Jeremy Pearlman

Jeremy Pearlman asked about clinical feedback received from neurologists and surgical teams regarding the installed OneRF brain ablation products. He also inquired if NeuroOne had information on specific U.S. regions showing the most adoption for Zimmer Biomet's distribution and how that success might be replicated. Additionally, he sought clarification on the sales and marketing expense responsibilities for 2026 and the breakdown of Q1 fiscal 2026 revenue, specifically if it was primarily restocking or included additional purchases beyond initial expectations.

Answer

CEO Dave Rosa reported positive clinical feedback, noting the system's success in reducing or eliminating seizures, its ease of use, and the ability to perform ablations at the patient's bedside. He mentioned the establishment of a registry to capture long-term outcomes. Mr. Rosa stated that NeuroOne does not have information on specific U.S. regions for Zimmer Biomet's adoption. He clarified that per their agreement, Zimmer Biomet is responsible for all marketing and sales costs, with NeuroOne providing training and field support. CFO Ron McClurg confirmed that most of the Q1 fiscal 2026 revenue was attributed to restocking and replenishing inventory, distinguishing it from the initial stocking order placed by Zimmer Biomet in Q1 fiscal 2025.

Jeremy Pearlman asked for a detailed timeline regarding the Aethlon Medical oncology trial, specifically the completion of Cohort 2 patient treatments, the Data Safety Monitoring Board (DSMB) meeting, and the expected timeframe for their decision on advancing to Cohort 3. He also inquired about the efficiency of enrolling patients for Cohort 3, given the reported pool of interested participants. Additionally, Pearlman questioned the rationale behind the five-day gap between Hemopurifier treatments in Cohort 2 and whether extending this gap might be more beneficial. Finally, he sought clarification on potential regulatory hurdles, including FDA approval and safety testing, for integrating the Hemopurifier with the SLAMB system.

Answer

Dr. Steven LaRosa, Chief Medical Officer, clarified that the third Cohort 2 patient would be treated by the end of February, with the DSMB meeting in late March, and a decision expected on the same or next business day. He expressed optimism about Cohort 3 enrollment, noting that a queue of pre-screened potential participants, identified through TrialFax and Dedicated, is ready for consent once the DSMB approves advancement. Regarding treatment frequency, Dr. LaRosa explained that the Monday/Friday schedule for Cohort 2 (two treatments in a week) and the planned Monday/Wednesday/Friday for Cohort 3 (three treatments) were informed by rapid EV turnover and literature from plasma exchange trials suggesting 2-3 treatments per week are needed to keep EV numbers down. He also stated that the SLAMB system is not yet FDA approved, and Aethlon would likely need to conduct safety tests and a certain number of treatments with the integrated system once the SLAMB system receives its own approval.

Jeremy Pearlman from Maxim Group asked about the Aethlon Medical oncology trial timeline, specifically the expected Data Safety Monitoring Board (DSMB) response time for advancing to Cohort 3. He also questioned the speed of Cohort 3 enrollment given the existing pool of potential participants, the rationale behind the Monday/Friday treatment interval in Cohort 2, and the regulatory hurdles for integrating the Hemopurifier with the SLAMB system.

Answer

Steven LaRosa, CMO of Aethlon Medical, stated that the DSMB is expected to provide a decision on Cohort 3 advancement within hours or the next business day after their late March meeting. He expressed optimism about rapid Cohort 3 enrollment due to a pre-screened participant queue. Dr. LaRosa explained the Monday/Friday treatment interval was informed by Mayo Clinic data suggesting 2-3 treatments per week are needed to reduce EVs, and that the current design allows for kinetic analysis. He clarified that the SLAMB system is not yet FDA approved, and Aethlon would need to conduct safety tests for integration.

Jeremy Pearlman of Maxim Group asked for the rationale behind conducting a separate trial in India with the same endpoint as the Australian study, and requested more visibility on the enrollment and data timeline for the Australian trial.

Answer

Executive Steven Larosa explained that separate trials for India and Australia are necessary to avoid confounding data due to genetic and comorbidity differences in the populations. Regarding the timeline, he stated that initial safety data for the first cohort is expected in January, with the first set of EV and T-cell data anticipated in the summer of the following year. CEO James Frakes added that the company plans to report data after each cohort completes, rather than waiting for the full study to conclude.

Jeremy Pearlman of Maxim Group asked about the drivers behind stable gross margins despite lower revenue, the current level of customer concentration risk, and whether a competitor's recent product recall has created a business advantage for Rockwell.

