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UPCOMING MILESTONES
Complete post-operative clinical follow-up of remaining patients in the CarpX first-in-human (FIH) clinical safety study in New Zealand, all of whom have met the study’s primary effectiveness endpoint by successfully completing their CarpX procedures and await electrodiagnostic testing at 90 days to document that they have met the study’s primary safety endpoint;
Resubmit CarpX’s 510(k) application to the U.S. Food and Drug Administration (FDA);
Complete transfer of EsoGuard assay from an academic medical center laboratory to ResearchDx, Inc. one of the nation’s leading commercial contract diagnostic organizations;
Begin full U.S. commercial launch of EsoGuard as a Laboratory Developed Test (LDT), the first such test designed to detect Barrett’s Esophagus, a precursor to deadly esophageal cancer which affects millions of patients;
Complete Center for Medicare and Medicaid Services (CMS) process to secure a reimbursement code for EsoGuard LDT;
Accelerate commercial launch of the EsoCheck™ Esophageal Cell Collection Device with Collect+Protect™ technology;
Secure FDA sign-off on EsoGuard IVD clinical trial protocol during an in-person pre-submission meeting scheduled for October 9, 2019;
Complete creation of EsoGuard IVD clinical trial operations infrastructure required to establish EsoGuard as an FDA-registered In-Vitro Diagnostic (IVD);
Begin recruiting clinical trial sites and enroll first patient in the EsoGuard IVD clinical trial;
Initiate pilot human clinical trials using EsoCheck in other prevalent diseases including eosinophilic esophagitis and infectious fungal/viral esophagitis in immunocompromised patients;
Complete recently initiated formal M&A process led by global professional services firm Alvarez & Marsal to secure a strategic partner or acquirer for the NextFlo Infusion System and provide a source of non-dilutive capital to the Company;
Secure FDA sign-off on protocol for a small PortIO™ clinical safety study in New Zealand during an in-person pre-submission meeting with the FDA in support of PortIO’s de novo application;
Initiate FIH clinical study for long-term PortIO use in dialysis patients and those with poor venous access in Columbia, South America;
Complete PortIO animal study documenting unprecedented six-month maintenance-free patency; and
Complete DisappEAR six-month GLP animal study to support future FDA 510(k) submission.
PRODUCT UPDATES
CarpX Minimally Invasive Carpal Tunnel Device
20 patients underwent successful CarpX procedures in New Zealand, which completed the enrollment and treatment portion of the CarpX first-in-human (FIH) clinical safety study in support of CarpX’s FDA 510(k) re-submission.
All patients met the study’s primary effectiveness endpoint.
All patients who have completed their 90-day follow-up, met the study’s primary safety endpoint and the remaining are fully expected to meet it based on clinical observations to date.
The U.S. Patent and Trademark Office (USPTO) granted PAVmed a broad patent covering the technology underlying the CarpX device, expanding the PAVmed intellectual property (IP) portfolio that now includes over 75 patents and patent applications across 10 families.
CarpX is a minimally invasive device designed to treat carpal tunnel syndrome, which PAVmed believes will dramatically reduce recovery times compared to traditional open surgery and target an estimated $1 billion immediately addressable domestic market opportunity, but do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools of the percutaneous intervention and minimally invasive surgery revolutions. The balloon catheter device is inserted under the scarred ligament in a minimally invasive fashion, tensioning the ligament while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure.
The 20-patient CarpX clinical safety study nearing completion in New Zealand uses a protocol developed in close consultation with the FDA to support a 510(k) pre-market re-submission to commercially market the device for minimally invasive carpal tunnel release. It builds on extensive pre-clinical work documenting a narrow sliver of thermal spread, as well as safety and effectiveness substantially equivalent to a predicate. The study’s primary effectiveness endpoint is intraoperative confirmation of complete transverse carpal ligament division by endoscopic visualization of its cut edges across its entire width. The study’s primary safety endpoint is the absence of nerve injury as documented by two electrodiagnostic motor nerve tests performed at a 90-day follow up visit.
