Latest / WTR Small-Cap Spotlight / Pulsenmore (PLSM): Safe and Sound: Pulsenmore Brings Prenatal Ultrasound Home

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Pulsenmore (PLSM): Safe and Sound: Pulsenmore Brings Prenatal Ultrasound Home · WTR Small-Cap Spotlight

• 0:00
  SPEAKER_00: Welcome to the WTR Small Cap Spotlight Podcast.
• 0:04
  SPEAKER_00: I'm your host, Tim Gerderman, Vice Chair and Co-Founder and Chief Marketing Officer of Water Tower Research.
• 0:10
  SPEAKER_00: Today we're joined by Dr.
• 0:12
  SPEAKER_00: Elizabeth Sonenshine, founder and CEO of Pauls and Moore, NASDAQ, and Tel Aviv's stock exchange ticker symbol, PLSM.
• 0:21
  SPEAKER_00: Pauls and Moore is a medical device company that has developed the first FDA de novo authorized prescription home use prenatal ultrasound system.
• 0:30
  SPEAKER_00: Expectant mothers use a small handheld device paired with their smartphone to capture limited fetal ultrasound images at home, guided step by step by a mobile app or by a clinician over telehealth, and those images are securely transmitted for remote physician review and interpretation as part of a physician-led prenatal monitoring.
• 0:52
  SPEAKER_00: To date, more than 250,000 home scans have been performed on the platform globally.
• 0:58
  SPEAKER_00: Building on its prenatal care platform, Paulson Moore is pursuing a broader women's health strategy, and the company's development pipeline includes fertility and IVF monitoring applications, which are commercially available in some markets already.
• 1:11
  SPEAKER_00: Also joining is my WTR equity research colleague James Kisner.
• 1:15
  SPEAKER_00: Good morning, gentlemen, and thank you for joining the show.
• 1:19
  SPEAKER_00: Good morning.
• 1:20
  SPEAKER_00: Good to see you.
• 1:20
  SPEAKER_00: Good morning.
• 1:22
  SPEAKER_00: Elizabeth, you founded Paulsumore in 2014 after a long career building medical device and technology companies.
• 1:28
  SPEAKER_00: What was the original problem that you saw in prenatal care that convinced you to spend the next decade building a home use ultrasound platform?
• 1:36
  SPEAKER_00: And for listeners new to the story, how would you describe what Pauls More does in just plain simple English language?
• 1:44
  SPEAKER_01: After many years building medical technology companies, I became fascinated by a simple question.
• 1:52
  SPEAKER_01: Why is ultrasound, one of the most powerful tools in medicine, still largely available only inside clinics and hospitals?
• 2:00
  SPEAKER_01: In pregnancy, the gap is especially clear.
• 2:05
  SPEAKER_01: Expectant mothers spend months between scheduled visits, often wanting reassurance or additional monitoring, while healthcare systems are facing growing demand and limited resources.
• 2:19
  SPEAKER_01: It seems clear that ultrasound needs to become more accessible.
• 2:23
  SPEAKER_01: That was the starting point for Pulsar More.
• 2:27
  SPEAKER_01: Our vision was to bring ultrasound into home while keeping physicians and healthcare providers at the center of the care process.
• 2:38
  SPEAKER_01: We developed a solution that combines a handheld ultrasound device, a smartphone, and a remote clinical workflow.
• 2:46
  SPEAKER_01: This allows scans to be performed at home and reviewed by healthcare professionals.
• 2:53
  SPEAKER_01: In simple terms, Parson More enables healthcare providers to extend ultrasound-based care beyond the walls of the clinic.
• 3:01
  SPEAKER_01: We are helping make monitoring more convenient for patients and more scalable for healthcare systems.
• 3:08
  SPEAKER_01: We began in prenatal care because the need is significant and well defined.
• 3:14
  SPEAKER_01: But from the beginning, we view this as a platform technology.
• 3:18
  SPEAKER_01: Like you said, today we are advancing additional women's health applications, including fertility and IVF monitoring, with the goal of making ultrasound more accessible wherever it can improve care.
• 3:32
  SPEAKER_01: Always, always subject to appropriate clinical and regulatory pathway.
• 3:38
  SPEAKER_00: That's a great overview.
• 3:40
  SPEAKER_00: I appreciate it.
• 3:40
  SPEAKER_00: And as I mentioned before, the uh podcast recording started as a father of two adult children.
