8/14/2026

speaker
Operator
Conference Operator

Good morning and welcome to the PAVMED second quarter 2026 business update conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Please note, this event is being recorded. I would now like to turn the conference over to Matt Riley, PAVMED's Vice President of Investor Relations. Please go ahead.

speaker
Matt Riley
Vice President of Investor Relations

Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PABMED, along with Dennis McGrath, Chief Financial Officer. The press release announcing our business update and financial results is available on PABMED's website. Please take a moment to read the disclaimers about Florida Green Statements in the press release. The business update, press release, and conference call all include Florida Green Statements, and these Florida Green Statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC. For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part 1, Item 1A, entitled Risk Factors and PADMED's Most Recent Annual Report on Forms 10-K filed with the SEC, and any subsequent updates filed in quarter reports on Forms 10-Q and subsequent Forms 8-K. Steps as required by law of PADMED disclaims any intentions or obligations to publicly update or advise any forward opening statements to reflect changes in expectations or in events, conditions, or circumstances on which these expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward opening statements. I would now like to turn the call over to Dr. Lishan Aklog.

speaker
Dr. Lishan Aklog
Chairman and Chief Executive Officer

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. So we're seeing tangible progress across each of our core businesses. Lucid continues to advance key reimbursement and commercialization initiatives, Ferris is building commercial momentum while advancing its implantable towards FDA submission, and our relaunched medical device portfolio is moving Port IO and Octerus forward under Joe Virgilio's leadership. We believe this progress across our portfolio positions is meant to create meaningful long-term shareholder value. So let me walk through the key developments, beginning with Lucid. Lucid continues to advance its reimbursement and commercial initiatives. as LUSIB's largest shareholder, PadMed, remains well-positioned to benefit from LUSIB's continued progress and future value creation. I encourage you to listen to yesterday's LUSIB Business Update call for greater detail on these developments. Of course, Medicare coverage remains LUSIB's most important near-term milestone, and we're confident that we will ultimately secure positive draft coverage. Commercial coverage expanded recently with a new positive VisaGuard coverage policy from the Laboratory Benefit Manager. and LBM Concert. Multiple health plans of Concert have already adopted the policy. VA commercialization is progressing well and we expect success as the new federal budget cycle progresses. Continued progress across health systems and health economics is further strengthening the foundation for future growth. So let's now move on to VAERS. The commercial phase of our Ohio State University strategic engagement is accelerating with patient onboarding steadily increasing since We also secured a large purchase order to support ongoing commercial patient onboarding for the rest of the year. The clinical rollout is continuing across additional departments. Approximately two-thirds of the planned departments have now been onboarded. Additional departments continue to move through the implementation process. Our current efforts are focused on reducing workflow friction and driving adoption within participating departments. Our implantable physiologic monitor development is also progressing well. We're targeting an early 2027 FDA 510 The design enhancements have now increased the project battery life beyond the two-year target, and design freeze remains targeted for this month with full verification and validation testing to follow. The long lead time biocompatibility testing has already been initiated in line with our FDA pre-submission guidance. Our new contract manufacturer has successfully completed this trial build with devices performing well in preliminary verification testing, and we completed our first phase of animal testing. This was also successful. So now let's move on to our medical device portfolio, starting with Port IO. As a reminder, Port IO is an implantable intraosseous port that's designed to provide long-term vascular access through the bone marrow cavity, particularly for patients with difficult or compromised fetus access. The positive First in Human results were published in the Journal of Vascular Access, supporting continued advancement of our regulatory strategy. Briefly, the First in Human study evaluated Port IO in 10 patients across multiple clinical sites and it demonstrated 100% device patency with 90% of patients completing the full intended implant duration. No device related adverse events were reported. Peer review publication now provides us with an important foundation as we advance Port IO towards its next development and regulatory milestones. Primary focus right now is on the FDA pre-submission process and we expect to submit a meeting request in the fourth quarter. The history has been that the regulatory pathway Based on our prior engagement with FDA, it's been our expectation that Port IO would be subject to the de novo pathway. However, engagements with outside regulatory consultants suggest that the publication of our first human studies may give us a shot at proceeding to a straight 510 . This would create a much shorter timeline and lower cap requirements to get to commercialization. And now let's finish up with OCTERIS. And as a reminder, OCTERIS is developing a multimodal endoscopic imaging platform licensed from Duke University that's designed to identify esophageal dysplasia during upper endoscopy and help guide more accurate biopsy and treatment. The multimodal imaging probe development work is ongoing at Duke. There's continued refinement of the probe, processing speeds have improved substantially, and these improvements are intended to support real-time imaging and analysis during the procedure. These technical advances set the stage for our upcoming clinical validation work at UNC, which we're preparing for. IRB approval is expected in October, and our initial FDA pre-submission draft is completed, and the regulatory work is now focused on preparing for that submission. With that, I'll hand the call over to Dennis for an update on our financials.

Disclaimer

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