Full Press Release Details
Jaffe Announces Corporate Rebranding to Reflect Prioritization of its Development Pipeline on Venous Disease Programs
Hancock Jaffe changing name to enVVeno Medical Corporation and ticker symbol to NASDAQ: NVNO, effective October 1, 2021 -
Development strategy to focus on venous disease and advancement of the VenoValve -
Initiated development of second product for the treatment of venous disease; expected to be unveiled in mid-2022 -
Management to host a conference call with live video webcast at 4:30 p.m. ET today, September 21st -
Calif. - September 21, 2021 - Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI) ("Hancock Jaffe" or
the "Company"), a medical device company focused on improving the standard of care in the treatment of venous disease, announced
today a corporate update which includes a planned corporate rebranding and strategic prioritization of the Company's development
corporate rebranding to enVVeno Medical Corporation and narrowing of our strategic focus reflects our decision to go all in on the VenoValve
and the treatment of venous disease. We believe that the market for the treatment of venous diseases has enormous potential to drive
significant shareholder value over the next several years," said Robert Berman, Hancock Jaffe's CEO. "We are excited
about the progress we've made and the potential for the VenoValve, and the SAVVE study is ready to begin enrolling patients. As
a result, we believe this program is on a clear path forward and could change the treatment paradigm for deep venous CVI."
October 1, 2021, the Company will be renamed enVVeno Medical Corporation. The Company's common stock and warrants will continue
trading on the Nasdaq exchange under the new ticker symbols "NVNO" and "NVNOW", respectively. For current shareholders
of Hancock Jaffe with shares in electric form, the name change will require no action. Shareholders with Hancock Jaffe stock certificates
should contact the Company's transfer agent to obtain new certificates.
Company is ready to begin enrollment for the U.S. pivotal trial for the VenoValve, a potential treatment for deep venous Chronic Venous
Insufficiency (CVI). CVI occurs when valves inside of the veins of the leg fail, resulting in insufficient blood being returned to the
heart. The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial will consist
of 75 patients at up to 20 centers throughout the U.S. The primary endpoints for the U.S. pivotal trial will be the same as for the Company's
successful first-in-human trial and include: the occurrence of Material Adverse Events (MAEs) in less than 26 percent of patients at
30 days post-VenoValve implantation, for the primary safety endpoint; and improvement of reflux equal to at least 30 percent at six months
following VenoValve surgery, as the primary effectiveness endpoint. MAEs are defined as the composite of all-cause mortality, deep wound
infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also
included in the SAVVE study as secondary endpoints. Interested patients can learn more about the SAVVE trial by visiting www.venovalve.com.
light of the early clinical success the VenoValve, and the potential size of the venous disease market, the Company has begun development
of a second device for the treatment of venous disease which the Company is calling enVVe. The Company expects to unveil enVVe in mid-2022.
At this time, Hancock Jaffe has elected to not pursue further development of the CoreoGraft device as a treatment for patients undergoing
cardiac bypass surgery, as it falls outside of the Company's new strategic focus.
afflicts approximately 2.4 million people in the U.S. and occurs when valves inside of the veins of the leg fail, causing blood to flow
in the wrong direction (reflux) and creating increased pressure inside of the veins of the leg (venous hypertension). CVI is a debilitating
condition that can make everyday tasks such as bathing, sleeping, and walking extremely difficult for patients. There are currently no
effective treatments for deep venous CVI.
previously announced, the Hancock Jaffe management will host a corporate update conference call with live video webcast today, Tuesday,
September 21, 2021 at 4:30 p.m. ET. The call will be led by Robert Berman, Chief Executive Officer of Hancock Jaffe, who will be joined
by Dr. Marc Glickman, Chief Medical Officer of Hancock Jaffe. Interested participants and investors may access the conference call by
dialing (877) 407-9708 (domestic) or (201) 689-8259 (international). The live webcast will be accessible on the IR Calendar
page of the Investors section of the Hancock
Jaffe website, www.hancockjaffe.com, and will be archived for 90 days.
Hancock Jaffe Laboratories, Inc.
Jaffe Laboratories (Nasdaq: HJLI) is a medical device company focused on the development of innovative bioprosthetic (tissue-based)
solutions to improve the standard of care in the treatment of venous disease. The Company's lead product, the VenoValve , is
a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). In healthy patients, valves
inside the veins of the leg assist in propelling blood up the leg, and back to the heart and lungs. Affecting approximately 2.4 million
people in the United States, CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of
blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases,
venous ulcers that are difficult to heal and become chronic. Implanted into the femoral vein, the VenoValve is designed to act as a one-way
valve, to help restore proper blood flow in the leg. The VenoValve is currently being evaluated in the SAVVE pivotal study with data
expected in late 2022.
Note on Forward-Looking Statements
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, with respect to our name change, our progress with the VenoValve and the expected timeline related to the SAAVE U.S. pivotal
trial, including the timing of beginning patient enrollment, the VenoValve's ability to fill the unmet medical needs of CVI sufferers
and our development of a second device for the treatment of venous disease) 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
Thomas, JTC Team, LLC
McAdam, Chronic Communications, Inc.