Do PortIO and Octaris technologies include global rights or only U.S. rights?

PortIO is internal IP, so PAVmed owns full global rights. The license with Duke University for Octaris technology also includes worldwide rights. “the PortIO is an internal IP, so it's not a license. PAVmed owns the full rights to that. And the license with Duke University for the [ Octaris ] technology includes worldwide rights as well.”

Can management provide metrics on patient onboarding for the Veris platform and milestones for commercial traction?

Management stated they are not providing hard numbers but confirmed the OSU agreement targets 1,000 commercial patients in a registry over a year, which they believe is attainable. Enrollment has accelerated, with two-thirds of departments now onboarded. “The target of getting to 1,000 patients within the first year is still both us and the colleagues at OSU. I believe that's attainable, and we expect to reach that. And the enrollment has really accelerated over the last couple of months.”

What will the Octaris clinical validation study demonstrate, and what is the timeline to potential FDA submission?

The validation will focus on modifying the probe for user-friendliness and ergonomics, building on prior work that established the technology's ability to measure nuclear size for esophageal dysplasia. This is a step towards design freeze of the definitive probe. The overall project is still several years away from commercialization. “So the validation work is really a step in the process of getting to design freeze of the definitive probe, on the probe side of things... this overall project is still several years away.”

PAVM

PAVmed (PAVM) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 14, 2026

Source: earnings call transcript

Executive summary

PAVmed Q2 FY26 — Strategic Progress Across Core Businesses

PAVmed reported tangible progress across its core businesses in Q2 FY26, with Lucid advancing reimbursement and Veris building commercial momentum while developing its implantable device. The relaunched medical device portfolio, including PortIO and Octaris, is also moving forward, with PortIO showing promising first-in-human results and exploring a faster regulatory pathway. The company remains committed to its diversified model, aiming to enhance shareholder value through multiple opportunities despite increased R&D spend and a modest cash balance.

Highlights

Lucid continues to advance reimbursement and commercialization initiatives, with new positive EsoGuard coverage policy from VN Concert and progressing VA commercialization.
Veris is building commercial momentum with accelerating patient onboarding at Ohio State University and a large purchase order secured for ongoing patient onboarding.
Veris implantable physiologic monitor development is progressing well, targeting early 2027 FDA 510(k) submission, with battery life exceeding 2-year target and successful first phase animal testing.
PortIO first-in-human study demonstrated 100% device patency and 90% patients completing full intended implant duration, with no device-related adverse events.
PAVmed's non-GAAP loss decreased to $1.7 million, or $0.27 per share, compared to a higher loss in the prior year.

Concerns

Cash balance at June 30, 2026, was $3.8 million, not inclusive of expected warrant exercises.
Equity method investment balance for Lucid shares decreased to $33 million, reflecting a closing price of $1.07 on June 30, down from $1.09 at year-end and $1.15 at March 31.
R&D expenses increased by approximately $650,000 sequentially and $1.3 million year-over-year, largely due to Veris implantable device development.

Guidance & targets

Category	Target	Timeline	Confidence
Veris implantable FDA 510(k) submission	Early 2027 high materiality	CY2027 · FY27	High
PortIO FDA pre-submission meeting request	Fourth quarter medium materiality	Q4 · FY26	High
Veris OSU strategic engagement patient onboarding	1,000 patients medium materiality	Over a year	High
Veris implantable design freeze	This month medium materiality	August 2026	High
Octaris IRB approval	Expected in October medium materiality	October 2026	High

Deals & partnerships

Ohio State University (OSU) Strategic engagement for Veris commercialization and patient onboarding. large purchase order over a year

Agreement involves a commitment for OSU to enroll 1,000 commercial patients in a registry over a year, with EHR integration completed in spring.

Risks & headwinds

Cash balance not inclusive of expected warrant exercises. Current

$3.8 million cash at June 30

Mitigation:Expectation of $30 million from warrants upon positive EsoGuard LCD and $2.5 million from Veris warrants upon FDA clearance.

