November 2, 2016 – Source: McGill University

Some potentially good news for aging Baby Boomers: researchers believe that they have developed a hip replacement that will last longer and create fewer problems for the people who receive them than those currently in use. The secret? An implant that “tricks” the host bone into remaining alive by mimicking the varying porosity of real bones.

Interestingly, the key factor that distinguishes the new implant is that is LESS rather than more solid than those in current use, while still being just as strong.

Tricking bones into staying alive

Damiano Pasini, the man behind the design of the new hip replacement, points at the pyramid-like shapes visible on its surface. The implant is known as a femoral stem and connects the living femur with the artificial hip joint. “What we’ve done throughout the femoral stem is to replicate the gradations of density found in a real femur by using hollowed-out tetrahedra,” he explains. “Despite the fact that there are spaces within the tetrahedra, these forms are incredibly strong and rigid so they’re a very efficient way of carrying a load. Just think of the lattice-work in the legs of the Tour Eiffel.”

Pasini teaches mechanical engineering at McGill University and first started working on the concept for the implant more than 6 years ago. He smiles ruefully as he pulls earlier versions of the implant down from the shelves in his office to show how far he has come since then. He elaborates:

“So because the implant loosely mimics the cellular structure of the porous part of the surrounding femur, it can “trick” the living bone into keeping on working and staying alive. This means that our implant avoids many of the problems associated with those in current use.”

Indeed, the main problem with most implants is that because they are solid, or only porous on the surface, they are much harder and more rigid than natural bone. As a result, the implants absorb much of the stress along with the weight-bearing role that is normally borne by the living femur. Without sufficient stress to stimulate cell formation, the bone material in the living femur then becomes reabsorbed by the body and the bone itself begins to deteriorate and become less dense. This is one of the reasons that many implants become painful and need to be replaced after a time. It also explains why people often have difficulty if they have to have the same hip replaced a second time, because there simply isn’t enough normal, healthy bone to hold the implant in place.

It is a problem that orthopaedic surgeons are seeing more and more frequently.

Implants not so easy the second-time around

Dr. Michael Tanzer from the Jo Miller Orthopaedic Research Laboratory at McGill has been collaborating with Damiano Pasini for several years. “Because people engage in various sports where they may be injured more than they did in the past, we see younger people needing hip replacements more frequently,” says Dr. Tanzer. “And because people are also living longer, they often need to have the same hip replaced a second time. Unfortunately, I’ve seen many cases where people simply don’t have enough living bone for that to work easily. We are optimistic that this implant will reduce these kinds of problems.”

After successfully performing various tests on their implant, the researchers are so convinced that their femoral stem will work that they have already filed patents on it. They believe that because their current design is fully compatible with existing surgical technology for hip replacements it should be easier for the FDA to approve and surgeons to adopt.

Fits existing implant technology

In the meantime, Burnett Johnston, who started working with Damiano Pasini on developing the implants when he was a Masters student has now enrolled at McGill’s medical school.

His goal? To be the first person to actually implant one of these replacement hips once he qualifies as a surgeon and the new femoral stems have been fully tested, adjusted and accepted — something that Damiano Pasini estimates may happen in about three-five years’ time.

Story Source:

Materials provided by McGill University. Note: Content may be edited for style and length.

November 10, 2016

November 1, 2016 – Elizabeth Hofheinz, M.P.H., M.Ed.

When researchers from the University of Michigan Medical Center looked into it, they found that the use of tranexamic acid (TXA) in their state varied widely and that the data suggested that TXA had a significant effect on the risk of transfusion. Brian R. Hallstrom, M.D. is associate chair for Quality and Safety in the Department of Orthopaedic Surgery at the University of Michigan Medical Center. He commented to OTW, “One of our first quality improvement projects in the Michigan Arthroplasty Registry was reducing unnecessary blood transfusion.”

