Johnson & Johnson Just Got Hit With a $1B Verdict Over Faulty Hip Implants

 

By  – December 2, 2016

A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who said they were injured by Pinnacle hip implants.

The jurors found that the metal-on-metal Pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks.

J&J JNJ 0.47% , which faces more than 8,000 lawsuits over the hip implants, said in a statement it would immediately appeal the verdict and was committed to defending itself and DePuy from further litigation over the Pinnacle devices.

The six plaintiffs awarded more than $1 billion are California residents who were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws. Plaintiffs claimed the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

Both companies denied any wrongdoing stemming from the development and marketing of the devices.

According to plaintiff’s lawyer Mark Lanier, the total verdict of $1.041 billion included $32 million in compensatory damages. The rest were punitive damages.

 

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Memphis Looks to Medical Manufacturing to Cut Poverty

BY JOHNNY MAGDALENO | DECEMBER 2, 2016

Poverty rates have dropped in Memphis, Tennessee, since the start of the decade, but it’s still one of the poorest large urban areas in the U.S. With 18.4 percent of its 1.3 million residents taking home annual incomes below the federal poverty threshold, it’s second only to Tucson, Arizona, when it comes to lacking opportunity for a living wage.

One local industry could help: medical device manufacturing. And the city was just awarded nearly $6 million from the U.S. Department of Labor to help fortify the system of community colleges, manufacturers and workforce organizations pulling talent from Memphis’ poorest communities to prep them for this booming sector.

Similar cash injections went to 22 similar efforts throughout the U.S. — 18 of which are urban areas with populations greater than 50,000 — as part of President Barack Obama’s community college reimbursement plan, called America’s Promise. The $111 million doled out during this round will help these cities build up the types of cross-sector workforce programs backed by federal law through the Workforce Innovation and Opportunity Act, enacted back in 2014. It’ll also help cover community college costs for disadvantaged workers looking for additional training.

Pauline Vernon, of the Greater Memphis Alliance for a Competitive Workforce (GMACWorkforce), says her region has been building a pipeline around medical device makers for the past few years. Shelby County hosts the second-largest cluster of these manufacturers in the U.S.

Part of the reason why the region is so attractive to this sector? Expediency. Memphis is home to FedEx’s World Hub, the company’s largest express shipping location.

“If somebody needs a knee replacement on the West Coast tomorrow, it can be manufactured here today and in the surgeon’s hands tomorrow,” says Vernon. “And that’s the basis for a lot of our biomedical facilities here.”

She says this Department of Labor support was “a pretty easy award” to get. Seventeen of the region’s medical device manufacturers formed a nonprofit in March 2015 to tackle the same issues at the core of the America’s Promise program. That coalition, the Greater Memphis Medical Device Council (GMMDC), brought a laundry list of job demands to Vernon and her co-workers.

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Bones from hip replacement transplants give new life

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Amplitude Surgical Successfully Carries out a 65 Million Euro Bond Financing Placement

December 01, 2016 – VALENCE, France–(BUSINESS WIRE)–

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading player on the global surgical technology market for lower-limb orthopedics, today announces the completion of a new 65 million euro bond issue. This new bond debt has enabled the Group to carry out the early repayment of 35 million euros of its previous debt while providing it with an additional 30 million euros, which will give the Group the necessary financial resources to pursue its international development.

Philippe Garcia, CFO of Amplitude Surgical, says: “This bond issuance represents a key milestone to strengthen our financial structure. With a more favorable interest rate and greater financial flexibility, this additional 30 million euros of funding will enable us to finance our expansion, notably in the United States, and to move into new territories.

This new bond debt carries a 5% annual coupon and has a maturity of six years. The terms of the existing residual debt have been significantly improved, with a 100-bp reduction in the margin and a 2-year extension of the maturity date to September 2023.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
philippe.garcia@amplitude-ortho.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

OrthoSpace Completes Equity Financing Round

CAESAREA, Israel, Dec. 1, 2016 /PRNewswire/ — OrthoSpace, Ltd. (http://orthospace.co.il/), a global innovative shoulder implant company, today announces that it has closed on a $7 million equity financing round.  The funds will be used to support the ongoing US Investigational Device Exemption (IDE) FDA Study, build out the Company’s commercial activities in Europe, South America and Asia and provide working capital.  Existing investors, HealthpointCapital LLC, Smith & Nephew and TriVentures participated in this round, alongside a new investor, Johnson & Johnson Innovation – JJDC, Inc.

