“OrthoSensor is leading the way in Intelligent Orthopedics, a new field that harnesses the latest innovations in sensors, microelectronics and wireless communications with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease,” said Jay Pierce, Chief Executive Officer of OrthoSensor. “We have launched our first product, the OrthoSensor Knee Balancer, and are developing a full portfolio of products to transform total joint and spine arthroplasty procedures through sensor enabled soft tissue balancing, mechanical alignment, intelligent implants and evidence based analytics.  We are pleased to have the opportunity to discuss our progress and future opportunities at the Canaccord Genuity Musculoskeletal Conference.”

To access a webcast replay of this presentation, visit www.orthosensor.com. Following the completion of the conference, the webcast will be available on the News & Events page for 90 days.

About OrthoSensor, Inc.
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery.  OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

Contact:
Stephanie Marks for OrthoSensor, Inc.
smarks@lazarpartners.com
212-843-0211

Rachel Kessler for OrthoSensor, Inc.
rkessler@lazarpartners.com
917-660-0608

Sunrise, FL, February 3, 2012:  OrthoSensor, Inc., the leader in intelligent orthopedics, announced that the United States Patent Office has granted the company two more key patents related to its intelligent orthopedic surgical platform.  These patents enhance OrthoSensor’s intellectual property portfolio of more than 130 patents pending and issued.  The latest patents relate to ultrasonic alignment and post-operative pain inhibition.

The patents, numbers 8,098,544 and 8,099,168, are respectively entitled “Method and system for enhancing accuracy in ultrasonic alignment” and “Post-operative pain inhibitor for joint replacement and method thereof.”

“OrthoSensor is pioneering the field of intelligent orthopedics and our strong patent estate underscores our vision and leadership in this new category of orthopedic surgery,” said Jay Pierce, Chief Executive Officer of OrthoSensor.  “These most recent patents further strengthen our intellectual property in the area of ultrasonic alignment and will also support our development of a line of intelligent implants, including the first smart knee.”

Intelligent Orthopedics is a new field that harnesses the latest innovations in sensors, microelectronics and wireless communications with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease.  OrthoSensor is developing a portfolio of products to transform total joint and spine arthroplasty procedures through sensor enabled soft tissue balancing, mechanical alignment, intelligent implants and evidence based analytics.

Complications of balancing, mal-alignment and poor orthopedic implant positioning are key drivers of revision surgery associated with total joint replacement and spine surgery. Projected U.S. hospital cost associated with total joint revision surgery is anticipated to be $8.6 billion in 2015. OrthoSensor’s intelligent, low cost, single use devices are being designed to provide orthopedic surgeons quantifiable, intra-operative feedback on soft tissue balancing and mechanical alignment in order to improve clinical and economic outcomes.

About OrthoSensor, Inc.
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery.  OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

Contact:
Stephanie Marks for OrthoSensor, Inc.
smarks@lazarpartners.com
212-843-0211

Rachel Kessler for OrthoSensor, Inc.
rkessler@lazarpartners.com
917-660-0608

OrthoSensor: Will Sensor-Enabled Data Transform Orthopedics?

By David Cassak
June 2011

• OrthoSensor is building a three-legged platform, with intelligent implants, and analytics, all driven by sensor and other micro-electronics technology that feed back to surgeons vital data both intra- and post-operatively.
• Critical to OrthoSensor’s strategy: that improving outcomes in orthopedic surgery rests on developing better, data-rich surgical techniques, rather than novel implants made of new materials or design features.
• OrthoSensor has already begun to form corporate partnerships, including one with Stryker, and is convinced it can prove that “instruments sell implants” and that its novel technology can move market share.
• OrthoSensor still has to prove the clinical benefit of data-driven orthopedics, but the company’s biggest decision may come in whether it continues to partner with large implant companies or develops its own line of implants.

To read the full In Vivo article, download the pdf

Patent Enhances OrthoSensor’s Strong IP Portfolio in Mechanical Alignment and Positional Sensing

Sunrise, FL, October 25, 2011: OrthoSensor, Inc., the leader in intelligent orthopedics, announced that the United States Patent Office has granted the company a key patent related to its intelligent orthopedic surgical platform. The patent, number 8,000,926 is entitled “Method and System for Positional Measurement Using Ultrasonic Sensing.”

