Stakeholder Update | 2025

Production‑Grade Hardware Achieved

Transitioned from advanced prototypes to production‑grade hardware, establishing a manufacturable, serviceable platform suitable for real‑world deployment.

Foundational User Interface Infrastructure Built

Implemented the core user‑facing software and web infrastructure required for device configuration, monitoring, and lifecycle management.

OTA & Device Management Infrastructure Established

Deployed over‑the‑air update and device management systems enabling remote updates, diagnostics, and long‑term fleet support—critical prerequisites for scale.

Internal Tooling Expanded >10×

Built and deployed a significantly expanded internal tooling stack across engineering, data systems, manufacturing workflows, and operations—dramatically increasing development velocity and execution capacity.

Validated Market Fit via Organic D2C Demand

Confirmed strong early market pull through direct‑to‑consumer engagement driven organically via the website and social channels.

Genesis Dynamics Initiated

Launched Genesis Dynamics as a focused commercialization and deployment entity, structurally separating core R&D from go‑to‑market execution.

Manufacturing Engineering Talent Onboarded

Added dedicated manufacturing engineering expertise to support design‑for‑manufacturing, process development, and early production planning.

Genesis Foundry Groundwork Laid

Initiated foundational planning for Genesis Foundry, defining early manufacturing strategy, process flows, and production architecture.

Physical Footprint Expanded

Transitioned from a single R&D environment to a multi‑site operational footprint:

• Established a small‑scale manufacturing facility in Washington, IL
• Opened a River North, Chicago office to engage engineering, design, and go‑to‑market talent
• Initiated Foundry team build‑out planning targeted for Q1–Q2 2026

Regulatory Strategy Advanced with Engaged Counsel

Engaged DLA Piper partners to guide device registration strategy and regulatory expansion in parallel with Foundry planning, with initial device registration targeted for Q1 2026.

Expanded IP Protection

Continued strengthening HuMod's intellectual property portfolio across mechanical systems, control architectures, and system‑level innovations.

Vision

Genesis Foundry is the core manufacturing and deployment system built and operated by Genesis Dynamics, serving as its primary product and operational engine for delivering Genesis limb systems at scale. Foundry is an end‑to‑end, centralized manufacturing and deployment platform that converts a single anatomical scan into a fully fabricated, autonomously calibrated limb replacement system.

Strategic Position

Genesis Foundry is made possible by HuMod's prior development of next‑generation below‑knee systems, including the ankle and foot. Foundry is not a standalone concept; it is the natural extension of owning the full technology stack required to design, manufacture, and deploy advanced limb systems. By controlling the core hardware, interfaces, and control architecture, HuMod is uniquely positioned to introduce a centralized, deterministic deployment model rather than competing incrementally within legacy clinic‑based fabrication workflows.

This strategic position is reinforced by HuMod's intense focus on end‑user experience. Genesis systems are already designed for automated calibration and adjustment, enabling a low‑friction onboarding experience for both clinicians and users. As a result, Foundry can replace fragmented, clinic‑based fabrication with a scan‑to‑system pipeline that delivers complete, ready‑to‑fit Genesis devices with reduced reliance on clinic-based fabrication.

The Foundry Pipeline

1. Scan Intake & Validation — Anatomical scans are captured via mobile devices, ingested, normalized, and automatically validated for completeness and viability.
2. Automated Design & Configuration — Generative modeling produces bespoke anatomical interfaces while configuring standardized Genesis modules (such as the existing below- knee ankle and foot systems) within fixed constraints.
3. Build & Assembly — Fabrication instructions are generated; bespoke components are produced and integrated with standardized modules.
4. Calibration & QA — Each system undergoes system‑level validation, calibration, and safety checks.
5. Fulfillment — Fully assembled systems ship directly to clinics or users, ready for fitment and activate.

The output is a complete Genesis Limb Replacement—not a kit, partial device, or design file.

Tier One Foundry Capability (2026)

In 2026, Foundry launches with a deliberately constrained Tier One capability:

• Single below‑knee limb system (Genesis Ankle with integrated socket)
• Fixed actuation, structural, power, and electronics modules
• Validated alignment, stiffness, and control parameter bounds
• Limited size and load classes aligned with initial use cases

Cases outside the validated envelope are identified at intake and routed through traditional clinical workflows until Foundry capability expands.

Tier One success is defined by repeatable, end‑to‑end production and deployment with no clinic‑level fabrication or tuning required.

Foundry is not designed to change everything at once—it is designed to earn coverage of the market systematically, beginning with a closed, predictable system and expanding only as reliability is proven.

Strategic Objective

Genesis Foundry is designed to support a more centralized and consistent deployment model for advanced limb systems by:

• Centralizing manufacturing intelligence
• Enforcing standardized system interfaces
• Collapsing deployment timelines from months to days
• Decoupling clinical care from manufacturing labor
• Creating a scalable, defensible infrastructure layer

Foundry is infrastructure—not software tooling—and becomes more valuable as volume, data, and operational learning compound.

Q1–Q2

• Prepare Genesis Ankle for initial commercial deployment
• Finalize onboarding, support, and lifecycle workflows
• Activate waitlist and prepare logistics for early users

Q2

• Launch Genesis Ankle to the existing D2C waitlist
• Deliver initial systems directly to users via Genesis Dynamics
• Establish early replacement, service, and feedback loops

Q1

• Finalize Tier One Foundry configuration envelope and validation protocols
• Advance Foundry manufacturing, calibration, and QA infrastructure
• Continue business development and clinical partner engagement

Q2–Q3

• Ongoing technical, operational, and process development across Foundry
• Incremental validation of scan intake, automated design, and assembly workflows
• Prepare supply chain, tooling, and staffing for pilot‑scale operation

Q4

• Execute first Genesis Foundry pilot deployment
• Validate end‑to‑end scan‑to‑system workflow under clinical conditions
• Assess readiness for expanded Foundry throughput and broader deployment