Science

Discovery Phase (Pre-2022)

From Scientific Insight to Patent Protection

Identification of immune dysfunction as a core driver of ALS progression
Conceptual development of SELanetx™: a device enabled therapy to induce apoptosis and rebalance immune activity (M1 → M2 macrophage polarization)
Initial IP filed and patents granted in the U.S., Japan, and internationally
Founding team includes research, research neurologists, with backgrounds such as Harvard, Stanford, and Mayo Clinic
Seed-stage funding secured to begin early-stage exploration

From Concept to Demonstration

Closed-loop blood processing device v1.0 fabricated and tested
Preclinical efficacy in transgenic SOD1 ALS mouse models

Key Finding: Treated mice maintained motor function (treadmill test); significant improvement over control
Establishment of proprietary Apoptogenic Immuno Metabolism Platform™
Filed additional patents related to process improvements and protocols
Initiated internal safety and usability evaluations of the prototype

From Discovery to Collaboration

Preclinical Phase II partnership with Indiana University School of Medicine
Clinical engagement with Gregory W. Fulton ALS Clinic (Top 3 ALS clinic globally) to plan early human trials
IRB ethics consultation underway for compassionate-use alignment
SELanetx™ TM platform research extended to MS and Parkinson’s disease models
Partnership discussions with device manufacturers and university research centers

From Lab to Human Trials

Launch of expanded ALS mouse study for dose optimization and durability
Initiation of IRB submission and first-in-human trial planning
Target enrollment: 30-40 ALS patients in IRB trial at partner clinics
SELanetx™ MB platform research extended to MS and Parkinson’s disease models
Early engagement with FDA consultants to outline approval application
Feasibility study for manufacturing supply chain with ISO partners

From Trials to Impact