The following companies are ranked by 2010 revenue and net sales reported in financial statements. Companies selected for inclusion where chosen because of their focus on orthopedics and spine, profitability of the company and public availability of company financial information. This list is not an endorsement of included companies.
1. Medtronic (Minneapolis). Medtronic reported full year revenue of $15.8 billion for the fiscal year ending in April, 2010. The company's spinal business alone contributed $3.5 billion to the overall revenue report. The company had a successful year, receiving FDA clearance for the Kyphon Xpander II in October and for the CD Horizon System for pedicle screws in December. The latter device was the first device cleared under the FDA's newly-established category for pediatric adolescent idiopathic scoliosis patients. In July, the company sought FDA approval for its Amplify vertebral stabilizing device that uses bone morphogenic protein. The FDA's Orthopaedic and Rehabilitation Device panel voted in favor of recommending the device for approval at the time. However, the FDA officially denied Amplify approval in March 2011. The company also launched several spinal systems last year, including the VERTEX SELECT and KYPHON Express Curette.
2. Stryker (Kalamazoo, Mich.). Stryker reported net sales of $7.3 billion at the 2010 year's end, which was a 7.8 percent increase over the company's net sales from 2009. The company's president and CEO Stephen P. MacMillian, attributes its success to the ability to offer a diverse range of products. The company has a presence in the hip, knee, trauma and spine device markets, which has been strengthened by a few key acquisitions over this past year. Stryker acquired Gaymar Industries, a company producing ulcer and temperature management products, for $150 million in August, Boston Scientific's neurovascular business for $1.5 billion in October, and Porex Surgical, a porous plastics manufacturer in November. The company also made the strategic move of selling its biologic OP-1 products to Olympus for $60 million in December. Between transactions, Stryker managed to launch several products this year, including the ADM X3 mobile bearing system new generation technology in March and the iVAS inflatable vertebral augmentation system in April.
3. DePuy Orthopadics (New Brunswick, N.J.). DePuy Orthopaedics, a subsidiary of Johnson & Johnson, reported full-year sales of $5.6 billion worldwide in 2010. The company recalled its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System in July and suffered the repercussions of related litigation expenses throughout the rest of the year. However, the company did experience success in launching new spine systems, the COUGAR LS cage system and the EXPEDIUM system. In 2010 company also launched a knotless rotator cuff anchor and meniscal repair system and signed a distribution agreement with Osseon Therapeutics for the distribution of Osseoflex steerable spine augmentation needle in the United States.
4. Zimmer Holdings (Warsaw, Ind.). Zimmer reported net sales of $4.2 billion for the full year of 2010, which represents a 3 percent increase over net sales for 2009. David Dvorak, the company's president and CEO, attributes the success to worldwide growth and product introductions in 2010, for which there were many. The company introduced the Continuum acetabular cup system in March and received FDA clearance for the Natural Nail System Retrograde Femoral Nails in December. In addition focusing on new products, the company acquired Beijing Montagne Medical Device to expand its hip, knee and surgical instruments market, as well as SoPlus Orthopaedic Surgical Power Tools, both in December. The most lucrative markets for Zimmer last year were the reconstructive markets, followed by the knee, hip, trauma and spine markets. The company plans to focus 2011 efforts on joint reconstruction and emerging further in the European and Asian Pacific markets, which lagged behind American markets in all reported categories last year.
5. Smith & Nephew (London, England). Smith & Nephew reported approximately $4 billion in revenue for 2010, which is a 4 percent increase over the 2009 reported revenue. While merger and acquisition rumors have swirled around the company over the past few months, its value continues to increase. David Illingworth, CEO of Smith & Nephew who plans on retiring in April, attributes the company's success to ongoing efficiency and presence in its target markets: orthopedics, endoscopy and advanced wound management. The orthopedic department was responsible for $2.195 billion of the company's overall annual revenue, due to the strength of its knee franchise. The company's LEGION knee system proved an important product for the company's line. Last year, the company launched the FAST-FIX meniscal repair system and the TWINFIX suture anchor for rotator cuff repair. In December, the company announced plans to add 100 employees to its Memphis location and recently hired Billie Jean King, a tennis player, as spokesperson.
