Posted on | October 30, 2013 | No Comments
BIOMET IMPLANTS FIRST U.S. STEMLESS SHOULDER (Orthopedics This Week)
Biomet, Inc.’s new stemless shoulder is moving and grooving in its first U.S. patient. This inaugural implant of the Comprehensive Nano Stemless Shoulder took place in October at the University of Virginia Medical Center in Charlottesville. The surgery was part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study and was performed by Stephen Brockmeier, M.D.
“We are excited to be a part of the clinical trial evaluating this potentially significant evolution in shoulder arthroplasty,” Brockmeier said. “I was impressed with the initial fixation of the stemless implant and was able to perform the shoulder replacement with minimal bone removal and components aligned with the patient’s natural anatomy.”
Posted on | October 26, 2013 | 1 Comment
NICE WANTS LONGER LASTING HIPS (Orthopedics This Week)
The Brits, who first raised warnings about metal-on-metal hips, have issued a new draft guidance with stricter benchmarks for quality.
The National Institute for Health and Care Excellence (NICE) issued the draft guidance on October 18, 2013. The guidance recommends that a new hip should work well in at least 95% of cases over 10 years.
NICE’s Professor Carole Longson commented, “Importantly, as we now have more information about how long artificial joints can last, we have recommended the use of prostheses with a proven lower revision rate. This means that a new joint should work well in at least 95% of cases over 10 years, so a revision may be needed in 5% or fewer cases over this period. Our existing guidance advises that prostheses should work well in at least 90% of cases, so repeat surgery may be needed in up to 10% of cases over 10 years.”
Posted on | October 25, 2013 | No Comments
PALM HARBOR, Fla., Oct. 25, 2013 /PRNewswire/ — SpineDirect, an innovative spinal fusion company that boasts a full compliment of spinal fusion products (spinedirectonline.com), officially launches its business this week in the US. The company’s focus is on the growing demand from hospitals to purchase spinal fusion products at a much reduced price, yet not compromise the high-quality designs and manufacturing practices that lead to successful patient outcomes. When one of the founders of SpineDirect was recently asked how this was accomplished, he responded, “We decided to eliminate the need for an expensive medical rep (commissioned company representative) that’s traditionally present in each surgery. Instead, SpineDirect offers quality training to the hospital partner and it’s staff to accomplish this role.”
Posted on | October 25, 2013 | No Comments
In earlier articles I have predicted the rise of Smart Implants in Orthopedic medicine. Now it’s 2013 and there is no stopping it…embedded sensors are coming to Orthopedics. This is driven by a convergence of three areas – new technology capabilities in embedded sensing, a growing understanding of embedded chip capabilities by Orthopedic manufacturers, and incentives for manufactures (product differentiation) and healthcare providers (more cost effective care).
Now let’s get specific. What will be the first applications of Smart Implants in Orthopedics? And when will these new applications emerge? I see four generations of embedded chip technology coming to Orthopedics.
“Smart tools intra-operatively” 1st Generation in 2009
The first chips will be used in Orthopedic surgery this year. Instruments with chips and RFID tags will help surgeons make better decisions during surgery. Smart instruments and trials with embedded sensors will help surgeons with the implant positioning and load balancing during surgery. I consider smart tools simply another level of surgical navigation, but these new tools with chips and RFID tags have several advantages over optical systems. This technology is cheap, portable, disposable and most important of all, may give manufacturers a way to earn another fee for each joint
replacement surgery. Major orthopedic companies are working on these applications now.
