NiTi Challenges Surgical Staple Market

Full article reprinted from Start Up - August/September 2009

Start-Up -- Surgical staples underpin surgeries in every operating room in the country, and are, well, staples of the businesses of Ethicon Endo-Surgery and Covidien, which together control 95% of the US surgical staples market. But now, in colorectal, bariatric, and thoracic procedures, some of the most promising markets for surgical staples, a threat is entering from the wings. NiTi Surgical Solutions has begun selling an alternative to staples, with a platform that it calls BioDynamix Anastomosis Technology, by which it describes compression devices that adjust to an organ's diameter to promote healing that's as natural as possible. Read more...

NiTi Challenges Surgical Staple Market

Full article reprinted from Start Up - August/September 2009

Surgical staples underpin surgeries in every operating room in the country, and are, well, staples of the businesses of Johnson & Johnson's Ethicon Endo-Surgery Inc. and Covidien Ltd. Together the two control 95% of what Medtech Insight estimates is a $520 million US surgical staples market. Ethicon has managed to grab the lead, with an almost 56% market share, by introducing new products specifically for colorectal, bariatric, and thoracic procedures, but Covidien won't be left behind. In July it announced that it would acquire Power Medical Interventions Inc., an innovative company developing computer-assisted endomechanical surgical instruments, endoscopic cutters and staplers, with, it just so happens, a focus on minimally invasive colorectal, bariatric, and thoracic surgeries. Covidien was acting on its announced intention of focusing on single-incision laparoscopic surgery as an interesting growth opportunity. It offered, in aggregate, $64 million for Power Medical, which had 2008 sales of $8 million. With Power Medical's SurgASSIST stapler, for minimally invasive surgery, Covidien defends its share of the wound closure business.

But another threat is entering from the wings. NiTi Surgical Solutions Ltd. has begun selling an alternative to staples, and it too is targeting the colorectal and bariatric markets, with a platform that it calls BioDynamix Anastomosis Technology, by which it describes compression devices that adjust to an organ's diameter to promote healing that's as natural as possible. Founded in Israel in 1996, NiTi is taking advantage of the features of the metal nitinol--shape memory, elasticity, and the ability to control the pressure--to advance devices for the reconnection, following resection, of the colon, small intestines, esophagus, the bowel, and other hollow structures in the body. Its initial market focus covers more than 1,000,000 gastrointestinal tract resections each year worldwide.

NiTi is in the market already (in the US, several countries in Europe, Canada and Korea) and it recently gathered up some more resources to help it increase penetration. In August, NiTi raised $18.5 million in a Series F financing round led by Forbion Capital Partners, which was joined by existing investors Evergreen Venture Partners, Israel Healthcare Ventures, MBVC, Alice Ventures and SCP Vitalife.

NiTi's first product is ColonRing, an alternative to staples for creating an anastomosis following colon resection, a treatment for colorectal cancer and diverticulitis. ColonRing is a two-part nitinol ring including an anvil ring, and a bottom ring, with nitinol leaf springs between the upper and lower halves of the ring that help the ring maintain compression against variable pressures. After surgical resection of the colon, the surgeon places the anvil ring in the proximal side of the colon (via trocar access). He next comes through the rectum and places the other half of the ring in the distal side of the resected vessel. He connects the anvil to the hand piece and clicks it in place. A series of small spikes holds the tissue in place while it is compressed together to begin what the company calls its "biodynamic" healing process. The surgeon then releases the cutting blades on the delivery device to clear the internal pathway. Finally, the delivery device is removed without disrupting the ColonRing.

In seven to 10 days, the tissue that's been crushed between the two ring halves becomes necrotic, causing the ring to release. The released ColonRing is expelled through the bowel, leaving nothing behind in the body. The tissue along the outer part of the ring then heals at approximately the same time.

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Single-incision laparoscopy or natural orifice surgery: Which will win the day, or is there room for both? Find out in the NEW 48-Page SPECIAL REPORT from Medtech Insight: "Fulfilling the Promise of the Scarless Surgery Revolution -- When will breakthrough endoscopic technologies hit prime time?" Find out more... 

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Companies mentioned in this article:

Covidien Ltd.

Johnson & Johnson

Ethicon Endo-Surgery Inc.

Niti Surgical Solutions Ltd.

Power Medical Interventions Inc.

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No publication reviews leading edge companies and technology better than START-UP. Each issue of START-UP profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.