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Antibiotic-Releasing Polymer May Help Eradicate Joint Implant Infection

Posted On July 21, 2017 By OrthoSpineNews In Recon /  

July 19, 2017 – Source: Massachusetts General Hospital

In the new approach to treating prosthetic joint infection, developed by Massachusetts General Hospital investigators, the infected prosthesis and affected tissue are removed and the new prosthesis, incorporating an antibody-releasing polymer, is implanted in a single procedure. The antibiotic — in this example vancomycin — is released over time to eradicate any bacteria that remain and prevent future infection. Courtesy of Jeremy Vincentius Suhardi, Harris Orthopædics Laboratory, Massachusetts General Hospital.

A team of Massachusetts General Hospital (MGH) investigators has developed an antibiotic-releasing polymer that may greatly simplify the treatment of prosthetic joint infection. In their recent report published in Nature Biomedical Engineering, the researchers describe how implants made from this material successfully eliminated two types of prosthetic infection in animal models.

“Currently, most infections involving total joint replacement prostheses require a two-stage surgery, in which the patient’s daily activities are largely compromised for four to six months,” says Orhun Muratoglu, PhD, director of the Harris Orthopedics Laboratory in the MGH Department of Orthopedic Surgery, a co-author of the report. “Our finding that polyethylene, the most commonly used weight-bearing surface in total joint surgery, can be made to safely and effectively release antibiotics implies that fully weight-bearing implants made with this material could be used to treat infection in a single procedure, reducing both the inconvenience and the risk of complications for patients.”

 

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Collagen Matrix Celebrates 20 Years of Science, Technology and Innovation

Posted On July 20, 2017 By OrthoSpineNews In Biologics /  

OAKLAND, N.J., July 18, 2017 /PRNewswire/ — It started with an idea that transformed into a success story, 20 years in the making. Today, Collagen Matrix, celebrating its 20th anniversary, has developed collagen and mineral based medical devices that have helped patients worldwide with over 7.5 million products sold. The Company has grown from a start-up business with a handful of employees to nearly 200 team members located in two state-of-the-art facilities totaling 73,000 sq. ft. and now distributes products worldwide.

Advancing the Science
The Company’s passion for advancing the science of tissue repair and regeneration has helped the healthcare industry by designing, developing and manufacturing innovative medical devices that support the body’s natural ability to regenerate. Collagen Matrix has built two decades of science, technology and innovation into its robust product portfolio in five key therapeutic areas – Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair.

Teamwork, Leadership & Evolution
Collagen Matrix is very proud of its evolution and advancement, which shows how determination, perseverance and teamwork can provide significant success. “To see what has transpired here in just 20 years is an incredible achievement for this organization,” said Bart J. Doedens, Chief Executive Officer. “We continue to build on our capabilities to help our customers provide products that solve clinical challenges, and we confidently look forward to what the next 20 years will bring.”

“The past two decades have been an extraordinary journey,” said Shu-Tung Li, Ph.D., Founder and Chief Scientific Officer, “Our focused commitment to R&D continues to position us as the expert in producing collagen based products and has facilitated the Company’s success. We wouldn’t be here without the dedication and commitment of our employees and support of our customers.”

New Branding, Website & Celebration
To celebrate, the Company has launched new branding for its five Business Units and developed a technologically savvy new website, www.CollagenMatrix.com, with interactive product videos, downloadable marketing and sales literature and numerous valuable resources for its users. A formal event is planned for the fall where the Collagen Matrix team members will celebrate the Company’s success.

About Collagen Matrix
Collagen Matrix, Inc., founded in 1997, delivers a full line of the highest-quality collagen and mineral based medical devices that support the body’s natural ability to regenerate. The Company currently manufactures finished medical devices in the areas of Dental, Spine, Orthopaedic, Dural Repair and Nerve Repair Surgery. The evolution of the Company’s leadership, proprietary technologies, manufacturing expertise and product portfolio has established a solid foundation for continued growth. Opportunities continue to exist for collaboration through Product Distribution, Product Development and Contract Manufacturing. More information about Collagen Matrix can be found at www.CollagenMatrix.com.

Contact: Margo Lane
201-405-1477
mlane@collagenmatrix.com

SOURCE Collagen Matrix, Inc.