This patent enhances OrthoSensor’s intellectual property portfolio of more than 100 patents pending and issued. The latest patent relates to the ultrasonic sensing of mechanical alignment and position in OrthoSensor’s intelligent orthopedic surgical platform.

“We are extremely pleased to be awarded this key patent supporting OrthoSensor’s surgical platform,’ said Jay Pierce, Chief Executive Officer of OrthoSensor. “OrthoSensor is pioneering the use of this and similar technologies to enable the adoption of intelligent orthopedics. Our ultrasonic alignment and sensing technology is highly accurate, easy to use and requires no capital equipment investment.”

Intelligent Orthopedics is a new field that harnesses the latest innovations in sensors, microelectronics and wireless communications with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. OrthoSensor is developing a portfolio of products to transform total joint and spine arthroplasty procedures through sensor enabled soft tissue balancing, mechanical alignment, intelligent implants and evidence based analytics.

Complications of balancing, mal-alignment and poor orthopedic implant positioning are key drivers of revision surgery associated with total joint replacement and spine surgery. Projected U.S. hospital cost associated with total joint revision surgery is anticipated to be $8.6 billion in 2015. OrthoSensor’s intelligent, low cost, single use devices are being designed to provide orthopedic surgeons quantifiable, intra-operative feedback on soft tissue balancing and mechanical alignment in order to improve clinical and economic outcomes.

About OrthoSensor, Inc.
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

MAHWAH, NJ, and SUNRISE, FL, August 17, 2011 – Stryker Corporation’s Orthopaedics Division and OrthoSensor, Inc., the leader in intelligent orthopedics, today announced an agreement in which OrthoSensor will provide the OrthoSensor™ KneeTrial, designed for use with Stryker’s Triathlon Knee System. The OrthoSensor Knee Trial is an intelligent trial that provides quantitative, intra-operative feedback to surgeons to optimize joint balance during total knee arthroplasty.

The OrthoSensor Knee Trial has embedded micro-electronics and sensors in single-use trial inserts, delivering data to optimize the final ligament balance and patients’ specific joint kinematics. The sensor wirelessly transmits this key information to a graphic display of real-time feedback, enabling the surgeon to visualize and quantify joint loading and balance. With this evidence, the surgeon can make an informed choice to modify implant positioning, adjust leg alignment and optimize soft tissue balance through a full range of motion.

“The single radius design philosophy of Stryker knees is a perfect complement to OrthoSensor’s innovative technology,” said Doug Leach, vice president of global research and development, knee reconstruction at Stryker Orthopaedics. “The Triathlon Knee System is uniquely suited to the finer elements of ligament balancing and being able to take advantage of this new offering provides us with the opportunity to combine our advanced orthopaedic implant technology with cutting-edge sensor technology.”

Stryker’s Triathlon Knee System offers patients the potential for improved motion¹ and better fit², and remains classified as the knee system that outperforms the most frequently used brands in terms of revision rates as identified in the National Joint Registry of England and Wales.^3,4.

“By integrating sensors into the surgical suite, OrthoSensor is leading the evolution in intelligent orthopaedic surgery and we are pleased to collaborate with Stryker Orthopaedics to turn this new field into a reality,” said Jay Pierce, CEO of OrthoSensor. “Until now, surgeons have lacked quantifiable data about joint kinematics and their decisions varied based on individual judgment, experience and skill set. OrthoSensor’s intelligent surgical systems will provide surgeons, hospitals and health plans access to real-time data to improve patient care, measure clinical outcomes and lower costs related to treating musculoskeletal disease.”

About Stryker Orthopaedics
Stryker Orthopaedics is a division of the Stryker Corporation, one of the world’s leading medical technology companies. Stryker Orthopaedics offers an extensive orthopaedic product portfolio including hip, knee and upper extremity reconstructive devices, bone cement, trauma implants, bone substitutes and spine systems. For more information about Stryker Orthopaedics, visit: http://www.stryker.com/en-us/products/Orthopaedics/index.htm

About Stryker
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.