• 3:45
  SPEAKER_00: I remember all the hassles involved with that.
• 3:47
  SPEAKER_00: So I think this is a remarkably clever idea, and I uh congratulate you on that idea, James.
• 3:53
  SPEAKER_02: Sure.
• 3:54
  SPEAKER_02: So uh thanks again for joining us, Elizar.
• 3:56
  SPEAKER_02: So um in October 2025, uh Paulson Moore received FDA De novo marketing authorization for a prescription home use prenatal ultrasound.
• 4:06
  SPEAKER_02: So that was a I think a category-defining moment.
• 4:08
  SPEAKER_02: Can can you walk us through why that authorization matters competitively and how that changed the conversation you're having with U.S.
• 4:16
  SPEAKER_02: providers and health plans?
• 4:18
  SPEAKER_01: The FDA DeNovo authorization was a defining milestone for Palsan Moore because it established a new regulatory category for prescription home use prenatal ultrasound in the United States.
• 4:32
  SPEAKER_01: DeNovo is a complex pathway that relatively few medical device companies successfully navigate, particularly for products that create an entirely new category rather than fit within an existing one.
• 4:47
  SPEAKER_01: That distinction reflects years of clinical development, regulatory work, and evidence generation.
• 4:55
  SPEAKER_01: From a competitive standpoint, this creates a meaningful differentiation and a real market access milestone.
• 5:04
  SPEAKER_01: It has changed the conversation we are having in the US from future potential to discussion on implementation, adoption, workflow, and integration into routine care pathway.
• 5:19
  SPEAKER_02: Wow, that sounds truly groundbreaking.
• 5:21
  SPEAKER_02: Um let's spend a minute on the technology itself, you know, because what you've built is non-obvious.
• 5:26
  SPEAKER_02: An ultrasound that a patient can use at home to capture images a clinician can actually rely on.
• 5:32
  SPEAKER_02: You know, what were the hardest parts of making that work?
• 5:35
  SPEAKER_02: And what does the clinical evidence show, both from your studies and from the more than 250,000 real-world home scans that have been performed to date?
• 5:46
  SPEAKER_01: You are absolutely right.
• 5:48
  SPEAKER_01: The challenge wasn't building a smaller ultrasound device.
• 5:52
  SPEAKER_01: The real challenge was enabling someone with no ultrasound training to perform a scan at home and generate information that the clinician can confidently use.
• 6:04
  SPEAKER_01: That requires us to solve several problems simultaneously.
• 6:08
  SPEAKER_01: We had to simplify the scanning process, provide intuitive guidance through an app, ensure reliable image acquisition, and create a workflow that keeps the physician involved in the interpretation and clinical decision making.
• 6:26
  SPEAKER_01: The goal was never to turn patient into a sonographer.
• 6:30
  SPEAKER_01: The goal was to extend physician-led care beyond the clinic.
• 6:35
  SPEAKER_01: That's why we've spent years generating both clinical and real-world evidence.
• 6:40
  SPEAKER_01: Our FDA clinical validation included a multi-center study conducted at the leading academic and clinical institutions, comparing home use scans with standard clinical assessment.
• 6:55
  SPEAKER_01: The results demonstrated that the women can successfully perform guided scans at home and provide clinically useful information for remote physician review, which ultimately supported the FDA de novo authorization.
• 7:12
  SPEAKER_01: To date, more than 250,000 home scans have been performed through our platform across multiple countries, hospitals, and healthcare systems under different care models.
• 7:25
  SPEAKER_01: In some countries, Pulsan will support national scale remote monitoring programs.
• 7:31
  SPEAKER_01: In others, it is integrated into hospital-at-home initiatives or hybrid high-risk pregnancy program where some person visit can be replaced with virtual encounter support by homework person.
• 7:46
  SPEAKER_01: That real-world experience is incredibly valuable because it shows that the technology is adaptable to different healthcare systems, and published evidences have shown benefits such as reduced maternal anxiety, fewer unnecessary emergency department visits, greater patient engagement, and high satisfaction among both patients and providers.
• 8:15
  SPEAKER_01: We don't just have a technology that works.
• 8:18
  SPEAKER_01: We have evidence from both clinical studies and large-scale real-world implementation demonstrating that home ultrasound can become part of the routine care delivery, which is ultimately what drives long-term adoption and value creation.
• 8:45
  SPEAKER_02: Let's talk a little bit about manufacturing here.
