MicroPort® Orthopedics Receives NMPA Marketing Approval for its Procotyl®-L Acetabular Cup System and Profemur® Preserve Hip Stem

Suzhou, China, 27 January 2022 —Suzhou Minimally Invasive Orthopedics (Group) Co., Ltd. (MicroPort® Orthopedics) recently announced that it has received registration certificates from the National Medical Products Administration (NMPA) in China for two products, the Procotyl®-L acetabular cup system (Procotyl®-L) and the Profemur® Preserve hip stem. These two products have strong track record of clinical success. This recent milestone will further improve the hip replacement portfolio of MicroPort® Orthopedics in China.

The Procotyl®-L acetabular cup system is an upgraded version of the Lineage® acetabular cup series, which was firstly launched in the EU market in 2006. The Procotyl®-L cup features titanium alloy, a biocompatible material, and an irregularly layered porous titanium beaded coating. Its interior has a proprietary internal taper and rim-locking design, featuring 18° RIM-LOCK™, which allows the polyethylene and ceramic liners to be locked, ensuring the stability of the prosthesis joint.

Procotyl®-L Cup is supported by substantial clinical follow-up data, and is well recognized by doctors and patients for its stability and clinical performance. A six-year follow-up[1] showed that the Procotyl®-L cup achieved a high prosthesis retention rate of 98.6%. In another study, the mean Oxford hip score and the visual analog scale score (VAS, a visual analog scale used to assess patients' pain levels) for the Procotyl®-L cup at 5.88 years after implantation also showed promising results. Notably, in 2020, the Procotyl®-L cup received a “10A*” rating from the Orthopaedic Data Evaluation Panel (ODEP), the world’s leading rating agency in the orthopedic industry. The rating means that the product has been clinically followed up and evaluated for more than 10 years, and in this process, comprehensive and robust follow-up data has been collected from a large number of subjects to validate the quality of the product.

The Profemur® Preserve hip stem is the latest generation of hip stems with metaphyseal fixation, designed to provide a more stable solution for an increasingly younger patient population. In recent years, there has been a trend of younger patients undergoing hip replacement surgery, posing a challenge to the traditional monomorphic femoral stem, as younger patients have higher requirements for postoperative mobility, and therefore higher demands for preserving their proximal femoral bone mass.

Profemur® Preserve also addresses the difficulty of placing traditional prostheses through an incision in a minimally invasive manner. It innovatively adopts a “tri-taper” wedge-shaped geometry, which increases the contact area of the metaphysis and shortens the stem, whilst ensuring the stability of the prosthesis to maximize the preservation of the cancellous bone. This results in safer hip replacement surgery and further improves postoperative satisfaction.

Mr. Zixin Weng, President of MicroPort® Orthopedics China, commented, “The vision of MicroPort® Orthopedics is to create a complete product portfolio and provide total medical solutions for patients. As a leading global developer and manufacturer of high-end medical devices in this rapidly aging world, we will further improve the joint product line of MicroPort® Orthopedics by adhering to the MicroPort® philosophy of ‘The Patient Always Comes First,’ providing more accessible medical solutions for the targeted treatment of patients with bone and joint diseases in China.”

[1] Ashley Parker, David Fitch .Patient Reported Outcomes and Mid-term Survivorship of a Hydroxyapatite Coated Acetabular Cup with a Delta Ceramic on Delta Ceramic Bearing Compared with Other Cementless Cups. ISTA 29th Annual Congress, Boston, October 5-8, 2016

About MicroPort® Orthopedics

MicroPort® Orthopedics is a subsidiary of MicroPort Scientific Corporation (00853.HK). Underpinned by the core strengths of innovative design and industry-leading manufacturing capabilities, MicroPort® Orthopedics has provided a range of high-quality and affordable treatment solutions to patients in more than 60 countries and regions worldwide, offering joint products that have already benefited nearly 1.4 million patients globally to date. In addition to its medical pivot knee products, MicroPort® Orthopedics continues to develop innovative technologies to provide patients with high-quality total medical solutions.