About OrthoSensor, Inc.
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

1. Greene, K.A. Range of Motion: Early Results from the Triathlon® Knee System, Stryker Literature Ref # LSA56. 2005.
2. Hitt, K., et al. Anthropometric Measurement of the Human Knee: correlation to the Sizing of Current Knee Arthroplasty Systems, JBJS, Vol. 85-A, supplement 4, 2003.
3. The National Joint Registry of England and Wales.Annual Report 2010. Table 3.11 Based on mean Revision Rates at three years according to brands for knee replacement procedures undertaken between 1st April 2003 and 31st December 2009, which were linked to a HES/PEDWepisode.
4. The National Joint Registry of England andWales.Annual Report 2009. Table 3.7 Based on mean Revision Rates at three years according to brands for knee replacement procedures undertaken between 1st April 2003 and 30th November 2008, which were linked to a HES/PEDWepisode.

Sunrise, FL, June 9, 2011: OrthoSensor, Inc., the leader in developing intelligent orthopedic implants and sensor-assisted surgery systems, announced that it has received certification from the International Organization for Standardization (ISO), meeting the requirements of the ISO 13485:2003 standard. The ISO 13485 standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

“We are pleased that the ISO has validated the quality of OrthoSensor’s management system for the design and manufacture of our intelligent orthopedic devices,” commented Jay Pierce, Chief Executive Officer of OrthoSensor. “As we prepare for the limited release of our first product, the OrthoSensorTM Knee Trial, we believe that our customers will be pleased to know that we have met the exacting requirements and standards of the ISO organization. We are committed to remaining at the forefront of the latest breakthroughs in quality process management.”

The ISO has certified that OrthoSensor has implemented and maintains a Quality Management System for the design, manufacture and distribution of orthopedic implants and positioning, balancing and alignment support devices, remote monitoring devices and systems.

About OrthoSensor
OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

Contact:
Stephanie Marks for OrthoSensor
smarks@lazarpartners.com
212-843-0211

Rachel Kessler for OrthoSensor
rkessler@lazarpartners.com
917-660-0608

MIAMI, FL – May 17, 2011 – CareCloud, the company modernizing healthcare management with powerful cloud-based software and services, today announced that it has been chosen as the informatics solution partner for OrthoSensor, Inc., the leader in developing intelligent orthopedic devices. CareCloud will apply its advanced architecture and ubiquitous cloud computing platform
to assist OrthoSensor in collecting and reporting specific clinical data to hospitals and surgeons.

“OrthoSensor’s intelligent devices are designed to enable evidence based orthopedic surgery,” said Jay Pierce, CEO of OrthoSensor. “Utilizing CareCloud’s technology platform, OrthoSensor will provide hospitals and surgeons the ability to integrate real time data on implant placement and performance with patient records. By linking this information and remotely monitoring musculoskeletal health, OrthoSensor’s intelligent devices have the potential to improve clinical outcomes and reduce costs in orthopedics.”

Using microelectronics and sensors, OrthoSensor’s intelligent devices will provide surgeons new, real-time, actionable information about orthopedic implant placement and performance. With CareCloud’s highly extensible Platform-as-a-Service solution, OrthoSensor will be able to integrate clinical data from its devices directly into patient records. The OrthoSensor Analytics platform will run via a web browser on simple computing devices including the iPhone®, iPad® and other mobile devices, making it easier for hospitals and physicians to access the information.

“OrthoSensor is taking advantage of CareCloud’s adaptive technology to enable rapid implementation in hospital surgical settings and procedure suites,” said Albert Santalo, President and CEO of CareCloud. “This is just one of the ways we continue to customize the CareCloud experience to meet the needs of a wide range of healthcare enterprises.”

CareCloud provides medical practices with a powerful, secure cloud-based platform for practice management, electronic medical records and patient portals, automating everything a successful, modern medical practice needs, like appointment scheduling, billing, and payment processing. Delivered in the cloud, data is more secure, less expensive and easily accessible, anytime, anywhere, on any device (desktop, laptop, or tablet).

For more information on CareCloud’s full suite of practice management solutions, visit www.carecloud.com.

About CareCloud

CareCloud’s mission is to revolutionize the healthcare experience through on-demand software and services. Leading the charge to bring cloud computing to the healthcare industry, CareCloud delivers an integrated suite for medical practice management, revenue cycle management, and electronic health records to maximize physician practice performance. CareCloud currently services over 800 physicians and other healthcare providers throughout the United States and was recently named winner of IBM’s SmartCamp Silicon Valley for its innovative new technology. For more information, visit CareCloud online at www.carecloud.com, or check blog.carecloud.com for the latest updates, news, and opinions.