The Company’s product, InSpace™, is an orthopedic biodegradable balloon system that is a simple, minimally invasive method that addresses unmet clinical needs in rotator cuff repair.  InSpace is marketed in Europe, Israel, Russia and Hong Kong where 10,000 balloons have been implanted. It is indicated for patients who suffer from a rotator cuff injury, and it reduces shoulder pain and improves the range of motion. The procedure can be performed in an outpatient setting.

Itay Barnea, CEO of OrthoSpace, commented, “This is an exciting time for OrthoSpace.  We are seeing great traction for InSpace among the European shoulder community where surgeons are grateful for a simple, effective option to treat rotator cuff injury.  US surgeons have begun to learn about and gain experience with our device through participation in the US IDE Study, where enrollment is well underway.  We are pleased to complete this financing to continue to invest in the Company’s growth, and we look forward to offering InSpace in additional major markets worldwide.”

OrthoSpace, Ltd.

OrthoSpace is a privately held medical device company located in Caesarea, Israel.  The Company’s product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair.  InSpace is CE Marked and commercialized in Europe, Israel, Russia and Hong Kong and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the system in the United States.

HealthpointCapital, LLC

HealthpointCapital is a values-driven, research-based private equity firm exclusively focused on the orthopedic and dental device businesses. HealthpointCapital has more than $800 million of institutional capital under management and is the only firm of its kind to focus exclusively on the $45 billion worldwide orthopedic and dental device industry.

Smith & Nephew plc

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).

TriVentures

TriVentures is a venture capital fund focused on investing in medical device and digital health technologies from seed stage to industry leaders. TriVentures has over $130 million under management dedicated to ventures primarily in Israel and the United States.

Johnson & Johnson Innovation – JJDC, Inc. (JJDC)

Johnson & Johnson Innovation – JJDC is the venture capital subsidiary of Johnson & Johnson that has been investing since 1973 in the medical device, diagnostic, pharmaceutical, and consumer health areas. JJDC’s goal is to create opportunities that meet the strategic needs of its operating affiliates while providing visibility to innovative emerging technology, businesses and business models. JJDC invests in companies across the continuum from early stage seed investments to advanced stages of series venture management.

 

Contact: Ariella Golomb, 212-810-4742

SOURCE OrthoSpace, Ltd.

 

Mark Getelman, MD, Orthopedic and Sports Medicine Doctor in Los Angeles, Launches New Orthopedic Educational Website

VAN NUYS, CA (PRWEB) DECEMBER 01, 2016

Orthopedic and sports medicine doctor in Los Angeles Mark Getelman, MD has launched a new orthopedic education website LASPORTSORTHOMD.COM developed by eMedical Media. As a leader and innovator in the field of orthopedics, Dr. Getelman has recently co-authored a highly acclaimed textbook on Shoulder Arthroscopy detailing the latest and most advanced arthroscopic techniques, and he also pioneered the Hospital-Corner Repair for the treatment of shoulder instability. As a national leader in his speciality, he recently completed his term on the Board of Directors of the Arthroscopy Association of North America and was recently named the most outstanding medical specialist in a tri-county region.

The website has been designed to help patients learn about the anatomy, pathology, diagnosis and current treatment options for acute and chronic shoulder and knee injuries. Dedicated to educating patients, Dr. Getelman created this website to help patients advocate for their own best care.

Dr. Getelman specializes in disorders of the knee and shoulder with an emphasis on sports medicine. The knee is the largest joint in the body and the shoulder is the most mobile joint in the body. These two joints are extremely susceptible to sports and work-related injuries. Through this educational portal, patients can improve their knowledge of knee and shoulder pathology along with the most up-to-date treatment options available.

