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Oct 2011

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July 2014

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June 2015

March 2016

Innovationin Cryoablation

IceSphere™ 1.5 Family 37°C gelOptimal spacing: 1.0 – 2.0 cm *IceSphere™ 1.5, IceSphere™ 1.5 S

One Needle0°C 33mm x 37mm

-20°C 23mm x 29mm-40°C 15mm x 23mm

Three Needles0°C 54mm x 50mm

-20°C 45mm x 40mm-40°C 36mm x 31mm

Two Needles0°C 48mm x 41mm

-20°C 38mm x 32mm-40°C 29mm x 22mm

Four Needles0°C 58mm x 59mm

-20°C 48mm x 49mm-40°C 38mm x 41mm

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

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-40° C-20° C

-0° C

±3mm width±4mm length

Actual Size ±5mm

-40° C

0° C-20° C

IceRod™ 1.5 Family* 37°C gelOptimal spacing: 1.0 – 1.5 cm*IceRod™ 1.5 PLUS, IceRod™ 1.5 CX

Two Needles0°C 51mm x 45mm

-20°C 41mm x 35mm-40°C 30mm x 25mm

Three Needles0°C 59mm x 54mm

-20°C 49mm x 44mm-40°C 39mm x 34mm

Four Needles0°C 60mm x 61mm

-20°C 51mm x 51mm-40°C 40mm x 42mm

One NeedleIceRod™ 1.5 CX0°C 36mm x 53mm

-20°C 26mm x 45mm-40°C 17mm x 39mm

One NeedleIceRod™ 1.5 PLUS0°C 35mm x 52mm

-20°C 25mm x 45mm-40°C 16mm x 40mm

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-40° C

-20° C

-0° C

-40° C

-20° C

-40° C

-20° C

Actual Size ±3mm width ±4mm length Actual Size ±5mm

-0° C

-0° C

-40° C

0° C-20° C

-40° C-20° C

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IcePearl™ 2.1 CX 37°C gelOptimal spacing: 1.0 – 1.5 cm

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20

10

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10

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One Needle0°C 36mm x 41mm

-20°C 27mm x 32mm-40°C 18mm x 26mm

Three Needles0°C 60mm x 53mm

-20°C 49mm x 43mm-40°C 40mm x 34mm

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

Four Needles0°C 61mm x 62mm

-20°C 51mm x 52mm-40°C 41mm x 44mm

Two Needles0°C 51mm x 44mm

-20°C 41mm x 34mm-40°C 32mm x 25mm

±3mm width±4mm length

Actual Size ±5mm

-40° C

0° C-20° C

IceFORCE™ 2.1 CX 37°C gelOptimal spacing: 1.5 – 2.0 cm

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10

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One Needle0°C 42mm x 57mm

-20°C 32mm x 49mm-40°C 23mm x 42mm

Three Needles0°C 64mm x 67mm

-20°C 54mm x 56mm-40°C 44mm x 47mm

Four Needles0°C 71mm x 73mm

-20°C 61mm x 62mm-40°C 50mm x 52mm

Two Needles0°C 61mm x 50mm

-20°C 52mm x 40mm-40°C 42mm x 30mm

±3mm width±4mm length

Actual Size ±5mm

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

0° C-20° C

-40° C

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IceEdge™ 2.4 37°C gelOptimal spacing: 1.5 – 2.0 cm

Two Needles0°C 59mm x 50mm

-20°C 49mm x 39mm-40°C 39mm x 28mm

Three Needles0°C 66mm x 66mm

-20°C 56mm x 56mm-40°C 45mm x 48mm

Four Needles0°C 71mm x 73mm

-20°C 62mm x 62mm-40°C 52mm x 53mm

One Needle0°C 40mm x 55mm

-20°C 30mm x 48mm-40°C 21mm x 41mm

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10

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±3mm width±4mm length

Actual Size ±5mm

-40° C

-20° C

-0° C

-40° C

-20° C

-0° C

-40° C-20° C-0° C

-40° C

0° C-20° C

Cryoablation Needle OptionsRoom temperature gel

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IceEDGE™ 2.449mm x 63mm34mm x 51mm22mm x 43mm

IceFORCE™ 2.1 CX50mm x 64mm35mm x 51mm24mm x 43mm

IceRod™ 1.5 Family43mm x 60mm28mm x 47mm17mm x 41mm

IcePearl™ 2.1 CX44mm x 49mm30mm x 35mm20mm x 27mm

IceSphere™ 1.5 Family39mm x 45mm26mm x 32mm16mm x 24mm

Actual Size ±3mm width ±4mm length

-40° C

0° C-20° C

-40° C

0° C-20° C

-40° C

0° C-20° C

-40° C-40° C

0° C-20° C

0° C-20° C

Galil Medical Cryoablation Needles may not be available in all markets Intended UseGalil Medical patented Cryoablation Needles are components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.Indications for UseGalil Medical Cryoablation Systems and Needles are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation needles, used with a Galil Medical Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. Galil Medical Cryoablation Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.A full list of specific indications can be found in the Galil Medical Cryoablation System User Manuals.Contraindications There are no known contraindications.Warnings / Precautions / Adverse EventsA thorough understanding of the technical principles, clinical applications, and risks associated with cryoablation is necessary before using Galil Medical products to conduct cryoablation. Use of such products should be restricted to use by or under the supervision of physicians trained in cryoablation with a Galil Medical Cryoablation System.A full list of the warnings, precautions, and adverse events can be found by referencing the respective device Instructions for Use document or Cryoablation System User Manual.

Galil, the Galil logo, IceEDGE, IceFORCE, IcePearl, IceRod, IceSphere, Visual-ICE and i-Flow are trademarks of Galil Medical Ltd. IceEDGE, IceFORCE, IcePearl, IceRod, IceSphere, Visual-ICE and i-Flow are registered trademarks in the US. ‘Imagine where we can go’, BTG and the BTG roundel logo are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. Galil Medical Ltd is a BTG International group company. MGC15-NDL150-04 Aug. 2016

To optimize tumor coverage and provide appropriate margins, use of multiple needles is recommended. Multiple needles placed in an adjacent configuration will typically create a large, coalesced iceball. In clinical use, patient anatomy, tissue and tumor properties affect needle placement. Needle type, number of needles placed, tissue and tumor characteristics, surrounding vasculature and treatment duration affect iceball size.

Monitoring iceball formation provides direct control throughout the procedure and is key to successful cryoablation.

Iceball dimensions are provided to assist users in selecting the cryoablation needle(s) and needle placement to appropriately ablate the target area. To optimize appropriate margins, needles should be placed to create lethal ice beyond the perimeter of the target tissue. Note: The -20°C isotherm is 0.5 cm from the edge of the visible ice.

Needle testing was conducted in a laboratory setting in either 37°C temperature controlled gel or in room temperature gel. Isotherm measurements were made following two 10-minute Freeze cycles separated by a 5-minute passive Thaw cycle.

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Innovationin Cryoablation

Galil Medical Inc. 4364 Round Lake Road Arden Hills, MN 55112 USA Tel: +1 651 287 5000 or +1 877 639 2796

Galil Medical Ltd. Tavor Building 1 Yokneam Israel 2069203 Tel: +972 (4) 9093200

galilmedical.com