About OrthoSensor

OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

Clinica Hot Pick of the Month: OrthoSensor

by Tina Tan

May 2011

Medtech Ventures

Specialty area(s): Intelligent orthopaedic surgical instruments, implants and analytics

Based in: Sunrise, Florida

Founded in: 2007

No. of employees: 10 full time employees and outsourced product development and contract manufacturing

Total investment received to date: $27m

Investors: Ziegler Meditech Equity Partners and a number of unnamed strategic investors

Annual hospital charges associated with failure of total joint implants are expected to amount to $8.6bn by 2015 in the US alone, according to analysts. Many of these early implant failure cases are due to implant malposition, ligament instability and poor limb alignment. Surgeons rely on their experience and training to perform a total joint arthroplasty and until now, they have not had dynamic feedback during surgery to confirm that their “feel” of the joints’ soft tissue balance is optimal.

“Total joint arthroplasty today is more of an art than a science. It is based on feel and the results are very dependent on the subjectivity of the surgeon,” says Jay Pierce, CEO of OrthoSensor, a company that is launching a product in June to help surgeons place knee implants more effectively using intelligent devices that provide quantifiable data and feedback. “Implant failure is primarily driven by poor soft tissue balancing or malalignment of the implant and limb axis. That is a major unmet need which we’re focused on.”

The OrthoSensor Knee Trial is an “intelligent”, disposable trial insert, designed to replace the standard spacer block that is used to balance the knee during implant procedure.

“After the trial prosthesis has been placed, the surgeon will take the knee through a range of motion to determine whether or not effective soft tissue balance and appropriate knee kinematics is achieved,” explains Mr Pierce. “If they put the implant in the patient and one of the ligaments is too tight, the components in that compartment will likely wear down prematurely. If the ligaments are too loose, the patient will experience pain and instability of the knee.”

The OrthoSensor Knee Trial has embedded sensors which pick up pressure or load data on the various compartments of the knee and wirelessly transmit this data in real-time to a graphic user interface (which can be displayed on any standard computer or tablet, says Mr Pierce). The surgeon can then see on the interface if one compartment of the knee has more pressure than another and adjust this accordingly by realigning the implant, releasing tight ligaments to equalise the intercompartment pressure and optimise the balance in the knee. Once this is achieved, the surgeon can dispose of the OrthoSensor Knee Trial and implant the final prosthesis.
“So for the first time, surgeons will have a quantifiable way of achieving adequate balance,” the CEO tells Clinica, adding that another significant advantage to the technology is the lack of a learning curve.

“That’s key about this product. Without changing surgical workflow, the OrthoSensor Knee Trial adds intelligence to the standard instruments and trials used today.”

The knee trial was cleared by the US FDA at the end of 2009, and OrthoSensor has partnered with one of the “largest joint replacement companies” to release its device – customised to the specific geometry of this company’s knee implants – beginning with a limited clinical launch in June.

OrthoSensor’s platform technology integrates microelectronics, sensing technology and radiofrequency telemetry into surgical instruments and implant trials. It has been developed initially for unicompartmental, bicompartmental and total knee repalcements and has applications in other joints including the spine, hip, and shoulder. The firm already has an agreement with a spine implant company and the first spinal trial is expected to be launched towards the end of 2011, says Mr Pierce. “We’ve been having discussions with many of the implant firms over the last year and selected the first ones for knee and spine and we’re actively looking for application partners for hip as well,” he says, adding that he expects the hip trial insert to come “soon after the spine trial.”

In tandem with its surgical platform, OrthoSensor is developing a platform of intelligent orthopaedic implants that will allow remote monitoring of various parameters specific to the implant in situ and the surrounding bone, such as relative loading and position, material wear, osteolysis, motion, heat, synovial viscosity and implant interface changes.

“With our intelligent orthopaedic implant platform, we’re taking the sensors and electronics that have been built and applied to our disposable surgical tools and we plan to embed them into knee, hip or spine implants,” says Mr Pierce.

“At home, the patient will have a receiver that wirelessly communicates with the microchip in the knee and pulls data out that would alert physicians to the early presence of an infection, for example, or loosening of an implant, and changes in bone density.

