NEW YORK, Feb. 26, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today provided an update on its business.
“I am pleased to report that PAVmed’s 2019 is off to an excellent start with continued progress as we approach multiple value-creating milestones,” said Lishan Aklog M.D., PAVmed’s Chairman and CEO. “With CarpX’s first-in-human (FIH) 510(k) clinical safety study in process, EsoCheck CCD’s 510(k) application in the interactive review phase and EsoCheck Dx’s Laboratory Developed Test (LDT) designation imminent, a full business update seems warranted.
CarpX™ Update
CarpX is a minimally invasive device designed to treat carpal tunnel syndrome. The Company believes CarpX 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 U.S. regulatory clearance of CarpX through the FDA’s 510(k) pathway, which is based on demonstrating substantial equivalence (SE) to a previously cleared predicate device. CarpX is being manufactured in Massachusetts by a medical device contract manufacturer with lines scalable to accommodate demand for the foreseeable future following regulatory clearance.
As previously described in more detail, the initial 510(k) application review period expired before the FDA’s branches were able to reach a consensus on SE and it therefore recommended a 510(k) re-submission following an in-person pre-submission meeting held on January 7, 2019. During this meeting, the FDA recommended clinical testing to definitively document CarpX procedural safety in humans and indicated that data from a properly structured clinical study outside of the U.S. would be acceptable, precluding the need to engage in the FDA’s time-consuming Investigational Device Exemption (IDE) process required for U.S. studies. PAVmed offered to amend its previously planned FIH clinical trial (ClinicalTrials.gov Identifier: NCT03747510) in New Zealand to meet this clinical testing recommendation and postponed the initiation of the amended study until study parameters were finalized with the FDA.
“I am pleased to report that following multiple discussions, we recently reached a consensus with the FDA on the parameters of the CarpX FIH safety study, including pre- and post-operative electrodiagnostic testing to document device safety,” said Dr. Aklog. “Our Chief Medical and Commercial Officers, Dr. Brian deGuzman and Shaun O’Neil, just returned from a highly successful seven-day trip to New Zealand to complete all of the preparatory work for this critical study.”
The CarpX FIH safety study is 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 defined as the absence of certain serious device-related adverse events over a limited 90-day follow-up period. Patients are currently undergoing pre-operative assessment and five CarpX procedures per day are currently scheduled at two sites for March 27th, March 28th, April 3rd and April 4th.
“I am excited that we have reached full alignment with the FDA on CarpX’s pathway to clearance and that we have completed extensive preparations to assure that this clinical study will be successful,” said Dr. Aklog. “I am confident that the study will replicate the extensive successful cadaver testing performed to date and document the clinical safety of the CarpX procedure. I look forward to using this data to, once and for all, establish substantial equivalence in our 510(k) re-submission and secure FDA clearance to offer this groundbreaking technology to patients. I am especially pleased that we were able to avoid a lengthy and expensive U.S. study and that, once cleared, human clinical data from this study will support an accelerated adoption and sales growth curve in both the domestic and international markets.”
EsoCheck™ Update
EsoCheck is a revolutionary technology licensed by PAVmed’s majority-owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), which was highlighted as one of the year’s significant advances in cancer prevention in the National Cancer Institute’s 2020 Annual Plan and Budget Proposal submitted to Congress. It consists of two distinct products. EsoCheck CCD is a balloon catheter designed to collect cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. EsoCheck Dx is a methylated DNA biomarker test (mVIM + mCCNA1) 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). The Company believes the EsoCheck technology has the potential to save many lives through early BE detection, with an immediately addressable domestic market opportunity of at least $2 billion based on tens of millions U.S. GERD patients who are BE screening candidates based on published guidelines. Lucid is pursuing a two-phase regulatory and commercialization strategy which seeks to maximize the EsoCheck technology’s long-term commercial opportunity while providing near-term value-inflection commercial milestones. The first phase seeks to commercially launch EsoCheck CCD as an FDA 510(k)-cleared cell collection device and separately launch EsoCheck Dx as a Laboratory Developed Test (LDT), which does not currently require FDA review. The second phase seeks a specific indication for widespread BE screening using the two EsoCheck products based on published guidelines.
