Niamh O’Neill and Kamran Zamanian, Ph.D., iData Research08.31.23
The U.S. Orthopedic Soft Tissue (OST) Repair market is projected to be worth $2.9bn by 2029. The relatively stable growth is due, in large part, to the steady incidence rate of tendon and ligament injuries that occur in the population. The market covers both upper (rotator cuff repair and reconstruction, shoulder labrum and biceps tenodesis) and lower (Achilles tendon repair and reconstruction, ACL/PCL reconstruction, meniscus repair and hip arthroscopy) extremities. The lower extremities account for nearly half of the total market value.
In 2022, ACL/PCL Reconstruction was the third largest segment of the combined OST and sports medicine market, representing a significant portion of the total market value. It was also the second-fastest growing market over the forecast period (2022-2029). Despite the size and growth rate of the market, treatment options available have remained unchanged for the past three decades. ACL reconstruction, using grafts and fixation devices, is still the gold standard treatment offered by surgeons, even though there is a risk of re-rupture requiring revision surgery.
To address this problem, Dr. Martha M. Murray and Miach Orthopaedics developed the Bridge Enhanced ACL Restoration (BEAR) Implant, the first truly innovative development in ACL treatment in 30 years. It is set to transform the surgical landscape – and consequently the market – over the next decade.
During an ACL reconstruction procedure, the surgeon completely removes the remainder of the torn ACL and a harvested graft is used in combination with fixation devices, such as staples and screws, to rebuild the ligament. Grafts are usually derived from the patient (known as an autograft) or a deceased donor (known as an allograft) and sources commonly include the Achilles, hamstring or tibialis tendons. The surgeon drills holes in the patient’s tibia to hold the harvested patellar tendon with the fixation devices.
The most common types of allografts used are the bone-patella-tendon-bone (BTB), non-sutured, and pre-sutured options. Pre-sutured allografts are the most recent addition to the market, saving surgeons around 30 minutes of procedure time compared to the non-sutured alternatives. Pre-sutured allografts are the fastest-growing segment of ACL Reconstruction, projected to grow significantly over the forecast period. In addition, the higher ASP means it is the main driver of the overall market growth.
The most commonly performed ACL reconstruction procedures include two fixation devices for tibial and femoral sites. Fixation devices offer the most variety for surgeons and include interference screws, intratunnel fixation, washer and post, cross-pin and cortical fixation devices. While interference screws remain the preferred choice of device used, adjustable loop cortical fixation devices can be adjusted to the graft size instead of resizing the graft, providing a greater variety of graft sizes for use. Consequently, the cortical fixation device market was the fastest-growing ACL/PCL fixation device segment.
Firstly, patient demographics have changed over the past two decades and ACL reconstruction surgeries are no longer exclusively associated with the sports industry. One study showed a 22% increase in the incidence rate of ACL procedures over a 12-year period. An aging population, mixed with an active lifestyle has seen an increase in older people requiring ACL surgery. However, the highest rate of ACL reconstruction occurs in adolescents, aged 13 to 17. Adolescents are also twice as likely to need revision surgery within 5 years of reconstruction.
Autografts are by far the preferred graft type used by surgeons. However, despite their donor matching superiority, procedures using autograft tissues require an additional surgery to harvest and prepare the patient tissue. Multi-site incisions increase the risk of infection, morbidity and complications at the donor site.
The alternative, allografts, are also limited for several reasons. First, the demand for donor tendons far exceeds the supply of available allografts. Second, processing donor tissue uses a highly complex technique involving gamma radiation and disinfection stages to remove blood, lipids and containments, followed by rinsing to remove any residual solutions. Although safety standards and processing techniques continue to improve, there is still a risk of disease transmission or tissue rejection from allografts that would not normally occur with autografts.