Patients searching online for insight and practical knowledge on shoulder and knee pain will find information on conditions such as:

Rotator Cuff Injury
Meniscus Tear
ACL Injury
Shoulder Instability
Articular Cartilage Damage

Treatment options discussed on the website include non-surgical, surgical and biological options. A patient’s history, symptoms and activity level will help determine the right course of treatment. Patients seeking an accurate diagnosis and treatment plan must visit a qualified professional in person. Patients searching online for treatments of the shoulder and knee will find information on:

Latarjet Reconstruction
Revision Surgery for Failed ACL Reconstruction
Pectoralis Major Tendon Repair
Meniscal Repair and Knee Ligament Reconstruction
Rotator Cuff Repair including Dermal Allograft Augmentation and Superior Capsular Reconstruction

Orthopedic and Sports Medicine Doctor in Los Angeles, Dr. Getelman – with the support of his team – is focused on keeping people of all ages active by providing the most progressive treatment for shoulder and knee conditions along with all sports related injuries. For patients who are seeking a diagnosis or second opinion, Dr. Getelman sees patients in his Van Nuys and Thousand Oaks offices and also offers film reviews and consultations. To make an appointment, please call the office at 805-367-8888 or click here for his contact form.

About Mark Getelman, MD

Shoulder and Knee Specialist and Sports Medicine Doctor in Los Angeles, Mark Getelman, MD is board certified in orthopedic surgery and sports medicine. He practices at the Southern California Orthopedic Institute with offices located throughout the greater Los Angeles, CA area. His sub-specialty practice focuses on the arthroscopic and minimally invasive treatment of the shoulder and knee, such as rotator cuff and labral repair, articular cartilage defects surgery, knee ligament reconstruction and shoulder stability treatment. Dr. Getelman has returned patients of all activity levels to sports participation after treating new injuries or revision of previously failed surgeries.

JRI Orthopaedics strengthens Chinese links

30 Nov 2016 – By Aimee Robinson, Business Quarter

British healthcare company JRI Orthopaedics has strengthened its presence in China and the Far East after securing a new multi-million pound deal.

The company has secured regulatory approval to sell its hip product portfolio in China and has signed an exclusive distribution deal with China’s largest domestic orthopaedic producer, AK Medical.

The Chapeltown firm expects to sell a minimum of 10,000 hip implants in China over the next five years.

Keith Jackson, JRI Orthopaedics chief executive, said: “China has a population of 1.3 billion but currently only 250 million people have access to a hip replacement. The potential is huge and we see this as a significant market for the company.

“There is a really good appetite for high-quality, innovative British brands. Our proven, world class, precision manufacturing capabilities and efficiencies means we have defied convention to manufacture Chinese-designed products for the Chinese market here in Sheffield.

 

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UnitedHealthcare Launches New Value-Based Care Payment to Help Improve Health Outcomes and Reduce Costs for Knee, Hip and Spine Procedures

December 01, 2016

MINNETONKA, Minn.–(BUSINESS WIRE)–UnitedHealthcare has launched a new value-based care payment for knee, hip and spine procedures that focuses on quality patient care and better outcomes. The initiative – the Spine and Joint Solution – is available to employers nationwide and works with health care facilities that perform a higher number of these surgeries and have demonstrated better outcomes and fewer complications.

The Spine and Joint Solution gives UnitedHealthcare employer-sponsored plan participants access to surgeons and facilities that qualify as UnitedHealthcare Centers of Excellence and accept bundled case rates for certain procedures, including knee and hip replacement, spinal fusion and spinal disc repair. The program currently includes more than 40 health care facilities in 25 markets across the country, with plans to expand to more than 40 markets during 2017.

The bundled payment method reimburses a care provider or hospital for a defined episode of care, such as knee or hip replacement, under a single fee or payment. This is a shift away from the common fee-for-service structure in which a care provider is paid for each treatment, appointment or test, generating multiple claims within a single, broader episode of care.

The Spine and Joint Solution is currently available nationwide to large and mid-sized companies with self-funded health plans, helping expand access to high-quality, cost-effective care and potentially saving employees out-of-pocket costs. Since the program’s introduction as a pilot in 2015, participating employers have recorded an average savings of $10,000 or more per operation when compared with median costs in the same metropolitan area. Through the initiative, eligible employees may save more than $1,000 in out-of-pocket costs per procedure when accessing a participating facility rather than another in-network medical facility.