6. Synthes (West Chester, Penn.). Synthes reported global revenue of $3.7 billion during 2010. The company, which focuses on producing and marketing implants and biomaterials, achieved 8.6 percent global revenue growth over last year. The company acquired Anspach, a surgical power tools manufacturer, in November. It was also successful in receiving FDA clearance for a forefoot/middlefoot system in August and an anterior clavicle plate system in September. During the fourth quarter, the company and its former subsidiary, Norian, paid $23.2 million in fines for illegally testing spinal bone cement. However, the company's president and CEO, Michael Orsinger, says it will continue to focus on improving its performance in the spine business during 2011.
7. Biomet (Warsaw, Ind.). For the 2010 fiscal year ending in May 2010, Biomet reported net sales of $2.7 billion, which represented an 8 percent increase over 2009. The company is dedicated to finding minimally invasive surgical solutions, advanced biomaterials and patient-matched implants for orthopedic conditions. The company began planning a $26 million expansion of its Warsaw campus in July and acquired the Massachusetts-based Cytosol Laboratories in the same month. The company also received several FDA clearances on new devices, including the SMPLE plate and screws last March and the Bio-Modular Reverse Shoulder in October. The company has products in the total hip and knee markets, extremities, spine and sports medicine markets.
8. DJO Global (San Diego). DJO Global, which changed its official name from DJO earlier this year, reported net sales of $966 million during 2010. Last year, the company deployed a new commercial strategy in the United States, integrating the marketing, sales and commercial shared services group under new leadership. The company also completed integration of its Chattanooga, Tenn., business into other DJO sites savings. To further its market reach, the company acquired a distributor in South Africa and strengthened its vascular therapy with the acquisition of Elastic Therapy. The company celebrated the production of its one millionth DonJoy Defiance Knee Ligament Brace in February and received FDA clearance for its surgical revision femoral hip system in March. In Jan. 2011, Leslie H. Cross, president and CEO of DJO Global, announced his plans to retire and transition into his role as the non-executive chairman of the DJO board of directors.
9. Integra LifeSciences (Plainsboro, N.J.). Integra LifeSciences reported total revenues for 2010 at $732.1 million, which reflected a 7 percent increase over 2009 revenues. In 2010, the company launched the Dura Gen Plus dural regeneration matrix and reached the landmark of implanting its Vu a-POD device in more than 800 patients. The Vu a-POD received FDA clearance in Oct. 2010. The company was also busy launching four new surgical instruments in 2010 at the Association of periOperative Registered Nurses conference and commercially launched its Paramount pedicle screw system. Last year, the company's orthopedics business brought in more than $290 million and instrument sales topped $166 million.
10. Orthofix (Lewisville, Texas). Orthofix reported net sales of $564.4 million during 2010, which was a slight increase from the $545.6 million reported at the end of 2009. The company settled a patent dispute during the fourth quarter, where it paid NuVasive a $2 million settlement. The company's fourth quarter net sales were down compared with last year, but it has experienced several successes over the past year. The company released its FUSION XT knee brace in August and Firebird pedicle screw system in October. In addition to its orthopedic products, Orthofix also produces a vascular and anesthesia product line. In the future, the company plans on expanding its sports medicine, spine and biologics business.
11. Wright Medical Group (Arlington, Tenn.). This global medical device company is focused on providing surgical solutions in the orthopedic market with an emphasis on the foot and ankle product markets. Wright Medical Group reported net sales of $519 million in 2010, with a majority of that coming from the hip and knee product lines. The company launched several products this past year, including the VALOR hindfoot fusion nail system in June and the EVOLUTION medial-pivot knee system in July. The company also received a $2.4 million grant from the Department of Defense in October to complete a clinical study of its OSTEOSET T bone graft substitute pellets in combat-related open fracture wounds. Despite industry challenges, Wright Medical CEO Gary D. Henley continues to project growth over the next year.
