Benjamin Haynor

Benjamin Haynor requested more details on the Playbook digital surgical platform, specifically how it fits into hospital operations, the problems it solves, and its unique contributions. He also asked about notable and attractive subspecialties OrthoPediatrics is considering for expansion.

Answer

David Bailey (President and CEO) described Playbook as a first-of-its-kind digital health platform for children's hospitals, designed to streamline surgical procedures through custom workflows, capture data, and provide metrics to improve efficiency and quality in pediatric orthopedics. Regarding subspecialty expansion, he mentioned continued scaling in OPSB and leveraging their commercial presence for partnerships in areas like ENT (e.g., IOTA Motion) and cardiovascular, noting these verticals often have unmet needs and potentially more favorable economic dynamics, particularly for cash flow.

Benjamin Haynor from Lake Street Capital Markets asked for more details on the Playbook digital surgical platform and its role in hospitals, as well as the specific subspecialties the company is looking to expand into.

Answer

President and CEO David Bailey described Playbook as a first-of-its-kind digital health platform for children's hospitals, designed to streamline surgical procedures, capture data, and improve efficiency and patient care. Regarding expansion, he highlighted continued scaling in OPSB, leveraging the IOTA Motion partnership for ENT, and interest in the cardiovascular space, emphasizing less capital-intensive verticals with favorable economic dynamics.

Benjamin Haynor asked for more detail on the productive conversations with the FDA regarding the eLLi system's submission pathway. He also inquired about the first wave of products planned for launch in the EU following MDR approval and their potential market impact.

Answer

CEO David Bailey expressed optimism about the eLLi pathway, stating the likelihood of a large, multiyear PMA study is now very low, as the FDA recognizes the need for the device. Regarding EU MDR, he explained the first approvals will be for Trauma and Limb Deformity products and critical updates to existing systems. He noted that a major catalyst will be launching the 4.5/5.0 Fusion system, which is crucial for capturing Scoliosis market share in Europe.

Benjamin Haynor asked if the company could share the categories of the new Durable Medical Equipment (DME) products.

Answer

Carrie Lachance, Chief Executive Officer, mentioned accreditation for products like Foot Defender and HidraWear in the Ostomy category. However, she preferred not to disclose more details until the company could prove out the success and reimbursement of these new products.

Inquired about the impact of ALJ decisions on formalizing payer policies, the current status of payer decision-making processes, pipeline metrics like cost and attrition, how to replicate the success of the German operations in the U.S., and the growth expectations for non-ReWalk products within the guidance.

Answer

Management explained that a high win rate in ALJ cases is key to influencing policy, rather than the sheer number of cases. They noted that newer claims are being processed, indicating progress in formalizing procedures. It is too early for detailed pipeline attrition metrics. To replicate German success in the U.S., the company will focus on disciplined execution and new channel partners. The guidance assumes year-over-year growth for both the AlterG and MyoCycle product lines.

Benjamin Haynor of Lake Street Capital Markets sought clarity on the process with DME MACs for establishing uniform claim criteria, what specifically is accelerating the claims process, whether commercial insurers will adopt similar criteria, and the reason for the year-over-year increase in G&A expenses.

Answer

CEO Lawrence Jasinski explained the process with MACs has been an informal, collaborative effort to standardize submission requirements, particularly around documenting home use, which should create more predictable approvals. He noted commercial payers are less bound by CMS's 'brace' categorization and focus more on clinical outcomes, using single-case agreements. CFO Michael Lawless clarified that the G&A increase included a one-time bad debt expense of approximately $300,000, as the company reserved for very old claims that would not meet the newly clarified submission criteria.

Benjamin Haynor of Lake Street Capital Markets inquired about how much the new CorLife and MYOLYN partnerships contribute to the 2025 revenue guidance and asked for clarification on the causes of patient attrition for the ReWalk system.

Answer

CEO Larry Jasinski and CFO Mike Lawless explained that the impacts from the CorLife and MYOLYN partnerships are factored into guidance conservatively. They noted these deals open up significant new market segments. Regarding attrition, Jasinski clarified it was mainly due to seasonal deferrals and minor patient issues around the holidays, not lost cases, a factor they are learning to anticipate in Q4.

