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Stimwave Awarded U.S. Government DAPA Contract

Posted On April 24, 2017 By OrthoSpineNews In Neuro, Regulatory /  

April 21, 2017

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced it has been awarded a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency. Stimwave, which distributes the Stimwave Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System, received a five-year contract, negotiated by TAMM Net, Inc., which is the first global agreement for spinal cord stimulators by a U.S. government agency.

“We are extremely pleased Stimwave received a DAPA. The successful product validation process now allows Stimwave products to be accessed and used by doctors at all military treatment facilities across the globe,” said Laura Perryman, CEO and president of Stimwave. “Multiple facilities have been pleased to hear they can now acquire our products through their purchasing vehicles.”

Stimwave’s devices use Wireless Pain Relief® technology and are 95 percent smaller than any other neuromodulation device on the market. Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.

Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

About TAMM Net, Inc.

TAMM is a consultancy that provides services to biomedical manufacturers seeking opportunities or overcoming obstacles presented by the U.S. government. TAMM provides complete reimbursement, full federal contracting services, regulatory affairs, and facilitating sales to federal medical facilities. http://www.tammnet.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

Contacts

Glodow Nead Communications
Evan Nicholson, Sonia Sparks, Kati Stadum, and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

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Bioventus Names David Varner Vice President of Marketing, Active Healing Therapies

Posted On April 24, 2017 By OrthoSpineNews In Biologics /  

April 24, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced it has named David Varner as Vice President of Marketing, Active Healing Therapies (AHT). Varner will be responsible for developing and executing global strategic marketing plans for the AHT business. He will also provide leadership to its sales training, marketing intelligence, marketing, external communications and professional affairs & medical education business functions.

“We are very pleased David is joining us to lead global marketing for our Active Healing Therapies business,” said John Nosenzo, Chief Commercial Officer, Bioventus. “His deep experience in healthcare sales, marketing and operations roles combined with his ability to create high performing teams and launch new initiatives will help Bioventus continue to develop our AHT product portfolio and accelerate our growth in orthobiologics around the world.”

Varner joins Bioventus from Beckman Coulter Diagnostics, where he served as Vice President, Global Sales Operations. Previously he worked in the Life Sciences Division of GE Healthcare in a succession of marketing and sales leadership positions, last serving as the company’s General Manager, Global Marketing Operations. Prior to that, Varner spent 13 years in a variety of sales, marketing and operations roles with Siemens Medical Diagnostics (formerly Bayer Diagnostics).

Varner earned a Bachelor of Arts from The College of William and Mary.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

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Intuitive Surgical Leads China Surgical Robotics Systems Market

Posted On April 21, 2017 By OrthoSpineNews In Robotics /  

VANCOUVER, British Columbia, April 21, 2017 /PRNewswire/ — According to a new series of reports on the China surgical navigation and robotics systems market by iData Research (www.idataresearch.com), the market in China is currently dominated by Intuitive Surgical, but has seen the entrance of companies such as Medtech and Accuray, predominantly in neurosurgery and radiosurgery applications. The market as a whole is expected to increase considerably as system sales increase and revenue from procedures, maintenance and services increases as a result of the growing installed base.

“The MIS robotic device market in China is the most mature and sees Intuitive Surgical as the market leader, but several companies are developing systems which will compete with Intuitive’s system,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “As the installed base grows, the number of procedures will increase yearly, yielding a higher percentage of revenue from procedures.”

The Chinese robotic assisted surgery system market is expected to grow at a compound annual growth rate (CAGR) of over 14% through 2023 as a result of increasing adoption of robotic technologies in the neurosurgery, minimally invasive surgery (MIS), radiosurgery and spinal markets. Currently, the MIS, neurosurgery, and radiosurgery application segments are firmly established in China. Very small installed bases exist for systems with spinal applications and these are also expected to exhibit growth.

