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FinancialRobotics

US $5 million granted to spinal cord injury robotics research project

October 5, 2016 OrthoSpineNews

5th October 2016

Studies have shown that activity-based interventions can offer a promising approach to the improvement of motor function following spinal cord injury. Sunil Agrawal, professor of mechanical engineering and of rehabilitation and regenerative medicine at Columbia Engineering (New York City, USA) is at the forefront of research efforts to improve recovery through the development of novel robotic devices and interfaces that help patients retrain their movements.

One of Agrawal’s current projects, “Tethered pelvic assist device (TPAD) and epidural stimulation for recovery of standing in spinal cord injured patients,” has recently won a five-year US$5 million grant from the New York State Spinal Cord Injury Board. The project is a collaboration with co-principal investigator, Susan Harkema, and Claudia Angeli in the Department of Neurological Surgery at the University of Louisville, USA, and Joel Stein, chair of the Department of Rehabilitation and Regenerative Medicine, and Ferne Pomerantz , assistant professor of rehabilitation and regenerative medicine in the Department of Rehabilitation and Regenerative Medicine, both at Columbia University Medical Center (New York City, USA). Agrawal’s focus is on improving the effectiveness of stand/balance training during spinal cord injury rehabilitation by using a unique robotic system—Tethered Pelvic Assist Device (TPAD)—invented in his Robotics and Rehabilitation (ROAR) Laboratory at Columbia Engineering.

Agrawal’s TPAD is a wearable, light-weight cable-driven robot that can be programmed to provide both motion perturbations to the pelvis as well as corrective forces to stabilise it. The Agrawal and Harkema groups will combine their expertise and technologies for balance training of SCI patients during standing.

Harkema’s group at the University of Louisville has pioneered the use of activity-based rehabilitation for spinal cord injury patients and, more recently, the use of epidural stimulation of the lumbosacral spinal cord during stand training of spinal cord injury subjects. Their results show the effectiveness of stand training of spinal cord injury patients by combining epidural stimulation and principles of motor learning. The group has successfully shown this strategy to work with the most severely injured individuals.

Even though these patients are able to stand, they are unable to maintain balance. As a result, they have difficulty in transferring this skill to the activities of daily life.

“We are using this technology for the first time to enhance the effectiveness of balance recovery during stand training of spinal cord injury survivors,” says Agrawal, who has, in the past, received funding from the US National Institutes of Health to work extensively on gait training of stroke survivors by designing robotic exoskeletons that can be worn by patients during training in the rehab clinics. “Robotic exoskeletons are typically designed to assist in training of human movements during the swing phase of the gait, but there are currently no robotic devices that can effectively be used for posture and balance training during standing.”

Agrawal’s TPAD consists of a pelvic belt with multiple cables connected to motors, a real-time motion capture system, and a real-time controller to regulate the tensions in the cables. The device is programmed to provide pelvic forces in any direction and respond to motions of the human body. Its tethers can also be configured to apply symmetric or asymmetric forces on the pelvis, as needed by an intervention. The system design allows placement of motors and pulleys on a frame to achieve cable configurations to be able to apply corrective or perturbative forces on the pelvis in any direction, whether these be up, down, or sideways.

“Our TPAD, along with its extensions, can be used in a variety of interventions during walking or standing,” adds Agrawal, who is also a member of Columbia’s Data Science Institute. “So sensory input, repetition, and challenged behaviour can drive the spinal networks to adapt appropriately and generate functional activation across the level of injury. This functional load bearing and acquisition of balance can have a tremendous impact on the continued health and quality of life of individuals with spinal cord injury.”

In addition to the TPAD grant, Agrawal was honored recently by the American Society of Mechanical Engineering with its Machine Design Award for his “seminal contributions to the design of robotic exoskeletons for gait retraining of stroke patients.”

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Robotics

Ekso Bionics® Launches Ekso GT with Smart Assist

October 5, 2016 OrthoSpineNews

RICHMOND, Calif., Oct. 04, 2016 (GLOBE NEWSWIRE) — Ekso Bionics Holdings, Inc. (EKSO), a robotic exoskeleton company, today announced it recently has shipped the first device incorporating SmartAssist, its next generation gait therapy software, allowing the company to expand the range of patients who can participate in robotic therapy.

