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New Access Vascular Clinical Studies Find Catheters Composed of Advanced Biomaterials Significantly Reduce Complication Rates

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Data presented at the AVA Annual Scientific Meeting shows impactful reductions in occlusions, DVT, and phlebitis using materials that mimic the body’s chemistry

BEDFORD, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) — Access Vascular, Inc. (AVI), a company addressing the most common and costly vascular access complications through its advanced biomaterial platform, today shared initial findings from two new clinical studies that demonstrate a significant reduction in complications when using AVI’s consistently hydrophilic materials for peripherally inserted central catheters (PICC) and midline catheters.

Presented at the Association for Vascular Access (AVA) Annual Scientific Meeting 2021, these early findings highlight the potential for catheters made from advanced biomaterials to reduce patient risks, clinician frustration, and medical expense in vascular access and other applications.

Today, the use of polyurethane-based materials results in catheter-related complication rates for 30i-34ii% of insertions because the human body rejects it as a foreign substance. In contrast, AVI’s HydroPICC® and HydroMID™ catheters made from consistently hydrophilic material are designed to mimic the body’s natural chemistry and reduce both intraluminal and extraluminal complications.

The first retrospective clinical study compared complication rates such as occlusions and replacements in 61 standard PICCs and 60 HydroPICCs, respectively. The study found a statistically significant reduction in complication rates for the HydroPICC group.

The second retrospective study compared complication rates of occlusions, replacements, deep vein thrombosis (DVT), and phlebitis in 100 standard midline catheters and 100 HydroMID catheters. While the data analysis is being finalized, the interim data analysis indicates significantly lower DVT and phlebitis rates in the HydroMID group compared to the standard group. In addition, the total failure rate in the HydroMID group was also significantly lower than in the standard group.

“As a clinician, my mission is to deliver the best possible experience to my patients,” said Joe Bunch, RN, CEO of ProVasc Solutions LTD, and principal investigator for both studies. “These studies confirmed my real-world experience with AVI catheters – there are simply no escalations on these lines. That means better patient outcomes and less risk.”

Access Vascular’s HydroPICC and HydroMID catheters are made from an entirely new catheter material designed to work in concert with the body’s natural chemistry, thus helping to reduce both complications and associated medical expense. In use at a number of health systems today, this technology leverages new materials but maintains all current clinician practices and workflows.

“We are extremely pleased to share the results of these studies at the AVA Annual Scientific Meeting and with the broader medical community. This clinical data proves it’s possible to transform patient outcomes and significantly reduce total medical expenses,” said James Biggins, CEO of Access Vascular. “For too long, incremental improvement and high rates of complications have been a reality for vascular access. AVI’s growing family of devices leverages transformational first mile technologies whose ability to remain patent and reduce clinical complications will fundamentally change how treatment is delivered to patients.”

To learn more about Access Vascular and its HydroPICC and HydroMID products, please visit www.accessvascularinc.com/ava2021.

About Access Vascular

Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material which retains significant amounts of water. Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and complications that come with it. Our patented and FDA cleared products are HydroPICC® and HydroMID™. For more information, please visit www.accessvascularinc.com.

Media Contact:
Anastasia Mironova
VP, Strategy & Marketing
(206) 778-6685


i Grau D, Clarivet B, Lotthé A, Bommart S, Parer S. Complications with peripherally inserted central catheters (PICCs) used in hospitalized patients and outpatients: a prospective cohort study. Antimicrob Resist Infect Control. 2017;6(1):18.

ii Leroyer C, Lashéras A, Marie V, et al. Prospective follow-up of complications related to peripherally inserted central catheters. Med Mal Infect. 2013;43(8):350-355.


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Source: https://www.biospace.com/article/releases/new-access-vascular-clinical-studies-find-catheters-composed-of-advanced-biomaterials-significantly-reduce-complication-rates/?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 [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at [email protected], 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 [email protected]; 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 [email protected]; 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 [email protected].

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
[email protected]

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
[email protected]

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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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 [email protected].

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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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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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