BREAKING PEDRA Xauron earns FDA Breakthrough Device Designation for critical limb ischemia $4.7M Series A led by SEEDS Capital & strategic vascular-device makers First device to read deep-tissue foot perfusion in real time - under 10 seconds Up to 4 angiosomes monitored at once, no contrast required CEO Kareen Looi previously sold Setagon to Medtronic Headquartered in Singapore · Founded 2014
Company Dossier · Medical Devices

PEDRA

Technology · Singapore

Turning a surgeon's guess into a number - real-time, deep-tissue perfusion for the foot.

PatencyPerfusionPerformance
2014Founded
$4.7MSeries A
<10sTo Feedback
FDABreakthrough
FDA
Breakthrough
Device
PEDRA Xauron Perfusion System - bedside monitor displaying the PEDRA Technology logo and the tagline Patency. Perfusion. Performance.
The PEDRA Xauron Perfusion System at rest, boot screen glowing. In the angio suite it does something no monitor did before: quantify whether blood is reaching the tissue, moment to moment. — Product photograph, PEDRA Technology
The Feature · Singapore

The Number Surgeons Never Had

For decades, physicians restoring blood flow to a failing foot judged their work by looking at X-ray images. PEDRA Technology decided that judgment deserved a measurement.

In a hospital angiography suite, a vascular surgeon threads a wire into a diabetic patient's leg, opens a blocked artery, and injects contrast dye. The X-ray blooms with a picture of the pipes. What it does not show - what no routine tool showed in real time - is whether the tissue at the far end of those pipes is actually being fed. The surgeon closes up and hopes. That gap between opening an artery and knowing the foot is perfused is the problem PEDRA Technology set out to close.

Founded in Singapore in 2014, PEDRA Technology built the PEDRA Xauron Perfusion System, which the company describes as the first device to deliver real-time, quantitative deep-tissue perfusion readings during a procedure. It is aimed squarely at peripheral arterial disease (PAD) and its most severe form, critical limb threatening ischemia (CLTI) - a condition whose five-year mortality can exceed 50 percent, worse than many cancers.

What it actually does

The Xauron uses laser-based sensing to read microvascular blood flow beneath the skin of the foot. It returns a quantitative perfusion index in under ten seconds and can track up to four channels at once, letting a clinician watch several foot angiosomes - the distinct territories fed by different arteries - rather than settle for a single reading. It needs no contrast and adds no radiation of its own. Its sensors are radiolucent, so they can sit inside the angiographic field without blocking the X-ray image the surgeon is already relying on.

That combination is the point of difference. Existing ways to gauge perfusion - toe pressures, ankle-brachial index, transcutaneous oxygen, skin perfusion pressure - tend to be indirect, surface-level, or taken before and after rather than during the procedure. Contrast-based angiographic perfusion software reads the image, not the tissue. PEDRA's bet is that a direct, deep-tissue, real-time number changes the decision a physician makes while the patient is still on the table.

Who is behind it

PEDRA is led by CEO and founder Kareen Looi, a serial entrepreneur in vascular devices who previously founded Setagon, a US coronary-stent company acquired by Medtronic. The technical core is CTO Whye-Kei Lye, who holds a Yale physics PhD and is credited with more than 31 patents. The clinical voice belongs to CMO Paul Hayes, a former vascular surgeon at Cambridge. Around them sits an international advisory board of vascular specialists across Singapore, the United States and Europe.

Who it is for

The customers are hospitals and the physicians who work their angio suites: vascular surgeons, interventional cardiologists and radiologists, and the limb-salvage teams treating diabetic and PAD patients. The business is classic B2B medtech - a capital monitor plus single-use sensors - supported by a clinical evidence program whose goal is to make perfusion monitoring a standard of care rather than an optional extra.

The money and the recognition have followed the thesis. In September 2020 PEDRA closed a $4.7 million Series A led by SEEDS Capital, the investment arm of Enterprise Singapore, alongside M&L Healthcare Investments and two strategic manufacturers of peripheral vascular devices. In January 2021 the FDA granted the Xauron system Breakthrough Device Designation for periprocedural use in CLTI - a status that prioritizes review for devices that could meaningfully help patients with serious conditions. It is, the company notes, the first perfusion monitor for CLTI to receive it.

Where it fits in the market is a quieter story than a headline unicorn. PEDRA is a small, focused team working a specific, high-stakes wedge: the moment of decision inside a limb-salvage procedure. If perfusion monitoring becomes routine, the payoff is measured less in revenue multiples and more in amputations avoided.