“Smart diagnostics on demand” 2nd Generation in 2012
In 2012, chips will help provide better care during regular patient visits. The first smart implants with embedded sensors will relay diagnostic data from inside the patient to a physician or health care worker in the hospital setting post-surgery. These smart implants delivery much more information than x-rays. They may provide data in the doctor’s office, such as implant positioning, load bearing data, range-of-motion (ROM) data, dislocation potential, bone ingrowth measurement, particle count around an implant (a link to osteolysis), temperature, pH, lactate, glucose levels and other local biochemistry. These chips will become the “black box” in every implant. Other applications may be the use of smart diagnosis chips for use in human clinical trials and animal trials to derive more meaningful data with fewer subjects. The only application that exists today is a 2005 JNJ DePuy custom knee patient with a total knee with an embedded transducer that relays load information from the tibial implant.
“Smart diagnostics by exception” 3rd Generation in 2015
Around 2015, tiny diagnostic chips in total joint devices will sit silently for years until a problem is detected. The patient could be anywhere when the chip comes alive and sends diagnostic data through existing wireless infrastructure to the hospital of record. These smart implants will only send wireless data when they detect problems, such as, an early infection (based on bio markers present), osteolysis (the silent killer in joints), and stress shielding leading which often leads to bone erosion, loosening and revision surgery. This will add enormous value to the health care system.
“Smart diagnostics and treatment by exception” 4th Generation in 2021
In the early 20’s smart implants will be able to analyze and treat. This breed of smart implants will detect a problem and “self treat” the problem by delivering drug therapies locally as needed. They may delivery antibiotics and growth factors long after surgery. Once again these smart on-board drug delivery vehicles will be completely dormant until they are needed.
Posted on | October 24, 2013 | 1 Comment
Wright takes MicroPort global in 51 days (with Video) (Memphis Business Journal)
If you could put together a $290 million deal in less than two months, would you do it?
Wright Medical Group Inc. and MicroPort Scientific Corp. needed 51 days to finalize MicroPort’s acquisition of Wright Medical’s OrthoRecon hip and knee implant business, it was revealed this week at the Musculoskeletal New Ventures Conference at the FedEx Institute of Technology.
While the two companies spent three years getting to know each other, Ted Davis, president of OrthoRecon who will become president of MicroPort Orthopedics Inc. once the deal is final, said MicroPort’s decision to acquire OrthoRecon took him by surprise.
But Jonathan Chen, vice president of international business and investor relations for MicroPort, said the acquisition instantly gave his company a global footprint. Before, 90 percent of MicroPort’s business had come from China.
“We had a spinal business that was much smaller in scale, but now we have a platform in the fastest growing orthopedic markets,” Chen said. “Orthopedics completes our portfolio.”
While the two companies agreed on the acquisition in June, it still must be approved by the Hong Kong Exchange to be approved. That approval is expected soon.
Meanwhile, the two companies are in the process of integrating their operations, Davis said.
“We continue to run the business while trying to drive the separation,” Davis said. “There’s the deal aspect and also the transition planning, then there’s the actual execution after day one. We’re through the first two, but we’ll have to let you know about the last one.”
Stryker to pay $13M to settle civil charges of bribing doctors in 5 countries – Argentina, Greece, Mexico, Poland, and Romania
Posted on | October 24, 2013 | No Comments
Stryker to pay $13.2 mln to settle civil bribery charges (press release)
Stryker agreed to pay >US $13.2MM to settle alleged violations of the Foreign Corrupt Practices Act by bribing doctors and government-employed officials in 5 countries to obtain or retain business. (Sources: Reuters and SEC.gov)
REUTERS - Medical device maker Stryker Corp will pay $13.2 million to settle civil charges alleging the company bribed doctors and government officials to win business in five different countries, U.S. regulators said Thursday.
The Securities and Exchange Commission said that the company tried to mask its $2.2 million bribes in Argentina, Greece, Mexico, Poland and Romania by booking them as legitimate expenses for charitable donations, travel costs and commissions.
Stryker is settling the case without admitting or denying the charges.
Posted on | October 24, 2013 | No Comments
Amedica Corporation, a biomaterial company, announced today that it has entered into a distribution agreement with K2M that will provide surgeons and hospitals in Europe with access to Amedica’s Silicon Nitride interbody spinal fusion devices. K2M is the largest privately-held spinal device company in the world.
