PAVmed Stock

PAVmed Inc. (PAVmed) is a highly differentiated, multi-product, commercial-stage medical technology company.

The company engages in advancing a broad pipeline of innovative medical technologies from concept to commercialization.

The company's central focus is predominantly on commercial expansion and execution, including the acceleration of EsoGuard and Veris Cancer Care Platform commercialization. As resources permit, the company will continue to explore internal and external innovations that fulfill the company's project selection criteria without limiting ourselves to any target specialty or condition. The company is continuously re-assessing each project's long-term commercial potential relative to other projects in the company's pipeline, accelerating or decelerating the project and reallocating resources accordingly.

The company operates in one segment as a medical technology company, with the following lines of business: Diagnostics, Medical Devices and Digital Health. Below is a summary of each of the company's key products within these sectors, including in particular EsoGuard and the Veris Cancer Care Platform, the company's two leading products. The company is also pursuing a number of research and development project and product opportunities across these three lines of business, which have either been developed internally or have been presented to the company by clinician innovators and academic medical institutions for consideration.

EsoGuard and EsoCheck

The flagship product of the company's majority-owned subsidiary Lucid Diagnostics Inc. ('Lucid'), the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent esophageal adenocarcinoma ('EAC') deaths, through early detection of esophageal precancer in at-risk gastroesophageal reflux disease ('GERD,' also commonly known as chronic heartburn, acid reflux or simply reflux) patients.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at the company's CLIA-certified laboratory. Cell samples, including those collected with EsoCheck, as discussed below, are sent to the company's laboratory for testing and analyses using the company's proprietary EsoGuard NGS DNA assay.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. This proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.

EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University ('CWRU'). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly screening test for the early detection of adenocarcinoma of the esophagus ('EAC') and Barrett's Esophagus ('BE'), including dysplastic BE and related pre-cursors to EAC in patients with chronic gastroesophageal reflux ('GERD').

Commercialization

The company's EsoGuard commercialization efforts span multiple channels, including targeting primary care physicians and GI physicians, who have generally embraced the company's message that EsoGuard has the potential to expand the funnel of BE-EAC patients who will need long term EGD surveillance and, potentially, treatment with endoscopic esophageal ablation.

To assure sufficient testing capacity and geographic coverage, the company has built its own network of Lucid Test Centers, staffed by Lucid-employed clinical personnel, where patients can undergo the EsoCheck procedure and have the sample sent for EsoGuard testing at Lucid's CLIA-certified laboratory. The company's test center network includes locations in metropolitan areas in Arizona, California, Colorado, Florida, Idaho, Illinois, Nevada, Ohio, Oregon, Texas and Utah.

In addition to the company's base test center network, Lucid has established a satellite test center program, whereby the company is expanding the company's footprint by making the company's personnel available to perform cell collection services in physician offices. Further, the company has sought to expand its outreach by successfully conducting multiple '#CheckYourFoodTube Precancer Testing Event' for organizations, such as the San Antonio Fire Department, where samples are collected from the organization's employees for testing with EsoGuard at Lucid's CLIA-certified laboratory.

The company has also established an EsoGuard Telemedicine Program, in partnership with UpScript, LLC, an independent third-party telemedicine provider, that accommodates EsoGuard self-referrals from direct-to-consumer marketing.

Clinical Utility and Clinical Trials

Demonstrating EsoGuard's clinical utility, which requires providing evidence that the test has a meaningful impact on clinical practice, is very important for a variety of purposes, including, importantly, for Medicare and private payor payment and coverage. It has been established that one of the most important factors to private payors in deciding whether to grant payment and coverage will be demonstration that the EsoGuard test, when ordered by physicians, provides information that can be used to identify or exclude patients who would benefit from additional management and/or treatment. Clinical utility studies are also important for general EsoGuard commercialization by facilitating physician understanding of test indications and potential benefit to the patients.