Overall, the surgical robotics market in China is still in its infancy. In addition to imported systems, several domestic companies are developing systems in a variety of procedural segments. Hong Kong has been a leading region for early system placements, with the first system, a da Vinci®, installed in Hong Kong’s Prince of Wales Hospital in 2005. As many robotics companies begin to expand partnerships with established medical device companies, sales of robotic surgery systems are expected to increase significantly. Gynecological procedures are the largest specialty of the da Vinci® system in China, followed by general surgery.

Additional competitors in the China robotic assisted surgery market include Accuray with their CyberKnife® system and Medtech who currently sells ROSA®, the only robotic surgery system approved for neurosurgical procedures by the China Food and Drug Administration (CFDA). Neurosurgical procedure applications include stereoelectroencephalography (SEEG) treatment for epilepsy, as well as hydrocephalus shunt, electrode placement, endoscopy and deep brain stimulation. It is expected that other companies will enter the Chinese market in the near future.

For Further Information

More on the surgical robotics market in China can be found in a series of reports published by iData Research entitled the China Market Report Suite for Surgical Navigation and Robotics Systems. The segmentation for surgical navigation includes systems with neurosurgery applications, spinal surgery applications, ear, nose and throat (ENT) applications, and orthopedic hip and knee applications. The segmentation for surgical robotics systems includes robotically assisted neurosurgery systems, minimally invasive surgery (MIS), robotically assisted radiosurgery systems and an appendix with qualitative data regarding robotically assisted spinal surgery systems.

The iData report series on robotic surgery systems covers the U.S., China, Australia, Japan, India and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about robotic surgery systems market data, register online or email us at info@idataresearch.net for a China Market Report Suite for Surgical Navigation and Robotics Systems brochure and synopsis.

About iData Research

iData Research (www.idataresearch.com) is an international market research and consulting firm, dedicated to providing the best in business intelligence for the medical device industry. Our research empowers our clients by providing them with the necessary tools to achieve their goals and do it right the first time. iData covers research in: Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Endoscopy, Dental Operatory Equipment, Dental Material, Dental Lasers, Dental Prosthetics, Dental CAD/CAM, Dental Bone Graft Substitutes, Ophthalmics, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Vascular Access, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Operating Room Equipment, Surgical Microscopes, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics and more.

We have built a reputation and earned our clients’ trust based on consistent and uniquely intelligent research that allows our customers to make confident decisions and impact their businesses. A combination of market expertise and over a decade of experience has resulted in a deep understanding of the medical device industry that has inspired innovation and propelled our clients to success.

Contact Info
Marvin Cidamon
Marketing Coordinator
iData Research Inc.
604-266-6933 Ext. 205
marvinc@idataresearch.net

 

SOURCE iData Research

Related Links

https://www.idataresearch.com

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3-D Printable Implants May Ease Damaged Knees

Posted On April 21, 2017 By OrthoSpineNews In Biologics, Top Stories /  

PUBLISHED IN  – By KARA MANKE

A cartilage-mimicking material created by researchers at Duke University may one day allow surgeons to 3-D print replacement knee parts that are custom-shaped to each patient’s anatomy.

Human knees come with a pair of built-in shock absorbers called the menisci. These ear-shaped hunks of cartilage, nestled between the thigh and shin bones, cushion every step we take. But a lifetime of wear-and-tear — or a single wrong step during a game of soccer or tennis — can permanently damage these key supports, leading to pain and an increased risk of developing arthritis.

The hydrogel-based material the researchers developed is the first to match human cartilage in strength and elasticity while also remaining 3-D-printable and stable inside the body. To demonstrate how it might work, the researchers used a $300 3-D printer to create custom menisci for a plastic model of a knee.

“We’ve made it very easy now for anyone to print something that is pretty close in its mechanical properties to cartilage, in a relatively simple and inexpensive process,” said Benjamin Wiley, an associate professor of chemistry at Duke and author on the paper, which appears online in ACS Biomaterials Science and Engineering.

