UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): July 26, 2019
Hancock Jaffe Laboratories, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38325 | 33-0936180 | ||
| (State or other jurisdiction | (Commission | (I.R.S. Employer | ||
| of incorporation) | File Number) | Identification No.) |
70 Doppler
Irvine, California 92618
(Address of principal executive offices) (Zip Code)
(949) 261-2900
(Registrant’s telephone number, including area code)
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:
| ☐ | 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 $0.00001 per share | HJLI | The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in 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 ☒
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 July 26, 2019, Hancock Jaffe Laboratories, Inc. (the “Company”) issued a press release announcing that the Company’s principal investigator for its first-in-man VenoValve study in Bogota, Colombia, Dr. Jorge Hernando Ulloa, reported new 90 day VenoValve data at the Second Annual Society of Vascular and Endovascular Surgery Congress of Central America and the Caribbean. A copy of the presentation made by Dr. Jorge Hernando Ulloa is attached as Exhibit 99.1 to this Current Report and a copy of the press release issued by the Company is attached as Exhibit 99.2 to this Current Report.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Presentation at the Second Annual Society of Vascular and Endovascular Surgery Congress of Central America and the Caribbean | |
| 99.2 | Press release, dated July 26, 2019 |
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.
| HANCOCK JAFFE LABORATORIES, INC. | |
| Dated: July 26, 2019 | /s/ Robert A. Berman |
| Robert A. Berman | |
| Chief Executive Officer |
Principle Investigator Dr. Jorge Hernando Ulloa Reports New 90 Day VenoValve Data at the Second Annual Society of Vascular and Endovascular Surgery Congress of Central America and the Caribbean
Reflux Now at Normal Levels in All Four VenoValve Patients
IRVINE, California., July 26, 2019 – Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that on Thursday, July 25, 2019, Dr. Jorge Hernando Ulloa, the Principle Investigator for HJLI’s first-in-man VenoValve study in Bogota, Colombia, reported new 90 day VenoValve data at the Second Annual Society of Vascular and Endovascular Surgery Congress of Central America and the Caribbean. Dr. Ulloa reported that for all four patients with working VenoValves, reflux has been reduced to normal levels seen in patients without Chronic Venous Insufficiency (“CVI”). Reflux is the primary end point for HJLI’s ongoing VenoValve trial and is the main cause of severe CVI of the deep vein system. All patients had severe CVI prior to receiving their the VenoValve device, and the data was reported on patients 90 days post VenoValve surgery implant.
Dr. Ulloa also reported that overall, reflux has been reduced an average of sixty-eight (68%) across all patients with the working VenoValves device, significantly more than the forty five percent (45%) reduction that was reported this past June, at which time patients were 60 days post-surgery. VCSS scores, a measurement of venous disease severity graded by the clinician, has also continued to improve, with the average improvement across all four patients now at forty-nine percent (49%), compared to pre-operative levels. Pain across the patients, which is measured by a VAS score, has also decreased thirty nine percent (39%).
Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “Our ninety (90) day data shows substantial improvement in our patients in all important areas. In addition, we have not experienced any significant device related adverse events. At this point, the results that we are seeing with the VenoValves is exceptional.”
CVI is a condition that occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards. The backwards flow of blood is known as reflux. The VCSS or Venous Clinical Severity Score consists of ten parameters that are used by clinicians to assess venous disease. The VAS score is a measure for pain that is commonly used in clinical trials. Reflux, VCSS scores, and VAS scores are all end points in Hancock Jaffe’s first-in-man Bogota study.
HJLI expects to release 180-day results for these five patients, and incremental results for other patients enrolled in the study, in October of 2019. A sixth patient that underwent a VenoValve implantation in June of 2019 is making excellent progress. The VenoValve is not currently functioning on one patient. That patient continues to do well and has shown modest improvement compared to pre-VenoValve surgery. To date, there have been no serious device related adverse events associated with the VenoValves.
The initial phase of the first-in-man Colombian study will include up to ten patients who suffer from severe CVI. HJLI has implanted VenoValves in six patients and will continue to provide updates on patient enrollment and additional VenoValve implantations.
The purpose of the first-in-man study is to provide HJLI with valuable feedback to make any necessary product modifications or adjustments to the surgical implantation procedure for the VenoValve. HJLI expects to use the data from its first-in-man Bogota study as part of its Investigational Device Exemption (“IDE”) application to be submitted to the U.S. Food and Drug Administration (“FDA”) in order to begin the VenoValve U.S. pivotal trial. HJLI expects to file the IDE application in early 2020.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system, representing a potential addressable U.S. market of approximately $14 Billion. Estimates indicate that direct medical costs from CVI in the U.S. exceed $30 Billion a year. There are currently no FDA approved devices, or effective treatments for deep venous CVI.
The meeting of the Society of Vascular and Endovascular Surgery of Central America and the Caribbean was hosted by the Society of Vascular and Endovascular Surgery of the Dominican Republic, in Santo Domingo. The conference focuses on the most recent technological advances in vascular and endovascular surgery and is aimed at specialists in vascular and cardiovascular medicine, as well as dermatologists, radiologists, vascular sonographers, nephrologists, cardiologists and family doctors.
About Hancock Jaffe Laboratories, Inc.
Hancock Jaffe Laboratories (NASDAQ: HJLI) specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. Hancock Jaffe currently has two lead product candidates: the VenoValve®, a porcine based valve which is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency; and the CoreoGraft®, a bovine tissue based off the shelf conduit intended to be used for coronary artery bypass surgery. Hancock Jaffe has a 20-year history of developing and producing FDA approved medical devices that sustain or support life. The current management team at Hancock Jaffe has been associated with over 80 FDA or CE marked medical devices. For more information, please visit HancockJaffe.com.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of Hancock Jaffe Laboratories, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the performance of the new board members described herein) may differ significantly from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
HJLI Press Contacts:
Amy Carmer
Tel: 949-261-2900
Email: ACarmer@HancockJaffe.com
Media & Investor Relations Contact:
MZ North America
Chris Tyson
Managing Director
(949) 491-8235
HJLI@mzgroup.us
www.mzgroup.us