The team had plenty of cases to work with: 23,236 primary total knee arthroplasty cases and 11,489 primary total hip arthroplasty cases in the MARCQI (Michigan Arthroplasty Registry: Collaborative Quality Initiative).

Dr. Hallstrom, co-director of MARCQI, added, “The adoption of TXA into orthopaedic practices has been slow due to concerns among surgeons and anesthesiologists about the potential risks of the medication. We found the TXA group received significantly fewer blood transfusions. In addition, our large, statewide experience supports other smaller studies that have not shown an increase in blood clots or cardiovascular events. In fact, we found an association with fewer blood clots in knee replacement patients and fewer readmissions in hip replacement patients.”

“Published rates of transfusion after hip and knee replacement have historically been quite high. TXA offers one tool to help surgeons reduce the need for blood transfusion which will reduce risk to patients, stress on the blood supply and cost to the system.”

“The combination of multimodal pain control, rapid rehabilitation and reduced blood loss and swelling has really revolutionized the care of hip and knee replacement patients over the last few years. These and other factors will only serve to improve the quality and value of care for the many patients having these remarkable, life changing procedures as we move into the next era of health care.”

Great Results for Novel Osteoporosis Therapy

A new study utilizing data from the ACTIVE (Abaloparatide Comparator Trial in Vertebral Endpoints) trial has found that regardless of bone density, age, and previous history of fracture, abaloparatide-SC offers consistent protection against bone fractures in postmenopausal women.

Felicia Cosman, M.D. is an osteoporosis specialist and medical director of the Clinical Research Center at Helen Hayes Hospital, senior clinical director of the National Osteoporosis Foundation and professor of medicine at Columbia University.

Dr. Cosman commented to OTW, “Some patients with osteoporosis who might be candidates for abaloparatide treatment have prior fractures from osteoporosis whereas others have very low bone density without a fracture history. In this study we sought to determine whether abaloparatide would work similarly well in both groups of women. Furthermore, we believed it was important to show that abaloparatide could work in younger patients as well as the very old and to demonstrate that abaloparatide could reduce fractures in women who had either low spine and/or low hip BMD [bone mineral density].”

READ THE REST HERE

October 20, 2016 – By Susan Scutti, CNN

(CNN)-Swiss surgeons successfully used an experimental technique, which includes harvesting cells from the nasal septum, to repair damaged knee joints in patients. Two years later, these patients report improvements in pain and knee function, according to a study published Thursday in the journal The Lancet.

“The treatment is safe and feasible,” said study co-author, Dr. Ivan Martin.

Between 2004 and 2011, nearly two million Americans underwent a knee surgery due to cartilage problems. As the population ages, these surgeries will become increasingly common, experts say, however the existing techniques aren’t optimal. This study indicates a promising new option could be within sight.

“Moreover, results indicate that the tissue being formed at the patients’ repair site improves in composition over time, getting more and more similar to healthy cartilage,” said Martin, a professor of surgery and biomedicine at University Hospital Basel in Switzerland. “Patients’ satisfaction was also, on average, improving over time.”

Engineered Cartilage

Joint conditions in the knee often begin with damage to articular cartilage — the tissue at the end of a bone that cushions the joint. This cartilage is necessary for pain-free movement. Unfortunately, cartilage lacks its own blood supply, so it has very little ability to repair itself once damaged.

Since 2001, Martin and his team have been investigating a new surgical approach to repairing knees. It uses engineered cartilage tissue grown from patients’ own cells, taken from the nasal septum.

The rationale behind this is based on the fact that nasal cells “have a larger and more reproducible capacity to form new cartilage,” said Martin. In fact, he and his team demonstrated this in past studies.

“We further established that the cartilage tissue generated by nasal chondrocytes [one type of cell] can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment,” added Martin. In one of their pre-tests for the current study, he implanted engineered tissue into goat joints and found it “efficiently integrated with surrounding articular cartilage.”

