08.12.22
Rank: #10 (Last year: #N/A)
$464 Million
Prior Fiscal: $407 Million
Percentage Change: +14.2%
R&D Expenditure: $49.6M
Best FY21 Quarter: Q4 $125M
Latest Quarter: Q1 $106.4M
No. of Employees: 1,087
Global Headquarters: Lewisville, Texas
KEY EXECUTIVES:
Jon Serbousek, Director, President, and CEO
Doug Rice, CFO
Kimberley Elting, President, Global Orthopedics
Kevin Kenny, President, Global Spine
The Olympics generate its fair share of comeback stories. This one, however, never quite made it to the grand stage, but it’s a substantial success story all the same.
At 39, 2000 Olympic platform diving gold medal winner Laura Wilkinson was planning to give the competition one more try. While coming out of retirement in 2017 at her age would certainly have been enough of a challenge for most, she soon realized that years of hitting the water at high rates of speed had done significant damage to her spine. Just a year after she started her quest to make her return at the Tokyo Olympics (originally planned for 2020, but took place in summer of 2021 due to COVID), she became an Orthofix patient. She went through a successful spinal fusion procedure that married an Orthofix cervical plate system to stabilize her spine, the Trinity ELITE allograft to aid in bone fusion, and the CervicalStim device to stimulate bone growth post-surgery. Following her recovery period, Wilkinson was able to return to the pool to continue her quest for Olympic glory.
“When my doctor first told me that I needed spinal fusion surgery, I have to admit it was a little scary,” Wilkinson said. “That’s one of the reasons why I started sharing my journey on social media and posting the different stages I was going through. I wanted people to see that you can overcome these challenges and get your life back. It was important to me to encourage other people who were dealing with cervical disc degeneration and showcase a possible path for recovery.”
In May 2021, Orthofix proudly announced it was continuing its sponsorship of the diver and her hope to reach the games. Unfortunately, on June 13, 2021, Wilkinson finished 10th in the women’s 10-meter platform finals, which was the last step in qualifying for the Olympic team. She exited the pool to a standing ovation from all in attendance.
“I didn’t even realize it was going on in the whole pool,” Wilkinson revealed to KPRC 2's Christine Noel. “I wish I could have taken a minute to see that, but that was very special.”
Orthofix enjoyed its own special moment in 2021. The firm announced it reached a significant milestone in September—more than 60,000 of the company’s M6-C artificial cervical discs had been implanted worldwide. The implant is a next-generation artificial disc designed to mimic the natural motion of a native disc. Developed to replace an intervertebral disc damaged by cervical disc degeneration, the M6-C disc is indicated as an alternative to cervical fusion. First approved for distribution under the CE mark in the EU and other international geographies, the M6-C disc received FDA approval in 2019.
The successful spine solution was just one of the reasons for the favorable financials the company enjoyed in 2021. Its end tally for the fiscal was $464.5 million, an increase of 14.2% over the previous period.
All business units also enjoyed positive growth for the 12-month period. Global Spine, which is comprised of three segments, contributed $359 million to the company’s coffers. The largest division—Bone Growth Therapies—added $187.4 million to the total, an increase of 9.4%. Spinal Implants skyrocketed 21.3% to $115.1 million. Third, biologics celebrated a modest 1.7% rise to end at $56.4 million. All three units attributed the gains to the continued recovery from the decrease in procedures due to the COVID pandemic. In fact, Bone Growth Therapies and Biologics were still below their 2019 revenue totals so the recovery would likely continue into the next fiscal.
Sister division—Global Orthopedics—ballooned 24.4% to finish the year at $105.5 million. Its $20.7 million increase was attributed primarily to the pandemic recovery, as well as continued growth of the FITBONE product line and favorable foreign currency exchange rates.
While the M6-C disc was achieving milestones in terms of number of implantations, it was not one of the new products the company was making headlines with in 2021. There were a number of those, however, including the aforementioned FITBONE product.
In February, the organization announced it was launching the system in the U.S. and Europe. The FITBONE intramedullary lengthening system was developed for limb lengthening and deformity correction of the femur and tibia bones. Implanted through a minimally invasive procedure, the system consists of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control set that enables the patient to manage the distraction phase at home. In September, the firm announced the first pediatric case involving the technology took place.
April produced a 510(k) clearance and first patient implant of the 3D-printed CONSTRUX Mini Ti Spacer System. Developed to enhance anterior cervical discectomy and fusion procedures, the spacer with Nanovate Technology is the first 3D-printed titanium interbody introduced to the market by the company.
