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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Musculoskeletal News Roundup 28-Aug-14

FUNDING
The Canadian federal government plans to invest $14.9 million in a new facility for medical device commercialization in Ottawa. The Medical Devices Commercialization Centre, stems from the University of Ottawa’s Medical Devices Innovation Institute and will initially be housed at the University of Ottawa Heart Institute. The not-for-profit center’s mandate will be to help get medical devices to market more quickly and efficiently by creating a collaborative network to help remove commercialization obstacles for devices designed and produced in Canada.

M&A
Integra Lifesciences expressed to analysts that the company could be interested in exploring strategic alternatives for its Spine business. Integra's management team believes that Integra's Spine unit would need a significant investment in order to compete in the market with Medtronic, Johnson & Johnson, Stryker and others, an investment that the company is not prepared to make.

Tecomet entered into an agreement to acquire 3D Medical Manufacturing Inc., a contract manufacturer of critical high precision medical device components, implants, instruments, cutting tools and mechanical / electro-mechanical assemblies. The transaction will help Tecomet control cost, provide high quality complex components and reduce lead-times to meet customers’ most advanced requirements. Furthermore, 3D Medical provides advanced manufacturing expertise in the extremities market.

REGULATORY
Arthrosurface received 510(k) clearance from the FDA for its KISSloc Suture System, a mini plate and suture implant intended for the correction of a Hallux Valgus deformity. The system consists of two low profile plates and a self-cinching suture construct that corrects Hallux Valgus by reducing the intramedullary angle between the first and second metatarsal bones.

PRODUCT INTRODUCTION & UPDATE
Surgeons at Peking University Third Hospital in China commenced the world's first 3D-printed vertebra surgery. The procedure was conducted on a 12-year-old Chinese boy who had a cancerous vertebra. The doctors removed the cancerous vertebra and implanted the 3D-printed piece between his first and third vertebrae. The surgeons expounded that the 3D-printed implant was an improvement on conventional methods and enabled for a quicker recovery time.

Expanding Orthopedics announces the first implantation of its FLXfit, a 3-D expandable minimally invasive interbody cage. FLXfit helps allow for a wide anterior footprint coverage in minimally invasive, unilateral TLIF approaches and has articulated self-guidance features for to assist with placement after expansion.

LEGAL
Arthrex settled with Parcus Medical on litigation in which Arthrex asserted trade secret and patent infringement in the field of orthopedics. As part of the settlement, Parcus acknowledges that certain ex-Arthrex employees took proprietary information, including product manufacturing programming and manufacturing know-how, from Arthrex relating to Arthrex products and that this information was found in Parcus’ possession without Arthrex’s authorization. Remedial measures include the purging of the Arthrex proprietary information from Parcus and compensation to Arthrex.

CLINICAL
Carmell Therapeutics presented data from a recent clinical study on the use of its REPAIR Bone Putty to augment the healing of open tibia fractures. The study demonstrated a reduction in infection rates of IIIA and IIIB injuries. REPAIR incorporates a bio-active material manufactured from blood plasma containing a concentration of natural plasma and platelet-derived healing factors which bathe the injured tissue as the material degrades over several weeks.

RESEARCH
Researchers at MIT have developed a new approach to bone regeneration and reconstruction called "layer-by-layer assembly". The approach utilizes a very thin, porous, nanostructured, biodegradable poly(lactic-co-glycolic acid) scaffold sheet that incorporates a polyelectrolyte multilayer coating containing active bone morphogenetic protein-2 (BMP) and platelet-derived growth factor-BB (PDGF). The coating carries physiologically relevant amounts of BMP and PDGFs, as little as 200 ng, which are eluted over readily adapted time scales to encourage bone regeneration.

APPOINTMENTS
Amedica Corporation elected Dr. Sonny Bal as its Chairman of the Board of Directors. Dr. Bal has served on Amedica's board since February 2012, and is replacing Amedica's former chairman, Dr. Max Link, who retired from his service on the Amedica board effective August 20, 2014. Dr. Bal is a Professor of Orthopaedic Surgery at the University of Missouri, Columbia, specializing in joint replacement surgery and ceramic bearings, and is also an Adjunct Professor of Material Sciences at the University of Missouri at Rolla. Furthermore, he is a member of the American Academy of Orthopaedic Surgeons (AAOS), the American Association of Hip and Knee Surgeons, and the Association of Bone and Joint Surgeons.