As noted, all 20 study patients underwent successful minimally invasive carpal tunnel release using the CarpX device and met the study’s primary effectiveness endpoint. There were no device-related adverse events. Key intra- and post-operative observations which strongly support CarpX’s clinical and commercial potential include:
The final set of procedures were completed in 15-20 minutes “skin-to-skin”, indicating that the CarpX procedure can be performed in the same or less time as traditional carpal tunnel release after only a short learning curve.
As they gained experience, surgeons were able to use progressively smaller incisions. The final set of procedures were performed through the smallest keyhole incisions that would pass the introducer sheath, approximately 5-10 mm each, with no incision crossing the base of the palm, the problematic area for healing, recovery and persistent pain after traditional surgery.
CarpX’s balloon appeared to create more space within the carpal tunnel at completion of the procedure compared to traditional surgery, a unique feature which has the potential to enhance both short and long-term outcomes.
CarpX required less power and lower balloon pressures to cut the scarred ligament in live human patients than it had previously demonstrated in cadavers, an unexpected positive finding which should further enhance procedure safety and effectiveness.
Most importantly, initial patient feedback has been very positive, including one patient who noted his recovery was much faster than a friend who had a “mini-open” carpal tunnel release and insisted the procedure on his other hand be performed with CarpX.
As noted, all patients who have completed their 90-day follow-up testing have met the study’s primary safety endpoint and, based on clinical observations, it is expected that all the remaining patients will meet it as well. PAVmed will resubmit the CarpX 510(k) application incorporating the study’s clinical safety and effectiveness data once 90-day follow-up is completed in all 20 patients.
U.S. Patent 10,335,189 entitled “Systems and Methods for Percutaneous Division of Fibrous Structures”, was recently granted by the USPTO and includes broad independent claims covering a device such as CarpX with a catheter, an expandable member such as a balloon, and a cutting element such as a pair of bipolar radiofrequency electrodes. The claims are not limited to CarpX or carpal tunnel syndrome and cover device embodiments which can be developed to treat a broad spectrum of conditions, such as plantar fasciitis and compartment syndromes, where compression by fibrous tissue causes pain or other debilitating symptoms. The CarpX IP portfolio also includes multiple international and follow-on patent applications.
EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device
Received FDA 510(k) marketing clearance for the EsoCheck™ Cell Collection Device with Collect +Protect technology.
Engaged ResearchDx Inc., one of the nation’s leading full-service commercial contract diagnostic organizations (CDO), and initiated transfer of the EsoGuard Esophageal DNA test from the clinical laboratory at the academic medical center which developed the test to ResearchDx.
Successfully replicated the EsoGuard assay at ResearchDx and began validation testing to establish the EsoGuard Laboratory Developed Test (LDT) under ResearchDx’s CLIA/CAP certificate.
Filed pre-submission package and scheduled October 9, 2019 pre-submission meeting to secure FDA sign-off on the EsoGuard IVD clinical trial protocol to support a future de novo or Pre-Market Approval (PMA) application, which will seek a specific Barrett’s Esophagus screening indication for EsoGuard on samples collected with EsoCheck in high-risk GERD patients.
Hired former director of global clinical trial operations of a large multi-billion-dollar Fortune 500 medical device company to serve as Lucid’s Chief Operating Officer, tasked with building the clinical trial operations infrastructure for the upcoming EsoGuard IVD clinical trials.
Secured CPT reimbursement code for the EsoGuard LDT under the Proprietary Laboratory Analysis (PLA) process, and successfully advanced the code through the CMS Clinical Laboratory Fee Schedule (CLFS) process, leading to an in-person meeting with CMS to discuss reimbursement under this code.
EsoGuard and EsoCheck are revolutionary technologies licensed in 2018 by PAVmed’s majority-owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), from Case Western Reserve University.
The EsoCheck cell collection device, which is now FDA 510(k)-cleared, is a non-invasive device designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. (EsoCheck animation). The sampled cells can then be subjected to any commercially available diagnostic test including EsoGuard.
EsoGuard is an esophageal DNA test which has been shown in a 408-patient human study published in Science Translational Medicine to be highly accurate at detecting Barrett’s Esophagus (BE), a pre-cursor to highly lethal esophageal cancer (EAC) in patients with chronic heart burn or acid reflux (GERD).