12. NuVasive (San Diego). NuVasive reported full year revenue of $478.2 million in 2010, a 29.1 percent increase over 2009. The company, focused on producing minimally invasive equipment for spine surgery, was successful in gaining insurance coverage for its extreme lateral interbody fusion procedure from two major insurance companies in March of 2010 and two additional companies in January of 2011. The company presented clinical evidence in support of XLIF at the 2010 North American Spine Society annual meeting in Orlando, Fla. Last year, the company received FDA clearance for its Spherx II-Mas deformity spinal system. The company also initiated a patent infringement lawsuit against Globus Medical in October and settled a patent dispute with Orthofix in December, which included a $2 million settlement from Orthofix for patent infringement.
13. ArthroCare (Austin, Texas). ArthroCare, a company focused on developing minimally invasive surgical products, reported total revenue of $355.4 million during 2010. The company's sports medicine business was most successful, contributing nearly $232 million to the company's overall revenue. In 2010, the company received FDA clearance for its Spinewand surgical device in May, Spartan PEEK suture implant system in October and the SpeedFix anchors in November. The company published a clinical study in March about plasma disc compression for treating low back pain associated with contained herniated discs. Throughout the year, the company presented at several conferences, including the Piper Jaffray 22nd Annual Health Care Conference and the UBS Global Life Sciences Conference.
14. Exactech (Gainsville, Fla.). Exactech, a bone and joint restoration product developer and producer, recently reported full year revenue for 2010 at $190.5 million. The company is focused on manufacturing and marketing implant devices, surgical instrumentation and biologic services to hospitals and physicians across the country. The bulk of the company's revenue comes from its knee business, which reined in total revenue of $76.5 million last year. Over the past year, the company acquired several spine product lines and related technology from VertiFlex, a minimally invasive spine technology company. During the fourth quarter, the company agreed to pay $3 million in an anti-kickback settlement and entered into a deferred prosecution agreement. However, the company has been focused on product development and had several devices cleared last year, including the Exactech Euinoxe poximal humorous fracture plate system in May and the Optetrak Logic combination tibial tray in August.
15. Alphatec Spine (Carlsbad, Calif.). Alphatec Spine is a medical device company that designs, develops, manufactures and markets spine products with a focus on treating conditions related to the aging spine. Last year, the company reported full year revenue at $171.6 million, which was a 42.3 percent increase over 2009 revenues. The company has been working on its market presence through the launch of its PureGen Osteoprogenitor Cell Allograft in September and acquisition of Scient'x S.A. The company also launched proprietary aging spine products, the Osseofix, OsseoScrew and Helifix, in the European market. In October, former Johnson & Johnson CFO Michael O'Neill became the CFO of the company's parent company, Alphatec Holdings. That same month, the company signed an agreement with Cleveland Clinic spin-off Merlot OrthopediX to develop and commercialize its bone anchorage technology for the spine.
16. RTI Biologics (Alachua, Fla.). RTI Biologics, an orthopedic and other biologic implants provider, recently reported total 2010 revenue of $166.2 million, owing in large part to the company's sports medicine and spine business, which generated more than $45 million and $33 million last year, respectively. Last January, the company donated its Matrix HD, a sterilized dermis allograft, to treat an eight-year-old patient with dystrophic epidermolysis bullosa. The event marked the first time terminally sterilized allograft dermis was used to treat the disease. The company also donated the product to surgeons treating patients in Haiti after last January's earthquake. In March 2010, the company launched a hotline designed to help physicians and consumers with sports medicine reimbursement questions. The company also entered into an agreement with Athersys to access its Multipotent Adult Progenitor Cell technologies in Sept. 2010.
17. Orthovita (Malvern, Penn.). This specialty spine and orthopedic company focuses on orthobiologic and biosurgery products. Orthovita reported product sales of $94.7 million in 2010. In September, the company published a study on using its Cortoss product for treating vertebral compression fractures with vertebroplasty and kyphoplasty. The study yielded positive results on using the company's bone augmentation material, which could promote further use in the future. The company also experienced success in receiving FDA clearance for the Vitos Bioactive Foam-2X Bone Graft Substitute for use as non-structural bone void filler for the spine, pelvis and extremities. The product was recently launched at the 2011 American Academy of Orthopaedic Surgeons annual meeting in San Diego. The company has begun 2011 off strongly with FDA clearance for its Vitoss Bimodal Bone Graft Substitute.
