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PAVmed Signs Letter of Intent to License Groundbreaking Endoscopic Esophageal Imaging Technology
Prnewswire· 2025-08-26 12:01
Core Viewpoint - PAVmed Inc. has formed a new subsidiary to license advanced endoscopic imaging technology from Duke University, aimed at improving the diagnosis and treatment of esophageal dysplasia, which is a precursor to esophageal cancer [1][8]. Group 1: Technology and Collaboration - The technology involves a multi-modality probe that combines angle-resolved low coherence interferometry (a/LCI) with optical coherence tomography (OCT), potentially offering a more efficient alternative to traditional biopsies [1]. - PAVmed will collaborate with Lucid Diagnostics as a strategic and equity partner in this initiative [1]. - The technology is expected to enable real-time detection and immediate treatment of dysplasia during endoscopic procedures, addressing the limitations of traditional biopsy methods [3][6]. Group 2: Clinical Implications - Dr. Nicholas Shaheen highlighted that this technology could transform the diagnosis and treatment of esophageal precancer, improving patient outcomes and healthcare resource utilization [2]. - Prior clinical research indicated that the a/LCI technology demonstrated 100% sensitivity and 88% overall accuracy in detecting precancerous changes during live examinations [6]. - The integrated a/LCI and OCT technology has shown comparable sensitivity and improved specificity for detecting dysplasia, with results pending peer-reviewed publication [6]. Group 3: Company Strategy and Market Potential - PAVmed's CEO, Dr. Lishan Aklog, expressed optimism about the commercialization of this technology, anticipating that widespread adoption will significantly increase the diagnosis of esophageal precancer [7]. - The venture aligns with PAVmed's structure of independently financeable subsidiaries and builds on successful partnerships with academic medical centers [8]. - The exclusive worldwide license agreement for the a/LCI + OCT technology is contingent upon the execution of a definitive license agreement [8].
PAVmed(PAVM) - 2025 Q2 - Quarterly Results
2025-08-14 12:00
Exhibit 99.1 PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results Lucid processed 2,756 EsoGuard 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT Business ...
PAVmed Provides Business Update and Reports Second Quarter 2025 Financial Results
Prnewswire· 2025-08-14 12:00
Lucid processed 2,756 EsoGuard® 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2025 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diver ...
PAVmed(PAVM) - 2025 Q2 - Quarterly Report
2025-08-14 00:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-37685 PAVMED INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (IRS Employer ...
PAVmed(PAVM) - 2025 Q2 - Earnings Call Transcript
2025-08-13 13:30
Financial Data and Key Metrics Changes - Revenue for the second quarter was $1,200,000, reflecting a 40% increase from the first quarter and matching the previous quarterly high [9][39] - The cash balance at the end of the second quarter was $31,100,000, with a quarterly burn rate of $10,300,000, slightly better than the average burn rate of the previous four quarters [39][40] - Non-GAAP net loss for the second quarter was $9,900,000, which is an improvement of $1,200,000 sequentially [45] Business Line Data and Key Metrics Changes - EtherCAT test volume for the second quarter was 2,756 tests, within the target range of 2,500 to 3,000 tests per quarter [7] - The company invoiced nearly $7,000,000 for 2,756 tests, with revenue recognized at approximately $1,200,000, indicating a 40% sequential revenue increase and a 19% year-over-year increase [42][47] Market Data and Key Metrics Changes - The company is targeting a Medicare population that constitutes approximately 40% to 50% of the 30 million patients recommended for screening under existing guidelines [57] - Currently, the Medicare portion of testing is running in the 10% to 15% range, primarily due to a lack of targeted efforts [58] Company Strategy and Development Direction - The company is focused on securing Medicare coverage, which is seen as a critical milestone for accelerating commercialization efforts [6][36] - A Multi X Contractor Advisory Committee (CAC) meeting is scheduled for September 4, which is viewed as a significant step towards achieving a positive Medicare coverage policy outcome [12][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming CAC meeting and the potential for a positive outcome regarding Medicare coverage [36][54] - The company is taking proactive steps to prepare for increased Medicare patient engagement once coverage is secured [36][59] Other