• Lucid Diagnostics Revenue: $1.2 million in the fourth quarter.
• EsoGuard Test Volume: 4,042 tests, representing a 45% growth quarter-on-quarter.
• Veris Health Financing: $2.4 million private placement at a $35 million pre-money valuation.
• NIH Grant for Veris: $1.8 million, payable over two years.
• Cash Flow: Operating at cash flow breakeven with incremental expenses offset by dedicated funding.
• Non-GAAP Loss: $688,000 for the fourth quarter, offset by NIH grant proceeds of $900,000.
• Management Service Income: $3.2 million from Lucid Diagnostics for the quarter.
• Operating Expenses: Approximately $5.2 million, including $700,000 in stock-based compensation.
• GAAP Net Income: $1.3 million or $0.12 per common share on a diluted basis for the quarter.
• Non-GAAP Operating Expenses: $4.2 million for the fourth quarter.

• Warning! GuruFocus has detected 3 Warning Signs with PAVM.

Release Date: March 25, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• PAVmed Inc (NASDAQ:PAVM) successfully completed a strategic transformation to stabilize its corporate structure and balance sheet, positioning the company for sustainable growth.
• Lucid Diagnostics, a subsidiary of PAVmed Inc (NASDAQ:PAVM), achieved a 45% growth in test volume quarter-on-quarter, generating $1.2 million in revenue.
• The company secured its first positive commercial insurance coverage policy for EsoGuard with Highmark Blue Cross Blue Shield in New York.
• PAVmed Inc (NASDAQ:PAVM) strengthened its balance sheet through long-term debt refinancing and a registered direct common stock offering, extending its cash runway.
• Veris Health, another subsidiary, completed a private placement financing with gross proceeds of $2.4 million, reflecting strong investor confidence in its long-term commercial potential.

Negative Points

• PAVmed Inc (NASDAQ:PAVM) faces uncertainties related to forward-looking statements, which are subject to known and unknown risks that could affect actual results.
• The company is still awaiting a response from the MolDX Group regarding Medicare coverage for EsoGuard, which introduces uncertainty in reimbursement timelines.
• PAVmed Inc (NASDAQ:PAVM) has ongoing discussions with financial and strategic investors for direct investment in PortIO Corp, indicating a need for additional funding.
• The deconsolidation of Lucid Diagnostics from PAVmed Inc (NASDAQ:PAVM)'s financial statements has led to complexities in financial reporting and understanding historical data.
• The company is dependent on securing funding for Veris Health and PortIO to cover incremental development costs, which could impact future operations if not obtained.

Q & A Highlights

Q: Can you provide details on the Veris Health Care Cancer platform's pilot program with Ohio State and the nature of the contract? A: Lishan Aklog, Chairman and CEO, explained that the engagement with Ohio State is both a commercial and strategic partnership. The contract will involve Ohio State enrolling a substantial number of patients in a registry, which will help in data collection for ongoing improvements and AI development. Ohio State will also be the first site for the initial implantation of the device once FDA cleared.

Q: What is the timeline for the implantable device's FDA approval now that funding is secured? A: Lishan Aklog stated that the manufacturing process is being rebooted, and they expect to be ready for submission by the end of this year or early 2026. The FDA has been engaged in pre-submission meetings, and it appears a full-blown clinical trial may not be necessary, which could expedite the process.

Q: Are there any competing products for Veris as you engage with other cancer centers? A: Lishan Aklog noted that while there are generic remote patient monitoring tools, Veris is unique as it is specifically designed for cancer patients undergoing systemic therapy. The implantable device is a proprietary technology that will serve as a significant differentiator and barrier to entry for competitors.

Q: What is the path to FDA approval for PortIO, and are additional studies required? A: Lishan Aklog explained that PortIO is a new category of device using the intraosseous site for long-term vascular access. The pathway involves a de novo submission, and they plan to launch an IDE study with 50-80 patients, aiming for FDA clearance within two years of the study's start.

Q: Can you provide insights into discussions with other institutions for Veris pilot launches and learnings from OSU? A: Lishan Aklog mentioned that they have had meaningful conversations with about a dozen cancer centers and more advanced discussions with four or five. The focus is currently on advancing the implantable device, and they plan to expand pilot sites after its clearance, leveraging data from the OSU engagement.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.