Orthofix’s Post

A new 24-month study results showcase the remarkable efficacy of Trinity Elite in lumbar spinal fusion: • 95.3% fusion success, confirmed by independent review of thin-cut CT and lack of angular and translational motion • High rates of successful lumbar arthrodesis regardless of surgical approach or risk factors • Significant improvements in pain and disability scores With more than 15 years on the market and 350,000 procedures recorded, Trinity allografts have consistently demonstrated safety and performance in aiding bone repair. This latest study reinforces Trinity Elite an efficacious alternative to autograft for musculoskeletal defects. Tissues are exclusively processed by MTF Biologics. Read the full publication at https://lnkd.in/gtk2TSr8 and learn more about Trinity Elite at https://lnkd.in/gdr5VB9T #TrinityElite #LumbarSpinalFusion #SpineSurgery #BoneHealing #MTFBiologics #Orthofix

A new 24-month study results showcase the remarkable efficacy of Trinity Elite in lumbar spinal fusion: • 95.3% fusion success, confirmed by independent review of thin-cut CT and lack of angular and translational motion • High rates of successful lumbar arthrodesis regardless of surgical approach or risk factors • Significant improvements in pain and disability scores With more than 15 years on the market and 350,000 procedures recorded, Trinity allografts have consistently demonstrated safety and performance in aiding bone repair. This latest study reinforces Trinity Elite an efficacious alternative to autograft for musculoskeletal defects. Tissues are exclusively processed by MTF Biologics. Read the full publication at https://lnkd.in/gtk2TSr8 and learn more about Trinity Elite at https://lnkd.in/gdr5VB9T #TrinityElite #LumbarSpinalFusion #SpineSurgery #BoneHealing #MTFBiologics #Orthofix

Microcatheters Market | Grows at CAGR of 5.5% by 2028 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐁𝐫𝐨𝐜𝐡𝐮𝐫𝐞-https://lnkd.in/dp8UzkQu The global microcatheters market in terms of revenue was estimated to be worth $874 million in 2023 and is poised to reach $1,142 million by 2028, growing at a CAGR of 5.5% from 2023 to 2028. Boston Scientific Medtronic Terumo Medical Corporation Johnson & Johnson Cook Medical Abbott BKK B. Braun Melsungen AG Cardinal Health Becton, Dickinson and Company Teleflex Stryker Merit Medical Systems, Inc. MicroVention-Terumo Zeus Industrial Products, Inc. Biomerics Integra LifeSciences Penumbra, Inc. Sequent Medical Nitiloop Ltd. Medyria Oxford Endovascular Ltd. Centerline Biomedical Revascular Therapeutics Perfusion Tech GVMED DISTRIBUIDORA DE MEDICAMENTOS Beacon Endoscopic Agilent Technologies

I’m thrilled to announce that Carelog has received FDA Breakthrough Device Designation for our innovative ECG algorithm that detects diastolic dysfunction—an often underdiagnosed precursor to heart failure with preserved ejection fraction (HFpEF). Early detection is critical, as HFpEF patients face significant challenges: current treatment options are limited, mostly pharmaceutical, and the 5-year survival rate for these patients can range from 40% to 60%. Our AI-powered ECG solution provides a non-invasive, accessible method to detect diastolic dysfunction early, potentially enabling clinicians to intervene sooner and improve patient outcomes. By offering an alternative to costly and complex imaging methods like echocardiography, we hope to change the way HFpEF is managed, giving patients a better chance at long-term survival. A huge thank you to our incredible team and partners for their dedication and innovation. We’re excited to continue pushing the boundaries of cardiovascular care! #FDA #breakthrough #healthtech #ECG #cardiology #AI #diastolicdysfunction #HFpEF #earlydiagnosis #medicaldevice #innovation

Check out AUX-001 Phase 1a results presented at European Society of Cardiology annual meeting in London by Uwe Tigör, MD, our Chief Medical Officer at Auxilius Pharma. Phase 1a study explored the safety, tolerability, and pharmacokinetics of our compound, which is promising new medication for chronic stable angina. Now that the meeting’s embargo has lifted, we’re thrilled to share these results with you! Check out the attached presentation for more details. If you’d like the full version of the deck, feel free to reach out directly to Uwe Tigör, MD or Jedrzej Litwiniuk, MHA. #cardiology #CSAP #AUX001 #ESC #newmedication #biotech #news