Answer

CFO Jesse Neri attributed stable gross margins to organizational rightsizing and investments in manufacturing efficiency. CEO Dr. Mark Strobeck added that the departed customer's business had lower margins, mitigating the impact of the revenue loss. Neri confirmed customer concentration risk has significantly decreased, with the former top customer now at ~10% of revenue, down from ~45%. Dr. Strobeck also confirmed that Rockwell is actively supplementing supply for customers affected by a competitor's product recall, reinforcing Rockwell's position as a reliable supplier.

Jeremy Pearlman from Maxim Group asked for an update on international and West Coast expansion efforts, the strategy for replacing lost revenue by targeting smaller providers, and whether the current 2025 guidance accounts for potential new customer wins.

Answer

President and CEO Dr. Mark Strobeck detailed that international expansion is focused on Latin America and that the company is evaluating the best method for West Coast entry, potentially a new facility. He affirmed that the opportunity to replace lost revenue is significant by targeting customers in their existing footprint, internationally, and on the West Coast. Dr. Strobeck clarified that the current 2025 guidance is based on the existing customer base, meaning any new contracts would provide potential upside.

The analyst inquired about the progress of international and West Coast market expansion, the potential to replace lost revenue from the largest customer, and whether the current guidance includes potential new customers.

Answer

The company is expanding internationally, primarily in Latin America, and is considering establishing a facility on the West Coast after reaching a critical mass of customers there. Management believes there is a large enough opportunity to replace a significant portion of the lost revenue through expansion in their existing footprint, Latin America, and the West. The reaffirmed revenue guidance is based on the current customer base, so any new customers signed would represent potential upside.

Jeremy Pearlman asked for an update on the timeline and process for securing temporary G codes, requested performance metrics for clinics using the Elevate360 consulting service, and inquired about the strategy for the TheraClear device given its flat installed base.

Answer

CEO Dolev Rafaeli explained that the company has petitioned CMS for temporary G codes to accelerate expanded reimbursement, with a final rule expected in November 2025. Regarding Elevate360, he provided a detailed case study of a successful clinic and committed to sharing broader metrics in the future. He also confirmed that while the primary focus remains on the high-upside XTRAC device, the TheraClear installed base is still growing and expected to approach 200 units by year-end.

Inquired about the process and timeline for obtaining temporary G codes, requested performance metrics for the Elevate360 program, and asked about the strategy for the TheraClear device given its flat installed base growth.

Answer

The company has submitted a comprehensive application to CMS for temporary G codes and increased reimbursement rates, with a final rule expected in November. While specific metrics for the Elevate360 program were not provided, anecdotal evidence shows significant revenue growth in participating clinics. The primary focus remains on the XTRAC business due to its larger potential, though TheraClear is still a growing part of the business.

Asked about the potential domestic impact of tariffs, the strategy for the XTRAC installed base (growth vs. utilization), and details about the "Elevate 360" program's scale and potential.

Answer

The domestic business has minimal direct tariff impact, with the main effect being on outbound international sales and service. The XTRAC installed base is considered at a low point, and the focus is on both improving utilization in existing accounts via the "Elevate 360" program and expanding into new, productive clinics. The Elevate 360 program is currently being applied to about 100 accounts (roughly 10% penetration) and has shown significant success in turning around underperforming clinics and driving expansion.

Jeremy Pearlman asked about the potential impact of tariffs on the domestic business, whether the XTRAC installed base has bottomed out, and the company's go-forward strategy regarding utilization versus new clinic acquisition. He also requested more detail on the Elevate 360 program's scope and effectiveness.

Answer

Executive Dolev Rafaeli clarified that tariffs primarily threaten outbound international sales and service, with minimal direct impact on the domestic supply chain. He stated the XTRAC installed base is at a low point and the strategy involves both removing underperforming devices and redeploying them to more productive clinics. Rafaeli provided a detailed overview of the Elevate 360 consulting program, explaining how it uses analytics to drive utilization and has expanded from 5 to nearly 100 accounts, showing significant success in boosting revenue and expanding device placements within partner clinic groups.

Jeremy Pearlman of Maxim Group asked about the criteria for identifying underperforming XTRAC accounts for device removal and the process for selecting promising new clinics for placement.

Answer

Dolev Rafaeli (executive) explained that account performance is measured against a fixed expense threshold of approximately $15,000-$16,000 per device. Accounts falling below this run rate are either targeted for performance improvement through a consultative process or have their device removed. Rafaeli noted that good new accounts are often former customers returning or clinics with a high pre-existing patient volume. He anticipates a higher rate of removals and placements in the near term to optimize the installed base.

Jeremy Pearlman of Maxim Group questioned the current installed base of FDA units and year-end targets, the specific strategies to help clinics increase utilization, and the status of the resubmitted 510(k) application for the Transdermal Infusion (TDI) system.