• 8:57
  SPEAKER_02: So, why did you build that capability in-house and what does it do for your costs and your supply reliability as you start scaling in the United States?
• 9:07
  SPEAKER_01: From the beginning, we understood that if home ultrasound was going to become a scalable healthcare solution, we couldn't think only about the clinical aspect.
• 9:16
  SPEAKER_01: We also had to think about how to manufacture it at scale.
• 9:21
  SPEAKER_01: The ultrasound transducer is the heart of the device.
• 9:25
  SPEAKER_01: It's one of the most complex and critical components from both a performance and cost perspective.
• 9:32
  SPEAKER_01: Early on, we made the strategic decision to develop proprietary automated production capabilities rather than rely entirely on traditional manual manufacturing approaches.
• 9:46
  SPEAKER_01: That decision required significant investment, but we believe it has become an important competitive advantage.
• 9:55
  SPEAKER_01: First, automation helps us improve consistency and quality.
• 10:00
  SPEAKER_01: It gives us greater control over production capacity and supply as demand grows.
• 10:07
  SPEAKER_01: And of course, it helps us create a path toward lower unit cost as volume increases.
• 10:13
  SPEAKER_01: For a company bringing an entirely new category to the market, scalability matters.
• 10:20
  SPEAKER_01: It is not enough to have a clinical validated product.
• 10:24
  SPEAKER_01: You need to be able to manufacture it reliably and economically as adoption grows.
• 10:31
  SPEAKER_01: We view our manufacturing capabilities as an important part of the overall platform we've built.
• 10:40
  SPEAKER_01: Over the past decade, we develop expertise not only in ultrasound technology, clinical workflow software and regulatory execution, but also in production processes required to support large-scale deployment.
• 10:58
  SPEAKER_01: Together, those capabilities create meaningful barriers to entry and position us well as we expand in the US market.
• 11:16
  SPEAKER_02: So you first announced some partners, the Center for Fetal Medicine in Los Angeles and TLC Perinatal in Maryland are specialists in maternal fetal medicine practices rather than the big national hospital systems or telehealth platforms.
• 11:31
  SPEAKER_02: Can you walk us through the commercial strategy, the different channels you're targeting, and what the model looks like in practice for those first partners?
• 11:40
  SPEAKER_01: What's exciting is that we see multiple pathways to scale in the US.
• 11:46
  SPEAKER_01: One channel is specialist maternal fetal medicine and OBGYN practices that want to extend care beyond the clinic.
• 11:55
  SPEAKER_01: Another is health system investing in remote monitoring and hospital at home programs.
• 12:01
  SPEAKER_01: We also see opportunities with innovative care models that combines virtual and in-person care, particularly for high-risk pregnancy, where follow-up visits can be supported remotely.
• 12:17
  SPEAKER_01: We are also expanding through telehealth.
• 12:20
  SPEAKER_01: Recently we announced a collaboration agreement with UMAHealth, one of the largest virtual prenatal care providers in the US with access to patients across all 50 states.
• 12:32
  SPEAKER_01: This partnership demonstrates how our platform can integrate into scalable virtual maternity care models and complements our work with specialist practice.
• 12:46
  SPEAKER_01: So we are currently in a limited market release, partnering with innovative early adopters who are helping us validate both the clinical workflow and the commercial model before broader commercialization, and we learn more from this real-world implementation than we could in years of conference room and planning.
• 13:11
  SPEAKER_01: Our strategy at this stage is intentionally focused.
• 13:16
  SPEAKER_01: We want to establish successful encore customers across several key channels, including specialist practices, telehealth providers, and health system.
• 13:27
  SPEAKER_01: As we build clinical evidence, operational experience, and customer success stories, we will use those reference sites to scale our commercial efforts across the US.
• 13:40
  SPEAKER_02: So I think as a lot of listeners may know, um, you know, one of the challenges in this market is the US health plans.
• 13:49
  SPEAKER_02: You know, getting paid by U.S.
• 13:50
  SPEAKER_02: health plans is often the make or break variable in digital health.
• 13:53
  SPEAKER_02: Can can you walk us through how you're thinking about the reimbursement path and including the billing pathways available at launch and the work to secure broader coverage, plus how employers and value-based arrangements fit in.
• 14:08
  SPEAKER_01: Our ultrasound solution is billable using the limited ultrasound scan under the guidance of the physician.