After we reach adulthood, the meniscus has limited ability to heal on its own. Surgeons can attempt to repair a torn or damaged meniscus, but often it must be partially or completely removed. Available implants either do not match the strength and elasticity of the original cartilage, or are not biocompatible, meaning they do not support the growth of cells to encourage healing around the site.

Recently, materials called hydrogels have been gaining traction as a replacement for lost cartilage. Hydrogels are biocompatible and share a very similar molecular structure to cartilage: if you zoom in on either, you’ll find a web of long string-like molecules with water molecules wedged into the gaps.

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Stryker’s Spine Division to Feature Comprehensive Product Portfolio at AANS 2017 Conference

Posted On April 21, 2017 By OrthoSpineNews In Spine /  

April 21, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division will exhibit its comprehensive suite of spinal products at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, April 22–26, 2017, at the Los Angeles Convention Center (booth No. 1301). This exhibition includes a number of advanced spinal products and technologies that Stryker’s Spine division has introduced in the past year. The company also will offer a Lunch-and-Learn educational program for AANS members attending the meeting.

“This is an exciting time, both for the field of spinal surgery and for Stryker’s Spine division,” said Bradley Paddock, President of the company’s Spine division. “Our expanding portfolio of spinal procedural innovations and differentiated technologies demonstrates our commitment to bringing state-of-the-art products to physicians and their patients. We will continue to increase and strengthen our leadership position in this segment and are thrilled to showcase our latest technology advances at the AANS conference.”

Stryker’s Spine division’s products offer advancements for both traditional and minimally invasive surgical techniques. Recently introduced technologies that will be highlighted at the meeting include:

  • The Tritanium Posterior Lumbar (PL) Cage, a 3D-printed interbody fusion device designed to aid in lumbar spinal fixation for patients with degenerative disc disease, including up to Grade 1 spondylolisthesis, and degenerative scoliosis. It is manufactured using Stryker’s proprietary Tritanium Technology, which allows for the creation of porous structures that are designed to mimic cancellous bone in pore size, level of porosity, and interconnectivity of the pores.1 The cage is now offered in a variety of new sizes, which were introduced at the 2017 AAOS conference in March.
  • Aero-C Cervical Stability System (Aero-C), the only StraightForward anterior cervical discectomy and fusion (ACDF) device that offers uniform compression across the interbody space.2 Using Aerofoil™ Compression Technology, Aero-C is designed to pull the vertebral bodies toward the implant as it is inserted, creating compressive forces at the implant-to-endplate interface.2
  • Xia CT (Xia 4.5 Cortical Trajectory), which includes implants and instruments used in less invasive LITe LIF posterior lumbar interbody fusion procedures for patients with degenerative disc disease, spondylolisthesis, and trauma. The cortical trajectory procedure facilitates a smaller midline incision to help achieve decompression, fixation, and fusion.3 It also is intended to be more muscle sparing than standard open procedures that require lateral dissection, and its reduced incision may allow for more efficient exposure and closure time.3
  • The LITe BIO Delivery System, a hand-held device used to facilitate delivery of bone graft material to spinal surgery sites, simplifies graft delivery, accommodates a surgeon’s preferred graft materials,4 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.

Stryker’s Spine division will host the Lunch-and-Learn seminar, “Tritanium: A Novel Highly Porous Titanium Alloy for Interbody Fusion Procedures,” Monday, April 24 from 1:10–1:55 p.m. The seminar will be presented by Matthew J. McGirt, M.D., from the Department of Neurosurgery at the University of North Carolina.

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.

References

1. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.
2. PROJ0000050417 Aero-C Anchor Induced Compression Testing Design Iteration Memo
3. Lee GW, Son JH, Ahn MW, Kim HJ, Yeom JS. (2015) The comparison of pedicle screw and cortical screw in posterior lumbar interbody fusion: a prospective randomized noninferiority trial. The Spine Journal 15, 1519-1526.
4. 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.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Aero, Aerofoil, LITe, StraightForward, Stryker, Tritanium, and Xia. All other trademarks are trademarks of their respective owners or holders.