The company is seeking to accelerate its collection of clinical utility data through a range of trials that can be efficiently executed. These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400 San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in respect of which the company expects to publish results in the first half of 2023); an ongoing investigator-initiated, retrospective, single-center, study with 500 patients (in respect of which the company expects to publish results mid-2023), a virtual-patient randomized controlled trial with intended recruitment of 100-200 physician participants (in respect of which the company expects to publish results this year); a Lucid-sponsored multi-center, prospective, observational study with 500 patients; and a Lucid-sponsored registry at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed consent and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey. Both Lucid-sponsored observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.

As previously disclosed, consequently, the company has decided to delay for the time being the two previously commenced clinical trials, the 'EsoGuard screening study' ('BE-1') and the 'EsoGuard case-control study' ('BE-2'), as the company is devoting its clinical resources to the studies cited above, which the company expects will more efficiently generate the clinical data the company is prioritizing to drive EsoGuard commercialization.

Manufacturing

EsoCheck is manufactured for the company by its partners Coastline International, a high-volume device manufacturer, and Sage Product Development. Through mid-2023, the company expects to further transition from Sage to Coastline as the manufacturing process is further optimized. The company's line capacity can produce up to 25,000 units per year. With Coastline's improvement and expansion, there is capacity to scale exponentially. The company's EsoGuard Specimen Kits are manufactured for the company by its partner Path-Tec. The warehousing, logistics, fulfillment and customer support of the company's products is managed for the company by its partners HealthLink International (a leading third-party logistics company) and Path-Tec.

License Agreement

Under the terms of Lucid's license agreement with Case Western Reserve University ('CWRU'), Lucid acquired an exclusive worldwide right to use the intellectual property rights to the EsoGuard and EsoCheck technology for the detection of changes in the esophagus and on sample preservation. The license agreement terminates upon the expiration of the last-to-expire licensed patent, or on May 12, 2038, in countries where no such patents exist, or upon expiration of any exclusive marketing rights for a licensed product that have been granted by FDA or other U.S. government agency, whichever comes later. The EsoCheck patents, which are the last to expire, begin to expire in May 2035.

Regulatory

In June 2019, the company received FDA 510(k) clearance to market EsoCheck in the U.S. as a device indicated for use in the collection and retrieval of surface cells of the esophagus in adults followed by FDA 510(k) clearance in 2022, expanding the use of EsoCheck in adults and pediatric populations in the U.S. In December 2019, the company's CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical validity allowing the company to commercialize it as a Laboratory Developed Test (LDT).

In February 2020, the company received FDA 'Breakthrough Device Designation' for EsoGuard as an in-vitro diagnostic ('IVD') medical device. The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions by expediting their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection balance. The Centers for Medicare and Medicaid Services and the United States Congress continue to work to provide an expedited coverage pathway for emerging technologies.

In May 2021, the company received CE Mark certification for EsoCheck (under the Medical Devices Directive 93/42/EEC), and in June 2021, the company completed CE Mark self-certification for EsoGuard (under the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC)), indicating both may be marketed in CE Mark European countries.

The company's longer-term strategy is to secure a specific indication, based on published guidelines, for BE screening in certain at-risk populations using EsoGuard on samples collected with EsoCheck. This use of EsoGuard together with EsoCheck as a screening system must be cleared or approved by the FDA as an IVD device.

Laboratory Operations

On February 25, 2022, the company's new, wholly owned subsidiary, LucidDx Labs Inc. ('LucidDx Labs'), acquired from RDx, certain licenses and other related assets necessary for LucidDx Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA. Since March 2022, the company has conducted EsoGuard testing at its own laboratory with, until recently, the assistance of RDx, which had continued to provide certain testing and related services for the laboratory in accordance with the terms of a management services agreement ('MSA-RDx'), dated and effective February 25, 2022. Recently, however, the company accelerated the development of internal resources necessary to operate the laboratory entirely on its own. Accordingly, Lucid's subsidiary LucidDx Labs and RDx agreed terminate the MSA-RDx effective as of February 10, 2023, such that LucidDx Labs now operates the laboratory itself, which will improve the efficiency of the performance of the EsoGuard assay.

Veris Cancer Care Platform

In May 2021, the company formed Veris Health, a majority-owned subsidiary, focused on digital health technology. In connection with its formation, Veris Health acquired Oncodisc, a digital health company with groundbreaking tools to improve personalized cancer care through remote patient monitoring. Oncodisc's core technologies include the first intelligent implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics.