Even though published society guidelines recommend screening in high-risk patients to detect and treat BE before it progresses to EAC, very few such patients currently undergo screening. In fact, most patients diagnosed with EAC are neither aware of their underlying BE, nor that they missed the opportunity to undergo treatment which could have prevented progression to EAC if the BE had been diagnosed earlier.
The estimated immediately addressable domestic market opportunity for EsoGuard is at least $2 billion based on very modest penetration of tens of millions of U.S. GERD patients currently recommended for BE screening according to published society guideline.
EsoGuard uses next generation sequencing (NGS) of bisulfite-converted DNA to detect methylation at 31 sites on two genes (VIM and CCNA1). Complex bioinformatic algorithms are used to quantify the percentage of DNA with methylation at more than a specified proportion of sites, generating a binary result on whether or not the patient has BE. Clinical studies of EsoGuard have demonstrated greater than 90% sensitivity and specificity at detecting BE.
Lucid’s strategy is to advance EsoGuard down two parallel paths, denoted EsoGuard LDT and EsoGuard IVD, which allows it to enter the commercial market and generate revenue while seeking to maximize the long-term value of the product as a widespread screening test.
EsoGuard LDT is a Laboratory Developed Test which uses the above DNA NGS assay to detect BE. Although EsoGuard has completed CLIA/CAP certification and is available as an LDT from the clinical laboratory affiliated with the academic medical center which developed the test, Lucid decided to transfer EsoGuard LDT to a high-capacity commercial laboratory before initiating marketing and a full commercial launch.
As noted, ResearchDx Inc., one of the nation’s leading full-service commercial contract diagnostic organizations (CDO), has initiated transfer of the EsoGuard assay. Their team has quickly replicated, with near perfect correlation, the results from the academic laboratories that had previously performed the assay and has begun the validation testing required to establish EsoGuard as an LDT under their CLIA/CAP certificate. Once this transfer is complete, Lucid will initiate a full commercial launch of EsoGuard LDT. ResearchDx is also manufacturing the custom EsoGuard specimen collection kits and will be performing the assay for the EsoGuard IVD clinical trial.
The process to secure CMS and subsequently private payor coverage for EsoGuard LDT is steadily progressing. Since securing a CPT reimbursement code from the American Medical Association (AMA) under the Proprietary Laboratory Analysis (PLA), EsoGuard LDT has cleared additional hurdles, including technical advisory review, the CPT Editorial Review Panel, the CMS Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting and the CLFS panel. Lucid has engaged a leading law firm whose CMS reimbursement consultants previously served in leadership positions in the CMS group which reviews LDT reimbursement codes and held an in-person meeting with CMS to discuss the EsoGuard LDT code.
The EsoGuard IVD path seeks to secure a specific Barrett’s Esophagus screening indication for EsoGuard as an FDA-cleared In-Vitro Diagnostic (IVD) device in high-risk GERD patients as defined by published society guidelines. This will allow EsoGuard and EsoCheck to be broadly marketed together as a single diagnostic tool to screen patients for BE. It requires a de novo or PMA submission to the FDA supported by strong clinical data demonstrating that EsoGuard performed on samples collected with EsoCheck is sufficiently sensitive and specific to serve as a widespread screening tool in high-risk GERD patients recommended for screening.
Lucid, its world class medical advisors, which include the authors of the published society guidelines, and its regulatory advisors, which includes the former head of the FDA’s IVD branch, have designed a robust two-arm clinical study to support an FDA de novo or PMA submission. The screening arm will enroll GERD patients without a prior diagnosis of BE who satisfy the American College of Gastroenterology (ACG) BE screening guidelines. The case control arm will enroll patients with a previous diagnosis of non-dysplastic BE, dysplastic BE or EAC. In both arms EsoGuard/EsoCheck will be compared to the goal standard of endoscopy with biopsies.
Lucid recently hired Randy W. Brown, former director of global clinical trial operations of a large multi-billion-dollar Fortune 500 medical device company, to serve as Lucid’s Chief Operating Officer. He is tasked with building the clinical trial operations infrastructure for the EsoGuard/EsoCheck clinical trials, including a contract clinical research organization (CRO) partner, allied clinical research personnel and the quality design control process required to establish EsoGuard as an FDA-registered In-Vitro Diagnostic (IVD). Lucid plans to begin recruiting clinical trial sites soon and is targeting enrollment the first EsoGuard IVD clinical trial patient by the end of 2019.