Content ID TRITA-PR-7_13958

Contacts

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

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Ziptek LLC Receives FDA Approval For ZipE®, the Innovative Knotless Tissue Repair Device

Posted On April 21, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

By on April 20, 2017

Ziptek LLC, founded by Sarasota-based orthopedic surgeon Dr. William Bennett M.D., is proud to announce its newly obtained FDA-approval for the ZipE® knotless tissue repair and attachment device. ZipE® is an absorbable button that moves down a suture, locking itself from moving backward with each forward movement. It can be used in minimally-invasive techniques and open surgeries to accomplish tissue-to-tissue and tissue-to-bone repair. Most importantly, since it functions similar to a zip tie, ZipE® prevents the need to tie knots in small spaces and creates a superior contact of the repaired tissue compared to any other device on the market.

Ziptek LLC exhibited at the March 2017 AAOS Meeting in San Diego and garnered significant national and international interest by surgeons and distributors alike for the newly FDA-approved ZipE®. Given that the U.S soft tissue repair market generates $2 to $3 billion per year, with at least 500,000 rotator cuff and 1,000,000 ankle ligament cases annually, the ZipE® can play a major role in transforming the surgical outcomes of countless patients. It offers the unprecedented ability to disperse pressure across a larger surface area and help prevent the suture from tearing out through the tissue. This makes ZipE® incredibly valuable for better and improved tissue healing with a far lower rate of non-healing and re-tears.

 

 

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7D Surgical Enters Into Key Distribution Agreements in the United States for Its Breakthrough Image Guidance System for Spine Surgery

Posted On April 21, 2017 By OrthoSpineNews In Spine, Top Stories /  

TORONTO, April 20, 2017 /PRNewswire/ — 7D Surgical, developer of ground breaking surgical navigation technologies, announced today that it has entered into exclusive sales representative agreements with two premier American medical device distributors covering key strategic geographies in the United States.  Surgical One Inc. will represent 7D Surgical in several states from the Midwest to the Gulf Coast, while DB Surgical will cover the southeast U.S., including the important medical device markets in Florida.

“Proven distribution partners, such as Surgical One and DB Surgical, will complement our direct sales force in the commercialization of the MvIGS technology for the execution of our rapid growth strategy,” said Beau Standish, Chief Executive Officer of 7D Surgical.  “Both companies have the infrastructure, footprint and existing relationships that are required to effectively promote the benefits of 7D Surgical’s fast, cost effective and radiation-free image guided spine surgery to a large and underserved market.”

The 7D Surgical System is the first and only Machine-Vision Image Guided Surgery (MvIGS) platform. For the first-time spine surgery patients can be quickly, easily and automatically registered using only visible light and 7D Surgical’s Flash RegistrationTM technology. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new MvIGS platform can achieve an incredibly fast surgical workflow for spine procedures. 7D Surgical anticipates adding additional qualified distribution partners in coming months.

“When Surgical One learned about the new MvIGS system, we recognized immediately that the 7D Surgical technology had erased the traditional barriers to spinal image guidance adoption and the low utilization of existing alternatives,” said Al Ludvigsen, President of Surgical One Inc. “We are thrilled to exclusively represent this fast, radiation-free solution for spinal image guidance to the clinicians and patients we support.”

“While spinal image guidance had been shown in studies to reduce surgical complications, we have yet to see widespread adoption of existing technologies among spinal surgeons,” said Debbie Burg, President of DB Surgical.  “We see the introduction of the 7D Surgical System MvIGS technology as a game-changer with the potential to finally expand the use of IGS in spine surgery.”

About 7D Surgical

7D Surgical is a privately owned Toronto-based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada-approved MvIGS system delivers profound improvement to surgical workflows in spine surgery, providing the promise of similar future advancements in other surgical specialties.  www.7Dsurgical.com

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
www.7Dsurgical.com
155698@email4pr.com

About Surgical One, Inc.

