Rion’s Post

We are proud to announce the initiation of our Phase 2A study, which aims to assess the efficacy and safety of our novel regenerative exosome therapeutic, Purified Exosome Product™ (PEP™), in managing Diabetic Foot Ulcers (DFU). This significant milestone highlights our commitment to revolutionizing regenerative medicine and addressing critical unmet healthcare needs in chronic diseases like DFUs.   Building upon our Phase 1B study's success at Mayo Clinic, RION's Phase 2A trial marks a pivotal advancement in creating regenerative biologics for Diabetic Foot Ulcers. This rigorous, randomized, multi-center study is set to enroll 40 participants throughout the United States, carefully stratified into two groups to compare the standard of care against the innovative topical treatment with PEP™ exosomes. The findings will be instrumental, shaping the trajectory for future clinical research and laying the groundwork for a Biologics License Application (BLA)—a critical step in meeting the urgent need for new therapeutic options in diabetic wound care.   For more information about our trial and deeper insight into our breakthrough regenerative exosome technology, please read our press release by clicking the link below.   https://lnkd.in/ervYnYQU #Rion #RegenerativeMedicine #Exosomes #DiabeticFootUlcer #Diabetes

#CRDL Cardiol Therapeutics Announces Completion of the MAvERIC Phase II Study! The MAvERIC Phase II study in Recurrent Pericarditis is now completed, with Results to be Presented at the American Heart Association Scientific Sessions 2024. Cardiol Therapeutics Inc. a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on Monday, November 18th, 2024, at the American Heart Association. Having recently reported the positive primary endpoint data from the MAvERIC-Pilot study demonstrating that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation at 8 weeks, we are delighted that the data has been accepted for oral presentation in such a prestigious session of the American Heart Association Scientific Sessions 2024, the premier global event for advancements in cardiovascular science and medicine," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. Read the full article here https://lnkd.in/gbnnyYcX Cardiol Therapeutics Inc. #PFE #MRNA #BIOTECH #PHARMA

Cardiol Therapeutics (CRDL | NSDQ) Announces Completion of the MAvERIC Phase II Study! The MAvERIC Phase II study in Recurrent Pericarditis is now completed, with Results to be Presented at the American Heart Association Scientific Sessions 2024. Cardiol Therapeutics Inc. a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced the data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis will be reported in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture that runs from 9:45 a.m. to 11:00 a.m. Central Time, on Monday, November 18th, 2024, at the American Heart Association. Having recently reported the positive primary endpoint data from the MAvERIC-Pilot study demonstrating that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation at 8 weeks, we are delighted that the data has been accepted for oral presentation in such a prestigious session of the American Heart Association Scientific Sessions 2024, the premier global event for advancements in cardiovascular science and medicine," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. Read the full article here… https://lnkd.in/gbnnyYcX #CRDL #CARDIOL #BIOTECH #PHARMA #TRIALS #Pericarditis Cardiol Therapeutics Inc.

Sirius begins patient dosing in phase 1 trial of next─generation, long─acting factor XI siRNA anticoagulant to treat thromboembolic disorders

InCarda Therapeutics showcases promising results with FlecIH-103, an inhaled solution for converting paroxysmal atrial fibrillation (PAF) to sinus rhythm. The Phase 3 RESTORE-1 trial demonstrated a 31% cardioversion rate with inhaled flecainide, achieving normal sinus rhythm in approximately 13 minutes, significantly outperforming the placebo. Despite low enrollment, the study highlighted substantial pharmacoeconomic benefits, with patients experiencing quicker discharge and symptom resolution post-conversion. Notably, the need for electrical cardioversion decreased in the treatment arm, showcasing the efficacy of FlecIH-103. InCarda is now shifting towards a new drug-delivery platform backed by promising Phase 1 clinical data. These positive results support the continuation of the study, potentially propelling FlecIH-103 into registrational trials. The findings from the RESTORE-1 trial underscore the safety and effectiveness of inhaled flecainide as a rapid and non-invasive therapy for PAF patients, reducing the reliance on invasive procedures. Explore more: https://lnkd.in/dGwkjpmb Meisa Propst Prashanti Madhavapeddi - PhD

