‫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.

الصورة:  https://mma.prnewswire.com/media/1869091/Munster_Germany_team.jpg

  الشعار: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg 

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

Logo – https://mma.prnewswire.com/media/1869148/Logo_black_bg_Logo.jpg

 

US Stock Market Closes Higher

US stock market indices rose today, at the close of the trading session on the New York Stock Exchange.

The Dow Jones Industrial Average closed up 315.50 points, or 0.97%, to close at 32845.13 points, while the Nasdaq Composite Index rose 228.10 points, or 1.88%, to close at 12,390.69 points, and the Standard & Poor's 500 Index rose 57.86 points, or 1.42%, to close at 4130.29 points.

Source: Saudi Press Agency

Saudi Fund for Development Participates in Laying Foundation Stone for Abobo University Hospital Project in Côte d’Ivoire

A delegation from the Saudi Fund for Development (SFD) participated today in laying the foundation stone for the Abobo University Hospital project in the economic capital, Abidjan, Côte d'Ivoire, as the Fund contributes to financing it with a soft development loan with a total value of $22.72 million.

The project aims to establish a hospital with a capacity of 600 beds on a land area of 18,000 hectares. It includes centers for pediatrics, dialysis and other medical departments.

The ceremony of laying the foundation stone for the project was held under the patronage of the Prime Minister of the Republic of Côte d'Ivoire Patrick Achi, in the presence of the Minister of State, Minister of Foreign Affairs and Mayor of Abobo area, Kandia Camara; Minister of Health and Hygiene Pierre Dimba; Speaker of Parliament Adama Bictogo; Director General of the Arab Bank for Economic Development in Africa Dr. Sidi Ould Tah, and the Saudi Ambassador to the Republic of Côte d'Ivoire Abdullah bin Hamad Al-Subaie.

Source: Saudi Press Agency

Holy Kaaba’s Cover “Kiswa” Replaced

The General Presidency for the Affairs of the Grand Mosque and the Prophet’s Mosque adorned today the holy Kaaba with a new cover or "Kiswa" in an annual process under the supervision of the General President of the Presidency Sheikh Dr. Abdurrahman bin Abdulaziz Al-Sudais.

The replacement of the Kaaba's Kiswa was carried out by a team selected from King Abdulaziz Complex for Holy Kaaba Kiswa, as the team began to dismantle the old Kiswa with the new one.

The new kiswa consisting of four separate sides and the door curtain. Each of the four sides of the holy Kaaba was raised separately to the top of the Kaaba in preparation for its unfolding on the old side, and fixing the side from above by tying it down and dropping the other end of the side, after the ropes of the old side were loosened. By moving the new side up and down in a permanent movement, then the old side fell from below and the new side remained, and the process was repeated four times for each side until the dress was completed, then the belt was weighed in a straight line to the four sides by stitching it.

The number of pieces of the Kiswa belt of the holy Kaaba is 16 pieces, in addition to six pieces and 12 lamps at the bottom of the belt.

The holy Kaaba's kiswa consumes about 850 kg of raw silk, which was dyed black inside the complex, 120 kg of gold wire, and 100 silver wires.

About 200 professional workers and administrators working at King Abdulaziz Complex for Holy Kaaba Kiswa, all of whom are trained, qualified and specialized citizens.

King Abdulaziz Complex for Holy Kaaba Kiswa includes several sections: laundry, automatic weaving, manual weaving, printing, belts, gilding, sewing and assembling the Kiswa.

It also includes the largest sewing machine in the world in terms of length, as it is 16 meters long by using a computer system, in addition to some support departments such as: laboratory, administrative services, quality, public and health relations for workers, and occupational safety in the complex.

Source: Saudi Press Agency

US House Passes Assault Weapons Ban, Senate Unlikely to Approve

The US House passed a bill Friday that would ban the sale of assault-style weapons and high capacity magazines for

the first time since a similar ban lapsed in 2004, dpa reported.

The 217-213 vote saw seven members cross party lines, but Democrats still overcame objections from Republicans, who argued it infringes on Second Amendment rights. Five Democrats voted against the bill, and two Republicans voted for it.

The evenly divided Senate is unlikely to pass the measure, but Democrats argued Friday's vote was seen a needed step amid a wave of mass shootings across the country.

"These military style weapons are designed to kill the most people in the shortest amount of time," Judiciary Chairman Jerrold Nadler said during floor debate. "Quite simply, there is no place for them in our streets." The vote is the latest in a series of Democratic gun control bills to advance through the House since a wave of mass shootings this year, including an elementary school shooting in Uvalde, Texas that killed 19 students.

The bill, HR 1808, would ban the sale, possession and transfer of high capacity magazines and assault-style weapons by name - such as the AK-47 - and features, such as a pistol grip. The bill would also ban the sale of some firearm accessories like pistol braces.

President Joe Biden's administration backed the bill Friday.

Source: Saudi Press Agency