Since EsoCheck is FDA-cleared as a generic esophageal cell collection device, Lucid is also aggressively pursuing market opportunities in prevalent esophageal conditions other than BE.
Eosinophilic esophagitis (EoE) is a common inflammatory condition of the esophagus whose incidence has grown dramatically in the past two decades and frequently coexists with Inflammatory Bowel Disease (IBD). EoE patients currently undergo multiple invasive endoscopies to monitor response to treatment. The University of Pennsylvania is initiating a Lucid-sponsored pilot study to determine whether EsoCheck can replace endoscopy in the surveillance of EoE patients, which would have a dramatic clinical and economic impact on the disease.
Patients with compromised immune systems, such as bone marrow transplant and HIV patients, often undergo endoscopy to evaluate swallowing difficulties to rule out fungal or viral infectious esophagitis. Lucid is engaged with physicians caring for these patients to determine whether these conditions can be diagnosed with EsoCheck instead of endoscopy in these compromised patients.
Other Lead Products
PAVmed’s PortIO™ is an implantable intraosseous vascular access device which allows direct access to the bone marrow, a well-established route for the delivery of medications, fluids and other substances, addressing an estimated $700 million market opportunity based on patients with poor veins and those with renal failure whose veins must be carefully preserved for current or future hemodialysis.
PortIO continues to advance through the FDA’s de novo pathway as PAVmed seeks an initial 7-day implant duration. The FDA-requested GLP animal study has been completed along with supplementary cadaver and acute animal studies. This excellent pre-clinical data will form the basis of an upcoming in-person pre-submission meeting to secure FDA sign-off on the protocol for a small PortIO clinical safety study in New Zealand in support of PortIO’s de novo application.
A separate animal study has now documented that PortIO remains patent and functional for an unprecedented four months, without fluid flushes or any other form of maintenance, with full expectation that this will remain the case when the six-month study is completed in a few weeks. This is highly differentiating because all other vascular access devices require regular flushes with anti-coagulants or other substances to maintain their patency and functionality.
Based on this encouraging animal data, PAVmed will initiate a first-in-human clinical study for long-term (up to 60 days) PortIO use in dialysis patients and those with poor venous access in Columbia, South America.
PAVmed’s NextFlo™ disposable intravenous (IV) infusion set seeks to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated one million infusions of fluids, medications and other substances delivered each day in hospitals and outpatient settings in the United States. NextFlo is designed to deliver highly accurate gravity-driven infusions independent of the height of the IV bag, using inexpensive, easy-to-manufacture disposable mechanical parts. NextFlo testing has demonstrated constant flow rates across a wide range of IV bag heights, with accuracy rates comparable to electronic infusion pumps. (NextFlo Demonstration Video). PAVmed has finalized commercial-ready and packaged working samples of the NextFlo infusion set for use in strategic discussions.
PAVmed recently engaged Deloitte Consulting LLP to perform a comprehensive market research and strategic analysis of NextFlo. They demonstrated a very large addressable market and recommended PAVmed seek a long-term strategic partnership or acquisition for NextFlo. PAVmed subsequently engaged the global professional services firm Alvarez and Marsal, which, armed with the detailed Deloitte Consulting report, has initiated a formal M&A process targeting over 70 potential strategic partners or acquirers, including the market leader in the space, who has contacted the company expressing interest in the technology.
PAVmed’s DisappEAR™ resorbable pediatric ear tubes, manufactured from a proprietary aqueous silk technology licensed from Tufts University and two Harvard teaching hospitals, seeks to revolutionize the care of the estimated one million children who undergo bilateral ear tube placement each year to treat complex or recurrent middle ear infections or fluid collections, by eliminating the need for a second procedure as well as the standard difficult-to-administer post-operative ear drop regimen.
A three-month animal study of DisappEAR to support a future FDA 510(k) submission has been completed with excellent results. The resorbable ear tubes, machined from blocks of proprietary silk, performed very well from a functional and anatomic point of view, retaining their position and remaining patent for the duration of the study. In addition, the ear tubes demonstrated unexpected surfactant properties which appear to provide several unique benefits over traditional plastic tubes, including enhanced flow of fluids in and out of the tube and potential intrinsic antimicrobial properties.