Later that same month, Orthofix announced the 510(k) clearance and first patient implant of the FORZA Ti TLIF Spacer System. The titanium 3D-printed interbody spacer with Nanovate Technology was introduced to help optimize transforaminal lumbar interbody fusion (TLIF) procedures. The optimized design, porosity, and surface allows bone to grow into and through the spacer. The U.S. launch and first patient implant of the system took place in June.
Orthofix also secured the exclusive license to commercialize the portfolio of Italy-based IGEA S.p.A’s bone, cartilage, and soft tissue stimulation products in the U.S and Canada. Under the terms of the agreement, Orthofix obtained the rights to pursue FDA approvals and sell IGEA’s platform of orthopedic products within the two countries. The line expanded Orthofix’s bone growth therapies portfolio of pulsed electromagnetic field products with additional treatment modalities and indications such as low-intensity pulsed ultrasound and capacitive coupling for fracture management.
May saw the expansion of the firm’s pediatric offerings with FDA 510(k) clearance of the OrthoNext digital platform, a software tool for deformity analysis and preoperative planning for pediatric orthopedic procedures. U.S. and European full market launch also took place that same month for the OSCAR PRO Ultrasonic Arthroplasty Revision System. Designed to reduce the challenges associated with revising failed cemented arthroplasties, the OSCAR PRO is an ultrasonic surgical system that aids in the removal of cement during complex joint revision surgeries.
In the middle of the dog days of summer, the organization announced the launch and first patient implants with the fiberFUSE Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone. The fiberFUSE Strip is formulated as a convenient, preformed bone-graft strip to enable optimized application for posterior cervical, posterior lumbar, and degenerative spinal procedures.
On the last official day of summer, Orthofix told of the full market launch of the Opus Mg Set osteoconductive scaffold, a synthetic magnesium-based bone void filler for orthopedic procedures. Opus Mg Set provides a procedure-specific solution for orthopedic fracture care and trauma applications by filling non-structural bony voids or gaps during surgery. Available in both a moldable and injectable form, this solution provides immediate compressive strength at the surgical site post-implantation. When injected or placed into bony voids or gaps, it forms a supportive scaffold to help facilitate the natural bone-healing process.
$464 Million
Prior Fiscal: $407 Million
Percentage Change: +14.2%
R&D Expenditure: $49.6M
Best FY21 Quarter: Q4 $125M
Latest Quarter: Q1 $106.4M
No. of Employees: 1,087
Global Headquarters: Lewisville, Texas
KEY EXECUTIVES:
Jon Serbousek, Director, President, and CEO
Doug Rice, CFO
Kimberley Elting, President, Global Orthopedics
Kevin Kenny, President, Global Spine
The Olympics generate its fair share of comeback stories. This one, however, never quite made it to the grand stage, but it’s a substantial success story all the same.
At 39, 2000 Olympic platform diving gold medal winner Laura Wilkinson was planning to give the competition one more try. While coming out of retirement in 2017 at her age would certainly have been enough of a challenge for most, she soon realized that years of hitting the water at high rates of speed had done significant damage to her spine. Just a year after she started her quest to make her return at the Tokyo Olympics (originally planned for 2020, but took place in summer of 2021 due to COVID), she became an Orthofix patient. She went through a successful spinal fusion procedure that married an Orthofix cervical plate system to stabilize her spine, the Trinity ELITE allograft to aid in bone fusion, and the CervicalStim device to stimulate bone growth post-surgery. Following her recovery period, Wilkinson was able to return to the pool to continue her quest for Olympic glory.
“When my doctor first told me that I needed spinal fusion surgery, I have to admit it was a little scary,” Wilkinson said. “That’s one of the reasons why I started sharing my journey on social media and posting the different stages I was going through. I wanted people to see that you can overcome these challenges and get your life back. It was important to me to encourage other people who were dealing with cervical disc degeneration and showcase a possible path for recovery.”
In May 2021, Orthofix proudly announced it was continuing its sponsorship of the diver and her hope to reach the games. Unfortunately, on June 13, 2021, Wilkinson finished 10th in the women’s 10-meter platform finals, which was the last step in qualifying for the Olympic team. She exited the pool to a standing ovation from all in attendance.
“I didn’t even realize it was going on in the whole pool,” Wilkinson revealed to KPRC 2's Christine Noel. “I wish I could have taken a minute to see that, but that was very special.”
