enVVeno Medical Corporation (NVNO)

enVVeno Medical to Participate in the Virtual Investor Closing Bell SeriesJune 2, 2026 9:01 AM
ACCESS NewswireLive video webcast with Robert Berman, Chief Executive Officer of enVVeno Medical, on Tuesday, June 9that 4:00 PM ETRegister hereIRVINE, CA / ACCESS Newswire / June 2, 2026 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that Robert Berman, Chief Executive Officer of enVVeno Medical will participate in a Virtual Investor Closing Bell event on Tuesday, June 9, 2026 at 4:00 PM ET.As part of the event, Mr. Berman will discuss the Company's recently reported IDE approval of its enVVe® System, marking a first-ever FDA IDE approval for a U.S. pivotal study of a non-surgical replacement venous valve.Additionally, there will be a live question and answer session with audience participants. Mr. Berman will answer as many questions as possible in the time allowed.A live video webcast will be available on the Events page of the Company's website (www.envveno.com). A webcast replay will become available two hours following the live event and will be accessible for 90 days.About enVVeno Medical CorporationenVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently developing the enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe Deep Venous Insufficiency (DVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.INVESTOR CONTACT:JTC Team, LLC
Jenene Thomas

enVVeno Medical Discusses FDA IDE Approval in Virtual Investor "What This Means" SegmentMay 12, 2026 9:02 AM
ACCESS NewswireFirst-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-surgical Replacement Venous ValveIDE approval positions enVVeno to advance what could become the first effective treatment option for the approximately 3 million U.S. patients suffering from DVIWatch the "What This Means" video hereIRVINE, CA / ACCESS Newswire / May 12, 2026 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), today announced that Robert Berman, Chief Executive Officer of enVVeno Medical participated in a Virtual Investor "What This Means" segment. As part of the segment, Mr. Berman discussed the Company's recent news announcing the U.S. Food and Drug Administration's (FDA) first-ever IDE approval awarded to enVVeno to proceed with a U.S. pivotal study of a non-surgical replacement venous valve.The Virtual Investor "What This Means" segment featuring enVVeno Medical is now available here.About enVVeno Medical CorporationenVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently developing the enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe Deep Venous Insufficiency (DVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.Cautionary Note on Forward-Looking StatementsThis press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing (may differ significantly from those set forth or implied in the forward-looking statements. 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.INVESTOR CONTACT:
JTC Team, LLC
Jenene Thomas

enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe SystemMay 7, 2026 8:05 AM
ACCESS NewswireCompany ended the first quarter with approximately $25 million in cash and investmentsCapital on hand should fund operations through multiple key milestones into Q3 2027Company recently received FDA IDE approval to commence TAVVE U.S. Pivotal Study for non-surgical replacement venous valve, enVVe SystemTAVVE site selection is underway with patient enrollment expected to commence later this yearIRVINE, CA / ACCESS Newswire / May 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the first quarter 2026, ending the quarter with approximately $25 million in cash and investments and confirming the Company's strategic focus on the development of its next-generation enVVe® System for the treatment of deep venous insufficiency. "With a strong balance sheet, significant physician interest in the enVVe valve, and a clearly defined regulatory pathway, we are well positioned to execute the TAVVE study and advance the Company towards multiple near-term and long-term milestones," said Robert Berman, Chief Executive Officer of enVVeno Medical.Landmark FDA IDE Approval for TAVVE StudyIn April 2026, enVVeno Medical announced that the U.S. Food and Drug Administration (FDA) granted IDE approval for the Company's Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study, marking the first-ever FDA approval for a U.S. pivotal study of a non-surgical replacement venous valve. The study will evaluate the Company's minimally invasive enVVe® System for the treatment of patients with severe deep chronic venous insufficiency (CVI), a condition affecting approximately 3 million patients in the United States with limited treatment options.Summary of Financial Results for the First Quarter 2026Cash and investments totaled $24.9 million as of March 31, 2026, compared to $28.2 million as of December 31, 2025. The Company believes its current cash and investment resources are sufficient to fund operations into the third quarter of 2027, including advancement of the TAVVE pivotal study.Cash burn for the first quarter was $3.3 million, consistent with the Company's projected cash burn rate of approximately $3 million to $4 million per quarter. The Company anticipates that its cash burn rate may increase to approximately $4 million to $5 million per quarter in 2026 as it prepares for and initiates the TAVVE pivotal study.Net loss for the first quarter of 2026 was $3.8 million, or a net loss of $5.89 per basic and diluted common share, compared to a net loss of $4.5 million, or a net loss of $7.75 per basic and diluted common share, in the first quarter of 2025.About enVVeno Medical CorporationenVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently developing the enVVe System, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe Deep Venous Insufficiency (DVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.Cautionary Note on Forward-Looking StatementsThis press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing may differ significantly from those set forth or implied in the forward-looking statements. 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.INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC

enVVeno Medical Receives First-Ever FDA IDE Approval for a U.S. Pivotal Study of a Non-Surgical Replacement Venous ValveApril 29, 2026 8:05 AM
ACCESS NewswireFirst-in-Class enVVe system to be evaluated in TAVVE U.S. Pivotal TrialClinical site activation and patient enrollment expected to commence later this yearLarge unmet clinical need for approximately 3 million U.S. patients with severe deep Chronic Venous InsufficiencyPotential multi-billion-dollar untapped U.S. marketCompany has approximately $25 million in cash and investments to fund operations into Q3 2027IRVINE, CA / ACCESS Newswire / April 29, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that the U.S. Food and Drug Administration (FDA) has awarded the Company the first-ever IDE approval to proceed with a U.S. pivotal study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (TAVVE®) pivotal study will evaluate the Company's minimally invasive enVVe® System for patients with severe deep Chronic Venous Insufficiency (CVI). This IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg."We have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to see in evaluating the safety and efficacy of enVVe and that we are in complete alignment," said Robert Berman, enVVeno Medical's Chief Executive Officer. "We have also been busy speaking with clinical sites that are interested in participating in the TAVVE study. A transcatheter-based non-surgical replacement venous valve has always been considered the "holy-grail" for patients with severe CVI and the interest and enthusiasm among physicians and their clinical teams has been extremely high. We are excited to be able to officially start the process of selecting and activating clinical sites and look forward to the first implantation procedure using the enVVe System."About the TAVVE Study
The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.Key features of enVVe system include:Minimally invasive procedure requiring no general anesthesia or overnight hospital stay;Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy;Frame geometry that accommodates the natural dilation and contraction of the vein;3 enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;Unique, mono-cusp leaflet design that is laser cut from porcine pericardium tissue;Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; andDelivery via an over-the-wire, coaxial, single-stage pull system for ease of use.enVVeno also announced that as of March 31, 2026, the Company had approximately $25 million cash and investments on hand which is expected to fund operations into the third quarter of 2027.About CVI
Deep venous CVI occurs when insufficient blood is returned to the heart and lungs from the lower leg. The disease is most often caused by blood clots (deep vein thromboses or DVTs) resulting in permanently damaged valves in the deep veins of the leg. When valves inside the deep veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension).Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that there are approximately 3 million patients in the U.S. with severe deep venous CVI, costing the U.S. healthcare system in excess of $20 billion each year.About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is currently developing enVVe system, which includes a first-in-class non-surgical replacement venous valve being developed for the treatment of severe deep Chronic Venous Insufficiency (CVI). The enVVe valve is designed to act as one-way valve, to help assist in propelling blood up the leg, and back to the heart and lungs. As a transcatheter delivered device, the enVVe procedure will be performed under light sedation and should not require an over-night hospital stay.Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing (may differ significantly from those set forth or implied in the forward-looking statements. 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.INVESTOR CONTACT:
JTC Team, LLC
Jenene Thomas