The SmartAssist technology, which is currently available for Ekso GT devices in Europe, offers new options to therapists for customizing training in gait and balance. The SmartAssist software allows physical therapists to vary the support of the device for each leg independently – from full power to free walking – and thereby meet the specific needs of patients.  This capability enables the Ekso GT to rehabilitate a larger range of patients, from those too weak to walk to those who are nearly independent.

“SmartAssist has definitely made a change to how we use the exoskeleton and broadened the spectrum of conditions we can use it for,” commented Louis Martinelli, Neurological Physiotherapist at Hobbs Rehabilitation in Winchester, England. “The therapists can now adjust the settings to vary the support we give, not only to the swing phase but the stance phase of gait, giving the participant access to an optimal walking pattern.”

The Ekso GT with SmartAssist is a comprehensive gait therapy tool that can support a broad spectrum of patients.  The technology allows patients to be more actively engaged in their rehabilitation than ever before, enabling more activity with higher intensity than previously possible.

“Ekso GT with SmartAssist software was developed to expand the applications for use within clinics.  The addition of pre-gait exercises have facilitated earlier mobility for some patients who could not have otherwise been mobile and our new FreeGait advanced mode can help patients progress to community ambulation,” commented Thomas Looby, chief executive officer of Ekso Bionics.  “We are excited to offer this as another life changing solution for patients who use our exoskeletons for rehabilitation.”

The SmartAssist software is not yet available in the United States.

About Ekso Bionics®
Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of R&D projects intended to benefit U.S. defense capabilities. The company is headquartered in the Bay Area and is listed on the Nasdaq Capital Market under the symbol EKSO. For more information, visit: www.eksobionics.com.

About Ekso™ GT
Ekso™ GT is the first FDA cleared exoskeleton cleared for use with stroke and spinal cord injuries from L5 to C7. The Ekso GT with smart Variable Assist™ (marketed as SmartAssist outside the U.S.) software is the only exoskeleton available for rehabilitation institutions that can provide adaptive amounts of power to either side of the patient’s body, challenging the patient as they progress through their continuum of care. The suit’s patented technology provides the ability to mobilize patients earlier, more frequently and with a greater number of high intensity steps. To date, this device has helped patients take more than 55 million steps in over 120 rehabilitation institutions around the world.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) a projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing to fund the Company’s operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company’s products, the Company’s failure to achieve broad market acceptance of the Company’s products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company’s medical device products, the failure to obtain or maintain patent protection for the Company’s technology, failure to obtain or maintain regulatory approval to market the Company’s medical devices, lack of product diversification, existing or increased competition, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. To learn more about Ekso Bionics please visit us at www.eksobionics.com. The Company does not undertake to update these forward-looking statements.

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Spine

SI-BONE, Inc. Continues Leadership in Clinical Evidence Transparency Initiative Adding INSITE 2-Year RCT Results to Yale University Open Data Access Program

October 5, 2016 OrthoSpineNews

SAN JOSE, Calif., Oct. 5, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced it has submitted INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004) 2-year randomized controlled trial (RCT) data to Yale University’s Open Data Access (YODA) program as part of its ongoing effort to promote data transparency regarding its clinical trials. INSITE is a RCT of MIS SI joint fusion with iFuse compared to non-surgical management.  The trial enrolled 148 subjects at 19 centers in the U.S.  Earlier this year, SI-BONE initiated a partnership with YODA and released 2 year results from a sister study, SIFI (Sacroiliac Joint Fusion With iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion that included 172 subjects treated at 26 U.S. centers.  The goal of the partnership between SI-BONE and YODA is to make data from key clinical trials of sacroiliac joint fusion available to approved researchers to allow secondary analyses of clinical trial data and set a new standard for transparency of clinical evidence in medical devices.

