Pulsenmore (NASDAQ:PLSM) held its quarterly earnings conference call on Monday. Below is the complete transcript from the call.
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Summary
Pulsenmore Ltd launched its U.S. commercial operations in the first half of 2026, signed initial U.S. provider agreements, and expanded its e-commerce platform.
The company announced a strategic partnership with Ouma Health to expand access to remote prenatal care, focusing on underserved U.S. communities.
First half 2026 revenue was 6.1 million shekels, up 53% year over year, driven by increased sales of Pulsenmore ES units.
Pulsenmore completed regulatory clearances for its ES Terra product line from the FDA and Israeli Ministry of Health.
The company secured non-dilutive funding through AI grants and continues to expand its IP portfolio with multiple patents.
Plans to scale revenue focus on broader adoption, expansion to additional clinical partners, and increasing recurring revenue streams.
Operating loss remained flat year over year at 20.8 million shekels despite increased commercial activity.
Pulsenmore is actively exploring additional technology developments and products beyond its current home ultrasound system.
The company’s strategic focus includes expanding into markets such as France, the UK, and Japan.
Full Transcript
Miri Segal, Investor Relations
Welcome to Pulsenmore’s First Half Financial Results Conference Call. Following the prepared remarks, we will open the call for a question and answer session. Excuse me, if you could mute your line. Thank you. Anyone who would like to ask a question should share it in the chat or email. Email me directly at [email protected]. Please note that today’s call is being recorded. Joining me on the call today are Dr. Elazar Sonnenschein, Founder and Chief Executive Officer, and Eran Hirsch, Chief Financial Officer.
Earlier today we issued a press release with our financial results and business updates for the first half of 2026, ending June 30th. The release is available on the Investor Relations section of our website at pulsenmore.com. Before we begin, I would like to remind listeners that statements made on this call may include forward-looking statements within the meaning of applicable securities law. Statements are subject to risks and uncertainties and could cause actual results to differ materially from those anticipated.
Additional information regarding these risks is included in our filings with the U.S. Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements except as required by law. With that, I would like to turn the call over to Dr. Elazar Sonnenschein, Pulsenmore’s Founder and CEO. Elazar, please go ahead.
Elazar Sonnenschein — Group CEO
Thank you, Miri, and thank you all for joining us today. During our last earnings call we discussed entering a new phase for Pulsenmore, moving from FDA authorization and our Nasdaq listing milestone into planting the seeds for future execution. The first half of 2026 delivered on that. We launched our U.S. commercial operations, signed our first U.S. provider agreements, and made real progress across regulatory, manufacturing, and strategic fronts.
At Pulsenmore, our mission goes beyond technology. We are committed to transforming the standard of prenatal care for women around the world. As the first FDA-cleared home ultrasound solution for pregnancy, we are enabling expectant mothers to access care from the comfort and safety of their homes, fundamentally improving the quality, accessibility, and timeliness of treatment. Our technology empowers physicians with real-time insights while giving women greater confidence and peace of mind during one of the most important periods of their lives.
In doing so, we are enhancing care through proactive monitoring throughout pregnancy, enabling earlier detection of potential complications, improving access to care, and leveraging technology to extend high-quality medical service to women living in remote and underserved areas. I would like to discuss the business progress in the first half of 2026. Since receiving the FDA authorization, we moved forward quickly into real clinical adoption milestones.
We completed our first U.S. provider onboarding at the end of January, and by February we had recorded our first U.S. home ultrasound patient scan. Our first two commercial agreements with the Center of Fetal Maternal Ultrasound in Los Angeles and TLC Prenatal Care in Silver Spring, Maryland, meant that within weeks of launch, physicians were already using the platform with real patients. In April, we officially opened the U.S. e-commerce platform for online orders, providing patients with an online channel through which to purchase our technology after receiving a prescription from their provider.
In June, we proudly announced a strategic partnership with Ouma Health to expand access to remote prenatal care across the U.S., with a focus on underserved communities and maternity deserts. Ouma Health is a maternity telemedicine company providing comprehensive care from preconception through postpartum. Its clinicians are licensed in all 50 states, and it has Medicaid enrollment in 20-plus states. This is an important step in building the infrastructure for broader system-level partnerships going forward.
As Dr. Sina Haeri, the CEO of Ouma Health, said, Ouma cares for patients who often face significant geographic and logistical barriers to prenatal care, including those living in maternity deserts and underserved communities. Pulsenmore technology keeps patients connected to a clinical team that can review the information and guide next steps remotely. This partnership helps Ouma make virtual maternity care more clinically complete, especially for patients who cannot easily access specialty care in person.