Cardiol Therapeutics Inc. (@cardiolrx) recently announced positive topline results from its Phase II MAvERIC-Pilot study, investigating the impact of CardiolRx™ on patients with symptomatic recurrent pericarditis. The study enrolled 27 adult patients across prominent clinical sites in the U.S., including the Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital. The results demonstrated a significant reduction in pericarditis pain, with the mean pain score dropping from 5.8 at baseline to 2.1 (64%) after eight weeks of treatment. Additionally, 80% of patients with elevated baseline C-reactive protein (CRP) levels achieved normalization, indicating a substantial reduction in inflammation. 'We are delighted to share the exceptional primary endpoint data from the MAvERIC-Pilot study, which demonstrated that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation,' said David Elsley, President & CEO of Cardiol Therapeutics. With an estimated 38,000 patients in the U.S. experiencing recurrent pericarditis annually, the need for effective treatments is critical. Cardiol Therapeutics aims to provide an accessible and non-immunosuppressive therapeutic option, potentially surpassing existing therapies. The positive results set the stage for a forthcoming Phase III trial. #RecurrentPericarditis #CardiolTherapeutics #CardiolRx #ClinicalTrials #Biotechnology #Healthcare @cardiolrx @mayoclinic @clevelandclinic @massgeneralnews

Vivacelle Bio Enrolls First Patient in Phase 3 Trial of Hypovolemia Due to Septic Shock for Phospholipid Nanoparticle-Based VBI-S KANSAS CITY, Mo., Sept. 3, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced that it has enrolled the first patient in a Phase 3 trial for its lead therapeutic candidate, phospholipid nanoparticle-based VBI-S, to treat both absolute and relative hypovolemia due to septic shock and has initiated six trial sites. VBI-S is the first successful treatment for the overproduction of nitric oxide and to address both absolute and relative hypovolemia. https://lnkd.in/dV7uGcPU

Metabolic Disorders Solve Programme   We see that metabolic disorders are increasing day by day in the world and many people and organizations are trying to solve them. They make everyday new medicine combinations. In this way, all Allopathic, Ayurveda, Homeopathic, colour path, Iso path, naturopathy, Antipathy, Zyso pathy, Bio-chemic- path, fruit path, vitamin path, home path, acupressure path, acupuncture path, spiritual path, rake path electro-homoeopath, leaf path, flower path, Unani, Siddha, and Every country have Indigenous systems of medicine, Traditional systems of medicine but all are failed to cure diabetes and metabolic disorders All kinds of metabolic disorders first time has no signs and symptoms and no discomfort, but when problems arise in the body we go to the Doctor because they develop very slowly and produce many kinds of diseases. We see that all kinds of metabolic disorders take place due to mutations of enzymes, lipids, and any food we eat which means we are not eating properly as required for digestion and mixing all enzymes. To solve this problem I wrote a Book (English) “Your Health Is In Your Mouth” (Hindi) “Aap Ka Sawasth Aap Ke Muh Me” You can find in a Google search

Humacyte made significant strides in the second quarter of 2024 to further our mission to improve patient’s lives and transform the practice of medicine. Laura Niklason MD and PhD, founder and CEO of Humacyte and Dale Sander, Chief Financial Officer, Chief Corporate Development Officer, Treasurer shared our Q2 2024 results on August 13th, 2024. FDA Extends Review of ATEV™ BLA for Vascular Trauma: The FDA notified Humacyte that additional time is needed to complete the review of the Biologics License Application (BLA) for the acellular tissue engineered vessel (ATEV) in vascular trauma, a first-in-class product granted Priority Review. Humacyte remains confident in the approvability of ATEV. ATEV Shows Positive Patency Results in Phase 3 Hemodialysis Access Trial: Topline results from the V007 Phase 3 trial (N=242) demonstrated ATEV's positive functional patency at 6 and 12 months (co-primary endpoints; p=0.0071) and significantly longer hemodialysis duration over 12 months (p=0.0162) compared to autogenous fistula, the current standard of care. ATEV Receives 3rd RMAT Designation for Advanced PAD: The FDA granted ATEV its third Regenerative Medicine Advanced Therapy (RMAT) designation for treatment of advanced peripheral artery disease (PAD), recognizing its potential impact for patients facing amputation. Progress in CABG and BioVascular Pancreas Programs: Humacyte reported progress across its pipeline, including promising preclinical results for the BioVascular Pancreas in type 1 diabetes, and positive 6-month primate data on ATEV remodeling for coronary artery bypass grafts. We are proud of these milestones and look forward to sharing more at upcoming medical meetings. Thank you to our dedicated team and partners for making these advancements possible! View the full press release here: https://lnkd.in/eTYJcP6H The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. #Humacyte #BiotechInnovation #Biotech $HUMA

Cardiol Therapeutics: MAvERIC-Pilot Results Achieve CardiolRx™ Proof-of-Concept as an Active Drug for Recurrent Pericarditis We would assign a USD $10 per share price target to Cardiol (around C$13.60). We think this >5x upside target is very achievable over the next year if the data readouts on CardiolRx™ continue to be strong. #CardiolRx #Pericarditis #Heart #Cardiology #CVD #CRDL https://lnkd.in/gzXMjWdV