STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

NEW YORK–(BUSINESS WIRE)–A report on the STAR™ Ankle prosthesis published in the journal, Foot & Ankle International (May 2011 edition, Volume 32 #5 © American Orthopaedic Foot & Ankle Society) is the first long term U.S. prospective study of the three-part STAR total ankle joint replacement following the Pre Market Approval (PMA) by the FDA (U.S. Food and Drug Administration) in May 2009. Foot and ankle surgeons, Jeffrey A. Mann MD, Roger A. Mann MD and Eric Horton MD of Oakland, CA reported that 91 percent of prostheses remain implanted at an average follow-up of 9.1 years. Further, 92 percent of the patients were satisfied with their outcome.

“These results help confirm longer term observations of total ankle replacement patients in Europe and will lead to greater acceptance and progress of the procedure in the U.S.”

The long term study was conducted on 84 STAR total ankle replacements, performed in 80 patients. Postoperatively, patients were evaluated with the AOFAS® (American Orthopaedic Foot & Ankle Society) score for pain and function, and serial radiographs were evaluated for stability and alignment of the prosthesis. Implant failure, secondary procedures, and complications were recorded. The report notes a statistically significant decrease in pain and improvement of functional outcomes.

The report concluded that “the first U.S. prospective long-term survivorship data with the STAR Ankle prosthesis found it to be an excellent long-term option for the treatment of ankle arthritis.”

David B. Thordarson MD, Editor-in-Chief of Foot & Ankle International, commented: “These results help confirm longer term observations of total ankle replacement patients in Europe and will lead to greater acceptance and progress of the procedure in the U.S.”

A copy of the article is available to non-subscribers of Foot & Ankle International at: http://www.datatrace.com/medical/FAI_body.htm

1 The authors are paid consultants to SBi.

About Small Bone Innovations, Inc.

Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. SBi was the first company to focus purely on small bones & joints by integrating established companies and professionals in the field. It offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints.

SBi has facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries.

For a notice on Forward Looking Statements and more information about SBi, please visit: http://www.totalsmallbone.com/us/press.php4

 

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

February 01, 2017

CHICAGO–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International is heading into 2017 with significant momentum in its U.S. spine business, including the appointment of a new Medical Director following breakout business performance in 2016. Effective immediately, noted spinal surgeon and data scientist S. Raymond Golish, MD, PhD, MBA will serve as Medical Director of the Medacta USA Spine Division. Dr. Golish will support Medacta’s U.S. subsidiary in its spine product development and commercial activities, helping the company expand upon its culture of collaboration, clinical excellence, and evidence-based and patient-centric innovation.

Dr. Golish is a fellowship-trained spinal surgeon, medical device and data scientist, and experienced healthcare administrator and executive. He currently acts as Medical Director of Spinal Surgery and of Clinical Trials at Jupiter Medical Center (Jupiter, Florida) and is a practicing spinal surgeon at Florida Spine Center in Palm Beach, Florida. He serves as Chairman of the American Academy of Orthopaedic Surgeons (AAOS) Biomedical Engineering Committee and Chairman and Director of the Board for the Research Committee of the North American Spine Foundation. From 2012 to 2016, he was a voting member on the U.S. Food and Drug Administration’s Orthopaedic and Rehabilitation Devices Panel. Dr. Golish received his PhD and MD from the University of California, Los Angeles in 2002 and 2004, respectively. He completed his spinal surgery fellowship at Stanford University in 2010 and received his MBA from Duke University in 2013.

“With his diverse experience as a surgeon, medical data scientist and expert in U.S. regulatory affairs, Dr. Golish will be an important addition to the Medacta spine team as it continues to introduce methodical, thoughtful and evidence-based innovations,” said Francesco Siccardi, Executive Vice President of Medacta International. “His steadfast dedication to patient safety and the role that medical device innovation can play in improving life aligns well with our ideals at Medacta, and we are thrilled to have him on board as we look to meet our ambitious growth targets in the year ahead.”

Dr. Golish joins Medacta following an impactful year. The company’s Spine Division experienced more than 140 percent sales growth in 2016 and now boasts five consecutive quarters of 24 percent quarter-over-quarter growth. Last year, the Division increased its customer base by 105 percent and added more than 40 new field agents selling its products in the U.S.