Orthofix enjoyed its own special moment in 2021. The firm announced it reached a significant milestone in September—more than 60,000 of the company’s M6-C artificial cervical discs had been implanted worldwide. The implant is a next-generation artificial disc designed to mimic the natural motion of a native disc. Developed to replace an intervertebral disc damaged by cervical disc degeneration, the M6-C disc is indicated as an alternative to cervical fusion. First approved for distribution under the CE mark in the EU and other international geographies, the M6-C disc received FDA approval in 2019.
The successful spine solution was just one of the reasons for the favorable financials the company enjoyed in 2021. Its end tally for the fiscal was $464.5 million, an increase of 14.2% over the previous period.
All business units also enjoyed positive growth for the 12-month period. Global Spine, which is comprised of three segments, contributed $359 million to the company’s coffers. The largest division—Bone Growth Therapies—added $187.4 million to the total, an increase of 9.4%. Spinal Implants skyrocketed 21.3% to $115.1 million. Third, biologics celebrated a modest 1.7% rise to end at $56.4 million. All three units attributed the gains to the continued recovery from the decrease in procedures due to the COVID pandemic. In fact, Bone Growth Therapies and Biologics were still below their 2019 revenue totals so the recovery would likely continue into the next fiscal.
Sister division—Global Orthopedics—ballooned 24.4% to finish the year at $105.5 million. Its $20.7 million increase was attributed primarily to the pandemic recovery, as well as continued growth of the FITBONE product line and favorable foreign currency exchange rates.
While the M6-C disc was achieving milestones in terms of number of implantations, it was not one of the new products the company was making headlines with in 2021. There were a number of those, however, including the aforementioned FITBONE product.
In February, the organization announced it was launching the system in the U.S. and Europe. The FITBONE intramedullary lengthening system was developed for limb lengthening and deformity correction of the femur and tibia bones. Implanted through a minimally invasive procedure, the system consists of the implanted intramedullary nail, a subcutaneously implanted receiver, and an external control set that enables the patient to manage the distraction phase at home. In September, the firm announced the first pediatric case involving the technology took place.
April produced a 510(k) clearance and first patient implant of the 3D-printed CONSTRUX Mini Ti Spacer System. Developed to enhance anterior cervical discectomy and fusion procedures, the spacer with Nanovate Technology is the first 3D-printed titanium interbody introduced to the market by the company.
Later that same month, Orthofix announced the 510(k) clearance and first patient implant of the FORZA Ti TLIF Spacer System. The titanium 3D-printed interbody spacer with Nanovate Technology was introduced to help optimize transforaminal lumbar interbody fusion (TLIF) procedures. The optimized design, porosity, and surface allows bone to grow into and through the spacer. The U.S. launch and first patient implant of the system took place in June.
Orthofix also secured the exclusive license to commercialize the portfolio of Italy-based IGEA S.p.A’s bone, cartilage, and soft tissue stimulation products in the U.S and Canada. Under the terms of the agreement, Orthofix obtained the rights to pursue FDA approvals and sell IGEA’s platform of orthopedic products within the two countries. The line expanded Orthofix’s bone growth therapies portfolio of pulsed electromagnetic field products with additional treatment modalities and indications such as low-intensity pulsed ultrasound and capacitive coupling for fracture management.
May saw the expansion of the firm’s pediatric offerings with FDA 510(k) clearance of the OrthoNext digital platform, a software tool for deformity analysis and preoperative planning for pediatric orthopedic procedures. U.S. and European full market launch also took place that same month for the OSCAR PRO Ultrasonic Arthroplasty Revision System. Designed to reduce the challenges associated with revising failed cemented arthroplasties, the OSCAR PRO is an ultrasonic surgical system that aids in the removal of cement during complex joint revision surgeries.
In the middle of the dog days of summer, the organization announced the launch and first patient implants with the fiberFUSE Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone. The fiberFUSE Strip is formulated as a convenient, preformed bone-graft strip to enable optimized application for posterior cervical, posterior lumbar, and degenerative spinal procedures.
On the last official day of summer, Orthofix told of the full market launch of the Opus Mg Set osteoconductive scaffold, a synthetic magnesium-based bone void filler for orthopedic procedures. Opus Mg Set provides a procedure-specific solution for orthopedic fracture care and trauma applications by filling non-structural bony voids or gaps during surgery. Available in both a moldable and injectable form, this solution provides immediate compressive strength at the surgical site post-implantation. When injected or placed into bony voids or gaps, it forms a supportive scaffold to help facilitate the natural bone-healing process.