|PAVM - 1.26 |
Conference call to be held on April 4, 2019 at 4:30 p.m. Eastern time
NEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today reported financial results for the three and 12 months ended December 31, 2018 and provided a business update.
“I am very pleased with the progress PAVmed has made during what has been a very active and productive fourth quarter of 2018 and in recent months,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “We have achieved several important milestones across our lead product pipeline and are poised to complete several more in this quarter.”
Refinanced senior secured debt under favorable terms, including a lower coupon rate and no attached warrants, strengthening our balance sheet by removing the July 2019 debt maturity overhang and increasing our working capital runway;Reached a consensus with the FDA on the parameters of the CarpX™ minimally-invasive carpal tunnel device’s first-in-human (FIH) safety study and completed the complex logistics necessary to initiate and complete the treatment phase of the study in Christchurch, New Zealand in the coming weeks;Completed the EsoGuard™ (formerly EsoCheck™ Dx) methylated DNA biomarker diagnostic test’s Laboratory Developed Test (LDT) validation process and filed for a Proprietary Laboratory Analysis (PLA) diagnostic CPT billing code through the American Medical Association, which is the first step in securing Medicare reimbursement;Completed the EsoCheck™ esophageal cell collection device’s GLP animal study as well as additional manufacturing verifications requested by FDA to support its 510(k) pathway regulatory clearance;Launched a world-class Lucid Diagnostics medical advisory board consisting of internationally renowned experts in gastroesophageal reflux disease (GERD), Barrett’s Esophagus (BE) and esophageal cancer, with specific expertise and experience in developing the current published society guidelines on the management of BE;Appointed a veteran life sciences industry executive with extensive experience in the development and execution of clinical and regulatory strategy, including sophisticated clinical trials, as Lucid’s Chief Medical Officer;Completed the PortIO™ implantable intraosseous vascular access device’s GLP animal study, requested by the FDA to support its de novo pathway regulatory clearance;Completed a PortIO pilot animal study demonstrating an unprecedented maintenance-free implant duration of over 60 days, which a former president of the Society of Interventional Radiology described as a “truly groundbreaking accomplishment” which would represent “one of the most important advances in long-term vascular access”;Completed a series of bench-top tests of the NextFlo™ Infusion System demonstrating flow accuracy comparable to expensive electronic infusion pumps, independent of intravenous (IV) bag height, which a leading critical care physician described as a breakthrough which would “revolutionize how we deliver infusions to patients while significantly lowering costs”.CarpX
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 immediately addressable domestic market opportunity of over $1 billion.
PAVmed has been working closely with the FDA to secure its U.S. 510(k) regulatory clearance of CarpX. During a pre-submission meeting earlier this year, the FDA recommended clinical testing to definitively document procedural safety in humans and indicated that data from a clinical study outside of the U.S. would be acceptable, precluding the need to engage in the FDA’s time-consuming IDE process required for U.S. studies. PAVmed offered to amend its previously planned FIH clinical trial ( ClinicalTrials.gov Identifier: NCT03747510) in Christchurch, New Zealand to meet this clinical testing recommendation and postponed the initiation of the study until study parameters were finalized with the FDA and local logistical matters could be finalized.
Following multiple discussions, PAVmed reached a consensus with the FDA on the parameters of the study – a single-arm, two-center, two-surgeon, 20-patient study of the CarpX procedure in carpal tunnel syndrome patients, with a device safety primary endpoint over a limited 90-day follow-up period. Final logistical matters led to a brief delay in the initiation of the study which was exacerbated by a temporary freeze on all elective surgeries following the tragic events in Christchurch last month. These logistical matters have now been addressed and the elective surgery freeze has been lifted, allowing treatment to be initiated and completed in the coming weeks.
The EsoGuard (formerly EsoCheck Dx) DNA biomarker diagnostic test and the EsoCheck device, which collect cells from a targeted region of the esophagus in a five-minute office-based procedure, are revolutionary technologies licensed by PAVmed’s majority-owned subsidiary, Lucid Diagnostics Inc. (“Lucid”). Lucid decided to rename the diagnostic test EsoGuard to better distinguish it from the EsoCheck cell collection device since each technology has promising applications that are independent of the other. This change will be formally introduced at the major upcoming gastroenterology meeting, Digestive Diseases Week (DDW), where Lucid will have a strong presence including exhibits and presentations. Lucid is pursuing a two-phase regulatory and commercialization strategy which seeks to maximize the technologies’ long-term commercial opportunity while providing near-term value-inflection commercial milestones.
EsoGuard is a methylated DNA biomarker diagnostic test which has been shown in a published human study to be highly accurate at detecting Barrett’s Esophagus (BE), a pre-cursor to highly lethal esophageal cancer in patients with chronic heart burn or acid reflux (GERD). Lucid believes that the EsoGuard diagnostic test, when performed on samples collected by EsoCheck, has the potential to save many lives through early BE detection. The estimated immediately addressable domestic market opportunity for EsoGuard is at least $2 billion based on tens of millions of U.S. GERD patients who are BE screening candidates according to published guidelines.
The EsoGuard Laboratory Developed Test (LDT) validation process has been completed at the central reference laboratory in Cleveland. This week the American Medical Association (AMA) confirmed receipt of Lucid’s application for a Proprietary Laboratory Analysis (PLA) diagnostic CPT billing code for EsoGuard. This is the first step towards securing Medicare and subsequently private payor reimbursement for the diagnostic test.