Bravo® pH monitoring
Given Imaging Ltd. Acquires Medtronic Bravo(R) pH Monitoring Business
December 10, 2008
by Joan Trombetti, Writer
Given Imaging Ltd. has acquired the Bravo® pH monitoring business for the diagnosis of Gastroesophageal Reflux Disease (GERD) from Medtronic for $20 million. The only wireless, catheter-free pH test for GERD, the Bravo system uses a disposable capsule temporarily placed in the esophagus that measures pH levels and transmits the data to an external receiver.
pH testing is considered the gold standard for diagnosing GERD(1) and during 2007 over 258,000 pH procedures were conducted in the US(2). Datamonitor estimates that around 147 million people in the US, Japan, France, Germany, Italy, Spain and the UK (around 20% of the population) suffer from GERD. The Bravo pH monitoring system is sold mainly in the US and to a lesser extent in Europe and is backed by strong reimbursement coverage in the US.
Under the terms of the agreement, Given Imaging will pay Medtronic $20 million. A small portion of the purchase price is contingent upon Medtronic completing the development of a new capsule delivery system already underway. During the first 12 months after the transaction closes, Medtronic will continue to supply the Bravo products to Given Imaging. During this 12-month period, Given Imaging intends to complete the transition of the Bravo system manufacturing operations to Israel. Given Imaging expects to incur a one-time charge of approximately $5m in the fourth quarter of 2008 in connection with the acquisition.
The catheter-free Bravo pH Monitoring System changed pH testing by using a capsule that collects pH data and transmits it via radio frequency telemetry to a small external pager-sized receiver worn by the patient. Traditional pH testing involves inserting a very small catheter into the nostril and advancing it into the stomach. Then another catheter, called an impedance pH probe, is inserted into the nostril and advanced into the esophagus where it remains in place for 24 hours. Challenges to traditional pH testing include throat irritation, difficulty sleeping and discomfort during eating or drinking.
The Bravo system allows patients to maintain their regular diet and activities. The Bravo system also minimizes throat and nasal discomfort associated with conventional catheter-based pH systems and eliminates social embarrassment that accompanies traditional pH testing with no visible indication that a pH test is taking place. By extending pH data collection to 48 hours, 24 hours beyond the recording capability of conventional catheter systems, the Bravo system provides the physician with additional data needed for an accurate GERD assessment. The Bravo system increases the likelihood of documenting relationships between atypical symptoms and reflux events with a 48-hour monitoring period, said a 2003 study published in The American Journal of Gastroenterology. The subject of over 50 peer-reviewed and industry publications, the Bravo pH Monitoring System also is supported by a strong intellectual property estate.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging markets a number of available capsules: the second-generation PillCam SB 2 video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the second-generation PillCam ESO 2 video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 820,000 sold allowing patients worldwide to benefit from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries. For more information, visit http://www.givenimaging.com.
pH testing is considered the gold standard for diagnosing GERD(1) and during 2007 over 258,000 pH procedures were conducted in the US(2). Datamonitor estimates that around 147 million people in the US, Japan, France, Germany, Italy, Spain and the UK (around 20% of the population) suffer from GERD. The Bravo pH monitoring system is sold mainly in the US and to a lesser extent in Europe and is backed by strong reimbursement coverage in the US.
Under the terms of the agreement, Given Imaging will pay Medtronic $20 million. A small portion of the purchase price is contingent upon Medtronic completing the development of a new capsule delivery system already underway. During the first 12 months after the transaction closes, Medtronic will continue to supply the Bravo products to Given Imaging. During this 12-month period, Given Imaging intends to complete the transition of the Bravo system manufacturing operations to Israel. Given Imaging expects to incur a one-time charge of approximately $5m in the fourth quarter of 2008 in connection with the acquisition.
The catheter-free Bravo pH Monitoring System changed pH testing by using a capsule that collects pH data and transmits it via radio frequency telemetry to a small external pager-sized receiver worn by the patient. Traditional pH testing involves inserting a very small catheter into the nostril and advancing it into the stomach. Then another catheter, called an impedance pH probe, is inserted into the nostril and advanced into the esophagus where it remains in place for 24 hours. Challenges to traditional pH testing include throat irritation, difficulty sleeping and discomfort during eating or drinking.
The Bravo system allows patients to maintain their regular diet and activities. The Bravo system also minimizes throat and nasal discomfort associated with conventional catheter-based pH systems and eliminates social embarrassment that accompanies traditional pH testing with no visible indication that a pH test is taking place. By extending pH data collection to 48 hours, 24 hours beyond the recording capability of conventional catheter systems, the Bravo system provides the physician with additional data needed for an accurate GERD assessment. The Bravo system increases the likelihood of documenting relationships between atypical symptoms and reflux events with a 48-hour monitoring period, said a 2003 study published in The American Journal of Gastroenterology. The subject of over 50 peer-reviewed and industry publications, the Bravo pH Monitoring System also is supported by a strong intellectual property estate.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging markets a number of available capsules: the second-generation PillCam SB 2 video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the second-generation PillCam ESO 2 video capsule to visualize the esophagus; the Agile(TM) patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 820,000 sold allowing patients worldwide to benefit from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries. For more information, visit http://www.givenimaging.com.