Earlier this year, Amedica and K2M conducted a successful pilot program in select markets in Europe where surgeons were provided the opportunity to integrate Silicon Nitride interbody devices into their offerings for patients suffering from a variety of disorders requiring spinal fusion. This pilot program demonstrated a need in these strategic markets for spinal fusion devices devised from a different biomaterial.
Posted on | October 23, 2013 | 1 Comment
The European Parliament today votes not to require medical devices to undergo an approval process akin to that required by the FDA’s pre-market approval program.
The European Parliament today failed to back an EU panel’s recommendation to enact strict requirements for medical device approvals that would have matched those required by the FDA’s pre-market approval program.
The EU body voted instead to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the “notified bodies” that govern medical device regulation there.
The regulations must still be approved by the governments of the individual countries in the EU. That’s not expected to take place until next year at the earliest and more likely in 2015, Reuters reported.
“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council. We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices,” said Serge Bernasconi, CEO of the European medical device trade group Eucomed, in prepared remarks.
Last month a parliamentary panel OK’d more stringent oversight of medical devices in the European Union that would have required clinical trials for implants and other Class III devices across the pond.
Posted on | October 23, 2013 | No Comments
Biotechnology startups have stampeded to the public markets this year, but their colleagues in the medical device field have sat quietly on the sidelines.
So far this year, 27 venture-backed biopharmaceutical companies have gone public, compared to just one medical device company, according to industry tracker Dow Jones VentureSource.
While biopharmas generally go public in greater numbers than medical device companies, the spread has never been this great–in 2007, for example, 19 biopharmas went public, compared to 10 medical device companies, a more representative ratio.
Dating back to 1992, biopharma IPO frequency has ranged from roughly equal to that of medical devices, to double or triple the rate in some years. The biggest spread was in 2000, at the height of the last IPO boom, when 46 biopharmas went public, compared to nine medical device companies.
Medtronic Spine brings an innovative access to L5-S1 called the OLIF approach (Oblique Lateral Interbody Fusion)
Posted on | October 22, 2013 | No Comments
MEDTRONIC CLAIMS “FIRST” IN LATERAL ACCESS SPINE SURGERY (Orthopedics This Week)
Medtronic, Inc. says it has scored a first by introducing the first procedure that allows lateral access to the most common operative level of the spine. According to an October 21, 2013, announcement, the OLIF51 procedure enables reproducible lateral access to the L5-S1 disc space.
“For the first time, along with the OLIF25 Procedure, the surgeon community has a combination of procedures that offer an extensive approach to all levels of the lower lumbar spine in one patient positioning,” said Richard Hynes, M.D., spine surgeon at The B.A.C.K. Center in Melbourne, Florida.
Referred to as Oblique Lateral Interbody Fusion for L5-S1, this procedure, says the company, eliminates the need to reposition the patient during surgery and incorporates Medtronic’s comprehensive surgical platform of access, interbody, neuromonitoring, navigation, fixation and biologic options,” said stated the announcement.
Posted on | October 21, 2013 | No Comments
- THE TEN BEST NEW SPINE TECHNOLOGIES FOR 2013 (Orthopedics This Week)
- The winners of the 2013 Orthopedics This Week Best New Technology award for spine are:
- Benvenue Medical, Inc.
- Globus Medical, Inc.
- Johns Hopkins University/Siemens Healthcare
- AFcell Medical, Inc.
- Orthozon Technologies, LLC
- Paciera Pharmaceuticals, Inc.
- PhDx Systems, Inc.
- Trakya University in Turkey.
