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Study Determines Medtech Innovations Contribute $23B in Annual Savings to the U.S. Economy

According to a new report published by the Milken Institute, the benefits of medical technology contribute a net added benefit of $23 billion per year for the U.S. economy by counteracting the fiscal impact of chronic disease.

In the study, entitled, "Healthy Savings: Medical Technology and the Economic Burden of Disease", the research team evaluated medtech innovations for heart disease, diabetes, colorectal cancer and musculoskeletal disease. The researchers determined that certain technologies, including colonoscopy and sigmoidoscopy; angioplasty in combination with echocardiography, electrocardiography and pacemakers; and joint replacement (arthroplasty) procedures utilizing magnetic resonance imaging (MRI) devices, all result in "considerable" cost savings and health benefits for patients.

Joint arthroplasty specifically, can relieve pain, "dramatically" reduce sick days and raise productivity. Joint replacement procedures often improve the chances of curing a patient's chronic condition and extending their survival, therefore boosting the national economy by expanding individuals' workforce participation and galvanizing stronger on-job performance.

Furthermore, the researchers constructed three alternative trajectories through 2035 for continued medtech innovation for each of the four diseases. In the scenario that assumes medtech innovations follow an accelerated path, the study concludes a cumulative net gain of $1.4 trillion for the U.S. economy.


Musculoskeletal News Roundup 18-Jul-14

EARNINGS
Johnson & Johnson reported financial results for 2Q:14. Total revenue was $19.5 billion in 2Q:14, beating consensus estimates by 3% and representing an increase of 9% compared to $17.9 billion in 2Q:13. Gross margin for 2Q:14 decreased to 69.0%, from 69.3% in 2Q:13. Domestic sales increased 15%, while international sales increased 4% in 2Q:14. Total Orthopedic sales increased 3% with domestic and international orthopedic sales growing 2% and 6% respectively. Hips increased 5% worldwide driven by strong volume growth results in primary hip stem platform sales. Knees worldwide increased 1% on an operational basis with the U.S. flat and sales outside the U.S. increasing 4% on an operational basis. Knee growth was driven by the launch of ATTUNE fixed bearing knee platform and offset by price pressures across the region and softness in the U.S. market. Trauma grew 7% on an operational basis with sales outside the U.S. up 11%. Worldwide Spine growth was 1% on an operational basis with the U.S. down approximately 2% due to pricing pressures, and International Spine sales increasing 4%.

Medicrea reported financial results for 1H:14. Total revenue was EUR 11.9 million ($16.2 million) in 1H:14, increasing 3% on a constant currency basis from EUR 11.9 million ($14.3 million) in 1H:13. Revenue growth by market was: U.S. +13%, France +36%, Europe (2%), South America (53%) and Asia (35%). Management stated that the situation in Europe has stabilized following two years of pricing cuts imposed by national health system reforms, and that import difficulties encountered by the company's leading distributor in Brazil which contributed to a globally mediocre performance over 1H:14, have now been resolved. Additionally, the company has added a new export sales team and Vice President of International Sales to further supplement sales overseas. All growth rates are on a reported basis, unless stated otherwise.

SpineGuard reported financial results for 1H:14. Total revenue was €2.1 million ($2.9 million) in 1H:14, representing a decrease of 6% on a constant currency basis compared to €2.3 million ($3.0 million) in 1H:13. The decrease in revenue was primarily due to a short-term unfavorable implementation of ACA in the United States. SpineGuard's Asia-Pacific and Middle East regions recorded satisfactory progress, particularly in Japan and Saudi Arabia with new positive prospects expected during 2H:14. Latin American revenue was penalized by the Brazilian distributor’s reorganization in response to changing market conditions. In Europe, growth continued in several countries such as France, Germany and Switzerland.

Stryker reported financial results for 2Q:14. Total revenue was $2.4 billion in 2Q:14, beating consensus estimates by 1% and representing an increase of 7% compared to $2.2 billion in 2Q:13. Gross margin for 1Q:14 decreased to 65.8%, from 67.0% in 2Q:13. The company's segments grew by: Knees +3%, Hips 2%, Trauma & Extremities +11%, Instruments +8%, Endoscopy +18%, Medical +4%, Spine (2%) and Neurotechnology +8% respectively in 2Q:14. International revenues grew by 5% in 2Q:14 compared to 2Q:13 and represented 34% of total revenue in 2Q:14. All growth rates are on a constant currency basis.

