No flow through the instrument
The medication does not flow through the reusable AXIS™ body.
AXIS™ · Closed Path Injection System
AXIS™
Closed Path Injection System
The governed injection system designed to protect both the patient and the medication from fill through delivery
AXIS™ combines a reusable smart manual injection instrument with a single use, exact dose Closed Drug Module. The prescribed volume is calculated and filled before administration, removing device level dose selection, drawing, and measurement from the delivery event. Together, the instrument and module create one governed system designed to preserve medication identity, dose integrity, sterility, authorization, and traceability.
The medication remains entirely inside the disposable Closed Drug Module and its integral sterile fluid path. It never flows through, contacts, or enters the reusable AXIS™ instrument.
For the patient, AXIS™ verifies the module, protocol, authorization, expiration, use state, and exact dose record before delivery. For the medication, the closed disposable pathway preserves separation from the reusable instrument and the surrounding environment until controlled administration.
System classification
Governed smart manual injection system
Disposable component
Single use exact dose Closed Drug Module
Identity verification
NFC and governed unit identity
Clinical posture
Physician directed
Hi, I am ALETHA. I help you understand your data and prepare it for your practitioner. I do not make clinical decisions; your practitioner does.
ALETHRA™ governs; ALETHA™ guides. Learn more
One Integrated System
The instrument and
the module function as
one governed architecture.
AXIS™ is not an injector paired with a separate generic cartridge platform. The reusable instrument and disposable Closed Drug Module are designed to function as one integrated system. Separating these functions protects the medication while allowing the reusable instrument to remain completely outside the sterile pathway.
Reusable AXIS™ Instrument
Remains completely outside the sterile pathway
- VerificationModule, protocol, and record checks
- AuthorizationRole and protocol eligibility
- Controlled actuationApplied externally to the module
- Status displayDose shown as read only status
- Refusal logicInvalid events refused before delivery
- Event captureBound to the ALETHRA™ governed record
One Governed System
Designed to preserve
- Medication identity
- Dose integrity
- Sterility
- Authorization
- Traceability
Single Use Closed Drug Module
Contains the complete sterile drug contact pathway
- Prescribed medicationOne authorized medication and protocol
- Exact prescribed volumeCalculated and filled before administration
- Integral sterile fluid pathSealed from fill through delivery
- Governed identityNFC readable, signed authorization data
- Single useNot reset for another use
Closed From Fill Through Administration
The medication never
passes through
the reusable device.
The Closed Drug Module is filled and sealed within the authorized manufacturing environment. Once sealed, the medication remains enclosed inside its dedicated drug contact pathway until the moment of administration. The reusable AXIS™ instrument interfaces only with the exterior mechanical surfaces of the module. It does not become part of the fluid path.
No contact with the medication
The reusable instrument does not contact the medication.
No contact with sterile surfaces
The reusable instrument does not contact the needle or internal sterile surfaces.
No residual pathway
A previously administered compound does not leave a drug contact pathway inside the reusable instrument.
No reuse of the fluid path
The disposable fluid path is not reused for another patient, medication, or administration.
Protected from exposure
The medication remains protected from ambient exposure from sealed fill through controlled delivery.
This architecture is designed to reduce contamination, cross contact, environmental exposure, cleaning dependency, and carryover risk associated with reusable drug contact mechanisms.
The Closed Drug Module
The module is the
prescribed dose and
sterile delivery pathway.
Each AXIS™ Closed Drug Module is a single use, prefilled delivery component prepared for one authorized medication, protocol, and exact prescribed volume. It is the medication identity, prescribed delivery volume, sterile pathway, authorization object, and traceable administration record operating within AXIS™.
Governed information the module may carry
- Module identityUnique module identity and governed unit identifier.
- Formulation mappingMedication and formulation mapping.
- Protocol associationAuthorized volume and protocol association.
- Batch and lotBatch, lot, fill, packaging, expiration, and stability information.
- Signed authorizationNFC readable identity and signed authorization data.
- Use statePrior use status, tamper state, and applicable handling history.
Depending on the authorized configuration, module components may include the reservoir, plunger and stopper system, septum, sterile seals, needle pathway, passive shield, and tamper control features.
Dose Control by Design
The prescribed dose
is established before
administration.
AXIS™ moves dose calculation and volume preparation out of the point of administration. The authorized prescriber determines the dose, and the authorized pharmacy or manufacturing environment prepares the Closed Drug Module to contain that exact prescribed amount. There is no dose dial, no manual volume calculation, and no need to draw medication from a vial into a separate syringe.