Additional animals are being followed for longer durations to confirm device stability and corroborate these findings. In vitro antimicrobial testing is also being performed to determine whether the surface properties have an intrinsic antimicrobial effect which would obviate the need for antibiotic coating. A separate GLP animal study is comparing DisappEAR to standard plastic ear tubes with and without antibiotic ear drops.
Other Recent Corporate Highlights
Engaged an external investor and public relations firm, KCSA Strategic Communications, to assist in raising PAVmed’s profile within the investment community;
Joined the Russell Microcap® Index on July 1st which results in automatic inclusion in the appropriate growth and value style indexes; and
Closed on a registered direct offering of common stock for net proceeds of approximately $1.8 million in late June.
Lol... looks like the market thinks this company is a joke
The company had a prearranged offering which put a lid on the price. It was a small offering, plus they had a convertible deal with a discount that ends today. Keep in mind this is a tiny company with capital needs, and no guarantee the FDA would approve their product. The stock price should start to melt upward with the selling pressure easing soon. Also, the company is going on the Russell Micro Cap Index starting July 1. The stock should get some demand. Anyway, Esocheck is going to be a good product for PAVM.
Same here. Others make 100% within an hour pre market on such news...
I wonder why the stock price didn’t budge then?
FDA Approval. A new beginning for this company in a multi-billion addressable market. Esocheck clearly superior to the competitor's simple sponge product lol. I wouldn't be surprised if we hear of a partnership soon!
NEW YORK, June 24, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product medical device company, today announced that its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), has received 510(k) marketing clearance for its EsoCheck Cell Collection Device™ (“EsoCheck”) from the U.S. Food and Drug Administration (FDA).
“I have spent my career seeking to improve the care of patients with gastroesophageal reflux disease and Barrett’s Esophagus and to prevent deaths from esophageal cancer. I have actively participated in the development of key advances in this field and am particularly excited that EsoCheck is now available as an FDA-cleared tool in our armamentarium. EsoCheck’s unique ability to sample cells from a targeted area of the esophagus has the potential to save lives through the early detection of esophageal abnormalities,” said Nicholas J. Shaheen MD, MPH, Professor of Medicine and Epidemiology and Chief of the Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine, Director of American College of Gastroenterology (ACG) Institute for Clinical Research and Education.
EsoCheck is a non-invasive cell collection device that is designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. The patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed. The sampled cells can then be subjected to any commercially available diagnostic test. FDA determined that EsoCheck is substantially equivalent to legally marketed predicate devices for its indications for use, namely “the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age or older”.
“I am excited to report this major milestone for PAVmed and Lucid,” said Lishan Aklog, MD, PAVmed’s Chairman and CEO and Lucid’s Executive Chairman. “We are proud to have received FDA clearance for EsoCheck just over one year from the day we founded Lucid and licensed this groundbreaking technology from Case Western Reserve University. We look forward to offering EsoCheck to physicians and patients this summer and believe EsoCheck presents many advantages over existing sponge-on-a-string esophageal cell collection devices. These devices have a capsule which must be digested in the stomach before it can be used to sample cells, while EsoCheck can begin sampling immediately upon insertion. More importantly, EsoCheck’s Collect+Protect™ technology allows it to perform a targeted sample of the lower esophagus, while spherical sponge-on-a-string devices sample cells from the entire esophagus, throat and mouth which dilutes and contaminates the lower esophageal cells.”
About PAVmed
PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance innovative products to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its five lead technologies provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (EsoGuard™/EsoCheck™), vascular access (PortIO™), pediatric ear infections (DisappEAR™) and medical infusions (NextFlo™). The company is also developing innovative products in other areas, such as catheters and tissue ablation, while seeking to further expand its pipeline through engagements with clinician innovators and leading academic medical centers. For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube.
Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market any of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
Contacts:
Investors
Mike Havrilla
Director of Investor Relations
(814) 241-4138
JMH@PAVmed.com
Media
Shaun O’Neil
Chief Commercial Officer
(518) 812-3087
SMO@PAVmed.com
https://finance.yahoo.com/news/pavmed-subsidiary-lucid-diagnostics-receives-144650232.html
The market thinks otherwise
Very positive Business update (link below). Some pretty exciting and transforming catalysts upcoming later this year. If they can partner or sell PortIO and / or NextFlo (which they are trying to do), that would take care of any cash requirements to get their two main devices, CarpX and EsoCheck / EsoGuard, to market without further dilution. Second half of year could (and should) see dramatic increase in SP with total addressable markets for CarpX and EsoCheck over $3B ($1B for CarpX and $2B for EsoCheck), and these are domestic only, not outside US. A little patience may be very well rewarded here over the next 2-4 quarters, notwithstanding my colleague elcheepo who bashes the company at every turn but provides no justification for the negative outlook.
https://finance.yahoo.com/news/pavmed-reports-first-quarter-2019-133000952.html
More good progress keeps emerging. Report-out below indicates benefits they weren't even looking for. They have a lot of shots on goal here and could see some real appreciation in SP by late this year with EsoCheck (and EsoGuard), CarpX, DisappEar, and PortIO all humming along in variance stages of delivery. A little patience may pay off very handsomely.
https://finance.yahoo.com/news/pavmed-reports-excellent-disappear-animal-133000595.html
News: $PAVM PAVmed Announces NextFlo(TM) Breakthrough
Groundbreaking disposable gravity-driven intravenous (IV) infusion set achieves flow accuracy comparable to expensive electronic infusion pumps, independent of IV bag height. NEW YORK, March 20, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ ) (the “Company” or...
Read the whole news https://marketwirenews.com/news-releases/pavmed-announces-nextflo-tm-breakthrough-7858310.html
Do you think the truth is an ulterior motive?
Waking up from a long winter hibernation......and the links below are two of their secondary products. Very positive advancements on both. Future looks bright, but patience is required (2-3 quarters). Everything they are doing seems to be on the right track now (after the delay in CarpX approval) with real paths for approval for both CarpX and EsoCheck. My only concern is they may be running a little low on cash but hopefully they will address that at next CC and not have to dilute. With market cap at $29M today (they do have 17M warrants out with a strike of $1.60 expiring 2024) and total potential market of $3B (with just CarpX and EsoCheck), reward to risk is very outsized here with multiple shots on goal this year. Very long and adding. GL
https://seekingalpha.com/pr/17449710-pavmed-announces-nextflo-breakthrough
https://seekingalpha.com/pr/17442613-pavmed-announces-portio-breakthrough
You sure do seem to feel the need to state the same opinion over and over again. It's as if your have ulterior motives...
Still time to get in on this before fireworks start soon. Very upbeat and positive business update this am:
https://finance.yahoo.com/news/pavmed-provides-business-123000591.html
This is one of my favorite small companies with the likelihood of impending device approvals, potential market opportunities, improvement over existing processes / technology, cash on hand, diversification, ownership / management. As of 2018 proxy statement, CEO owns 26.6% of stock himself and controls another 22.8% through Pavilion Venture Partners (just under 50% total) so he has a huge vested interest in making this all work. Two business updates already this year indicate things are on the move and more news is forthcoming soon. While taking longer to get approvals from FDA on CarpX and EsoCheck, they seem to be working closely with them on formulating a game plan that will ensure approval. I'm willing to wait it out as I think they will ultimately be successful.
So is this done? Or are they dying the death of a thousand cuts?
Heard back from IR within an hour of e-mailing Mike Havrilla asking if the company would be providing an update on the pre-submission meeting with the FDA yesterday on CarpX. His response:
"PAVmed plans to issue a comprehensive business update press release by the end of this week which will include the outcome of the FDA pre-submission meeting and the next steps for CarpX in addition to providing updates for our other product pipeline devices."
Looking forward to what they have to say as it will hopefully provide a clear and fast track to CarpX approval.
Hoping to hear an update on the pre-submission meeting for CarpX with the FDA scheduled for today. After the lack of action by the consulting branch in August (lead branch recommended approval), the company was putting all their ducks in a row to push this forward, starting today with the FDA meeting. Feedback as to how it went would be helpful. I will be writing IR to see if there is any comment.
