices). The Company received
applicable regulatory clearances or authorizations for the ES Tera
product line from the FDA and Israel's Ministry of Health Medical Device
Division, as applicable.
-- Initial ES Tera production lots and first shipments to the U.S. market
were completed
-- After the period ended June 30, 2026, in July 2026, the Company announced
that it has been selected to participate in Israel's Healthcare AI
Regulatory Sandbox Program, established by the Israel Innovation
Authority and the Ministry of Health. As part of the program, the Company
will lead a NIS 3 million (approximately $1 million) project in which the
grant approved amounted to NIS 1.2 million (approximately $0.4 million).
In August 2026, the Company announced that it received a second AI grant,
after the Israel Innovation Authority approved NIS 3.8 million
(approximately $1.27 Million) for the SmartScan AI Program. The second
grant brings the total AI grants approved for the Company in the past
months to NIS 5 million (approximately $1.67 million), supporting two
programs with a combined scope of NIS 9.3 million approximately $3.12
million.
Manufacturing & Operations
-- Pulsenmore sold approximately 4,265 devices during the first half of 2026
-- Pulsenmore progressed planning for new production facilities and
infrastructure expansion
-- The Company continued development of its proprietary automated ultrasound
transducer production line, with plans to establish automated
manufacturing operations in Israel beginning in 2027.
Intellectual Property
Pulsenmore strengthened its intellectual property portfolio with multiple newly granted patents during H1 2026, including patents related to:
-- Ultrasound imaging systems for non-skilled users -- Systems for acquiring ultrasound images -- Wearable ultrasonic devices
Regulatory Achievements
Key regulatory milestones achieved during H1 2026 included:
-- U.S. clearance expansion for the Pulsenmore ES Tera device
-- Submission of a Q-Sub application for potential expansion of Pulsenmore
ES indications in the U.S
Private Placement with a Single Healthcare Focused Institutional Investor
In June 2026, the Company entered into a securities purchase agreement with a healthcare-focused institutional investor, for the purchase and sale of 1,562,500 pre-funded warrants and ordinary warrants to purchase up to 1,562,500 ordinary shares in a private placement at a combined purchase price of $4.7999 per pre-funded warrant and accompanying ordinary warrant), representing a premium to the then Nasdaq Minimum Price under Nasdaq rules.
The gross proceeds from the offering were NIS 22.5 million (approximately $7.5 million), before deducting placement agent commissions and other offering expenses.
Management Commentary
"The first half of 2026 marked a transformative period for Pulsenmore as we initiated commercial operations in the United States following FDA authorization and achieved multiple strategic milestones across commercialization, regulation, manufacturing, and innovation," said Dr. Elazar Sonnenschein, Chief Executive Officer of Pulsenmore Ltd. "As we move into the second half of the year, our focus is on scaling the commercial base and converting the early stages of this year to actual revenues. We believe our achievements to date position Pulsenmore for continued growth as we expand access to remote maternal-fetal healthcare worldwide."
Financial Results for the period ended June 30, 2026
-- Revenues for the six months ended June 30, 2026, amounted to NIS 6.1
million (approximately $2 million), representing an increase of NIS 2.1
million (approximately $0.7 million), or 53%, compared to NIS 4 million
(approximately $1.3 million) for the six months ended June 30, 2025. The
increase in revenues from 2025 to 2026 resulted primarily from a higher
volume of Pulsenmore ES units sold to our main customer, Clalit, fueled
by the Company's enhanced marketing efforts, and also from revenue
recognition of 300 Pulsenmore FC units in 2026.
-- Gross profit for the six months ended June 30, 2026, amounted to NIS 2.2
million (approximately $0.7 million), representing an increase of NIS 0.7
million (approximately $0.2 million) or 53%, compared to NIS 1.5 million
(approximately $0.5 million) for the six months ended June 30, 2025. The
gross profit resulted primarily from a higher volume of Pulsenmore ES
units sold, and also from revenue recognition of 300 Pulsenmore FC units
in 2026.
-- Operating expenses for the six months ended June 30, 2026, amounted to
NIS 23 million (approximately $7.7 million), representing an increase of
NIS 0.9 million (approximately $0.3 million) or 4%, compared to NIS 22.1
million (approximately $7.4 million) for the six months ended June 30,
2025. The increase in operating expenses was primarily attributable to
the Company's ongoing commercialization activities, product development
efforts, and advertising expenses.
-- Operating loss amounted to NIS 20.8 million (approximately $7 million)
for the six months ended June 30, 2026, compared to operating loss of NIS
20.6 million (approximately $6.9 million) for the six months ended June
30, 2025, representing an increase of NIS 0.2 million (approximately $0.1
million), or 1%.
-- Net financial expenses for the six months ended June 30, 2026, amounted
to NIS 14.3 million (approximately $4.8 million), representing an
increase of NIS 11.8 million (approximately $4 million), or 472%,
compared to NIS 2.5 million (approximately $0.8 million) for the six
months ended June 30, 2025. The increase was driven primarily by the
private placement completed during the period, which resulted in the
recognition of the excess of initial fair value of pre-funded warrants
over transaction proceeds.
-- Total comprehensive loss for the six months ended June 30, 2026, amounted
to NIS 35 million (approximately $11.8 million), compared to total
comprehensive loss of NIS 23.2 million (approximately $7.7 million) for
the six months ended June 30, 2025, representing an increase of NIS 11.8
million (approximately $4.1 million), or 51%.
-- As of June 30, 2026, the Company had cash, cash equivalents, and
short-term bank deposits of NIS 70 million (approximately $23.4 million)
Webcast Details
Pulsenmore will host a webcast to review the results today on August 31 at 8:30am Eastern Time / 3:30pm Israel Time.
Webcast: https://teams.microsoft.com/meet/35050418577919?p=r5gfAIMDL65KJ8zKj3