OrthoSensor has yet to decide whether to manufacture its own proprietary intelligent implants or, like with its surgical platform, partner with orthopaedic companies and integrate its sensing and telemetry technology into other firm’s devices. “This is a disruptive, marketing-changing technology and we’re keeping our options open. We believe this is an opportunity to change the playing field for orthopaedic implants, and move from mechanics – geometric design and material science on which the market has been largely based – to integrated electronics, using microsensors and wireless telemetry to drive effective placement and ongoing remote monitoring,” says Mr Pierce.

If all goes well, the firm could be launching its first smart implant as early as the end of 2012, the CEO tells Clinica.

www.clinica.co.uk © Informa UK Ltd 2011

Download as PDF

The importance of proper ligament balance and implant alignment is well understood in clinical literature to maximize implant longevity. Joint instability and mal-alignment after implantation causes approximately 36% of all implant failures, burdening the patient and requiring high cost revision.

Until now, surgeons have lacked quantifiable data optimizing patient specific joint load, alignment, balance, post-operative recovery and implant management. Presently, decisions concerning these factors vary based on an individual surgeon’s judgment, experience and skill set.

OrthoSensor’s portfolio of intelligent surgical systems and implants will change this paradigm. Surgeons, hospitals and other healthcare providers will now have access to real-time data on joint kinematics – during and after the joint replacement procedures – to improve and maximize patient care, measure clinical outcomes, and lower costs related to implant failures and patients’ musculoskeletal health.

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This document was last updated on May 15, 2010.

This website is owned and provided by OrthoSensor, Inc. (“OrthoSensor”), a manufacturer of medical devices in the field of orthopedics. The site may be used for informational purposes only. This Terms of Use Agreement sets forth the standards of use of the OrthoSensor website. By using the OrthoSensor.com website you (the “User”) agree to these terms and conditions. If you do not agree to the terms and conditions of this agreement, you should immediately cease all usage of this website. We reserve the right, at any time, to modify, alter, or update the terms and conditions of this agreement without prior notice. Modifications shall become effective immediately upon being posted at OrthoSensor.com website. Your continued use of the site after amendments are posted constitutes an acknowledgement and acceptance of the Agreement and its modifications.

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This document was last updated on May 20, 2010.

OrthoSensor Analytics will use the data and analytics generated by OrthoSensor’s intelligent devices to lower the incidence, morbidity, and cost associated with implant failure and bone degradation. Initially, OrthoSensor Analytics will be available for operating room applications, subsequent applications will support use in physicians’ offices and patients’ homes.

OrthoSensor’s electronics can be integrated into current orthopedic implants and standard instrumentation used today. These intelligent products will enable post-operative, remote monitoring of the implants and improve the ability to measure clinical and economic outcomes. In the long term, intelligent implants can provide early warning signals about joint instability, sensing shifts in load, position, and stability. Armed with this new quantifiable information, physicians can intervene earlier on decisions regarding rehabilitation, surgical intervention, or other treatment to prevent long-term pain or potentially catastrophic events.

OrthoSensor developed its Surgical product line to reduce implant failures by addressing the root causes: poor soft tissue balance and malalignment. Research shows that instability and malalignment cause approximately 36% of all orthopedic implant failures.

OrthoSensor’s Surgical platform informs the surgeon by providing real-time, evidenced-based data to optimize the positioning and balance of orthopedic implants. A complete intra-operative solution, these intelligent devices provide patient-specific kinematic information and evidence of stability, reducing misalignment and improving overall implant longevity.

OrthoSensor’s accurate, inexpensive, disposable and easy-to-use surgical products have been designed with custom sensors to provide the surgeon with quantifiable, load balancing feedback. They integrate seamlessly within the current surgical workflow environment. Data is communicated in real-time via wireless radio frequency (RF) telemetry and displayed on a customizable graphic user interface (GUI).

With multiple intra-operative and implantable product configurations, OrthoSensor is developing devices for joint arthroplasty, trauma, spine, and other musculoskeletal procedures. The first commercial application of the technology platform is the OrthoSensor™ Knee Trial, which has received FDA 510(k) clearance. Initial use will be customized for unicompartmental, bicompartmental, tricompartmental and revision knee arthroplasty. With this intelligent trial, the surgeon will be able to see the absolute loads on the knee and determine the exact center of loading through the joint’s full range of motion.

OrthoSensor’s product platforms will be complemented by software designed to generate patient specific reports, analytics and other data from the operating room, as well as from other healthcare providers .