A Message from PAVmed
An Overview of our Debt Refinancing
Dear Friends,
Eighteen months ago we raised $5 million in debt financing by issuing 15% senior secured notes to Scopia Holdings LLC to fund our ongoing operations. As stipulated in the note, we have been paying half of the interest in cash every six months and the rest has accrued. The note, including principal and accrued interest, were due to be paid in full in approximately six months.
As we have disclosed in previous updates, we have been working diligently over the past few months to refinance this debt well in advance of its maturity as we enter a year marked by important commercial and regulatory milestones.
We are pleased to announce that yesterday, we completed this refinancing of our senior secured debt with a single institutional investor. For full details please CLICK HERE or on the above image to review the related Form 8-K filed with the SEC yesterday.
The refinancing of our senior secured debt, well ahead of its maturity date, further strengthens our balance sheet through key value-inflection milestones in 2019. In addition to removing the July 2019 debt maturity overhang, it increases our working capital by approximately $1.45 million and does so under terms favorable to our company including a lower coupon rate and no attached warrants.
We issued $7.75 million of two-year 7.875% convertible senior secured notes to an institutional investor which yielded net cash proceeds of approximately $6.45 million after deducting the original issue discount and transaction fees. We used $5 million of the net cash proceeds to repay the outstanding principal of the 15% senior secured notes held by Scopia Holdings. In addition, Scopia Holdings agreed to accept 600,000 shares of our common stock at a price of approximately $1.30/share (a premium of over 41% to yesterday’s closing price) for payment of all due and accrued interest. We intend to use the $1.45 million in net proceeds as additional working capital to advance our lead products towards commercialization.
The new notes are convertible at $1.60, reflecting a premium of over 74% to yesterday’s closing price. They include an interest-only period with the first of 37 bi-monthly installment payments due on June 28, 2019 and a maturity date of December 31, 2020. We have the option to make installment payments in cash or by issuing shares of common stock valued at a modest discount to the volume-weighted average price (VWAP) of our stock at the time of payment. To reiterate, payment in cash or stock is fundamentally at PAVmed’s discretion. The detailed terms of the note are provided in the Form 8-K and accompanying exhibits, including customary covenants, equity and capital market conditions as well as the opportunity to accelerate payments under certain mutually beneficial conditions.
We are very happy to enter what promises to be an exciting 2019 with our fiscal house in order and a strong, stable balance sheet to support our drive toward commercialization of our lead products.
As always, please free to contact me with any questions.
Happy Holidays!
J. Michael Havrilla
Director, Investor Relations
PAVmed Inc. | NASDAQ PAVM
M 814-241-4138
E JMH@PAVmed.com
One Grand Central Place
60 E. 42nd Street | Suite 4600
New York, NY 10165
www.PAVmed.com
If you were not the original recipient of this email and would like to join our mailing list, please CLICK HERE to join. Below are links to our Twitter, website, LinkedIn, and YouTube pages; and I would like to encourage you to follow us on each.
Copyright © 2018 PAVmed, All rights reserved.
PAVmed contacts and investors.
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It’s about time they gave an update
Thanks Burp
“During the past several months we have been working diligently and methodically to ensure that we enter the FDA pre-submission meeting in the strongest possible position and with the highest probability of securing near-term clearance,” Dr. Aklog explained. “First, we formally engaged the founding partner of one of nation’s leading FDA law firms to advise us through this process. We then prepared a pre-submission package which carefully codified the large amount of testing data and other documentation generated during the review of the original application, in a manner and structure easily digestible by newly-assigned FDA personnel.”
PAVmed submitted this comprehensive package last month. A pre-submission meeting with the FDA has been scheduled for January 7, 2019. The lead branch for this resubmission remains unchanged but the FDA has assigned a new, more senior, lead reviewer. He will work closely with the lead branch reviewer and chief who participated in the review of the initial application.
“We are excited to have secured a pre-submission meeting with the FDA and eagerly anticipate the opportunity to make our case that CarpX is substantially equivalent to the predicate device and should be granted 510(k) marketing clearance,” Dr. Aklog said. “We anticipate that, as requested, specified senior FDA personnel empowered to make executive decisions on our application will be present at the meeting. PAVmed management will be joined at the meeting by a world-class team, including our FDA counsel and recognized experts in carpal tunnel surgery who strongly support CarpX’s substantial equivalence arguments.
