Globe Newswire07.07.21
Integrity Implants Inc., a privately held medical device company focused on Adaptive Geometry technology designed to enable MIS spine surgery, and Fusion Robotics LLC, a privately held medical technology company focused on efficient and cost-effective navigation and robotic targeting solutions for spine surgery, have consummated a merger combining the two companies. The combined company will be re-branded as “Accelus” and is uniquely positioned to accelerate the adoption of minimally invasive surgery as the standard of care in spine.
“Accelus will create opportunities for wide-scale adoption of robotics in spine surgery—both in hospitals and ambulatory surgery centers (ASCs)—by addressing previous constraints related to cost and efficiency,” said Chris Walsh, who will serve as the CEO of Accelus. “Both Fusion Robotics and Integrity Implants have built enabling technology platforms that create a force multiplier for spinal care. Our products and culture create accessibility to fit each patient’s anatomy, each surgeon’s preferred approach, and each healthcare facility’s space and budget limitations, embodying our core principle of access without compromise.”
Although the benefits of MIS have been recognized for decades, broad adoption in the spine market is still constrained relative to other orthopedic and interventional procedures. The combination of Fusion Robotics’ efficient, compact and scalable robot with Integrity Implant’s unique Adaptive Geometry implants will enable the rapid acceleration of MIS adoption.
“We believe Accelus is poised to be the next dominant player in the spine market,” said Alex Lukianov, who will serve as chairman of the new company’s Board of Directors. “Accelus will uniquely accelerate penetration of MIS while fostering a culture of outstanding performance together with an unparalleled product development engine to continually simplify surgical procedures. Our growth prospects are tremendous.”
Integrity Implants’ flagship FlareHawk Lumbar Interbody Fusion Device received U.S. Food and Drug Administration (FDA) clearance in 2016 and CE mark approval in 2021, and to date more than 10,500 FlareHawk devices have been implanted in more than 8,000 patients. Integrity Implants also holds FDA clearances for its LineSider Spinal System, FlareHawk TiHawk Interbody Fusion System and Toro-L Interbody Fusion System. Fusion Robotics received a 510(k) clearance for its initial product offering and started performing spine procedures in the U.S. market earlier this year.
"This combination of teams and technology represents a transformative opportunity to accelerate innovation in spine,” said neurosurgeon Kevin Foley, M.D., chief robotics officer of Fusion Robotics. “The implant portfolio is complementary to the robotics platform, and with the rapid strides we are making in robotics development—specifically related to our fluoroscopy-based robotics system—the synergies will become even more robust in the coming months."
Accelus’ corporate office, R&D, distribution and Accelus Clinical Education (ACE) surgeon training facility will be headquartered in Palm Beach Gardens, Fla. Additional ACE labs and R&D centers will be located in Boulder, Colo. and San Diego, Calif.
The company’s executive management team will consist of leaders from both Integrity Implants and Fusion Robotics, who bring decades of experience and leadership across spine, navigation and surgical robotics. Accelus’s Board of Directors will be composed of Fusion Robotics’ founders Lukianov and Brad Clayton; Integrity Implants’ founders Walsh and Wyatt Geist; and current Integrity Implants Directors Nate Ward, Ned Lipes and Paul Birkmeyer.
“The organizational synergies go beyond products and technology, as we are pulling together the ‘A-team’ of spine,” Walsh added.
“Accelus will create opportunities for wide-scale adoption of robotics in spine surgery—both in hospitals and ambulatory surgery centers (ASCs)—by addressing previous constraints related to cost and efficiency,” said Chris Walsh, who will serve as the CEO of Accelus. “Both Fusion Robotics and Integrity Implants have built enabling technology platforms that create a force multiplier for spinal care. Our products and culture create accessibility to fit each patient’s anatomy, each surgeon’s preferred approach, and each healthcare facility’s space and budget limitations, embodying our core principle of access without compromise.”
Although the benefits of MIS have been recognized for decades, broad adoption in the spine market is still constrained relative to other orthopedic and interventional procedures. The combination of Fusion Robotics’ efficient, compact and scalable robot with Integrity Implant’s unique Adaptive Geometry implants will enable the rapid acceleration of MIS adoption.
“We believe Accelus is poised to be the next dominant player in the spine market,” said Alex Lukianov, who will serve as chairman of the new company’s Board of Directors. “Accelus will uniquely accelerate penetration of MIS while fostering a culture of outstanding performance together with an unparalleled product development engine to continually simplify surgical procedures. Our growth prospects are tremendous.”
Integrity Implants’ flagship FlareHawk Lumbar Interbody Fusion Device received U.S. Food and Drug Administration (FDA) clearance in 2016 and CE mark approval in 2021, and to date more than 10,500 FlareHawk devices have been implanted in more than 8,000 patients. Integrity Implants also holds FDA clearances for its LineSider Spinal System, FlareHawk TiHawk Interbody Fusion System and Toro-L Interbody Fusion System. Fusion Robotics received a 510(k) clearance for its initial product offering and started performing spine procedures in the U.S. market earlier this year.
"This combination of teams and technology represents a transformative opportunity to accelerate innovation in spine,” said neurosurgeon Kevin Foley, M.D., chief robotics officer of Fusion Robotics. “The implant portfolio is complementary to the robotics platform, and with the rapid strides we are making in robotics development—specifically related to our fluoroscopy-based robotics system—the synergies will become even more robust in the coming months."
Accelus’ corporate office, R&D, distribution and Accelus Clinical Education (ACE) surgeon training facility will be headquartered in Palm Beach Gardens, Fla. Additional ACE labs and R&D centers will be located in Boulder, Colo. and San Diego, Calif.
The company’s executive management team will consist of leaders from both Integrity Implants and Fusion Robotics, who bring decades of experience and leadership across spine, navigation and surgical robotics. Accelus’s Board of Directors will be composed of Fusion Robotics’ founders Lukianov and Brad Clayton; Integrity Implants’ founders Walsh and Wyatt Geist; and current Integrity Implants Directors Nate Ward, Ned Lipes and Paul Birkmeyer.
“The organizational synergies go beyond products and technology, as we are pulling together the ‘A-team’ of spine,” Walsh added.