Oncodisc was founded in 2018 experienced physician entrepreneurs, James Mitchell, M.D., who joined Veris Health as its full-time Chief Medical Officer, and Andrew Thoreson, M.D., who serves as a Veris Health consultant. They previously co-founded Redsmith, Inc., an interventional catheter company whose technology was acquired by C.R. Bard Inc., now BD Inc. (NYSE: BDX). Oncodisc received a National Science Foundation ('NSF') Small Business Innovation Research ('SBIR') grant award to support its early work and completed both the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.

The Veris Cancer Care Platform ('CCP') is a digital cancer care platform with physiologic data collection, symptom reporting and telehealth functions, designed to improve personalized cancer care through remote patient monitoring. Cancer patients enrolled in the Veris CCP receive a VerisBox with Veris-branded Bluetooth enabled connected health care devices. The devices transmit clinical data to cancer care teams to detect early signs of common cancer-related complications, provide longitudinal trends of physiologic and clinical data, and offer data-driven risk management tools for precision oncology. Veris CCP integrates directly with practices' and systems' Electronic Health Record ('EHR') systems, allowing care teams to easily view and interact with this data. The company is also developing a groundbreaking implantable physiologic monitor containing biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment. The implantable will seamlessly interact with the Veris CCP. These technologies are the subject of multiple patent applications and one issued patent.

Veris Health leverages a business-to-business sales model. Its software-as-a-service recurring-revenue business model seeks to generate 100% recurring revenue through oncology practice and hospital-based subscriptions. These entities pay monthly fees for each patient on the platform, through which they are able to drive revenues from remote physiologic monitoring (and, in the future, device implantation) under existing CPT codes, as well as through the upcoming CMS Enhancing Oncology Model (EOM) bonuses and incentives. Veris also plans to build a commercialization model around the oncology data it is collecting. The company has identified multiple potential use cases across a number of verticals, including clinical trials, commercial use cases, and as a means to improve patient care.

In addition to targeting the oncology market, Veris plans to expand into the hospital-at-home market, cardiovascular diseases, end-stage renal disease, and lung disorders like COPD. The company has already initiated R&D efforts around an enhanced implantable cardiac monitor capable of detecting cardiac arrhythmias and other physiologic parameters critical for high-risk cardiac patients. Future devices will combine novel sensing technology with seamless communication, engaging user interface design, and data analytics driving actionable clinical insights for patients with congestive heart failure. These technologies will then be expanded for high-risk kidney disease and pulmonary patients.

Commercialization/Sales

The company's Veris commercialization efforts have targeted the full spectrum of oncology care providers, with a focus on independent oncology practices, participants in CMS's Oncology Care Model (OCM) and EOM, and innovative, progressive health systems. The growing adoption of value-based models has provided a strong tailwind, as the Veris CCP addresses many requirements of these programs, including electronic Patient Reported Outcomes ('ePROs') and the use of data for quality improvement.

Manufacturing

The components comprising the Veris Cancer Care Platform are supplied to the company by its partners TransTek and their U.S.-based subsidiary, Mio Labs. Each has passed a SOC-2 audit by an outside auditor. The final packaging of the overall box and order fulfillment is managed by Impilo, a partner with TransTek and Mio Labs. The customer support is managed internally, while partnering with Zendesk for customer service management.

Regulatory

The Veris CCP software is considered a non-device Medical Device Data System ('MDDS') that is excluded from the statutory definition of a medical device under the FDC Act and as confirmed in the FDA's MDDS Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. Therefore, Veris CCP is not subject to the FDA's regulatory requirements for devices.

Veris Health is also developing an implantable cardiac monitor and is interacting with the FDA via pre-submission process, seeking agreement on regulatory strategy and required testing to seek clearance of the monitor. The company plans to make its 510(k) submission for the implantable monitor in late 2023.

As Veris Health is sourcing the devices included in the VerisBox from the third-party 510(k) holders for those products, such holders are responsible for any losses, damages, claims or other liabilities that may arise with respect to those devices used with the Veris CCP software, notwithstanding Veris Health commercial branding being added to the devices or the devices' packaging.

