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TAMPA, Fla., Feb. 13, 2023 /PRNewswire/ -- Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon. Magic Touch PTA has received US FDA IDE approval for its BTK indication The Magic Touch PTA Sirolimus Coated Balloon Catheter is indicated for the treatment of Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Disease. CMI received their first IDE approval for their Magic Touch Sirolimus Coated Balloon for the Coronary ISR indication earlier in September 2022. The Magic Touch PTA Sirolimus Coated Balloon Catheter has also been granted with a breakthrough device designation in BTK by the US FDA. Currently, Plain Old Balloon Angioplasty (POBA) is the standard of care for the treatment of the BTK arterial occlusion disease, along with few recently approved Paclitaxel Coated Balloons as well as stents. The IDE approval will allow Concept Medical to gather safety and effectiveness data for the Magic Touch PTA Sirolimus Coated Balloon to support a future Premarket Approval (PMA) in the USA, providing patients and physicians with an alternate product for the treatment of BTK arterial disease. The CE marked Magic Touch PTA Sirolimus Coated Balloon Catheter has already been widely studied in multiple clinical trials outside the United States (OUS) and has shown promising safety and efficacy results. The product is currently being investigated in Europe in two randomized controlled trials (RCTs) for the BTK indication. The LIMES RCT is a study designed to compare the Magic Touch PTA Sirolimus Coated Balloon Catheter against POBA, while the Debate BTK Duell is a study against Paclitaxel coated balloon catheter. Prof. Sahil Parikh (Columbia University Irving Medical Center, USA) who has been encouraging innovative technologies in Peripheral Intervention in the USA, stated that, "Concept Medical's proposed clinical trial studying the Magic Touch PTA in BTK indication, will collect significant data on safety and efficacy of the device, thus paving its way to treat patients in US. With Sirolimus Coated Balloon already receiving an IDE approval in coronary arteries, and breakthrough device designations for multiple indications, along with the vast OUS clinical data, it will surely be looked up to by the US physicians and patients with PAD." Prof. Edward Choke (Sengkang General Hospital, Singapore), one of the early investigators of the Magic Touch PTA Balloon and who possibly has the widest experience with the device, and is also conducting a RCT against POBA – FUTURE BTK adds, "The field of BTK angioplasty needs effective solutions to its problem of poor patency rates. This is an exciting phase III trial that will determine whether the novel Magic Touch PTA Sirolimus coated balloon can maintain the patency of BTK arteries for a longer period of time, compared with our current gold standard of plain balloon angioplasty. This is a key goal in our efforts to reduce the number of repeated interventions and to save the legs of our patients with the severest form of peripheral arterial disease. If successful, this has the potential to be a game changer." About Magic Touch PTA Magic Touch PTA is a CE approved and commercially marketed Sirolimus DCB, developed using proprietary Nanolute Technology– the drug delivery technology platform of Magic Touch PTA balloon, is designed to deliver sub-micron particles of Sirolimus to reach the deepest layers of the vessel walls. About Concept Medical Inc. CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.
Audits in the supply chain of the toy industry / TÜV Rheinland successfully goes through qualification process of the ICTI Ethical Toy Program (IETP). BANGALORE, India, Feb. 13, 2023 /PRNewswire/ -- TÜV Rheinland can start offering audits as part of the ICTI Ethical Toy Program (IETP) with immediate effect. The globally active testing service provider has now qualified to neutrally and independently audit companies' compliance with the standards defined by the IETP. To become part of the program, TÜV Rheinland successfully went through a qualification process that included scrutinizing the quality of TÜV Rheinland's audits and the company's own compliance systems. TUV Rheinland factory audit In the future, TÜV Rheinland auditors will audit supplier companies in the toy industry, primarily in China and Southeast Asia. Compliance with social and environmental standards in the supply chain is becoming increasingly important, not least due to legal requirements. By getting certified according to the standards of the IETP, suppliers can show their customers that they reliably comply with the required social and environmental standards. The standards defined in the IETP deal, for example, with occupational safety, exclusion of child labor and all forms of modern slavery, and compliance with environmental regulations. The IETP is an independent, non-profit organization founded in 2004 to secure and improve ethical and sustainable standards in the global supply chain of the toy industry. Member companies include the likes of Mattel, Lego and Walmart. Further information on supply chain audits by TÜV Rheinland is available at www.tuv.com/supply-chain-audits. About TÜV Rheinland: TÜV Rheinland stands for safety and quality in virtually all areas of business and life. The company has been operating for more than 150 years and ranks among the world's leading testing service providers. It has more than 20,000 employees in over 50 countries and generates annual revenues of around 2.1 billion euros. TÜV Rheinland's highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards. In doing so, the independent experts generate trust in products as well as processes across global value-adding chains and the flow of commodities. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.tuv.com Media Contact: Samrat SinhaE: Samrat.Sinha@ind.tuv.comM: +91 9880307376