SurgicalOne, Inc. is the premier surgical specialty distribution company in the Midwest to Midsouth. Our 30 direct employees cover 10 total states, with sales representatives and service repair technicians in each major market. We represent the top tier, finest microsurgical, neurosurgical and spinal product manufacturers in the world. Since our founding in 2000, we have maintained a relentless, singular focus on patients, surgical clinicians and medical facility administrators. Our ultimate goal is improved patient outcomes, combined with the highest level of clinician satisfaction. www.surgicalone.com

About DB Surgical

DB Surgical is dedicated to bringing transformational surgical technologies to hospitals and surgery centers. The company focuses on introducing tools that enable surgeons to advance patient outcomes beyond those available today. Since 1997, DB Surgical has worked with industry-leading surgeons to understand and meet the evolving needs of healthcare providers. The company is based in Coral Springs, FL and has 18 professionals located throughout Florida, Georgia, and Alabama focusing on the Neuro, Spine, ENT, Cardiovascular, Ophthalmic, and Plastic Reconstructive surgical disciplines. In addition to providing cutting-edge technologies, DB Surgical also offers a complete line of specialty surgical products designed to create value within the healthcare supply chain. www.DBSurgical.com.

Contact:
Phone: 954-340-2727
Fax: 954-340-1221
Email: sales@dbsurgical.com

Forward-looking Statements

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. 7D Surgical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond 7D Surgical’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. 7D Surgical does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“Flash Registration™,” as well as the “7D” logo, whether standing alone or in connection with the words “7D Surgical” are protected trademarks of 7D Surgical.

SOURCE 7D Surgical

Related Links

http://www.7Dsurgical.com

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Zimmer Biomet Holdings to Present at 42nd Annual Deutsche Bank Securities Annual Health Care Conference

Posted On April 20, 2017 By OrthoSpineNews In Recon /  

WARSAW, Ind., April 20, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that it will be participating in the Deutsche Bank Securities 42nd Annual Health Care Conference at the InterContinental Hotel in Boston, Massachusetts on Wednesday, May 3, 2017.  Zimmer Biomet will present at 11:20 a.m. Eastern Time.

A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  The webcast will be archived for replay following the conference.

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

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FDA Clears Halyard Health’s COOLIEF* for the Management of Osteoarthritis Knee Pain

Posted On April 20, 2017 By OrthoSpineNews In Regulatory /  

LAS VEGAS, April 20, 2017 /PRNewswire/ — American Society of Interventional Pain Physicians Annual Meeting, Booth #407 — Halyard Health (NYSE:  HYH), a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its COOLIEF* Cooled Radiofrequency (Cooled RF) thermal treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA). The first and only RF treatment to be cleared specifically to relieve OA knee pain, COOLIEF RF is a minimally invasive, thermal radiofrequency pain management system using water-cooled technology to safely deactivate pain-causing sensory nerves.

This new clearance is based on results from a 151-patient prospective, randomized multi-center study comparing COOLIEF Cooled RF to intra-articular steroid injections in patients suffering from knee pain due to osteoarthritis. In 74.1 percent of the cooled RF patient group, pain was reduced by at least 50 percent at six months and maintained in over 65.4 percent of those patients for a full 12 months post procedure1,2. At baseline, 67.1 percent of the cooled RF group and 62.7 percent of the steroid injection group reported symptoms of severe arthritis1,2. Results indicate that six months post-procedure, only 5.2 percent of the cooled RF group reported the same severity level versus 37.3 percent of patients treated with steroid injections, as measured by the Oxford Knee Score1. In addition, the cooled RF patient group’s Oxford Knee Score remained low for 12 months with only 11.5 percent reporting severe symptoms at that point1. The Oxford Knee Score is a validated outcomes instrument designed to assess function and pain associated with the knee1.