Product Pipeline

Below is a summary of certain of the other leading products within the company's development pipeline. While the company is devoting substantially all of the company's resources to the acceleration of EsoGuard and Veris Cancer Care Platform commercialization, as resources permit, the company will continue to explore innovative technologies, such as the company's EsoCure, CarpX and NextFlo products as more fully described below, that fulfill the company's project selection criteria without limiting ourselves to any target specialty or condition.

Esocure

In connection with the company's efforts to expand the company's presence in the EAC diagnostic market, the company is also developing the EsoCure Esophageal Ablation Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment. The company has successfully completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. An acute and survival animal study of EsoCure Esophageal Ablation Device has also been completed, demonstrating successful direct thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. When resources permit, the company plans to conduct additional development work and animal testing of EsoCure to support a future FDA 510(k) submission.

CarpX

CarpX is a patented, single-use, disposable, minimally invasive surgical device for use in the treatment of carpal tunnel syndrome. CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need for endoscopic or other imaging equipment, and therefore will be significantly less invasive than existing treatments. To use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates tension in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation between the target ligament and critical structures such as the median nerve. Radiofrequency energy is briefly delivered to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. CarpX will be significantly less invasive than existing treatments.

CarpX received FDA 510(k) marketing clearance in April 2020, with the first commercial procedure successfully performed in December 2020. In May 2021 European CE Mark Certification was received for CarpX. The company's limited-release commercialization efforts through 2022 were focused on engaging key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure development and surgical-time optimization, and ease of use. As a result of this clinical input, the company has initiated a product development project to incorporate intraluminal ultrasound into the device to include real time imaging of the ligament to be cut together with critical anatomic structures, and will continue to pursue that project, as resources permit.

PortIO

The company's PortIO implantable intraosseous vascular access device is being developed as a means for infusing fluids, medications and other substances directly into the bone marrow cavity and from there into the central venous circulation. The intraosseous route provides a means for infusing fluids, medications and other substances directly into the bone marrow cavity which communicates with the central venous circulation via nutrient and emissary veins. This route is well established, having been used for decades in a variety of settings, including trauma, especially military trauma, and pediatric emergencies. It has been shown to be bioequivalent to the intravenous route. Complication rates are low and there are few contraindications. Available intraosseous devices pass through the skin into the bone and are therefore limited to short term use. PortIO is a novel, implantable intraosseous vascular access device which does not require accessing the central venous system and does not have an indwelling intravascular component.

Business

Status of Lucid Clinical Trials

Lucid is seeking to accelerate the company's collection of clinical utility data through a range of trials that can be efficiently executed. These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400 San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in respect of which the company expects to publish results in the first half of 2023); an ongoing investigator-initiated, retrospective, single-center, study with 500 patients (in respect of which the company expects to publish results mid-2023), a virtual-patient randomized controlled trial with intended recruitment of 100-200 physician participants (in respect of which the company expects to publish results this year); a Lucid-sponsored multi-center, prospective, observational study with 500 patients; and a Lucid-sponsored registry at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed consent and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey. Both Lucid-sponsored observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.

As previously disclosed, consequently, Lucid has decided to delay for the time being the two previously commenced clinical trials, the 'EsoGuard screening study' ('BE-1') and the 'EsoGuard case-control study' ('BE-2'), as Lucid is devoting the company's clinical resources to the studies cited above, which the company expects will more efficiently generate the clinical data Lucid is prioritizing to drive EsoGuard commercialization.

LucidDx Labs Laboratory Operations Update

On February 14, 2023, Lucid Diagnostics and LucidDx Labs Inc. entered into an agreement (the 'MSA Termination Agreement') with RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause. The termination was effective as February 10, 2023. Until the termination of the MSA-RDx, RDx had continued to provide certain testing and related services for the Laboratory in accordance with the terms of the MSA-RDx. Recently, however, Lucid accelerated the development of internal resources necessary to operate the Laboratory entirely on its own. Accordingly, termination of the MSA-RDx will improve the efficiency of the performance of the EsoGuard assay.