Important Information - The company has strengthened its balance sheet with a public offering that netted $16,100,000 in proceeds, providing sufficient resources to ramp up commercial efforts after securing Medicare approval [15][39] - The publication of a pilot study in the American Journal of Gastroenterology highlighted the effectiveness of EsoGuard, which could expand the total addressable market significantly if similar results are replicated in ongoing studies [16][18] Q&A Session Summary Question: Insights on the multi-jurisdictional CAC meeting - Management indicated that the meeting is a positive sign of collaboration among Medicare contractors, suggesting they are in the late stages of the coverage determination process [52][53] Question: Percentage of business currently from Medicare - Currently, the Medicare portion of testing is around 10% to 15%, with plans to increase this significantly once Medicare coverage is secured [58][59] Question: Timing expectations post-CAC meeting - Management expects a draft LCD to be published relatively quickly after the CAC meeting, with a comment period following that [62][70]
PAVmed to Hold a Business Update Conference Call and Webcast on August 14, 2025
Prnewswire· 2025-07-31 12:01
Conference Call and Webcast at 8:30 AM Eastern Time Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at pavmed.com. About PAVmed PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics (Nasdaq: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the Eso ...
PAVmed Subsidiary Veris Health Completes $2.5 Million Direct Equity Financing
Prnewswire· 2025-06-24 12:01
Core Insights - PAVmed Inc. completed a private placement equity financing for its subsidiary Veris Health, raising $2.5 million at a pre-money valuation of approximately $35 million [1][2][3] Group 1: Financing Details - Veris Health sold shares at $1.40 per share, with proceeds aimed at advancing its implantable physiological monitor through FDA clearance expected in 2026 [2][3] - The financing follows a previous $2.4 million round completed earlier in the year, indicating ongoing investor interest and confidence in Veris Health's potential [1][2] Group 2: Product and Technology - Veris Health focuses on personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2][4] - The Veris Cancer Care Platform integrates remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration to enhance patient care [4][5] Group 3: Strategic Importance - The financing is seen as a significant milestone for both PAVmed and Veris, providing necessary capital to fund the development and commercialization of the implantable physiological monitor [3][4] - The monitor is expected to serve as a key differentiator in the market, enhancing personalized care in conjunction with the Veris Cancer Care Platform [3][5]
PAVmed Subsidiary, Veris Health, Enters into Strategic Partnership Agreement with The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Prnewswire· 2025-06-03 12:31
Core Insights - Veris Health Inc. has established a strategic partnership with The Ohio State University Comprehensive Cancer Center (OSUCCC – James) following a successful pilot program of the Veris Cancer Care Platform™ [1][4] - The partnership aims to enhance personalized cancer care through remote patient monitoring and the development of the Veris Cancer Care Platform [2][3] Group 1: Partnership Details - The agreement includes a long-term, multi-project collaboration to further develop and commercialize the Veris Cancer Care Platform and its implantable physiologic monitor [2][3] - Key components of the partnership involve expanding commercial utilization across cancer care service lines, full electronic health record (EHR) integration, and launching a large clinical registry and clinical trial [3][4] Group 2: Platform Features - The Veris Cancer Care Platform offers remote physiological data collection, symptom reporting, telehealth capabilities, and EHR integration, aiming to improve personalized cancer care [4][5] - Patients enrolled in the platform receive a VerisBox™ with connected health care devices that transmit data to a cloud-based clinician portal, along with a patient smartphone app for symptom reporting and health tracking [5] Group 3: Company Background - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors, with Veris Health as its majority-owned subsidiary [7] - Veris Health focuses on enhancing personalized cancer care through innovative technologies, including the development of an implantable physiological monitor [7]
PAVmed(PAVM) - 2025 Q1 - Earnings Call Presentation
2025-05-15 19:52