Inquired about the relationship between the proposed CMS physician fee schedule and the local coverage determination (LCD), the company's satisfaction with the new rates, the market impact of the LCD uncertainty, and progress towards the 1,000 capital sales milestone.

Answer

The company clarified that the LCD and the physician fee schedule are separate issues. They are very pleased with the proposed 300%+ increase in the SRT delivery code, which they've lobbied for for years. The LCD created a temporary "pause" in the market, but they are confident their lobbying efforts will be successful and that ultrasound will remain a key part of their offering. They expect unit sales to accelerate once there is clarity on the reimbursement situation.

Benjamin Haynor of Lake Street Capital Markets sought clarification on the drivers of the 65% growth in FDA treatments, the customer profile at smaller conferences, and the deployment strategy for multi-site agreements, including how unit placement decisions are made.

Answer

CFO Javier Rampolla attributed the 65% treatment growth primarily to organic increases from existing sites (60%) with a smaller portion from new go-lives (5%). President Michael Sardano described smaller conferences as ideal for reaching high-volume rural practices perfect for FDA agreements. Chairman and CEO Joseph Sardano explained that large groups typically start by installing units in their 10-20 biggest practices, and that Sensus's patient data aligns very well with the customers' own analysis of high-volume locations, building confidence in the partnership.

Benjamin Haynor of Alliance Global Partners inquired about the clinical feedback on the CAPTAIN trial data following its release at the AUA conference, the company's plans for presenting this data to commercial insurers, and the level of commercial interest observed at the Profound booth during the event.

Answer

CEO Arun Menawat described the feedback on the CAPTAIN data as "very positive," noting it was more impactful for driving adoption, particularly at teaching hospitals, than initially anticipated. He confirmed that conversations with commercial insurers have begun. Chief Commercial Officer Thomas Tamberrino added that booth activity at AUA was "fantastic," with significant interest in the TULSA AI volume reduction module and compelling economic models leading to numerous follow-up meetings.

Benjamin Haynor of Alliance Global Partners inquired about the clinical feedback on the CAPTAIN trial data since its release, the company's plans for presenting the data to commercial insurers, and the level of commercial activity at the AUA conference booth.

Answer

CEO Arun Menawat described the feedback on the CAPTAIN data as overwhelmingly positive, particularly from teaching hospitals, which he believes will drive mainstream adoption. He confirmed that conversations with private insurers have begun. Chief Commercial Officer Thomas Tamberrino added that booth activity at AUA was 'fantastic,' leading to a growing sales pipeline and compelling discussions around the TULSA-PLUS program's economic model.

Benjamin Haynor of Lake Street Capital Markets asked about the reaction of MRI manufacturers to the new reimbursement proposal, how physicians might segment Medicare versus commercial patients across different sites of care, and the specific time savings and adoption rates for the new TULSA AI modules, Contouring Assistant and Thermal Boost.

Answer

CEO Arun Menawat stated that MRI companies view the reimbursement as a key factor that helps justify an MR-centric prostate care strategy, making it easier to sell their systems into ASCs and OBLs. He suggested physicians will likely create customized economic models, potentially directing higher-paying commercial patients to their own facilities. Menawat and COO Mathieu Burtnyk added that the Thermal Boost module is used in about 50% of cases, and the Contouring Assistant AI is expected to enable physicians to perform more procedures per day, with specific data to be published later.

Asked about the marketing efforts for the Owlet360 subscription, the long-term potential for retaining users on the platform as children age, and the potential competitive advantage from tariffs impacting rivals.

Answer

Marketing for Owlet360 utilizes in-app messaging, email, and SMS, with plans to continue driving awareness through social media. The company sees a long-term opportunity by expanding camera-related subscription features for older children. Management confirmed they see a competitive advantage from tariffs, as many competitors manufacture in China, viewing it as an opportunity to gain market share.