“Medacta’s key differentiator is its unique corporate culture, which focuses on excellence in patient care, quality, evidence and innovation in a way that moves the field forward while keeping safety paramount,” said Dr. Golish. “It’s an exciting time for Medacta as a whole, but especially for its Spine Division, which experienced transformative growth in 2016 and is poised to meet or even exceed upon the bold growth targets set for 2017.”

In 2016, Medacta’s Spine Division unveiled three new products, including the MySpine Low Profile Guide. Dr. Golish was one of the first U.S.-based surgeons to utilize the 3D-printed pedicle screw guide following its FDA clearance in October 2016. The pedicle screw guide builds on the MySpine Standard Profile, named by Orthopedics This Week as a Best New Technology for Spine Care when it was released in 2014.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

for Medacta USA
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

KILKENNY, Ireland, Nov. 16, 2022 /OrthoSpineNews/ — Spinal Stabilization Technologies (SST) has announced the start of the LOPAIN2 clinical trial of the PerQdisc™ Nucleus Replacement Device (NRD).

SST’s PerQdisc Nucleus Replacement Device will be studied in patients with degenerative disc disease (DDD) of the lumbar spine, which causes severe back pain, in patients without stenosis or instability. The PerQdisc is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently, there is no good surgical option for these patients. SST’s PerQdisc NRD aims to treat discogenic low back pain while maintaining disc height and preserving range of motion.

This trial is enrolling 72 patients and taking place in seven research centers in South America. Data from the LOPAIN2 trials will be used to file for the CE Mark under the Medical Device Regulation (MDR) in Europe. The LOPAIN2 trial is registered on clinicaltrials.gov (NCT05508360).

“We’re impressed with the quality of clinical trial research in the South American region,” said Mark Novotny, CEO of SST. “These are advanced research centers with fully staffed research teams. The patient care and follow-up are excellent. In an earlier trial, no patient was lost to follow-up. The surgeons and their research staff we are working with are all highly trained in clinical research and motivated to make our trials in South America a success.”

Dr. Javier Duarte, principal, investigator at Hospital Americano in Asuncion Paraguay, the largest enroller in the overall SST clinical trial program, stated, “The results I’m getting with the PerQdisc are excellent. I have been able to refine the technique to a point where I’m comfortable routinely offering the option to my DDD patients.”

“I believe nucleus replacement is finally here to stay. I enrolled and treated the first patient in LOPAIN2. The procedure is easy to learn, and the result is a custom implant that is fitted perfectly to the patient’s anatomy,” added Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.

SST will attend numerous meetings in 2023 to present the clinical data from its programs and present the technique to surgeons worldwide.

About Spinal Stabilization Technologies, Ltd
Spinal Stabilization Technologies, Ltd (SST), an Irish company headquartered in Kilkenny, Ireland, develops novel technologies for treating patients with lumbar discogenic back pain. SST’s products and techniques are based on the philosophy that less invasive surgery may be associated with better clinical outcomes and could improve the lives of many patients with limited options for treating their back pain. The company has extensive worldwide intellectual property and is focused on evidence-based medicine.

For more information, physicians may visit https://www.sstspine.com/

MEDIA CONTACT: Paul Maccabee, 612-366-5287

$250K Pediatric Device Competition Now Accepting Proposals

August 4, 2016

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is now accepting proposals for medical devices that address a significant, yet unmet pediatric need. This year, up to six innovations will be awarded up to $50,000 each during the “Make Your Medical Device Pitch for Kids!” competition on Saturday, Oct. 8, 2016 at the nation’s leading pediatric innovation symposium hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

The FDA-funded consortium, led by the Sheikh Zayed Institute for Pediatric Surgical Innovation and the A. James Clark School of Engineering at the University of Maryland, invites proposals from innovators—researchers, entrepreneurs, and clinicians—with a pediatric medical device concept that lends itself to commercialization. In addition to the prize money, winners will receive consultation services from NCC-PDI. (For competition details, click here.)

