‫تجربة LIMES المعشاة ذات الشواهد حول بالون سيروليموس المطلي في BTK تأخذ الخطوة الأولى: بدأ تسجيل المرضى

Concept Medical Inc. ، وهي شركة رائدة في تطوير منصات أجهزة توصيل الأدوية للتدخل الوعائي، أعلنت عن بدء تجربة LIMES .

مونستر، ألمانيا, 30 يوليو / تموز 2022 /PRNewswire/ — قامت LIMES (تجربة معشاة ذات شواهد متعددة المراكز لتقييم سلامة وفعالية بالون SeroLIMus المغلف بالأدوية مقابل رأب الوعاء القياسي لعلاج الانسداد تحت الرضفة في المرضى الذين يعانون من مرض السكري الشرياني) بتسجيل 15 مريضًا، وهو أمر مشجع حيث تتطلع الشركة إلى تحقيق قفزة في علاج مرض الشريان المحيطي (PAD).

Study team at the University Hospital Münster Germany -LIMES RCT - First Patient Enrolled!

بدأت LIMES من قبل المستشفيات الجامعية جينا ولايبزيغ في ألمانيا وبقيادة الباحث الرئيسي ( PI ) الأستاذ الدكتور أولف تيشغرابر إلى جانب الباحث الرئيسي المشارك البروفيسور توماس زيلر والبروفيسور ديرك شاينرت، وهي تجربة مستقبلية متعددة المراكز وعشوائية الشواهد ( RCT ) تم تصميمها وتهدف إلى تقييم Magic Touch – PTA 0.014 “و 0.018” ( Concept Medical Inc ) مقابل POBA (Plain Old Balloon Angioplasty) في مقارنة وجهًا لوجه (1: 1). بدأت التجربة مع تسجيل مريض المؤشر في 31 مارس 2022 من قبل الأستاذ الدكتور ناسان ماليار في مستشفى جامعة مونستر في ألمانيا.

من المقرر أن يسجل LIMES RCT 230 مريضًا، عشوائيًا في 1: 1 موضة ( Magic Touch-PTA: POBA ) في 19 مركزًا حاليًا في جميع أنحاء ألمانيا والنمسا. سيشمل عدد المرضى الذين يعانون من نقص تروية الأطراف الحرجة المزمنة الموثقة ( CLI ) في الطرف المستهدف المعرف باسم فئة رذرفورد السريرية (RCC) 4 أو 5 أو 6 الذين تتراوح أعمارهم بين ≥18 عامًا. تقيم الدراسة المرضى الذين لديهم قطر وعاء مرجعي (RVD) ≥2 و ≤4.0 مم وانسداد كلي (تضيق بنسبة 100%) للآفة المستهدفة. لا يوجد حد أدنى لطول الآفة المطلوبة، ولا يوجد حد لطول الآفة ولا يوجد قيود على عدد الأجهزة المستخدمة. ستكون المتابعة لكل زيارة داخلية في 30 يومًا و 6 و 12 و 24 و 36 شهرًا.

سيقيس RCT فعالية البالونات المغلفة بال Sirolimus في بيئة معقدة ( CLTI ) من قطاع PAD (الموجود أسفل الجزء P3 من الشريان المأبضي إلى مفصل tibiotalar ) مقابل المعيار الحالي للرعاية، مما يجعل التجربة مهمة وواحدة نتطلع إليها. نقاط النهاية الأولية للدراسة هي مركب إنقاذ الأطراف والمباح الأولي خلال 6 أشهر. إضافة إلى أهمية التجارب العشوائية المضبوطة، فإن نقطة نهاية السلامة الثانوية الرئيسية هي مركب من أحداث الأطراف الضائرة الرئيسية ( MALE ) والوفاة المحيطة بالجراحة ( POD ) في 30 يومًا. سيقوم مختبر أساسي أعمى بتقييم المباح في 6 و 12 و 24 شهرًا عن طريق الموجات فوق الصوتية المزدوجة وتصوير الأوعية الدموية الكمي ( QVA ) في حالة وجود أي TLR .Concept Medical Logo

يوضح البروفيسور أولف تيشغرابر نقطة حول سبب قيمة RCT من حيث تدخل DCB في الانسداد تحت المأبضي، “تتعامل إعادة التوعي BTK مع منطقة الأوعية الدموية الأكثر تحديًا في المرضى جدًا. سيحل LIMES السؤال عما إذا كان رأب الأوعية بالبالون sirolimus لديه القدرة على أن يصبح المعيار المستقبلي للرعاية في تدخلات BTK “ ، بعد عرضه الأخير في LINC 2022 .