FUNDING
Trice Medical closed the first tranche of an $11.6 million Series B financing led by Safeguard Scientifics, and with participation from BioStar Ventures and other existing investors. Proceeds from the funding will support Trice's efforts to commercialize and market its initial diagnostic arthroscopy product, mi-eye, into the physician's office.

M&A
St. Jude Medical entered into an agreement to acquire NeuroTherm, Inc. for $200 million. NeuroTherm’s technology utilizes radio waves to destroy nerves that cause back, knee and foot pain and will complement other St. Jude pain-treatment products, including spinal cord stimulators. St. Jude expects the deal to add between $10 million and $15 million to St. Jude’s 2014 revenue.

REGULATORY
Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio Surgical System, patellofemoral joint (PFJ) replacement surgery. The PFJ application expands the Navio Surgical System’s indications from unicondylar knee replacement to offer the full suite of partial knee replacement options. The addition of patellofemoral joint replacement enables Blue Belt customers to offer robotics-assisted surgery to a greater population of patients who may be suffering from early to mid-stage osteoarthritis and choose partial knee replacement as an alternative to total knee replacement.

Ellipse Technologies received strong recommendations from the National Institute for Health and Care Excellence (NICE) and the British National Health Service (NHS) for the use of its MAGEC (MAGnetic Expansion Control) system. The recommendations were triggered by recently published medical technology guidance from NICE, encouraging the NHS to use the MAGEC system in children aged two years and over who suffer from early onset scoliosis. This was then followed by a published draft policy by NHS with a similar endorsement.

Synergy Biomedical received 510(k) clearance from the FDA for its BIOSPHERE PUTTY as a bone graft extender for use in the posterolateral spine. The putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure and is designed to be gently packed as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine.

PRODUCT INTRODUCTION & UPDATE
Biomet Sports Medicine launched its JuggerKnotless Soft Anchor device, the latest product offering in its all-suture implant family. The device is utilized for labral repair surgery in the shoulder and helps allow surgeons to secure soft tissue without the use of surgical knots.

Cayenne Medical launched its SureLock All-Suture Anchor System for surgeries involving the shoulder and extremities. The system provides fixation through an inserter-controlled deployment method, eliminating manual tensioning, which can lead to partial deployment, anchor pull-out, or anchor displacement. The system is composed of Ultra High Molecular Weight Polyethylene (UHMWPE) suture and requires a smaller pilot hole compared to traditional anchors, helping to minimize bone removal and the overall anchor footprint.

DePuy's Mitek Sports Medicine, launched its MONOVISC High Molecular Weight Hyaluronan, a single-injection treatment for knee pain related to osteoarthritis and the PEAK Platelet Rich Plasma (PRP) System, a new device that produces PRP in only 2 and a half minutes. MONOVISC is intended to provide up to six months of pain relief and helps restore joint mobility in patients suffering from pain associated with osteoarthritis of the knee by helping to replace the naturally occurring hyaluronan found in healthy joint fluid, and to cushion, protect and lubricate the knee joint. The PEAK PRP System separates PRP from a sample of a patient's own blood and consistently produces 3mL of high quality PRP from 27mL of whole blood.

Titan Spine received clearance from the FDA to commercially release its Endoskeleton TL system, a spinal fusion system utilizing a lateral approach. The system features proprietary roughened titanium surface technology designed to participate in the fusion process by creating an osteogenic response to the implant’s topography.

CLINICAL
Biorestorative Therapies received approval from the Western Institutional Review Board to complete a retrospective safety study on selected subjects previously treated by its brtxDISC, a non-surgical treatment for bulging and herniated lumbar discs that is intended for patients who have failed non-invasive procedures and face the prospect of surgery. Results for the study, entitled “Re-consenting and Follow-Up of Adults from a Retrospective Study Using Autologous Transplantation of Marrow Derived Mesenchymal Stem Cells to Degenerated Intervertebral Disc,” are expected by the end of the year. The objective is to determine the safety of subjects who received autologous stem cell transplants into their disc. Safety results from the study will be used to support an Investigational New Drug/ Investigational Device Exemption (IND/IDE) filing with the FDA.