18. Kensey Nash (Exton, Penn.). Kensey Nash, a medical device company focused on regenerative sports medicine solutions, reported fiscal year 2010 revenue of $80.6 million. Last June, the company entered into a collagen supply agreement with St. Jude Medical and a strategic agreement with Arthrex for marketing the company's Extracellular Matrix products. In November, the two companies entered into a European distribution agreement for the company's Cartilage Repair Device, which is in an FDA-approved pilot clinical trial. The company won FDA clearance for its Meso BioMatrix Surgical Mesh in May 2010 and its Medeor Matrix in Feb. 2011. While the company's sales have been declining in recent months, president and CEO Joe Kaufmann remains optimistic about the ongoing expansion of the company's ECM products, which are distributed by Synthes.
19. MAKO Surgical (Ft. Lauderdale, Fla.). MAKO Surgical, producers of RIO systems, reported total revenue of $44.3 million in 2010, a $10 million increase over 2009. A total of 33 RIO systems were sold worldwide in 2010, 13 of those in the fourth quarter. The company reported a total of 3,485 MAKOplasty procedures performed in 2010, which is a 118 percent increase from 2009. In November, the first MAKOplasty total hip replacement was performed on a patient in Los Angeles. The technology was previously used most prominently during partial knee replacements. The company continues to build upon its 58 clinical studies currently in process assessing the MAKOplasty technology.
20. TranS1 (Wilmington, N.C.). TranS1 reported 2010 revenues at $26.1 million, a more than $2 million decrease from the amount reported in 2009. The company has been going through a leadership transition recently, naming a new vice president of research and development, Stephen Ainsworth, in Oct. 2010 and a new CEO, Ken Reali, in January of 2011. Mr. Reali attributed the 2010 falling revenues to insurance company denials of the AxiaLIF technology, however Humana recently decided on a positive coverage policy, which could mean additional payors won't be too far behind. The company released its AxiaALIF 2L+ in July 2010, the second generation of its lumbar fusion system. It also received FDA clearance for a lateral interbody fusion device last August.
Read other coverage on orthopedic and spine devices and companies:
- 42 Orthopedic and Spine Device Companies to Know
- 50 Orthopedic and Spine Devices to Know
- 7 Critical Orthopedic and Spine Device Industry Trends
1. Medtronic (Minneapolis). Medtronic reported full year revenue of $15.8 billion for the fiscal year ending in April, 2010. The company's spinal business alone contributed $3.5 billion to the overall revenue report. The company had a successful year, receiving FDA clearance for the Kyphon Xpander II in October and for the CD Horizon System for pedicle screws in December. The latter device was the first device cleared under the FDA's newly-established category for pediatric adolescent idiopathic scoliosis patients. In July, the company sought FDA approval for its Amplify vertebral stabilizing device that uses bone morphogenic protein. The FDA's Orthopaedic and Rehabilitation Device panel voted in favor of recommending the device for approval at the time. However, the FDA officially denied Amplify approval in March 2011. The company also launched several spinal systems last year, including the VERTEX SELECT and KYPHON Express Curette.
2. Stryker (Kalamazoo, Mich.). Stryker reported net sales of $7.3 billion at the 2010 year's end, which was a 7.8 percent increase over the company's net sales from 2009. The company's president and CEO Stephen P. MacMillian, attributes its success to the ability to offer a diverse range of products. The company has a presence in the hip, knee, trauma and spine device markets, which has been strengthened by a few key acquisitions over this past year. Stryker acquired Gaymar Industries, a company producing ulcer and temperature management products, for $150 million in August, Boston Scientific's neurovascular business for $1.5 billion in October, and Porex Surgical, a porous plastics manufacturer in November. The company also made the strategic move of selling its biologic OP-1 products to Olympus for $60 million in December. Between transactions, Stryker managed to launch several products this year, including the ADM X3 mobile bearing system new generation technology in March and the iVAS inflatable vertebral augmentation system in April.
3. DePuy Orthopadics (New Brunswick, N.J.). DePuy Orthopaedics, a subsidiary of Johnson & Johnson, reported full-year sales of $5.6 billion worldwide in 2010. The company recalled its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System in July and suffered the repercussions of related litigation expenses throughout the rest of the year. However, the company did experience success in launching new spine systems, the COUGAR LS cage system and the EXPEDIUM system. In 2010 company also launched a knotless rotator cuff anchor and meniscal repair system and signed a distribution agreement with Osseon Therapeutics for the distribution of Osseoflex steerable spine augmentation needle in the United States.