• 14:16
  SPEAKER_01: At the same time, we are working to build the clinical, health economic, and real-world evidence needed to support broader coverage discussion with payers.
• 14:26
  SPEAKER_01: Ultimately, reimbursement decisions are driven by demonstrated clinical value and healthcare resource utilization.
• 14:35
  SPEAKER_01: That's one reason why our growing body of real-world evidence is so important.
• 14:42
  SPEAKER_01: In the US, 35% of the counties are considered maternity care desert where millions of women live in areas with limited access to care.
• 14:54
  SPEAKER_01: And health systems are increasingly looking for ways to extend care beyond traditional clinical settings.
• 15:03
  SPEAKER_01: That's one reason we are seeing interest not only from providers but also from payers, employers, and organizations operating under value-based care models.
• 15:16
  SPEAKER_02: All right, that's that's that's very helpful to know.
• 15:18
  SPEAKER_02: So um Israel has been your proving ground.
• 15:22
  SPEAKER_02: You replaced thousands and thousands of devices with patients and accumulated years of real-world data.
• 15:27
  SPEAKER_02: So, what has Israel taught you that you're carrying in the US launch?
• 15:31
  SPEAKER_02: And how do you think about Israel's both a revenue-based and a real-world evidence engine?
• 15:39
  SPEAKER_01: Israel has been incredibly important for us because it allowed us to move beyond proving that technology works and focus on proving that it can become part of the routine clinical care.
• 15:53
  SPEAKER_01: Over the years, we've deployed tens of thousands of devices and accumulated real-world experience.
• 16:01
  SPEAKER_01: One of the key reasons we've been able to generate that experience is our collaboration with CLIT, Israel's largest healthcare organization, which is responsible for approximately half of all births in the country.
• 16:18
  SPEAKER_01: Working with an organization of that scale gave us the opportunity to evaluate not only the technology itself, but also how home ultrasound can be integrated into real-world health health delivery.
• 16:34
  SPEAKER_01: The evidence consistently shows high patient engagement and satisfaction, reduce anxiety, and fewer unnecessary visits related to pregnancy concern.
• 16:47
  SPEAKER_01: Those insights helped shape both our product development and our commercialization strategy.
• 16:55
  SPEAKER_01: From business perspective, Israel remains an important revenue generation market, but it's also an invaluable innovation engine.
• 17:06
  SPEAKER_01: By the time we enter the US, we weren't introduced a concept that had only been tested in clinical studies.
• 17:15
  SPEAKER_01: We were bringing a platform that has already been used extensively in routine care at scale with one of the world leading healthcare systems.
• 17:26
  SPEAKER_02: Yeah, that sounds like a very compelling in-market experience that you can reapply in the US.
• 17:32
  SPEAKER_02: Let's talk about that platform some more.
• 17:34
  SPEAKER_02: So, you know, it's a common architecture, spanning the device, mobile app, and clinician dashboard, and has the ability to support a range of clinical use cases, I understand.
• 17:46
  SPEAKER_02: So you already have a second product focused on IVF and fertility monitoring, which is approved and contracted in Israel, and a third early stage program focused on lung fluid monitoring for patients with conditions like congestive heart failure.
• 18:00
  SPEAKER_02: So, how do you think about expanding the platform over time and which of those additional indications is commercially closest?
• 18:09
  SPEAKER_01: From the beginning, our vision was never to build a single product company.
• 18:14
  SPEAKER_01: We viewed home ultrasound as a platform opportunity.
• 18:18
  SPEAKER_01: The core capability we've developed, including the ultrasound hardware, software, connectivity, clinical workflow, and remote core infrastructure, can potentially support multiple clinical applications.
• 18:33
  SPEAKER_01: Pregnancy was our first focus because it represents a significant unment need and a large market opportunity.
• 18:42
  SPEAKER_01: But underlying platform extends beyond pretend I care.
• 18:47
  SPEAKER_01: A good example is our fertility and IVF monitoring solution, which is already approved and commercially deployed in Israel.
• 18:56
  SPEAKER_01: Fertility treatment often requires frequent ultrasound monitoring, making it particularly well suited for home-based model.
• 19:06
  SPEAKER_01: So fertility, currently the most advanced expansion opportunity with our pipeline.
• 19:13
  SPEAKER_01: Our approach is discipline.
• 19:15
  SPEAKER_01: We don't look at the new indications simply because they're technically feasible.