enVVeno Medical Reports Full Year 2025 Financial Results and Highlights Strategic Advancement of enVVe(R) SystemMarch 27, 2026 8:30 AM
ACCESS NewswireCompany accelerated development of the enVVe® System, completing pre-clinical studies and progressing toward a 2026 pivotal trial initiationStrong financial position expected to provide an operating runway into mid-2027 through the achievement of key clinical milestonesIRVINE, CA / ACCESS Newswire / March 27, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced financial results for the year ended December 31, 2025 and provided a corporate update highlighting its strategic focus on the development of its next-generation enVVe® System. Robert Berman, Chief Executive Officer of enVVeno Medical Corporation, stated, "2025 represented a significant inflection point for the Company. Following the FDA's decision regarding the VenoValve®, we made the strategic determination to accelerate development of the enVVe System, a less invasive, transcatheter-based approach designed to address prior regulatory considerations while broadening the potential physician adoption base." Mr. Berman added, "With pre-clinical development complete and active discussions underway with the FDA, we are now focused on initiating our pivotal trial in 2026 and believe the enVVe System represents a transformative opportunity to address a large and underserved patient population suffering from severe chronic venous insufficiency."Chronic venous disease is the most prevalent chronic condition in the United States, affecting an estimated 70% of the adult population. Severe chronic venous insufficiency (CVI), a more advanced form of the disease, impacts approximately 3.5 million patients in the United States, including roughly 1.5 million individuals with venous leg ulcers. Currently, there are no approved surgical or non-surgical replacement venous valves available, highlighting a significant unmet medical need.The enVVe System is a first-in-class, non-surgical, transcatheter-based replacement venous valve designed to treat severe deep CVI by restoring proper one-way blood flow in the leg veins. The system is intended to eliminate the need for open surgery, reduce procedural risk, expand adoption across multiple physician specialties and improve patient quality of life. Looking ahead, the Company's primary focus in 2026 will be advancing the enVVe System into clinical development, including finalizing alignment with the FDA on the pivotal trial design, initiating the pivotal trial and progressing toward potential regulatory approval.Summary of Financial Results for the Full Year 2025For the year ended December 31, 2025, the Company reported a net loss of $19.5 million, compared to a net loss of $21.8 million in 2024. Research and development expenses totaled $10.0 million, representing a 19% decrease year-over-year, while selling, general and administrative (SG&A) expenses were $10.9 million. As of December 31, 2025, the Company held $28.2 million in cash and investments. The Company expects its cash burn rate to increase modestly in 2026 to approximately $4 million to $5 million per quarter as it prepares for and initiates the enVVe system pivotal trial.About enVVeno Medical CorporationenVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.Cautionary Note on Forward-Looking StatementsThis press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (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 and timing may differ significantly from those set forth or implied in the forward-looking statements. 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.INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC

https://finance.yahoo.com/news/envveno-medical-updates-regulatory-status-124500652.html

NVNO....................................https://stockcharts.com/h-sc/ui?s=NVNO&p=W&b=5&g=0&id=p86431144783

NVNO under $5

hugely positive data

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Hancock Jaffe Laboratories Inc., HJLI, changed to enVVeno Medical Corp., NVNO

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Hancock Jaffe Laboratories Announces $20 Million Registered Direct Offering Priced At-the-Market Under NASDAQ Rules

IRVINE, CA / ACCESSWIRE / September 7, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has entered into a definitive agreement with a fund managed by Perceptive Advisors, a leading life sciences investment firm, to purchase $20 million of its common stock and pre-funded warrants in a registered direct offering priced at-the-market under Nasdaq rules.

The offering consists of 2,540,650 shares of common stock and pre-funded warrants at a purchase price of $7.8720 per share. The gross proceeds are estimated to be $20 million before deducting the placement agent's fees and other estimated offering expenses. The closing of the offering is expected to take place on or about September 9, 2021, subject to the satisfaction of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as exclusive placement agent in connection with the offering.

