RTI Launches Addition to Osteobiologic Portfolio

RTI Biologics Inc. has launched BioAdapt DBM Foam, a flexible demineralized bone matrix (DBM) solution with unique handling capabilities. The first implantation of the foam occurred June 24 in a foot and ankle procedure.

BioAdapt is the newest addition to RTI’s osteobiologic product portfolio. Designed to maximize ease of use, BioAdapt is a sterile, room temperature implant offered in five pre-shaped options to meet the bone grafting needs of trauma, reconstructive, spine and extremity surgeons. Its foam-like properties allow it to expand with hydration to adapt to the contours of the surgical site.

RTI Biologics is located in Alachua, Fla.

IlluminOss Medical System Used in Fibula Fracture

IlluminOss Medical Inc. has debuted its Photodynamic Bone Stabilization System, a way to repair and stabilize a broken ankle, in an 80-year-old woman.

The stabilization system is inserted through a tiny hole in the confines of the bone, according to the East Providence, R.I.-based company. The implant is then formed with gentle inflation, conforming to the inside of the bone to provide axial and rotational stability. This prevents soft tissue irritation.

“I was able to treat the patient in less than forty minutes and am totally satisfied with the result,” said Thomas Gausepohl, M.D., a trauma surgeon in Germany who performed the first implant. He added that the patient did not need an external plaster cast to walk after the procedure.

“This case demonstrates the power of IlluminOss’ platform to treat clinical applications throughout the anatomy. Utilizing a minimally invasive implant that conforms to the patient, we are proving the versatility of the IlluminOss Photodynamic system that will advance fracture treatment and provide improved patient care,” said Scott Rader, president and CEO ofIlluminOss Medical.

Ellipse Technologies Offers Noninvasive Treatment for Children with Early Onset Scoliosis

According to preliminary clinical data from Ellipse Technologies Inc., children with early onset scoliosis (EOS) can be treated safely, effectively and non-invasively with the MAGEC1 System, a new technology from the company.

The MAGEC1 allows physicians to modify rod length and the force applied to the spine as patients respond to therapy. The System is designed to eliminate the need for repeat surgeries, which should result in a reduction in complications and costs, company officials said.

“The current ‘gold standard’ procedure for correcting spinal deformities in children requires repeated open surgeries over the course of many years,” said Ed Roschak, chief operations officer of Ellipse Technologies. “MAGEC1 is designed to be an effective alternative to repeat surgery when used by spine surgeons to treat EOS.”

The MAGEC1 System is CE-marked and being sold through distribution partners in Europe and various countries worldwide. It is not yet available for use in the United States.

Ellipse Technologies is headquartered in Irvine, Calif.

Kelyniam Ships Custom Skull Implants

Kelyniam Global Inc. has begun to commercially ship its custom skull implants, which are designed and manufactured on an individual patient basis to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects.

“We are excited to have begun commercial shipment of our state-of-the-art custom skull implants,” said James Ketner, president and CEO of Kelyniam. “We are confident our technology, form, fit and function will enhance patient outcomes and empower surgeons by providing them with more and better treatment options than our competitors.”

According to the company, implants can be delivered to surgeons 24 hours after receipt of the order. Kelyniam uses streamlined computer-aided design and manufacturing techniques to provide the implants quickly. Executives claim the technology also helps reduce the time between trauma and implantation.

“We initially became involved with the medical device industry back in 2008 when we were supplying stereolithography models to a device manufacturer,” said Ketner. “When we saw how those implants were being made, we decided that a better manufacturing process could be used to deliver a higher tolerance product and faster deliverable turnaround time.”

Kelyniam hopes to produce more than 40 implants per month by the end of 2012. The company is based in New Britain, Conn.

Integra Introduces Interbody Cervical Fixation System

Integra LifeSciences Holdings Corporation has introduced the Zuma-C Anterior Cervical Fixation System, the first integrated plate and interbody cervical device.

The new Zuma design is based on the original Zuma platform, which is used in the anterior lumbar spine, and it is available in a variety of implant sizes. The Zuma-C features color-coded instruments that can be used in anterior cervical discectomy and fusion, a surgical procedure to remove a herniated or degenerative neck disc. The System also has a low-profile anterior fixation plate and a radiolucent interbody; the short articulating plate allows for optimal screw placement in bone and provides a favorable biomechanical environment, according to the company.