Dose control
AXIS™
Preparation
One module is prepared for one prescribed administration
Prescribed amount
Calculated and filled before the clinical delivery event
Dose selection
The practitioner cannot increase or decrease the dose on the AXIS™ instrument
Dose display
Displayed as verified read only status
Module checks
A mismatched, expired, unauthorized, or previously used module can be refused before delivery
Event record
Bound to the module identity and governed event history
Once identity, protocol, expiration, use state, and authorization checks are satisfied, AXIS™ delivers the full authorized module contents. This architecture is designed to remove device level dose selection and measurement steps and thereby reduce the risk of calculation, drawing, transcription, and partial selection errors at the point of administration.
How AXIS™ Works
Verify before delivery,
and preserve the event afterward.
01 Identify
AXIS™ reads the module NFC identity and governed unit identifier.
02 Authenticate
The system checks the signed record and verifies that the module is recognized within the authorized AXIS™ environment.
03 Confirm
AXIS™ evaluates the medication, protocol, dose metadata, expiration, use state, device relationship, and user authorization.
04 Refuse when necessary
AXIS™ is designed to refuse an administration event when the module is unauthorized, expired, previously used, mismatched, outside the approved protocol, or unable to complete required verification.
05 Deliver
Once required checks are satisfied, the practitioner retains physical control of the smart manual administration. The reusable instrument applies actuation externally while the medication remains within the disposable sterile pathway.
06 Close the lifecycle
Following administration, the module transitions to its used state. Electronic and mechanical controls are designed to prevent unauthorized reuse.
07 Record
AXIS™ binds the module identity, authorization result, administration event, device state, time, and applicable exception information to the ALETHRA™ governed record.
Governed Refusal
AXIS™ verifies before
it permits an
administration event.
AXIS™ is designed to evaluate the module before delivery begins. A refusal does not silently disappear. The event and its reason can be preserved in the governed history for authorized review.
Check
The system may refuse an event when it detects
Identity
An unrecognized module or identity mismatch
Protocol
An unauthorized protocol
Module state
An expired or previously used module
Authorization
An invalid or missing authorization
Tamper state
A broken or inconsistent tamper state
Device relationship
An incompatible device relationship
Record
A required record that cannot be verified
Single Use by Design
One module,
one sterile pathway,
one governed administration.
After administration, the Closed Drug Module is not reset for another use. Its electronic identity transitions to a used state, while mechanical controls are designed to prevent refilling, reattachment, or unauthorized reuse.
The disposable module
The complete drug contact pathway remains with the disposable module for controlled disposal.
The reusable instrument
The reusable AXIS™ instrument remains isolated from the medication and can continue operating without becoming a shared fluid pathway between administrations.
Why the Closed Path Matters
Reuse the intelligent
instrument, never the
medication pathway.
AXIS™ is designed around a clear principle: reusable intelligence and actuation remain outside the medication pathway, while every drug contact and sterile delivery component stays with the disposable module.
Compound protection
Protection of sensitive compounds and reduced ambient exposure. Reduced contamination, cross contact, and carryover risk.
Hardware separation
Separation of reusable hardware from medication and sterile surfaces.
Exact prescribed volume
Without device level dose selection, drawing, or measurement.
Module authentication
Module level authentication and anti counterfeiting controls, and prevention of unauthorized reuse.
Traceability
Traceability from authorized fill through administration.
Clear attribution
Clear attribution of every verified, refused, and completed event.
ALETHRA™ Governance
Every module has an identity.
Every administration
has a history.
ALETHRA™ governs the authorization and evidence layer surrounding AXIS™. The governed record can connect medication identity, authorized source, fill and packaging events, date and time, facility or location, batch and lot information, module identity, protocol authorization, expiration, use state, device relationship, administration event, refusal reason, and correction history.
Preserved history
Original events are preserved. Authorized corrections are recorded as new linked events rather than silently replacing prior history.
Clinical boundary
ALETHRA™ does not make the clinical decision. It governs identity, authorization, state, provenance, and evidence boundaries around the decision made by the licensed practitioner.
Designed for Professional Clinical Environments
Physician directed,
role controlled,
and traceable.
AXIS™ is intended for qualified clinics, licensed practitioners, authorized pharmacies, healthcare programs, and approved professional environments. Access is controlled through registration, qualification review, protocol eligibility, and role based authorization.
Physician Directed · Human in the Loop
All diagnoses, prescriptions, medication selections, dosing decisions, and clinical outcomes remain the responsibility of independent licensed medical professionals. AXIONOVA™ does not practice medicine.
AXIS™ Access
Register for governed system access.
AXIS™ is not offered as an unrestricted consumer injection device. Access requires professional qualification, authorized protocols, and applicable regulatory and clinical review.
Regulatory and Development Notice
AXIS™ and its Closed Drug Module architecture are subject to applicable development, manufacturing, quality, medical device, combination product, pharmacy, prescribing, and jurisdiction specific regulatory requirements.
Product configurations, materials, compatible medications, clinical indications, and commercial availability may vary by jurisdiction and authorization status. Compounded medications, where applicable, must be prepared by licensed pharmacies pursuant to valid prescriptions and are not FDA approved.