4. Zimmer Holdings (Warsaw, Ind.). Zimmer reported net sales of $4.2 billion for the full year of 2010, which represents a 3 percent increase over net sales for 2009. David Dvorak, the company's president and CEO, attributes the success to worldwide growth and product introductions in 2010, for which there were many. The company introduced the Continuum acetabular cup system in March and received FDA clearance for the Natural Nail System Retrograde Femoral Nails in December. In addition focusing on new products, the company acquired Beijing Montagne Medical Device to expand its hip, knee and surgical instruments market, as well as SoPlus Orthopaedic Surgical Power Tools, both in December. The most lucrative markets for Zimmer last year were the reconstructive markets, followed by the knee, hip, trauma and spine markets. The company plans to focus 2011 efforts on joint reconstruction and emerging further in the European and Asian Pacific markets, which lagged behind American markets in all reported categories last year.
5. Smith & Nephew (London, England). Smith & Nephew reported approximately $4 billion in revenue for 2010, which is a 4 percent increase over the 2009 reported revenue. While merger and acquisition rumors have swirled around the company over the past few months, its value continues to increase. David Illingworth, CEO of Smith & Nephew who plans on retiring in April, attributes the company's success to ongoing efficiency and presence in its target markets: orthopedics, endoscopy and advanced wound management. The orthopedic department was responsible for $2.195 billion of the company's overall annual revenue, due to the strength of its knee franchise. The company's LEGION knee system proved an important product for the company's line. Last year, the company launched the FAST-FIX meniscal repair system and the TWINFIX suture anchor for rotator cuff repair. In December, the company announced plans to add 100 employees to its Memphis location and recently hired Billie Jean King, a tennis player, as spokesperson.
6. Synthes (West Chester, Penn.). Synthes reported global revenue of $3.7 billion during 2010. The company, which focuses on producing and marketing implants and biomaterials, achieved 8.6 percent global revenue growth over last year. The company acquired Anspach, a surgical power tools manufacturer, in November. It was also successful in receiving FDA clearance for a forefoot/middlefoot system in August and an anterior clavicle plate system in September. During the fourth quarter, the company and its former subsidiary, Norian, paid $23.2 million in fines for illegally testing spinal bone cement. However, the company's president and CEO, Michael Orsinger, says it will continue to focus on improving its performance in the spine business during 2011.
7. Biomet (Warsaw, Ind.). For the 2010 fiscal year ending in May 2010, Biomet reported net sales of $2.7 billion, which represented an 8 percent increase over 2009. The company is dedicated to finding minimally invasive surgical solutions, advanced biomaterials and patient-matched implants for orthopedic conditions. The company began planning a $26 million expansion of its Warsaw campus in July and acquired the Massachusetts-based Cytosol Laboratories in the same month. The company also received several FDA clearances on new devices, including the SMPLE plate and screws last March and the Bio-Modular Reverse Shoulder in October. The company has products in the total hip and knee markets, extremities, spine and sports medicine markets.
8. DJO Global (San Diego). DJO Global, which changed its official name from DJO earlier this year, reported net sales of $966 million during 2010. Last year, the company deployed a new commercial strategy in the United States, integrating the marketing, sales and commercial shared services group under new leadership. The company also completed integration of its Chattanooga, Tenn., business into other DJO sites savings. To further its market reach, the company acquired a distributor in South Africa and strengthened its vascular therapy with the acquisition of Elastic Therapy. The company celebrated the production of its one millionth DonJoy Defiance Knee Ligament Brace in February and received FDA clearance for its surgical revision femoral hip system in March. In Jan. 2011, Leslie H. Cross, president and CEO of DJO Global, announced his plans to retire and transition into his role as the non-executive chairman of the DJO board of directors.