On the regulatory side, we supported FDA and AMAR submissions to our ES Terra product line and ultimately received the applicable clearances from both the FDA and the Israeli Ministry of Health. Initial ES Terra production lots and first shipments to the U.S. market are completed. We also submitted the Q-Sub application, a formal but not binding process to get early FDA feedback before a full submission, to explore expanding our indication in the U.S. in the future. We sold approximately 4,265 devices during the first half of the year. It is important to emphasize that we see the initial device sales as the first step in our U.S. expansion. As we build our installed base, increase adoption, and reach scale, we expect to have opportunities to develop recurring revenue streams over time. So while our focus today is on market penetration and establishing a meaningful U.S. footprint, we believe the longer-term opportunity extends well beyond the initial sale of the device.
We also continued building our proprietary automated ultrasound transducer production line, which we expect to begin operation in Israel in 2027. In Israel, we strengthened our partnership with Clalit Health Services through an addendum covering our Pulsenmore FC follicle monitoring product. We also strengthened our IP portfolio with multiple newly granted patents covering ultrasound imaging for non-skilled users, systems for acquiring ultrasound images, and wearable ultrasonic devices.
Just after the six-month period ended, in July we received two strong votes of confidence in our technology. We were selected for the Israeli Healthcare AI regulatory sandbox program, and in August we received a second AI grant for our Smart Scan AI program. Together those programs bring 5 million new shekels, approximately $1.67 million. These amounts are non-dilutive funding across a combined approximately $3.11 million in scope. What we see tells us that regulators and funders see meaningful opportunity in AI-driven ultrasound, as we do.
On the clinical front, our evidence base continues to expand. Since the beginning of the year, four peer-reviewed studies evaluating the Pulsenmore platform have been published, originating from leading clinical centers in the Netherlands, Israel, and the U.S. Together these studies provide evidence across several dimensions, including the usability and feasibility of patient-operated home ultrasound, as well as its potential to reduce maternal anxiety and support new models of remote prenatal care.
I would particularly highlight two recently published studies evaluating one of the most important applications we are developing: the biophysical profile, or BPP, a standard fetal surveillance assessment used repeatedly in many high-risk pregnancies. Independent studies conducted at Rabin Medical Center in Israel and the University of Michigan demonstrated that women remotely guided by a clinician were able to perform the ultrasound component of the BPP from home, with high agreement compared with conventional clinic assessment.
The U.S. study has also attracted attention from the clinical community and was recently featured by Contemporary OB/GYN, including an interview with the University of Michigan principal investigator, Dr. Alex Spiel, discussing the potential for remote BPP to become part of future antenatal surveillance models. Beyond the clinical significance, we believe BPP could also become important to our future commercial strategy. BPP is an established clinical procedure with existing reimbursement pathways in the U.S. If further clinical development and regulatory work support its adoption for remote care, this could enable new business models. Before I hand the call to Eran, I want to highlight that we are early in a large, multi-year opportunity, and we build our U.S. strategy with a clear view of how this business actually scales. Agreements convert to volume through an onboarding and testing process, and it takes time for these initiatives to reflect in actual financial results.
A great example of building the right strategy in the U.S. is our collaboration with Ouma Health, our most significant U.S. relationship today. Every new account is the start of a relationship. Usage, follow-on orders, and engagement build over the following quarters as adoption matures. That means a meaningful share of the units we placed are still early in their revenue curve. As we scale and expand our installed base, we expect more opportunity to generate recurring revenue.
Ouma has a footprint across the United States, giving us a large addressable base with a phased approach. The process starts with a demo and testing period, typically 30 to 60 days, before a site or provider moves to live volume. That means most of the revenue opportunity from this partnership is still ahead of us and not yet reflected in our current numbers. To accelerate that pace, we brought a Chief Commercial Officer and are building out our U.S. team. That investment is already underway, and we expect its impact to build over coming quarters as it fully ramps. With that, I will now turn the call over to Eran Hirsch, our Chief Financial Officer, to review our financial results.
Eran Hirsch — Chief Financial Officer
Thank you, Elazar. Hello, everyone, and thank you for joining the call. Before we begin, I’d like to mention that throughout this call we’ll be referring to a slide presentation available for download in the Investor Relations section of our website. I encourage you all to follow along with the slides. The financial results I will review are detailed in the press release issued earlier today and reflect Pulsenmore’s performance for the six months ended June 30, 2026.
Before I get into specific figures, I want to give you the proper lens we use to assess our financial results, because the P&L today captures only the earliest stage of the longer revenue curve. Our U.S. commercialization was launched this year, and every new agreement, including Ouma Health, moves through an onboarding and implementation process before it converts to volume. Let’s move to our P&L slide. Revenue for the first half of 2026 totaled 6.1 million shekels, approximately $2 million, representing an increase of 53% compared to 4 million shekels, approximately $1.3 million, in the first half of 2025.