For the new study, Martin and his colleagues took the all-important step of testing their ideas in humans. They began by enlisting the help of 10 patients, who range in age from 18 to 55, all with cartilage lesions of the knee.

READ THE REST HERE

BEDFORD, Mass., Oct. 24, 2016 (GLOBE NEWSWIRE) — ConforMIS Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, announced today that Mark A. Augusti has been named the Company’s President and Chief Executive Officer, effective when he joins the Company on November 14, 2016.  The Company also expects that Mr. Augusti will be appointed to the Company’s Board of Directors following the commencement of his employment. Mr. Augusti will succeed current President and Chief Executive Officer, Philipp Lang, M.D. MBA, and Dr. Lang will continue to serve on the Board of the Company.

Mr. Augusti’s 27-year business career has been marked with executive management responsibility in medical technology sales, marketing and general management.  Mr. Augusti joined Integra LifeSciences Corporation (Integra) in April 2014 and is Integra’s Corporate Vice President and President of Orthopedics and Tissue Technologies. Mr. Augusti is responsible for the management of the Orthopedics and Tissue Technologies global division which includes spine and extremity implants, orthobiologics, tissue products, and the private label business. His responsibilities include U.S. commercial leadership, global portfolio management, evaluation of corporate development opportunities and overall strategic direction. Prior to joining Integra, Mr. Augusti served as Chief Executive Officer at Bioventus LLC, from May 2012 to August 2013, and was a member of the company’s Board of Directors during the same period. Prior to that Mr. Augusti spent nine years with Smith & Nephew Inc., from April 2003 to April 2012, in a series of leadership roles, including President of Smith & Nephew’s Biologic Division, where he was appointed to lead Smith & Nephew’s new biologics initiative.  He also served as Smith & Nephew’s President of the Orthopaedic Trauma & Clinical Therapies Global Business and Senior Vice President and General Manager of the Trauma business. In 2000, Mr. Augusti joined J.P. Morgan Securities as a Vice President in the Private Funds group.  Prior to that, from 1987 to 2000, he spent 13 years at GE Medical Systems Inc., where he held various sales, marketing and strategic management roles, both in the U.S. and internationally. Mr. Augusti received his M.B.A. from the UCLA Anderson School of Management and his B.S. in Computer Science and Economics from Duke University.

Kenneth P. Fallon, III, Chairman of the Board of ConforMIS, said, “Mark Augusti’s experience and performance in a number of challenging roles was a significant factor in his selection as ConforMIS’ President and Chief Executive Officer. Mark has led teams that delivered strong growth during his tenure at Integra.  In Integra’s most recently reported quarter, Mark’s Orthopedics and Tissue Technologies division revenue grew 38% from the prior-year period for both the quarter and six-months ended June 30, 2016. Our Board is looking forward to his commercial and operational leadership in unlocking the full value of our proprietary technology for customized joint implants.”

Mr. Augusti said, “I am extremely honored to be joining ConforMIS. I am impressed with this compelling technology and unique value proposition for the advancement of joint arthroplasty.  From my discussions with surgeons that use ConforMIS customized implants, it is clear to me that the clinical benefits gained from ConforMIS’ customized implant systems are tremendous – not only for patients, but for doctors and hospitals as well. Surgeons that use ConforMIS implants are passionate about the results they are achieving.  I look forward to working with Dr. Philipp Lang and the ConforMIS Board as we continue to move the company forward.”

Dr. Lang said, “ConforMIS’ vision is ‘One Patient, One Implant’, each customized and designed to restore the natural shape of a patient’s knee. The clinical benefits to the patient paired with the potential for economic savings to the hospital, when compared to leading off-the-shelf brands, have helped transform ConforMIS into a rapidly growing medical device company. Just a few weeks ago, we announced that we had sold over 50,000 customized knee implants since our inception, which represents a substantial increase over the 30,000 we had sold as of June of 2015 at the time of our IPO. This is a testament to our cutting-edge technology, and I am really excited about the prospects of ConforMIS as we move forward.”

