Ceterix Orthopaedics Announces FDA Clearance of the NovoStitch Pro Meniscal Repair System

FREMONT, Calif.–(BUSINESS WIRE)–Ceterix^® Orthopaedics, Inc., a leader in the development of cutting-edge surgical tools for orthopaedic surgeons, today announced U.S. Food and Drug Administration (FDA) clearance of the company’s NovoStitch^® Pro Meniscal Repair System. This next-generation meniscal repair system is a significant product evolution, offering enhanced technical features to improve the ease of use and workflow for the surgeon.

Ceterix’s NovoStitch systems enable surgeons to place stitches arthroscopically in tight joint compartments, allowing them to address complex meniscal tears that have not been amenable to repair in the past. Enhancements in the newly FDA-cleared NovoStitch Pro system include an ergonomic and intuitive handle design, the addition of well-defined visual cues for precise stitch placement, and improved control and stability from upper jaw texturing.

“The new NovoStitch Pro meniscal repair system represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair,” said Dr. Peter Kurzweil, president of Memorial Orthopaedic Surgical Group in Long Beach, Calif. “The technological enhancements incorporated into the new system offer the potential to repair tear types that were previously considered difficult or impossible to sew, with improved control and access for the surgeon. I look forward to incorporating it into my practice.”

The meniscus is a crescent of soft cartilage resting between the femur and tibia that cushions the knee and provides stability to the joint. Meniscal tears are one of the most frequently occurring knee injuries and are most often treated by a procedure called a meniscectomy, in which a surgeon removes the torn tissue. Meniscectomy has been shown to increase a patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life. A 2015 health economics study determined that effective meniscal repair can result in long-term cost savings vs. meniscectomy due to the reduced risk of requiring costly future interventions¹.

“This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus,” said John McCutcheon, Ceterix’s president and CEO. “Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint.”

Arthroscopic surgery is a minimally-invasive procedure in which an orthopaedic surgeon treats a damaged joint through small incisions using specialized tools guided by a tiny camera called an arthroscope. Meniscus surgery is the most common arthroscopic procedure in the United States, with roughly one million performed annually^2,3.

About Ceterix^® Orthopaedics

Ceterix^® Orthopaedics develops surgical tools that fill unmet clinical needs for physicians who treat soft tissue joint injuries such as meniscus tears. Founded in 2010 with the vision of improving outcomes of arthroscopic procedures, Ceterix’s novel meniscal repair system enables surgeons to place suture patterns that were previously only possible in open procedures, or not at all. The NovoStitch^® Pro Meniscal Repair System has received 510k clearance in the United States and is indicated for approximation of soft tissue in meniscal repair procedures. The company is based in Fremont, Calif., and is backed by investors Versant Ventures, 5AM Ventures, and CRG. For more information, please visit www.ceterix.com and follow us at @ceterix on Twitter.

¹ Feeley, B. et. al. The Cost-Effectiveness of Meniscal Repair versus Partial Meniscectomy: A Model-based Projection of Clinical Outcomes and Costs in the United States Healthcare System. ISPOR Annual Meeting 2015.
² Brinker MR, O’Connor DP, Pierce P, Woods GW, Elliott MN. Utilization of orthopaedic services in a capitated population. J Bone Joint Surg Am. 2002 Nov; 84-A (11):1926-32.
³ New Hampshire Outpatient Surgery: Knee arthroscopy data. Vol. 2008. New Hampshire Comprehensive Health Care System; 2006.