SI-BONE’s iFuse is the only SI joint fusion device with a patented triangular profile that resists joint motion and is supported by more than 45 peer-reviewed publications.  No other SI joint fusion device has peer-reviewed published evidence supporting safety and effectiveness, and iFuse is the only such device commercially available in the United States with an indication statement that includes claims regarding improved pain, patient function and quality of life.

“Interest in clinical trial data-sharing has increased markedly, with several recent editorials in the New England Journal of Medicine on the topic. SI-BONE welcomes independent analysis of its clinical trial data, as it may shed new light on aspects of the treatment procedure. SI-BONE encourages its colleagues in both industry and academia to share their clinical trial data,” said Daniel Cher, MD, Vice President of Clinical Affairs, SI-BONE.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders.  The company develops, manufactures and markets minimally invasive products for the SI joint.  SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface creating an interference fit designed to help decrease joint motion, and allow for biological fixation to support long-term fusion.  iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 45 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse (www.si-bone.com/results).  It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9734.100516 

SOURCE SI-BONE, Inc.

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FinancialRecon

ConforMIS Announces Sale of Over 50,000 Customized Knee Implants

October 4, 2016 OrthoSpineNews

BEDFORD, Mass., Oct. 04, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced a significant milestone.  ConforMIS has sold more than 50,000 implants, each individually sized and shaped to fit each patient’s unique anatomy.  Unlike manufacturers of traditional “off-the-shelf” knee replacement implants that offer products with a limited range of sizes and geometries, ConforMIS offers a broad line of customized knee implants designed to restore the natural shape of a patient’s knee.  To commemorate this milestone, a group of male and female patients, ages 40-75, will be gathering in Boston to kick-off the ConforMIS Patient Ambassador Program.

“We are thrilled to be commemorating this important company milestone together with our deeply committed team of ConforMIS employees dedicated to delivering innovative, high quality technology.  We are in the business of helping surgeons and healthcare professionals treat their knee replacement patients by offering them a broad line of customized knee implants for individualized orthopedic care.  Understanding that patient-to-patient communication is one of the most meaningful experiences for potential patients seeking joint replacement options, we are excited to introduce a new program designed to facilitate and enable patient connectivity,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “With over 50,000 implants sold, we feel the timing is right to launch this initiative.  Our patients are unique, each and every one of them, and our Patient Ambassador Program will allow the everyday ConforMIS patient to share his or her story with others fighting a similar battle.”

This week ConforMIS is holding its first Patient Ambassador Summit, a special gathering of patients from across the United States treated with ConforMIS customized knee implants in one or both knees. This group includes some of the earliest patients to be treated with a ConforMIS knee implant alongside more recent patients.  The Patient Ambassador group is comprised of patients that have either a partial or total ConforMIS customized knee replacement ranging from the iUni, iTotal CR and iTotal PS, and each will share their personal story.  This week, these patients will have the opportunity to experience firsthand how ConforMIS solutions are individually designed and manufactured using its proprietary software and 3D printing technology.

Each ConforMIS partial and total knee implant, including iTotal® CR, iTotal® PS, iDuo® and iUni®, is developed using proprietary algorithms and computer software to map the articular surfaces of the knee joint, define the areas of disease and convert the imaging data into a three-dimensional model of the knee.  ConforMIS engineers then use computer-aided design, or CAD, software to design the customized implant and single-use, sterile surgical instrumentation that will precisely match the three dimensional model of the patient’s knee.

The focus on innovation in customized implants continues today at ConforMIS.  In March 2016 the company launched iTotal PS, which nearly triples the company’s addressable market.  Like iTotal CR, iTotal PS implants are customized for each patient to avoid compromises on implant fit, rotation and alignment, which can cause residual pain and functional limitations after surgery.

 About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up athttp://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the Patient Ambassador Program, the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, the impact of patient communication programs, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Investor contact:

Oksana Bradley

ir@conformis.com

(781) 374-5598

 

Media contacts:

Bill Berry

Berry & Company Public Relations

Bberry@berrypr.com

(212) 253-8881

 

Lynn Granito

Berry & Company Public Relations

Lgranito@berrypr.com

(212) 253-8881

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Spine

Eurospine 2016: joimax Launches Its New MultiZYTE SI-Joint Endoscopic Therapy Set And Its New Intracs Interaoperative Navigation Tracking & Control System

October 4, 2016 OrthoSpineNews

IRVINE, Calif., Oct. 4, 2016 /PRNewswire-iReach/ — joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally invasive spinal surgery, will again exhibit at Eurospine 2016 taking place from October 5 – 7 in Berlin. During the conference, joimax®will launch two new products – the MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy Set and its new Intracs® Interaoperative Navigation Tracking & Control System.

