Pediatric Medtech · Smart Wearable · FDA Class I Exempt

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

Over 2.8 million children in the US alone have lower limb malalignment that will not self-correct. Until now, the main clinical option has been surgery. GV Correct offers a non-surgical alternative.

See How It Works Get Early Access
2.8M+
Children affected
in the US alone
EU+US
Granted
patents
Scroll
🇺🇸
FDA Class I Exempt — no prescription required
🏛️
Research origin: University of Tartu
📄
EU Patent EP3113729 · US Patent 11,083,664
🇺🇸
Headquartered in Boston, USA
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. GV Correct is designed to fill that gap.

2.8M
U.S. children aged 7–12 with lower limb malalignment — knock knees and bowlegs combined
Current treatment landscape
✗
Bracing — no clinical evidence
✗
Kinesiotape — short-term only
⚠
Surgery — effective, invasive
✓
GV Correct — fills the gap
How It Works

A smart orthopedic system. Not a brace.

The GV Correct 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
A 9g 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 — GV Correct System GV Correct garment diagram
9g
Sensor weight
8h/day
Wear protocol
7–12
Patient age range
Bluetooth
Data transfer
GV Correct offers a promising non-surgical option for families dealing with pediatric knock knees.
Dr. Jana Kritt
Dr. Jana Kritt
Pediatric Orthopaedist
Head of Traumatology & Orthopaedics
Tallinn Children's Hospital
Who It's For

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

GV Correct 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 GV Correct is being developed to extend to more severe presentations as well.

1
Child aged 7–12 with lower limb malalignment
The active growth phase is when lower-limb alignment is most responsive to support. GV Correct is designed to be worn during this period.
2
Mild to moderate severity
GV Correct is designed for the broad population of children with mild to moderate lower-limb malalignment.
3
Used with or without a clinical referral
GV Correct 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.
4
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 GV Correct 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. Validated 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. 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. Involving your child's doctor or physiotherapist is encouraged but not 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 validation
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. GV Correct is classified as FDA Class I Exempt, meaning no prescription is required. That said, we always recommend involving your child's pediatrician or orthopedist in the decision.
What ages does it work for?
GV Correct 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 GV Correct 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?
Traditional bracing has no published clinical evidence for genu valgum or varum. GV Correct is the only garment in this category supported by 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. GV Correct 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 validated the technology.

Don Hammond
Don Hammond
CEO · Co-founder
↗ LinkedIn
Sten Dubin
Sten Dubin
CSO · Co-founder
↗ LinkedIn
Eric Hennessy
Eric Hennessy
CTO · Co-founder
↗ LinkedIn
Dan Alldridge
Dan Alldridge
COO · Co-founder
↗ LinkedIn
Clinical, Scientific & Regulatory Advisors
Dennis Shay
Dennis Shay, Ph.D.
Regulatory Affairs Advisor · RAC (Devices — Global) · CQA · FDA 510(k), Q-Sub & SaMD Specialist
Prof. Arved Vain
Prof. Arved Vain, PhD
Clinical Lead · Inventor of device and method · Associate Professor in Biomechanics, University of Tartu
Anna-Liisa Tamm
Anna-Liisa Tamm, PhD
Clinical Studies Advisor · Co-inventor · Head of Physiotherapy, Tartu Health Care College
Ivi Vaher
Ivi Vaher, PhD
Clinical Studies Advisor · Co-inventor · Senior Lecturer & Physiotherapist, Tartu Health Care College
Get in Touch

Join us early.

Whether you're a parent interested in early access, an investor, a clinician, or a potential partner — we want to hear from you.

For Parents
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General Enquiries
Investors, clinicians, research & partnerships
Questions about investment opportunities, clinical partnerships, research collaboration, or media enquiries — reach out and we'll respond promptly.