PETALING JAYA, Malaysia, Feb. 13, 2023 /PRNewswire/ -- In collaboration with Ziemer Ophthalmic Systems AG (Ziemer), one of the leading Ophthalmic companies based in Switzerland, VISTA Eye Specialist (VISTA) will be hosting surgeons from around the world on 22nd February, to participate in a variety of activities featuring the Ziemer LDV Z8 Femtosecond Laser Platform - one of the most advanced laser platforms in the world. A first ever in Malaysia, the event will be held prior to the 38th Asia-Pacific Academy of Ophthalmology Congress in Kuala Lumpur on the 23rd of February. Over 50 eye surgeons from over 10 countries are expected to attend this showcase. VISTA Eye Specialist to showcase latest eyecare technology by Ziemer Ophthalmic Systems AG on 22nd-23rd Feb in their Petaling Jaya Center. "Our collaboration with VISTA is focused on an educational aspect and an opportunity for aspiring doctors to be able to understand the Z8 technology through experience - hence named - Ziemer Experience Center with VISTA. The Z8 low energy laser is the only Laser platform in the world that is able to perform different femto laser applications such as Flap Creation for LASIK, Femtosecond Assisted Laser Cataract Surgery (FLACS), Corneal Lenticule Extraction (CLEAR) and many other cornea applications," explains Dominique Van Herzeele, Sales Director at Ziemer. "The experience center offers opportunities to witness LASIK and FLACS live surgeries performed by VISTA surgeons, while also being able to hands-on experience CLEAR in the wetlab offered on-site." There will also be Presentations and a Panel Discussion on these advanced technologies. The "experience" for these surgeons also includes the opportunity to hear from experienced Z8 surgeons and users in the region including those from India, Singapore, Korea and also VISTA's own - Dr. Aloysius Joseph Low, the Medical Director and Dr. Alan Koh, the Chief Ophthalmic Surgeon - through experience sharing presentations and also an expert panel discussion. "These presentations will allow visiting surgeons to learn the tips and pearls of wisdom that these speakers have amassed over the years, which will aid them to cut short their learning curve and also help them to achieve better results - hence providing for better patient outcomes," adds Dr. Aloysius. "To allow more surgeons around the world to be able to participate and learn, we will be streaming the presentations and the panel discussion live on Zoom and Facebook. Our goal is that through this event, we will be able to help more doctors to have greater understanding of these latest technologies to help more patients around the world to see from blur to clear, and live life with great vision," ends Grace Heng, Chief Growth at VISTA. About VISTA Eye Specialist Founded in 1999, VISTA is one of the leading eye specialist that specializes in Cataract and Refractive Surgery with 14 clinics across Malaysia. VISTA is committed to changing lives through premium vision care, employing modern technology and clinical practices to provide safer vision correction procedures with the best possible results, "From Blur to Clear".
LOS ALTOS, Calif., Feb. 10, 2023 /PRNewswire/ -- Antaris, creator of the most advanced software platform for space, announced today that the world's first satellite fully conceived, designed and manufactured using the company's end-to-end cloud platform has successfully reached orbit. JANUS-1 rode on the Indian Space Research Organization's (ISRO) SSLV-D2 rocket, which was launched from the Satish Dhawan Space Centre of India under a commercial arrangement with New Space India Limited (NSIL). The satellite features five payloads from a range of global providers, which will be commissioned and begin nominal operations in the coming days. Photograph of JANUS-1 demonstration satellite, the world's first built on the Antaris software platform. "This is a very proud moment for our company and the global space ecosystem," said Antaris Co-Founder and Chief Technology Officer Karthik Govindhasamy. "We did something that has never been done before—we designed, built and launched a complex satellite in just months, not years, at a fraction of traditional costs. Our cloud-based platform made this all possible, and we have proven that this software is the future of the satellite industry." Additional tech demonstration satellites from Antaris and manufacturing partners Ananth Technologies and XDLINX Labs are planned for 2023, including 6U, 12U and 27U satellite reference architectures. Interested parties are encouraged to contact Antaris via www.antaris.space/orbitwithus to learn more about participation. JANUS-1 is a 6U satellite featuring payload and subsystem technologies from AICRAFT, Morpheus Space, Netra, SayariLabs Kenya, SpeQtral, Transcelestial and Zero-Error Systems (ZES) that will perform internet of things (IoT) communications, advanced experimental laser communications, radio communications and machine learning (ML) during orbit. Antaris SatOS software manages core bus responsibilities while orchestrating multitenant payloads and onboard computing—in addition to showcasing secure TT&C protocols with Amazon Web Services (AWS) and ATLAS Space