“I see many patients who suffer with chronic osteoarthritis knee pain in my practice who are not immediate candidates for knee replacement surgery due to co-morbidities, such as obesity or other chronic health issues,” said Dr. Timothy Davis, founder and medical director, Orthopedic Pain Specialists, and investigator in the recent study. “COOLIEF Cooled RF treatment provides significant pain relief for patients with OA of the knee until they are able to undergo surgery. Until now there have been few options available for my patients.”

According to the Centers for Disease Control and Prevention, OA affects over 30 million adults in the U.S. and is caused by the damage and breakdown of cartilage between bones that can lead to joint pain, swelling and stiffness3. The prevalence of OA is on the rise as both the age and weight of Americans continue to increase4. As cases of OA increase, so do associated economic costs including treatment, adaptation of lives and homes to help patients manage pain caused by the disease, and lost work productivity5.

Surgery can be beneficial in properly selected patients, but due to BMI, age, co-morbidities, invasiveness or lack of necessary support systems, some patients are either not candidates for surgery, or are forced to delay surgery6. Patients suffering from chronic knee pain wait an average of nine years until they are ready or qualify for surgery6.

Prior to surgery, initial treatments for knee pain often include nonsteroidal anti-inflammatory drugs, opioids and steroid injections. Medication provides only short-term relief and comes with serious risks, which include opioid abuse and dependence7. According to the Mayo Clinic, one in four patients prescribed opioid painkillers is at risk to progress to episodic or long-term prescription use8. Healthcare providers are becoming more conservative in the use of opioids to reduce associated complications such as nausea, respiratory depression, and even death9,10,11. Steroid injections can provide relief for months at a time, but may have to be repeated for continued pain relief6.     

“Many OA patients try unsuccessfully for years to treat their chronic knee pain with conservative pain therapies before turning to surgery. This treatment is clinically proven to be significantly more effective in relieving OA knee pain, increasing functionality, and decreasing the need for pain medication for up to a year1,” said Lisa Kudlacz, vice president and general manager, Global Interventional Pain, Halyard Health. “The U.S. consumes an astounding 80 percent of the global opioid supply with only five percent of the population7,12. At Halyard we are committed to helping curb the opioid epidemic by providing solutions that help patients manage pain without the risk of addiction.”

To learn more about COOLIEF, please visit http://www.halyardhealth.com/chronicpain.

About Halyard Health
Halyard Health Inc. (NYSE: HYH) is a medical technology company focused on eliminating pain, speeding recovery and preventing infection for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery and preventing healthcare-associated infections. Halyard’s business segments – Medical Devices and Surgical and Infection Prevention (S&IP) – develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit www.halyardhealth.com.

*Registered Trademarks or Trademarks of Halyard Health, Inc. or its affiliates.

1 Halyard Health Inc. sponsored study: A Prospective, Multi-Center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain. Final results 03Apr2017. Study available upon request from Halyard.
2 Davis T. Cooled RF Ablation Superior to Corticosteroids in Knee Osteoarthritis. Pain Medicine News [Internet]. 2017Feb2; Available from: http://www.painmedicinenews.com/Multimedia/Article/02-17/Cooled-RF-Ablation-Superior-to-Corticosteroids-in-Knee-Osteoarthritis/40262/ses=ogst?enl=true
3Osteoarthritis Fact Sheet [Internet]. CDC.gov. Centers for Disease Control and Prevention; 2017 [cited 2017Apr12]. Available from: https://www.cdc.gov/arthritis/basics/osteoarthritis.htm
4 Bliddal H, Christensen R. The treatment and prevention of knee osteoarthritis: a tool for clinical decision-making. Expert Opinion on Pharmacotherapy. 18 June 2009; 10(11):1793-804.
5 Altman RD. Early Management of Osteoarthritis. Am J Manag Care. 2010;16 (Suppl Management):S41-47.[PubMed]
6 KS&R. Halyard sponsored study: Osteoarthritis Pain Landscape & Patient Journey. 2015. Data on file.
7AAOS – American Academy of Orthopedic Surgeons. Opioid Use, Misuse, and Abuse in Orthopaedic Practice. Information Statement 1045. http://www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/advistmt/1045%20Opioid%20Use,%20Misuse,%20and%20Abuse%20in%20Practice.pdf Published October 2015.
8 Mayo Clinic. “One in four people prescribed opioids progressed to longer-term prescriptions.” ScienceDaily, July 1, 2015. www.sciencedaily.com/releases/2015/07/150701115325.htm
9 Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, et al. Relationship Between Pain and Opioid Analgesics on the Development of Delirium Following Hip Fracture. Journal of Gerontology. 2003;58A(1):76–81.
10 Sieber FE, Mears S, Lee H, Gottschalk A. Postoperative Opioid Consumption and Its Relationship to Cognitive Function in Older Adults with Hip Fracture. Journal of the American Geriatrics Society. 2011Dec;59(12):2256–62.
11 Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016Jul;18(4):245–52.
12 American Society of Interventional Pain Physicians. Fact Sheet

