Advancing Objective Burn & Wound Assessment Through Physiologic Imaging

Since late 2024, Perfusio has executed a focused development roadmap to reduce technical, clinical, and regulatory risk across its handheld MSPV™ burn assessment platform. These milestones reflect structured progress toward integrating objective physiologic imaging into real-world burn care workflows.

FDA Predicate Foundation

Built upon FDA-cleared CERTES™ perfusion imaging platform

Active Burn Center Collaboration

IRB-approved clinical engagement with HCA Healthcare Research Institute (HRI) and Burn Reconstructive Centers for America (BRCA)

AI-Enabled Burn Classification

Generation 2 handheld system aligned with scalable manufacturing and AI-enabled workflow

Q4 2024

Governance & Strategic Realignment

Perfusio completed a capital and leadership realignment to advance its handheld burn and wound assessment platform through disciplined execution. Rich Balot was appointed Chief Executive Officer and Joffre Alvarez was appointed Chief Operating Officer, aligning governance with product-stage development and clinical advancement.

Strategic Impact: Strengthened operational stability and leadership focus to advance objective burn assessment within clinical care environments.

Q1 2025

Handheld Burn Imaging Proof-of-Concept

Perfusio successfully translated its multi-spectral physiologic visualization (MSPV™) technology from the FDA-cleared CERTES™ system into a compact handheld prototype designed for burn and wound assessment.

This milestone demonstrated preservation of perfusion and tissue viability imaging fidelity within a portable form factor suitable for emergency department, burn unit, and bedside use.

Strategic Impact: Established technical feasibility of handheld objective burn-depth and perfusion assessment, materially reducing engineering risk toward clinical deployment.

Q2 2025

Clinical Activation Within Leading Burn Networks

Perfusio initiated IRB-approved clinical collaboration with HCA Healthcare Research Institute (HRI) and Burn and Reconstructive Centers of America (BRCA), supporting prospective multimodal imaging within active burn centers.

The collaboration focuses on objective burn-depth classification, perfusion-based tissue viability assessment, workflow integration in triage and surgical planning, and AI refinement using real-world datasets.

Strategic Impact: Anchored platform validation within one of the largest U.S. burn networks, strengthening clinical credibility and adoption readiness.

Q3 2025

Federal Validation & AI Advancement

Perfusio was invited for full submission to the Department of Defense Military Burn Research Program (MBRP) and awarded NIH SBIR Phase I funding.

The NIH-supported program advances a second-generation handheld burn assessment system featuring production-aligned hardware and software architecture, integrated AI-enabled workflow, and an animal study to further refine Burn AI using MSPV feature-engineered inputs.

Strategic Impact: Accelerates transition from feasibility prototype to manufacturable, clinically informed burn assessment system.

Q1 2026

North Carolina Matching Grant

Following NIH validation, Perfusio secured a $75,000 award under the One North Carolina SBIR/STTR Matching Funds Program to support continued refinement of the handheld system.

Strategic Impact: Extended non-dilutive development support while advancing toward production-aligned deployment.

Q1 2026

Generation 2 Production-Aligned Platform

Perfusio is advancing a Generation 2 handheld system incorporating production-equivalent architecture, edge-based AI inference, and workflow-aligned design informed by clinical engagement.

The system supports objective burn-depth evaluation, dye-free perfusion monitoring, repeatable bedside imaging, and structured clinical decision support.

Strategic Impact: Positions MSPV™ as a clinically engaged, production-ready burn assessment platform suitable for scalable deployment.

Platform Strengthening & Defensibility

Perfusio’s burn assessment platform is built upon a defensible technical and regulatory foundation:

  • FDA-cleared CERTES™ predicate platform

  • 25+ international patents issued or pending

  • European Unitary Patent coverage for multi-spectral physiologic analytics

  • Proprietary AI architecture leveraging MSPV feature-engineered inputs

The handheld system delivers dye-free, repeatable physiologic imaging designed for routine burn evaluation without workflow disruption. While focused initially on burn and wound care, the architecture maintains flexibility for expansion into adjacent tissue viability and surgical applications.

Why This Matters Now

Burn depth assessment remains largely dependent on subjective visual evaluation, contributing to variability in triage decisions, excision timing, and graft planning. Routine access to objective, physiology-based data at the point of care remains limited within standard burn workflows.

Perfusio’s recent milestones — handheld translation of MSPV™, activation within leading burn networks, AI-supported classification advancement, and transition to production-aligned architecture — materially reduce the technical and clinical barriers to adoption.

As burn centers prioritize consistency and data-informed decision-making, portable physiologic imaging represents a practical evolution in care delivery. Collectively, these developments position MSPV™ at a meaningful inflection point in advancing objective burn-depth assessment within clinical practice.