December 22, 2014 1:41 AM ET

Healthcare Equipment and Supplies

Company Overview of ConforMIS, Inc.

Company Overview

ConforMIS, Inc., a medical device company, designs, develops, manufactures, and commercializes customized orthopedic implants and instrumentation in the United States. It offers femoral and tibial knee implants for the treatment of osteoarthritis and joint damages. The company was founded in 2004 and is based in Bedford, Massachusetts.

28 Crosby Drive

Bedford, MA 01730

United States

Founded in 2004

Phone:

781-345-9001

Fax:

781-345-0147

Key Executives for ConforMIS, Inc.

Chief Financial Officer
Age: 50
Senior Vice President of Operations
Chief Legal Officer and General Counsel
Senior Vice President of Knee Implant Engineering
Compensation as of Fiscal Year 2014.

ConforMIS, Inc. Key Developments

Perdue & Kidd Files First Suit against ConforMIS, Inc. for Defective Custom Knee Implants

Perdue & Kidd filed a lawsuit against ConforMIS, Inc. this week, claiming the ConforMIS iTotal G2 custom knees were defective and injured plaintiff, Mary Jane Martine. This is the first lawsuit filed in the country against ConforMIS with these allegations. Mary Jane Martine, a 65-year-old nurse, had two separate knee replacement surgeries with the ConforMIS iTotal G2 knee, the first in October 2012 and the second in April 2013. By December 2013, Mary Jane began experiencing a host of complications with her right knee replacement. She suffered from severe knee pain, heard popping sounds, and was unable to extend her knee or even stand on it. Mary Jane's doctor found that both her right and left iTotal G2 implants were defective. Mary Jane was left with no option but to undergo bilateral implant removal surgery because both of her ConforMIS knees were not working and could not be salvaged. The ConforMIS iTotal G2 knee replacement line was cleared by the US Food and Drug Administration (FDA) through the 510(k) process in September 2012. While ConforMIS claimed to the FDA that its iTotal G2 knee was substantially similar to devices previously cleared for sale, it marketed the implants as a new and different design for knee replacement.

ConforMIS, Inc. Announces Results from Clinical Study

ConforMIS, Inc. announced results from a clinical study evaluating hospital outcomes and costs in patients undergoing total knee arthroplasty using either ConforMIS iTotal customized, individually made knee implants or standard off-the-shelf implants. Results were presented by Steven D. Culler, PhD, Associate Professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University, at the 2014 International Congress for Joint Reconstruction (ICJR) Pan Pacific Orthopaedic Congress. Researchers conducted a retrospective analysis of 248 TKA hospitalizations for patients having received either a ConforMIS iTotal customized knee implant (126) or a standard OTS implant (122) between March 2010 and November 2013. Patients with OTS implants demonstrated an adverse event rate of 13.9% while the ConforMIS rate was significantly lower at 1.6%. Data also showed that patients treated with ConforMIS customized implants had significantly lower blood transfusion rates of 2.4% compared with 10.7% for the OTS implants. Other studies have found that the average costs associated with blood transfusion is about $2,200 which coincides with higher risk of complications and longer hospital stays. An analysis of total hospital costs (excluding costs associated with discharge) found no statistical difference between the ConforMIS and OTS knee replacement. However, the study showed that significantly fewer ConforMIS patients were discharged to more costly acute care facilities (0.8% for ConforMIS vs. 7.4% for OTS). According to a recent study of discharge costs following TKA, the average cost of discharge to an acute inpatient rehabilitation facility was $16,464 on top of the hospitalization costs.

ConforMIS, Inc. Announces Results from Several Clinical Research Studies Highlighting the Benefits of the iTotal Customized Total Knee Replacement

ConforMIS, Inc. announced results from several clinical research studies highlighting the benefits of the iTotal customized total knee replacement. Results were shown this week at the British Association for Surgery of the Knee (BASK) meeting in Norwich, UK. The iTotal system, the only customized total knee replacement system on the market, demonstrated zero blood transfusions and positive clinical outcomes. A recent Cleveland Clinic study reported a 12% rate of blood transfusions for traditional, off-the-shelf knee replacements. These transfusions were associated with increased costs of over $2,200 per incident, longer hospital stays and a higher incidence of complications. In a review of 106 iTotal replacements, including 15 simultaneous bilateral replacements, there were no blood transfusions required. Even more important, 100% of patients reported a normal feeling knee only seven months after the procedure. This is in contrast to high dissatisfaction rates reported in the literature, ranging from 15% to 39% of knee replacement patients with standard, off-the-shelf implants. ConforMIS clinical results presented at BASK include: Early Outcomes Utilizing a First-Generation Customized Patient-Specific TKA Implant (P0185). Intraoperative Assessment of Mechanical Alignment Accuracy Determined by Computer Navigation in a Patient-Specific TKA (Total Knee Arthroplasty) System (Session 6). In Vivo Tibial Fit Analysis of Customized, Patient-Specific TKA Versus Off-the-Shelf TKA (P0181).

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