For Healthcare Providers

With over 26 years of established clinical success, low-intensity pulsed ultrasound (LIPUS) devices have been shown to accelerate fracture repair and enhance non-union healing.4-7

How does LIPUS work?

Low-intensity pulsed ultrasound (LIPUS) medical devices use ultrasound waves to create nano-motion at the fracture site that stimulates a biochemical response through integrin mechano-receptors by enhancing the production of cyclo-oxygenase 2 (COX-2) that triggers molecules to enhance fracture repair.2

Adapted from Harrison A, Lin S, Pounder N, Mikuni-Takagaki Y. Ultrasonics. 2016;70:45-52.
COX-2=cyclo-oxygenase 2; PGE2=prostaglandin E2

Key clinical trials supporting LIPUS device treatment

1994
(Double-blind RCT)

Treatment

LIPUS device for 20 mins per day (n=33) vs. Placebo (n=34)

Lipus Device Studied

I_e: 30 mW/cm2
f_aw: 1.5 MHz
PRF: 1 kHz
PW: 200 μs

Type and Location of Fracture

Fresh fractcure (<7 days)

Tibia

Demographics

Skeletally mature men and non-pregnant women
<76 years old

Key Results

Decrease in time to overall healing: 96 ± 4.9 days vs. 154 ± 13.7 days, p=0.0001

~38% faster healing with LIPUS device vs. placebo

Reference

Heckman JD, Ryaby JP, McCabe J, et al. J Bone Joint Surg Am. 1994;76(1):26-34.

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A_er=effective radiating area; DF=duty cycle (duty factor); f_aw= ultrasound frequency or frequency Sine waves; I_e=effective intensity (spatial average temporal average); P=temporal average power; PRF=pulse repetition frequency (repetition rate/modulation frequency); PW=pulse duration (signal burst or signal burst width, pulse burst width, modulating signal burst width); Q=beam type; R_bn=beam non-uniformity ratio

1997
(Double-blind RCT)

Treatment

LIPUS device for 20 mins per day (n=30) vs. Placebo (n=31)

Lipus Device Studied

I_e: 30 mW/cm2
f_aw: 1.5 MHz
PRF: 1 kHz
PW: 200 μs
DF: 20%

Type and Location of Fracture

Fresh fracture (<7 days)

Radius

Demographics

Men and non-pregnant women
>21 years old
Included smokers

Key Results

Time to union: 61 ± 3 days vs. 98 ± 5 days, p<0.0001

~38% faster time to union with LIPUS device vs. placebo

Reference

Kristiansen TK, Ryaby JP, McCabe J, et al. J Bone Joint Surg Am. 1997;79(7):961-973.

Go to publication

2001
(Self-pairing)

Treatment

LIPUS device for 20 mins per day (n=29)

Lipus Device Studied

I_e: 30 mW/cm2
f_aw: 1.5 MHz
PRF: 1 kHz
PW: 200 μs
DF: 20%

Type and Location of Fracture

Non-unions (failure to unite >6 months from fracture) on:

Tibia
Femur
Radius/ulna
Scaphoid
Humerus
Metatarsal
Clavicle

Average non-union fracture age is 61 weeks.

Demographics

Men and non-pregnant women
18-90 years old
Included smokers

Key Results

25 of 29 non-union cases healed in an average time of 22 weeks.

~86% healed

Reference

Nolte PA, van der Krans A, Patka P, et al. J Trauma. 2001;51(4):693-703.

Go to publication

2015
(Registry)

Treatment

LIPUS device (n=4,190)

Lipus Device Studied

I_e: 30 ± 30% mW/cm2
f_aw: 1.5 ± 5% MHz
PRF: 1.0 ± 10% kHz
PW: 200 ± 10% µs
DF: 20%
A_er: 3.88 ± 1% cm2
P: 117 mW (±30%)
R_BN: 4.0 maximum
Q: Collimated

Type and Location of Fracture

Fresh fracture (≤90 days old)

Tibia
Fibula
Femur
Metatarsal
Radius
Humerus
Scaphoid
Clavicle
Ankle
Ulna
Metacarpal

Closed fractures (n=3,212)
Open fractures (n=147)

Demographics

Men and women

Included comorbidities:

Smoking
Diabetes
Hypertension
Vascular insufficiency
Osteoporosis
Cancer
Cardiovascular disease
Alcoholism
Renal disease
Rheumatoid arthritis

Key Results

Heal rate:
>94% healed

Elderly (≥60 years old) had similar heal rate to the population as a whole.

Days to treatment was significantly shorter for patients who healed (38.3 [±24.3] mean days) vs. those who failed (47.1 [±27.3] mean days), p=0.0001; (earlier treatment provides better outcomes).

Reference

Zura R, Mehta S, Della Rocca GJ, et al. BMC Musculoskelet Disord. 2015;16:45-55.

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UNIO Technical Specifications

I_e: 30 ± 30% mW/cm2
P: 117 ± 20% mW
R_BN: 4.0 Max
A_er: 3.88 ± 5% cm2
ƒ_awf: 1.5 ± 5% MHz
Waveform: Pulsed
PW: 200 ± 5% μs
PRF: 1.0 ± 5% kHz
DF: 20%
Q: Collimated

Why UNIO for your patients?

HEALTH CANADA APPROVED

UNIO is a Health Canada approved Class II medical device (Licence No. 109919) indicated for the treatment of fresh bone fractures and established non-unions excluding treatment of the skull and vertebral column.

EASY-TO-USE AT HOME

UNIO’s one-touch system offers 20 minutes of low-intensity pulsed ultrasound (LIPUS) treating fresh and non-union fractures.1

ACCELERATES HEALING

LIPUS devices have demonstrated accelerated healing in fresh fractures compared to placebo and higher heal rates in non-union fractures.2-7

What type of patients can use UNIO?

UNIO is indicated for treatment of fresh bone fractures and established non-unions excluding treatment of the skull and vertebral column. The location and type of fracture will influence results.1

The UNIO device can be used in the presence of metal screws and plates.1

The UNIO device is intended for non-invasive use only, and must only be used as prescribed by a physician or other Medical Professional for its intended use, in accordance with the UNIO User Guide.1

People with cardiac pacemakers should get clearance from their physician prior to use.1

Evidence of safety and efficacy has not been established in certain populations. Refer to the UNIO User Guide for more information.

Email UNIO to receive a EN/FR copy of the user guide at [email protected]

How do I get my patients started with UNIO?

UNIO must be prescribed by a Physician or Medical Professional. Please contact us for more information on how to prescribe for your patients.