SOURCE Halyard Health, Inc.

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DePuy Synthes Acquires Tissue Regeneration System’s 3D Printing Technologies to Treat Bone Defects

Posted On April 20, 2017 By OrthoSpineNews In Financial /  

WEST CHESTER, Pa., April 20, 2017 /PRNewswire/ — DePuy Synthes Products, Inc., part of the Johnson & Johnson Family of Companies, has acquired 3D printing technology from Tissue Regeneration Systems, Inc. (TRS). The 3D printing methods developed by TRS will help enable DePuy Synthes to create patient-specific, bioresorbable implants with a unique mineral coating intended to support bone healing in patients with orthopaedic and craniomaxillofacial deformities and injuries. Financial terms of the transaction have not been disclosed.

The acquisition from TRS brings exciting new technology with the potential to truly personalize health care solutions in Trauma, a priority platform for the business, and builds on DePuy Synthes’ leadership in delivering ground-breaking innovation that improves patients’ lives. With more than 50 strategic collaborations, the Johnson & Johnson Family of Companies is harnessing 3D printing technology to develop patient-specific healthcare solutions that can mean increased satisfaction and better clinical outcomes.

“We are systematically investing in building a pipeline of 3D printed products,” said Ciro Römer, Company Group Chairman, DePuy Synthes. “The TRS technology, which will be added to the DePuy Synthes Trauma Platform, is the latest example of how we are working toward developing next-generation technologies that transform healthcare delivery with individualized solutions for patients.”

DePuy Synthes began collaborating with TRS in 2014 through Johnson & Johnson Innovation, which seeks and invests in the best science and builds novel partnerships at all stages of development across the medical device, consumer healthcare and pharmaceutical sectors. Johnson & Johnson Innovation facilitated the collaboration between DePuy Synthes and TRS.

“The acquisition of the TRS technology by DePuy Synthes is testament to our ability to identify and work collaboratively with promising early-stage companies and entrepreneurs to accelerate bringing innovative new products to market,” said Robert G. Urban, PhD, Global Head, Johnson & Johnson Innovation. “We are excited at the potential this technology holds to help improve patient outcomes.”

Founded in 2008, TRS is an early-stage medical device company headquartered in Plymouth, Mich., commercializing skeletal reconstruction and bone regeneration technology based on research performed at the University of Michigan and the University of Wisconsin.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding anticipated product applications and benefits of 3D printing technologies, including technology recent acquired from Tissue Regeneration Systems, Inc. (TRS). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes Products, Inc., Johnson & Johnson Innovation LLC and/or Johnson & Johnson. Among other risks, there can be no assurance that the technologies acquired from TRS will be successfully developed into effective healthcare solutions and result in commercially successful products. Other risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. DePuy Synthes Products, Inc., Johnson & Johnson Innovation LLC and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

©DePuy Synthes 2017. All rights reserved.

SOURCE DePuy Synthes

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