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Stonegate Capital Partners Initiates Coverage on PAVmed, Inc. (PAVM)

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DALLAS, TX / ACCESSWIRE / December 17, 2018 / PAVmed Inc. (PAVM)

COMPANY DESCRIPTION

PAVmed, Inc. (PAVM) is a highly differentiated multi-product medical device company that focuses on developing high-margin, single-use products for interventional or acute care. The Company's product pipeline includes CarpX™, a percutaneous device for the treatment of carpal tunnel syndrome, EsoCheck™, a non-invasive device and DNA biomarker assay test to detect an esophageal cancer precursor, PortIO™, an implantable intraosseous vascular access device, DisappEAR™, an antimicrobial resorbable ear tube, and NextFlo™, a highly accurate disposable infusion system, in addition to several other candidates. PAVmed™ was founded in 2014 and is based in New York, New York, with 8 full-time employees as last reported.

SUMMARY

  • CarpX is a minimally invasive device for the treatment of carpal tunnel syndrome, which will likely expand the current market opportunity as a treatment option for those that suffer but currently choose to avoid open wound hand surgery that comes with a lengthy recovery period. Using the existing carpal tunnel release system as a predicate and seeking approval under the 510(k) pathway, PAVmed expects FDA approval and to begin marketing CarpX mid-2019.

  • The EsoCheck Technology (cell collection device, or EsoCheck™ CCD™ + proprietary EsoCheck DNA biomarkers, or EsoCheck™DX™) is designed to detect Barrett's Esophagus, which is a primary precursor to esophageal cancer. EsoCheck offers many advantages over the current standard of care, an upper endoscopy, including being less invasive but just as accurate with the results produced. PAVmed expects a commercial launch 1H19.

  • PortIO is an implantable intraosseous vascular access device that can be used to deliver medications, fluids, nutrition, as well as other substances; by enabling direct access to the bone marrow cavity for infusion, this device addresses an area of medical need where traditional vascular access devices can fall short. The PortIO device recently completed a 7-day animal study with excellent results; a GLP study is planned, with an IDE application to follow shortly thereafter, and the trial commencing in 2019.

  • As part of PAVmed's business model, the Company has several product candidates in its pipeline at various stages of development, but all following pathways for medical device approval. PAVM seeks to commercialize high-margin and single use, technologically advanced products, 2 or more of which are likely to receive FDA approval and launch in 2019. The Company is evaluating partnership arrangements (or a potential sale) for the remaining candidates in its pipeline and is always looking to acquire or license additional candidates that hold promise.

  • The Company was founded by two cardiovascular surgeons with accomplished histories in their field of medicine alongside Michael Glennon, an experienced medical device executive; in addition to this team's business leadership skills, the physicians, Dr. Aklog and Dr. deGuzman, are also notably the inventors of five of the seven total medical devices in PAVmed's pipeline.

  • In the past year, the Company has made great strides towards simplifying and strengthening its balance sheet, and PAVmed has made a conscious effort to maintain a lean but efficient level of overhead. As of 9/30/18, PAVmed reported approximately $9.2M of cash on hand, sufficient to fund its operations and meet its major milestones in 2019; given the Company's current cash burn, it is likely that PAVmed will need to seek additional funding in the upcoming year in order to continue progressing its pipeline. However, we do note that there is the potential for non-dilutive capital infusions should PAVmed choose to sell or partner any of its current product candidates.

  • With promising near-term commercialization opportunities as well as several additional candidates in the pipeline, all in total addressing market sizes over $3 billion, our valuation analysis for the most advanced PAVmed programs results in an estimated range of $2.11-$5.49/share, with a mid-point of approximately $3.38

The full report can be accessed by clicking on the link below: http://stonegateinc.com/reports/PAVM%20DEC%202018%20Final%20v2.pdf

AboutStonegate Capital Partners

Stonegate Capital Partners is a Dallas-based corporate advisory firm dedicated to serving the specialized needs of small-cap public companies. Since our inception, our mission has been to find innovative, undervalued public companies for our network of leading institutional investors who seek high-quality investment opportunities.

SOURCE: Stonegate Capital Partners