CHESTERFIELD, Mo.--(BUSINESS WIRE)--NiTi Surgical Solutions, an innovative surgical device company, today announced the Japan Patent Office and the Patent Office of China have issued patent certificates that cover two of the company’s products, the Hand CAC™ 30 Compressions Anastomosis Clip applicator and CAR™ 31 Compression Anastomosis Ring. 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.
The Japanese Patent and Trademark Office approved the issuance of patent number 4296151 covering NiTi’s Hand CAC 30. In addition, The Patent Office of China issued patent numbers ZL03812116.6 and ZL03817485.5 covering Hand CAC 30 and CAR 31 respectively. The patents, which were assigned to NiTi by the inventors of the technology, cover the company’s anastomosis products which are based on the novel BioDynamix™ Anastomosis technology and further strengthen the company’s global intellectual property estate and presence in the surgical market.
“We are pleased to strengthen the company’s intellectual property portfolio around its core technology with the issuance of these two patents,” said Itay Itzhaky, chief executive officer of NiTi Surgical Solutions. “Our products are designed to leverage the body’s natural healing process and offer a unique set of benefits for surgeons and their patients. We believe these characteristics, which will extend across our BioDynamix technology platform of products, will support rapid adoption among leading surgeons around the world.”
The Japan patent and one of the China patents cover NiTi’s Hand CAC 30 applicator which is used for side-to-side anastomosis. This sterile, single patient, single-use device is CE-marked and cleared by the FDA. It deploys the Compression Anastomosis Clip (CAC™) during side-to-side and end-to-side anastomoses. The palm-sized applier instrument is designed for colorectal, gastric and upper GI surgeries.
The second China patent for Intratubular Anastomosis Apparatus, is related the CAR 31. CAR 31 also incorporate Nitinol elements and leverages the BioDynamix approach to healing for use in end-to-end compression anastomosis.
NiTi’s line of innovative medical devices for use in compression anastomosis incorporate the company’s novel BioDynamix Anastomosis technology and Nitinol-based elements across the company’s unique line of products in applying consistent compression, without the need for staples, to sections of the intestine after surgery, such as in colon cancer treatment, in order to promote complete and natural healing. In human trials and clinical practice, NiTi’s BioDynamix Anastomosis technology has shown the potential to provide durable anastomosis with encouraging results in the rate of complications, particularly in low cases. The technology has been used in over 7,500 procedures performed globally to-date.
Itzhaky added, "Having commercialized the first major advancement in over 30 years of colorectal surgery with the launch of ColonRing, our anastomosis technology represents a significant breakthrough in the development of non-staple closure devices. We look forward to continuing to bring innovative, game-changing surgical products to the global marketplace.”
About ColonRing™ with BioDynamix™ Anastomosis Technology
NiTi Surgical Solutions has leveraged the features of Nitinol in the ColonRing, NiTi’s Compression Anastomosis Ring device recently launched in the United States. ColonRing represents a revolutionary closure technology for surgeries such as colon cancer surgery and has been successfully applied in over 2,200 patients to date. 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.
ColonRing represents the first major advancement in colorectal surgery in more than 30 years and addresses the significant drawbacks of traditional staples. Colonoscopic examination at six months demonstrated an effective, seamless anastomosis with excellent wound healing. In animal clinical 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 Evergreen Venture Partners, Forbion Capital Partners, Israel Healthcare Ventures (IHCV), MBVC and Alice Lab, and SCP Vitalife. For more information, please visit www.nitisurgical.com.
Contact:
Pure Communications Dan Budwick, 973-271-6085 or Ashlea Kosikowski, 910-509-3974