“This year, we are combining our annual FDA-funded consortium pitch competition with our Institute’s annual symposium to bring greater attention to promising devices and give competition participants more exposure to investors, policy makers and children’s hospital executives that evaluate pediatric innovations,” said Kolaleh Eskandanian, PhD, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “Our goal is to bring needed devices to children faster and to focus greater attention to helping bridge the gap that often follows the prototyping phase in the device development life cycle.”

Competition finalists will pitch their medical device to a distinguished panel of judges at the Sheikh Zayed Institute’s fourth annual Pediatric Surgical Innovation Symposium, “Helping Kids and the Economy Grow Stronger Through Innovation,” at the Marriott Wardman Park in Washington, DC. The one-day conference will bring together innovators, local economic development strategists, investors, patient advocates, and policy makers to stimulate pediatric device innovation and bring solutions to market faster.

See more at: http://www.mpo-mag.com/contents/view_breaking-news/2016-08-04/250k-pediatric-device-competition-now-accepting-proposals/#sthash.I60rKJWh.dpuf

For symposium agenda and registration, visit www.pediatric-surgery-symposium.org

 

First Single-Use Rigid Endoscope to be Demonstrated at AAOS

RANCHO SANTA MARGARITA, Calif.–(Business Wire)–Integrated Endoscopy, Inc. will demonstrate its nuvis™ Single-Use Arthroscope—the only single-use rigid endoscope commercially available in the United States—at the 2015 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 25–27, 2015, in Las Vegas (booth No. 674).

The launch of the nuvis Single-Use Arthroscope comes at a time of heightened awareness about serious patient safety issues connected with endoscopic procedures, including a number of recent high-profile infection outbreaks caused by bacteria build up in difficult-to-clean endoscopes.

“We’re excited to introduce the nuvis Single-Use Arthroscope to orthopedic surgeons,” said George Wright, president and CEO of Integrated Endoscopy. “Our discussions with orthopedic surgeons across the country underscore the importance of exceptional optical quality in a disposable endoscope. The nuvis Arthroscope is the first single-use rigid endoscope based on 21st century optical technology. Its excellent optics and improved safety provide first-time quality for every procedure, benefiting surgeons and patients alike.”

READ MORE HERE

Medtronic backs top doc with royalties

A decade ago, orthopedic surgeon Dr. Larry Lenke had an idea of how to do things a little better in the operating room.

Lenke, who specializes in correcting spinal deformities, pitched his idea for an anterior spine surgery system to Medtronic Inc., one of the world’s largest medical device companies.

Since that time, Lenke has led Medtronic’s development of a complete spinal surgery system that can be customized according to the patient’s size. The Legacy Spinal System is now one of the leading systems used by orthopedic surgeons worldwide.

In the first three months of 2010, Lenke earned $832,000 in royalties from Medtronic, putting him on track to top $3 million in royalties this year.

Lenke is one of three local orthopedic surgeons who were paid a total of nearly $1.2 million in royalties by Medtronic in the first quarter of this year for medical innovations they helped develop, according to disclosures made public by the company this month.

“Not a lot of places in the country have orthopedic surgeons who are doing this kind of work,” said Thomas Sullivan, president of Rockpointe Corp., a medical education company based in Columbia, Md. “Clearly St. Louis is one of the nation’s leaders.”

Lenke received between .5 percent and 1 percent of sales of the systems in royalties.

“The royalties are very small, but the sales are large,” he said. Lenke is the co-chief of adult and pediatric spinal, scoliosis and reconstructive surgery and the Jerome J. Gliden professor of orthopedic surgery at the Washington University School of Medicine, the director of spinal surgery at Shriners Hospital for Children, and a spine consultant to the St. Louis Rams and Blues.

Dr. Matthew Gornet of the Orthopedic Center of St. Louis in Chesterfield received $209,000 in first-quarter royalties from Medtronic for his contributions to a pedicle screw and PEEK rod spinal fixation system. Dr. K. Daniel Riew, a professor of orthopedic surgery and neurological surgery and chief of cervical spine surgery at the Washington University School of Medicine, received $143,000 in royalties for his contributions to a posterior spinal fixation system distributed by Medtronic.

