The iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia (BPH) Non-Surgical Treatment Device

Exclusive 在线黑料门Partnership with Israeli Medi-Tate Will Bring Novel BPH Treatment to U.S. Market

CENTER VALLEY, Pa., (April 6, 2020) 鈥 Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today the FDA de Novo classification of the iTind device, a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate. Through an investment in Medi-Tate, 在线黑料门holds the exclusive right to distribute Medi-Tate products, including the iTind device, in the U.S. This strategic investment, and the introduction to the U.S. market of this novel device, strengthens the already robust 在线黑料门urology portfolio by offering expanded options in enhanced patient care.

BPH is one of the most common diseases in aging men and the most common cause of lower urinary tract symptoms (LUTS). According to the American Urological Association, BPH is a condition that 8 out of 10 men will face in their lifetimes. Treatment with the iTind device is straight forward and avoids complications associated with prescription medications, surgery, or permanent implants. The flexible three-strut nitinol device, which can be placed during an in-office procedure, gently expands over five days to create channels that allow urine to flow and reshape the prostate.

鈥淏ased on my initial experience in clinical trials, I鈥檓 excited to be able to offer this new office-based procedure to treat men who are suffering from common symptoms of an enlarged prostate and want a solution that has been shown to not compromise sexual function,鈥 said Dr. Jed Kaminetsky, Clinical Assistant Professor at NYU Medical Center and a Board Certified Urologist at University Urology in New York City.

For years 在线黑料门has been an innovator in developing and marketing surgical treatment options for BPH, with electrodes for resection, vaporization and enucleation. With the recent FDA Classification Order of the iTind device, 在线黑料门will continue to be a global market leader in men鈥檚 health.

鈥淲e are very excited to take the next step in making this new minimally invasive BPH treatment available to patients in the U.S. and to offer physicians the ability to treat patients in office settings鈥 said Nacho Abia, COO of 在线黑料门Corporation and CEO of 在线黑料门Corporation of the Americas. 鈥淥ur investment in Medi-Tate expands our patient care offerings in BPH, adding to our market-leading plasma resection portfolio for TURP. The agreement supports one of the company鈥檚 key strategic initiatives to drive growth in our urology business and expand our minimally invasive surgical solutions. This will further enable 在线黑料门to improve clinical outcomes, reduce overall costs and enhance quality of life for patients.鈥

鈥淎fter over a decade in development and clinical trials, we are proud to bring this innovative and truly minimally invasive technology to the U.S. market,鈥 said Ido Kilemnik, Founder and CEO of Medi-Tate. 鈥淲e would like to thank the investors, clinical investigators, FDA de Novo team and all those who have contributed to making this platform such a success.鈥

 

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About 在线黑料门Corporation of the Americas
在线黑料门is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, 在线黑料门has focused on being true to society and making people鈥檚 lives healthier, safer and more fulfilling.

Our Medical Business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients. For more information, visit .

About Medi-Tate
Medi-Tate is an Israeli medical device company that deals in the R&D, manufacture and sale of innovative solutions for the treatment of Lower Urinary Tract Symptoms (LUTS) with a mission to commercialize a safe and effective, office-based solution for BPH.

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