Decline in Lucid share value impacting equity investment balance. Q2 FY26

Equity method investment balance of $33 million reflects Lucid shares at $1.07 on June 30, down from $1.09 at year-end and $1.15 at March 31.

Increased R&D expenses. Q2 FY26

Non-GAAP R&D increased by approximately $650,000 sequentially and $1.3 million year-over-year.

Mitigation:These increases are tied mostly to R&D efforts for the Veris implantable device, indicating strategic investment.

What to watch in Q3 FY26

Lucid Medicare coverage decision

Next quarter

Current Confident in ultimately securing positive draft coverage

Target Positive draft coverage

Why it matters

Medicare coverage is Lucid's most important near-term milestone and critical for its commercialization and future growth, impacting PAVmed's investment.

Of course, Medicare coverage remains Lucid's most important near-term milestone, and we're confident that we will ultimately secure positive draft coverage.

Find out whether PAVM delivers this. Inve re-checks your case every morning.

Q&A highlights

What is the anticipated news flow after the Q4 FDA meeting request for PortIO, and what is the expected regulatory pathway for 2027?

Management clarified that while the meeting request is in Q4, the actual meeting might be in early 2027. They are exploring a 510(k) pathway for PortIO, which would be shorter and less capital-intensive than the previously anticipated De Novo pathway, especially given the successful first-in-human study.

“it appears that we may, there's no certainty yet, but that we may be able to pursue a 510(k) pathway with existing short-term intraosseous devices as a predicate.”

asked by Edward Woo · answered by Lishan Aklog

2 min read 5 chapters

Detailed narrative

Lucid Diagnostics Progress

Lucid is advancing key reimbursement and commercialization initiatives, with Medicare coverage being a critical near-term milestone. A new positive EsoGuard coverage policy from VN Concert has expanded commercial coverage, with multiple health plans adopting it. VA commercialization is progressing, and continued progress across health systems and health economics is strengthening future growth.

PAVmed remains Lucid's largest shareholder with approximately 15% common shares and 25% voting interest.

Veris Commercialization and Development

The commercial phase of the Ohio State University strategic engagement is accelerating, with patient onboarding steadily increasing since EHR integration went live. A large purchase order was secured to support ongoing commercial patient onboarding for the rest of the year, and two-thirds of planned departments have been onboarded.

The implantable physiologic monitor development is targeting an early 2027 FDA 510(k) submission, with battery life now exceeding the 2-year target and design freeze targeted for August 2026. Biocompatibility testing has been initiated, and the first phase of animal testing was successful.

PortIO Medical Device Portfolio

PortIO, an implantable intraosseous port for long-term vascular access, demonstrated positive first-in-human results published in the Journal of Vascular Access. The study showed 100% device patency and 90% patients completing the full intended implant duration, with no device-related adverse events.

The company expects to submit an FDA pre-submission meeting request in Q4 2026 and is exploring a 510(k) pathway instead of the longer De Novo pathway, which would shorten timelines and reduce capital requirements.

Octaris Endoscopic Imaging Platform

Octaris is developing a multimodal endoscopic imaging platform licensed from Duke University to identify esophageal dysplasia. Probe development work at Duke is ongoing, with improved processing speeds for real-time imaging. Clinical validation work is being prepared at USC, with IRB approval expected in October 2026. An initial FDA pre-submission draft is completed, and regulatory work is focused on preparing for submission.

Financial Restructuring and Capital

In February, PAVmed completed a $30 million Series D preferred stock offering and issued a $15 million senior secured note, using proceeds to redeem Series C preferred stock and retire convertible debt. The Series D preferred shares converted to common stock in March.

The company also issued $30 million in warrants callable upon positive EsoGuard LCD and $2.5 million from Veris warrants callable upon Veris implantable device clearance.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.