يلفت RCT انتباه واهتمام المجتمع بالنظر إلى مجموعة المرضى المعقدة التي سيشملها، واستخدام البالون المغلف بالـ Sirolimus ، والذي يثبت بالفعل جدارته في SFA ضد POBA و Paclitaxel في العديد من التجارب العشوائية المضبوطة. Magic Touch PTA هو sirolimus DCB الوحيد المتاح تجاريًا ل PAD ، والذي تم منحه أيضًا تسمية Breakthrough Device Designation . باكليتاكسيل يثير الأفكار الثانية بسبب مخاوف السلامة التي أثارتها إدارة الأغذية والعقاقير الأمريكية في العلاج المحيطي، Sirolimus هو الأكثر طلبًا واحتمالًا محتملًا للبديل التالي في علاج PAD . من المؤكد أن تقييم البالون المطلي بالـ Sirolimus في هذا الإعداد المعقد سيضيف وزنًا وقيمة إلى بالون Magic Touch PTA Sirolimus المطلي كمستقبل للتدخل المحيطي.

نبذة عن MagicTouch PTA

Magic Touch PTA هو أول بالون مغطى بالدواء، حيث أُسند إلى “تصميم جهاز الاختراق” من قبل إدارة الغذاء والدواء الأمريكية ( FDA) ، لعلاج أضرار أسفل الركبة في الشرايين المحيطية. MagicTouch PTA عبارة عن بالون مطلي بطبقة sirolimus معتمد من الاتحاد الأوروبي ويتم تسويقه تجاريًا، وقد تم تطويره باستخدام تقنية النانولوت الخاصة وهي منصة تكنولوجيا توصيل الأدوية الخاصة ببالون MagicTouch PTA ، وهي مصممة لتوصيل جزيئات شبه ميكرون من sirolimus للوصول إلى أعمق طبقات جدران الأوعية.

نبذة عن شركة Concept Medical Inc (CMI)

يقع المقر الرئيسي لشركة Concept Medical Inc (CMI) في تامبا بولاية فلوريدا ولديها مكاتب تشغيلية في هولندا وسنغافورة والبرازيل ووحدات تصنيع في الهند. تتخصص الشركة في تطوير أنظمة توصيل الأدوية ولديها منصات تقنية فريدة وحاصلة على براءة اختراع يمكن نشرها لتوصيل أي دواء / عامل صيدلاني عبر الأسطح اللمعية للأوعية الدموية.

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FTX Exchange FZE Receives Dubai’s First Virtual Asset Service Provider MVP Licence from the Virtual Assets Regulatory Authority

DUBAI, United Arab Emirates, July 29, 2022 /PRNewswire/ — FTX Exchange FZE, today announced that it has received approval to enter Dubai’s ‘Minimum Viable Product’ (MVP) programme for Virtual Assets under the world’s only specialist regime for this sector operated by the Virtual Asset Regulatory Authority (VARA). As a subsidiary of FTX Europe, FTX Exchange FZE (FTX) becomes the first Virtual Asset Service Provider (VASP) to receive this MVP licence to operate its Virtual Asset (VA) Exchange and Clearing House services in Dubai, United Arab Emirates.

FTX MENA

Earlier this year, FTX became the first fully regulated Exchange to receive a provisional licence and ready itself to trial complex crypto derivatives dedicated to professional institutional investors in the UAE. Having successfully concluded VARA’s rigorous regulatory evaluation, it has now been fully approved to transition to an operational MVP licence, enabling the Company’s VA Exchange to deploy regulated crypto derivatives products, and trading services to Qualified Institutional Investors across the region. In addition, the VARA MVP Licence also grants FTX permission to act as a Clearing House, operate an NFT Marketplace, and provide Custodial Services under tightly prescribed parameters for specific class of consumers – assuring strong guardrails for market protection and economic security.