Answer

Chairman and CEO Joseph Sardano stated the company is not providing specific guidance on FDA unit installations but is moving aggressively. He explained that Sensus uses data analytics and targeted digital marketing to help clinics drive patient volume, and confirmed these costs are included in the S&M expense forecast. Regarding the TDI system, Sardano and President Michael Sardano noted that no follow-up questions have been received from the FDA since the March 7th submission, which they view as a positive sign for approval.

Jeremy Pearlman inquired about the Veris Health pilot program, including feedback and platform changes, OSU's exclusivity rights, and the strategic rationale and financing model for expanding into the biopharma segment.

Answer

Dr. Lishan Aklog, Chairman and CEO, stated that the Veris pilot feedback was excellent and met all metrics, leading to process improvements but no core platform changes. He clarified that OSU does not have broad exclusivity. Regarding biopharma, Dr. Aklog explained it leverages PAVmed's existing infrastructure and subsidiary financing model, where new ventures raise their own capital, to seize opportunities in a capital-rich sector without straining parent company resources.

Jeremy Pearlman inquired about the anticipated structure of the commercial contract with Ohio State for the Veris Health platform and sought clarity on the FDA approval timeline for the implantable device following its recent funding.

Answer

Dr. Lishan Aklog, Chairman and CEO, described the Ohio State agreement as a comprehensive commercial and strategic partnership that includes patient enrollment commitments and establishes them as the first site for the implantable device post-clearance. He projected an FDA submission for the implantable device by late 2024 or early 2025, noting that positive FDA engagement may allow them to avoid a full human clinical trial.

Jeremy Pearlman asked for an explanation of the spread between the 3% comp for all clinics and the -2% comp for mature clinics, and what strategies were being implemented for the latter. He also questioned if the 2025 guidance was a best-case scenario and what other assumptions, besides dynamic pricing, were underpinning it.

Answer

Executive Jake Singleton noted that the comp spread between system-wide and mature clinics has been consistent for the last 5-6 quarters. Executive Sanjiv Razdan detailed that the guidance is supported by multiple initiatives beyond just pricing, including stronger promotional activity, a new pain-centric marketing message, enhanced digital marketing from a new agency, and the launch of a new mobile app to drive patient engagement.

Jeremy Pearlman from Maxim Group inquired about the company's strategy for top-line growth in 2025, whether any further cost-cutting opportunities exist, and the potential business impact from tariffs.

Answer

Executive Rajiv Kanishka De Silva outlined a two-pronged growth strategy: normalizing order rhythms with new international distribution partners and launching a new body system in the U.S. in the second half of the year. He indicated that the company's cost base is now efficient and the focus is on growing sales, not further significant cuts. He also stated that with manufacturing in Israel and the U.S., they do not anticipate a substantial near-term impact from tariffs.

Inquired about the strategy for achieving top-line growth in 2025, the potential for further cost-cutting measures, and the possible impact of tariffs on the business.

Answer

The growth strategy involves normalizing ordering rhythms with international distributors and launching a new body system in the U.S. in the second half of the year. The company believes it is operating leanly and does not see significant further cost-reduction opportunities. Regarding tariffs, a substantial near-term impact is not expected as products are manufactured in the U.S. and Israel, which has been protected from recent tariff increases.

Jeremy Pearlman, on behalf of Anthony Vendetti, inquired about Nephros' strategies to strengthen customer engagement and recover programmatic reorders, the timeline for the full rollout of the online filter tracker, and the target market for the new HydroGuard UltraFilter.

Answer

Executive Robert Banks explained that Nephros is enhancing customer engagement by emphasizing the risks of off-label filter use and offering new installation services. He confirmed the online filter tracker, which sends automated replacement reminders, is on schedule for a Q1 2025 rollout after successful beta testing. Banks described the new HydroGuard UltraFilter as a complementary product that also opens new, higher-flow markets like sterile processing, aligning with emerging ST108 standards and allowing Nephros to compete more effectively.

Jeremy Pearlman of Maxim Group asked whether the focus on cash-pay and concierge medicine is a short-term bridge or a long-term strategy, and inquired about the potential impact of state-level biomarker testing legislation on the business.

Answer

CEO Dr. Lishan Aklog clarified that this is a supplemental strategy, not a shift, and part of an "all of the above" approach to drive revenue. While traditional reimbursement will become the dominant pathway after Medicare approval, he noted the concierge and self-insured employer markets are significant and will likely remain a focus. Regarding legislation, Dr. Aklog confirmed they are actively engaged in these efforts, but cautioned that translating state mandates into actual payment from payers is a lengthy process and not a panacea.