Financial Performance - PAVmed's Q1 2025 revenue and management fee income was $3158 thousand, a decrease of $352 thousand compared to $3510 thousand in Q1 2024[23] - The company's operating expenses decreased significantly from $15046 thousand in Q1 2024 to $5454 thousand in Q1 2025, a reduction of $9592 thousand[23] - Net income for Q1 2025 was $18623 thousand, a substantial improvement of $37135 thousand compared to a loss of $18512 thousand in Q1 2024[23] - PAVmed reported an EBITDA of $19007 thousand in Q1 2025, compared to a negative EBITDA of $14813 thousand in Q1 2024, an increase of $33820 thousand[23] - Non-GAAP adjusted loss improved by $7705 thousand, from a loss of $8615 thousand in Q1 2024 to a loss of $910 thousand in Q1 2025[23] - Non-GAAP adjusted loss per share improved from $(099) in Q1 2024 to $(007) in Q1 2025, an increase of $092[23] Balance Sheet - PAVmed's cash position increased by $1515 thousand, from $1185 thousand in 4Q24 to $2700 thousand in 1Q25[22] - Equity method investments in Lucid increased by $21004 thousand, from $25637 thousand in 4Q24 to $46641 thousand in 1Q25[22] - Senior secured convertible notes decreased by $22500 thousand, from $29100 thousand in 4Q24 to $6600 thousand in 1Q25[22] - Preferred shares outstanding were 24480 thousand in 1Q25[22] - Shares outstanding increased from 112 million to 168 million, an increase of 56 million shares[22] Business Updates - Lucid Diagnostics' EsoGuard revenue for Q1 2025 was $08 million, with a test volume of 3034[17] - PAVmed strengthened its balance sheet by netting approximately $161 million in proceeds from an underwritten public offering of common stock[17]
PAVmed(PAVM) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:32
Financial Data and Key Metrics Changes - The company reported a revenue of $800,000 for the last quarter, with a test volume of 3,034, which is at the upper end of the target range of 2,500 to 3,000 tests per quarter [9] - A significant balance sheet improvement was noted with a public offering netting $16,100,000, resulting in a pro forma cash position of $40,000,000 at the end of Q1, extending the runway well into 2026 [10] - The company achieved a large GAAP net income of $18,600,000 before non-controlling interest and preferred dividends, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [22][23] Business Line Data and Key Metrics Changes - Lucid, the diagnostic subsidiary, is positioned to capitalize on a large clinical and market opportunity, with ongoing efforts to secure Medicare coverage [6][11] - Verus has restarted the development of a key implantable physiologic monitor, with favorable engagement from the FDA and a targeted filing for the first half of 2026 [12] - The incubator PMX is focusing on the PortIO implantable intraosseous device, with discussions ongoing with potential strategic partners [13] Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [10][11] - The company has a significant equity method investment balance of almost $47,000,000 reflecting a gain of $21,000,000 since year-end, representing an 82% increase in Lucid's stock price [18][19] Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to pursue attractive biopharma assets [8][36] - The strategic vision includes expanding partnerships and exploring new opportunities while maintaining focus on existing subsidiaries like Lucid and Verus [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute on strategic initiatives, highlighting the strong relationships with key cancer centers and the positive feedback from pilot programs [30][31] - The management team believes that the current market conditions will not hinder their ability to raise capital, citing successful recent financings [46][48] Other Important Information - The company has deconsolidated Lucid from its financial statements, which has impacted the historical understanding of its financials [16][21] - The company continues to explore additional assets and opportunities to diversify its portfolio, with a focus on maintaining operational independence among its subsidiaries [8][40] Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, meeting all pre-specified performance metrics and demonstrating clinical success [29][30] Question: Exclusive rights to the platform - There are no exclusive rights limiting broader commercialization; the agreement allows for a registry and initial implantable procedures at the cancer center [32][33] Question: Strategic rationale for biopharma expansion - The company is leveraging its infrastructure and management services to pursue biopharma opportunities, which align with its history of adapting to market needs [36][39] Question: Impact of market volatility on capital raising - Management indicated that market volatility has not affected their ability to raise capital, with successful recent financings demonstrating investor confidence [46][48]