conix
3年前
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:
https://www.accesswire.com/662829/Hancock-Jaffe-Laboratories-Announces-20-Million-Registered-Direct-Offering-Priced-At-the-Market-Under-NASDAQ-Rules
Released September 7, 2021
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Techmozz
4年前
- 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.
dealerschool2006
4年前
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.
https://finance.yahoo.com/news/hancock-jaffe-laboratories-announces-pricing-133000959.html?guccounter=1&guce_referrer=aHR0cHM6Ly9maW52aXouY29tL3F1b3RlLmFzaHg_dD1ISkxJ&guce_referrer_sig=AQAAAFufyBdpJkUcOyiIxm6m3Qa_ZJy6mL5za5ZcXhCccVXMFXCLIzvK8pUHkSs6qai00lI99D_vINVosbtdSIiCL55CRslJ9TE0sGJjSlmiHxowh4li9B4K_F_H2XfS15w9vsZQ0liZYskaMkpiW6HKYkUn7j6NJ0nZ2K6GhDakNNC7
conix
4年前
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
conix
4年前
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.
The GidDy uP Kid
4年前
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
OffTheGrid
4年前
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.
conix
4年前
Hancock Jaffe Announces Positive Nasdaq Listing Determination
September 21, 2020
Extension Granted for Continued Listing
IRVINE, CA / ACCESSWIRE / September 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 that the Nasdaq Hearings Panel (the "Panel") has granted the Company's request for continued listing on The Nasdaq Capital Market pursuant to an extension through December 28, 2020, to evidence compliance with the minimum $1.00 bid price requirement.
To evidence compliance with the rule, the Company must 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 by December 28, 2020. The extension constitutes the full extent of the Panel's discretion in this matter. The Company is taking definitive steps to timely evidence compliance with the terms of the Panel's decision and will provide an update regarding its compliance efforts when available.
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 VenoValveÒ, 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; an
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