Pediatric Medtech · Smart Wearable · FDA Class I Exempt

The First Smart Wearable
System for Supporting
Pediatric Lower-Limb
Alignment.

Over 7.4 million children worldwide have lower limb malalignment that will not self-correct. Until now, the main clinical option has been surgery. SmartAlign™ offers a non-surgical alternative.

See How It Works Get Early Access

7.4M+

Children affected
worldwide

EU+US

Granted
patents

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The Problem

A large, underserved population with no good non-surgical option.

Lower limb malalignment is common in children. In many cases, this issue resolves naturally over time. But a significant population presents with persistent deformity — causing pain, gait disturbance, and long-term joint damage — and today faces a binary choice: wait indefinitely, or undergo invasive surgery.

Families have lacked a comfortable, non-invasive option between observation and surgery. SmartAlign is designed to fill that gap.

7.4M

children aged 7–12 with lower limb malalignment — knock knees and bowlegs combined

A Gap in Options

Today, families choose between two extremes.

For most mild-to-moderate cases, there has been little in between watching and waiting or moving to surgery.

Watch and Wait

The default for most mild-to-moderate cases

No active treatment

The child is monitored while the growth window narrows. Alignment may worsen over time, and any change is often caught late.

Families can face months or years of uncertainty and concern, with no clear timeline.
If alignment does not improve on its own, options narrow as the child grows.

Surgery

Reserved for the most severe cases

An invasive procedure

Surgical correction typically involves hardware placed during a child's growth, and later removed.

It carries the risks that come with any surgery, including anesthesia, complications, and a period of recovery.
It is a significant step, usually considered only once alignment is severe.

Until now, families have had little in between. SmartAlign is designed to fill that gap.

How It Works

A smart orthopedic system. Not a brace.

The SmartAlign™ garment applies calibrated pressure to support limb alignment during normal daily activity. With a recommended wear time of around 8 hours a day, it supports daily alignment routines — while an embedded wireless sensor and the SmartAlign™ app give parents and clinicians real-time compliance data.

Mechanotherapeutic garment

Calibrated elastic straps apply medial pressure during movement. No restriction of daily activity — designed to be worn to school, during play, and everyday life.

Wireless pressure monitoring

An embedded sensor transmits pressure readings to the parent app via Bluetooth. Parents can view wear time and garment positioning data.

SmartAlign™ app

Parents monitor wear time and pressure range. Parents view wear time and garment positioning status.

Device Overview — SmartAlign™ System

SmartAlign garment showing adjustable tension at the waistband, internal elastic band, concealed pressure sensor and tensile force direction, with the connected parent app

Illustrative rendering. Not actual product.

7–12

Patient age range

Bluetooth

Data transfer

Who It's For

Built for every child who needs it — mild to moderate cases.

SmartAlign is designed for children aged 7–12 presenting with lower limb malalignment across the full mild-to-moderate spectrum. The earlier support begins during the growth years, the better the outcome. The next generation of SmartAlign is being developed to extend to more severe presentations as well.

Child aged 7–12 with lower limb malalignment

The active growth phase is when lower-limb alignment is most responsive to support. SmartAlign is designed to be worn during this period.

Mild to moderate severity

SmartAlign is designed for the broad population of children with mild to moderate lower-limb malalignment.

Used with or without a clinical referral

SmartAlign fits naturally into a clinical workflow — and is designed to be accessible enough for families to use independently. FDA Class I Exempt, no prescription required.

A non-invasive first-line option

For the first time, families and clinicians have a non-surgical, non-invasive support option — before watchful waiting becomes a longer-term problem.

What SmartAlign Offers

✓

Designed for children aged 7–12

✓

Addresses mild to moderate lower limb malalignment

✓

Non-invasive — no surgery, no immobilization

✓

Compatible with daily activity including school and sports

✓

Real-time monitoring for parents and clinicians

✓

Next generation in development for severe cases

Prevalence in target age group

~6.5%

average prevalence in Western countries among children aged 7–14

Clinical Evidence

Grounded in years of peer-reviewed research.

Developed in collaboration with the University of Tartu and Tartu Health Care College. Two peer-reviewed publications. Two granted patents. Developed and tested across multiple applied research phases.

University of Tartu
Pilot Study, 2021

Positive changes in biomechanical parameters observed in the study population. Full publication available on request.

Publication · 2021

Pilot Study — Pediatric Reports

Development and feasibility assessment of the garment and companion app in children with intermalleolar distance ≥5cm. Demonstrated positive biomechanical changes in muscle frequency and stiffness parameters.

Tamm, Vaher, Linkberg et al. · Pediatric Reports, pp. 495–503

Publication · 2018

Mechanotherapy Framework — Int. PMR Journal

Foundational study establishing the mechanotherapeutic approach and garment-with-pressure-applicator design. Established the baseline clinical protocol for lower limb alignment support in children.

Tamm, Linkberg, Vaher et al. · Int. Physical Medicine & Rehabilitation Journal, 3(3), 198–202

Patents · Granted

EU + US Patents on Device & Method

The mechanotherapeutic device and measurement method are protected across key markets. IP originated at the University of Tartu and Tartu Health Care College. GV Correct, Inc. holds exclusive licensing rights with an option to purchase upon first institutional funding.

EU Patent EP 3 113 729 B1 · 2020 | US 11,083,664 B2 · Granted

For Clinicians

Designed to integrate into your workflow.

GV Correct supports pediatric orthopedic and physiotherapy practices with an evidence-based, non-invasive option for mild-to-moderate lower limb malalignment. FDA Class I Exempt — no prescription required.

Intended Use

Clinical criteria

Children aged 7–12 with mild to moderate genu valgum or genu varum. Skeletally immature. No systemic contraindications. Suitable for daily wear compliance.

Evidence

Published research

Two peer-reviewed publications including a 2021 pilot study in Pediatric Reports. Full evidence pack available on request.

Reimbursement

CPT pathway

Reimbursement pathway via CPT coding currently in development. For clinical partnership enquiries or to request a physician brief, contact us directly.

FAQ

Common questions.

Everything parents and families need to know before getting started.

Does my child need a prescription?

No. SmartAlign™ is classified as FDA Class I Exempt, meaning no prescription is required. That said, we encourage you to involve your child's pediatrician or orthopedist if you have questions.

What ages does it work for?

SmartAlign is designed for children aged 7–12 — the window during which the body's growth plates are still open and most responsive to non-invasive alignment support.

Is it painful or uncomfortable?

The pressure applied by SmartAlign is adjustable and designed to be comfortable during daily wear. Parents can adjust pressure gradually over time. Pressure levels can be viewed in the SmartAlign™ app.

How is this different from orthotics or bracing?

Unlike traditional bracing, which has no published clinical evidence for genu valgum or varum, SmartAlign is a garment-based approach developed through peer-reviewed research.

What if my child won't wear it consistently?

The SmartAlign™ app displays wear time and garment positioning data to parents. The garment is designed with comfort, discretion, and kid-friendly wear in mind, which itself supports higher compliance.

Is this covered by insurance?

Insurance coverage is not yet available. SmartAlign is available as a cash-pay product, payable by credit card. To make it more accessible, the cost can be spread across 12 monthly installments. A reimbursement pathway via CPT coding is in development for future clinical distribution.

Leadership

Commercial team. Clinical depth.

GV Correct, Inc. is led by a management team combining commercial, technical, and operational experience — backed by the research team that invented and developed the technology.