According to disclosures from Washington University, during 2009 Riew received more than $200,000 in royalties from Medtronic, along with between $100,000 and $200,000 in royalties from Warsaw, Ind.-based Biomet Spine and between $10,000 and $25,000 in royalties from Manhattan Beach, Calif.-based Osprey Biomedical Corp. Riew also holds an equity position in Osprey, according to Washington University’s disclosures.

In addition to the orthopedic surgeons, Dr. Jane Chen, a cardiologist and assistant professor of medicine at Washington University, was paid between $5,000 and $9,999 in training and education fees by Medtronic in the first quarter of 2009.

Washington University requires all faculty physicians to annually disclose all payments, whether consulting fees or royalties, received from medical companies. Of the 1,390 physicians who filed disclosures last year, only 11 received royalty payments, according to Dr. James Crane, chief executive of Washington University Physicians and associate vice chancellor for clinical affairs at the medical school.

Lenke and Riew were both among the highest paid employees at Washington University in fiscal 2009, according to the university’s most recent 990 filing with the IRS. Lenke received $909,816 in total compensation for the year, and Riew received $1.07 million, according to the filing.

Top earner

Only three other doctors or physician groups were paid more in Medtronic royalties than Lenke in the first quarter, according to Medtronic’s physician registry. Dr. Kevin Foley of Germantown, Tenn., was the top earner, receiving $3.97 million in royalties for 10 different products or systems.

In total, Medtronic made payments to more than 220 doctors or doctors groups around the country, and it paid more than $15.7 million in royalty and consulting fees to physicians in the quarter.

Fridley, Minn.-based Medtronic announced in February 2009 that it soon would be making its physicians’ payment public, amidst a whistleblower lawsuit over such payments. A federal judge eventually threw out that lawsuit.

The disclosure by Medtronic precedes a disclosure requirement, the Physicians Payments Sunshine Act, that will go into effect in 2012 as part of the recently passed federal health reform legislation.

Critics claim that ongoing payments to physicians by medical device or pharmaceutical firms create a conflict of interest, influencing which drugs doctors prescribe or which surgical devices they recommend. The Sunshine Act will require medical companies to publicly disclose all payouts to physicians over $10.

“Transparency is very important in medicine,” Lenke said. “That’s why I applaud Medtronic for being the first company to make these disclosures.”

Lenke receives no royalties from Medtronic devices he uses in his own practice or those used by his team or at any BJC HealthCare Hospital.

Read more: Medtronic backs top doc with royalties – St. Louis Business Journal

Medline Enters Orthopedic Foot and Ankle Market

Written by Ellie Rizzo | June 23, 2014

Medical supply manufacturer and distributer Medline, based in Mundelein, Ill. is responsible for the creation of many innovative and cutting-edge surgical products. March marked the first time Medline ventured into the orthopedic foot and ankle device market, with its introduction of  the Medline Unite™ Cannulated Screw System.  

After nearly a year of successful implantations, the company launched the cannulated screw system at the Ambulatory Surgery Center Association’s annual conference. “Cannulated screws are used every day in surgery centers,” says Wesley Reed, director of orthopedics at Medline Industries. The nickel-free, titanium-alloy screws are offered in smaller trays to reduce wasted space, and the screws and instruments are color-coded to ensure OR efficiency, reducing the likelihood of intra-operative error. Tray design also improves sterilization and disinfection, according to a news release.

In addition, each tray includes both headed and headless screw options, swapping the common hex drive for a star drive, according to Mr. Reed: “One problem a surgeon faces while  inserting or removing a screw is stripping out the head of the screw.  The star drive reduces the chance of screw strip-out,” he said.

READ THE REST AT BECKER’S

Medartis, Inc. Introduces New Product at AAOS

KENNETT SQUARE, Pa.–(BUSINESS WIRE)–Medartis, Inc. will introduce their New APTUS Adaptive Watershed Plating System at the American Academy of Orthopaedic Surgeons (AAOS) Annual show today in Las Vegas. Scott G. Edwards, MD, Chief, Division of Hand & Elbow Surgery, Georgetown University, conducted the Medartis employee training workshop for the new system. During the show, Medartis staff will be on site, Booth #4070, to demonstrate and discuss the new system as well as the expanded line of Medartis products.