Related Links

http://www.collagenmatrix.com

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SANUWAVE Appoints Alat Medika Indonesia as Distributor for dermaPACE and Liaison to Clinical Trials Participation for Company’s Wound Care Product(s) in Indonesia

Posted On July 20, 2017 By OrthoSpineNews In Biologics, Top Stories /  

SUWANEE, GA–(Marketwired – Jul 20, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the Company has appointed Alat Medika Indonesia as distributor for dermaPACE® and liaison for clinical trials participation for Company’s wound care product in Indonesia. The expected revenue from this agreement will be north of $1 million over the next three years.

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “This decision to engage Alat Medika Indonesia was made to increase our focus and visibility within Indonesia for the wound care market. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Indonesian market. It is well known that diabetes and related concerns need to be addressed within Indonesia and having access to outstanding technology such as SANUWAVE’s within the country is a positive step. We will need speedy access to potential clinical trials to ensure we add value with our product offering as well as clinical proven outcome. These factors will lead to faster market entry and closer ties with identified Key Opinion Leaders (KOLs),” concluded André Mouton.

Christian Hainsch, Chief Product Officer of Alat Medika International Group, declared, “Setting the ‘PACE®‘ in wound healing in Indonesia! A technical milestone in professional wound healing is coming to Indonesia. With dermaPACE, SANUWAVE developed an innovative medical device for patients suffering from diabetic wounds, ulcer or burn injuries. One of the major indications for the use of dermaPACE, and most important for Indonesia, is the treatment of diabetic ulcers. With dermaPACE the regeneration process of tissue from chronic wounds is increased and can be an alternative to amputation or medication based treatment. Diabetes and other patients benefit from a simple, painless and side-effect free treatment for faster healing and quicker recovery to improve quality of life,” concluded Mr. Hainsch.

SANUWAVE is using this occasion to further educate on our lead wound care product dermaPACE. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www.sanuwave.com.

About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About Alat Medika Indonesia
Being a reliable partner for hospitals, doctors and health care facilities, Alat Medika Group Indonesia brings the best medical devices to Indonesia. Serving the health care market with dedication, passion and highest quality technology standards the expert team of Alat Medika provides local medical practitioners, clinics and hospitals with a full range of medical devices ranging from laboratory equipment to radiology, sonography, laser technology for diagnostics, therapy and health care. Our team of technical and medical experts helps customers all over Indonesia to identify their needs, supply best in class medical devices and maintain and service the health care infrastructure.

Contact:
PT. Alat Medika Indonesia
Graha Mustika Ratu Bldg. 10th Floor
Jl. Jend. Gatot Subroto Kav. 74-75
Jakarta 12870 – Indonesia
sales@almed-indonesia.com
Phone: +62 21 83708874

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

  • Contact:

    Millennium Park Capital LLC
    Christopher Wynne
    312-724-7845
    cwynne@mparkcm.com

    SANUWAVE Health, Inc.
    Andre Mouton
    Vice President International Sales and Relations
    +1-615-823-9907 (Cell)
    +1-678-569-0881(Fax)
    Skype: andre.w.mouton
    Andre.Mouton@sanuwave.com

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If You Have Lumbar Spinal Stenosis, There’s an Exciting New Option

Posted On July 20, 2017 By OrthoSpineNews In Spine /  

July 18, 2017 / By Family Health Team

If you’ve struggled with lumbar spinal stenosis (LSS), you know it can impact your life. People with severe LSS often can’t stand longer than a few minutes or walk more than a few hundred feet without feeling severe pain.

Bulging disk and/or enlargement of the ligaments in your spine can cause LSS. When the spinal canal narrows, it causes nerve compression. When someone with LSS stands or walks, the spinal canal narrows even more, causing low back and leg pain that is relieved with sitting or bending forward.

Until a few years ago, the only treatment options available were either of two extremes: conservative therapies or open spine surgery.

Weighing treatment options for LSS

However, conservative treatments, such as NSAIDS, physical therapy and epidural steroid injections, only work for a fraction of people. Also, when they do work, the effect is often not sustained and requires repeated treatments.

Open spine surgery, on the other hand, works to relieve pressure on spinal nerves, but surgery and anesthesia may carry increased risk in older patients.

Now, there’s a new outpatient option called mild®, which stands for minimally invasive lumbar decompression. It is only an option for patients who have significant LSS due to thickening of the ligamentum flavum, or ligaments of the spine.