Operations, who are providing ground communications services. The project was completed in just 10 months from concept to launch readiness with a cost savings of 75% over comparable satellite missions. Based on data captured during the build, Antaris anticipates that future spacecraft missions can be ready for launch in as few as six months. While the launch marks the start of JANUS-1's on-orbit mission, the satellite has been 'in flight' for months via the company's unique TrueTwin™ digital twinning technology which creates a digital version of the satellite at the start of the project and then integrates with hardware-in-the-loop as hardware becomes available. "We're so proud of the entire Antaris team and our incredible manufacturing partners," noted Antaris Co-Founder and CEO Tom Barton. "Together, we have broken down major barriers that have historically hampered satellite design and production. We hope JANUS-1 will serve as an inspiration to the entire space ecosystem and look forward to partnering with other New Space pioneers who are ready to go fast and work with us to make space easy." About Antaris™ Antaris software dramatically simplifies the design, simulation and operation of satellites. We bring New Space thinking to an Old Space world, giving our customers maximum control and flexibility while improving time-to-orbit, reducing costs and optimizing engineering reuse. With investors including Lockheed Martin Ventures, Acequia, HCVC and E2MC, Antaris is revolutionizing Software for Space™. Learn more at www.antaris.space
ACEH SINGKIL, Indonesia, Feb. 10, 2023 /PRNewswire/ -- Apical, a leading global vegetable oil processor with an expanding global footprint, together with non-profit organisation, IDH the Sustainable Trade Initiative (IDH), has officially signed a Memorandum of Understanding (MoU) for promoting the Production, Protection, and Inclusion (PPI) Compact in the Aceh Singkil District. The PPI Compact targets will be achieved mainly through the implementation of one of Apical's key programmes, the Sustainable Living Village (SLV) Programme. Apical is part of Royal Golden Eagle or RGE, a global group of resource-based manufacturing companies founded by Sukanto Tanoto. The SLV Programme is a stakeholder-inclusive programme that nurtures sustainable livelihood models through collaboration with partners, communities, and villagers, with an aim to improve community resilience and livelihood sustainability. The SLV Programme will implement activities contributing to the PPI Compact, such as conducting a comprehensive baseline study on Environmental, Social and Governance (ESG) issues to identify threats and opportunities for village-to-landscape level intervention; mapping of stakeholders' plots on the field and identifying High Conservation Value and High Carbon Stock areas; as well as facilitating the incubation of the business case for SLV financing to be feasible and bankable. The MoU represents a mutual commitment to drive positive social impact for the community and environment, and marks the beginning of a three-year partnership. The MoU was signed by the Program Director of IDH, Nassat Idris and the Director of Sustainability at Apical Group, Bremen Yong Kin Kong. The signing of the MoU was witnessed by the District Secretary of Aceh Singkil, Drs Azmi MAP and Head of the Planning Agency of Aceh Singkil, Ahmad Rivai S.H. Aceh Singkil plays a crucial role in protecting the Leuser Ecosystem, consisting of 2.6 million hectares of tropical forest and home to various Sumatran animal species such as the orang utan, rhinocerous, Sumatra tiger, and the elephant. In Singkil, rapid illegal land conversion for oil palm plantations poses a challenge to this vital ecosystem's sustainability. "The Government of Aceh Singkil welcomes and appreciates all parties, IDH, Apical and the communities, that have initiated and are actively involved in the SLV programme. We hope that the SLV Programme will help to elevate positive socio-economic welfare for all," explained Mr Rivai. In February 2022, centred on creating positive social, environmental and business impact, Apical launched its sustainability roadmap, Apical2030. Under the fourth strategic pillar of Apical2030, Inclusive Progress, the SLV programme aims to nurture communities by empowering livelihoods. The SLV programme strives to alleviate poverty, as well as uplift and nurture communities by fostering inclusion and enhancing livelihoods, while ensuring environmental sustainability. Tailored initiatives suited to different communities will be developed with the aim of enhancing capacity building and empowering the community by collaborating with local partners, such as Yayasan Ekosistem Lestari and Forum Konservasi Leuser. "We are grateful to be given this opportunity to collaborate with IDH and the communities to implement custom-made programmes that are suited to the locals' specific needs. We understand that different communities have different concerns and that CSR programmes are not one-size-fits-all. With the SLV, we hope that we are able to alleviate poverty, as well as enhance and nurture the community's livelihoods by bridging knowledge gaps and driving capacity building," said Mr Yong. IDH and Apical have a mutual understanding to develop a co-funding partnership to promote the PPI Compact with the SLV programme as the main pillar. The Compact, which has been implemented in Aceh Tamiang, proves to be an effective model that is scalable in supporting the Aceh Province's initiative to promote sustainable palm