Researchers Develop a New Delivery Approach for Bone Regeneration

A team of researchers at MIT have developed a new approach to bone regeneration and reconstruction called "layer-by-layer assembly".

The approach utilizes a very thin, porous, nanostructured, biodegradable poly(lactic-co-glycolic acid) scaffold sheet that incorporates a polyelectrolyte multilayer coating containing active bone morphogenetic protein-2 (BMP) and platelet-derived growth factor-BB (PDGF).

The coating carries physiologically relevant amounts of BMP and PDGFs, as little as 200 ng, which are eluted over readily adapted time scales to encourage bone regeneration. This feature differentiates this delivery methodology from other bioactive materials which tend to release growth factors too quickly, leading them to be rapidly cleared (by the body) from the treatment site before they can induce tissue repair. Based on electrostatic interactions between the polymer multilayers and growth factors alone, the team's implant sustained mitogenic and osteogenic signals with the chosen growth factors in an easily tunable and controlled manner to direct endogenous cell function.

Furthermore, the researchers observed that this delivery system helped facilitate vascular tissue growth in the affected area, providing a pathway for the stem cells and precursor osteoblasts (cells that produce bone) to reach the site and regenerate the bone and other tissues.

The team concluded that this approach could be clinically useful, and has benefits as a synthetic, off-the-shelf, cell-free option for bone tissue repair and restoration.


Integra Lifesciences Expresses Interest to Divest Spine Business

Last week, Glenn Coleman the CFO of Integra Lifesciences, expressed to analysts that the company is interested in exploring strategic alternatives for its Spine business.

Integra's management team believes that Integra's Spine unit would need a significant investment in order to compete in the market with Medtronic, Johnson & Johnson, Stryker and others, an investment that the company is not prepared to make. On the 2Q:14 earnings call, Integra's CEO, Peter Arduini, conveyed that for Spine, the company would rather plan to focus on organically running the business than going out and doing a large amount of acquisitions.

Integra's Spine segment offers comprehensive spinal fusion and orthobiologic technologies. Key spinal hardware products include integrated interbody fusion devices, minimally invasive solutions, and deformity correction. Key orthobiologic products consist of demineralized bone products, collagen ceramic matrices and pure synthetic bone grafting solutions.

For 2Q:14, the company reported that its U.S. Spine & Other segment grew 4% on a constant currency basis. This was the first year-over-year increase the segment has seen in five quarters.

Management imagines that a combined sale of the company's Orthobiologics and Spine Hardware businesses would be the most attractive to strategic and financial buyers.


Musculoskeletal News Roundup 21-Aug-14

EARNINGS
Medtronic reported financial results for its fiscal 1Q:15. Total revenue was $4.3 billion in 1Q:15, beating consensus estimates by 1% and increasing 4% from $4.1 billion in 1Q:14. Gross margin for 1Q:15 decreased to 74.1%, from 75.0% in 1Q:14. The company's Core Spine and Interventional Spine segments grew by (2%) and 4% respectively, while BMP (Biologics), declined by 11%. The company's overall Spine segment declined by 3%. International revenue was $1.9 billion in 1Q:15, increasing 3% from $1.9 billion in 1Q:14. International revenue accounted for 45.4% of Medtronic's total revenue in 1Q:15, decreasing from 46.0% in 1Q:14. All growth rates are on a constant currency basis.

Orthofix International determined that certain entries in its previously restated filed financial statements were not properly accounted for under U.S. generally accepted accounting principles (GAAP). Specifically, the company has determined that its historical method of accounting for certain revenue adjustments (related to uncollectible patient co-pay and self-pay amounts) as bad debt expense rather than as contra-revenue was incorrect. As a result of the foregoing, Orthofix expects to reduce equally both its historical net sales and its sales and marketing expense by approximately $6 million, $9 million, $2 million and $3 million for the fiscal years ended December 31, 2011, 2012 and 2013 and the fiscal quarter ended March 31, 2014, respectively. Therefore, due to foregoing corrections, Orthofix will again restate its financial statements for the fiscal years ended December 31, 2011, 2012 and 2013 (including the quarterly periods therein) and the fiscal quarter ended March 31, 2014. The company intends to include restated financial statements for these periods in amendments its 2013 Form 10-K and 1Q:14 10-Q.

