Real-Time Lesion Tracking · Needle Placement · Motion-Synchronised Delivery

SyncAblate tracks the lesion in real time, predicts the optimal moment to advance the needle, and ensures energy is only delivered when the probe is confirmed on target — even as the anatomy moves.

Precision that knows
where the target will be.

Developing a hardware-enforced control architecture that guides needle placement and physically conditions therapeutic energy on real-time verified positional confidence — transforming ablation precision for moving anatomical targets in liver and lung procedures.

Interventional Radiology Device Manufacturers Research Partners Investors

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3 Patent Applications Filed

<10ms Hardware Inhibition Latency

85% Energy-On Duty Cycle

PCT International Filing 2027

✓ Validated in Simulation

The Clinical Problem

"No current system tells the surgeon precisely when to advance the needle into a moving target — or physically prevents advancement when it is not safe to do so."

The lesion moves. During liver and lung procedures, targets shift up to 25mm with every breath. Getting the needle into the centre of a moving lesion on the first attempt requires knowing exactly when to advance — not guessing.

Surface sensors are not enough. Respiratory belts and IR sensors measure chest wall movement — a proxy for the lesion, not the lesion itself. Internal EM and ultrasound fusion tracks the target directly.

Humans can't react fast enough. The optimal insertion window during end-exhalation lasts fractions of a second. Manual timing relies on clinician reaction time of 150–300ms. Hardware enforcement closes in under 10ms.

Why It Matters

PROBLEM

During liver and lung procedures, the lesion moves up to 25mm with every breath. Getting the needle to the centre on the first attempt — and confirming position before energy fires — remains an unsolved clinical problem.

SOLUTION

SyncAblate fuses EM needle tracking with real-time ultrasound lesion tracking and a 200ms predictive model — then physically enforces the optimal insertion and energy delivery window in hardware, not software.

IMPACT

First-attempt needle placement accuracy in free-breathing patients — no breath-hold required. Reduced procedure time, reduced tissue trauma, and motion-verified energy delivery once the needle is confirmed on target.

The Platform

A layered control architecture
built on hardware certainty.

SyncAblate is a hardware control module that integrates with existing imaging and therapeutic energy systems. It tracks the lesion and needle in real time, predicts the optimal window for advancement and energy delivery, and enforces that window in hardware — allowing the existing ablation generator to fire only when the target is verified to be within the defined safety margin.

SyncAblate does not replace existing imaging or ablation devices. It connects between them — enabling motion-synchronised, position-verified needle placement and energy delivery on platforms already in clinical use.

Layer 01

Predictive Targeting

A predictive motion model estimates target position 150–300ms ahead, compensating for imaging and system latency. Energy arrives where the tumour will be — not where it was observed.

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Layer 02

Hardware Safety Gate

An FPGA-controlled fail-safe relay sits in series with the generator activation pathway. Energy physically cannot be delivered unless positional confidence exceeds a defined threshold — enforced in hardware, independent of software.

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Layer 03

Deterministic Sensor Reacquisition

A hardware-governed duty cycle periodically interrupts energy delivery to create electromagnetically quiet windows. Ground-truth position is reacquired at each window, preventing accumulated prediction error over multi-minute procedures.

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Output

Therapeutic Energy Delivery

The existing ablation generator fires — with no hardware modification. The system integrates as a modular interceptor between the clinician's footswitch and the generator activation port.

"The clinician retains full control. Energy delivery simply cannot occur outside defined positional safety limits."

The system functions like an aviation safety envelope applied to ablation. Compatible with existing generators in Australian and international interventional radiology suites. No modification of regulated generator hardware or software required.

Applicable across radiofrequency ablation, microwave ablation, cryoablation, HIFU, laser ablation, and irreversible electroporation.

Technical FAQ

Questions from clinicians
and engineers.

Answers to the questions most commonly raised by interventional radiologists, biomedical engineers, and potential development partners.

Clinical & Performance

How does SyncAblate handle unpredictable respiratory patterns? +

The system does not rely on a simple periodic waveform model. The Layer 01 predictive engine uses a sliding-window algorithm that continuously adapts to irregular breathing, sudden patient movement, and breath-hold deviations. The safety envelope is recalculated every few milliseconds. If the pattern becomes too irregular to predict with sufficient confidence, positional confidence drops below the threshold and the hardware gate inhibits delivery automatically — the same fail-safe behaviour as a sensor disconnection.

Does the pulsed duty cycle affect ablation volume or thermal dose? +

At an 85% energy-on duty cycle, the impact on total thermal dose is clinically negligible. The reacquisition windows are measured in tens of milliseconds — long enough for ground-truth sensor reacquisition, but too short for significant tissue cooling to occur. Published data on existing pulsed ablation protocols supports this. The net effect is a marginally extended total procedure time with no meaningful change in ablation zone geometry.

