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Hancock Jaffe Announces Corporate Rebranding to Reflect Prioritization of its Development Pipeline on Venous Disease Programs

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  • 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

IRVINE, CA / ACCESSWIRE / 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 pipeline.

“The 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.”

Effective 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.

The 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.

In 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.

CVI 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.

Conference Call Details

As 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.

About Hancock Jaffe Laboratories, Inc.

Hancock 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.

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, 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 law.

###

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/664914/Hancock-Jaffe-Announces-Corporate-Rebranding-to-Reflect-Prioritization-of-its-Development-Pipeline-on-Venous-Disease-Programs

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Source: https://www.biospace.com/article/releases/hancock-jaffe-announces-corporate-rebranding-to-reflect-prioritization-of-its-development-pipeline-on-venous-disease-programs/?s=93

Medical Devices

Paragon 28, Inc. Announces Pricing of Initial Public Offering

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Oct. 15, 2021 02:35 UTC

ENGLEWOOD, Colo.–(BUSINESS WIRE)– Paragon 28, Inc. (NYSE: FNA) (“PARAGON”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced the pricing of its initial public offering of 7,812,500 shares of its common stock at a public offering price of $16.00 per share, for total gross proceeds of $125.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the shares are being offered and sold by PARAGON. PARAGON’s common stock is expected to begin trading on the New York Stock Exchange on October 15, 2021, under the ticker symbol “FNA.” The offering is expected to close on October 19, 2021, subject to the satisfaction of customary closing conditions. In addition, PARAGON has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

BofA Securities and Piper Sandler are acting as joint lead book-running managers for the offering. Canaccord Genuity is acting as a lead manager. JMP Securities and Needham & Company are acting as co-managers.

A registration statement relating to the shares being sold in this offering was declared effective by the U.S. Securities and Exchange Commission on October 14, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20211014006180/en/

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Source: https://www.biospace.com/article/releases/paragon-28-inc-announces-pricing-of-initial-public-offering/?s=93

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Medical Devices

Apollo Endosurgery Announces Closing of Public Offering and Exercise in Full of Option to Purchase Additional Shares

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AUSTIN, TX / ACCESSWIRE / October 15, 2021 / Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced today the closing of its previously announced underwritten public offering. Apollo sold 9,660,000 shares of its common stock, including 1,260,000 shares sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares, at a public offering price of $7.75 per share for gross proceeds of approximately $75 million, before deducting underwriting discounts and commissions and offering expenses.

Piper Sandler, Cowen and Stifel acted as the joint book-running managers for the proposed offering. Craig-Hallum and Lake Street acted as co-managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by Apollo with the Securities and Exchange Commission (the “SEC”), which was declared effective by the SEC on May 19, 2021. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus related to the offering may be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at prospectus@psc.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com.

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

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, less invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications and the treatment of obesity. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 75 countries today and include the X-Tack® Endoscopic HeliX Tacking System, the OverStitch® Endoscopic Suturing System, the OverStitch Sx® Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.

CONTACT:

Apollo Endosurgery, Inc.
Jeff Black, 512-279-5126
investor-relations@apolloendo.com

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com

SOURCE: Apollo Endosurgery, Inc.

View source version on accesswire.com:
https://www.accesswire.com/668389/Apollo-Endosurgery-Announces-Closing-of-Public-Offering-and-Exercise-in-Full-of-Option-to-Purchase-Additional-Shares

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Source: https://www.biospace.com/article/releases/apollo-endosurgery-announces-closing-of-public-offering-and-exercise-in-full-of-option-to-purchase-additional-shares/?s=93

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Medical Devices

Neuvotion Secures over $1M in Seed Funding to Commercialize Neurostimulation Technology

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DARIEN, Conn., Oct. 14, 2021 /PRNewswire/ — Neuvotion, Inc., an early-stage medical device company developing neurostimulation products for the rehabilitation and physical therapy markets, today announced that it has received over $1M in seed funding.  The Long Island Angel Network, an organized group of individual angel investors based on Long Island, and the Good Shepherd Rehabilitation Network,  a nationally recognized rehabilitation leader, have provided the company with its first equity investment. This seed funding will be used by Neuvotion to expand its team, conduct a multi-site clinical study, and seek FDA clearance for its initial product.

Further, Neuvotion secured exclusive worldwide rights to transformative technology developed by its founder, Chad Bouton, who is a professor at the Feinstein Institutes for Medical Research at Northwell Health. “I am inspired by the prospect of helping the millions of patients who have experienced a stroke, traumatic injury, or are living with movement impairment, to reach their goals,” said Chad Bouton, Founder & CEO of Neuvotion. “We are working to commercialize NeuStim™ and other technologies so they can be used in clinical practice, and ultimately in the home to increase quality of life and independence.”

“We have been very impressed with Professor Bouton’s work and are pleased to support its commercialization through our seed investment in Neuvotion,” said Steve Winick, Managing Director of Topspin Fund and member of the Long Island Angel Network. “As a leading provider of rehabilitation services, we see tremendous clinical potential for Neuvotion’s NeuStim technology,” added Michael Spigel, PT, MHA, President & CEO of Good Shepherd Rehabilitation Network. “We look forward to serving as a foundational research partner in Neuvotion’s upcoming multi-site clinical study. We feel strongly that this technology can help transform lives for people with spinal cord injuries, strokes and other neurological conditions.”