REGULATORY
According to new analysis provided by the Evaluate Group, the average premarket approval (PMA) review time in 2014 has been 18.4 months, twice as quick as the average time of 35.9 months in 2013. The Center for Devices and Radiological Health (CDRH) has awarded 17 PMAs in 1H:14, increasing 89% from the nine PMAs awarded in 1H:13.

Oxford Performance Materials (OPM) received 510(k) clearance from the FDA to market its OsteoFab Patient-Specific Facial Device, a 3-D printed facial polymeric implant that is custom-printed for each transplant patient using MRI or CT scan images. OPM prints the implants using its proprietary powder formulation, which are similar to bone and support bone attachment. Biomet will be the exclusive global distributor for the new implant.

PRODUCT INTRODUCTION & UPDATE
Aesculap Implant Systems launched its S4 Element minimally invasive surgical (MIS) system, a posterior lumbar pedicle screw fixation system which utilizes endoscope technology to gain direct visualization, providing the ability to confirm rod location and orientation. The system offers a rescue technique and instrumentation designed to help minimize risk of open conversion during a MIS percutaneous lumbar spinal fusion procedure, and reduces exposure to radiation.

CLINICAL
A team of researchers at Texas A&M University have developed a new shape-memory polymer (SMP) for craniomaxillofacial (head, face or jaw) reconstruction and filling of bone defects. The "self-fitting" material expands with warm salt water and molds to the precise shape of the bone defect without becoming brittle, and as its porous, acts like a scaffold, supporting the growth of new bone tissue. The research team created the new SMP by linking together molecules of poly(ε-caprolactone), an elastic, biodegradable substance, and coated it with polydopamine, a sticky material that helps lock the polymer into place by prompting the formation of a certain bone mineral. The researchers determined that an SMP utilizing a polydopamine coat, generated not only 5x more osteoblasts than those without a coating, but encouraged osteoblasts to produce greater quantities of runX2 and osteopontin, two proteins critical for new bone formation.

Ceterix Orthopaedics announced the results of a systematic literature review evaluating the success rate of repairing horizontal meniscus tears. The study, published online in the journal Arthroscopy, examined more than 16,000 articles and nine studies with evaluable data reporting results of horizontal cleavage tear repairs. A total of 98 repairs of horizontal tears were reported. Using reoperation as the criterion for treatment failure, 77 of the repairs were successful, resulting in an overall success rate of 78%, demonstrating that meniscus repair can be successful.

REIMBURSEMENT
SI-BONE announced that Priority Health, the third largest commercial insurer in Michigan, published an update to its Lumbar Fusion Medical Policy No. 91590-R4 providing positive coverage for SI-BONE's iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint. The policy states that the fusion procedure, may now be considered medically necessary for members with SI joint disruptions and degenerative sacroiliitis.


Researchers Develop New Shape-memory Polymer for Craniomaxillofacial Reconstruction

A team of researchers at Texas A&M University have developed a new shape-memory polymer (SMP) for craniomaxillofacial (head, face or jaw) reconstruction and filling of bone defects.

The "self-fitting" material expands with warm salt water and molds to the precise shape of the bone defect without becoming brittle, and as its porous, acts like a scaffold, supporting the growth of new bone tissue.

Currently, the most common method for filling craniomaxillofacial bone defects is autografting, a process in which surgeons harvest bone from elsewhere in the body, such as the iliac crest, and then try to shape it to fit the bone defect. Autograft though, is a rigid material that is difficult to shape, and complications can arise at the harvesting site. Another approach is to utilize bone putty or cement to plug gaps, but these materials can become brittle when they harden, and lack pores, or small holes, that would encourage new osteoblasts (the cells that produce bone), to move in and rebuild the damaged tissue.

SMPs are materials whose geometry changes in response to heat, and upon reaching 140 degrees Fahrenheit, become soft and malleable. Therefore during surgery, a surgeon could warm an SMP to that temperature and fill in a defect with the softened material. As the SMP cools to body temperature, it resumes its stiff texture and "locks" into place.

The research team created the new SMP by linking together molecules of poly(ε-caprolactone), an elastic, biodegradable substance, and coated it with polydopamine, a sticky material that helps lock the polymer into place by prompting the formation of a certain bone mineral. The researchers determined that an SMP utilizing a polydopamine coat, generated not only 5x more osteoblasts than those without a coating, but encouraged osteoblasts to produce greater quantities of runX2 and osteopontin, two proteins critical for new bone formation.

The next step for this new SMP are preclinical studies to test its ability to heal craniomaxillofacial bone defects in animals.



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