What is the system's end-to-end latency from detection to inhibition? +

The hardware relay opens in under 2ms of the FPGA issuing an inhibit command — this is the deterministic hardware path. Total system latency from positional confidence dropping below threshold to generator output ceasing is governed by the relay opening time plus the generator's own power-down ramp, which is typically 20–30ms for standard RF generators. The system is designed around a worst-case budget of 87ms for the full reacquisition cycle, with a 13ms margin against the 100ms quiet window.

Hardware & Integration

How does the system interface with existing generators? +

SyncAblate is a modular interceptor. It connects to the generator's standard footswitch activation port — the same port the clinician's footpedal normally connects to. When the clinician presses the pedal, the signal reaches the FPGA first. If the target is within the positional safety margin, the relay closes and the signal passes to the generator in under 2ms. If not, the relay stays open and no signal reaches the generator. The generator has no awareness that the interceptor is present — it simply sees a footswitch input.

Does integration require any modification to our imaging stack or generator software? +

No. SyncAblate ingests standard sensor data streams — electromagnetic tracking, ultrasound, and available imaging — and processes them externally on its own hardware. It operates as a fully independent safety layer. Your existing regulated generator hardware and software remain unmodified and within their original regulatory clearance. This is a deliberate architectural choice: modifying a cleared medical device would require re-submission. SyncAblate avoids that pathway entirely.

Which electromagnetic tracking and ultrasound platforms are compatible? +

The architecture is designed to be sensor-agnostic at the hardware level. The primary validated configuration uses an NDI Aurora-class electromagnetic tracker as the ground-truth reacquisition sensor and a standard B-mode ultrasound as the primary tracking modality during active delivery. The sensor arbitration logic in the FPGA is configurable, allowing integration with alternative EM and ultrasound platforms. CT fluoroscopy, cone-beam CT, and optical tracking embodiments are covered in the patent portfolio.

Safety & Regulatory

What happens if the system loses tracking entirely during a procedure? +

The hardware safety gate is fail-safe by design. If positional confidence drops below the required threshold for any reason — sensor disconnection, excessive interference, or loss of tracking — the FPGA relay opens immediately, halting energy delivery in under 2ms. Energy cannot resume until tracking confidence is restored and verified above the threshold. The clinician is never locked out: they retain the ability to abort the procedure at any point by releasing the footpedal, which overrides the system entirely.

Which ablation modalities is the architecture compatible with? +

The hardware-enforced inhibition logic is modality-agnostic. The relay intercepts the activation pathway regardless of the energy type the generator produces downstream. Compatibility covers radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, laser ablation, high-intensity focused ultrasound (HIFU), and irreversible electroporation (IRE). All six modalities are explicitly claimed in the patent portfolio.

What is the anticipated regulatory pathway? +

Because SyncAblate does not modify any cleared medical device and functions as an add-on safety accessory, the anticipated pathway in Australia is TGA Class IIb under the AIMD framework, with a parallel CE Mark submission under the EU MDR for international markets. The modular interceptor architecture was specifically designed to maintain the regulatory status of existing generators, which substantially simplifies the submission scope. This will be refined in consultation with a regulatory affairs specialist prior to any clinical trial submission.

Additional technical documentation is available under mutual NDA. Contact us to request access →

How It Works

Not a beam device.
Not a navigation tool.
A gate.

SyncAblate works with the needles clinicians already use. It does not reposition tissue, direct energy from outside the body, or replace any existing device. It controls when the needle advances and when energy fires — enforced at the hardware level.

Real-time imaging

Tumour tracked continuously

Predictive model

200 ms positional forecast

Conditions check

Position · confidence · respiratory phase

Yes

Gate stays closed

No action permitted

Hardware gate opens

FPGA relay · <5 ms response

Needle advancement

Manual or robotic

Energy delivery

RF · microwave · IRE

"The hardware interlock does not suggest when to act — it physically enforces it. No software fault, OS crash, or human reaction time can change that."

The FPGA relay sits in series with the activation pathway. It cannot be overridden by software. If positional confidence drops for any reason — sensor loss, motion irregularity, EM interference — the gate opens in under 5 milliseconds and delivery stops. The clinician retains full manual override at all times via the footpedal.

Clinical Relevance

Why it matters
in practice.

The same core architecture applies across multiple clinical scenarios. The problem — a target that moves faster than the system can respond — is consistent. So is the solution.

LIVER ABLATION

10–25 mm per breath cycle

The liver moves substantially with respiration. Once the needle is placed, the window in which the tip and tumour are actually aligned can be a fraction of a second. SyncAblate turns that window from a judgement call into a hardware-enforced event.

LUNG ABLATION

Up to 40 mm displacement

Pulmonary nodules can shift 40 mm through a full breathing cycle. Breath-hold reduces this but cannot be sustained across a full ablation. SyncAblate gates delivery throughout the procedure without requiring breath-hold.