• 19:23
  SPEAKER_01: We focus on areas where there is a clear clinical need, frequent monitoring requirements, and a meaningful opportunity to improve care delivery through remote monitoring.
• 19:36
  SPEAKER_02: So um I'm gonna turn to financial uh results just for a second here.
• 19:41
  SPEAKER_02: Um 2025 showed a big step step up with full-year revenue of about 12.5 million, and the net loss cut roughly in half to about 5 million.
• 19:51
  SPEAKER_02: A large part of that reflected the one-time GE settlement.
• 19:54
  SPEAKER_02: But as you ramp in 2026, how are you thinking about building durable operating leverage in the underlying business and balancing US commercialization investment against preserving your runway?
• 20:07
  SPEAKER_01: The resolution of the GE partnership was strategically important beyond the financial impact.
• 20:14
  SPEAKER_01: It restored full commercial freedom, mainly in the US, and removed a significant source of uncertainty in the market.
• 20:22
  SPEAKER_01: We ended 2025 with 21.7 million in liquid assets, providing approximately 18 to 24 months of runway at the current operating pace.
• 20:34
  SPEAKER_01: 2026 is focused on building the US Commercial Foundation, and capital is being allocated to our sales and revenue generating activities.
• 20:45
  SPEAKER_01: We expect early accounts to mature and new partnerships to materialize.
• 20:51
  SPEAKER_01: So 2027 is expected to be a meaningfully stronger year for revenue growth.
• 20:59
  SPEAKER_02: Okay, that that's a good segue to just kind of wrap up here.
• 21:02
  SPEAKER_02: Um, you know, Paulsonore is at the start of what is realistically a multi-year US commercialization story on top of a platform with multiple clinical pipelines.
• 21:13
  SPEAKER_02: As you look over the next 12 to 18 months, what are the priorities that you and the team are most focused on, and what should investors be watching as the signals that you're executing well?
• 21:24
  SPEAKER_01: The next months are really about execution.
• 21:26
  SPEAKER_01: We are focused on expanding adoption of our prenatal solution in the US, expanding our claims by generating additional clinical evidences, advancing new applications for our prenatal platform, and grow our fertility solution, which we believe represents a significant opportunity with women health.
• 21:49
  SPEAKER_01: For decades, ultrasound has been one of medicine's most valuable diagnostic tools.
• 21:56
  SPEAKER_01: Yet, access to it has been limited to hospital and clinic.
• 22:00
  SPEAKER_01: We believe that's beginning to change.
• 22:04
  SPEAKER_01: We've spent years building the technology, clinical evidence, regulatory foundation, manufacturing capabilities, and real-world experience needed to help drive that transformation.
• 22:17
  SPEAKER_01: As we continue to achieve our objective, Parson Wall will be the company that helps redefine how ultrasound is delivered, making it more accessible, more connected, and available wherever it can improve care.
• 22:33
  SPEAKER_01: That's the vision we are building toward, and that's what motivates our team every day.
• 22:41
  SPEAKER_02: Well, Elizar, that's a really exciting story, and uh, and this sounds like a very innovative company.
• 22:46
  SPEAKER_02: So we'll be watching closely and following it going forward.
• 22:49
  SPEAKER_02: I'd like to hand the the uh the mic back to Tim to uh make some closing comments.
• 22:54
  SPEAKER_00: Thanks, James.
• 22:55
  SPEAKER_00: And Elizar, thanks so much today for uh joining us and talking about Paulson Moore and your business model.
• 23:00
  SPEAKER_00: Every now and then I hear a story where I I literally want to kind of hit myself in the head and say, why didn't I think of that?
• 23:06
  SPEAKER_00: Because this one is just there's such an obvious need for it.
• 23:08
  SPEAKER_00: I think it's really cool, and best wishes you start to scale in the United States.
• 23:13
  SPEAKER_01: Thank you so much.
• 23:15
  SPEAKER_00: Thank you for listening, and don't forget to subscribe as well as visiting www.watertowerresearch.com to stay up to speed on the company's small cap written research reports, podcasts, fireside chats, industry specific symposiums, and conference schedules.
• 23:31
  SPEAKER_00: We will see you next time for another edition of the WTR Small Cap Spotlight Podcast.
• 23:36
  SPEAKER_00: Finally, a special thanks to the producer and editor of the podcast, Krista Fitzpatrick.