[November 24, 2014]

Ceterix Announces Enrollment of First Patient in Study of Suture Repair of Horizontal Meniscus Tears

Ceterix^® Orthopaedics, Inc., a developer of novel surgical tools for arthroscopic procedures, today announced enrollment of the first patient in STITCH (A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears¹), a new evaluation of suture-based meniscal repair for patients with horizontal meniscus tears, a common type of knee injury.

Patients with horizontal cleavage tears often undergo meniscectomy - partial removal of the meniscus - because common opinion has held that meniscus repair is not effective for this tear type, despite meniscectomy's well-established limitations and long-term consequences, including the increased risk of arthritis.² Additionally, a recently published systemic literature review shows that healing rates for horizontal cleavage tears are comparable to other meniscal tear types that are routinely repaired.³

The primary objectives of the STITCH study are to assess the success of horizontal meniscus tear repair using the company's NovoStitch^® suture passer or other suture-only techniques, and to assess improvements in knee pain and function after repair. The study will include 30 patients at up to 10 investigational sites in the United States.

"Sincethe early days of meniscal repair surgery, it has been often repeated, on the podium and in and publications, that horizontal cleavage tears cannot be repaired due to their degenerative nature," said orthopaedic surgeon Peter Kurzweil, M.D., principal investigator of the STITCH study. "This study is designed to further investigate whether these types of tears can indeed heal, as the literature review suggests, when repaired with suture-based therapy."

Arthroscopic surgery is a minimally invasive surgical procedure performed by an orthopaedic physician in which a damaged joint is treated, through small incisions with specialized tools, under the guidance of a tiny camera called an arthroscope. Meniscus surgeries are the most common arthroscopic surgery in the United States, with roughly one million procedures annually.

Ceterix's NovoStitch suture passer enables surgeons to place stitches arthroscopically in tight joint compartments and thereby address complex knee, hip and shoulder injuries that have not been amenable to repair in the past.

About Ceterix Orthopaedics

Ceterix™ Orthopaedics develops surgical tools that expand and improve what is possible for physicians who treat soft tissue injuries such as meniscus tears, hip and shoulder labrum tears, and rotator cuff tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix's novel suture passing device enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The company is based in Menlo Park, Calif. and is backed by investors Novo Ventures, Versant Ventures and 5AM Ventures. For more information, please visit http://www.ceterix.com/.

¹ http://www.clinicaltrials.gov/ct2/show/NCT02237001

² Papalia, R. et. al. Meniscectomy as a risk factor for knee osteoarthritis: a systematic review. British Medical Bulletin. 2011; 99:89-106.

³ Kurzweil, P. et.al. Repair of Horizontal Meniscus Tears: A Systematic Review. Arthroscopy. 2014 Aug 6.

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