OrthoSensor’s software will deliver early warning signs of implant failure, bone degradation and other musculoskeletal analytics. This near real-time data will enable rapid resolution of complications and prevent the need for more aggressive and costly surgical intervention.

Intra-operatively, OrthoSensor’s graphic user interface (GUI) displays real-time, dynamic feedback during surgery to quantify appropriate soft tissue gap balance. With OrthoSensor Intelligent Implantables—implant devices with embedded sensors—the system will facilitate ongoing assessment of the device’s load, stability, and overall functionality.

OrthoSensor’s technology platform will enable evidence-based orthopedic surgery and comparative effectiveness by streaming data from the surgical suite, physician’s office or the patient centered medical home. The ability to wirelessly transmit the data demonstrating optimal surgical techniques or the effectiveness of various treatment protocols will help enhance clinical outcomes, while reducing cost.

Numerous sensor combinations, with ultra high precision technology, have been designed to recognize changes in many physical properties, including:

The minimal power requirements of OrthoSensor’s disposable instrument line enable an accurate, easy-to-use and low-cost alternative to computer-assisted surgery systems.

OrthoSensor’s technology incorporates the latest advances in communications, circuitry, wireless technologies and sensors to deliver real-time, dynamic feedback to the surgeon intra- and post-operatively. OrthoSensor’s products will lead to broader proliferation of evidence-based medicine in orthopedic surgery.

OrthoSensor has designed customized, low-power, miniaturized systems to seamlessly integrate within a surgical workflow and eliminate the need for expensive capital equipment. Its technology platform includes embedded sensor electronics and application specific integrated circuitry (ASIC), which provides data via wireless radio frequency (RF) telemetry to be displayed on a graphic user interface (GUI). These sensors monitor changes in many physical properties, including change in load, density, motion, heat, viscosity, and material interfaces. This information is valuable for real-time, quantifiable, intra-operative use as well as long-term disease management.

OrthoSensor has a robust intellectual property portfolio with nineteen patents issued, and more than 80 patents pending.

OrthoSensor has created a line of intelligent, low-cost and easy-to-use systems that will extend from the operating room throughout the lifecycle of the implanted orthopedic device. The Company’s products will be used in knee, hip and shoulder replacement procedures, as well as in spinal and trauma applications. Its proprietary technologies and applications will also allow remote monitoring of orthopedic implant function and patients’ musculoskeletal health.

OrthoSensor has three product platforms:

• OrthoSensor™ Surgical: Accurate, low cost, and easy-to-use surgical products will include dynamic load balancing and alignment solutions, which will reduce early revisions and increase implant life.
• OrthoSensor™ Implantables: Will use precise, low-cost implantable sensor systems to monitor numerous parameters throughout the life cycle of the implant.
• OrthoSensor™ Analytics: Deliver evidence-based medicine by capturing implant data and linking it to patients, physicians, and procedures.

Electronics and Sensors: The Era of Smart Orthopaedics

OrthoSensor is moving orthopaedics surgery from an art to a science.

By Maria Fontanazza

February 2011

Evidence-based medicine is becoming more important than ever, and OrthoSensor is taking the next logical step forward by embarking on new territory—intelligent orthopaedic devices. The technology is designed for evidence-based orthopaedic surgery and remote implant monitoring.“Our belief is that the future of orthopaedics is moving from mechanics (materials sciences, geometry, etc.) to more electronics—the use of microelectronics sensor to drive sensorassisted surgery and remote monitoring,” says Jay Pierce, CEO of OrthoSensor (Sunrise, FL). He believes that the company’s technologies will be a disruptive force in orthopaedics. OrthoSensor was founded in 2007 by an orthopaedic surgeon who envisioned using electronics and sensors to treat musculoskeletal diseases.

So far, its technology integrates electronics such as sensors and wireless capabilities to create systems that give surgeons real-time information while they’re performing procedures. “We’re harnessing the convergence of orthopaedic devices, technology, and the Internet to form this category of intelligent devices,” says Pierce. The route to these devices involves low-power, miniaturized components.

The company built an application specific integrated circuit (ASIC), identified multiple sensing technology that measures the clinical parameters that are important to orthopaedic surgeons, and has included RFID in the technology platform. Eventually this technology will be applied to the spine, hip arthroplasty, total joint reconstruction, osteoporosis treatments—basically every segment in musculoskeletal disease, says Pierce.