Prior to the AAOS, the new system had been made available in limited release and received positive reviews from surgeons who have used it. After working with the new Medartis APTUS Adaptive Distal Radius System, Richard H. Gelberman, MD, Professor and Chairman of Washington University Orthopedics at Washington University School of Medicine said, “There are several features of this new system that define its position as a third generation fixed angle device: the advanced watershed design, the opportunity for site specific multi-axial fixation and the ease provided by having 2.5 mm screws throughout.”

Andrew J. Weiland, MD, Orthopaedic Surgeon at the Hospital for Special Surgery (HSS), Professor of Orthopaedic Surgery, Weill Medical College at Cornell University also had the opportunity to use the new system and found, “The new Medartis Watershed plate design provides surgeons with increased flexibility in placement of the plate according to the characteristics of the fracture. The Tri-Lock Screw System adds additional flexibility to ensure appropriate screw placement.”

ConforMIS Announces Positive Results from Customized iTotal PS Total Knee Replacement Comparative Study

BEDFORD, Mass., April 12, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (Nasdaq:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced results from the first study of its iTotal® PS total knee replacement presented at the 2017 British Association for Surgery of the Knee (BASK) Annual Meeting.

Researchers at a leading academic institution compared the knee motion, or kinematics, of patients implanted with a ConforMIS iTotal PS customized total knee replacement to patients implanted with an off-the-shelf Zimmer-Biomet NexGen® PS total knee replacement.  Similar to previously reported studies with the iTotal CR, this study demonstrated that ConforMIS iTotal PS patients’ knee motion patterns more closely resemble those of a normal knee than patients’ knee motion patterns with the traditional, off-the-shelf implant.

When a healthy knee bends, the lateral condyle, or outer portion of the end of the thigh bone or femur, rolls back on the shin bone or tibia and rotates externally, towards the outside of the knee. In this single-center study, financially supported by ConforMIS, researchers assessed the kinematics of 31 patients (13 patients with a ConforMIS iTotal PS implant and 18 patients with an off-the-shelf implant) at least six months after surgery using advanced real-time mobile x-ray imaging and 2D-3D registration.  Patients who received a ConforMIS iTotal PS demonstrated greater average range of motion during a deep knee bend (112° vs. 94°*). Additionally, iTotal PS patients saw greater lateral femoral rollback (11.73mm vs. 4.69mm*), medial translation (2.8mm vs. 1.0mm*) and greater axial rotation (10.85° vs. 7.58°) during deep knee bend, which is consistent with normal knee motion. (Note: * indicates statistical significance with p≤0.05)

“All findings from this study suggest that the iTotal PS has the kinematic and functional benefits that have been demonstrated with iTotal CR compared with traditional, off-the-shelf implants,” said William Kurtz, MD, Chief of Orthopedics at St Thomas Hospital in Nashville, TN and clinical investigator in the study. “Patients want to return to everyday activities after their recovery and, in my experience, maintaining normal knee motion is critical to achieving those goals. I have found that when you alter patients’ normal kinematics, as happens with off-the-shelf implants, there’s a greater risk that the patient won’t be able to return to their regular activities.”

In addition, two studies, financially supported by ConforMIS, were presented at BASK highlighting the variability in femoral and tibial anatomy which cannot be replicated by off-the-shelf implants, which are offered in a limited number of shapes and sizes:

  • A retrospective review of 24,042 CT data sets used to design customized iTotal implants found that 61% of knees exhibited a distal femoral offset of >1mm. Additionally, 83% exhibited >2mm of posterior condylar offset. Off-the-shelf implants are designed with fixed condylar offsets, which are unable to retain the natural condylar shape of the knee.
  • A similar analysis was conducted on tibial implants and found that the tibial trays were within 2mm or less of symmetrical only 12% of the time, while 22% were found to have asymmetry >5mm. The authors concluded that tibial trays that are either symmetric or have a fixed asymmetry based on medio-lateral size, as off-the-shelf implants do, may face challenges between maintaining proper rotation and adequate coverage.