#CheckYourFoodTube Events

In January 2023, Lucid successfully completed its first #CheckYourFoodTube Precancer Testing Event, in partnership with Rachelle Hamblin, M.D., M.P.H., and the San Antonio Fire Department (SAFD), to detect esophageal precancer in at-risk members of the department. The SAFD testing event was held over two weekends in January, which has been designated as Firefighter Cancer Awareness Month by the International Association of Fire Fighters (IAFF). A total of 391 members, nearly one-quarter of the department, who were deemed by Dr. Hamblin to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed by Lucid clinical personnel using its EsoCheck Esophageal Cell Collection Device. Firefighters with suspected esophageal precancer based on a positive EsoGuard result were identified, including some less than forty years of age, and will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, to prevent progression to esophageal cancer. These events, which Lucid looks to expand across the country, are an extension of Lucid's recently introduced and expanding satellite Lucid Test Center (sLTC) program, which brings the company's precancer testing directly to patients-at their physician's office and now at large testing day events. Lucid demonstrated that its nurse practitioners can each perform up to fifty EsoCheck procedures in a day, and its laboratory team handled over two hundred incoming samples in a day, while maintaining turnaround times at target. These successes provide an excellent foundation for future testing events as the company continues to drive EsoGuard commercialization using all the tools at the company's disposal.

Veris Health Commercialization Update

In December 2022, Veris Health signed a license agreement for the Veris CCP software with its first customer, New Jersey Cancer Care. Since, Veris Health onboarded the first cohort of patients of that practice onto the Veris CCP as well, and has signed license agreements with two additional cancer centers. These successes lay the groundwork for Veris Health's expansion plans with respect to the Veris CCP software as it seeks to onboard cancer centers and patients across the country.

Intellectual Property

The company owns or has the right to use intellectual property rights, such as patents, trademarks, copyrights, trade secrets and know-how, pertaining to the company's EsoCheck and EsoGuard technology, the company's Veris technology and the company's EsoCure, CarpX and PortIO products, among other technologies and products.

The company has applied for, licenses or owns 55 domestic and foreign patents across 11 families of products, including patents protecting the company's EsoCheck, EsoGuard and Veris technology.

PAVmed also has (directly or through its subsidiaries) proprietary rights to a range of trademarks, including among others, PAVmed, Lucid Diagnostics, LUCID, VERIS, Oncodisc, CarpX, EsoCheck, EsoGuard, EsoCheck Cell Collection Device, Collect + Protect, EsoCure Esophageal Ablation Device, NextFlo, and PortIO.

Government Regulation

Generally, products the company develops must be cleared by the FDA before they are marketed in the United States. Before and after approval or clearance in the United States, the company's products are subject to extensive regulation by the FDA under the FDCA and/or the Public Health Service Act, as well as by other regulatory bodies.

To request marketing authorization by means of a 510(k) clearance, the company must submit a pre-market notification demonstrating the proposed device is substantially equivalent to another legally marketed medical device, has the same intended use, and is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than does a legally marketed device.

In addition to FDA restrictions on marketing and promotion of drugs and devices, other federal and state laws restrict the company's business practices. These laws include, without limitation, anti-kickback and false claims laws, data privacy and security laws, as well as transparency laws regarding payments or other items of value provided to healthcare providers.

The Foreign Corrupt Practices Act obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ('HIPAA') established comprehensive protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or 'Covered Entities': health plans, healthcare clearinghouses, and healthcare providers that conduct certain healthcare transactions electronically. Covered Entities and their business associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. Some of the company's activities, including at its Lucid Test Centers and within the company's clinical trials, involve interactions with patients and their health information which implicate HIPAA. The company's activities also involve the company entering into specific kinds of relationships with Covered Entities and business associates of Covered Entities, which also implicate HIPAA. Penalties for violations of HIPAA include civil money and criminal penalties.

The company's commercialization activities for EsoGuard subject Lucid to regulations of the Department of Transportation, the United States Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation of clinical laboratory specimens.

Research and Development Expenses

In the year ended December 31, 2022, the company's research and development costs were approximately $25.5 million.

History

The company was founded in 2014. It was incorporated in Delaware in 2014. The company was formerly known as PAXmed Inc. and changed its name to PAVmed Inc. in 2015.