Posted on | October 17, 2013 | No Comments
Wright Medical to buy French firm for $75 million (Memphis Business Journal)
Wright Medical Group, Inc. (NASDAQ: WMGI) announced today that it has entered into a definitive agreement to acquire Biotech International (Biotech), a leading, privately held French orthopaedic extremities company. The transaction will significantly expand Wright’s direct sales channel in France and international distribution network and add Biotech’s complementary extremity product portfolio to further accelerate growth opportunities in Wright’s global Extremities business.
Under the terms of the agreement, Wright will acquire 100% of Biotech’s outstanding equity shares on a fully diluted basis at a total offer price of up to $80 million as follows: $75 million payable at closing, comprised of approximately $55 million of cash and $20 million of Wright common stock, and up to an additional $5 million of cash contingent upon the achievement of certain revenue milestones in 2014 and 2015. All Wright common stock issued in connection with the transaction will be subject to a one-year lockup.
Posted on | October 16, 2013 | No Comments
Medical Devices and the Great Deflation (MassDevice)
The medical device industry’s financial growth has been cut dramatically following the Great Recession, even as sales volume has returned to pre-crisis levels. Is there an end in sight?
The medical device industry has “lost” about $131 billion in revenues since the financial collapse of 2008, according to analysts at Ernst & Young.
The findings, taken from the audit firm’s annual “Pulse of the Industry” report, paint a glum picture for the medtech industry, once considered to be “recession proof.”
Annual revenues for medical device companies in the U.S. and Europe grew at an annual rate of 13% from 2000 to 2007, according to the report. But even as the economy has recovered and sales volumes returned to pre-recession levels, sales growth across the medical device sector has increased just 7% since 2008. E&Y analysts estimated that the gap in growth totals about $131 billion in lost sales.
Posted on | October 15, 2013 | No Comments
STUDY: NO INTENTIONAL BIAS IN MEDTRONIC BMP STUDIES (Orthopedics This Week)
Study Finds NO Intentional Medtronic BMP Bias
His national database work was nominated for “Best Clinical Paper” at NASS. Kern Singh, M.D. an orthopedic surgeon with Midwest Orthopaedics at Rush who says that he has NO involvement with Medtronic, has found no intentional bias on the part of the company or in the studies it sponsored. Dr. Singh tells OTW,
“My colleagues and I used Medicare data, as well as a hospital database registry to look at trends in BMP from 2000-2011. This work, published recently in Spine, revealed a dramatic increase in the utilization of off-label BMP in back and neck surgeries. It was clear that after the FDA warning letter of 2008 there was a downward trend in the use of BMP in the cervical spine. Due to litigation concerns we are seeing a downturn in all uses of BMP because doctors are afraid that they would be sued for using it despite its effectiveness.”
Posted on | October 15, 2013 | No Comments
Medical Device Manufacturer Plans Expansion (OnlineTMD)
“From pharmaceutical to orthopedic leaders, Indiana’s sound fiscal policies, low-tax structure, and talented workforce continue to be a catalyst of growth and success for life sciences companies like Micropulse,” states Governor Mike Pence. “Indiana has developed a comprehensive formula of business-friendly and entrepreneur-friendly remedies that give companies in this sector a competitive edge and are further testament to the state’s reputation as the orthopedics capital of the world.”
The homegrown-Hoosier company develops and manufactures orthopedic instruments, implants and sterilization cases and trays, as well as incubates orthopedic startup companies in-house. The company will invest $14.3 million to equip and renovate its current 100,000ft2 facility in two phases through 2017. The project’s first phase, which includes equipment installation, is expected to be complete by late next year.
Small Orthos have the most to lose with the controversial 2.3% excise tax, as the Big Orthos fight it
Posted on | October 14, 2013 | No Comments
Small Device Companies May Bear Biggest Brunt of Controversial Tax (OrthoSpineNews)
Large companies making medical devices such as artificial knees are pushing for repeal of the controversial medical device tax attached to the health care law, but the tax’s repercussions may be more damaging in the short run to smaller, less vocal firms.