oil production in twelve sourcing districts within Aceh. "Efforts to ensure environmental sustainability, and social and economic equity are vital in fostering positive long-term changes that will improve the environment and elevate income levels. We look forward to working with Apical as part of a coalition in promoting sustainable palm oil with part of the focus on smallholder inclusion. This pilot will be extended to contribute towards provincial-level targets on sustainable palm oil," added Mr Idris. The SLV programme is focused on nurturing communities through empowering livelihoods by creating positive environmental impact, bridging knowledge gaps and generating socio-economic opportunities to reduce inequality gaps in society. "We are planning to roll-out the tailor-made programme under the SLV initiative in several Aceh communities by Q2 2023, with a goal of supporting 30 villages through the programme by 2030," added Mr Yong. About Apical Apical is a leading vegetable oil processor with an expanding global footprint. Our vertically integrated mid-stream refining and value-added downstream processing makes us an integral supplier that supports the food, feed, oleochemicals and renewable fuel needs across industries. To date, with integrated assets in strategic locations spanning Indonesia, China and Spain, Apical operates numerous refineries, oleochemical plants, renewable fuel plants and kernel crushing plants. Through joint ventures, Apical also has processing and distribution operations in Brazil, India, Pakistan, Philippines, UAE, USA and Vietnam. Apical's growth is built on the foundations of sustainability and transparency, and motivated by our strong belief that we can make a more meaningful impact even as we continue to advance our business and deliver innovative solutions to our customers. For more information, please visit the Apical website: https://www.apicalgroup.com/ About IDH IDH puts people, planet, and progress at the heart of trade by leveraging the power of markets to create better jobs, better incomes, a better environment, and gender equity for all. To catalyse change at scale, IDH innovates, convenes, and invests in inclusive and sustainable solutions that enable businesses to create value for people and planet, while improving their own performance. To create the greatest impact in the shortest amount of time, IDH focuses on empowering people within corporations the global financial sector and governments that have the most influence over value chains. Headquartered in the Netherlands, IDH has around 380 employees globally, operating in 20 landscapes and 12 commodities and sourcing regions with over 1000 public and private partners. In 14 years of operation, IDH has generated over 390 M in private sector investment and support for new business models that create better jobs, better incomes, a better environment, and gender equity for all. For more information, go to www.idhsustainabletrade.com
SINGAPORE, Feb. 10, 2023 /PRNewswire/ -- With the continuous growth of our APAC business, PEI-Genesis celebrated the opening of a new APAC South sales office in Singapore. A ribbon cutting ceremony followed by lion dance was held to mark this auspicious milestone. Steven Fisher (PEI-Genesis CEO), Alex Tsui (Vice President & Managing Director APAC) and Bernard Koh (Regional Sales Director South Asia) attended the ceremony together with our team of Sales Trusted Advisors from Singapore, Vietnam, Indonesia, Thailand, representatives of the core account customers and suppliers in Singapore. PEI-Genesis celebrated the opening of Singapore Office PEI-Genesis placed its first footprint in APAC since 2015. Today in APAC, PEI-Genesis has Sales Trusted Advisors in 10 major APAC markets, namely, Japan, South Korea, mainland China, Hong Kong, Taiwan, India, Singapore, Vietnam, Thailand and Indonesia. As one of the strategic regions, APAC South has a strong developed manufacturing economy, thus making it very attractive to PEI-Genesis. The management team completed the site selection and started the office in October 2021 but due to Covid pandemic measures we could only officiate the opening in December 2022. In addition to Sales Trusted Advisors, the new office has set up a call center and technical support engineers to serve local customers more effectively. Alex Tsui (Vice President & Managing Director APAC) said: "We are constantly investing in having more talents to engage closer with our local customers, supporting and communicating with them, simultaneously, we are also searching for new assembly site to support Mil-Aero customers in the region. The establishment of the APAC South office has once again fulfilled the promise of PEI to improve delivery speed, achieve good inventory management, as well as to strengthen the professional service capabilities of the local team." About PEI-GENESIS PEI-Genesis is one of the world's fastest assemblers of precision connectors and cable assemblies. From the largest connector component inventory in the world, we develop engineered solutions that support the military, industrial, medical, aerospace, transportation, and energy sectors worldwide. Headquartered in Philadelphia USA, PEI-Genesis has production facilities in South Bend, IN; Southampton, UK; and Zhuhai, China as well as sales offices throughout the Americas, Europe, and Asia. More information may be found at PEI-Genesis Contact:Eva Lau (Marketing Manager APAC, PEI-Genesis)Eva.lau@peigenesis.com+86-756-7619 207
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