“I am happy to report that both phases of our EsoCheck regulatory and commercial strategy are progressing well,” Dr. Aklog said. “In terms of the first phase, we submitted EsoCheck CCD for FDA 510(k) clearance in late November and received an initial response from the FDA in late January. This Additional Information (AI) letter requested additional head-to-head effectiveness data relative to previously cleared esophageal cell collection devices. We have discussed this request with the FDA reviewer and will be submitting existing human cell count data of EsoCheck vs. endoscopic brushings, collected from the ongoing NIH trial, to fulfill this request. The AI letter also requested some additional technical data related to the manufacturing and verification and validation testing of the device which will be ready for submission in a couple of weeks. I remain optimistic that EsoCheck CCD will be cleared expeditiously. The EsoCheck Dx methylated DNA biomarker test also remains on schedule to achieve LDT designation at its designated clinical reference laboratory in Cleveland this quarter. We are prepared to file for EsoCheck Dx reimbursement codes through the American Medical Association’s Proprietary Laboratory Analysis (PLA) process as soon as the test is available as an LDT.
“We have positioned resources to allow our second phase strategy to move forward in an accelerated fashion. The multi-center NIH-funded clinical trial comparing EsoCheck CCD+Dx to endoscopy has enrolled 200 patients and interim results have been accepted for presentation at the major annual gastroenterology meeting, Digestive Diseases Week (DDW), which occurs on May 18th through May 21st. Draft protocol synopses for the Lucid-sponsored clinical studies have been completed and will be finalized next week at an important meeting with former FDA officials retained through a leading regulatory consulting firm. Soon thereafter, we expect to file a pre-submission package with the FDA and secure a meeting date to discuss its clinical data requirements for a de novo or Pre-Market Approval (PMA) pathway submission to support the second phase’s goal of a specific indication for widespread BE screening using EsoCheck technology.”
Other Products
PAVmed’s other lead product pipeline devices include PortIO™, an implantable intraosseous vascular access device; DisappEAR™, a silk-based resorbable, antimicrobial pediatric ear tube; and NextFlo™, a fixed-rate intravenous infusion set based on a proprietary variable flow-resistor.
“The remaining lead products in our pipeline are progressing well and we believe will provide additional opportunities to enhance shareholder value by mitigating risk through diversification and offering potential sources of non-dilutive capital. In particular, I expect PortIO and NextFlo to have exciting developments in the very near future” Dr. Aklog explained.
“PortIO continues to advance along the FDA’s de novo pathway. The FDA-requested long-term GLP animal study implants and explants have been completed as has supplemental acute animal and cadaver studies designed to support the findings of the GLP study. The data will be submitted to FDA once pathologic analysis of the implant sites is completed. Based on encouraging animal data, we are planning a long-term FIH series in dialysis patients in Colombia, South America and intend to fulfill the likely FDA request for human clinical data with an OUS study in New Zealand.
“NextFlo has generated outstanding bench-top data, demonstrating that it is able to passively adjust its resistance and deliver constant flow across a wide, clinically-relevant pressure range. The project has moved into the industrial/human factors design phase, whereby the technology will be incorporated into a standard intravenous infusion set. Full design verification and validation testing will follow to support an FDA 510(k) submission later this year and we believe will be limited to bench-top testing. Demonstration of this groundbreaking technology to interested strategic partners will commence soon and proceed in parallel with the regulatory process.
“Finally, the DisappEAR™ animal study to evaluate resorption rates was initiated last quarter with successful implants of machined silk ear tubes. The initial set of explants at three months look excellent and are currently undergoing pathologic analysis. Upon completion, data from this animal study will be used to support a planned FDA 510(k) submission in 2019.”
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 products provide groundbreaking approaches to carpal tunnel syndrome (CarpX™), precancerous conditions of the esophagus (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, factors affecting the timing and effectiveness of the registration statement for our proposed rights offering; 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