Study shows patients treated with Smith+Nephew’s CARTIHEAL™ AGILI-C™ Cartilage Repair Implant have an 87% lower relative risk of Total Knee Arthroplasty or Osteotomy at 4 years¹*

Rhea-AI Summary

Smith+Nephew (NYSE:SNN) announced impressive results from a multicenter randomized controlled trial for its CARTIHEAL AGILI-C Cartilage Repair Implant. The FDA-approved implant demonstrated 87% lower relative risk of requiring total knee arthroplasty or osteotomy compared to standard care over 4 years. Key findings include:

The implant showed superior pain relief and quality of life improvements over 4 years, with better functional gains in daily activities and sports at 2 and 4 years. Notably, the scaffold effectively treated diverse patient groups regardless of age, lesion size, or osteoarthritis presence.

The technology's broad indication allows treatment of patients who previously had limited options, with comparable results across genders. The findings will be presented at the Arthroscopy Association of North America Annual Meeting (AANA 2025) in Washington DC, May 8-10.

Positive

• 87% reduction in risk of total knee arthroplasty and osteotomy compared to standard care
• Superior pain relief and quality of life improvements over 4-year period
• Better functional improvements in daily living and sports activities at 2 and 4 years
• Effective treatment across broad patient groups (age, lesion size, gender, osteoarthritis presence)
• FDA approval with previous breakthrough designation

Negative

• None.

Insights

Medical Device/Orthopedics Expert

SNN's CARTIHEAL Implant shows 87% reduced risk of knee surgery with superior pain relief and function across diverse patients—significant advancement in cartilage repair.

The clinical data for Smith+Nephew's CARTIHEAL AGILI-C Implant represents a potentially transformative advancement in knee cartilage repair. The 87% reduction in relative risk of subsequent Total Knee Arthroplasty or Osteotomy compared to standard treatments (debridement/microfracture) is remarkably impressive and clinically meaningful.

This technology addresses a critical treatment gap for patients with cartilage damage. Current options often provide limited relief or apply to restricted patient populations. In contrast, this implant demonstrates efficacy across diverse patient profiles – including various ages, lesion sizes, and even those with existing osteoarthritis – significantly expanding the addressable market.

The superior pain relief and functional improvements maintained through 4 years of follow-up provide compelling evidence of durable clinical benefit. For patients, the potential to delay or avoid total knee replacement represents a substantial quality-of-life improvement and addresses one of their primary concerns when seeking treatment.

The FDA's breakthrough designation and subsequent approval further validate the technology's clinical significance. The broad indication allows treatment of patients previously left with limited options, and the gender-based analysis confirming comparable results between males and females supports equitable application of this technology.

For surgeons seeking joint-preserving options for their patients, especially those with mild to moderate osteoarthritis, this implant offers a valuable addition to their treatment armamentarium. The upcoming presentation at AANA 2025 will likely accelerate awareness among key orthopedic specialists who drive adoption of new technologies in this space.

The CARTIHEAL Implant will be featured at the Arthroscopy Association of North America Annual Meeting (AANA 2025) this week

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces encouraging results for its CARTIHEAL AGILI-C Cartilage Repair Implant from a recent multicentre randomised controlled trial (RCT) treating knee cartilage defects. When compared to the current surgical standard of care,^* the implant demonstrated: 

• Superior pain relief: Patients treated with the CARTIHEAL AGILI-C Implant reported significantly better knee pain relief, and quality of life improvements over a 4-year period.^{1-3 **} 

• Superior functional gains: Patients treated with the CARTIHEAL Implant reported superior improvements in performing activities related to daily living, sport and recreation at 2 and 4 years. ^1-3

• Different patient profiles – same great results: The scaffold effectively treated a broad group of patients across age, lesion size, and presence of osteoarthritis while delivering clinically meaningful results.^{1-3 **} 

Smith+Nephew's FDA-approved CARTIHEAL Implant, which previously received breakthrough designation, is revolutionizing the cartilage repair landscape. In line with AANA's mission to improve patient outcomes through education and innovation, the implant’s broad indication allows physicians to treat patients who previously may not have had access.