ACL injury is often associated with knee degeneration, meaning an increased inflammatory response leading to post-traumatic osteoarthritis (PTOA). This has frequently been considered an unavoidable consequence of the trauma. However, a recent 2020 study suggests that ACL reconstruction is associated with a second inflammatory response that accelerates cartilage degradation. So, while ACL reconstruction restores joint stability, the patient’s biologic response coupled with reconstruction surgery does not fully address the injury.
For example, the meniscal repair market has seen a slight shift away from total meniscectomy (i.e., complete or partial removal of the meniscus) and toward meniscal preservation. This is resulting in further technological advancement and product development, fueling competition in the total meniscal repair market. In November 2020, Smith & Nephew released the concluding results from its two-year STITCH Study. The study investigated the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears, using Smith & Nephew’s NOVOSTITCH meniscal repair system. The results demonstrated an 82.6% success rate, statistically significant improvements in all patient-reported outcomes, and complete meniscal healing in all patients at six-months follow-up.
A similar shift has been observed between biceps tenodesis (i.e., detaching the biceps from the superior labrum and reattaching it to the humerus) over tenotomy (i.e., total release of the tendon from its attachment). While both procedures yield similar improvements in functional outcomes, there is an increased rate of cosmetic deformity (i.e., “Popeye”) for patients who undergo tenotomy. Therefore, while this trend is less strong in the biceps tenodesis repair market, as the shoulder is not a weight-bearing joint, biceps tenodesis repair provides cosmetic benefits for the patient, forcing partial conversion from tenotomy to repair.
In December 2020, the U.S. Food and Drug Administration (FDA) granted Miach Orthopaedics marketing approval of the BEAR Implant. MedStar Health is currently conducting a 10-year study to investigate the long-term outcomes of the repair technique. Results after a two-year follow-up, published in the American Journal of Sports Medicine, showed that knee stability and strength are on par with traditional ACL reconstruction outcomes. While decreased PTOA was demonstrated in animal samples, longitudinal data is needed to assess this outcome in humans.
The development of this repair technique highlights a significant gap in the market. With encouraging clinical evidence, other leading orthopedic companies are sure to follow suit and develop similar products to fill this gap. Although the ACL/PCL Reconstruction market is projected to grow steadily over the forecast period, technological advancements like the BEAR Implant will revolutionize the way surgeons treat torn ACLs and transform the ACL market over the next decade.
Bibliography:
American Academy of Orthopaedic Surgeons. (2022, January 31). Martha Murray, MD, FAAOS, presented with 2022 OREF Clinical Research Award for studies leading to FDA approval of first implant to stimulate ACL healing. Retrieved from Cision PR Newswire: https://www.prnewswire.com/news-releases/martha-murray-md-faaos-presented-with-2022-oref-clinical-research-award-for-studies-leading-to-fda-approval-of-first-implant-to-stimulate-acl-healing-301471155.html
Belk, J. W., Kraeutler, M. J., Houck, D. A., Chrisman, A. N., Scillia, A. J., & McCarty, E. C. (2021). Biceps tenodesis versus tenotomy: a systematic review and meta-analysis of level I randomized controlled trials. Journal of Shoulder and Elbow Surgery, 30(5), 951-960. doi:https://doi.org/10.1016/j.jse.2020.11.012.
