Spotlight on ConforMIS, an emerging growth Joint Replacement company
This is the fifth year, as part of our Top Company Report issue, that Orthopedic Design & Technology has profiled small and midsize emerging growth firms positioning themselves alongside (perhaps with the goal of overtaking or being acquired by) larger market leaders. This year’s installment provides an overview of four orthopedic companies vying for rank, digests their technologies, examines their sectors and what’s kept them busy during the past year.
• Philipp Lang, M.D., Chairman, President & CEO
• Paul Weiner, Chief Financial Officer
• Daniel Steines, M.D., Chief Technology Officer
• Matthew Scott, Sr. VP, Operations
• Amita Shah, Sr. VP, Regulatory and Quality Affairs
• John Slamin, Sr. VP, Knee Implant Engineering
Sector: Knee Implants
Location: Bedford, Mass. & Burlington, Mass. (manufacturing)
No two knees are exactly alike. Each of the planet’s 841 million sets of aged knee joints have subtle differences, whether it’s the size or shape of the femur and tibia (or both, in some cases), or form of the ligaments. Men, for instance, typically have larger femurs than women, while female knees usually have a greater Q angle (the angle the quadriceps and patella form with the knee joint) and are more narrow mediolaterally. There are cultural differences too: Western knees have a higher tibial torsion angle and lower varus alignment than their Japanese counterparts; East Asian males have smaller mediolateral/anteroposterior (ML/AP) ratio than Caucasian men; African-Americans have larger AP dimensions than Asians and Caucasians; and anterior cruciate ligament laxity is significantly different between Mayalsians and Westerners.
Ideally, such diversity would come with an assortment of replacements, each tailor-made to fit the patient.
For the most part, however, the selection of artificial knees in the United States is limited to a relatively small circle of standard-sized implants. There are none designed specifically for women or Far Eastern nations, nor are there any for African-Americans, Indians or Koreans.
ConforMIS is hoping to change that. Founded on the simple philosophy that knee implants should fit the patient (rather than the other way around), the 10-year-old privately held company has pioneered a technology to produce custom-fit 3-D implants using patient computed tomography (CT) scans to resurface bone and minimize the amount of tissue cut out. ConforMIS is on the leading edge of a revolutionary trend in medicine in which medical devices are tailored precisely to fit the individual patient, reducing surgery times, expediting recovery, and improving patient outcomes.
”The creation of an implant that matches the anatomy perfectly is a complete change from anything that we’ve seen before. We’re actually putting in a knee replacement that is specifically designed not only from an instrument standpoint but also from the implant standpoint to that person,” said Christopher J. Cannova, M.D., an orthopedic surgeon in Bethesda, Md., who has used ConforMIS technology to custom fit implants to his patients. ”The thing that we are looking at most as we advance knee replacement, and for that matter, joint replacement surgery in general, is we ultimately want patients to forget that they have a joint replacement. The way we are able to do that is by essentially creating a stable knee that feels like their native knee. This technology and this advancement is probably the biggest thing that we’ve seen so far that allows us to do that.”
ConforMIS’ iTotal platform is touted as the only U.S. Food and Drug Administration-approved custom total knee implant system where both the artificial joint and cutting tools necessary for surgery are tailored to the individual patient. Released commercially in October 2012, the iTotal Patient-Specific Tricompartmental Knee Replacement System converts a CT knee scan to a three-dimensional model by using proprietary algorithms to map the articular surface of the joint and define the area of disease.
The software uses that information to design the customized implants and instruments, correcting the data for any underlying arthritic deformity such as bone spurs, cysts or flattening of the joint.
The company uses 3-D printing technology to produce tools called iJigs that are shaped precisely to the implant. The instruments align perfectly to a patient’s knee, but they also have placement and cutting guides that enable surgeons to make specific cuts to remove a minimal amount of bone. With these tools, inserting the implant is much like snapping a Lego piece into position exactly where it belongs, resulting in considerably less manual effort and consequently, less chance for error.
Clearly, ConforMIS implants take longer to manufacture—four weeks compared with three for an off-the-shelf implant featuring customized instruments and just one week for traditional standard-sized replacements—but the shorter recovery time and improved flexibility make it worth the wait for many patients.
”Within four months I had two total knee replacements done the ConforMIS way. I have a cousin in Colorado who had a total knee replacement done the traditional way and I was there to help her recuperate. Believe it or not, my surgery was so much easier,” Sue Birtles, 58, noted in a video testimonial on the company’s website. ”She was not able to do the things I was able to do as far as the extension and the bend. [ConforMIS] was made to fit my knee, not somebody else’s knee—not a guy’s knee, not another woman’s knee…they didn’t pull it out of a box. It was made to fit me, and to me that made more sense.”
The iTotal system is economically sensible as well: The procedure is less invasive than traditional knee replacements, so hospitals benefit from savings on inventory management, sterilization, and operating room setup and turnover. ConforMIS implants also don’t typically require blood transfusions, which can increase procedural costs by more than $2,200, according to Cleveland Clinic data. Research presented earlier this summer at the International Congress for Joint Reconstruction (ICJR) Pan Pacific Orthopaedic Congress showed that patients receiving ConforMIS implants had a blood transfusion rate of 2.4 percent—compared to 10.7 percent with standard joints.
Other data presented at ICJR found the iTotal knee replacement significantly reduced the risk of adverse events in patients undergoing total knee arthroplasty (TKA) compared with standard off-the-shelf (OTS) implants. CEO Philipp Lang said the research ”underscores the value that a customized implant provides by reducing the negative outcomes of total knee replacement without increasing, and likely decreasing, the overall cost to the healthcare system.”
The retrospective analysis included 248 TKA hospitalizations for patients who had received either the iTotal knee replacement or an OTS device between March 2010 and November 2013. The company said patients with the iTotal implant had an adverse-event rate of 1.6 percent, compared with 13.9 percent for the OTS implants. Meanwhile, an analysis of total hospital costs, excluding those associated with discharge, found no statistical difference between either group, but significantly fewer patients implanted with iTotal were discharged to acute care facilities, at 0.8 percent, compared with 7.4 percent for OTS joints.
Other studies support patient and physician testimonials on comfort and tibial fit. In a population of 63 patients treated with iTotal, 100 percent achieved alignment within ± two degrees of the neutral mechanical axis, according to data presented by Gary A. Levengood, M.D., at the British Association for Surgery of the Knee meeting in Norwich, United Kingdom, this past spring. Restoration of alignment within three degrees of neutral is a widely confirmed indicator of improved long-term survivorship in TKA.
Nashville, Tenn., orthopedic surgeon William Kurtz, M.D., presented clinical results that showed iTotal patients regaining their mean pre-operative range of motion within four months. None of the 89 patients (106 knees treated) reported any dissatisfaction in four of five Knee Scoring System categories, including pain while sitting and function while performing recreational activities. All patients receiving iTotal reported a ”normal” feeling knee seven months after the procedure, Kurtz’s data found.
Also at the British Association for Surgery meeting, research demonstrated that use of iTotal significantly improves tibial fit when compared to OTS implants. ”This could play an important role in reducing knee pain and patient dissatisfaction…as well as implant loosening,” the study concluded.