9. Integra LifeSciences (Plainsboro, N.J.). Integra LifeSciences reported total revenues for 2010 at $732.1 million, which reflected a 7 percent increase over 2009 revenues. In 2010, the company launched the Dura Gen Plus dural regeneration matrix and reached the landmark of implanting its Vu a-POD device in more than 800 patients. The Vu a-POD received FDA clearance in Oct. 2010. The company was also busy launching four new surgical instruments in 2010 at the Association of periOperative Registered Nurses conference and commercially launched its Paramount pedicle screw system. Last year, the company's orthopedics business brought in more than $290 million and instrument sales topped $166 million.
10. Orthofix (Lewisville, Texas). Orthofix reported net sales of $564.4 million during 2010, which was a slight increase from the $545.6 million reported at the end of 2009. The company settled a patent dispute during the fourth quarter, where it paid NuVasive a $2 million settlement. The company's fourth quarter net sales were down compared with last year, but it has experienced several successes over the past year. The company released its FUSION XT knee brace in August and Firebird pedicle screw system in October. In addition to its orthopedic products, Orthofix also produces a vascular and anesthesia product line. In the future, the company plans on expanding its sports medicine, spine and biologics business.
11. Wright Medical Group (Arlington, Tenn.). This global medical device company is focused on providing surgical solutions in the orthopedic market with an emphasis on the foot and ankle product markets. Wright Medical Group reported net sales of $519 million in 2010, with a majority of that coming from the hip and knee product lines. The company launched several products this past year, including the VALOR hindfoot fusion nail system in June and the EVOLUTION medial-pivot knee system in July. The company also received a $2.4 million grant from the Department of Defense in October to complete a clinical study of its OSTEOSET T bone graft substitute pellets in combat-related open fracture wounds. Despite industry challenges, Wright Medical CEO Gary D. Henley continues to project growth over the next year.
12. NuVasive (San Diego). NuVasive reported full year revenue of $478.2 million in 2010, a 29.1 percent increase over 2009. The company, focused on producing minimally invasive equipment for spine surgery, was successful in gaining insurance coverage for its extreme lateral interbody fusion procedure from two major insurance companies in March of 2010 and two additional companies in January of 2011. The company presented clinical evidence in support of XLIF at the 2010 North American Spine Society annual meeting in Orlando, Fla. Last year, the company received FDA clearance for its Spherx II-Mas deformity spinal system. The company also initiated a patent infringement lawsuit against Globus Medical in October and settled a patent dispute with Orthofix in December, which included a $2 million settlement from Orthofix for patent infringement.
13. ArthroCare (Austin, Texas). ArthroCare, a company focused on developing minimally invasive surgical products, reported total revenue of $355.4 million during 2010. The company's sports medicine business was most successful, contributing nearly $232 million to the company's overall revenue. In 2010, the company received FDA clearance for its Spinewand surgical device in May, Spartan PEEK suture implant system in October and the SpeedFix anchors in November. The company published a clinical study in March about plasma disc compression for treating low back pain associated with contained herniated discs. Throughout the year, the company presented at several conferences, including the Piper Jaffray 22nd Annual Health Care Conference and the UBS Global Life Sciences Conference.
14. Exactech (Gainsville, Fla.). Exactech, a bone and joint restoration product developer and producer, recently reported full year revenue for 2010 at $190.5 million. The company is focused on manufacturing and marketing implant devices, surgical instrumentation and biologic services to hospitals and physicians across the country. The bulk of the company's revenue comes from its knee business, which reined in total revenue of $76.5 million last year. Over the past year, the company acquired several spine product lines and related technology from VertiFlex, a minimally invasive spine technology company. During the fourth quarter, the company agreed to pay $3 million in an anti-kickback settlement and entered into a deferred prosecution agreement. However, the company has been focused on product development and had several devices cleared last year, including the Exactech Euinoxe poximal humorous fracture plate system in May and the Optetrak Logic combination tibial tray in August.
15. Alphatec Spine (Carlsbad, Calif.). Alphatec Spine is a medical device company that designs, develops, manufactures and markets spine products with a focus on treating conditions related to the aging spine. Last year, the company reported full year revenue at $171.6 million, which was a 42.3 percent increase over 2009 revenues. The company has been working on its market presence through the launch of its PureGen Osteoprogenitor Cell Allograft in September and acquisition of Scient'x S.A. The company also launched proprietary aging spine products, the Osseofix, OsseoScrew and Helifix, in the European market. In October, former Johnson & Johnson CFO Michael O'Neill became the CFO of the company's parent company, Alphatec Holdings. That same month, the company signed an agreement with Cleveland Clinic spin-off Merlot OrthopediX to develop and commercialize its bone anchorage technology for the spine.