Benjamin Haynor of Lake Street Capital Markets asked about the long-term retention outlook for the Owlet360 subscription service and sought details on its official launch and early marketing progress. He also inquired if European adoption dynamics could mirror the U.S. pattern of reaching a critical mass and asked for an update on relationships with NICUs and hospitals.

Answer

President and CRO Jonathan Harris expressed confidence in Owlet360's retention, noting that future features like telehealth will enhance value. He confirmed the late-January public launch followed a beta period and that early feedback is extremely positive. Regarding Europe, Harris highlighted Germany as a strong market where CE clearance spurred a surge in adoption. He also confirmed that through DME partnerships, Owlet is seeing an increase in physicians and neonatologists recommending its products.

Benjamin Haynor inquired about the 2025 patient distribution mix for Indego Personal across its new channels, progress with PRIA Healthcare on claims, the capital budget outlook for institutional customers, and the sustainability of current gross margin levels.

Answer

CEO Scott Davis explained that while the enterprise business will still constitute 75-80% of 2025 revenue, the personal segment is expected to grow quarterly. He noted significant learnings from past claims submissions with PRIA, boosting confidence in the current pipeline. Davis acknowledged Q1 softness in institutional capital budgets due to macro uncertainty but affirmed that the company's recent gross margin performance above 50% is a sustainable baseline, supported by strong operational cost controls.

Benjamin Haynor of Lake Street Capital Markets asked about the qualification rate for personal device leads, the strategy for engaging private payers, demographic commonalities among qualified patients, and details on the new distribution partnership with National Seating & Mobility (NSM).

Answer

Executive Scott Davis explained that the lead qualification process currently prioritizes individuals with spinal cord injuries who have pure Medicare coverage. He stated that engaging private payers is a future step, pending consistent success with Medicare. Davis noted that the 25 qualified patients 'run the gamut' demographically, with motivation being a key factor. He described the exclusive NSM partnership as a crucial entry into the complex rehabilitation technology (CRT) industry, leveraging NSM's expertise with complex, high-ticket mobility devices.

Benjamin Haynor of Lake Street Capital Markets asked if purchasing delays from IDNs were related to the new CMS reimbursement, questioned the outlook for European sales in Q4, sought a timeline for label expansion into new neurological conditions, and requested clarification on the 20% revenue contribution from personal products.

Answer

Scott Davis (executive) clarified that IDN delays were due to the 'lumpy' nature of enterprise sales and macroeconomic uncertainty, not distraction from personal units. He confirmed strong demand and a backlog of over a dozen devices in Europe entering Q4. Regarding label expansion, Davis mentioned leveraging relationships with research hospitals for studies but stated the timeline is undefined. He confirmed the 20% personal product revenue figure was for total top-line revenue for the quarter.

Benjamin Haynor requested more details on Octiv partnerships beyond the most prominent ones, updates on future technology like new chips and form factors, and the typical decision-making timeline for medical schools adopting POCUS.

Answer

CEO Joseph DeVivo shared an anecdote about the Forest Neurotech partnership detecting brain activity in a comatose patient, highlighting Octiv's foundational potential. He confirmed the next-gen P5 chip is on track for production by late 2025. He also explained that medical schools typically finalize budgets for the upcoming academic year in the second calendar quarter, ahead of their June 30 fiscal year-end.

Benjamin Haynor of Lake Street Capital Markets asked for more specific metrics on the HomeCare pilot, such as the number of participants and duration. He also questioned if the recent capital raise would accelerate hardware developments like the iQ station and sought clarification on what new revenue streams are excluded from the 2025 guidance.

Answer

Chairman and CEO Joseph DeVivo shared that the pilot has trained 18 nurses and is designed for 200 patients, but it is too early for definitive readmission data. He clarified the capital raise ensures continued funding for key programs like the P5 chip, iQ station, and wearables, preventing cuts rather than funding new initiatives. CFO and COO Heather Getz specified that the 2025 guidance includes revenue from existing Octiv contracts signed in 2024 but excludes any new Octiv deals, HomeCare revenue, or Butterfly Garden revenue.