“It has a disproportionate burden on smaller device manufacturers,” said Kyle Pomerleau, an economist at the Tax Foundation, a Washington-based tax policy think tank.
Mesoblast acquires Osiris’ culture expanded stem cell business for $50M plus another $50M bonus for regulatory milestones
Posted on | October 14, 2013 | No Comments
MELBOURNE, Australia and NEW YORK, Oct. 10, 2013 (GLOBE NEWSWIRE) — Regenerative medicine company Mesoblast Limited (ASX:MSB) (USOTC:MBLTY) today announced the acquisition of the entire culture-expanded mesenchymal stem cell (MSC) business of Osiris Therapeutics (Nasdaq:OSIR) by the Mesoblast Group.
“The many commercial and strategic benefits of this transaction firm Mesoblast’s leadership position in the global regenerative medicine industry,” said Mesoblast Chief Executive Officer Professor Silviu Itescu.
The benefits derived from acquiring the approved and late-phase MSC products include:
- near term market launch of a mesenchymal lineage product in major jurisdictions;
- broadened late-phase clinical programs in strategic areas of focus; and
- leveraged roll out of infrastructure, skills and expertise needed to commercialize Mesenchymal Precursor Cell (MPC) products.
“Importantly, in 2014 we plan to have active products in Phase 3 clinical trials in all four core major therapeutic areas of focus: cardiovascular medicine (congestive heart failure), inflammatory/immune diseases (Crohn’s disease), orthopedics (spinal fusion and intervertebral disc repair) and oncology (acute Graft versus Host Disease, and cord blood expansion in bone marrow transplantation).”
Existing cash reserves are sufficient to meet current and new product development plans. Cost savings and other synergies are expected across personnel, capital expenditure, and manufacturing, and as a result there will only be a modest increase in operating cash burn.
Strategic and Financial Benefits of the Transaction
Posted on | October 9, 2013 | No Comments
Award from Orthopedics This Week Honors Best Spine Products, Engineers and Inventors
Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, won the 2013 Spine Technology Award in the minimally invasive spine care category for its Kiva VCF Treatment System. The fifth annual Spine Technology Awards are being presented byOrthopedics This Week and RRY Publications LLC at the North American Spine Society (NASS) annual meeting this week in New Orleans. The awards honor innovative spine surgery products and their engineering teams and inventors.
Posted on | October 7, 2013 | No Comments
Biomet Announces Definitive Agreement to Acquire Lanx, Inc. (press release)
Biomet, Inc., a global leader in the manufacture of musculoskeletal and biotechnology products, announced today that it has reached a definitive agreement to acquire Lanx, Inc., a full service spine company and a leader in minimally invasive techniques and technologies.
“Biomet Spine is the ideal home for the talent and technologies that Lanx has worked so hard to develop. The combination of these companies and their products will be a powerful force in the spine market of the future.”
The pending acquisition would expand Biomet Spine’s technology portfolio through the addition of innovative products currently offered by Lanx, including the Timberline® Lateral Approach Fusion System, and the Aspen®Minimally Invasive Fusion System. These products are complementary to Biomet Spine’s comprehensive offering of products, including the Lineum® OCT Spine System, MaxAn® Anterior Cervical Plate System, Cellentra™ VCBM and the Polaris™ Translation™ Screw System.
Posted on | October 7, 2013 | No Comments
BONE THERAPEUTICS, the leading biopharmaceutical company focused on innovative cell therapy products for the treatment of bone diseases, announces today that it has received clearance from the Competent Authorities in Belgium and the UK for a phase I/IIa trial with its allogeneic cell therapy product ALLOB® for the treatment of delayed union fractures.
ALLOB® is an allogeneic, osteoblastic (i.e. bone-forming) cell therapy product. ALLOB® has already shown safety and efficacy in preclinical studies and has the potential to become a first-line treatment for impaired fracture healing, thanks to its minimally invasive percutaneous administration, avoiding the need for surgery.« go back — keep looking »