The increase was driven primarily by a higher volume of Pulsenmore ES units sold to our main customer, Clalit, supported by enhanced marketing efforts, as well as revenue recognition on 300 Pulsenmore FC units in 2026. Gross profit for the first half was 2.2 million shekels, approximately $700,000, representing an increase of 53% from 1.5 million shekels in the first half of 2025. Operating expenses were 23 million shekels, approximately $7.7 million, representing an increase of 4% year over year, reflecting continued investment in commercialization, product development, and advertising expenses.
Operating loss was 20.8 million shekels, approximately $7 million, compared to 20.6 million shekels, approximately $6.9 million, in the first half of 2025. This was essentially flat year over year despite the significant increase in commercial activity. Net financial expenses for the period were 14.3 million shekels, approximately $4.8 million, compared to 2.5 million shekels, approximately $800,000, in the prior-year period. This represents an increase of 11.8 million shekels, approximately $4 million, or 472%.
This increase was driven primarily by the private placement completed during this period, which resulted in recognition of excess of initial fair value of pre-funded warrants over the transaction proceeds. Total comprehensive loss for the period was 35 million shekels, approximately $11.8 million, compared to 23.2 million shekels, approximately $7.7 million, in the prior-year period, representing an increase of 51%. Let’s move to the balance sheet slide.
As of June 30, 2026, we held cash and cash equivalents and short-term bank deposits of 70 million shekels, approximately $23.4 million. In June we entered into a securities purchase agreement with a healthcare-focused institutional investor for proceeds of 22.5 million shekels, approximately $7.5 million. This improves our balance sheet as we continue to scale U.S. commercial preparations. Historically, a new sales organization takes several quarters to become fully productive.
Combined with Ouma testing and implementation timelines, most of the benefits of this year’s hiring and partnership work are expected to build over the coming quarters. Our view is that the underlying model—device placement blending into recurring usage-based revenue at scale—is well suited to our strategy. With that, I will turn the call back to Elazar for closing remarks.
Elazar Sonnenschein — Group CEO
Thank you, Eran. To summarize, the first half of 2026 was a transformative period for Pulsenmore. We launched U.S. commercial operations, signed our first provider agreements, opened our e-commerce platform, and announced a strategic partnership with Ouma Health, all while advancing our regulatory pipeline with the ES Terra clearances and securing meaningful non-dilutive funding through two AI grants. As we move into the second half of the year, our focus is on scaling that commercial base.
We believe these achievements position Pulsenmore for continued growth as we expand access to remote maternal-fetal healthcare worldwide. We also want to take a moment to thank the Pulsenmore team for their dedication and hard work this year. Thank you again for joining us today and for your continued interest in Pulsenmore.
Miri Segal, Investor Relations
Thank you, Elazar. We will now open the line for the question and answer session. As a reminder, please submit your questions via the chat function. If your question is not answered in this session, I see that there are questions in Hebrew. We’re conducting this call in English, and some of them are very detailed. Please share your email and we’ll get back to you separately after the call. And also, if you don’t want to share it in the chat, you can email it in English.
I see several questions that were emailed in English, so we can take the ones that were sent in English. Just as a reminder, the email is [email protected], and hopefully if the questions are shortened in English, I can just read it out loud and the team can answer it. I will start with the ones that were emailed to me. There are a couple. Let me read it out loud. You’ve signed your first U.S. commercial agreements and completed onboarding. What’s the plan for expanding beyond these initial sites?
Elazar, would you like to take it?
Elazar Sonnenschein — Group CEO
Yes, thank you. Our first agreements with CFFM and TLC Prenatal Care, along with our e-commerce launch, give us an early foundation to learn from. Based on that feedback, we plan to expand to additional sites through the second half of 2026 while refining our operational processes to support a broader scale-up.
Miri Segal, Investor Relations
I will read them out loud, and again—oh, I see in English also. Okay, so I will read one of the emailed ones and then I’ll get back to the guest question. I see Ben had some questions. Let me just finish with the ones that were emailed directly to me. What’s a realistic assumption for the U.S. ramp-up over the next 12 to 18 months?
Elazar Sonnenschein — Group CEO
We are early in that ramp. Ouma has a nationwide footprint, but implementation generally includes a 30 to 60 days demonstration and testing period before moving to live volume. Over the next several quarters, we expect to move more sites through that testing phase and into production, with meaningful volume building through 2027 as our new U.S. commercial team and this partnership mature together.
Miri Segal, Investor Relations
Okay, can you provide an update on other technology developments or products in the pipeline beyond the current home ultrasound system?