Capobianco, A. (2020, December 16). FDA Authorizes Marketing of New Implant to Repair a Torn ACL. Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-new-implant-repair-torn-acl
Desai, N., Andernord, D., Sundemo, D., Alentorn-Geli, E., Musahl, V., Fu, F., . . . Samuelsson, K. (2017). Revision surgery in anterior cruciate ligament reconstruction: a cohort study of 17,682 patients from the Swedish National Knee Ligament Register. Knee Surgery, Sports Traumatology, Arthroscopy, 25, 1542-1554. doi:https://doi.org/10.1007/s00167-016-4399-0
Herzog, M. M., Marshall, S. W., L, L. J., Pate, V., Mack, C. D., & Spang, J. T. (2018). Trends in Incidence of ACL Reconstruction and Concomitant Procedures Among Commercially Insured Individuals in the United States, 2002-2014. Sports Health, 10(6), 523-531. doi:10.1177/1941738118803616
Hunt, E. R., Jacobs, C. A., Conley, C. E.-W., Ireland, M. L., Johnson, D. L., & Lattermann, C. (2020). Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. Journal of Orthopaedic Research, 39, 1281-1288. doi:10.1002/jor.24783
Kurzweil, P., Krych, A. J., Anz, A., Gwathmey, F. W., Loren, G., Lavery, M., & Flanighan, D. C. (2021, Marck 13). Favorable Reoperation Rate at 2 Years Following Repair of Horizontal Cleavage Tears Using an All Suture-Based Technique: A Prospective, Multicenter Trial. Arthroscopy, Sports Medicine, and Rehabilitation, 3(3), E773-E780. doi:https://doi.org/10.1016/j.asmr.2021.01.018
LaPrade, R. (2022). Posterior Cruciate Ligament Reconstruction. Retrieved from Dr. Robert LaPrade, MD: https://drrobertlaprademd.com/pcl-reconstruction/
MedStar Health. (2021, September 13). MedStar Health First in Nation to Offer Innovative BEAR Implant to Treat ACL Tears. Retrieved from MedStar Health: https://www.medstarhealth.org/news-and-publications/news/medstar-health-first-in-nation-to-offer-innovative-bear-implant-to-treat-acl-tears
MedStar Health Research Institute. (2022, March 28). Researchers at MedStar Health Use the BEAR Implant to Repair ACL Tears in Surgery and Evaluate Outcomes. Retrieved from MedStar Health: https://www.medstarhealth.org/blog/medstar-health-use-the-bear-implant-to-repair-acl-tears-in-surgery-and-evaluate-outcomes
Miach Orthopaedics. (2022). BEAR Implant. Retrieved from Miach Orthopaedics: https://miachortho.com/patients-and-families/bear-implant/
Murray, M. M., Fleming, B. C., Badger, G. J., Team, T. B., Kramer, D. E., Micheli, L. J., & Yen, Y.-M. (2020). Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomizeed Clinical Trial. The American Journal of Sports Medicine, 48(6), 1305-1315. doi:10.1177/0363546520913532
RegenMed. (2022). Allograft Processing. Retrieved August 30, 2022, from RegenMed: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.regenmed.ca/upload/documents/allograft-processing.pdf
Thorolfsson, B., Svantesson, E., Snaebjornsson, T., Sansone, M., Karlsson, J., Samuelsson, K., & Senorski, E. H. (2021). Adolescents Have Twice the Revision Rate of Young Adults After ACL Reconstruction With Hamstring Tendon Autograft: A Study From the Swedish National Knee Ligament Registry. Orthopaedic Journal of Sports Medicine., 1-8. doi:10.1177/23259671211038893
Niamh O’Neill is a research analyst at iData Research. She works on research projects regarding the medical device industry, publishing the U.S Orthopedic Soft Tissue report series.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.
In 2022, ACL/PCL Reconstruction was the third largest segment of the combined OST and sports medicine market, representing a significant portion of the total market value. It was also the second-fastest growing market over the forecast period (2022-2029). Despite the size and growth rate of the market, treatment options available have remained unchanged for the past three decades. ACL reconstruction, using grafts and fixation devices, is still the gold standard treatment offered by surgeons, even though there is a risk of re-rupture requiring revision surgery.
To address this problem, Dr. Martha M. Murray and Miach Orthopaedics developed the Bridge Enhanced ACL Restoration (BEAR) Implant, the first truly innovative development in ACL treatment in 30 years. It is set to transform the surgical landscape – and consequently the market – over the next decade.