H.E. Helal Saeed Almarri, Director General of Dubai World Trade Centre Authority that houses VARA said, “We are pleased to onboard FTX as the first VASP to enter the operational phase of the VARA MVP Programme. VARA’s operating model, based on our unique test-scale-adapt principle designed for secure and sustainable growth, is reflective of Dubai’s commitment to creating a globally interoperable model for the ‘future economy’. The MVP Phase, exclusive to select, responsible international players like FTX, will allow VARA to prudently structure guidelines and risk mitigation levers for secure commercial operations. We look forward to FTX’s active participation in this next stage of collaborative global VA innovation”.

FTX CEO, Sam Bankman-Fried, commented on the news, “The approval for FTX to receive the first MVP VASP licence from Dubai’s prudential supervision regime to fully operate our exchange is a tremendous honor and landmark achievement for our team. Our mission is to lead the way in growing the digital asset industry in countries and jurisdictions that possess a robust digital asset framework.”

With VARA’s letter of approval, FTX FZE Exchange will operate under a model which has rigorous regulatory oversight and mandatory FATF compliance controls that are in line with the requirements of Tier 1 international financial markets.

Patrick Gruhn, Head of FTX Europe, adds, “Over the last several months, we at FTX Europe have been working alongside regulators to secure the first official VASP-MVP licence to operate in the UAE region. The approval from Dubai’s VARA is yet another milestone for FTX Europe, and we look forward to expanding our presence within the Dubai, UAE and MENA regions as a result.”

Mohammad Hans Dastmaltchi, Chairman of the Board of FTX Exchange FZE, adds, “We are honored to be the inaugural MVP licence holder of the esteemed VARA Ecosystem. We are grateful and obliged to have our operating licence. This would not have been possible without the progressive business environment in Dubai, the thorough and trustworthy regulatory guidelines provided by VARA, and the outstanding support from their team. We are motivated and committed to being a constructive and responsible participant in the VARA ecosystem and looking forward to growing and strengthening our regional office in Dubai”.

About FTX Exchange FZE

FTX Exchange FZE is a subsidiary of FTX Europe and the Middle East division of FTX, a cryptocurrency exchange built by traders, for traders.  Through FTX Exchange FZE, users in the Middle East will soon be able to access FTX’s innovative products, including industry-leading derivatives, options and volatility products, tokenized stocks, and other services and products.

About FTX.COM

FTX is a cryptocurrency exchange built by traders, for traders. It offers innovative products, including industry-leading derivatives, options and volatility products, tokenized stocks, prediction markets, leveraged tokens and an OTC desk. FTX strives to be an intuitive yet powerful platform for all kinds of users, and to be the most innovative exchange in the industry.

To learn more about FTX.COM, please visit: https://ftx.com

FTX.COM is not available to US residents or residents of other prohibited jurisdictions, as set out in its Terms of Service.

About VARA

Dubai Virtual Assets Regulatory Authority [VARA] is the world’s first specialised regulator for the Virtual Assets sector. Established in March 2022, following the effect of Law No.4 of 2022, VARA is responsible by decree for licensing and regulating the Virtual Asset sector in the Emirate of Dubai and its free zone territories [excluding DIFC], and oversees all licensing requirements and applications for authorisation of Virtual Asset activities under UAE law. VARA plays a central role in creating Dubai’s advanced legal framework to protect investors and establish international standards for Virtual Asset industry governance, while supporting the vision for a borderless economy.

Media Contact
Jay Morakis
M Group Strategic Communications (on behalf of FTX)
+1 646 859 5951
ftx@mgroupsc.com

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Indonesia blocks Yahoo, Paypal, gaming websites over licence breaches

Jakarta, Indonesia has blocked search engine website Yahoo, payments firm Paypal and several gaming websites due to failure to comply with licensing rules, an official said on Saturday, sparking a backlash in social media.

Registration is required under rules released in late November 2020 and will give authorities broad powers to compel platforms to disclose data of certain users, and take down content deemed unlawful or that “disturbs public order” within four hours if urgent and 24 hours if not, Reuters reports.

Several tech companies had rushed to register in days leading to the deadline, which had been extended until Friday, including Alphabet Inc’s (GOOGL.O), Meta Platforms Inc’s (META.O) Facebook, Instagram and WhatsApp and Amazon.com Inc (AMZN.O).

Semuel Abrijani Pangerapan, a senior official at Indonesia’s Communications Ministry, said in a text message websites that have been blocked include Yahoo, Paypal and gaming sites like Steam, Dota2, Counter-Strike and EpicGames, among others.