MultiZYTE® SI Endoscopic Sacroiliac Joint Therapy is developed for the treatment of the Sacroiliac Joint Syndrome (SIJS), which has been rediscovered as a major back pain generator in recent years. This kind of pain is commonly felt in the lower back, the gluteal region, the hip and thigh and can even radiate into the leg and foot. Until the 1930s, SI-Joint was the main reason for low back pain, but since 1934 the focus has been on disc herniation. According to recent studies, 15 to 25% of all low back pain is caused by the SI-Joint and up to 43% in patients having undergone lumbosacral fusion. MultiZYTE® SI joimax® now offers a well developed and lasting treatment option for this disease.

The Intracs® Interaoperative Navigation Tracking & Control System was developed in cooperation between joimax® GmbH Karlsruhe and fiagon GmbH in Berlin, both located in Germany. With the Intracs® system, joimax® instruments can be navigated directly at the tip using Fiagons “chip at the tip” technology which allows tracking of instruments with a diameter in the 1mm range. The Intracs ® Navigation and Monitor Unit is integrated in the joimax® Endoscopic Tower and all necessary tools are tailored for the TESSYS® (transforaminal) and iLESSYS® (interlaminar) procedures as well as for minimally invasive stabilization procedures, like EndoLIF® and Percusys®. The main features of the Intracs® system are needle navigation through Vector-Tip-Target processing tools, the merging of 2D X-Rays with 3D- images of a patient’s CT or MRI scans, and the constant orientation control of any endoscope used in joimax procedures.

“With these two new developments we are in the position to enhance our endoscopic minimally-invasive product portfolio, driving adoption rates to meet new heights. With the world unique Intracs® system, navigation is now faster, safer and more accurate than ever before using an electromagnetic (EM) field. Radiation exposure for both, patients and surgeons will be significantly reduced,” says Wolfgang Ries, CEO and founder of joimax®.  “Additionally the learning curve for all spinal endoscopic procedures offered by joimax® will now be significantly reduced and the rapid expansion of all these techniques is now well layed-out,” he continues.

About joimax®

Founded in Karlsruhe, Germany, in 2001, joimax® is the leading developer and marketer of complete systems for endoscopic minimally invasive spinal surgery. With TESSYS® (transforaminal), iLESSYS® (interlaminar) and CESSYS® (cervical) for decompression procedures, MultiZYTE® RT (e.g. for rhizotomy) and with MultiZYTE® SI for SI-Joint therapy or with EndoLIF®and Percusys® for minimally-invasive endoscopic assisted stabilizations, proven endoscopic systems are provided that, together, cover a whole variety of indications.

In procedures for herniated disc, stenosis, pain therapy or spinal stabilization treatment, surgeons utilize joimax® technologies to operate through small incisions – under local or full anesthetic – via tissue and muscle-sparing corridors through natural openings into the spinal canal (e.g. intervertebral foramen, the “Kambin triangle”). For more information visit www.joimax.com

Media Contact: Melissa Brumley, joimax® Inc., 001 949 859 3472, Melissa.brumley@joimaxusa.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE joimax

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Regulatory

St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain

October 4, 2016 OrthoSpineNews

October 04, 2016

ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. approval of BurstDR™ stimulation, a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy. With FDA approval of BurstDR stimulation, which is exclusive to St. Jude Medical, the company aims to help patients find relief from their pain and suffering while also providing patients a better experience with their chronic pain therapy.

Chronic pain is a complex and challenging condition for physicians to manage, and a heavy burden for patients who find their lives profoundly limited by their pain. Many patients often move from treatment option to treatment option seeking pain relief, only to find a partial or incomplete response to therapy.

