Instituto Nacional Del Torax

VANCOUVER, British Columbia & NEW YORK--( BUSINESS WIRE )-- Integrated Nanotherapeutics (INT), a biotechnology company developing innovative treatments for autoimmune diseases, has received an award from Breakthrough T1D (formerly JDRF) to advance INT's technology to induce immune tolerance in type 1 diabetes (T1D). INT's development of an immune tolerizing therapeutic designed to train the immune system not to attack its own cells is now supported by an award from Breakthrough T1D under its Industry Discovery and Development Partnership (IDDP) program. The research project will explore the use of INT’s proprietary technology platform, which employs multi-cargo lipid nanoparticles (LNPs) to deliver multiple antigens using mRNA, along with immune-modifying small molecules, to re-train the immune system. In T1D, immune cells incorrectly recognize self-antigens made by insulin-producing beta cells in the pancreas as a threat, resulting in the attack and loss of these cells and insulin insufficiency. By co-delivering beta cell self-antigens and immune-modifying molecules that induce immune protection rather than attack, it may be possible to preserve the remaining beta cells and stop the progression of disease. This is a therapeutic strategy known as “tolerization”. Importantly, INT's approach aims to provide a tolerizing therapy with a relatively low patient burden in terms of frequency of treatment administration, and without the need for chronic immune suppression. INT’s collaboration with Breakthrough T1D, the leading global T1D research and advocacy organization, further bolsters the company’s focus on T1D as a leading indication for this groundbreaking technology. "We are excited to collaborate with Breakthrough T1D, whose expertise and network in the diabetes field are invaluable to our mission," said Dr. Chris Tam, co-founder and CEO of INT. "The funding and support from Breakthrough T1D will accelerate the pre-clinical development of our tolerizing therapeutic, bringing us closer to a treatment that could transform the lives of millions of people living with T1D." “We are excited to support INT on this project and look forward to working with them as they develop this innovative technology,” said Dr. Joshua Vieth, Director, Research at Breakthrough T1D. “Approaches that enhance the natural regulatory mechanisms of the immune system by promoting tolerance are a critical part of our strategy to develop therapies that provide sustained immune rebalancing and next-generation therapies for T1D.” About Integrated Nanotherapeutics (INT) Integrated Nanotherapeutics is a biotechnology company based in Vancouver, BC, Canada, dedicated to developing advanced treatments for autoimmune diseases. Leveraging a proprietary multi-cargo lipid nanoparticles platform, INT's tolerizing therapeutics co-deliver mRNA expressing antigens and small molecule immunomodulators simultaneously to train the immune system not to attack its own cells. INT’s first asset focuses on type 1 diabetes. For more information, visit www.integratedntx.com . About Breakthrough T1D As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.

NEW YORK, June 6, 2024 /PRNewswire/ -- Pradeep K. Yadav MD, Director of Structural Interventions, Piedmont Heart Institute, Atlanta presented the initial experience with the MiRus Siegel™ 8-Fr aortic transcatheter heart valve (THV) at the New York Valves conference. MiRus Siegel™ TAVR Five sequential patients with severe, symptomatic aortic stenosis (AS) were treated at the Instituto Nacional Del Torax in Santiago, Chile by Drs. C. Dauvergne, J. Sandoval and P. Yadav. Three patients had bicuspid aortic valves and two were tri-leaflet. Three patients had peripheral arterial disease with vascular access < 5.5 mm. There was no mortality or stroke at 30 days and no patients required a permanent pacemaker (PPM) or suffered vascular complications. At 30 days, the mean echo gradient was 6.7 mmHg; four of the five patients had no peri-valvular leak (PVL) and one bicuspid patient had trace PVL. "The ease of use and hemodynamics were impressive" commented Pradeep K. Yadav, MD. "On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning. The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability." The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon. The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil. "This initial data is striking and potentially heralds a new age for TAVR," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. "The ability to treat such complex patients with an 8 French system and without Nickel exposure should make TAVR safer and more broadly accessible. From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients. We are truly on the precipice of surgical-like outcomes with the Siegel THV!!" About MiRus, LLC. MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at . Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved. * MiRus® , Siegel™ are all trademarks of MiRus, LLC. Contact: Pam Cowart VP of Clinical Affairs [email protected] 770-861-4804 SOURCE MiRus

Based in Northern Ireland, Torax operates under ISO 9001 and ISO-13485 accredited quality systems for IVD product design, development, manufacture, and commercialisation EDX acquires IVD products developer Torax. (Credit: Louis Reed on Unsplash) EDX Medical has completed the previously announced acquisition of Torax Biosciences, a research company that develops immune assays and diagnostic testing solutions. Based in Northern Ireland, Torax operates under ISO 9001 and ISO-13485 accredited quality systems for IVD product design, development, manufacture, and commercialisation. Its expertise and facilities are said to complement the laboratory PCR and genomic sequencing tests developed by EDX. With the acquisition, Torax will become a wholly-owned subsidiary of EDX and add an experienced point-of-care diagnostics team and new product development. The company will also bring additional UK laboratory capacity in Northern Ireland to support EDX’s established laboratories in Cambridge. Torax founder and diagnostic and immuno-chemistry expert Lawrence McGrath will be appointed as EDX senior development scientist and will lead Torax as a director. Torax CEO Lawrence McGrath said: “We have a great deal of knowledge in terms of product design and innovation and we are now able to move our company to a new level as part of the EDX Medical Group. “This is an important step for us and we look forward to contributing further to this exciting clinical sector.” EDX is a healthcare company that develops advanced digital diagnostic products and services for cancer, heart disease, neurology, and infectious disease testing. Last year, the company announced a collaborative cancer biomarker programme for improving access to cost-effective tests for a range of cancers in the UK and Europe. The programme is part of its partnership with Tianjin Bioscience Diagnostic Technology, a research-based manufacturer of diagnostic products and reagents. Tianjin Bioscience selected EDX as its lead partner to validate and commercialise its suite of cancer biomarkers in Europe. EDX Medical founder professor Sir Chris Evans said: “We are delighted to announce this strategic acquisition of Torax at an exceptionally good value. It will add further strength and depth to EDX’s innovation and product development capabilities. “This enables us to provide an even wider range of testing solutions and data analysis. The Torax knowledge and capabilities in immunochemistry will accelerate our development of robust and innovative tests for cancer and other significant diseases.”