SUZHOU, China, April 24, 2021 /PRNewswire/ -- A new interventional solution from China for structural heart disease is about to be launched onto the market. Recently, TaurusOne® Transcatheter Aortic Valve Replacement System (hereinafter referred to as "TaurusOne®") developed by Peijia Medical (Suzhou) Co., Ltd., located in Suzhou Industrial Park, Jiangsu Province, was officially approved for commercialization by the National Medical Products Administration of the PRC ("NMPA") with registration number GXZZ 20213130275.Academician Gao Runlin of Fuwai Hospital Chinese Academy of Medical Sciences served as Principal Investigator for the TaurusOne® registration clinical trial completed by National Centre for Cardiovascular Disease, Fuwai Hospital, The Second Affiliated Hospital ZheJiang University School of Medicine, West China Hospital of Sichuan University, General Hospital of Northern Theater Command, the Second Affiliated Hospital of Harbin Medical University and the Second Xiangya Hospital of Central South University (in order of institution codes listed in the multi-center clinical trial protocol). The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA). One-year clinical study data for TaurusOne® definitively confirmed its safety and effectiveness as a treatment for severe aortic stenosis, with no significant difference in clinical results between the bicuspid aortic valve and tricuspid aortic valve."The NMPA registration approval of TaurusOne® is an important milestone for Peijia," said Dr. Zhang Yi, Chairman and CEO of Peijia Medical, "From now on, doctors in China will have a new product to conduct TAVR procedures, while patients suffering from aortic stenosis will have an additional solution."TaurusOne® consists of a prosthetic aortic valve, a delivery catheter and a compression loading system. The aortic valve leaflet is made of bovine pericardium and is processed with a proprietary anti-calcification technique. The stent's inflow end has an enhanced radial force design, given that China has a large proportion of patients with high aortic valve calcification or bicuspid aortic valves. A balanced waist design avoids blockage of the coronary artery while also maintaining a large orifice area. The inflow end is designed with inner and outer skirts to effectively avoid or reduce paravalvular leakage. The delivery catheter is ergonomically designed with a large handle for accurate operations; the catheter has a maximum outer diameter of 18 Fr and is divided into several segments for easier, more flexible passage and delivery.Data shows that the global market of TAVR reached USD 5 billion in 2020 and is expected to maintain a high growth rate. In China, the TAVR market is still at an early development stage, suggesting enormous potential. Explosive growth is anticipated in near future to bring the industry to RMB 5.06 billion in 2025.
The approval of TaurusOne® marks Peijia Medical's entry into the commercialization of TAVR products. With TAVR products as a cornerstone of the company's structural heart disease product line, Peijia Medical will focus on independent R&D and design to build a more complete portfolio for clinical practice and demonstrate its whole-process R&D and productive capacity in the field of structural heart disease. TaurusElite®, Peijia Medical's second-generation TAVR product, is currently in registration stage, while the company's third-generation TAVR product TaurusNXT® is in preclinical preparations. Peijia Medical's success in obtaining an "expedited" approval for TaurusOne® is largely due to the company's rigorous and solid work at the product's preliminary stages. It also shows China's regulatory authorities' encouragement and support for innovation, as well as the company's rigorous innovation and meticulousness in product development, in line with its credo:"Devotion to the Heart, Reverence for Life, and Pursuit of the Most Satisfying Clinical Products".About Peijia Medical:Peijia Medical was founded in 2012 and its headquarters are in Suzhou, Jiangsu Province, China. It was listed on the Hong Kong Stock Exchange in May 2020 (stock code 09996. HK). With "Devotion to the Heart, Reverence for Life" as its vision, Peijia Medical always puts life and safety in the first place, striving to maintain human life and health with its years of exploration in technology and its persistence in innovation. Peijia Medical's strategic layout can be summarized as the "Innovation-oriented, Simultaneous Treatment of Cardiovascular and Cerebrovascular Diseases". It is dedicated to the innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular interventions—covering aortic valve, mitral valve, tricuspid valve, surgical accessories, and diseases related to hemorrhage, ischemia and pathways in cerebrovascular intervention. It has built a relatively comprehensive product and solutions portfolio in the field of structural heart disease and cerebrovascular interventions in China. View original content:https://www.prnewswire.com/news-releases/peijia-medicals-taurusone-transcatheter-aortic-valve-replacement-system-approved-for-commercialization-301276343.htmlSOURCE Peijia Medical
The Academy of Country Music®, dick clark productions, and Wells Fargo announced today 55th Academy of Country Music Awards™ performer Mickey Guyton will appear in a special moment airing during the telecast to help raise awareness around the issue of hunger during the COVID-19 pandemic. Working with Feeding America®, the largest domestic hunger-relief organization in the country, and its network of member food banks, Wells Fargo is turning many of its locations across the country into mobile food distribution centers with the goal of providing 50 million meals* to individuals and families through the Wells Fargo Drive-Up Food Bank program.
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Country Music star Mickey Guyton will appear in a special moment airing during the 55th Academy of Country Music Awards on September 16 at 8pm ET/PT on CBS to help raise awareness around the issue of hunger during the COVID-19 pandemic. (Photo: Business Wire)
Additionally, Wells Fargo is joining forces with ACM Lifting Lives®, the philanthropic arm of the Academy of Country Music, and donating $100,000 to the ACM Lifting Lives COVID-19 Response Fund. Created in response to the growing need, the fund assists individuals working in the Country Music industry who are suffering a financial crisis as a result of the pandemic. This donation is in addition to the more than $175 million the Wells Fargo Foundation has donated to help address critical community needs such as food assistance, financial health, small business, and housing stability in communities across the United States since the beginning of the pandemic.
