Gentle, Label-Free Cell Separation for Critical Medicine
Arterial Dynamics applies advanced fluid mechanics to eliminate mechanical cell trauma in therapeutic apheresis and biomanufacturing. Our FDA Breakthrough-designated core protects cell viability without high G-forces, mechanical filters, or harsh chemical tags.
“Biological targets shift,
regulatory landscapes change,
but continuity is forever.“
– Label-Free Phase-Locked Microfluidics
The Arterial Dynamics Platform: 7 Microfluidic Cores
Cores 1 – 4
Clinical & Therapeutic Applications
Core 1: Sickle Cell Disease & Acute Exchange (Flagship Module)
FDA Breakthrough Device Designated. Exploits the stark divergence in cellular elasticity and cross-sectional asymmetry under curvature. Flexible healthy cells deform and align within primary streamlines, while non-yielding sickled cells experience lateral vortex displacement into an outer collection lane for targeted extraction without membrane contact or shear-induced hemolysis.
Core 2: Oncology & Hyperleukocytosis Blast Isolation
Leverages volumetric displacement and high nuclear stiffness. Because inertial forces scale steeply with cell volume, these oversized, rigid blasts experience strong lateral lift forces, snapping them into a single-file equilibrium margin for rapid extraction during acute hyperleukocytosis crises.
Core 3: Malignant Circulating Clusters (CTCs & Microemboli)
Deploys a specialized low-shear expansion zone that uses wall-effect lift to cushion fragile cell clusters away from channel surfaces. The system achieves high-fold background clearance without mechanical filtration, preserving fragile cell-to-cell junctions intact for liquid biopsy diagnostics.
Core 4: Sepsis & Blood-Borne Pathogen Clearance
Inverts the sorting paradigm by utilizing ultra-high-velocity curvature paths. Dominant inertial forces hold large background blood cells in central streamlines, while sub-micron, low-mass pathogens (Bacteria and Fungi) are governed by secondary drag forces, continuously sweeping them into perimeter boundary currents for waste shunting.
Cores 5–7
Research, Bio-Manufacturing & Diagnostics
Core 5: Point-of-Care (PoC) Decentralized Cell Manufacturing
Operates under low-velocity flow regimes to minimize secondary drag. The module translates sub-micron physical diameter variances along extended parallel tracks into distinct harvesting lanes, delivering high-purity, unactivated cellular payloads for CAR-T processing without magnetic or antibody tagging.
Core 6: Inline Perfusion & Gaseous Micro-Bubble (GMB) Safetyg
Exploits negative inertial lift forces in curved safety loops. Dense cellular components are focused outward toward channel margins, driving compliant micro-bubbles to aggregate along the low-pressure inner midline, where they passively coalesce and bleed off to protect ECMO and CPB patients from micro-strokes.
Core 7: Research Use Only (RUO) & Laboratory Automation
Features progressive step-tapered channels that skim large targets in deep initial stages before accelerating remaining fluid to focus mid- and small-scale targets. An integrated cryptographic interface automatically tunes pump dynamics to the cassette’s fluid matrix, maintaining low shear across variable media viscosities.
Latest Development Milestones
FDA CDRH Pre-Submission Completed
Arterial Dynamics completed formal Q-Submission written feedback (Q261876) with FDA CDRH. The agency’s guidance establishes clear non-clinical bench validation endpoints, including ASTM F1841-25 dynamic hemolysis and hemocompatibility profiling for LaminaFlow.
Federal SBIR R&D Proposals Advanced
Submitted updated technical responses for federal grant applications (NSF & NIH), highlighting LaminaFlow’s physics paradigm: achieving high-inertia secondary Dean vortex cell separation while suppressing wall shear stress below physiological thresholds (<50 Pa).
Advanced Physics for Gentle Cell Processing
Eliminate mechanical trauma, high shear forces, and chemical labels in critical therapeutics.
Arterial Dynamics applies advanced microfluidic principles to protect cellular integrity during apheresis, biomanufacturing, and diagnostics. By replacing high G-forces and mechanical filters with engineered fluid dynamics, our platform isolates target cell populations while preserving cell viability for critical therapeutic applications.
Frequently Asked Questions
Q: How does the Arterial Dynamics platform achieve label-free separation?
A: Our single-use microfluidic cores utilize precise fluid dynamics and channel geometry to separate cells based on physical and biophysical properties without using harsh chemical tags, antibodies, or mechanical filtration.
Q: What is the clinical focus of Core 1?
A: Core 1 is engineered for high-efficiency, non-contact apheresis to isolate damaged rigid erythrocytes during acute crisis states in Sickle Cell Disease, avoiding shear-induced hemolysis.
Q: Is the system compatible with existing bioprocess loops
A: Yes. Cores 4 and 6 are specifically designed for low-resistance inline integration into extracorporeal circuits (such as ECMO) and continuous bioprocess monitoring loops.
Q: What regulatory path is the flagship module following?
A: Core 1 s currently under active FDA review following a formal Breakthrough Device Designation Q-Submission, aimed at establishing an expedited regulatory pathway and collaborative feedback process for clinical development
Collaborate With Arterial Dynamics
We are actively engaged with academic research institutions, clinical partners, and strategic investors.