Reconstructing the ACL
Anterior and posterior cruciate ligaments (ACL/PCL) connect the bones that form the knee to stabilize joint movements. This prevents the femur from sliding against the tibia and vice versa. Injuries to the ACL/PCL are usually caused by excessive use, physical impact and/or general wear and tear. Because the knee is the most susceptible to joint pressure, ACL tears are one of the most common injuries among professional athletes. PCL tears are less common in isolation and surgeries to fix a torn PCL are usually performed in conjunction with ACL reconstructions.During an ACL reconstruction procedure, the surgeon completely removes the remainder of the torn ACL and a harvested graft is used in combination with fixation devices, such as staples and screws, to rebuild the ligament. Grafts are usually derived from the patient (known as an autograft) or a deceased donor (known as an allograft) and sources commonly include the Achilles, hamstring or tibialis tendons. The surgeon drills holes in the patient’s tibia to hold the harvested patellar tendon with the fixation devices.
The most common types of allografts used are the bone-patella-tendon-bone (BTB), non-sutured, and pre-sutured options. Pre-sutured allografts are the most recent addition to the market, saving surgeons around 30 minutes of procedure time compared to the non-sutured alternatives. Pre-sutured allografts are the fastest-growing segment of ACL Reconstruction, projected to grow significantly over the forecast period. In addition, the higher ASP means it is the main driver of the overall market growth.
The most commonly performed ACL reconstruction procedures include two fixation devices for tibial and femoral sites. Fixation devices offer the most variety for surgeons and include interference screws, intratunnel fixation, washer and post, cross-pin and cortical fixation devices. While interference screws remain the preferred choice of device used, adjustable loop cortical fixation devices can be adjusted to the graft size instead of resizing the graft, providing a greater variety of graft sizes for use. Consequently, the cortical fixation device market was the fastest-growing ACL/PCL fixation device segment.
Limitations of Reconstruction
Despite these recent technological advancements in ACL reconstruction, they are not without their limitations.Firstly, patient demographics have changed over the past two decades and ACL reconstruction surgeries are no longer exclusively associated with the sports industry. One study showed a 22% increase in the incidence rate of ACL procedures over a 12-year period. An aging population, mixed with an active lifestyle has seen an increase in older people requiring ACL surgery. However, the highest rate of ACL reconstruction occurs in adolescents, aged 13 to 17. Adolescents are also twice as likely to need revision surgery within 5 years of reconstruction.
Autografts are by far the preferred graft type used by surgeons. However, despite their donor matching superiority, procedures using autograft tissues require an additional surgery to harvest and prepare the patient tissue. Multi-site incisions increase the risk of infection, morbidity and complications at the donor site.
The alternative, allografts, are also limited for several reasons. First, the demand for donor tendons far exceeds the supply of available allografts. Second, processing donor tissue uses a highly complex technique involving gamma radiation and disinfection stages to remove blood, lipids and containments, followed by rinsing to remove any residual solutions. Although safety standards and processing techniques continue to improve, there is still a risk of disease transmission or tissue rejection from allografts that would not normally occur with autografts.
ACL injury is often associated with knee degeneration, meaning an increased inflammatory response leading to post-traumatic osteoarthritis (PTOA). This has frequently been considered an unavoidable consequence of the trauma. However, a recent 2020 study suggests that ACL reconstruction is associated with a second inflammatory response that accelerates cartilage degradation. So, while ACL reconstruction restores joint stability, the patient’s biologic response coupled with reconstruction surgery does not fully address the injury.
Growing Trend Towards Repair
Over the past few years, the OST market has seen a growing trend toward repairing torn ligaments and tendons.For example, the meniscal repair market has seen a slight shift away from total meniscectomy (i.e., complete or partial removal of the meniscus) and toward meniscal preservation. This is resulting in further technological advancement and product development, fueling competition in the total meniscal repair market. In November 2020, Smith & Nephew released the concluding results from its two-year STITCH Study. The study investigated the effectiveness of repairing Horizontal Cleavage Tears (HCTs), one of the most common meniscal tears, using Smith & Nephew’s NOVOSTITCH meniscal repair system. The results demonstrated an 82.6% success rate, statistically significant improvements in all patient-reported outcomes, and complete meniscal healing in all patients at six-months follow-up.