The securities described above are being offering by Hancock Jaffe Laboratories, Inc. pursuant to a registration statement on Form S-3 (File No. 333-237592) that was previously filed with the Securities and Exchange Commission (SEC) and declared effective on April 16, 2020. Such shares of common stock and pre-funded warrants may be offered only by means of a prospectus, including a prospectus supplement. A prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, NY 10019 or by email at prospectus@ladenburg.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction

About Hancock Jaffe Laboratories, Inc.

HJLI specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI 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. 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 closing of the offering) may differ significantly from those set forth or implied in the forward-looking statements.

INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
HJLI@jtcir.com
(833) 475-8247

MEDIA CONTACT:

Michelle McAdam, Chronic Communications, Inc.
michelle@chronic-comm.com
(310) 902-1274

SOURCE: Hancock Jaffe Laboratories, Inc.



View source version on accesswire.com:
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Released September 7, 2021

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- Goal of FDA Breakthrough Device Program is to speed up development by giving priority to devices that treat life-threatening or irreversibly debilitating conditions

- Company preparing to begin SAVVE U.S. pivotal trial for VenoValve

- VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe Chronic Venous Insufficiency in the deep veins of their legs

IRVINE, CA / ACCESSWIRE / August 3, 2021 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) ("Hancock Jaffe" or the "Company"), a developer of medical devices that restore cardiac and vascular health, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the VenoValve®, the Company's lead product, which is currently set to begin its U.S. pivotal trial. The FDA's Breakthrough Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.

The VenoValve is a potential treatment for a condition called Chronic Venous Insufficiency (CVI), a disease that afflicts approximately 2.4 million people in the U.S. CVI 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.

"We are very pleased to have the opportunity to work with the FDA on an expedited basis as we try to bring relief to the millions of patients who suffer from deep venous CVI and who currently have no effective treatment options," said Hancock Jaffe CEO Robert Berman. "The VenoValve significantly improved the lives of the patients in our first-in-human study, and we hope to replicate that success in our SAVVE U.S. clinical trial."

Data from the VenoValve first-in-human study, presented in December of 2020, indicated that average patient improvement in reflux was 54 percent, average improvement in disease manifestations (measured by rVCSS scores) was 56 percent, and average improvement in pain (measured by VAS scores), was 76 percent, all at one-year post-VenoValve surgery compared to pre-surgery levels. In addition, there were no material adverse events (MAEs) at 30 days post-VenoValve implantation.

The primary endpoints for the Company's SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of MAE in less than 10 percent of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30 percent at six months following VenoValve surgery. 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.

Preparation to begin enrollment of 75 patients at up to 20 centers throughout the U.S. for the SAVVE pivotal trial are being finalized, with the first patient expected to be enrolled in the study within the next 60 days. Interested patients can learn more about the SAVVE trial by visiting www.venovalve.com.

The goal of the FDA's Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the Agency's mission to protect and promote public health.

HJLI Chart

HJLI down due to pricing of its upsized underwritten public offering of units for gross proceeds of approximately $36 million, prior to deducting underwriting discounts and commissions and offering expenses payable by the company.

The public offering is comprised of 5,142,856 units, priced at a public offering price of $7.00 per unit, consisting of an aggregate of 5,142,856 shares of common stock and warrants to purchase 2,571,428 shares of common stock. The warrants have an exercise price of $7.00 per share and are exercisable for five years. The securities comprising the units are immediately separable and will be issued separately.

The closing of the public offering is expected to take place on or about February 11, 2021, subject to the satisfaction or waiver of customary closing conditions.

