Other cartilage repair products that were also developed include Zimmer’s DeNovo-NT, plug-type scaffolds for arthroscopic delivery like Dunlop Corp’s carbon fiber plug or Smith & Nephew’s True-Fit plug, Tigenex’s Chondromimetic implant and Histogenic’s NeoCart (collagen scaffold with autologous living cells).
Even so, within the overall market to treat deteriorating knees, cartilage repair product sales barely register.
In terms of dollars ($7 billion), knee replacement surgery is the principal treatment modality for patients suffering from end-stage osteoarthritis. Hospitals, physicians, suppliers and payers understand that that is the bread and butter of the industry.
A quick perusal of American Academy of Orthopaedic Surgeons’ (AAOS) clinical practice guidelines for osteoarthritis (OA) of the knee finds a whole range of pre-knee replacement therapies including NSAIDs, cortisone shots, platelet rich plasma injections and osteotomies.
But no technologies for cartilage repair or regeneration.
What Is Agili-C and How Is It Implanted?
The Agili-C is a biocompatible and biodegradable tapered-shaped solid implant. It is manufactured from aragonite (calcium-carbonate), derived from sea coral. When implanted into a pre-prepared osteochondral hole it acts as a 3D scaffold that potentially supports and promotes the regeneration of the articular cartilage and its underlying subchondral bone.
In previously published animal studies, Agili-C demonstrated the ability to regenerate hyaline cartilage—as confirmed by the presence of Type II collagen and proteoglycans, and the absence of Type I collagen—without relying on growth factors, or external stem cells.
One of the key attributes of Agili-C’s 3D scaffold is its interconnected porosity which maximizes cell contact and promotes matrix deposition.
The implant looks like this.
“Basically, what CartiHeal designed with the Agili-C is an implant with ideal porosity that enables simultaneous regeneration of the articular cartilage and remodeling of the subchondral bone,” explained Dr. Verdonk. “These micro holes on top of the biomaterial actually created an environment that is very similar to a controlled microfracture in very small, porous, well-defined and non-variable micropores.”
Implanting Agili-C, says Dr. Verdonk, is surprisingly simple. “The procedure to implant Agili-C is very close to what the orthopedic surgeon is used to, i.e., drill the hole, place the implant and push it in. Very user-friendly procedure. Only few minutes per implantation.”
What to Watch for in the Coming Months
Agili-C is a CE marked implant. Prior to this FDA IDE (investigational device exemption) study, it had been implanted in several hundred patients in a series of clinical studies in Europe. These studies were all prospective, multicenter, open-label, and controlled.
The first Interim Analysis of the current study is expected at the beginning of 2020.
Stay tuned.