A similar shift has been observed between biceps tenodesis (i.e., detaching the biceps from the superior labrum and reattaching it to the humerus) over tenotomy (i.e., total release of the tendon from its attachment). While both procedures yield similar improvements in functional outcomes, there is an increased rate of cosmetic deformity (i.e., “Popeye”) for patients who undergo tenotomy. Therefore, while this trend is less strong in the biceps tenodesis repair market, as the shoulder is not a weight-bearing joint, biceps tenodesis repair provides cosmetic benefits for the patient, forcing partial conversion from tenotomy to repair.
Miach Orthopaedics Built a Bridge
A torn ACL is unable to heal on its own due to the presence of synovial fluid, which prevents blood clots from forming, a prerequisite for healing. The Bridge Enhanced ACL Restoration (BEAR) technique was developed to address this problem. The BEAR Implant is a decellularized, bovine-derived, type I collagen implant that resorbs into the body within 8 weeks of implantation. The implant acts a bridge between the two torn ends of the ACL. During the arthroscopic procedure, a small amount of the patient’s own blood is injected into the implant and placed between the torn ACL. Unlike ACL reconstruction where the surgeon completely removes the torn ACL, the BEAR Implant allows the body to knit both torn ends back together while preserving the ACL’s original attachments to the femur and tibia.In December 2020, the U.S. Food and Drug Administration (FDA) granted Miach Orthopaedics marketing approval of the BEAR Implant. MedStar Health is currently conducting a 10-year study to investigate the long-term outcomes of the repair technique. Results after a two-year follow-up, published in the American Journal of Sports Medicine, showed that knee stability and strength are on par with traditional ACL reconstruction outcomes. While decreased PTOA was demonstrated in animal samples, longitudinal data is needed to assess this outcome in humans.
The Revolution is Coming
ACL injuries affect over 400,000 Americans annually, but only approximately half of those are treated surgically. The reasons for this range from initial misdiagnosis to lack of suitable treatment options. The current standard of care for a torn ACL is reconstruction. While there are benefits to this, the procedure may not restore joint motion and cannot guarantee a return to pre-injury activity. Miach Orthopaedics’ BEAR Implant enables the body to heal its own torn ACL, and it is the first innovation in ACL tear treatment in more than 30 years. It offers patients an alternative to reconstruction: repair. In recognition of her contribution, Dr. Murray was presented with the Orthopaedic Research and Education Foundation (OREF) Clinical Research Award in 2022 for outstanding clinical research related to musculoskeletal disease or injury.The development of this repair technique highlights a significant gap in the market. With encouraging clinical evidence, other leading orthopedic companies are sure to follow suit and develop similar products to fill this gap. Although the ACL/PCL Reconstruction market is projected to grow steadily over the forecast period, technological advancements like the BEAR Implant will revolutionize the way surgeons treat torn ACLs and transform the ACL market over the next decade.
Bibliography:
American Academy of Orthopaedic Surgeons. (2022, January 31). Martha Murray, MD, FAAOS, presented with 2022 OREF Clinical Research Award for studies leading to FDA approval of first implant to stimulate ACL healing. Retrieved from Cision PR Newswire: https://www.prnewswire.com/news-releases/martha-murray-md-faaos-presented-with-2022-oref-clinical-research-award-for-studies-leading-to-fda-approval-of-first-implant-to-stimulate-acl-healing-301471155.html
Belk, J. W., Kraeutler, M. J., Houck, D. A., Chrisman, A. N., Scillia, A. J., & McCarty, E. C. (2021). Biceps tenodesis versus tenotomy: a systematic review and meta-analysis of level I randomized controlled trials. Journal of Shoulder and Elbow Surgery, 30(5), 951-960. doi:https://doi.org/10.1016/j.jse.2020.11.012.