Fortunately, SCS therapy can transform quality of life for many people who are otherwise unable to find relief from chronic pain. BurstDR stimulation from St. Jude Medical has been clinically proven to improve upon traditional SCS by generating superior pain relief. With BurstDR stimulation, St. Jude Medical is also helping physicians address their patients’ physical and emotional responses to pain and reduce overall pain and suffering as measured by patients who reported their responses to therapy with BurstDR stimulation through visual analogue scale (VAS) scoring.

“As a physician, reducing the physical sensation of pain experienced by my patients is only part of my job; my ultimate goal is to help patients overcome both the physical pain and the suffering associated with their pain,” said Dr. Timothy R. Deer, president and chief executive officer of The Center for Pain Relief in Charleston, West Virginia. “Now, with BurstDR stimulation, St. Jude Medical has armed physicians with a new therapy option that can reduce patients’ pain and suffering, reduce paresthesia and help us offer our patients a more complete pain management option.”

St. Jude Medical’s proprietary BurstDR stimulation works differently from other stimulation designs, utilizing intermittent “burst” pulses designed to mimic the body’s natural nerve impulse patterns. While other companies have tried to mimic burst patterns, BurstDR stimulation from St. Jude Medical is the only approved form of burst stimulation to have been evaluated in a large scale, multicenter randomized controlled clinical trial.

The St. Jude Medical BurstDR stimulation was introduced after nearly a decade of research and study in collaboration with Prof. Dirk De Ridder, who filed the therapy’s initial patents in 2004. BurstDR stimulation was evaluated within the SUNBURST study, a prospective, randomized multicenter study which confirmed BurstDR stimulation offered superior pain relief over traditional SCS and that the therapy was preferred by most patients over traditional SCS therapy. In addition, BurstDR stimulation from St. Jude Medical has been studied in a large number of international real world studies that have helped the company assess the benefits of the therapy in patients worldwide.

“I am very excited that patients across the United States will now have access to BurstDR stimulation, which has enjoyed strong success across other global markets,” said Prof. De Ridder, from the University of Otago in Dunedin, New Zealand. “When I developed BurstDR stimulation my goal was to introduce an entirely new therapy option, and one that was rooted in the natural way in which the human body responds to and combats the sensation of pain.”

With FDA approval of BurstDR stimulation, patients receiving new implants of the St. Jude Medical Proclaim™ Elite and Prodigy MRI™ spinal cord stimulation systems will have immediate access to the new therapy. Combined, the Proclaim Elite SCS System and BurstDR stimulation offers patients the advantages of the St. Jude Medical Invisible Therapy™ portfolio and an entirely recharge free option, allowing patients to focus on their lives instead of their pain. In addition, patients previously implanted with upgradeable Protégé™ and Proclaim SCS systems will soon be able to upgrade their systems to deliver BurstDR stimulation without additional surgery.

“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Allen W. Burton, M.D., medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “With FDA approval of BurstDR stimulation, we are empowering physicians with a new therapy option in their fight against widespread chronic pain, and our goal is to continue to improve patient outcomes and get more patients the pain relief they deserve.”

About the St. Jude Medical Chronic Pain Portfolio

Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of chronic pain therapy solutions and the only medical device manufacturer in the world to offer radiofrequency ablation (RFA) and spinal cord stimulation (SCS) therapy solutions including BurstDR stimulation and stimulation of the dorsal root ganglion (DRG) for the treatment of chronic pain.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter@SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Justin Paquette, 651-756-6293
Public Relations
jpaquette@sjm.com

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Spine

Stryker’s Spine Division Announces Launch of New LITe® BIO Delivery System

October 4, 2016 OrthoSpineNews

October 04, 2016

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced the launch of its LITe BIO Delivery System, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites, which simplifies graft delivery, accommodates a surgeon’s preferred graft materials,1 and allows for direct visualization of graft placement.

The unique design of the LITe BIO Delivery System provides surgeons with a single-handed method to deliver any type of autograft, allograft, or synthetic bone graft material without obstructing visibility. The innovative delivery tool provides tactile, visual, and audible confirmation of bone graft delivery, and the mallet-free system eliminates the impaction of bone graft.

