Fujifilm Receives Japan Approval for First-in-Class Stem Cell Therapy for Meniscal Injuries
Key Insights
FUJIFILM Toyama Chemical (search) received manufacturing and marketing approval in Japan for SAVYSCUS® Injection (search), the first regenerative medical product approved for meniscal injury (search) under the Pharmaceutical and Medical Device Act.
The therapy uses autologous synovial mesenchymal stem cells (search) to treat meniscal injuries that would otherwise require meniscectomy, offering a meniscus-preserving treatment option.
Phase III trial results showed statistically significant improvement in Lysholm knee scores from 38.1 to 91.6 at 52 weeks, with 35.7% of patients achieving complete healing in the avascular central meniscus region.
FUJIFILM Corporation announced that its subsidiary FUJIFILM Toyama Chemical (search) has received manufacturing and marketing approval in Japan for SAVYSCUS® Injection (search), marking a significant milestone as the first regenerative medical product approved for meniscal injury (search) under the Pharmaceutical and Medical Device Act. The therapy offers a novel treatment approach for patients with meniscal injuries who would otherwise require meniscectomy.
Revolutionary Stem Cell Technology
SAVYSCUS® Injection (search) is composed of autologous synovial mesenchymal stem cells (search) that are isolated and expanded from synovial tissue harvested from the patient's own knee joint. The therapy is administered through a minimally invasive arthroscopic procedure, targeting patients with meniscal injuries for whom meniscectomy would otherwise be considered appropriate.
The treatment incorporates synovial mesenchymal stem cell-based technology developed by Professor Ichiro Sekiya, Director of the Center for Stem Cell and Regenerative Medicine at the Institute of Science Tokyo (search). This approach aligns with the growing interest in treatment strategies that emphasize preservation of the meniscus in orthopedic practice.
Addressing Critical Medical Need
Meniscal injuries represent a significant clinical challenge, with approximately 50,000 meniscal surgeries performed annually in Japan. Around half of these procedures involve meniscectomy, with this proportion increasing to 60% in patients over 40 years old. While meniscectomy can provide symptomatic relief, removal of meniscal tissue increases mechanical stress on articular cartilage and elevates the long-term risk of progression to knee osteoarthritis (search), which affects an estimated over 20 million people in Japan.
The meniscus plays a critical role in shock absorption, load distribution, and joint stability. Traditional treatment options include conservative management, meniscal repair, and meniscectomy. However, meniscal repair is applicable only to limited injury patterns and locations, making meniscectomy frequently selected for injuries unlikely to heal with repair.
Compelling Clinical Trial Results
The approval was based on results from a feasibility clinical trial led by Professor Sekiya and a pivotal Phase III clinical trial. FUJIFILM Toyama Chemical (search) submitted the manufacturing and marketing approval application on May 13, 2025, following completion of the Phase III study initiated in January 2023.
The Phase III study was a single-arm, multicenter clinical trial enrolling 19 patients with meniscal injuries indicated for meniscectomy, including those with suspected flap tears who had not achieved improvement following at least three months of conservative treatment.
Primary Endpoint Success
The primary endpoint measured the change in Lysholm knee score from screening to 52 weeks after administration. Results demonstrated remarkable improvement, with the Lysholm knee score increasing from 38.1 ± 8.9 at screening to 91.6 ± 8.2 at 52 weeks. The change in Lysholm knee score (least squares mean [95% confidence interval]) was 53.5 [48.7, 58.2], representing a statistically significant and clinically meaningful improvement.
The therapeutic benefit was sustained long-term, with the change in Lysholm knee score at week 104 reaching 57.8 [54.4, 61.2], indicating that the improvement in meniscal function and symptoms observed at week 52 was maintained over two years.
Secondary Endpoint Achievements
Secondary endpoints included arthroscopic image assessments by independent experts at 52 weeks and longitudinal MRI evaluations up to 104 weeks after administration. Based on arthroscopic image assessment, complete healing in the central region of the meniscus—an avascular zone where spontaneous healing is not expected—was observed in 35.7% of patients with flap tears (5 of 14 patients).
MRI evaluation showed improvement in 73.7% of all patients (14 of 19 patients). During the follow-up period, no reoperation related to meniscal re-tear was reported, and no adverse events with a causal relationship to the product were identified.
Comprehensive Orthopedic Solutions
Beyond SAVYSCUS® Injection (search), Fujifilm provides complementary technologies in the orthopedic field through its 3D image analysis system, SYNAPSE VINCENT®, which includes knee joint analysis software. This software has been utilized in epidemiological studies on knee osteoarthritis (search), including the Kanagawa Knee Study and its longitudinal follow-up study led by Professor Sekiya with cooperation from Kanagawa Prefecture.
The name SAVYSCUS® Injection (search) derives from the internationally recognized concept "Save the Meniscus," reflecting the philosophy of meniscus preservation. Through this innovative therapy, the Fujifilm Group aims to provide new treatment options for meniscal injury (search) and contribute to improving human health by offering comprehensive orthopedic solutions spanning prevention, diagnosis, and treatment.