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Historically, total ankle replacements have had low success rates compared to the more popular knee, hip and shoulder replacements. To put this into context, knee replacements have a success rate of nearly 96%, while ankle replacements succeed only 78% of the time, according to the American Academy of Orthopedic Surgeons. Patients opt for ankle fusion three times more often than replacement, even though there is a permanent loss of flexibility in the ankle joint with fusion.
The reasons are varied, but most notably, the human understanding of the complexity of the ankle joint anatomy, coupled with the lack of advanced technology to mimic it, has led to high rates of failure and complications in replacements.
Kinos Medical is leveraging the discovery of Sorin Siegler, Ph.D., a professor in Drexel University’s College of Engineering, to increase the viability of ankle replacements. Using modern imaging techniques, Dr. Siegler created highly accurate 3D computer renderings and simulations of the ankle bones and their movement. His analyses led to a new understanding of the ankle joint – and the 2014 Biomechanics Research Award for novel research around the morphological properties of the ankle joint.
A New Truth
Since the latter half of the 20th century, it had been accepted in the medical community that the ankle joint moves about a fixed axis, and that the talus bone functionally acted like a cone, facing the inside of the foot. Dr. Siegler’s modeling showed that both of those theories are incorrect.
Dr. Siegler proved through his highly detailed imaging that the ankle joint moves about three axes, including a side-to-side angle in addition to the previously-known hinge-type motion. Also, the talus bone should not be approximated by a conical shape
These discoveries explained why ankle replacements have such high failure rates: the implants did not mirror human ankle bones and function.
“He had been studying the biomechanics of the foot and ankle for 30 years,” said Brian Garvey, CEO of Kinos Medical. “Dr. Siegler leads our research efforts in addition to being a full-time professor. We started the company to further the development of his research and commercialize the next generation of total ankle replacement implants.”
Kinos Takes the Reins
Kinos uses precise 3D planning to provide surgeons with AI enabled semi-automated surgical plans where they can suggest a particular implant size and location and give them automatic diagnostic tools that enable implant placement.
“We have the ability to create both custom implants as well as custom instruments to help expedite the alignment and bone resection during the surgery,” Mr. Garvey said. “It starts with the 3D planning, then it goes to the world’s first biomechanically accurate ankle implant. We provide motion in all three anatomic planes, which is unlike any other device on the market today. With our conforming surface geometry, we are able to more closely mimic the natural biomechanics during gait than any other device.”
As with most implants, the closer to nature, the better. The Kinos Axiom Total Ankle System has shown in testing to reduce stress at the articulating surfaces, the stress experienced by the stabilizing soft tissues, and the stress at the bone-implant interface.
“We are able to package together several different technologies to create not just the next generation of total ankle systems, but really a revolution in total ankle surgery,” Mr. Garvey said. “We couple our preoperative planning software that utilizes advanced machine learning algorithms with providing patient specific instruments that help expedite surgery, as well as providing custom implants.”
The point is to provide complimentary features that aim to make it easier for the surgeon to diagnose, create a surgical plan and place implants that are biomechanically and kinetically competent. From there, Kinos will follow up with a significant investment in further technology that utilizes postoperative outcome data to influence future designs and technological advances specific to total ankles. Mr. Garvey describes the four pillars of their technology as the precision diagnosis and planning that utilizes machine learning; the biomechanically accurate, anatomically accurate implants; providing operative guidance with patient-specific instruments and navigation-assisted instruments; and providing custom solutions that tie each of these technologies together.
The Next-Gen Implant
The Axiom Total Ankle System creates motion in all three anatomic planes. Similar to the way a person’s foot and ankle function when walking, it provides plantarflexion and dorsiflexion, internal and external rotation, inversion and eversion. The need for anatomic motion is intensified when walking on uneven ground.
“We are able to significantly reduce the contact stress on the articulating surfaces, particularly when we look at out-of-plane motion,” Mr. Garvey said. “Most of the implants are designed to function as a simple, cylindrical hinge where one piece rotates about the other. Our device provides certainly that rotation, but then it also provides that independent motion to accommodate out of plane motion, which generally occurs when walking on uneven ground or even in the gait data that we’ve shown where you go up and down steps, pivot, and change directions, as well.”