 

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North America Spinal Implants Market CAGR of 5.1% 2024

Posted On July 20, 2017 By OrthoSpineNews In Spine /  

JULY 19TH, 2017/DATA BRIDGE MARKET RESEARCH

The North America spinal implants devices market is estimated at USD 4.7 billion in 2016 and is projected to reach USD 7.0 billion by 2024, at a CAGR of 5.1% during the forecast period from 2017 to 2024. The new market report contains data for historic year 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

The North America spinal implants market is segmented based on product type, surgery type, procedure type, end-user and geography.

On the basis of product the market is segmented into into spinal fusion, vertebral compression fracture treatment devices and spinal non-fusion. The spinal fusion segment is divided into cervical fusion and thoraco-lumbar fusion. spinal non-fusion devices market is segmented on the basis of product types into dynamic stabilization devices, artificial discs, annulus repair devices and nuclear disc prosthesis. The vertebral compression fracture (VCF) treatment devices are further segmented into two product type balloon kyphoplasty devices and verteboplasty devices.

The North America spinal implants market is also segmented based on procedure type into open surgery and minimally invasive surgeries.

 

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Richard Grant joins Spinal Simplicity, LLC as an Advisor and to serve on the Board of Managers

Posted On July 19, 2017 By OrthoSpineNews In Spine /  

OVERLAND PARK, KANSAS (PRWEB) JULY 19, 2017

Spinal Simplicity, a medical device company developing innovative solutions to treat complex spinal and orthopedic problems, announces Richard Grant has agreed to serve as an Advisor and will join the Company’s Board of Managers.

Richard Grant brings a wealth of experience to Spinal Simplicity as an accomplished medical device executive with over 30 years in the spinal and orthopedic medical industries. As President, CEO and Co-Founder of Breakaway Imaging, LLC, Mr. Grant successfully developed new imaging technology (the O-Arm), incorporating 2-D (fluoroscopy) and 3-D (CT) imaging, in a mobile platform optimized for orthopedic and spinal surgeries. Mr. Grant orchestrated the sale of Breakaway Imaging, LLC to Medtronic, Inc. in June 2007.

Mr. Grant also has extensive experience with early-stage medical device companies as evidenced by his work as President and CEO of TheraCell, Inc., in Northridge, CA, specializing in stem cell harvesting and processing for orthopedic applications, and, as President of Bonovo Orthopedics in Phoenix, AZ, a US-based company that manufactures and distributes spine and orthopedic instrumentation and implants in China. Mr. Grant currently serves on the Board of Directors of two medical device companies, an orthopedic bracing company and an ortho-biologic company, while also serving as the Chairman of the Board of a company specializing in computer-assisted total knee solutions. Notably, Mr. Grant also served on the Board of Directors of Excelsius Surgical (sold to Globus Medical), Nocimed (partnering with Nuvasive), and Angstrom Medica (sold to Pioneer Surgical).

Todd Moseley, CEO of Spinal Simplicity, applauded Mr. Grant’s significant industry experience stating, “Rich is an admired executive in the spine and orthopedic medical device world. Spinal Simplicity will benefit mightily from Rich’s knowledge and experience navigating early-stage companies from initial innovation to becoming market leaders. Our Company will have the unique advantage of calling upon Rich’s experience as we bring the Minuteman G3-R to the minimally-invasive spine market to enhance posterior supplemental fixation and fusion, as well as to introduce our ground-breaking Wolff’s Law™ plating technology to the spinal and orthopedic extremities market.”

Mr. Grant agreed that this is an extraordinary time for Spinal Simplicity, “As the Company experiences the positive responses being lauded by physicians to its revolutionary technology, it becomes more and more evident that the spinal and orthopedic markets are ready for innovative medical devices. The time is ripe to get the word out about the innovation being unveiled by Spinal Simplicity.”

Spinal Simplicity’s Minuteman® family of sterile-packed, posterior, non-pedicle supplemental fusion and fixation devices for use in the non-cervical spine (T1-S1) provides an alternative to traditional fixation, such as pedicle screws. The Minuteman® family of devices consists of a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumor.

About Spinal Simplicity 
Spinal Simplicity, LLC, headquartered in Overland Park, Kansas, is dedicated to the creation of simple solutions for the treatment of complex spinal and orthopedic problems. Spinal Simplicity has regulatory clearance for the Minuteman® system in the US, Europe, and Canada. Our vision is to be the leader in innovative, simplified surgical solutions, while delivering uncompromising quality. For more information, please visit http://www.spinalsimplicity.com.