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Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meetingwith FDACompany to Move Forward with Application for VenoValve U.S. Pivotal Trial

IRVINE, California, January 12, 2021 – Hancock Jaffe Laboratories, Inc.(Nasdaq: HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully concluded its VenoValve Pre-IDE meeting with the U.S. Food and Drug Administration (“FDA”). Topics presented at the meeting included the background and clinical need for the VenoValve, proposed study design, patient monitoring for safety and efficacy, bench testing protocols, and the VenoValve first-in-human results.

The proposed protocol for the U.S. pivotal trial is expected to be very similar to the protocol that was used for the VenoValve first-in-human study, which was successfully completed at the end of 2020, and which included endpoints for reflux time (the backwards flow of blood), VCSS scores (disease manifestations), VAS scores (pain), and VIENES quality of life scores. Patients enrolled in the first-in-human study experienced significant improvements in all study endpoints with no device related adverse events. Robert Berman, Hancock Jaffe’s Chief Executive Officer stated, “The Pre-IDE meeting with the FDA could not have gone better and is the last step before we file our application seeking approval to begin the VenoValve U.S. pivotal trial. Our first-in-human trial design provides an excellent roadmap for what we hope will be a successful pivotal trial and we look forward to filing our IDE application and working with the FDA to obtain IDE approval to begin patient enrollment.”


HJLI expects to propose a single-arm, multi-center study of an estimated seventy-five (75) patients. Depending on the results of the proposed pivotal study, HJLI could be eligible to apply for pre-market approval (“PMA Approval”) to market the VenoValve as early as six (6) months after the last patient in the pivotal trial receives their VenoValve implant. The proposed study will also include a multi-year follow-up observation period. Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of a Class III medical device before the device can be marketed to the public. Due in part to HJLI’s positive first-in-human results, provided that HJLI experiences similar results in the U.S. pivotal trial, feedback from the FDA indicated that a six (6) month study period prior to filing for PMA approval could be sufficient.
{00889796.DOCX.1}Several key opinion leaders and well-respected vascular surgeons from leading hospitals around the country have already expressed significant interest in participating in the VenoValve U.S. pivotalstudy. HJLI expects to file its IDE application in the first quarter of 2021 and will provide periodicupdates regarding site selection, IDE approval, and other important factors related to the proposed U.S. pivotal trial as HJLI progresses through the IDE approval process. In the event that the FDA has no major changes to the Pre-IDE testing that has been completed, HJLI expects to be in a position to begin patient enrollment for the U.S. pivotal trial as early as the end of the second quarter of 2021. The VenoValve was designed to treat a condition called chronic venous insufficiency (“CVI”), which occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards, which is known as reflux. Reflux results in increased venous pressure (venous hypertension), damage to the veins, and results in the pooling of blood in the lower leg. Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg.Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 Billion

Hancock Jaffe Deemed Compliant With All NASDAQ Continued Listing Requirements

Company Regains Compliance with NASDAQ Minimum Bid Requirement

IRVINE, CA / ACCESSWIRE / December 21, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the Company has received formal notification from the NASDAQ Hearings Panel (the "Panel") that the

Company has evidenced full compliance with the minimum bid price requirement and all other applicable criteria for continued listing on The NASDAQ Stock Market, that all compliance matters have been resolved, and that the Panel has closed the HJLI compliance file.

To evidence compliance with the minimum bid requirement, the Company needed to evidence a closing bid price of at least $1.00 per share for a minimum of ten, but generally not more than 20, consecutive business days. The Panel has determined to continue the listing of the Company's securities on The NASDAQ Stock Market and the Company has no further deficiencies.

About Hancock Jaffe Laboratories, Inc.

HJLI specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases. HJLI 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. For more information, please visit HancockJaffe.com.

HJLIW $2 TARGET PRICE TODAY WOOHOOOOOOOOOO

How we looking now?? Look at the post I’m replying to.

* * $HJLI Video Chart 12-11-2020 * *

Link to Video - click here to watch the technical chart video

Woof woof

GidDy uP HJLI...