NEEDLE PLACEMENT

The unsolved moment of action

No current system reliably compensates for motion at the moment of needle advancement. Clinicians advance manually from CT or ultrasound guidance — but by the time the decision is made and the hand moves, the target has shifted. The predictive model forecasts position 200 ms ahead specifically to close this gap.

WHAT DOESN'T CHANGE

The clinician's workflow

The same imaging. The same generator. The same needles. SyncAblate connects between existing systems as a modular interceptor — it does not replace capital equipment, retrain surgical technique, or alter the fundamental procedure. It adds a layer of hardware certainty to what is already being done.

Intellectual Property

A growing portfolio of
related patent applications.

Three provisional patent applications have been filed with IP Australia, covering distinct layers of the SyncAblate control architecture. A PCT international application is planned for early 2027.

Application 01 — Filed February 2026

Predictive Motion-Synchronised Therapeutic Delivery

Covers the AI-driven predictive targeting system and real-time motion synchronisation architecture for moving anatomical targets during continuous therapeutic energy delivery.

IP Australia Filed

Application 02 — Filed February 2026

Hardware-Enforced Positional Safety Inhibition

Covers the FPGA-controlled hardware safety gate architecture, fail-safe relay design, and modular interceptor embodiment that conditions energy delivery on verified positional confidence.

IP Australia Filed

Application 03 — Filed March 2026

Deterministic Sensor Reacquisition Architecture

Covers the hardware-governed pulsed duty cycle system that creates deterministic sensing windows for ground-truth positional reacquisition throughout multi-minute therapeutic procedures.

IP Australia Filed

Portfolio scope: Applications collectively cover predictive targeting, hardware safety control, and deterministic sensor verification across radiofrequency ablation, microwave ablation, cryoablation, HIFU, laser ablation, and irreversible electroporation. Sensor modalities include electromagnetic tracking, ultrasound, CT fluoroscopy, cone-beam CT, optical tracking, and MR tracking.

Full technical documentation is available for review under a mutual non-disclosure agreement.

Development Pathway

Engineering validation
in four structured phases.

A disciplined progression from computational modelling to pre-clinical validation, designed to satisfy regulatory requirements and de-risk early clinical adoption.

PHASE 01

Computational Simulation

Modelling of motion-synchronised energy gating across respiratory and cardiac motion profiles. Validation of positional confidence thresholds and inhibition timing.

PHASE 02

Bench Validation

Hardware validation using motion phantoms. Measurement of relay response times, gating accuracy, and system latency under simulated clinical conditions.

PHASE 03

Integration Testing

Imaging-guided integration testing with existing ablation platforms. Verification of signal interfaces, safety inhibition logic, and clinical workflow compatibility.

PHASE 04

Pre-Clinical Validation

Pre-clinical testing in relevant tissue models. Regulatory submission preparation targeting TGA Class IIb (Australia) and CE Mark under EU MDR.

Integration Model

Enabling technology,
not a competing platform.

SyncAblate is designed to sit between existing clinical systems — not replace them. This positions the technology as a high-value integration layer for established imaging and therapeutic energy platforms.

INPUT

Imaging & Tracking Platforms

CT fluoroscopy · Cone-beam CT · Ultrasound · Electromagnetic tracking · Optical tracking · MR tracking

SYNCABLATE MODULE

Hardware Control Layer

Positional confidence evaluation · Hardware safety gating · Motion synchronisation · Fail-safe relay control

OUTPUT

Therapeutic Energy Generators

Radiofrequency ablation · Microwave ablation · Cryoablation · Laser ablation · HIFU · Irreversible electroporation

Get In Touch

Clinical partnerships.
Licensing enquiries.
Research collaboration.

Request Technical Briefing Partner With Us Investor Enquiry

SyncAblate is actively seeking clinical feedback from interventional radiologists and oncologists, research collaboration with academic engineering groups, and discussions with medical device companies interested in licensing or development partnerships. Early conversations are welcomed — the technology is ready to discuss.

Full technical architecture and engineering documentation are available for discussion under a mutual non-disclosure agreement.

Inventor Frank Mirabito

Email [email protected]

Phone 0420 312 635

LinkedIn linkedin.com/in/frank-mirabito-34ab463b5

Location Sydney, NSW, Australia

Precision that knowswhere the target will be.

A layered control architecturebuilt on hardware certainty.

Questions from cliniciansand engineers.

Not a beam device.Not a navigation tool.A gate.

Why it mattersin practice.

A growing portfolio ofrelated patent applications.

Engineering validationin four structured phases.

Enabling technology,not a competing platform.

Clinical partnerships.Licensing enquiries.Research collaboration.

Precision that knows
where the target will be.

A layered control architecture
built on hardware certainty.

Questions from clinicians
and engineers.

Not a beam device.
Not a navigation tool.
A gate.

Why it matters
in practice.

A growing portfolio of
related patent applications.

Engineering validation
in four structured phases.

Enabling technology,
not a competing platform.

Clinical partnerships.
Licensing enquiries.
Research collaboration.