UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 2, 2020
PAVMED INC. |
(Exact Name of Registrant as Specified in Charter) |
Delaware | 001-37685 | 47-1214177 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
One Grand Central Place, Suite 4600, New York, New York | 10165 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (212) 949-4319
N/A |
(Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, Par Value $0.001 Per Share | PAVM | The Nasdaq Stock Market LLC | ||
Series Z Warrants to Purchase Common Stock | PAVMZ | The Nasdaq Stock Market LLC | ||
Series W Warrants to Purchase Common Stock | PAVMW | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 7.01. | Regulation FD Disclosure. |
On April 2, 2020, PAVmed Inc. (the “Company”) issued a press release announcing that the EsoCheck™ Esophageal Cell Collection Device with Collect+Protect™ Technology, developed and marketed by its majority owned subsidiary Lucid Diagnostics Inc., was named a Silver winner of the 2020 Edison Best New Product Awards in the Medical/Dental category and Testing Solutions subcategory. Attached as Exhibit 99.1 to this Current Report is a copy of the press release, which is incorporated herein by reference.
The information furnished under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the Company, except as shall be expressly set forth by specific reference in such document.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits: |
Exhibit No. | Description | |
99.1 | Press release. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: April 2, 2020
PAVMED INC. | ||
By: | /s/ Dennis M. McGrath | |
Dennis M. McGrath | ||
President and Chief Financial Officer |
Exhibit 99.1
PAVmed Subsidiary Lucid Diagnostics’ EsoCheck Esophageal Cell Collection Device Receives
Prestigious Edison Best New Product Award
NEW YORK, April 2, 2020 (GLOBE NEWSWIRE) — PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced that the EsoCheck™ Esophageal Cell Collection Device with Collect+Protect™ Technology, developed and marketed by its majority owned subsidiary Lucid Diagnostics Inc. (“Lucid”), was named a Silver winner of the 2020 Edison Best New Product Awards in the Medical/Dental category and Testing Solutions subcategory.
“After a thorough review, the Edison Awards judges recognize EsoCheck as a game-changing innovation standing out among the best new products and services launched in their category,” said Frank Bonafilia, Executive Director of the Edison Awards.
“We are honored that the Edison Awards has recognized EsoCheck as a game-changing innovation – placing it among the best new medical device products this year,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive Chairman. “We are proud to add this award to the list of recognitions Lucid’s products have received, including being highlighted as one of the year’s significant advances in cancer prevention by the National Cancer Institute in its 2020 Annual Plan and Budget Proposal submitted to Congress and receiving Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).”
The Edison Awards (www.edisonawards.com), named after legendary innovator Thomas Alva Edison, is among the most prestigious industry accolades honoring excellence in new product and service development, marketing, design and innovation. Originally established in 1987, the Edison Awards have recognized and honored some of the most innovative products and business leaders in the world. Winners are chosen as the “best of the best” within their respective categories by a panel of over 3,000 leading business executives from around the world.
EsoCheck is an FDA 510(k)-cleared non-invasive cell collection device designed to sample cells from the esophagus in a five-minute office-based procedure, without the need for endoscopy – the only such device capable of doing so in an anatomically targeted fashion without sample dilution or contamination (EsoCheck animation). Patients swallow a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs surface cells from the target area and protects them as the device is removed. The sampled cells can then be subjected to any commercially available diagnostic test, including Lucid’s EsoGuard™ Esophageal DNA Test, designed to facilitate the diagnosis of Barrett’s Esophagus (BE) and related conditions leading to and including highly lethal esophageal cancer. EsoCheck is also being evaluated, in collaboration with major academic medical centers, to assist in monitoring BE disease progression and in the diagnosis and management of Eosinophilic Esophagitis (EoE), a rapidly emerging allergy-mediated inflammatory condition of the esophagus similar to, and often associated with, inflammatory bowel disease (IBD).
Lucid licensed the EsoCheck technology from Case Western Reserve University (CWRU) in Cleveland, Ohio. CWRU faculty members Amitabh Chak M.D., Sanford Markowitz M.D., Ph.D. and Joseph Willis M.D. conceived and developed EsoCheck and are co-inventors of the underlying technology.
About PAVmed
PAVmed Inc. is a highly differentiated, multiproduct commercial stage 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 while seeking to further expand its pipeline through relationships with its network of clinician innovators at leading academic centers. PAVmed’s diversified product pipeline addresses unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its four operating divisions include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™ Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation Device with Caldus™ Technology), Minimally Invasive Interventions (CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome), Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, NextCath™ self-anchoring catheters, pediatric ear tubes and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn.
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 many 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
Media
Lauren Masselli
(207) 890-3747
Lauren@edisonawards.com