PAVmed (NASDAQ:PAVM) reported second-quarter progress across its Lucid Diagnostics, Veris Health and medical device portfolio businesses, while outlining regulatory and commercialization milestones expected over the coming quarters.
Chairman and Chief Executive Officer Dr. Lishan Aklog said the company is seeing progress across its core businesses, including reimbursement initiatives at Lucid, commercial onboarding at Veris and renewed development work for its PortIO and Octeris medical device programs.
Lucid Focuses on Medicare Coverage and Commercial Expansion
Lucid recently received a positive EsoGuard coverage policy from laboratory benefit manager LBM Concert, according to Aklog, and multiple health plans affiliated with Concert have adopted the policy. The company also said its Veterans Affairs commercialization efforts are progressing and that it expects further developments as the federal budget cycle advances.
PAVmed remains Lucid’s largest common shareholder, holding approximately 15% of Lucid’s common shares outstanding as of the call. Chief Financial Officer Dennis McGrath said PAVmed, together with its board and management, retains approximately 25% voting interest in Lucid, although PAVmed no longer has voting control.
The company’s equity-method investment balance was $33 million at June 30, reflecting its 31.3 million Lucid shares valued using Lucid’s June 30 closing price of $1.07 per share, McGrath said.
Veris Advances Ohio State Rollout and Implantable Device Program
Veris is expanding its commercial deployment at Ohio State University and The James cancer hospital following electronic health record integration, Aklog said. Patient onboarding has increased since the integration went live in the spring, and PAVmed received a large purchase order intended to support patient onboarding through the remainder of the year.
Approximately two-thirds of the planned departments are now onboarded, with additional departments moving through implementation. The company said it is concentrating on reducing workflow friction and increasing adoption among participating departments.
During the question-and-answer session, Aklog said the Ohio State strategic engagement includes a commitment to enroll 1,000 commercial patients in a registry over one year. While PAVmed did not provide current enrollment figures, he said the company and Ohio State believe the target remains attainable as enrollment has accelerated in recent months.
Veris is also developing an implantable physiologic monitor and is targeting an early 2027 submission to the Food and Drug Administration for 510(k) clearance. Aklog said design enhancements have extended projected battery life beyond the two-year target, while a design freeze remains targeted for August.
The company has initiated long-lead biocompatibility testing in line with FDA pre-submission guidance. Its new contract manufacturer completed a trial build, with devices performing well in preliminary verification testing, and PAVmed completed its first phase of animal testing successfully, according to Aklog.
PortIO Regulatory Strategy Could Shift to 510(k)
PAVmed’s PortIO program, an implantable intraosseous port intended to provide long-term vascular access through the bone marrow cavity, is advancing through regulatory planning following publication of first-in-human results in The Journal of Vascular Access.
The study evaluated PortIO in 10 patients at multiple clinical sites. Aklog said it demonstrated 100% device patency, with 90% of patients completing the intended implant duration and no device-related adverse events reported.
The company expects to submit a request for an FDA pre-submission meeting in the fourth quarter, though Aklog said the meeting itself could occur in early 2027. Historically, PAVmed expected PortIO to follow the FDA’s de novo pathway. However, the company is assessing whether the newly published clinical evidence could support a potentially faster 510(k) pathway using existing short-term intraosseous devices as predicates.
Aklog cautioned that there is no certainty that the 510(k) approach will be available. If successful, he said the route could reduce both the time and capital required for commercialization, although the company would still need to conduct a clinical trial.
PAVmed owns the PortIO intellectual property outright, Aklog said. He added that eventual commercialization could involve a small direct sales force and distributor partnerships, with vascular surgeons and interventional radiologists among the primary physician groups expected to implant the device.
Octeris Prepares for Clinical Validation
PAVmed’s Octeris program is developing a multimodal endoscopic imaging platform licensed from Duke University to help identify esophageal dysplasia during upper endoscopy. The Duke license provides PAVmed with worldwide rights, Aklog said.
Development work on the imaging probe is continuing at Duke, including refinements intended to make the probe smaller, more user-friendly and suitable for a broader range of patients. Processing speeds have improved substantially and are intended to support real-time imaging and analysis during procedures, according to the company.
PAVmed is preparing for clinical validation work at the University of Southern California, where institutional review board approval is expected in October. The company has completed an initial FDA pre-submission draft and is preparing for submission.
Aklog said the validation study is intended to support the probe’s development and eventual design freeze, while additional work remains on the system console and transition from laboratory development into a commercial setting. He described the overall Octeris project as still several years from completion.
Second-Quarter Financial Results
PAVmed reported a GAAP net loss of $6.6 million for the second quarter, compared with a $12.3 million loss in the prior-year period. McGrath said the year-over-year change was driven primarily by non-cash fair-value changes related to Lucid shares and convertible debt, which produced a charge of approximately $3.1 million in the latest quarter compared with $10.8 million a year earlier.
GAAP net loss attributable to PAVmed was $5.5 million, or $0.87 per share. On a non-GAAP basis, the loss was $1.7 million, or $0.27 per share.
Second-quarter non-GAAP operating expenses were $6.1 million, up about $200,000 sequentially and about $400,000 above the average of the prior four quarters. McGrath attributed the increase to Veris research and development, particularly work on the implantable device. He said future operating-expense increases are likely to be tied primarily to efforts to submit and obtain FDA clearance for that product.
Cash totaled $3.8 million at June 30. McGrath noted that the figure excludes potential proceeds from $30 million in warrants that become callable upon publication of a positive EsoGuard local coverage determination, as well as $2.5 million in Veris warrants callable upon FDA clearance of the Veris implantable device.
About PAVmed (NASDAQ:PAVM)
PAVmed Inc is a clinical-stage medical technology company focused on acquiring, developing and commercializing innovative medical devices aimed primarily at gastrointestinal endoscopy and related therapeutic areas. Its portfolio includes FDA-cleared products such as EsoFLIP® Distensibility System for the treatment of esophageal strictures and MUSE™ (Medigus Ultrasonic Surgical Endostapler) for endoscopic fundoplication in gastroesophageal reflux disease (GERD). In addition to its gastrointestinal franchise, PAVmed is advancing early-stage programs targeting indications in oncology, urology and dermatology.
Founded in 2012, PAVmed has built its pipeline through internal research and development as well as strategic collaborations and acquisitions.