Capobianco, A. (2020, December 16). FDA Authorizes Marketing of New Implant to Repair a Torn ACL. Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-new-implant-repair-torn-acl
Desai, N., Andernord, D., Sundemo, D., Alentorn-Geli, E., Musahl, V., Fu, F., . . . Samuelsson, K. (2017). Revision surgery in anterior cruciate ligament reconstruction: a cohort study of 17,682 patients from the Swedish National Knee Ligament Register. Knee Surgery, Sports Traumatology, Arthroscopy, 25, 1542-1554. doi:https://doi.org/10.1007/s00167-016-4399-0
Herzog, M. M., Marshall, S. W., L, L. J., Pate, V., Mack, C. D., & Spang, J. T. (2018). Trends in Incidence of ACL Reconstruction and Concomitant Procedures Among Commercially Insured Individuals in the United States, 2002-2014. Sports Health, 10(6), 523-531. doi:10.1177/1941738118803616
Hunt, E. R., Jacobs, C. A., Conley, C. E.-W., Ireland, M. L., Johnson, D. L., & Lattermann, C. (2020). Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. Journal of Orthopaedic Research, 39, 1281-1288. doi:10.1002/jor.24783
Kurzweil, P., Krych, A. J., Anz, A., Gwathmey, F. W., Loren, G., Lavery, M., & Flanighan, D. C. (2021, Marck 13). Favorable Reoperation Rate at 2 Years Following Repair of Horizontal Cleavage Tears Using an All Suture-Based Technique: A Prospective, Multicenter Trial. Arthroscopy, Sports Medicine, and Rehabilitation, 3(3), E773-E780. doi:https://doi.org/10.1016/j.asmr.2021.01.018
LaPrade, R. (2022). Posterior Cruciate Ligament Reconstruction. Retrieved from Dr. Robert LaPrade, MD: https://drrobertlaprademd.com/pcl-reconstruction/
MedStar Health. (2021, September 13). MedStar Health First in Nation to Offer Innovative BEAR Implant to Treat ACL Tears. Retrieved from MedStar Health: https://www.medstarhealth.org/news-and-publications/news/medstar-health-first-in-nation-to-offer-innovative-bear-implant-to-treat-acl-tears
MedStar Health Research Institute. (2022, March 28). Researchers at MedStar Health Use the BEAR Implant to Repair ACL Tears in Surgery and Evaluate Outcomes. Retrieved from MedStar Health: https://www.medstarhealth.org/blog/medstar-health-use-the-bear-implant-to-repair-acl-tears-in-surgery-and-evaluate-outcomes
Miach Orthopaedics. (2022). BEAR Implant. Retrieved from Miach Orthopaedics: https://miachortho.com/patients-and-families/bear-implant/
Murray, M. M., Fleming, B. C., Badger, G. J., Team, T. B., Kramer, D. E., Micheli, L. J., & Yen, Y.-M. (2020). Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomizeed Clinical Trial. The American Journal of Sports Medicine, 48(6), 1305-1315. doi:10.1177/0363546520913532
RegenMed. (2022). Allograft Processing. Retrieved August 30, 2022, from RegenMed: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.regenmed.ca/upload/documents/allograft-processing.pdf
Thorolfsson, B., Svantesson, E., Snaebjornsson, T., Sansone, M., Karlsson, J., Samuelsson, K., & Senorski, E. H. (2021). Adolescents Have Twice the Revision Rate of Young Adults After ACL Reconstruction With Hamstring Tendon Autograft: A Study From the Swedish National Knee Ligament Registry. Orthopaedic Journal of Sports Medicine., 1-8. doi:10.1177/23259671211038893
Niamh O’Neill is a research analyst at iData Research. She works on research projects regarding the medical device industry, publishing the U.S Orthopedic Soft Tissue report series.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.