“In its first year of release iTotal PS has met our expectations in terms of surgeon adoption and patient outcomes,” said Mark Augusti, MBA, Chief Executive Officer and President of ConforMIS. “Clinical research has demonstrated our implants offer superior clinical outcomes compared with off-the-shelf implants.  We are committed to continuing investing in the clinical study of our implants to demonstrate their superior clinical and economic value for patients, surgeons, hospitals, and payers across the healthcare continuum.”

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 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 450 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 ConforMIS’ clinical strategy, the potential clinical, economic or other impacts and advantages of using customized implants and the commercial launch of iTotal PS, 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 clinical studies 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.

 

CONTACT:

Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881

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

ConforMIS Announces Full Commercial Launch of iTotal® PS, the Only Customized Posterior Stabilized Total Knee Replacement System

BEDFORD, Mass., March 02, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, today announced the full commercial launch of iTotal® PS, the only customized posterior stabilized knee replacement system.  Over 1,000 patients have been treated by select orthopedic surgeons using the iTotal PS during the limited launch over the past twelve months.  The full commercial launch will take place at the American Academy of Orthopaedic Surgeons meeting in Orlando, FL from March 1–5, 2016.

Recent studies have demonstrated that approximately twenty percent or more of patients who receive an off-the-shelf total knee replacement are not satisfied with the results.  The ConforMIS iTotal PS was designed to address the shortcomings of traditional knee replacements, which come in a fixed set of sizes and shapes.  The customized iTotal PS implant builds on the advantages of the iTotal CR system, first introduced in May 2011. The iTotal PS implants are customized for each patient to avoid overhang, rotation, and sizing compromises, common causes of pain after surgery.  In addition, iTotal PS is designed to restore the natural shape of each patient’s knee and has a customized cam and spine to provide optimal stability throughout the full range of motion.

Primary total knee implants are designed to either retain the patient’s own posterior cruciate ligament (cruciate retaining, or CR), or substitute for it (posterior stabilized, or PS). PS implants use a cam and spine feature to serve the function of the posterior cruciate ligament.  The choice between CR and PS is largely based on surgeon preference. However, PS is heavily preferred in the US market, representing approximately 72% by revenue of all primary total knee replacements.  With the launch of iTotal PS, combined with its existing iTotal CR, iDuo and iUni products, ConforMIS can address a much greater population of patients.

“The goal of a total knee replacement is a predictable outcome and a happy patient, every time.  With off-the-shelf implants, most of the time we must make compromises,” said Jose A. Rodriguez, MD, Chief of Reconstruction Arthroplasty and the Director of the Arthroplasty Fellowship Program at Lenox Hill Hospital in New York City.  “With ConforMIS, many of these compromises are eliminated because the implant fits anatomically.  The reliability with which I can achieve a knee that fits better, and functions more naturally for my patients, is greater with iTotal PS than with standard, off-the-shelf implants.”

“The full launch of the iTotal PS nearly triples our addressable market.  We believe this launch is our single biggest commercial opportunity to date,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “With iTotal PS, we have now greatly expanded the number of patients who will be candidates for our customized knee replacement implants. We are very excited to bring the benefits of customized knee replacements to surgeons who prefer a posterior-stabilized design.  Since we initiated our limited launch of iTotal PS last year, the feedback from surgeons has been extremely positive.”

The ConforMIS customized knee replacement products offer significant benefits to hospitals with a unique just-in-time delivery model. This model includes a single, pre-sterilized kit of patient-specific instruments, a single reusable instrument tray, and no implant inventory. The ConforMIS iTotal CR has already demonstrated clinical and economic benefits for surgeons, patients, and hospitals for an entire episode of care, from the initial hospitalization through recovery.  We believe that promoting such clinical and economic benefits is critical to bundled payment programs such as the new Medicare Comprehensive Care for Joint Replacement (CJR).

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 ConforMIS’s strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, gross margin, operating trends, the potential clinical, economic or other impacts and advantages of using customized implants and the commercial launch of iTotal PS, 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, the impact of the CJR program, 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.

CONTACT:

Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881

Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881

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

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