Market Status
The Kinos Axiom Total Ankle System received FDA 510(k) clearance in June 2020. The company is moving forward to commercialization in 3Q20.
“The total portfolio that we’re developing has well over a billion-dollar market potential,” Mr. Garvey said. “That’s because some of our technologies, specifically around operative guidance, provide the opportunity to be exported to other orthopedic indications.”
For future applications, Kinos is eyeing anywhere that three-dimensional orthopedic diagnosis and planning is necessary, including additional joint replacements. But for now, their total focus is on ankle replacements.
“If you look at some of the leading products for ankle replacement surgery on the market today, you would see that they haven’t incorporated much improvement coming out of the research in the last few years,” Mr. Garvey said. “We look at it as not just an opportunity to make a better ankle implant, which is of course what we’re going to do and what we’ve done, but also providing several other aspects of technology that we’re developing that allow for better outcomes.”
In five years, Mr. Garvey sees Kinos as the leader in ankle replacement surgery with a full breadth of products geared toward various disease states of ankle replacement. To get there, the company will leverage their four pillars of precision: diagnosis and planning; biomechanically accurate implants; intraoperative guidance; and custom solutions.
“It starts with an implant for sure, but we have to make things easier for the surgeon,” he said. “We have to make things more predictable and the only way to get there is to incorporate as much data as we can into the process of defining how the ankle is for each particular patient, diagnosing that, creating an operative plan based on the three-dimensional pathology. Then helping the surgeon to be more precise in the operating room, utilizing the operative guidance technologies so that we can ultimately ensure that we’re going to reduce the failure rates that we are currently seeing with the other products on the market.”
Historically, total ankle replacements have had low success rates compared to the more popular knee, hip and shoulder replacements. To put this into context, knee replacements have a success rate of nearly 96%, while ankle replacements succeed only 78% of the time, according to the American Academy of Orthopedic Surgeons. Patients opt for ankle...
Historically, total ankle replacements have had low success rates compared to the more popular knee, hip and shoulder replacements. To put this into context, knee replacements have a success rate of nearly 96%, while ankle replacements succeed only 78% of the time, according to the American Academy of Orthopedic Surgeons. Patients opt for ankle fusion three times more often than replacement, even though there is a permanent loss of flexibility in the ankle joint with fusion.
The reasons are varied, but most notably, the human understanding of the complexity of the ankle joint anatomy, coupled with the lack of advanced technology to mimic it, has led to high rates of failure and complications in replacements.
Kinos Medical is leveraging the discovery of Sorin Siegler, Ph.D., a professor in Drexel University’s College of Engineering, to increase the viability of ankle replacements. Using modern imaging techniques, Dr. Siegler created highly accurate 3D computer renderings and simulations of the ankle bones and their movement. His analyses led to a new understanding of the ankle joint – and the 2014 Biomechanics Research Award for novel research around the morphological properties of the ankle joint.
A New Truth
Since the latter half of the 20th century, it had been accepted in the medical community that the ankle joint moves about a fixed axis, and that the talus bone functionally acted like a cone, facing the inside of the foot. Dr. Siegler’s modeling showed that both of those theories are incorrect.
Dr. Siegler proved through his highly detailed imaging that the ankle joint moves about three axes, including a side-to-side angle in addition to the previously-known hinge-type motion. Also, the talus bone should not be approximated by a conical shape
These discoveries explained why ankle replacements have such high failure rates: the implants did not mirror human ankle bones and function.
“He had been studying the biomechanics of the foot and ankle for 30 years,” said Brian Garvey, CEO of Kinos Medical. “Dr. Siegler leads our research efforts in addition to being a full-time professor. We started the company to further the development of his research and commercialize the next generation of total ankle replacement implants.”