HJLI... 11/24/2020...
8-K
https://www.otcmarkets.com/filing/html?id=14525980&guid=_ZqeU61SCPUg83h
S-1-A...https://www.otcmarkets.com/filing/html?id=14525142&guid=_ZqeU61SCPUg83h

HJLI...November 23, 2020...
Hancock Jaffe's VenoValve(R) Results Featured in Journal of Vascular Surgery Venous and Lymphatic Disorders

Preliminary First-in-Human Study Results Published in Peer-Reviewed Journal

IRVINE, CA / ACCESSWIRE / November 23, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the Journal of Vascular Surgery Venous and Lymphatic Disorders, published a paper featuring interim results from the VenoValve first-in-human trial. The article entitled "Human Trial Using the Novel Bioprosthetic VenoValve in Patients with Chronic Venous Insufficiency" is published online on the journal's website. This article emanated from a presentation on the VenoValve given at Southern Association of Vascular Surgery, January 8, 2020 conference in Palm Beach, Florida by Dr. Jorge Ulloa, the principal investigator for the study as well as President of Vascular Society of Colombia.

Dr. Marc Glickman, HJLI's Senior Vice President and Chief Medical Officer and co-author of the article stated, "JVS represents the pinnacle of peer-reviewed journals for vascular surgery. The journal focuses on latest and most innovative devices and treatments for vascular disease and is widely read by vascular surgeons and health care professionals. We are thrilled to have the opportunity to inform the medical community about our progress with the VenoValve".

HJLI expects to release additional updated results from the VenoValve first-in-human trial throughout the fourth quarter as additional patients complete the one-year study. The first phase of the Colombian study, during which all 11 patients will have achieved the important one-year milestone, will conclude in December of 2020. Preparations have begun for HJLI to file the IDE application with the U.S. Food and Drug Administration for the VenoValve U.S. Pivotal trial, which the company expects to file in Q1 of 2021.

The VenoValve is a porcine based bioprosthetic device that is implanted in the deep femoral vein of the leg to treat a condition called Chronic Venous Insufficiency ("CVI"). CVI occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards ("reflux"), and increasing pressure in the veins of the leg ("venous hypertension"). Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg. The VenoValve has demonstrated the potential to improve reflux, alleviate disease manifestations, reduce pain, promote venous ulcer healing, and significantly improve the quality of the lives of the 8 VenoValve patients that have completed the study to date.

Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 Billion a year. There are currently no FDA approved devices, or effective treatments for deep venous CVI.

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is the premier international journal of medical, endovascular, and surgical management of venous and lymphatic disorders. An abstract of the article can be accessed here: https://www.jvsvenous.org/article/S2213-333X(20)30636-3/fulltext#secsectitle0010 with public access to the full article soon to follow.

https://www.otcmarkets.com/stock/HJLI/news/story?e&id=1749975

HJLI... Daily bullish psar flip... GidDy uP HJLI...

http://schrts.co/cKSfPiCH

Does anyone has an idea of the price of such a device?

More great news released. First vein surgery completed successfully.

I have to be honest here. This stock makes no sense because we have had multiple good PR in the last weeks and we get only a minor blip and then it drops. They have two great medical products both of which appear to be far better than existing treatments.

Hancock Jaffe Announces One Year Follow-up Data on Ninth VenoValve Patient
Wednesday, October 21, 2020 12:15 PM
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Topic: Company Name Change
Patient Continues to Show Significant Improvement at One Year

IRVINE, CA / ACCESSWIRE / October 21, 2020 / Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI, HJLIW), a developer of medical devices that restore cardiac and vascular health, announced today that the ninth VenoValve patient in HJLI's first-in-human, clinical study has successfully reached the one-year milestone. Patient 9's chronic venous insufficiency ("CVI") has dramatically improved when compared to pre-surgery levels, with reflux (the backwards flow of blood) improving 75%, disease manifestations as measured by a venous clinical severity scores ("VCSS") improving 73%, and pain, as measured on a visual analog scale ("VAS"), improving 100%.