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Medovex Announces First Human Cases Using Its DenerveX Device and First Revenue Events

Posted On July 19, 2017 By OrthoSpineNews In Spine, Top Stories /  

ATLANTA, GA–(Marketwired – Jul 19, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), a developer of medical technology products, today announced the first human cases performed using its recently launched DenerveX™ System and first revenue events.

The DenerveX System which has recently received CE Mark approval and clearance for commercialization in the European countries, is a new and novel device designed for enduring relief of Facet Joint Syndrome related to lower back pain.

Jarrett Gorlin, Medovex CEO stated, “Our first human use cases for the DenerveX System which took place in Manchester, England recently with very encouraging initial procedural success. We anticipate performing up to as many as 30 plus additional procedures by the end of August. This is the beginning of delivering on our goal of ‘proof of principle’ in the adoption of the technology in this very sizable market.” Gorlin concluded, “We are also pleased to have also reached our first revenue events in the EU with others soon to expected to follow.”

The DenerveX System offers a fast and simple way to perform a safe Facet Joint Syndrome treatment.

Patrick Kullmann, Medovex President and COO., added, “With the DenerveX™ System, we can offer surgeons and pain management specialists the ability to attain precise treatment of the Facet Joint pain. The DenerveX treatment uses ‘Rotacapsulation™,’ a combination of high heat and rotational capsular tissue shaving, in a minimally invasive posterior procedure for the treatment of Facet Joint Syndrome. The DenerveX System offers an alternative to existing treatments only providing temporary relief.”

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

  • CONTACT INFORMATION
    Medovex Corp.
    Jason Assad
    470-505-9905
    Email Contact
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PathPartner Technology Contributes to Arthromeda’s Successful Preclinical Study of Arthrosight-PS™ Hip Alignment Navigation System

Posted On July 19, 2017 By OrthoSpineNews In Recon, Top Stories /  

FREMONT, CA–(Marketwired – July 19, 2017) – PathPartner Technology Inc., a technology enabler in developing intelligent systems, announces a successful cadaveric study of Arthromeda’s (www.arthromeda.com) innovative patient-specific hip alignment navigation product, Arthrosight-PS™.

In a recent press release, Arthromeda Inc., a developer of intelligent orthopedic navigation systems, announced the successful completion of cadaveric studies demonstrating the efficient performance of Arthrosight-PS™ at the Cincinnati Children’s Hospital and Medical Center (CCHMC, Cincinnati, OH). These cadaveric studies confirmed that the patient-specific Arthrosight-PS™ Hip Alignment System is an intuitive, all-in-one system for accurate implant positioning and providing real-time position angles (inclination and anteversion), leg-length and femoral offset difference measurements.

With an increase in the number of hip procedures, and 80% of them being represented by Total Hip Arthroplasty1; technology serves as a panacea to improve surgical methodologies and also as an enabler towards enhanced outcomes of surgeries. Accurate hip implant positioning is an extremely important criterion for patients, physicians, regulators and device companies. A device that enables the surgeons to perform accurate hip arthroplasty procedures with minimal interference in their work-flow is the need of the hour and this is being ably addressed by Arthrosight-PS™.

This was the result of an intense and ingenious design process, fabricated from Arthromeda’s intellectual property combined with their design input specifications and our talented team spanning the entire electronics engineering space that included hardware design, algorithms, firmware and application developments. PathPartner, with its vast experience in delivering state-of-the-art technologies from ideation to complete system solutions, provided critical support to build the platform that included MEMS sensors, laser sensors, photodiodes, wireless connectivity, Android applications and cloud solutions to provide an easy-to-use device in the operation-room offering accurate angular positioning (inclination and anteversion) and leg-length/femoral offset difference measurements.

“PathPartner has been a valuable partner to Arthromeda,” commented PJ Anand, Executive Chairman and Co-Founder of Arthromeda. “We fully intend to leverage this relationship with the PathPartner team to expand the platform into knee and shoulder procedures.”

“The joint positioning system that offers four key measurements (with an accuracy of 2 degrees for inclination/anteversion and 2 millimeters for leg-length/femoral offset difference), without the need for costly capital equipment, is a game changer in helping surgeons and patients in hip arthroplasty procedures,” commented PathPartner Technology Senior Vice President Raman Narayan.