Benjamin Haynor asked for specifics on the Butterfly Home Care pilot, including the business model and target population, and inquired about the economic structure of the newly announced subsidiary, OCTIV.

Answer

Joseph DeVivo, Chairman and CEO, explained the Home Care pilot is a service where Butterfly enables partners to reduce hospital readmissions through frequent, AI-powered bedside imaging, operating on a PMPM basis. He clarified that the new subsidiary, OCTIV, will monetize Butterfly's chip technology by licensing it to non-competitive industries. The economic model involves licensing fees, development fees, and a transfer price for the physical chips, creating long-term, recurring revenue streams from each new partner.

Benjamin Haynor of Lake Street Capital Markets asked about the utilization patterns of surgeons adopting the new osteotomy offerings, how the '4 classes of bunions' messaging might alter direct-to-patient marketing, and for an update on the SpeedPlate attach rate.

Answer

CEO John Treace and CFO Mark Hair explained that they are initially targeting surgeons who are high utilizers of MIS osteotomies and have lower Lapiplasty adoption. John Treace acknowledged that the new product breadth creates opportunities to evolve the direct-to-patient marketing message. He also confirmed that the SpeedPlate fixation system's attach rate is now 'north of 50%' of the overall fixation mix.

Ben Haynor from Lake Street Capital Markets asked about the demand for O&P clinician training, the process for a clinic to become a 'Center of Excellence,' and whether the Q4 guidance includes contributions from the O&P channel.

Answer

CEO Paul Gudonis explained that the Myomo Academy online platform helps scale training to meet growing demand. He detailed the 'Center of Excellence' certification as a 3-day, hands-on program covering the entire patient care process. CFO David Henry clarified that the Q4 guidance assumes a minimal contribution from the O&P channel, consistent with its 3% of revenue in Q3, viewing it as a more significant 2025 growth driver.

Ben Haynor from Lake Street Capital Markets asked for specifics on the O&P channel, including the number of clinicians who have started training and the nature of the relationship with Hanger. He also questioned what is required to scale manufacturing to 150-200 units per month and if there are any key bottlenecks.

Answer

CEO Paul Gudonis stated that O&P training has just begun with several clinics, including Hanger, but did not provide a specific number of trainees yet. Regarding Hanger, he confirmed a keen interest from their leadership but did not disclose further details. Gudonis explained that scaling manufacturing involves a balanced approach across the entire revenue cycle—from intake and reimbursement staff to field clinicians and production—to avoid bottlenecks, noting they are getting operating leverage as product revenue growth outpaces operating expense growth.

Benjamin Haynor from Alliance Global Partners asked for details on the source of the $9 million in new pharma services agreements, the steps needed to reinstate borrowing capacity under the SVB loan agreement, and whether delayed billing would impact collectibility. He also sought clarification on gross margin expectations after the facility consolidation.

Answer

Executive Jack Stover confirmed that new pharma agreements come from both new and existing clients, with average contract sizes and durations increasing. Regarding the SVB loan, Stover and CFO Fred Knechtel explained they are working to resolve a covenant compliance issue related to their quick ratio, which arose from the 10-Q filing delay, but reinstatement is not guaranteed. Stover assured that delayed billing poses no collectibility risk due to a 12-month billing window. Knechtel affirmed that gross margins are expected to improve post-consolidation as costs decrease and volume increases.

Benjamin Haynor from Alliance Global Partners asked how the company's messaging about eliminating unnecessary surgeries is resonating with clients during the pandemic, about the ability to close new pharma services contracts remotely, and about the strategic rationale for developing COVID-19 serology testing.

Answer

Executive Jack Stover explained that the value proposition of reducing unnecessary surgeries is resonating well as hospitals seek to optimize capacity. He noted that the pharma services business development team is exceptionally busy, as key contacts at large pharma companies are more available for virtual meetings. Regarding COVID-19 testing, Stover positioned it as a moral obligation and a service for existing pharma partners rather than a major new commercial venture, though it aligns with their hematology expertise.