Mr. Fallon said, “The Board appreciates Dr. Lang’s contributions to ConforMIS as founder and Chief Executive Officer. Dr. Lang has been instrumental in building a great company, and we look forward to his continued contributions as a member of our Board.”

About ConforMIS Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.ConforMIS.com. To receive future releases in e-mail alerts, sign up athttp://ir.ConforMIS.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our Board, strategy, future operations, future financial position and results, market growth, total revenue, the potential impact and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, gross margins and other results of operations, employee transition, retention and hiring plans, the impact of our voluntary recall on financial results and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONTACT:

Investor contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

BEDFORD, Mass., October 17, 2016 (GLOBE NEWSWIRE) – ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced that The Journal of Arthroplasty has accepted for printed publication, and published online, the results of an in vivo clinical study comparing the motion patterns of patients with a ConforMIS iTotal® CR implant versus patients with a traditional off-the-shelf total knee implant. The study demonstrated that ConforMIS iTotal CR patients exhibited motion patterns that were more consistent with the normal knee than the patients that had received traditional off-the-shelf implants.

“I have been using ConforMIS customized knee replacements for over five years and this study reinforces the results that I have observed in my patients that have received a ConforMIS iTotal CR implant,” said William Kurtz, MD, a fellowship-trained surgeon at Saint Thomas Midtown Hospital in Nashville, TN. “In my experience, the ConforMIS knee system typically gives my patients a better outcome than a standard off-the-shelf knee and a better opportunity to get back to doing the activities they love.”

In this study, researchers at the University of Tennessee’s Center for Musculoskeletal Research assessed the kinematics of 38 patients (24 patients with a ConforMIS iTotal CR implant and 14 patients with a leading off-the-shelf implant) all implanted by the same surgeon. Using state-of-the-art mobile fluoroscopy, researchers were able to analyze tibiofemoral kinematics, or motion patterns of the knee, and to evaluate each patient for weight-bearing range-of-motion, femorotibial translation, femorotibial axial rotation, and condylar liftoff during a weight bearing deep knee bend and a rise from a seated position.

When a healthy knee bends, the lateral condyle, or outer portion of the end of the thigh bone (femur), rolls back on the shin bone (tibia) and rotates externally towards the outside of the knee.  Patients who received a ConforMIS iTotal CR demonstrated greater lateral femoral rollback (4.0mm vs. 1.2mm) and better axial rotation (6.3° vs. 4.4°) during deep knee bend, which is closer to normal knee motion. These differences were statistically significant.

During a deep knee bend, 35% of patients with the off-the-shelf knee replacement experienced implant lift-off in early flexion (prior to 60°), while none (0%) of the patients with iTotal CR experienced implant lift-off in early flexion. According to the researchers, this demonstrates that the iTotal CR had improved mid-flexion stability compared to the standard off-the-shelf implant.  The researchers hypothesized that one reason iTotal CR patients exhibited less lift-off could be because the customized nature of the iTotal CR implant’s shape facilitates improved translation and rotation properties when compared to the traditional off-the-shelf implant, leading to a higher likelihood of a stable knee in mid-flexion. ConforMIS provided financial support for this study.

“This study is one of many examples of how ConforMIS challenges conventional wisdom in joint replacement and is leading the way in how patient outcomes are measured,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “As a company, we are continuing to support head-to-head, direct comparative studies against many implant designs, and we are supporting multiple studies in progress that are assessing various patient outcomes measures. Just as we are constantly innovating our product line, we are also looking to new and innovative ways to better measure patient outcomes as exemplified by the mobile fluoroscopy used in this study.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about future clinical studies, future results of clinical studies, the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

Lynn Granito

Berry & Company Public Relations, LLC

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GAINESVILLE, Fla.–(BUSINESS WIRE)– October 6, 2016

October 05, 2016