Elazar Sonnenschein — Group CEO
So while our primary focus remains on scaling the Pulsenmore Early Screening system and the ES Terra, we are actively exploring additional features and enhancements to expand our product capabilities, including our recently awarded AI grants. These efforts aim to improve clinical utility, streamline workflow, and broaden the application of our hybrid care model in maternal and prenatal health.
Miri Segal, Investor Relations
Okay, thank you. I’ll ask one more that was emailed to me and then we’ll go back to the chat. I see that it was translated to English, so just a second. How do you plan to scale revenues as adoption grows, and what are the key levers to achieve that growth?
Elazar Sonnenschein — Group CEO
Revenue scaling is expected to be driven by broader adoption of our commercial sites, expansion to additional clinical partners, and increasing recurring revenue from telehealth services and software. Strategic partnerships with healthcare providers and ongoing clinical validation are expected to also support adoption and help accelerate revenue growth over time.
Miri Segal, Investor Relations
In the chat we have several questions—at least let me start with them, and then, if needed and it’s more detailed, we can schedule a separate call. Not sure who the person is; we can’t see your email. We’d appreciate getting it so we can follow up with you separately. The proposed CMS rules for 2027 may impose stricter requirements on RPM/RTM models, including a requirement that clinical staff be employed directly by the billing entity rather than through an external provider.
What portion of Pulsenmore’s U.S. commercial model is dependent on RTM codes or external clinical staff? And just a minute—and what would be the quantitative impact on service costs and profit margin? Wow, this is a very detailed question. I think that I’ll stop here. Maybe, Elazar, you want to take it? And again, I think that because the rest of the questions are super detailed and specific, if you can share your email this will be helpful and we’ll get back to you separately.
Maybe, Elazar, you want to refer to what was asked so far.
Elazar Sonnenschein — Group CEO
So indeed there is a change starting from January 1st, but it is not related to us. It is good for us by means of the reimbursement, by means of the treatment, by means of the number of meetings that can be billed. Each meeting can be billed instead of a computed amount for the pregnancy. Now each meeting will be billed, and we are fine with that.
Miri Segal, Investor Relations
Okay, I’m trying to see if the rest of the questions are more outside of the U.S. Asia, Europe, and Australia: is the approved regulatory indication for the Pulsenmore ES broader than its U.S. indication? And then I’ll stop with this very long question. Again, please email us your email and we’ll get back to you directly, because I see that this question is super detailed, and I’d like to go to the next one as we need to complete the call. So can you answer that, Elazar, and then I’ll move to the next one, and hopefully anybody else that their question wasn’t answered can email us, and we will schedule a follow-up one-on-one.
Elazar Sonnenschein — Group CEO
Indeed, indeed. The indication in Australia is broader. We have good progress in Australia. We met with the government of Victoria, of New South Wales, and others, and it’s progressing as expected. And we have good coverage in Australia. In fact, the reimbursement in Australia is by far larger than any other country in the world. So we are enthusiastic, and we like to progress further in Australia.
Miri Segal, Investor Relations
Okay, are there plans and activities underway to expand into additional markets beyond the U.S., specifically focusing on countries with reasonable birth rates?
Elazar Sonnenschein — Group CEO
U.S. is the biggest one. As for the next two years we will not go to China, but we are looking at three different markets. The first one is France. We are working in France. We have three active accounts in France. We are working in the UK. There is an ongoing clinical trial in St George in London. We would like to extend the footprint in the UK and are in continuous discussion with the NHS. And the last one is Japan. We are in discussion with the PMDA.
Already met them, they asked us a few questions. We are going to meet them within 45 days or so, and then we will continue our discussion in order to get clearance also in Japan.
Miri Segal, Investor Relations
Great. I’ll take the last question, and please again email us. If we weren’t able to cover everything because the questions were too detailed, we’ll be happy to schedule a follow-up call and answer every question. I’ll just take the last one. Thank you for the important work you’re doing to improve prenatal care and potentially save lives—you do save lives. What is the single most important milestone investors should watch over the next 12 to 18 months to know that the U.S. commercial model is truly working?
Elazar Sonnenschein — Group CEO
We are in discussions with several institutions in the U.S., very important institutes, very known. I think that an announcement from the company regarding an agreement with two of them will demonstrate the workflow of the device in the U.S. market. This is the most important for us, and we are working hard that this will happen.
Miri Segal, Investor Relations
Thank you. Thank you, everyone, for joining us today. Again, if your questions weren’t answered, please email me at [email protected], and we’ll be happy to schedule follow-up calls and elaborate on any other questions that you may have. Thank you for joining us, and see you on our next call. Have a good day.
Elazar Sonnenschein — Group CEO
Thank you very much, Miri.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.
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