Musculoskeletal procedures are becoming increasingly common due to an aging population and higher obesity rates. For instance, the number of knee replacement surgeries performed nationally is expected to increase by 500 percent by 2030, according to a recent studyfrom the Healthcare Cost and Utilization Project. Moreover, these surgical procedures are expensive (knee/hip replacements average $35,000 per operation), and costs vary widely among care providers.

“Knee, hip and spine surgeries are among of the fastest increasing categories of medical procedures, so this program provides a new way to help improve the quality of care, produce better outcomes for patients and better manage costs for employers,” said Sam Ho, M.D., chief medical officer of UnitedHealthcare. “Our partnership with participating health care providers and facilities is an important step toward achieving better health outcomes while reducing the overall cost of care.”

UnitedHealthcare Value-Based Care Portfolio Continues to Grow
Value-based care models have made tremendous gains in adoption across America’s health care system over the last few years. UnitedHealthcare’s care provider reimbursements that are tied to a variety of value-based care arrangements have nearly tripled in the last three years to nearly $50 billion annually, and are expected to reach $65 billion by the end of 2018. To date, more than 14 million people, or nearly one in every three people enrolled in UnitedHealthcare benefit plans, currently access care from providers in value-based care relationships.

The Spine and Joint Solution currently partners with health care facilities that have been independently evaluated for providing quality patient care and better outcomes. Participating facilities are located in major markets nationwide, including Boston, Chicago, Dallas and Los Angeles.

“Providing the best outcomes and an exceptional patient experience in an affordable way are key to helping our patients live healthier lives,” said Tim Cappel, executive director of Population Health Management for Cincinnati’s The Christ Hospital, one of first facilities to participate in the program. “Employers seeking effective cost-containment strategies recognize the value of fixed and competitive prices. Through these and other innovative approaches, The Christ Hospital Health Network is transforming the way our patients receive care.”

For more information about the Spine and Joint Solution and Value-Based Care, visit www.uhc.com/valuebasedcare.

About UnitedHealthcare
UnitedHealthcare is dedicated to helping people nationwide live healthier lives by simplifying the health care experience, meeting consumer health and wellness needs, and sustaining trusted relationships with care providers. The company offers the full spectrum of health benefit programs for individuals, employers, military service members, retirees and their families, and Medicare and Medicaid beneficiaries, and contracts directly with 1 million physicians and care professionals, and 6,000 hospitals and other care facilities nationwide. UnitedHealthcare is one of the businesses of UnitedHealth Group (NYSE: UNH), a diversified Fortune 50 health and well-being company. For more information, visit UnitedHealthcare at www.uhc.com or follow @myUHC on Twitter.

Click here to subscribe to Mobile Alerts for UnitedHealth Group.

Contacts

UnitedHealthcare
Will Shanley, 714-204-8005
will.shanley@uhc.com

JOT Study Finds Generic Orthopaedic Implants Clinically Equivalent and Provide High Value

December 01, 2016

RENO, Nev.–(BUSINESS WIRE)–The Orthopaedic Implant Company (OIC), a medical device company that specializes in high-value orthopaedic implants, announced today the publication of an independent study examining the clinical and economic impact high-value orthopaedic implants have on the market.

The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center,” published in the Journal of Orthopaedic Trauma, examines the performance of a hospital’s cost containment program utilizing high-value orthopaedic trauma implants provided by The Orthopaedic Implant Company (OIC). Plates available for the study were pre-contoured, anatomic and variable-angle locking plates indicated for small fragment fractures of the clavicle, radius, humerus, tibia and fibula.

The study compares the cost and outcomes of 828 patients, half of whom received generic implants while the other half received conventional implants. Conclusions found clinical outcomes to be comparable and savings averaged $1,197 per case, or $458,080 collectively.

“We are pleased to see the positive impact our products have had for patients , not just clinically but financially as well,” said Itai Nemovicher, President and CEO of OIC. “Similar to the results seen with generic pharmaceuticals, this study validates the effectiveness that generic implants have in today’s value-driven healthcare environment.”

About Orthopaedic Implant Company: OIC entered the medical device market in 2010 with an innovative approach to delivering the highest quality implants at the lowest possible prices. OIC implants cost 50 to 60 percent less than the average market price of premium implants, saving health care systems millions of dollars a year. OIC’s high-quality, low-cost implants and products can be used for a variety of procedures, including treatment of orthopaedic trauma and spinal injuries.

