Osteoarthritis is a progressive disease in which the protective cartilage that covers the contact surfaces of the knee breaks down. As the cartilage deteriorates, it loses the ability to act as a smooth, impact-absorbing cushion. This eventually results in the underlying bone surfaces rubbing directly against one another, causing pain and debilitating loss of function.
Since more of the body’s weight naturally falls on the inner (medial) side of the knee, this is the area most likely to “wear out” especially in highly active or overweight individuals. As a result, medial osteoarthritis is the most common form of knee osteoarthritis.
Knee osteoarthritis impacts millions of adults. Its prevalence is projected to grow dramatically due to the aging population and the trend for adults to remain active later in life. Because of its widespread prevalence and debilitating effects, treating the disease also creates a major economic burden.
During the early, mild phases of knee osteoarthritis patients are commonly treated with conservative care therapies including braces, medications, and removal of damaged cartilage.
During the latter, severe phases of the disease, complex surgical treatments are utilized. In these procedures, the diseased bones of the knee are cut and either realigned (osteotomy) or replaced with artificial joints (arthroplasty). Because these surgeries are highly invasive, recovery can be lengthy and stability of the joint may never be fully regained. This can force patients to give-up activities that were previously part of an active lifestyle.
This leaves a large treatment gap in the management of medial osteoarthritis. For patients with moderate disease severity or those wishing to delay complex surgery as long as possible, there currently is no viable therapy. Cotera has designed the Latella™ device to potentially offer a new, earlier intervention treatment option for these patients.
The Latella device is a simple implant that is attached to the thigh bone (femur). It is constructed from medical grade titanium which has a long history of safe use in orthopedics. Since the device is built from a single piece of metal there are no moving parts to wear or break over time. The device is intended to serve as a long-term implant, but is also designed to be easily removed, thereby preserving future treatment options.
Implanting the device involves a simple surgical procedure using standard orthopedic tools and techniques. Since no bones are cut, patients can place weight on the treated leg immediately following surgery. This allows many patients to return home the same day. Surgery is followed by a period of physical therapy which helps soft tissues heal and accommodate the implant.
The LatellaTM device is designed to treat the load imbalance that exists in knees affected by osteoarthritis. It accomplishes this by shifting muscles and tendons to redirect the forces they apply across the joint. By redirecting these forces, pressure on the diseased areas of the joint causing pain may be reduced.
This approach is modeled after the biomechanical effect of the kneecap or “patella” on the front of the knee. The patella shifts the tendon attaching the thigh muscles to the lower leg (tibia) outward. This allows the muscles to pull on the tibia from a wider angle, amplifying by as much as 30% the torque generated to extend the lower leg.
Cotera reasoned that a similar approach could be used on the side of the leg. The iliotibial (IT) band runs from the hip to the knee and is comprised of elastic tissues and muscle. The Latella device is placed underneath the IT band, shifting it outward to increase the angle at which it pulls on the tibia. Like the patella, this modified angle amplifies the effect of the IT band, torqueing the lower leg to the side similar to an unloader brace. This takes pressure off the inner (medial) side of the knee, restoring a more normal load balance within the joint.
The LatellaTM device represents a novel approach to treating knee pain. It’s based on the proven physiological concept that small shifts in soft tissue geometry around the joint can have large effects on biomechanics. The approach offers many potential advantages applicable to the knee and other joints impacted by load imbalances.
The practice of medicine is becoming increasingly evidence-based. It’s no longer enough for a device to be novel, it must also deliver true clinical benefit. Cotera is committed to conducting rigorous clinical research studies to support regulatory approval and adoption of the LatellaTM device. Two initial clinical trials are currently underway:
This study was designed to evaluate the safety and technical feasibility of the Latella device in treating patients with medial knee pain due to osteoarthritis. Enrollment has been completed and the study is now in follow-up.
This study is designed to demonstrate the safety and effectiveness of the Latella device in treating patients with medial knee pain due to osteoarthritis. The study is being conducted at leading research centers in Europe and the U.S. and will enroll up to 80 patients.
Additional details about these studies can be found at www.clinicaltrials.gov.
At Cotera we have a clear goal – reducing pain and restoring function in patients suffering from joint disease. To do this, we design simple implants that shift muscles and tendons to redirect the forces they exert on joints. Redirecting these forces can correct the load imbalances within a joint that cause pain. It’s a simple concept, but one with many potential applications.
To achieve this goal, we’re also shifting our approach to innovation. Rather than focus on how many complex technologies we can add to a device, we’re focusing on how many we can eliminate, thereby reducing a product to its simplest yet most effective form. We’re also focusing on designs that amplify the body’s ability to heal itself rather than simply overriding or replacing diseased structures. It’s a different way of looking at things, but isn’t that what innovation is all about?
Cotera is a privately held company formed in 2011 by The Foundry, one of the world’s most prestigious and successful medical device incubators. Since its inception, The Foundry has formed over a dozen companies across a wide variety of therapeutic areas.
Cotera’s management team includes individuals with decades of multidisciplinary experience. This allows the team to overcome the many complex engineering, clinical, regulatory and commercial challenges involved in bringing novel medical devices to market.
Cotera is fortunate to have highly qualified board members with extensive industry experience. This allows them to contribute at multiple levels and serve as true partners in building our business.
Cotera is supported by two of the leading venture capital firms in the medical device industry. Domain Associates recently celebrated its 30th anniversary, during which time it has raised over $2.7B in capital and invested in over 250 companies. Versant Ventures enters its 17th year, having raised over $1.9B in capital and invested in over 110 companies.
Cotera is based in the San Francisco Bay Area. The local network of inventors, investors, researchers and business professionals provides an unmatched pool from which to draw talent… and inspiration. Visit us, and we think you’ll agree.
199 Jefferson Drive
Menlo Park, CA 94025
CAUTION – Investigational device. Limited by United States law to investigational use. Exclusively for clinical investigations.