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NiTi Surgical Solutions Announces Issuance of Key Patent For ColonRing Surgical Device

Tuesday, May 19, 2009

Innovative Nitinol Device Enables Natural Reconnection and Healing After Colon Cancer and Other Surgeries

Hollywood, FL & Chesterfield, MO -- NiTi Surgical Solutions, an innovative surgical device company, today announced the U.S. Patent and Trade Office (PTO) has issued U.S. Patent No. 7,527,185 covering compression anastomosis ring assembly for use in joining severed organ wall portions of a hollow organ. The patent, which was assigned to NiTi by the inventors of the technology, is the key patent covering the company’s novel ColonRing medical device -- a revolutionary closure technology for colorectal surgery such as colon cancer surgery. The ColonRing, launched earlier this month in the United States, is a medical device designed to help a patient’s body heal naturally, after which it is expelled from the body.

More than 500,000 surgeries involving gastrointestinal tract resection are performed in the United States annually. ColonRing represents the first major advance in this area in more than 30 years.

The safety and efficacy of ColonRing (also known as CAR™ 27) has been established in multiple clinical trials and commercial use in the United States, Europe and other parts of the world. NiTi's proprietary technology represents a breakthrough in natural healing with tissue-sparing, uniform compression anastomosis. The company’s unique line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing of the intestine after removing a section as part of a surgery, such as in colon cancer treatment. The company is commercializing a family of FDA-cleared and CE-marked disposable tissue closure devices.

"We are very pleased to see this patent issued, further strengthening our extensive intellectual property position in compression anastomosis," said Itay Itzhaky, chief executive officer of NiTi Surgical Solutions. "The novel ColonRing with BioDynamix™ Anastomosis technology is intended to address the risks associated with circular staples, offering surgeons and patients important benefits as there are no bowel wall punctures, no risk of staple line bleeding, and no permanent foreign bodies in the bowel. The ColonRing represents the first of several Nitinol devices we expect to bring to market as part of our BioDynamix technology platform."

About ColonRing™ with BioDynamix™ Anastomosis Technology

NiTi Surgical Solutions has leveraged the features of Nitinol in the ColonRing technology. In the ColonRing, the Nitinol leaf springs stretch to open the ring for placement in the bowel, and then gradually return to their original closed position, adapting to variations in tissue thickness and accommodating compressed tissue. The Nitinol leaf springs continuously apply constant force range of pressure around the full circumference of the anastomosis. As the compression progresses over several days, the tissue trapped within the ring becomes necrotic, while healthy tissue is generated along the ring’s outer perimeter.

In human trials and clinical practice, BioDynamix Anastomosis technology has shown the potential to provide durable anastomosis with encouraging results in the rate of complications, particularly in low cases. Colonoscopic examination at six months demonstrated a satisfactory and seamless anastomosis. In animal trials, ColonRing resulted in a time zero anastomotic burst strength up to three times stronger than circular staplers. In addition, histologic examination of resected anastomoses showed complete reepithelialization of the mucosa and a uniform anastomosis showing full recovery to the natural multi-layer tissue structure.

About NiTi™ Surgical Solutions

NiTi Surgical Solutions is focused on the BioDynamix™ of natural healing, offering state-of-the-art medical devices to optimize surgical outcomes for patients and physicians. NiTi Surgical Solutions currently markets its novel ColonRing™ device - the next generation of closure technology for colorectal resection - providing surgeons with a potentially safer and more effective alternative to standard staple-dependent closure techniques. NiTi continues to expand its core competencies and innovative technology to a variety of advanced surgical products, techniques, and procedures. NiTi Surgical Solutions is a privately held, venture backed company with headquarters in Israel and the U.S. The company’s investors include Alice Ventures, Evergreen Venture Partners, Israel Healthcare Ventures, MMT Funds and SCP Vitalife. For more information, please visit

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