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The LINX Refux Management Systemis the only available FDA-approveddevice to treat GastroesophagealRefux Disease (GERD), a debilitatingdisease that aects 1 in 5 U.S. adults.1

Millions o Americans suering rom GERD now have a new,

sae and eective treatment alternative.

The LINX System is a small, exible band omagnets enclosed in titanium beads. Themagnetic attraction between the beads helpskeep a weak esophageal sphincter closed toprevent reux. The LINX System is implantedaround the weak sphincter just above the

stomach in a minimally invasive procedurethat typically takes less than one hour.

FACT SHEET

GERD: The backstory

GERD spells misery or millions

o U.S. adults.

Whether you call it heartburn, acid reux,

or GERD, gastroesophageal reux disease

can spell misery or millions o adults

in the U.S. GERD is caused by a weak

muscle in the esophagus called the Lower

Esophageal Sphincter (LES) that allows acid

and bile to splash up rom the stomach into

the esophagus, oten causing injury to the

lining o the esophagus and symptoms like

heartburn, chest pain, regurgitation, sore

throat, and cough.

GERD is:

Caused by a mechanical defect and requires

a mechanical solution. Medications or

GERD are designed to control or suppress

acid production in the stomach. They do

not address the cause o GERD, a weak

sphincter muscle, and cant prevent refux.

Approximately 40 percent o GERD suerers

continue to have symptoms while taking

medications or GERD.2

Epidemic. 1 in 5 U.S. adults suers

rom GERD.

Serious. GERD can lead to serious

complications like stricture, Barretts

esophagus, and esophageal cancer.Adenocarcinoma, a type o esophageal

cancer, increased over 600 percent

between 1973 and 2006.3

Debilitating. GERD can cause daily pain,

lead to poor sleep, aect ood tolerance,

and limit daily activities.

Costly. The cost o GERD to U.S. employers

has been estimated at $75 billion per year.4

LES WeakLES

LINX is the only available FDA-approved device or thetreatment o GERD An FDA advisory panel votedunanimously in avor o the LINX Systems saety, efcacyand clinical beneft. This positive vote was ollowed byFDA approval on March 22, 2012.

LINX study results appeared in New England Journal ofMedicine The 3 year results o a 5-year clinical studyassessed 100 patients with chronic GERD beore and atertreatment with the LINX System.

Results rom the clinical study showed that ater treatmentwith the LINX System:

92 percent o patients achieved reedom rom dailyGERD medication

91 percent o patients achieved signifcant symptomimprovement

100 percent o patients eliminated severe regurgitation

99 percent o patients eliminated daily sleep disruptiondue to heartburn

94 percent o patients were satisfed with theiroverall condition

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Torax Medical, Inc.4188 Lexington Avenue North, Shoreview, Minnesota 55126, USA

www.toraxmedical.com info@toraxmedical.com

Phone: 1 (651) 361-8900Doc. No. 3721 Rev.

Date o f Issue: Feb. 2013

1International Foundation or Functional Gastrointestinal Disorders (IFFGD)2GERD Patient Study: Patients and Their Medications (AGA Institute)3Pohl, et al., Esophageal adenocarcinoma incidence: are we reaching the peak? Cancer Epidemiol Biomarkers

Prev; 19 (6); 1468-704Wahlquist P., et al. A Systematic review: the impact o gastro-oesophageal reux disease on work productivity.

Aliment Pharmaco l Ther2006; 24: 259-72

Figure 1

Figure 2

LES

LINXSystem

The LINX System treats a debilitating disease GERD at its source.

How It Works: LINX is designed to STOP REFLUX AT ITS SOURCE.

GERD is a caused by a mechanical deect and requires a mechanical solution.The LINX System is a small, exible band o magnets enclosed in titanium beads.The beads are connected by titanium wires. The LINX System is implantedaround the weak esophageal sphincter, just above the stomach. The magneticattraction between the beads keeps the weak esophageal sphincter closedto help prevent reux. (Figure 1) Swallowing orces separate the beads

temporarily to allow ood and liquid to pass into the stomach. (Figure 2)LINX is implanted laparoscopically in a minimally invasive procedure thattypically takes less than one hour. Patients generally go home within one day.

Current Treatments: Patients need an alternative.

Medications or GERD are designed to control or suppress acid productionin the stomach. They do not address the cause o GERD, a weak sphinctermuscle, and cant prevent reux. Approximately 40 percent o GERD suererscontinue to have symptoms while taking medications or GERD.

Current surgical treatments or GERD are perormed annually on an estimatedless than one-hal o 1 percent o GERD suerers in the U.S.

LINX System Abridged Brie StatementThe LINX Reux Management System is indicated or those patients diagnosed with Gastroesophageal Reux Disease (GERD) as defnedby abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy or the treatment o reux.

Caution: Federal law (USA) restricts these devices to sale by or on the order o a physician.

Contraindications: Do not implant the LINX System in patients with suspected or known allergies to titanium, stainless steel, nickel orerrous materials.

Warnings: The LINX device is considered MR unsae. Laparoscopic placement o the LINX device is major surgery.

General Precautions: The LINX device is a long-term implant or use in patients 21 years or older. Medical management o adversereactions may include explantation and/or replacement.

Potential Risks Associated with LINX System: Dysphagia, stomach bloating, nausea, odynophagia, increased belching, decreasedappetite, inability to belch or vomit, atulence, early satiety, device erosion, device migration, inection, pain, and worsening opreoperative symptoms.

For more inormation on the LINX Reux Management System, contact your physician or Torax Medical, Inc.For ull patient inormation visit www.toraxmedical.com.