#VRCI In Nov’23, expert organ transplant diagnostics firm Verici Dx (Mrkcap £16m) signed a ground breaking global licensing deal with Thermo Fisher Scientific ($215bn Mrkcap) to exclusively develop an assay for pre-transplant kidney testing. #TMO’s assay is to be based directly on #VRCI’s patented Clarava blood test that allows doctors to identify those patients (pre graft) most likely to require increased monitoring (post operation)- including adjustments to the type, dose & duration of immunosuppressants. Elsewhere, the agreement also granted Thermo Fisher Scientific the sole right (but not obligation) to manufacture, distribute & sell the prognostic worldwide. Alongside providing it with access to a portion of #VRCI’s proprietary urine samples – further highlighting the value stored within its treasure trove of research assets. In return Verici Dx received an upfront fee, augmented by staged payments dependent on operational deliverables (eg tech transfer & publications). Which in aggregate (assuming things go to plan) should equate to c.$5m by Nov24 with further instalments & ongoing royalties thereafter. Today #VRCI said it had “completed successful transfer of a portion of the urine samples” and “full payment had been received”. Meaning this alongside the Jan’24 $6.5m fund raise, should extend the group's cash run-way into 2026. CEO Sara Barrington adding: "We are delighted to announce the successful completion of this transfer, within the agreed timeline. This achievement not only highlights our commitment to delivering on our agreements, but also underscores the substantial value inherent in Verici Dx's data and sample assets for research purposes." Looking ahead, Singer Capital Markets have a target price of 20p/share and are forecasting sales to jump to $7.5m and $13.0m this year and next (vs $1.0m LY), with #VRCI also becoming profitable in 2025 ($1.3m EBITDA). Disclosure: Verici Dx are a Vox Markets client

☑️ CooperSurgical introduces a single-hand inserter for the Paragard IUD, a non-hormonal contraceptive with over 99% efficacy for up to ten years. ☑️ BD completes its $4.2 billion acquisition of Edwards Lifesciences Critical Care product group, now renamed BD Advanced Patient Monitoring. ☑️ FDA clears ZYNEX’s TensWave device, a transcutaneous electrical nerve stimulation (TENS) system for pain management, tailored for patients whose insurance plans cover TENS therapy exclusively. ☑️ THERAKOS, INC. gains CE certification under the revised EU MDR for its immunomodulation system, following the full application of the MDR regulation as of May 2024. ☑️ CairnSurgical, Inc. meets the enrollment goal for its breast cancer locator device trial in Europe, running parallel to a pivotal trial in the US. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Big News from Spin-off Lamina Therapeutics and INSERM-University of Strasbourg UMR1260 Regenerative Nanomedicine ! We are thrilled to announce that Lamina Therapeutics has received approval from the European Medicines Agency (EMA) and the ANSM Agence nationale de sécurité du médicament et des produits de santé to initiate our first-in-human Phase I clinical trial in knee #osteoarthritis! This groundbreaking trial, which will take place in #Strasbourg, France, represents a world first: combining a therapeutic implantable #medical #device with autologous #stem #cells (combined ATMP) to treat advanced osteoarthritis by regenerating both subchondral bone and cartilage. Osteoarthritis remains a major challenge for millions of patients worldwide, and we are excited to take a leading role in pioneering this innovative solution to restore joint function and improve quality of life. We are deeply grateful to our exceptional team (Rana Smaida, Lemmens Stephan, Nadia Benkirane-Jessel...), collaborators, and regulatory partners who have worked tirelessly to make this possible. We’re looking forward to sharing updates as we begin this exciting journey towards transforming osteoarthritis treatment. #Innovation #ClinicalTrial #RegenerativeMedicine #Osteoarthritis #MedicalDevice #StemCells #Healthcare #ATMP #LaminaTherapeutics

New featured CE! 🔗 https://bit.ly/4e8RVmL The blood-brain barrier (BBB) remains a significant blockade for effective drug delivery in treating diffuse intrinsic pontine glioma (DIPG). Low-frequency focused ultrasound (FUS) therapy in conjunction with intravenous microbubbles can transiently disrupt the BBB in a localized manner to facilitate drug delivery. This review examines recent preclinical studies evaluating the safety and feasibility of FUS-mediated BBB opening in the brainstem. #CME #MedEd #RadEd

(I worked out how to paste a figure on linkedin) This is the K-M curve I tried to paste yesterday. A 3.5 mths OS improvement with less toxicities is seriously important for no-AGA and PDL1 non-responsive pts, whose mOS is <1 year. Patients would be desperate to hear about this option, with equal efficacy to both squamous and non-squamous histology. And this is why I truely believe FDA will look at the data and approve the sub-population, but importantly, if Gilead can communicate wisely. #trop2 ADC #Sacituzumab Govitecan #NSCLC #PDL1 failure #FDA #Gilead #FDA