Despite decades of investigation, stem cell therapies are still facing challenges around their commercialization. The stem cell therapy market has been struggling to achieve approvals and high price tags have made it difficult to generate sales for those that do reach commercialization. Moreover, it is a challenging task to introduce foreign living cells into a system as complex as the human body. [Read more…]
The Market for Exosome Diagnostics – Leveraging Exosome-Based Diagnostics for Cancer and Beyond
To date, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC). [Read more…]
The Market for Exosome Therapeutics in 2024 – Clinical Trials and Trends
Exosomes have incredible properties that enable researchers to engineer exosomes as carriers for the delivery of drugs and target tissues of interest, while evading or modulating immune responses. Drug delivery and development of exosome-mediated therapies is a growing market segment, with over 50 companies forging ahead in this field. All the recent advances in exosome research are technology-based and this helps researchers to quantify exosome cargoes and subtypes, allowing for the tracking of exosomes with remarkable precision. This is helping companies to regulate exosome drug dosage and delivery, as well as deliver effective treatments for hard-to-treat diseases, such as cancer and neurodegenerative diseases. [Read more…]
Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication
-Phase 1b/2a clinical trial in acute ischemic stroke expected to initiate in 1H 2024-
-Marks the first IND for Aruna’s platform with plans to expand AB126, an unmodified exosome derived from proprietary neural stem cells, to other neurological indications including amyotrophic lateral sclerosis-
-Proprietary in-house GMP production capabilities enable scalable, reproducible production of clinical-grade exosomes with high purity and uniformity; analytical methods and well-characterized assays established to ensure therapeutic consistency-
Renowned Exosome Researcher Dr. Carla Mazzeo PhD Joins RESILIÉLLE Exosome Revolution in Cosmetics
Rochester NY, 16 February 17, 2024 – RESILIÉLLETM Cosmetics LLC, a leader in innovative skincare and haircare solutions, proudly welcomes to the company Dr. Carla Mazzeo PhD, a global authority in exosome research who has more than 30 publications. She will spearhead company advancements in exosome-based skin, scalp, and hair care. Dr. Mazzeo, a leader in exosome research since 2004, was a Director and Senior Scientific Researcher at Boston University and Boston University Medical Center. She brings unparalleled expertise to enhance RESILIÉLLE’s commitment to excellence. [Read more…]
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