“Integra has a long history of integrating companies to drive growth,” said Brian Larkin, global president, Spine and Orthobiologics, and head of Strategic Development for Integra. “We plan to continue this tradition in spine.”

Integra is headquartered in Plainsboro, N.J.

Nonfusion Market Growth Facing Challenges

According to Millennium Research Group, the nonfusion segment of Europe’s $570 million spinal implant market is facing some serious obstacles due to motion-preserving technology issues, as well as the introduction of new regulatory standards.

“Historically, procuring CE marking for a device was not as challenging as getting FDA (U.S. Food and Drug Administration) approval, as European authorities relied on post-market feedback to evaluate efficacy,” said Millennium Research Group analyst Mashkur Reza. “As a result, companies, including those based in the United States, would introduce newer technologies in Europe to garner clinical feedback on the devices as well as use the revenues to help fund [clinical trials in the United States].”

Although the use of technologies such as cervical artificial discs have contributed to growth in the nonfusion segment, many physicians have reverted back to spinal fusions because of poor clinical results associated with the use of nonfusion technologies such as interspinous process decompression devices and nuclear disc prostheses.

In addition, the European approval process is changing—regulations governing the sale of medical devices are becoming more focused on safety, and therefore growing more stringent. It is expected that procuring a CE mark increasingly will become difficult.

“The new CE mark approval process will require more pre-clinical data than before and will certainly deter the introduction of new spinal nonfusion devices,” Reza said. “These devices are often the product of small innovative companies that lack funding to conduct extensive clinical trials.”

Despite these obstacles, Millennium Research Group is predicting the nonfusion spinal implant market to grow by approximately 10 percent through 2015 due to greater demand for motion preservation and the gradual introduction of newer devices.

NovaBone Opens New Research and Development Facility

NovaBone Products LLC has opened a new research and development facility in Gainesville, Fla.

The company will use the 3,500-square-foot facility to implement its product development strategy.

“NovaBone has clearly demonstrated its commitment to new product development,” said Greg Pomrink, who recently was appointed vice president of research and development.

NovaBone produces and markets bioactive synthetic bone graft substitutes. The company is based in Jacksonville, Fla.

ConforMIS Gets Big Loan

ConforMIS Inc., a privately held medical device company that uses computedtomography scans and computer-aided deign technology to create custom knee implants, has received a $1.5 millionloan from MassDevelopment’s Emerging Technology Fund.

“With this new technology, ConforMIS will be able to provide knee replacements to those who are underserved by current designs,” said Marty Jones, president and CEO of MassDevelopment. “The Emerging Technology Fund helps companies that are starting or expanding manufacturing in Massachusetts, and this project is a triple play: boosting production, creating jobs, and serving the health needs of the commonwealth.”

Burlington, Mass.-based ConforMIS will use the loan to purchase multiple pieces of fabrication equipment andinstruments used in its operations.

“The loan from MassDevelopment will further support the expansion of our supply chain and manufacturing presence, which is critical to our competitiveness within the orthopedics industry,” said Philipp Lang, M.D., CEO of ConforMIS. “Ultimately, the loan will help ConforMIS push the orthopedics industry toward a more efficient and more personalized approach to osteoarthritis treatment, and ultimately enhance patients’ quality of life.”

Tornier Shoulder Replacement System Makes Strides

Tornier N.V.’s Simpliciti stemless shoulder joint replacement system has reached two milestone events: The first patient has been enrolled and treated successfully as part of a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study, and the systemcommercially has been released outside of the United States. Tornier made the announcements at the Annecy Live Surgery International Shoulder Advanced Course in Annecy, France, in June.

The first patient in the Simpliciti IDE study was treated on July 29 at Saint Agnes Hospital in Fresno, Calif., by Thomas W. Thomas, M.D., an orthopedic surgeon specializing in shoulder procedures. Tornier is the first orthopedic company to participate in a multi-center, prospective FDA-approved clinical trial for a stemless shoulder prosthesis. The trial will follow 157 patients for two years.

“Simpliciti is an alternative for patients needing a shoulder replacement that preserves humeral bone, simplifies the surgical approach and renders potential future interventions much less complicated,” Thomas said. “I was impressed with the straightforward nature of the Simpliciti operation, the instrumentation, and the humeral metaphyseal fixation.”