Physicians can at last see real-time perfusion changes during an interventional procedure in the angiographic suite.

Paul Hayes, MD — Chief Medical Officer, PEDRA Technology

The Case, In Figures

A few numbers frame why real-time perfusion feedback matters in critical limb ischemia.

>50%5-year mortality in CLTI
<10sTime to perfusion reading
4Angiosome channels
0Contrast dye required

Figures drawn from company materials and vascular clinical literature. CLTI = critical limb threatening ischemia.

Under The Hood

How The Xauron Reads A Foot

A simplified view of the perfusion loop, from sensor to decision.

Place sensors

Radiolucent sensors sit on the foot, inside the angiographic field, without blocking the X-ray image.

Read the tissue

Laser-based sensing measures microvascular blood flow in deep tissue - not just the skin surface.

Quantify perfusion

The system returns a quantitative perfusion index across up to four channels in under ten seconds.

Guide the decision

The physician sees whether the intervention actually improved perfusion, angiosome by angiosome.

Real-Time, Deep, Direct

An illustrative comparison of how perfusion is assessed. Bars indicate directional strengths of each approach, not exact clinical benchmarks.

Suitability for intra-procedural, deep-tissue feedback

Directional · higher = better fit for real-time limb-salvage decisions
PEDRA Xauron
95
ICG angiography
60
TcPO2 / SPP
45
Toe pressure / ABI
30
Angiogram (visual)
25

A qualitative illustration for context only. PEDRA's edge is combining real-time timing, deep-tissue depth, direct measurement, and no added contrast in one device.

One Device, One Question

Is the foot getting more blood now? The Xauron system exists to answer that, out loud, mid-procedure.

Flagship Product

PEDRA Xauron Perfusion System

Non-invasive, laser-based monitor for real-time, quantitative deep-tissue perfusion of the foot. Under 10 seconds to feedback, up to 4 channels, contrast-free, radiolucent sensors, portable with battery support.

Business Model

B2B Capital + Consumables

Sells to hospitals and vascular/interventional physicians: the monitor as capital equipment plus single-use sensors, backed by a clinical program to push toward standard-of-care adoption and reimbursement.

Expertise

Physics Meets Vascular Surgery

A founder who exited to Medtronic, a CTO with a Yale physics PhD and 31+ patents, and a former Cambridge vascular surgeon as CMO - guided by advisors across three continents.

Market Position

The Limb-Salvage Wedge

Focused on the decision moment inside PAD and CLTI procedures, where existing tools are indirect, surface-level, or taken before-and-after rather than live.

Milestones

2014

Founded in Singapore

Pedra Technology Pte Ltd is established to tackle tissue perfusion assessment in peripheral arterial disease.

2020

$4.7M Series A

Closes financing with SEEDS Capital, M&L Healthcare Investments and strategic vascular-device manufacturers.

2021

FDA Breakthrough Device Designation

The Xauron Real-Time Tissue Perfusion System is granted Breakthrough status for periprocedural use in CLTI.

2025

Advancing the Xauron system

Product materials show a refined multi-channel interface with per-angiosome perfusion (BPI) ratios.

Questions

Frequently Asked

What does PEDRA Technology make?

The PEDRA Xauron Perfusion System, a non-invasive, laser-based monitor that measures deep-tissue blood perfusion in the foot in real time during vascular procedures.

What problem does it solve?

During treatments for peripheral arterial disease and critical limb ischemia, physicians traditionally judge success from subjective X-ray images. PEDRA gives an objective, quantitative perfusion reading so they can tell whether blood is actually reaching the tissue.

Who founded and leads PEDRA Technology?

CEO and founder Kareen Looi, a serial vascular-device entrepreneur who previously founded Setagon (acquired by Medtronic). The team includes CTO Whye-Kei Lye and CMO Paul Hayes, a former Cambridge vascular surgeon.

Has the device been recognized by the FDA?

The Xauron system received FDA Breakthrough Device Designation in January 2021 for periprocedural use in critical limb threatening ischemia. That designation speeds review but is not the same as full marketing clearance.

How much funding has PEDRA raised?

PEDRA raised a $4.7M Series A round in September 2020, led by SEEDS Capital (Enterprise Singapore) with M&L Healthcare Investments and strategic vascular-device manufacturers.

See It In Action

Video, official channels, and press on PEDRA Technology and the Xauron perfusion system.