1: Source: Third Annual report of AJRR (American Joint Replacement Registry)

About PathPartner Technology

PathPartner offers design, development and integration services in advanced embedded technology. Based out of Fremont, Calif., PathPartner Technology Inc is an affiliate of PathPartner Technology Pvt. Ltd., Bangalore, India.

With an unparalleled experience in transforming innovative ideas into full-fledged products, PathPartner provides its clients the advantage of top-of-the-line technologies, superior performance and faster time-to-market options. Having the expertise in BSP & device drivers, multimedia codecs, algorithms, imaging and hardware design, PathPartner is geared for technology driven execution and quality delivery for corporations across industries including automotive, semiconductor, healthcare, cameras and surveillance.

More information is available at www.pathpartnertech.com.

CONTACT INFORMATION

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CMS proposes Medicare coverage for outpatient joint replacements, changes to SNF 3-day stay rule

Posted On July 19, 2017 By OrthoSpineNews In Recon, Regulatory, Top Stories /  

/July 17, 2017

The Centers for Medicare & Medicaid Services released two proposals last week that may change where beneficiaries receive joint replacements, and how accountable care organizations deal with the agency’s three-day stay rule waiver.

The first proposal, contained within a proposed rule concerning hospital outpatient prospective payments, would allow Medicare to cover knee replacement surgeries in outpatient facilities.

Research on conducting the procedures in outpatient settings has shown outpatients did not experience higher complication or readmission rates than inpatients, CMS said. If the rule were to be enacted, beneficiaries would still be able to undergo the procedures in an inpatient setting “based on the beneficiary’s individual clinical needs and preferences,” the agency said.

CMS also is soliciting public comment on possibly doing the same with hip replacements.

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OrthAlign, Inc. Announces First KneeAlign Cases for Total Knee Arthroplasty in Hong Kong

Posted On July 19, 2017 By OrthoSpineNews In Recon, Top Stories /  

HONG KONG (PRWEB) JULY 19, 2017

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the first KneeAlign® cases completed for total knee arthroplasty (TKA) in Hong Kong. These cases were completed by Hong Kong-based orthopaedic surgeon Professor Kevin K.W. Ho at Prince of Wales Hospital, one of the country’s leading public hospitals, in collaboration with OrthAlign’s local distribution partner Smith & Nephew Hong Kong.

OrthAlign provides highly accurate, computer-assisted, handheld technologies for surgeons to receive real-time, actionable data for precise alignment and positioning of components in total knee, unicondylar knee, and total hip (both posterior and anterior) arthroplasty surgeries. Over 15 peer-reviewed clinical studies have been published to date, validating OrthAlign’s accuracy, simplicity of use, and benefits in recovery for the patient.

Professor Ho stated, “KneeAlign is large console navigation in a small, handheld box. The technology is so easy to use and gives me accurate information that I need, all within the sterile field, without all of the hassles and extra costs that large console computer assisted surgery systems require. I was pleased with my first set of cases and will continue using it because I believe it is valuable for my practice in providing the best possible outcomes for my patients.”

“Navigation plays a very important role in Hong Kong’s joint arthroplasty market,” said Priscilla Chan, General Manager of Smith & Nephew Hong Kong & Taiwan. “Surgeons and hospital facilities believe in navigation, but cost and operational inefficiencies have been key barriers in adoption optimization. I believe OrthAlign provides a revolutionary technology that addresses those barriers and will finally give Hong Kong a product that can be accessible by every hospital and surgeon. We look forward to growing the business through our partnership with OrthAlign.”

In a published TKA clinical study by Denis Nam, M.D. (Rush University Medical Center, Chicago, IL), significant differences favoring the use of KneeAlign vs. conventional Computer Assisted Surgery were found with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was also a significant difference in overall mean mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.

In another study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).

“Hong Kong’s orthopaedic market may be one of the most fascinating in the world,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “There are so many dynamics in the marketplace, such as public vs. private hospitals, long queues for patients who are on 3-year waiting lists for their total knee arthroplasties, and a strong desire for technology by surgeons. Without question, hospitals and surgeons value navigation technology, and OrthAlign will be the best option for them, not only from a price point, but also in terms of accuracy and operational workflow. As OrthAlign continues to focus on its mission in expanding customer reach, we welcome Hong Kong to the growing OrthAlign family and look forward to working with Smith & Nephew Hong Kong in providing local hospitals, surgeons, and patients our technology.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

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