lambert
$AMIX The encouraging part: On Sept. 30, Autonomix reported positive FDA feedback supporting a potential 510(k) pathway for its standalone sensing platform. The company is targeting potential U.S. clearance in roughly 15 months, assuming development, validation and FDA review proceed successfully.
That's important because AMIX now has a more concrete regulatory path rather than simply a speculative technology story.
There are also encouraging preclinical/clinical signals:
Its pancreatic-cancer pain work has shown meaningful pain reduction in early human data.
Its renal-nerve preclinical work demonstrated the ability to detect and localize neural activity and confirm changes after ablation.
The company continues expanding its patent portfolio.
The problem: the market isn't rewarding those developments yet.
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