Miami Herald - OrthoSensor Develops High-tech Device to Improve Joint Replacements | Orthosensor Inc.

Miami Herald – OrthoSensor Develops High-tech Device to Improve Joint Replacements

BY JOSEPH A. MANN JR | December 2, 2012

Hundreds of thousands of Americans receive knee replacement surgery each year as Baby Boomers age and strive to remain active.

While prosthetic knees are expected to last as long as 20 years, the failure rate due to improperly balanced replacements or post-operative infection is a serious concern, since do-overs cause patients additional suffering and are more costly than the original operation.

IMPROVE OUTCOMES

OrthoSensor, a small company based in Sunrise, has developed a high-tech device that provides real-time data to orthopedic surgeons during knee replacement surgery and could help improve outcomes and reduce failure rates in this increasingly common operation.

The four-year-old company, which so far has raised $42 million in venture capital, is also advancing work on other implantable devices for orthopedic patients, including tiny units that electronically transmit data to physicians and nurses on internal temperature, blood acidity levels and other indicators that can be used to detect infections following orthopedic surgeries, as well as implants that send out sound waves to assess bone density.

“Our lives have been transformed by new technology in computer programming, cell phones, the Internet and miniaturization,” said Jay Pierce, the company’s president and CEO. “Everything is getting smaller. We have combined advanced technology, wireless communications, sensors and microelectronics to produce ‘intelligent orthopedic’ devices that improve outcomes in musculoskeletal disease and reduce healthcare costs,” said Pierce, who has worked in the medical device, technology and communications sectors for more than 27 years.

The company’s first product, the OrthoSensor Knee Balancer, contains sensors that help orthopedic surgeons properly balance a knee implant by transmitting data over a wireless system to a computer screen during the operation. Using this data on the screen, they can make adjustments to soft tissue around the knee and [better]* implant placement.

The goal of this device, now being used in trials by 30 hospitals and orthopedic teaching centers in Florida, New York, Michigan and 12 other states, is to achieve extremely accurate implant placement that will improve function of the new knee and reduce the need for costly revision surgery.

The knee balancer, which costs about $500 and is made in Phoenix, is used only once and then discarded to avoid the possibility of infection. It received approval from the U.S. Food and Drug Administration in late 2010 and took about two years to develop.

Before the OrthoSensor Knee Balancer was available for trials earlier this year, surgeons relied on their knowledge, experience and the “feel” of the implant and the patient’s leg to decide if a new knee was properly balanced.

“When we do knee replacements today, surgeons make their cuts, plant the prosthesis and then test how the prosthesis feels in their hands. That is the art to the procedure,” said Dr. Martin Roche, chief of orthopedics and director of the Holy Cross Orthopedic Institute in Fort Lauderdale, who developed the idea for the knee balancer and founded OrthoSensor in [2006]*.

‘[IMPROVED RESULTS]’*

“If one of the ligaments on each side is tight or loose, that is judged by the surgeon as he tensions and sees how the knee moves,” added Roche, who trained at the University of Miami and has been working in joint replacement at Holy Cross for the last 15 years. “With OrthoSensor, we’re integrating sensor technology into the trials, so now I can quantify how tight or how loose I am in that patient’s knee joint. This allows me to loosen or tighten ligaments, or use different thicknesses in the bearingsto obtain [improved results]*.

Despite their many years of training and experience, orthopedic surgeons up to now could not count on precise data about the alignment and balance of knee replacements…“We developed the knee balancer to deal with the unmet need of avoiding and reducing implant failure…” OrthoSensor’s CEO said. The cost of revisions — or redoing knee and hip implants — will reach an estimated $8.6 billion by 2015, Pierce added, and each revision normally costs more than the original operation. About seven percent of all knee replacements need revisions each year, he said, and 35 percent of all implant failures occur within two years of the original operation.

“We are very much focused on improving clinical outcomes and reducing costs,” said Pierce, whose company has grown to about 30 employees.

Roche, who holds multiple patent applications and has served as a consultant to DePuy Orthopedics and the Florida Marlins, so far has done more than 250 knee replacements with the OrthoSensor Knee Balancer and is educating other surgeons on its use.

Dr. Alejandro Gonzalez Della Valle, an orthopedic surgeon based in New York City, has been using the OrthoSensor Knee Balancer for the last several months. “OrthoSensor is doing something orthopedic surgeons have needed for a long time,” said Gonzalez Della Valle, who is associate attending orthopedic surgeon at the Hospital for Special Surgery in New York City.

‘REAL TIME’

“This device gives a very accurate measurement that corresponds to the pressure of the ligaments. You get the information in real time,” he added. “It makes knee surgery much more precise and it helped me be a better surgeon.”

Gregory J. Golladay, M.D., an orthopedic surgeon who specializes in minimally-invasive knee replacement and hip replacement at the Orthopaedic Associates of Michigan in Grand Rapids, has been using the OrthoSensor Knee Balancer since the first quarter of this year. “Many patients say that the new knee feels normal, and prior to OrthoSensor this was not unheard of, but was unusual,” he said.

Orthopedic surgeons will do about 660,000 knee replacements this year in the U.S., and  one-sixth will be revisions, added Golladay, who was a consultant to OrthoSensor and helped develop the device. The results of the current trials using the OrthoSensor could show that it plays an important role in reducing the need for revisions.

Aside from the knee balancer, OrthoSensor is also working on other devices to provide physicians with real-time data on implants during and after operations. Scheduled for launch in 2013 are new OrthoSensor devices for knee alignment and hip positioning surgeries. Implants that can monitor load, range of motion, and loosening are projected to be available in late 2014.

Using microelectronics and the latest technology, other implants under development will be able to provide data on infection, pain and bone density. Batteries in these implantable devices are designed to last 20 years.

DEVELOPING PRODUCT

Roche, who for many years was interested in using sensors and technology for surgery and patient care, worked with Fort Lauderdale-based Mako Surgical Corp. in 2005-2006 to help develop its RIO Robot arm for orthopedic surgery. He later met with engineers from Medtronic, a medical technology company, to discuss how sensors he had acquired in Israel might be used in medicine.

Roche and one of the engineers, Marc Stein, now chief technology officer at OrthoSensor, began collaborating. Roche subsequently met Pierce, then the CEO of Visible Assets, a company that made radio frequency identification tags for patients, and the three decided to work together at OrthoSensor.

“I always was interested in advanced technology, saw a medical need and was able to put the best team together,” Roche said. “With Baby Boomers aging, we’re expecting more knee replacements, and we will be expanding to other joints.”

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*Edited from the original version

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