According to Bradley Paddock, President of Stryker’s Spine division, the new LITe BIO Delivery System offers significant benefits. Although conventional bone graft delivery methods can accommodate any type of graft material, they can be cumbersome to use. Pre-filled delivery devices are more streamlined but can only be used with specific graft materials.

“Our new LITe BIO Delivery System is innovative in the marketplace, simplifying graft delivery for spine surgeons,” Paddock said. “Its sleek, versatile design can accommodate any bone graft material and provides surgeons with direct visualization to aid in the precise placement of the graft, which is important for optimal fusion. No other system combines all of these key features—the LITe BIO Delivery System truly is advanced delivery, simplified.”

The LITe BIO Delivery System is the latest addition to Stryker’s comprehensive spine portfolio, which includes products and instruments designed for access, interbody, fixation, and fusion. The patented system can be used for any type of spine fusion surgery, including minimally invasive procedures. The low-profile design allows visibility through a decompression tube without obstructing view. A radiolucent strip facilitates visualization under fluoroscopy, and the disposable cannula allows for delivery of up to 5cc of bone graft at one time.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

1. FDA Cleared Indications for Use: The LITe BIO Delivery System is intended to deliver autograft, allograft or synthetic bone graft materials to all orthopaedic surgical sites.

Content ID BILIT-PR-1_11158

Contacts

Sullivan & Associates
Barbara Sullivan, 714-374-6174
bsullivan@sullivanpr.com

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FinancialSpine

National Science Foundation Funds Nasseo, Inc. for Nanotube Technology on PEEK Orthopedic Devices

October 3, 2016 OrthoSpineNews

SAN DIEGO, Calif., Oct. 3, 2016 /PRNewswire/ — Nasseo, Inc., a medical technology company dedicated to developing enhanced surface technologies for dental and orthopedic applications, has been awarded a Small Business Innovation Research Grant from the National Science Foundation (NSF).

The NSF grant funding will further Nasseo’s work improving spinal implants by using a nano-engineered surface coating; Nasseo will conduct feasibility studies with an optimized nanotube surface on medical grade polyether ether ketone (PEEK).  When applied to PEEK implants, Nasseo’s nanotube surface technology maintains the benefit of the material’s radiolucency while providing an enhanced bone response. The Company’s aim is to improve the osseointegration of PEEK spinal interbody fusion devices.

“The National Science Foundation’s interest in advancing our work is a distinct honor. The grant will accelerate development of our unique platform surface technology, with an ultimate goal of improving clinical outcomes for orthopedic patient care,” says Nasseo’s Co-founder and CTO Dr. Garrett Cale Smith, who will also serve as primary investigator on the study. Prior to Nasseo, Smith co-founded Oculeve, Inc., a medical technology company acquired by Allergan PLC.

Nasseo holds four issued patents on nanotube platform technology.

To date, over 10 years of research have validated Nasseo’s nanotube surface technology; numerous studies have demonstrated enhanced bone cell response and anti-bacterial properties compared with conventional implant surfaces.

About Nasseo, Inc.
Nasseo, Inc. is a privately owned medical device company developing enhanced surface technologies for dental, spinal, and orthopedic applications. Nasseo was founded based on the intellectual property developed at the University of California, San Diego.  The Company’s TiArray Dental Implant System has received 510(k) clearance. Nasseo is headquartered in San Diego, CA, with research & development facilities in Phoenix, AZ.

SOURCE Nasseo, Inc.

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Spine

NuVasive Appoints Joan Stafslien as Executive Vice President, General Counsel

October 3, 2016 OrthoSpineNews

SAN DIEGO, CA–(Marketwired – October 03, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Joan Stafslien is joining the Company as executive vice president, general counsel and corporate secretary. In this role, Ms. Stafslien will oversee the Company’s global legal function, reporting to NuVasive’s chairman and chief executive officer, Gregory T. Lucier, and serving on the company’s executive leadership team.