"We are delighted to work with Wells Fargo for the 55th ACM Awards show this year and honored to have Mickey Guyton spotlight and raise awareness on the continued efforts of improving communities across the country,” said Lyndsay Cruz, executive director of ACM Lifting Lives. "Wells Fargo has provided countless resources for people to turn to during these challenging times, and their generous donation to the ACM Lifting Lives COVID-19 Response Fund will further assist those still in need in the Country Music industry seeking financial assistance.”
Hosted by reigning ACM® Entertainer of the Year and 15-time ACM Award winner Keith Urban, the 55th ACM Awards®, a Night of Heart and Hits Live from Nashville, Tennessee, will be broadcast on Wednesday, Sept. 16, (live 8:00-11:00 p.m. Eastern time/delayed Pacific time) on the CBS Television Network, and will be available to stream on demand on CBS All Access.
For the first time in the show’s history, the awards will take place in Nashville, broadcasting from three iconic Country Music venues: Grand Ole Opry House, Nashville’s historic Ryman Auditorium, and The Bluebird Cafe. As previously announced, the 55th ACM Awards will also feature performances by Jimmie Allen, Kelsea Ballerini, Gabby Barrett, Kane Brown, Luke Bryan, Eric Church, Luke Combs, Dan + Shay, Florida Georgia Line, Riley Green, Miranda Lambert, Tim McGraw, Maren Morris, Old Dominion and Thomas Rhett featuring Jon Pardi, Blake Shelton featuring Gwen Stefani, Tenille Townes, Carrie Underwood, Morgan Wallen, Trisha Yearwood and more to be announced.
Multimedia assets about the Wells Fargo Drive-Up Food Bank program can be found in the Wells Fargo Newsroom. For more information, visit ACMcountry.com. You can also like Academy of Country Music on Facebook, follow on Twitter at @ACMawards, follow on Instagram at @ACMawards, and sign up for the free ACM A-List for more immediate updates.
*50 million meals calculation is based on 1) Projected number of meals distributed through Wells Fargo Drive-Up Food Bank events and 2) Wells Fargo’s financial contributions to support Feeding America food banks 7/20/20-10/31/20. $1 helps provide at least 10 meals secured by Feeding America on behalf of local member food banks.
About Mickey Guyton
Mickey Guyton was born in Arlington, Texas, and began singing in church at a young age. She was drawn to a variety of artists with big voices including Dolly Parton, Cece Winans, Whitney Houston, and LeAnn Rimes. After signing to Capitol Records Nashville, Mickey’s first appearance was an all-star concert at the White House captured by PBS. In 2015, she released her self-titled EP featuring her debut single, "Better Than You Left Me.” The following year she was nominated for her first Academy of Country Music Award for New Female Vocalist. Mickey returned to the ACM Awards in 2019 performing "I’m Standing With You” from the BREAKTHROUGH movie soundtrack alongside Chrissy Metz, Carrie Underwood, Lauren Alaina, and Maddie & Tae. During the last few years, Mickey has been focused on her songwriting and will release her EP, Bridges, on Sept. 11. Bridges will include "What Are You Gonna Tell Her?”, which Variety called "... exquisitely sung, moving and brilliant,” as well as, "Black Like Me,” a song Mickey cowrote in March 2019 at a cross-genre writing camp. Due to demand, "Black Like Me” was released in June and has been praised by critics and fans alike, with HITS noting the song "nudges America’s conscience with personal truth and gospel fervor.” Her latest single, "Heaven Down Here,” was written in recent months as a plea to God to spare a little love for this world in need. Mickey and her music have been featured recently by The New York Times, CBS This Morning, NPR, Billboard, The Los Angeles Times, Entertainment Weekly, ELLE, Paste, Rolling Stone, The Wall Street Journal, American Songwriter, and Pollstar.
About the Academy of Country Music Awards™
The 55th Academy of Country Music Awards™ is dedicated to honoring and showcasing the biggest names and emerging talent in the Country Music industry. The show is produced for television by dick clark productions and will broadcast live on Wednesday, Sept. 16, 2020, on the CBS Television Network, and will be available to stream live and on-demand on CBS All Access. R.A. Clark, Amy Thurlow, Barry Adelman, Mark Bracco, and Linda Gierahn are executive producers. Damon Whiteside is executive producer for the Academy of Country Music.
About ACM Lifting Lives®
ACM Lifting Lives® is the philanthropic arm of the Academy of Country Music dedicated to improving lives through the power of music. Through partnerships with artists and strong ties in the music industry, ACM Lifting Lives® funds music health programs while also serving members of the music community who face unexpected hardships through its Diane Holcomb Emergency Relief Fund. With generous donations and the support of artists and fans, ACM Lifting Lives® has funded national music therapy programs serving various mental and physical health organizations. Some of the recipients have included patients at children’s hospitals and other healthcare facilities, recovering veterans, people with Williams syndrome, and individuals with mental illness. For more information, please visit www.ACMLiftingLives.org.
About Wells Fargo
Wells Fargo & Company (NYSE: WFC) is a diversified, community-based financial services company with $1.97 trillion in assets. Wells Fargo’s vision is to satisfy our customers’ financial needs and help them succeed financially. Founded in 1852 and headquartered in San Francisco, Wells Fargo provides banking, investment and mortgage products and services, as well as consumer and commercial finance, through 7,300 locations, more than 13,000 ATMs, the internet (wellsfargo.com) and mobile banking, and has offices in 31 countries and territories to support customers who conduct business in the global economy. With approximately 266,000 team members, Wells Fargo serves one in three households in the United States. Wells Fargo & Company was ranked No. 30 on Fortune’s 2020 rankings of America’s largest corporations. News, insights, and perspectives from Wells Fargo are also available at Wells Fargo Stories.
Additional information may be found at www.wellsfargo.com | Twitter: @WellsFargo.
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