The patient's presurgery levels for reflux, VCSS, and VAS were 2, 16, and 5, respectively. At one year post surgery, those levels were 0.5, 4, and 0, respectively. The improvement in reflux is significant, as the patient now has reflux in the range of what you would expect in a normal patient, without CVI. The VCSS improvement of 12 points means that the patient went from having an active ulcer and severe CVI, to barely any visible signs of the disease. A VAS score of 0 means that the patient is now completely pain-free. Overall, nine VenoValve patients have now completed the one-year first-in-human trial.

Dr. Marc H. Glickman, Hancock Jaffe's Senior Vice President and Chief Medical Officer stated, "It is remarkable for a patient who had severe chronic venous insufficiency to be completely pain free one year after VenoValve surgery. Our goal was never perfection and was to achieve marginal improvement in the lives of patients who suffer from this debilitating disease and who have no other effective treatment options. Thus far, our results have far exceeded our expectations."

CVI occurs when the valves in the veins of the leg are injured or destroyed, causing blood to flow backwards, which is known as reflux. Reflux results in increased venous pressure (venous hypertension), damage to the veins, and results in the pooling of blood in the lower leg. Deep venous CVI is a serious condition, often resulting in debilitating pain, swelling, and open sores (venous ulcers) on the lower leg. HJLI has implanted VenoValves in 11 patients over the course of a year as part of its first-in-man, Colombian study, which is the pre-cursor to the U.S. pivotal trial. Data is being reported today for the first eight VenoValve patients to reach the critical, one-year milestone. The eight VenoValve patients that are one-year post surgery have now completed the first-in-man, clinical study and this phase of the VenoValve study will conclude in December when the three remaining patients are all one year post surgery.

Next steps for the VenoValve include the continued monitoring of the remaining two VenoValve patients in Colombia, a Pre-IDE filing with the U.S. Food and Drug Administration ("FDA"), the completion of a series of functional tests and a GLP study mandated by the FDA, and the filing of an IDE application with the FDA, seeking approval to begin the U.S. pivotal trial, which HJLI expects to file in the first quarter of 2021.

Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 Billion a year. There are currently no FDA approved devices, or effective treatments for deep venous CVI.

Sorry to hear that... The Veno valve results and photos are also quite amazing, so two great products in the pipe.

Super excited, hoping for the best outcome for ourselves and the patients involved. Heart disease run rampant in my family. Any advancement in technology for heart disease is a plus. Fingers crossed.

News out

Agreed

$HJLIW is going to make investors some huge money in the fourth quarter here when some press releases drop. I think the gains there will be much bigger than the main stock. Much bigger. Something to consider

Still waiting

Get ready for the dump.

Easy short here.

Scam company without an ounce of Lithium.

This pos will never make it past 15.

We will short this one and keep profiting from this no Lithium scam company.

Price should hopefully pickup after most recent news today. Just part of news to come!

Direct offering. Closes Friday.

What’s happening

Lot’s of good potential PR this quarter some of which has potential to send it sky rocketing. They have what appears to be two great products which can make a significant difference in lives. I am playing long on this one.

Then will bounce again on Thursday for potential prs then drop again. Whats the problem w making money. Penny stocks re a gamble, just play money.

Ironic that we are over 20% lower now, eh?

In garbage penny stocks like this, never put faith into "after hours trades". All it takes is some know nothing to click on buy without caring about the price (which is typical of these markets), and people want to celebrate... "look at the after hours trade! We're going even higher tomorrow"... until it doesn't.

They probably didn't even know how to use google to do proper due diligence before buying!

Strong support @ 42. I can hold for 3 more months. Multiple pr’s are yet to drop before eoy.

Look at that after hours spike! Super excited for the $HJLIW shares I own!! The warrants are where the big money will be made here.

I would expect trial update news before merger news. Either way, lots of news coming between now and EOY.

I’m thinking so. AH hit 53