About Neuvotion
Neuvotion (www.neuvotion-inc.com) is an early-stage medical device company developing solutions for facilitating and restoring movement to the millions of patients experiencing impairment from stroke, traumatic injury, and other conditions. Its NeuStim™ technology combines highly targeted neurostimulation and artificial intelligence to make physical and occupational therapy more effective and efficient. Neuvotion is planning a multi-site clinical study to begin next year.

About Long Island Angel Network
The Long Island Angel Network (LIAN; http://www.liangels.net/) is a New York not-for-profit corporation consisting of individual angel investors interested in financing early-stage and emerging growth companies, primarily in technology- and innovation-focused areas. LIAN screeners endeavor to select companies for presentation that they judge likely to be of the greatest interest to members, but the Network does not make investment recommendations; investors’ decisions are made individually. LIAN’s goal is to back our region’s most exciting, promising early-stage growth companies.

About Good Shepherd Rehabilitation Network
Good Shepherd Rehabilitation Network (https://www.goodshepherdrehab.org/), a nationally recognized, not-for-profit rehabilitation leader with more than 70 locations throughout Pennsylvania and New Jersey, is committed to transforming lives through expertise, innovation, and compassion. Good Shepherd provides an exceptional patient experience for all ages and stages by developing leading-edge solutions, often for complex medical situations; serving as a test site for the newest rehabilitation technologies; and inspiring hope in all we do. Headquartered in Allentown, Pennsylvania, Good Shepherd also partners with Penn Medicine to provide rehabilitation and specialty services in the greater Philadelphia area and New Jersey through Good Shepherd Penn Partners.

If you would like more information about this topic, please call Travis Millman at +1 (917) 496-3663, or email info@neuvotion-inc.com.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/neuvotion-secures-over-1m-in-seed-funding-to-commercialize-neurostimulation-technology-301399861.html

SOURCE Neuvotion

 

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Source: https://www.biospace.com/article/releases/neuvotion-secures-over-1m-in-seed-funding-to-commercialize-neurostimulation-technology/?s=93

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Medical Devices

FEops HEARTguide Authorized by FDA for Unprecedented LAAo Planning Capabilities

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This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211014005139/en/

“The pre-operative insight provided by FEops HEARTguide™ is powerful and can help me to optimize decision making for selecting optimal device size and position,” said Dr Jacqueline Saw, Vancouver General Hospital, Canada. “FEops HEARTguide™ is an intuitive platform I can use to discuss cases with the entire heart team to streamline my pre-op planning workflow.”

“FDA authorization of FEops HEARTguide™ is a significant milestone as this is the first Interventional Cardiovascular Implant Simulation Software Device cleared on the US market,” said Peter Mortier, PhD, co-founder and CTO of FEops. “Research on this technology began more than 10 years ago. We have continued to develop it with the goal of helping healthcare professionals identify the most appropriate treatment strategy for each patient precisely, safely and efficiently. This De Novo clearance is only a first step, and we are already preparing for FDA 510(k) submissions for FEops HEARTguide™ LAAo workflow with Abbott’s Amplatzer™ Amulet™ device and Boston Scientific’s WATCHMAN FLX™ device.”

*The Owner/Operator Number for this Registration is: 10082838 and the listing number: DEN200030.

FEops HEARTguide™ is a one-in-its-kind procedure planning platform for structural heart interventions that provides physicians with unique insights to evaluate device sizing and positioning pre-operatively. The platform uses digital twin technology based on patient-specific virtual replicas of the heart. Besides the recent FDA clearance to enter the US market with its LAAo workflow with WATCHMAN™, FEops HEARTguide™ is also commercially available in the European Union, UK, Canada and Australia for its TAVI and LAAo workflows.

About FEops HEARTguide™

FEops HEARTguideTM cloud-based procedure planning environment uses digital twin technology to provide clinicians and medical device manufacturers with first-ever insights into the interaction between transcatheter structural heart devices and specific patient anatomy – pre-operatively. Additionally, this includes also a range of quality controlled, validated and AI-enabled** anatomical analyses. Such insights have the power to help ultimately to improve clinical outcomes in real-world hospital settings, as well as to accelerate research and development of novel device-based solutions.

** Currently available only in the European Union, UK, Canada and Australia for its TAVI and LAAo workflows.

About FEops

Privately held FEops, headquartered in Gent, Belgium, is a digital health player offering cloud-based procedure planning solutions in the structural heart space combining digital twin and AI technologies. In September 2017, FEops announced that it closed a 6 million euros financing, led by Valiance, and joined by existing investors Capricorn Partners and PMV. In December 2019, FEops has been awarded a grant of Euro 3.2 million from the European Innovation Council (EIC) accelerator programme.

www.feops.com

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Source: https://www.biospace.com/article/releases/feops-heartguide-authorized-by-fda-for-unprecedented-laao-planning-capabilities/?s=93

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