Misonix announced the publication study results on the utilization of its ultrasonic BoneScalpel in spinal fusion surgery. The retrospective study entitled, "Blood loss reduction during surgical correction of adolescent idiopathic scoliosis utilizing an ultrasonic BoneScalpel", published in the in Spinal Deformity, data from 20 consecutive patients with adolescent idiopathic scoliosis who underwent posterior spinal fusion using the ultrasonic BoneScalpel by a single surgeon with two control groups. The researchers concluded that use of the ultrasonic BoneScalpel to perform the bone cuts associated with facetectomies and apical Ponte-type posterior releases resulted in less bleeding compared with cuts made with standard osteotomes and rongeurs, limiting overall blood loss by 30 to 40%.

VertiFlex announced the publication of two-year clinical results for its Superion Indirect Decompression System. The prospective, multi-center, randomized FDA IDE trial, published in BMC Musculoskeletal Disorders, reported on the outcomes from the first 250 enrolled patients and compared the results with an alternative surgical control device. The study concluded that leg pain scores in Superion's group of patients improved more than 75% from baseline at two years, comparing favorably with surgical laminectomy, the gold standard for spinal decompression. Additionally, as the Superion procedure does not involve destabilizing muscle resection and bone removal, patients are generally able to leave the treatment facility in a few hours, as opposed to 2-3 days with more invasive procedures.

RECOGNITION
U.S. News & World Report released their annual list of the best orthopedic hospitals in the country this week, and New York City's Hospital for Special Surgery topped the list once again. The only change in the top five from last year's list was New York City's Hospital for Joint Diseases edged out Boston's Massachusetts General Hospital for the #4 spot.


Blue Belt Technologies Receives 510(k) Clearance for Patellofemoral Joint Replacement Application

Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio Surgical System, patellofemoral joint (PFJ) replacement surgery. The PFJ application expands the Navio Surgical System’s indications from unicondylar knee replacement to offer the full suite of partial knee replacement options.

The addition of patellofemoral joint replacement enables Blue Belt customers to offer robotics-assisted surgery to a greater population of patients who may be suffering from early to mid-stage osteoarthritis and choose partial knee replacement as an alternative to total knee replacement.

“We are pleased to announce this major milestone in the continued success and evolution of our Navio platform,” said Eric Timko, President and CEO of Blue Belt Technologies. “We focus our technology development efforts on clinically relevant applications that can benefit from reproducible precision. Adding patellofemoral replacement was the logical next step for us. This PFJ application will continue to arm our surgeon customers with the next-generation in robotics-assisted tools to safely and effectively treat a greater population of patients.”

The Navio Surgical System utilizes a CT-free, robotics-assisted approach for its partial knee replacement applications, and is notable for its open implant architecture. Smith and Nephew’s patellofemoral joint system, Journey PFJ, will be the first implant system available for use with the Navio PFJ application.


Hospital for Special Surgery Tops List of Best Orthopedic Hospitals

U.S. News & World Report released their annual list of the best orthopedic hospitals in the country this week, and New York City's Hospital for Special Surgery topped the list once again. The only change in the top five from last year's list was New York City's Hospital for Joint Diseases edged out Boston's Massachusetts General Hospital for the #4 spot.

The publication ranks the respective hospitals based on statistical analysis relating to mortality rates, patient safety, discharge rates, patient volume, nurse staffing, as well as the breadth of patient services provided and a reputation score calculated from a survey of physicians.

Below is a list of the top ten and the scores received:

#1: Hospital for Special Surgery
New York, NY
100/100

#2: Mayo Clinic
Rochester, MN
89.5/100

#3: Cleveland Clinic
Cleveland, OH
73.1/100

#4: Hospital for Joint Diseases
New York, NY
68.8/100

#5: Massachusetts General Hospital
Boston, MA
68.7/100

#6: Rush University Medical Center
Chicago, IL
65.8/100

#7: Cedars-Sinai Medical Center
Los Angeles, CA
63.3/100

#8: Thomas Jefferson University Hospital
Philadelphia, PA
63.2/100

#9: Beaumont Hospital
Royal Oak, MI
62.6/100

#9: Duke University Hospital
Durham, NC
62.6/100



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