Professor Elizaveta Kon from Humanitas Research Hospital, who plans to present 4-year outcomes of the implant with respect to gender during AANA 2025, highlighted the importance of inclusivity in study design. “We need a technology that we can trust to work in the patients we see day-to-day. This is where CARTIHEAL has excelled, showcasing superior performance across genders, lesion location, and more.”

Dr. Vinod Dasa of Louisiana State University School of Medicine finds the technology particularly meaningful for his patients. "The patients that come to see me are looking for a bridging procedure that enables them to continue their day-to-day life, playing with their kids and grandkids. In addition to the pain relief and functional gains, the 87% reduction in the risk of subsequent total knee arthroplasty (TKA) and osteotomy compared to the surgical standard of care resonates with almost every patient. The potential to delay if not avoid TKA is top of mind of almost every patient with mild/moderate osteoarthritis."

Using the CARTIHEAL Implant to treat a spectrum of cartilage pathologies will be featured during a lunch symposium on Friday, May 9 during AANA 2025. You can also learn more by visiting the CARTIHEAL Implant webpage here. 

To learn more about Smith+Nephew’s Sports Medicine joint repair solutions and enabling technologies, please visit our booth (#303) at AANA 2025 in Washington DC May 8-10, or visit www.smith-nephew.com. 

- ends –

Media Enquiries 

Dave Snyder          +1 (978) 749-1440 

Smith+Nephew      david.snyder@smith-nephew.com

* compared to debridement or microfracture  
  
**  over a 2- and 4-year follow-up  

 

References

1. Conte P, Anzillotti G, Crawford DC, et al. Differential analysis of the impact of lesions' location on clinical and radiological outcomes after the implantation of a novel aragonite-based scaffold to treat knee cartilage defects. Int Orthop. 2024;48(12):3117-3126 
2. Altschuler N, Zaslav KR, Di Matteo B, et al. Aragonite-Based Scaffold Versus Microfracture and Debridement for the Treatment of Knee Chondral and Osteochondral Lesions: Results of a Multicenter Randomized Controlled Trial. Am J Sports Med. 2023;51(4):957-967 
3. Kon, E., De Caro, F., Dasa, V., M Scopp, J., Di Matteo, B., Flanigan, D., Shabshin, N., Strickland, S., & Altschuler, N. (2025). Female patients report comparable results to males after the implantation of an aragonite-based scaffold for the treatment of knee chondral and osteochondral defects: a gender-based analysis of a RCT at 4 years' follow-up. J of Ortho and Traumatology, 26(1), 17. https://doi.org/10.1186/s10195-025-00829-y

 

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 17,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in around 100 countries, and generated annual sales of $5.8 billion in 2024. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.

 

^◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.

FAQ

What are the key benefits of Smith+Nephew's CARTIHEAL AGILI-C implant for knee cartilage repair?

The implant shows 87% lower risk of requiring knee surgery, superior pain relief, better quality of life, and improved function in daily activities and sports over 4 years. It effectively treats diverse patient groups regardless of age, lesion size, or osteoarthritis presence.

How does the SNN CARTIHEAL implant perform compared to standard knee cartilage treatments?

Compared to standard treatments like debridement or microfracture, the CARTIHEAL implant demonstrates significantly better pain relief, quality of life improvements, and superior functional gains over a 4-year period.

What is the success rate of Smith+Nephew's CARTIHEAL implant in preventing knee surgery?

The implant shows an 87% reduction in the risk of subsequent total knee arthroplasty (TKA) and osteotomy compared to surgical standard of care over a 4-year period.

Does the CARTIHEAL AGILI-C implant work equally well for all patient groups?

Yes, clinical trials show the implant effectively treats a broad range of patients across different ages, lesion sizes, genders, and presence of osteoarthritis while delivering meaningful clinical results.

What regulatory approvals has Smith+Nephew's CARTIHEAL implant received?

The CARTIHEAL AGILI-C implant has received FDA approval and was previously granted breakthrough designation status.