Kinos Takes the Reins
Kinos uses precise 3D planning to provide surgeons with AI enabled semi-automated surgical plans where they can suggest a particular implant size and location and give them automatic diagnostic tools that enable implant placement.
“We have the ability to create both custom implants as well as custom instruments to help expedite the alignment and bone resection during the surgery,” Mr. Garvey said. “It starts with the 3D planning, then it goes to the world’s first biomechanically accurate ankle implant. We provide motion in all three anatomic planes, which is unlike any other device on the market today. With our conforming surface geometry, we are able to more closely mimic the natural biomechanics during gait than any other device.”
As with most implants, the closer to nature, the better. The Kinos Axiom Total Ankle System has shown in testing to reduce stress at the articulating surfaces, the stress experienced by the stabilizing soft tissues, and the stress at the bone-implant interface.
“We are able to package together several different technologies to create not just the next generation of total ankle systems, but really a revolution in total ankle surgery,” Mr. Garvey said. “We couple our preoperative planning software that utilizes advanced machine learning algorithms with providing patient specific instruments that help expedite surgery, as well as providing custom implants.”
The point is to provide complimentary features that aim to make it easier for the surgeon to diagnose, create a surgical plan and place implants that are biomechanically and kinetically competent. From there, Kinos will follow up with a significant investment in further technology that utilizes postoperative outcome data to influence future designs and technological advances specific to total ankles. Mr. Garvey describes the four pillars of their technology as the precision diagnosis and planning that utilizes machine learning; the biomechanically accurate, anatomically accurate implants; providing operative guidance with patient-specific instruments and navigation-assisted instruments; and providing custom solutions that tie each of these technologies together.
The Next-Gen Implant
The Axiom Total Ankle System creates motion in all three anatomic planes. Similar to the way a person’s foot and ankle function when walking, it provides plantarflexion and dorsiflexion, internal and external rotation, inversion and eversion. The need for anatomic motion is intensified when walking on uneven ground.
“We are able to significantly reduce the contact stress on the articulating surfaces, particularly when we look at out-of-plane motion,” Mr. Garvey said. “Most of the implants are designed to function as a simple, cylindrical hinge where one piece rotates about the other. Our device provides certainly that rotation, but then it also provides that independent motion to accommodate out of plane motion, which generally occurs when walking on uneven ground or even in the gait data that we’ve shown where you go up and down steps, pivot, and change directions, as well.”
Market Status
The Kinos Axiom Total Ankle System received FDA 510(k) clearance in June 2020. The company is moving forward to commercialization in 3Q20.
“The total portfolio that we’re developing has well over a billion-dollar market potential,” Mr. Garvey said. “That’s because some of our technologies, specifically around operative guidance, provide the opportunity to be exported to other orthopedic indications.”
For future applications, Kinos is eyeing anywhere that three-dimensional orthopedic diagnosis and planning is necessary, including additional joint replacements. But for now, their total focus is on ankle replacements.
“If you look at some of the leading products for ankle replacement surgery on the market today, you would see that they haven’t incorporated much improvement coming out of the research in the last few years,” Mr. Garvey said. “We look at it as not just an opportunity to make a better ankle implant, which is of course what we’re going to do and what we’ve done, but also providing several other aspects of technology that we’re developing that allow for better outcomes.”
In five years, Mr. Garvey sees Kinos as the leader in ankle replacement surgery with a full breadth of products geared toward various disease states of ankle replacement. To get there, the company will leverage their four pillars of precision: diagnosis and planning; biomechanically accurate implants; intraoperative guidance; and custom solutions.
“It starts with an implant for sure, but we have to make things easier for the surgeon,” he said. “We have to make things more predictable and the only way to get there is to incorporate as much data as we can into the process of defining how the ankle is for each particular patient, diagnosing that, creating an operative plan based on the three-dimensional pathology. Then helping the surgeon to be more precise in the operating room, utilizing the operative guidance technologies so that we can ultimately ensure that we’re going to reduce the failure rates that we are currently seeing with the other products on the market.”
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Heather Tunstall is an ORTHOWORLD Contributor and owner of Tunstall Content.
