Orteq Promotes Joint Preservation with Meniscus Implant

A young college athlete tears her meniscus. In the U.S., if deemed unrepairable, the primary option is to undergo a partial meniscectomy. While the athlete is able to return to former activity levels a few weeks later, the clock starts ticking toward an inevitable early knee replacement and then potentially another replacement later in life.

Every year, more than 1.5 million partial meniscectomies and knee replacements are performed in the U.S. and Europe. However, more surgeons and researchers are campaigning to “save the meniscus,” making it an important topic of conversation within the emerging joint preservation market.

“While less than a decade ago, discussions centered around the ACL and getting stability right, now it’s all about saving the meniscus,” said Simon Coles, Chief Executive Officer of Orteq Sports Medicine. “While joint preservation hasn’t had much coverage historically, it’s becoming the most sensible thing to do, delaying a metal implant until patients absolutely need one.”

Save the Meniscus

The menisci of the knee joint are crescent-shaped wedges of fibrocartilage that provide increased stability to the knee, distribute load, absorb shock and lubricate the joint. A partial meniscectomy removes some of this cushion and leads to decreased contact area and increased pressures within the knee. If the first surgery fails, the only current option is to cut away more, resulting in even less cushion and more imbalance. The meniscus continues to wear away, eventually resulting in bone-on-bone contact. Consequently, many young patients are facing a knee replacement too early. That’s why Orteq and other proponents of joint preservation are pushing to save the meniscus.

“Research now shows that regenerating lost meniscus tissue can provide sustainable pain relief, improved function and return to sports participation,” Coles said. “Many of today’s surgeons now take a holistic approach when assessing a patient’s knee joint, considering many factors, including alignment, stability, meniscus and cartilage. As soon as you remove even part of the meniscus, the patient begins heading down the road toward osteoarthritis. Instead, if surgeons can use a meniscal scaffold to plug the gap in a tear, they can delay that progression and provide a new option for their patients.”

A Breakthrough Technology

Orteq Sports Medicine offers a unique alternative to partial meniscectomy. The London-based company’s ACTIfit biodegradable scaffold is the result of polymer science and tissue regeneration technology developed in the Netherlands. ACTIfit’s polymer is a biodegradable polyurethane and is processed by solvent casting/porogen leaching to create a porous scaffold.

Orteq Sports Medicine offers a unique alternative to partial meniscectomy.

While natural tissue regrowth is impossible once the damaged section of the meniscus has been removed, ACTIfit features a highly porous structure that facilitates the human body’s repair process by providing a scaffold to fill the injured area and allow blood flow and cells for new tissue growth. This provides a new cushion and may prevent further degeneration of the knee.

Coles said the ACTIfit is tough and easy to handle and customize in the operating room. Surgeons simply measure the gap in the meniscus tear, cut the scaffold to size and suture it in place.

“As an industry, we’re trying to offer surgeons better options than they ever had before to give the patient as much of a chance to heal as possible and return to a normal active lifestyle,” he said.

Orteq was founded in 2003 and the first implantation in man was in 2007. Surgeons in 30 countries have implanted the ACTIfit scaffold in 4,000 patients with irreparable meniscal tears. ACTIfit is approved under the European CE Mark and in Korea. ACTIfit received FDA Breakthrough Designation earlier this year. FDA grants Breakthrough Device Designation to medical devices that provide more effective treatment of irreversibly debilitating conditions. The goal of the program is to provide patients and healthcare providers with timely access to these medical devices by speeding their development, assessment and review while preserving regulatory standards.

Coles said that Orteq had an encouraging first interaction with FDA and is now taking the next steps toward FDA 510(k) clearance. Though it is uncertain how soon the ACTIfit could receive clearance for commercialization in the U.S., he is hoping that Orteq’s extensive body of scientific and clinical evidence from Europe will support a timely U.S. clearance.

“We’re delighted to have received Breakthrough Designation from FDA,” he said. “It’s almost like getting V.I.P. pass to the front of the line. We’ve received tremendous interest from the U.S. community of top American sports medicine surgeons ready to support our regulatory pathway as guided by FDA. We’re looking forward to continuing to work with the agency and getting our technology to patients as quickly as possible.”

Looking Ahead

Orteq is also working on commercializing its second technology, CartiONE, in Europe and developing pathways into the U.S. Cell-based therapies for articular cartilage repair require two surgeries: a biopsy, and then a second procedure to reinsert cultured cells. CartiONE, a single-stage Autologous Chondrocyte Implantation (ACI), only requires one procedure using the patient’s own cells and offers substantial cost savings to the healthcare system by avoiding two surgical procedures, expensive laboratory costs and double rehabilitation.

“CartiONE takes a different approach than traditional treatments,” Coles said. “CartiONE allows everything to be done in the operating room in one hour, from a biopsy to obtain bone marrow cells before manually mixing and using them to ‘fill the potholes’ in damaged knee cartilage.”

Orteq’s main research and development efforts focus on automating the process further.

The company is also looking to expand ACTIfit regulatory approvals from 30 to 50 countries and use its polymer in other joints, like the hip and shoulder. “Those are fast-growing, emerging markets with the same patients having the same problems,” Coles said. “Our vast evidence from basic science and clinical research is very reassuring and growing. We are excited about the opportunities regenerative medicine provides for reshaping the future of joint preservation.”


Kathie Zipp is an ORTHOWORLD Contributor.

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