16. RTI Biologics (Alachua, Fla.). RTI Biologics, an orthopedic and other biologic implants provider, recently reported total 2010 revenue of $166.2 million, owing in large part to the company's sports medicine and spine business, which generated more than $45 million and $33 million last year, respectively. Last January, the company donated its Matrix HD, a sterilized dermis allograft, to treat an eight-year-old patient with dystrophic epidermolysis bullosa. The event marked the first time terminally sterilized allograft dermis was used to treat the disease. The company also donated the product to surgeons treating patients in Haiti after last January's earthquake. In March 2010, the company launched a hotline designed to help physicians and consumers with sports medicine reimbursement questions. The company also entered into an agreement with Athersys to access its Multipotent Adult Progenitor Cell technologies in Sept. 2010.
17. Orthovita (Malvern, Penn.). This specialty spine and orthopedic company focuses on orthobiologic and biosurgery products. Orthovita reported product sales of $94.7 million in 2010. In September, the company published a study on using its Cortoss product for treating vertebral compression fractures with vertebroplasty and kyphoplasty. The study yielded positive results on using the company's bone augmentation material, which could promote further use in the future. The company also experienced success in receiving FDA clearance for the Vitos Bioactive Foam-2X Bone Graft Substitute for use as non-structural bone void filler for the spine, pelvis and extremities. The product was recently launched at the 2011 American Academy of Orthopaedic Surgeons annual meeting in San Diego. The company has begun 2011 off strongly with FDA clearance for its Vitoss Bimodal Bone Graft Substitute.
18. Kensey Nash (Exton, Penn.). Kensey Nash, a medical device company focused on regenerative sports medicine solutions, reported fiscal year 2010 revenue of $80.6 million. Last June, the company entered into a collagen supply agreement with St. Jude Medical and a strategic agreement with Arthrex for marketing the company's Extracellular Matrix products. In November, the two companies entered into a European distribution agreement for the company's Cartilage Repair Device, which is in an FDA-approved pilot clinical trial. The company won FDA clearance for its Meso BioMatrix Surgical Mesh in May 2010 and its Medeor Matrix in Feb. 2011. While the company's sales have been declining in recent months, president and CEO Joe Kaufmann remains optimistic about the ongoing expansion of the company's ECM products, which are distributed by Synthes.
19. MAKO Surgical (Ft. Lauderdale, Fla.). MAKO Surgical, producers of RIO systems, reported total revenue of $44.3 million in 2010, a $10 million increase over 2009. A total of 33 RIO systems were sold worldwide in 2010, 13 of those in the fourth quarter. The company reported a total of 3,485 MAKOplasty procedures performed in 2010, which is a 118 percent increase from 2009. In November, the first MAKOplasty total hip replacement was performed on a patient in Los Angeles. The technology was previously used most prominently during partial knee replacements. The company continues to build upon its 58 clinical studies currently in process assessing the MAKOplasty technology.
20. TranS1 (Wilmington, N.C.). TranS1 reported 2010 revenues at $26.1 million, a more than $2 million decrease from the amount reported in 2009. The company has been going through a leadership transition recently, naming a new vice president of research and development, Stephen Ainsworth, in Oct. 2010 and a new CEO, Ken Reali, in January of 2011. Mr. Reali attributed the 2010 falling revenues to insurance company denials of the AxiaLIF technology, however Humana recently decided on a positive coverage policy, which could mean additional payors won't be too far behind. The company released its AxiaALIF 2L+ in July 2010, the second generation of its lumbar fusion system. It also received FDA clearance for a lateral interbody fusion device last August.
Read other coverage on orthopedic and spine devices and companies:
- 42 Orthopedic and Spine Device Companies to Know
- 50 Orthopedic and Spine Devices to Know
- 7 Critical Orthopedic and Spine Device Industry Trends