Given Imaging is a pioneer in the field of capsular endoscopy. Its portfolio of products and patents puts the company years ahead of the competition. The company’s medical devices have now been used for over a decade the world over to diagnose a variety of upper and lower gastrointestinal diseases, in a minimally invasive, patient-friendly way.
On September 12, 2011, Homi Shamir, the CEO of Given Imaging, was ringing the closing bell at NASDAQ to celebrate the 10 year anniversary of the firm’s IPO. Now we are pleased to welcome Mr. Shamir to Medgadget, and we have a few questions for him about his firm and its future.
Shiv Gaglani, Medgadget:
Congratulations on a decade since the FDA approved the PillCam! In that time Given Imaging released a second generation PillCam with a wider panoramic angle, adjustable frame rate depending whether the PillCam is stationary or locomotive, and a data recorder capable of providing feedback to the PillCam during the procedure. These changes have been well-received by the GI community, with reports of enhanced diagnostic accuracy and sensitivity. What can we expect in the third generation of the PillCam?
Homi Shamir, CEO of Given Imaging:
We are always looking for ways we can continue to improve our technologies to ensure we are providing gastroenterologists with the highest quality tools to detect and diagnose gastrointestinal disorders. Currently, we are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics.
Your primary products have focused on esophageal and small bowel imaging as well as pH monitoring with the Bravo system. Can you give us a sneak peak of any other medical areas and challenges that Given Imaging is currently working on?
One of the products that we’re very excited about is PillCam COLON 2. Every year, more than 1.2 million people throughout the world are diagnosed with colon cancer. In fact, although colon cancer is one of the most preventable forms of cancer, it’s the second leading cause of cancer death as compliance for colon cancer screening remains low. PillCam COLON is designed for individuals who are not currently following colon cancer screening guidelines. We are marketing this product in Europe and a large clinical trial in the US and Israel is underway to support a filing with the FDA next year. In addition, we are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics.
Your acquired Sierra Scientific Instruments in March of last year and in the process expanded your diagnostic capabilities. Would you please comment on any medical devices in the pipeline from that acquisition?
Over the past year, we have focused on integrating the Sierra Scientific product line into our product offering. We have spent time in the field with physicians understanding their needs and have begun the process to tailor the offering accordingly. One of our future goals is to begin offering our products in one platform. As you may imagine space is limited in the endoscopy suite and we are working with physicians and nurses to offer not only cutting-edge medical technologies but also meet the needs of the entire gastroenterology staff.
Does Given Imaging have any plans to couple its technology with therapeutic applications?
We are investing in and developing new products to improve GI health such as magnetically controlled PillCam capsules as well as PillCam capsules that can deliver therapeutics. Unfortunately we can’t reveal anything more about that at this time.
What is the largest obstacle facing widespread adoption of the PillCam by hospitals/GI specialists?
PillCam SB has been widely adopted throughout the world and is recognized as the gold standard for imaging the small bowel. PillCam SB is available at more than 5,500 centers in 80 countries, and more than 1.5 million patients have ingested PillCam SB. In addition, 600 million individuals worldwide have reimbursed access to PillCam SB. Earlier this year, PillCam SB received FDA clearance for use in monitoring the progression of Crohn’s disease in patients. We believe that this could contribute to the future growth of this product. In June, we initiated a clinical trial for our PillCam COLON 2 product, an alternative for those who are unwilling or unable to undergo colonoscopy, which will form the basis of our planned submission to the FDA in 2012.