Contacts

Orthopaedic Implant Company
Steve Lichtenthal, 1-775-636-8281
steve@orthoimplantcompany.com

Tangible Solutions Aims to Achieve the Vision Behind “Industry 4.0” with Concept Laser

Grapevine, Texas, November 28, 2016  –Tangible Solutions has announced today that they will add 3D metal printing to their portfolio of capabilities. They will be integrating five Mlab cusing machines and one M2 cusing machine into their new 25,000 square feet facility in Fairborn, a suburb of Dayton, Ohio. This will render Tangible Solutions as one of the largest service providers of Concept Laser’s metal powder-bed technology in the country.

“We share Concept Laser’s vision for building a “smart factory” that supports the principles of Industry 4.0: automation, digitization and interoperability of various technologies within a factory. Concept Laser was the first and only 3D metal machine manufacturer to share a complete and tangible plan of helping organizations achieve industrial, serial production. We believe their technology roadmap will only make 3D metal printing more cost effective and flexible”, says Adam Clark and Chris Collins, Founders of Tangible Solutions.

“The team at Tangible Solutions are entrepreneurial and forward-looking; In only three years, they have made a positive impact in manufacturing in Ohio. We are committed to their success,” states John Murray, President and CEO of Concept Laser Inc.

Tangible Solutions was established in 2013 to offer services related to 3D printing, also known as additive manufacturing. Their offerings include 3D modeling and design, rapid prototyping, and developing course curriculum for education. The addition of metal 3D Printing in both reactive and non-reactive material allows them to broaden their reach with medical and aerospace customers. The Mlab cusing machines will be dedicated to printing with Titanium and the M2 cusing machine, nicknamed as the ‘workhorse’ for its stability and reliability, will print in variety of metal powder. The open architecture of Concept Laser’s machine portfolio allows customers the freedom to manufacture with any type of metal material; no restrictions are placed for using only Concept Laser’s metal powders.

Additive manufacturing involves taking digital designs from computer aided design (CAD) software, and laying horizontal cross-sections to manufacture the part. Additive components are typically lighter and more durable than traditional forged parts because they require less welding and machining. Because additive parts are essentially “grown” from the ground up, they generate far less scrap material. Freed of traditional manufacturing restrictions, additive manufacturing dramatically expands the design possibilities for engineers

Concept Laser recently made their vision of the “AM Factory of Tomorrow” a reality by releasing their new product called M LINE Factory which features a modular machine architecture with the ability to decouple pre-production from production. This allows factories to operate in parallel rather than sequentially, presenting economical series production.

ABOUT TANGIBLE SOLUTIONS

Tangible Solutions is a leading additive manufacturing company, providing prototype and contract manufacturing services, training and consulting, and research & development. Tangible Solutions services a wide variety of customers in the biomedical, aerospace, and automotive industries.

Tangible Solutions was established in 2013 to provide 3D printing and engineering design services. Quickly, Tangible became a leader in the Additive Manufacturing industry due to their knowledge about various 3D Printing methods and materials, quick turnaround times, and ability to produce professional products that held up to rigorous standards. Tangible Solutions also develops curriculum for workforce development that is in use today by government and academic institutions. The Tangible Solutions team is known for its subject matter expertise in Additive Manufacturing and dedication to customers.

ABOUT CONCEPT LASER

Concept Laser GmbH is one of the world’s leading providers of machine and plant technology for the 3D printing of metal components. Founded by Frank Herzog in 2000, the patented LaserCUSING® process – powder-bed-based laser melting of metals – opens up new freedom to configuring components and also permits the tool-free, economic fabrication of highly complex parts in fairly small batch sizes.

Concept Laser serves various industries, ranging from medical, dental, aerospace, toolmaking and mold construction, automotive and jewelry. Concept Laser machines are compatible with a diverse set of powder materials, such as stainless steel and hot-work steels, aluminum and titanium alloys, as well as precious metals for jewelry and dental applications.

Concept Laser Inc. is headquartered in Grapevine, Texas and is a US-based wholly owned subsidiary of Concept Laser GmbH. For more information, visit our website at www.conceptlaserinc.com

LaserCUSING® is a registered trademark of Concept Laser.