Tornier is headquartered in Amsterdam, The Netherlands.

KFx Medical Files Patent Lawsuit Against Arthrex

KFx Medical Corporation filed a patent infringement lawsuit in U.S. District Court for the Southern District of California against Arthrex Inc., a Naples, Fla.-based company.

In the suit, KFx Medical accuses Arthrex of infringing upon a patent (U.S. Patent No. 7,585,311) that broadly covers the method of knotless double row rotator cuff repair.

“It was necessary that KFx Medical file this patent infringement lawsuit on behalf of its investors and employees,” said Tate Scott, president and CEO of KFx Medical. “The protection and respect of intellectual property is a fundamental requirement of our country in order to encourage investment, innovation and job creation.”

In 2011, an anonymous party filed a request that the U.S. Patent Office re-examine the KFx Medical patent. During 2010, only 780 patent re-examination requests were filed, while in that same year more than 200,000 patents were issued. The U.S. Patent Office rejected all arguments made by the anonymous party and upheld the KFx Medical patent.

Crosstrees Medical Granted Patent for Delivery Technology

Crosstrees Medical Inc. has been granted a patent from the U.S. Copyright and Patent Office for the Crosstrees Pod System, a delivery technology developed to address the need for vertebral fracture repair devices that reduce the risk of complications in vertebral augmentation procedures such as nerve root compression, pulmonary embolism and arterial embolism. It currently is being evaluated in the United States in an Investigational Device Exemption clinical study.

“At Crosstrees, we are dedicated to improving the clinical outcomes of vertebral augmentation procedures for patients and our physician partners,” said Robert Scribner, president and CEO of Crosstrees. “The Crosstrees Pod System offers performance benefits that may improve surgical outcomes for patients with vertebral fractures.”

Devices using Crosstrees Pod technology feature a polymer material constructed to control the delivery of PMMA (polymethylmethacrylate) bone cement to the fracture site. Once it is at the site, the polymer construct is opened and removed from the vertebra, leaving only the filler material, which can help provide fracture fixation, pain relief and stability.

Boulder, Colo.-based Crosstrees is developing and commercializing a product portfolio that addresses the demand for improved vertebral fracture treatment. The company has developed a portfolio of issued patents in the United States, European Union, China and Taiwan, and has additional applications pending for a portfolio of therapeutic devices.

ArthroCare Receives FDA Clearance for PEEK Implant

Austin, Texas-based ArthroCare Corp. has received clearance from the U.S. Food and Drug Administration (FDA) for its SpeedLock Knotless Fixation Device.

SpeedLock, a push-in implant made of PEEK (polyetheretherketone) polymer, features independent bone lock, suture tensioning and suture lock, according to the company. The device is used to affix soft tissue to bone, primarily in labral repair procedures. SpeedLock adds to the company’s line of suture anchors and suture passing technology.

Bone Loss Prevention Experiment on Space Shuttle’s Final Mission

An experiment designed to reveal protective strategies against bone loss for astronauts during extended exposure to microgravity was performed on Atlantis’ final mission.

Researchers from the BioServe Space Technologies Center at the University of Colorado, led by Ted Bateman, Ph.D., associate professor in the joint department of biomedical engineering at the University of North Carolina in Chapel Hill and North Carolina State University in Raleigh, were aboard the shuttle’s final, 12-day mission. Bateman’s colleagues from the University of Colorado in
Boulder and HarvardUniversity in Boston, Mass., also are participating in the research, which may offer treatment for osteoporosis, a disease that afflicts roughly 10 million Americans.

“We’ve known for quite a while, since the 1970s and the Skylab missions, that astronauts are going to lose bone on these extended missions,” Bateman said. “Comprehensive work has been done to identify the amount of loss—about 1 to 2 percent per month, which is approximately five times the rate that postmenopausal women lose bone here on Earth.”

The Atlantis also carried 30 mice integral to Bateman’s research. Half were treated with a novel antibody that blocks sclerostin activity and has been shown to increase bone formation and mineral density in ground-based studies of mice.

“We expect that during spaceflight, with removal of gravitational loading, sclerostin levels will increase significantly,” Bateman noted. “We believe that this increase in sclerostin signal may be a primary reason why bone formation is reduced in astronauts and [also] in mice when they are in microgravity.”