The Week of

TETmedical has received FDA Breakthrough Device Designation for NSE-FAST, an experimental blood test designed to help physicians rapidly identify acute ischemic stroke.

Unlike CT scans, which can miss ischemic strokes in the early hours, NSE-FAST measures the activity of a brain-specific enzyme released into the bloodstream after neuronal injury.

The FDA designation is intended to speed development and regulatory review of the test, which TETmedical plans to evaluate in a pivotal multicenter clinical trial beginning later this year. If successful, NSE-FAST could become the first rapid blood test to aid in the diagnosis of acute ischemic stroke, potentially helping doctors begin treatment sooner when every minute counts. Here’s more: https://substack.com/home/post/p-203104208.

Definium Therapeutics reported positive Phase 3 results for DT120, its experimental LSD-based treatment for major depressive disorder.

In the 149-patient study, a single dose significantly reduced depression symptoms compared with placebo after six weeks, while also meeting key secondary endpoints and showing benefits that persisted for at least 12 weeks. The treatment was generally well tolerated, with no new safety concerns identified.

The results represent one of the strongest late-stage datasets yet reported for a psychedelic-based depression therapy and move the company a step closer to seeking FDA approval. Check it out: https://substack.com/home/post/p-203118896.

Unixell Biotechnology announced that it received FDA clearance to begin clinical testing of UX-DA003, an investigational stem cell therapy for Parkinson's disease.

The treatment uses induced pluripotent stem cells (iPSCs) to replace the dopamine-producing neurons that are gradually lost as the disease progresses, with the goal of addressing the underlying cause rather than simply managing symptoms.

While the therapy still faces years of clinical testing before it can reach patients, the milestone represents an important step forward for regenerative medicine and the use of stem cell therapies to treat neurodegenerative diseases. Here’s more: https://substack.com/home/post/p-203408284.

Dr. Peter Grinspoon is an author, primary care physician, and one of the clearest public voices on cannabis addiction, recovery, and policy, as well Leonard's personal friend. In the latest episode of "The Last Alchemist," Leonard and Peter discuss his new book, "Aging Well with Cannabis: Feel Better, Sleep Better, and Live Better with Marijuana and CBD" and what a more humane drug policy might look like. https://www.youtube.com/watch?v=cTXXJfnm5c4