Paypal, Yahoo’s parent private equity firm Apollo Global Management and U.S. game developer Valve Corporation, which runs Steam, Dota and Counter-Strike, did not immediately respond to requests for comment. EpicGames could not be reached for comment.

Hashtags like “BlokirKominfo” (block Communication Ministry), Epic Games and Paypal trended on Indonesian Twitter, with many writing messages criticising the government’s move as hurting Indonesia’s online gaming industry and freelance workers who use Paypal.

Pangerapan did not respond to a request for comment.

With an estimated 191 million internet users and a young, social-media savvy population, the Southeast Asian nation is a significant market for a host of tech platforms.

Source: Bahrain News Agency

KSrelief diagnoses 300 hearing-impaired students in Aden and Hadramout,

Aden, King Salman Humanitarian Aid and Relief Center (KSrelief) diagnosed 300 students with hearing impairments in centers for people with disabilities in the governorates of Aden and Hadramout, Yemen in preparation for providing them with hearing aids.

It is noteworthy that the project contributes to addressing the main challenges facing educational institutions in the field of people with disabilities and illiteracy eradication by providing school equipment for 20 centers for people with disabilities and 10 literacy schools in three governorates of Aden, Abyan and Hadramout.

This comes within the humanitarian and relief projects being implemented by the Kingdom of Saudi Arabia, represented by the Center, to support the Yemeni educational sector, improve its outputs, and help people with special needs in all fields.

Source: Bahrain News Agency

Russell grabs first F1 pole, Verstappen qualifies 10th

Budapest, George Russell stole the show Saturday at the Hungarian Grand Prix by earning his first career pole and first of the season for Mercedes — on the same day F1 champion and current points leader Max Verstappen qualified a season-worst 10th.

Russell screamed in celebration after a fast final qualifying lap helped him beat Ferrari drivers Carlos Sainz Jr. and Charles Leclerc, reports AP.

The Mercedes pace was surprising since Russell claimed Mercedes’ second practice was “disastrous” on Friday, when Russell was about a full second slower than Leclerc’s leading time.

Verstappen unleashed expletives as his qualifying bid was undone. He struggled with grip then complained of having “no power … nothing works” on his second attempt.

The Hungaroring track, nestled amid rolling hills just outside of Budapest, dried out somewhat for afternoon qualifying following a huge downpour during the third practice.

Leclerc — who leads F1 with seven poles this season — crashed while leading the French GP last Sunday to hand Verstappen a win that gave the Dutchman a 63-point lead over Leclerc in the standings.

But now Leclerc has an ideal chance to close the gap on Sunday on one of F1’s hardest tracks for passing.

Verstappen’s Red Bull teammate Sergio Perez had a disappointing session and started from 11th place.

Lando Norris of McLaren qualified fourth followed by Esteban Ocon —last year’s winner — Alpine teammate Fernando Alonso and Mercedes driver Lewis Hamilton, who is F1’s record holder with 103 poles.

Russell, who replaced Valtteri Bottas at Mercedes this year, landed his seat in part by overperforming for struggling backmarker Williams last year with an incredible performance in the wet to qualify second for the Belgian GP.

After a first pole, the British driver is eyeing a first win. Russell has what it takes to reach the top, Mercedes team principal Toto Wolff believes.

Source: Bahrain News Agency

Liverpool beats Man City 3-1 for Community Shield

London, Darwin Nunez shaded Erling Haaland in their first matchup by scoring Liverpool’s final goal as it beat Manchester City 3-1 in the Community Shield on Saturday.

City, last season’s English Premier League champion, and Liverpool, the FA and League Cup winner, paraded their big summer signings at King Power Stadium in Leicester but it was the Uruguay international who upstaged City’s Haaland.

Nunez came off the bench in the 59th minute with the score at 1-1 and his aerial presence won the late penalty from which Mohamed Salah put Liverpool in front for a second time, said AP.

But the former Benfica striker, having earlier been denied a goal by City goalkeeper Ederson, was not finished there and stooped to head home his first for the Reds in domestic competition in added time.

One new City signing did make his mark — former River Plate forward Julian Alvarez coming off the bench to cancel out Trent Alexander-Arnold’s opener — but the focus was really on the big men up top.

Source: Bahrain News Agency