“We continue to advance towards several other important CarpX milestones,” Dr. Aklog added. Next week we expect to secure Ethics Committee approval which should allow us to perform our first-in-human CarpX clinical series in New Zealand in December. The ISO 13485 certification process and quality management system setup required for CE Mark submission in 2019 are both well underway. We also continue our efforts to establish a commercial infrastructure through active discussions with distributors in the U.S. and abroad.”
Been holding few thousand warrants for a while- but shares are too cheap to pass up.
Totally agree DC. Pre-submission meeting with FDA 1/7 for CarpX. After not receiving concurrence from consulting branch in August, company seems to be getting all its ducks lined up and trying to take any doubt for approval out with new experts, lawyers with FDA experience, etc. EsoCheck has been accepted for 510(k) by FDA end of November. It's safe and effective and per CEO - "optimistic that EsoCheck CCD will be cleared expeditiously and available for clinical use in early 2019." Also working with investment bank to partner or sell one or more other devices. I think '19 is the year of Pavmed. I have been loading up on PAVMZ warrants with a 2024 expi date at $.30 - $.33 too. GLTA.
Pending Catalysts at 1.00 here are exceptional. Easy add and hold.
It is basically the same price it was 6 months ago in anticipation of CarpX approval which didn't come as planned in August. I don't expect it to go up or down much until word comes out from FDA meeting on CarpX Jan 7 and 510(k) submission of EsoCheck (FDA acknowledged receipt 11/29). There is also the possibility of news surrounding the investment bank shopping around PortIO or one of their other more minor devices. News is coming soon and I keep adding little chunks to my main position when I can as I think the next 3-6 months could bring significant SP increase (assuming good news on CarpX and EsoCheck).
Why is it going down? Overbought?
How much for the decoder ring?
LOL.. LOL... the chart shows something in deep of uncertainty.
this will hit .50 soon.
i appreciate the gimmicks they are snake oiling, but the wool isn't that thick over the eyes... lol
watch and learn how they churn this trick
Agree bUrRp......I have been picking up a few thousand warrants every week or so here in anticipation of a nice move up over the next few quarters. Am very patient with the company as they have several key catalysts upcoming soon with CarpX, EsoCheck, and other devices. Management is excellent and they are funded through commercialization. 2019 could be a VERY good year for PAVM SP. GL.
PAVmed Subsidiary Lucid Diagnostics Files 510(k) Submission with FDA for EsoCheck™ Cell Collection Device
Agree - several catalysts coming up very shortly - FDA meeting on re-submission of CarpX January 7, approval anytime to allow first-in-human CarpX clinical series in New Zealand in December, submission of EsoCheck CCD for 510(k) clearance by end of November, major investment bank exploring potential strategic partnerships including acquisition of PortIO. 2019 could be PAVM's year. Approval of CarpX and EsoCheck would, I think, result in SP being significantly higher next year. GL.
Looks more like .10
I did buy them for my ROTH..... my employer offers both a taxable and a Roth 401k. I put the vast majority in taxable to get the tax break now and some in the Roth that I consider more speculative. Am more conservative in the taxable one and more aggressive in the ROTH for the reason you mentioned - hoping for a nice tax free return in the ROTH, but it won't kill me if it doesn't work out. GL.
Hope you bought them in your Roth for HUGE tax savings...wouldnt want to have to pay tax bill when this hits $10...
Picked up 25,000 PAVMZ yesterday and today at $.30-$.32. With 6 years to expi, am definitely willing to pay the time premium today to get 3x more shares with the warrants as compared to the common based on the prospects they have ahead of them. Assuming approval even of only one of CarpX and EsoCheck, my feeling is this goes to $10 over the next 2-3 years with the size of those potential markets (company would still be only a $430M market cap after all warrants exercised). No doubt this is speculative but to me reward / risk here is justified on the verge of several catalysts coming up soon. GL!
True, from a trading perspective. Another difference is that the company actually receives money if/when the warrants are exercised.
2024...great value here imo. Warrants are the same as options..warranst are just issued by the company and options are traded on the CBOE
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