Clinical development

Our lead program is advancing through formulation development toward a first-in-human pilot study, with a clear regulatory path built on well-characterized active ingredients.

Program overview

Program
Formulation
Preclinical
IND / IRB
Phase 1 Pilot
Phase 2/3
Enso Patch Transradial Access
Active
In Progress
2026
2027
TBD
Enso Patch IV Access (Expansion)
Planned

Development timeline

Key milestones in our path from formulation to clinical proof-of-concept.

2025
Company Formation & Formulation Development
Established Enso Vascular, Inc. Initiated formulation development with contract manufacturing partner. Commenced iterative optimization of drug delivery profile.
H1 2026
Preclinical Data & IP Protection
In vitro permeation testing (IVPT) demonstrating therapeutic drug concentrations at target tissue depth. Provisional patent filing covering formulation and method of use.
H2 2026
IRB Submission & Pilot Study Preparation
IRB application for the SATORI pilot trial at an academic medical center. Final formulation optimization and clinical supply manufacturing.
2027
SATORI Pilot Trial
First-in-human clinical evaluation of the Enso Vascular Patch in patients undergoing transradial cardiac catheterization. Primary endpoints: safety, tolerability, and preliminary efficacy signals.
2027+
Regulatory Path & Pivotal Planning
Pre-IND interactions with FDA. Pivotal trial design informed by pilot data. Evaluation of expansion indications including IV access and dialysis.

Upcoming catalysts

Q2 2026

Optimized Formulation Lock

Final formulation selection incorporating permeation-enhanced drug delivery profile with confirmed stability.

Q3 2026

IRB Approval

Institutional review board approval for the SATORI pilot study, enabling first-in-human clinical evaluation.

Q4 2026

Clinical Supply Ready

GMP-compliant clinical batch manufacturing and release testing completed for pilot trial supply.

2027

SATORI First Patient

Enrollment of first patient in the SATORI pilot trial, representing a transformational proof-of-concept milestone.

Partner with us

We are actively seeking strategic partners and investors to support our clinical development program.

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