OrthoSensor has three product platforms—surgical, implantables, and analytics. The surgical segment consists of low cost, disposable, and intelligent devices that help a surgeon more effectively place an implant during surgery. “Today’s orthopaedic surgery is very much an art,” says Pierce. “We’re trying to move it to more of a science through evidence—[such as] quantifiable data that says the knee is balanced.” The implantables platform uses intelligent implants that will pull data such as early warning signs of infection, monitoring bone density, and material wear. This capability will enable doctors to remotely monitor the implant. The analytics platform involves a Web-hosted environment that will capture implant data and be used to improve clinical outcomes; it will go beyond the device registry concept to create a patient outcomes registry.

OrthoSensor is working closely with orthopaedic companies to create custom products that are compatible with a specific company’s implants. The company plans to release its intraoperative knee insert as a collaboration with two large orthopaedic implant companies this May. The single-use device addresses the challenge of mechanical knee alignment and provides effective joint kinematics. A smart implant (OrthoSensor’s second technology platform) could be launched sometime next year, says Pierce.

The company has raised $28 million thus far, and Pierce says the company is comfortable that it’s now well capitalized to meet its objectives.

Maria Fontanazza

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Ft. Lauderdale, FL, January 26, 2011:  OrthoSensor, Inc., the leader in developing intelligent orthopedic implants and sensor-assisted surgery systems, announced that it has arranged $21 million in Series B financing.  The Series B was led by Ziegler Meditech Equity Partners, LP, and an unnamed strategic investor.  OrthoSensor is developing and commercializing intelligent orthopedic devices that will enable evidence-based orthopedic surgery and remote monitoring of orthopedic implants with the goal of improving patient outcomes and reducing the cost of treating musculoskeletal disease.

By harnessing the latest innovations in orthopedic devices, electronics technology and wireless communications, OrthoSensor has created advanced sensor assisted systems that give surgeons new, real-time, actionable information about implant placement and performance.  Its portfolio of products will be used in knee, hip and shoulder replacement procedures, as well as in spinal and trauma applications.

“We are very pleased that OrthoSensor has attracted such distinguished investors and look forward to their support and counsel as we move into the commercialization phase for our products,” commented Jay Pierce, Chief Executive Officer of OrthoSensor.  “OrthoSensor is focused on transforming the treatment of musculoskeletal disease through low cost, intelligent devices that facilitate evidence-based surgical decisions, remote monitoring and comparative effectiveness in orthopedics.”

OrthoSensor has three product platforms: OrthoSensor Surgical, OrthoSensor Implantables and OrthoSensor Analytics.  The first OrthoSensor Surgical products are disposable, sensor-enabled devices that will provide quantitative, intra-operative feedback to surgeons to help ensure the proper balance and alignment of orthopedic implants.  These intelligent devices will allow real time optimization of patients’ specific joint kinematics.  Accurate implant placement and soft tissue balance have been shown to extend the life of implants, reduce the incidence of revision surgeries and improve patient function.

“The next wave of innovation in orthopedic surgery is going to be driven by devices that enable surgeons to make real-time, data-driven decisions and help to deliver on the promise of personalized medicine,” commented Eitan Machover, Managing Partner, Ziegler Meditech Equity Partners. “We are excited by OrthoSensor’s vision and look forward to supporting Jay and his team as they build the platform and capitalize on this tremendous market opportunity.”

About OrthoSensor

OrthoSensor, Inc. (www.orthosensor.com) is an innovative medical device company developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery.  OrthoSensor’s intelligent orthopedic devices utilize advanced sensor and wireless communication technology with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company’s intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, as well as enable remote monitoring of implant function and overall musculoskeletal health.

About Ziegler Meditech Equity Partners

Ziegler Meditech Equity Partners, LP (www.zmep.com) is a limited partnership focusing on investments in emerging medical device technologies. With over 50 years of experience in medical device development and commercialization, the ZMEP team looks to provide more than capital to its portfolio companies. ZMEP seeks partnerships with entrepreneurs where the technical and financial expertise of the ZMEP management team can assist in the creation of tomorrow’s leading medical device companies. With offices in the United States and Israel, ZMEP is positioned globally to partner with middle to late stage medical device companies showing great promise for success through commercialization.