Ms. Stafslien brings to NuVasive more than 20 years of experience as a legal advisor to medical technology companies. She joins NuVasive from CareFusion, where she served as general counsel and corporate secretary from 2009 until its acquisition by Becton Dickinson in 2015.

“Joan’s experience spans a broad spectrum of legal areas, including intellectual property, U.S. and International litigation, regulatory compliance, SEC matters and M&A, with extensive experience in the global medical technology sector,” said Mr. Lucier. “Joan’s understanding of complex medical technology companies on high growth trajectories makes her a perfect fit with the strong foundation we have established with our legal team. We continue to invest in building a world-class leadership team to support our growing innovation position in the global spine market.”

Ms. Stafslien’s career includes law firm and corporate experience. She previously served as CareFusion’s general counsel, corporate secretary and chief compliance officer where she led the legal team through the spin-off from Cardinal Health in 2009 and the acquisition by Becton Dickinson in 2015. Previously, she was the segment general counsel of Cardinal Health’s Clinical Technologies and Services from 2004 to 2009. Ms. Stafslien joined Cardinal Health through the acquisition of Alaris Medical Systems in 2004, where she served as deputy general counsel and assistant secretary. Prior to joining Alaris, she was in private practice with Brobeck, Phleger & Harrison. Ms. Stafslien serves on the advisory board of the Chemical and Biological Engineering Department of Northwestern University. She holds a law degree from University of Wisconsin Law School and a bachelor’s degree in Chemical Engineering from Northwestern University.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission.NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

CONTACT INFORMATION

  • Investor Contact:
    Suzanne Hatcher
    NuVasive, Inc.
    858-458-2240
    Email contact

    Media Contact:
    Michael Farrington
    NuVasive, Inc.
    858-909-1940
    Email contact

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Recon

How 10 hospitals took their total joint replacement programs to the next level

October 3, 2016 OrthoSpineNews

Written by Laura Dyrda – September 29, 2016

The following 10 hospitals and health systems updated their total joint replacement programs with new initiatives such as data analytics, bundled payments, quality improvement and telehealth.

Here are their stories

Baptist Health System (San Antonio). Global professional services firm Navigant partnered with Baptist Health System in 2012 to develop and implement a program that would fit under the Center for Medicare and Medicaid Innovation’s Bundled Payments for Care Improvement initiative. The updates involved redesigning teams and improving the clinical information sharing strategy for better overall care. The program went live in October 2013 for joint replacements, including new initiatives for physician engagement; post-acute network partnerships; gainsharing and funds flow; and supporting analytics. A 2016 case study showed the hospital saved $2.3 million in the first year after participating in BPCI. The hospital also reported a 10 percent reduction in readmissions, 20 percent reduction in skilled nursing utilization and 22 percent reduction in patient rehab utilization.

Hoag Orthopedic Institute (Irvine, Calif.). Hoag Orthopedic Institute participated in the Cambridge, Mass.-based Institute for Healthcare Improvement’s Joint Replacement Learning Community in 2014 to gather data and identify areas to maximize value. In 2015, the hospital welcomed a chapter of Avant-garde, which provides hospitals with technology and analytics tools to measure clinical and cost data, to improve scalability and to set standards for care. The next step in the hospital’s journey to providing value-based care includes further data analytics for care cycles through the continuum of care. The hospital also was the subject of a Harvard Business School case study examining outcomes, cost reduction and reimbursement. Finally, the hospital has a bundled payment system covering services and participated in the Integrated Healthcare Association’s pilot program in 2010 and the National Orthopedic and Spine Alliance program in 2015.

Hospital for Special Surgery (New York City). The adult reconstruction and joint replacement service at Hospital for Special Surgery provides more than 9,000 hip and knee replacements per year and U.S. News & World Report has ranked the hospital as No. 1 in orthopedics for seven consecutive years. The hospital is using telehealth to engage patients before and after their surgeries to improve outcomes and stay connected to the patients after they return home. HSS and ViiMed developed a standardized framework telehealth program for personalized patient education, information and recorded video activities designed to open lines of communication between patients and providers. Among total knee replacement patients, 97 percent report pain relief and 96.3 percent report return to function two years after surgery.

 

 

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