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Orthopedic and Dental Industry News Complete Archive »

Printable Weekly

Danaher to Acquire Nobel Biocare for $2.2B

Danaher Corporation entered into an agreement to acquire the Zürich, Switzerland-based Nobel Biocare, the second largest dental implant developer, in an all cash transaction valued at an enterprise value of $2.2 billion, or 3.0x LTM revenues, or 16.0x LTM EBITDA.

Under the terms of the transaction, Danaher will pay CHF 17.10 ($18.31) for each Nobel share, representing a 7% premium to the current 60 day volume weighted average share price (VWAP), and a 28% premium to the undisturbed 60 day VWAP before July 29, 2014, when Nobel confirmed the company was exploring a sales process.

Nobel Biocare offers dental implant systems for various indications, bone types and surgical protocols, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. Nobel would continue to operate as a stand-alone company within Danaher's dental platform after transaction close.

This deal gives Danaher a leading position in dental implant marketplace, and the largest consumable and equipment dental platform in the industry, with sales of nearly $3.0 billion. Danaher's management believes that Nobel's knowledge in implant dentistry, digital prosthetics and software segments, compliments Danaher's position in 3-D imaging, intraoral scanning and digital restorative solutions, further enabling both companies to optimize and integrate workflows.

The transaction is subject to the condition that at least 67% of all Nobel shares are tendered. The offer period is expected to start on or around October 16, 2014, and the deal is anticipated to be completed by late 2014 or early 2015.


Musculoskeletal News Roundup 12-Sep-14

FUNDING
Orchid Orthopedic Solutions received a grant from the Michigan Economic Development Corp. worth $0.3 million. Orchid will utilize the funding to train 35 employees which the company plans to hire as part of its $4.8 million facility expansion in Michigan.

M&A
ArchiMed, a private equity firm, acquired control of MediStream, a Lausanne-based manufacturer of orthopedic implants, through its Citieffe and Eqval operating units, for €12.0 million ($15.5 million), or 0.9x 2014 revenues. ArchiMed will provide balance sheet support through equity and banking relationships. The transaction closed late July.

REGULATORY
Cerapedics filed a Premarket Approval Application (PMA) with the FDA for its i-FACTOR Peptide Enhanced Bone Graft, which incorporates a small peptide as an attachment factor to stimulate the natural bone healing process and promote more predictable bone formation. The application is supported by data from a pivotal clinical trial demonstrating that i-FACTOR bone graft can be utilized as an alternative to autograft harvesting in anterior cervical discectomy and fusion (ACDF) procedures.

EOS imaging received approval from Brazilian National Health Surveillance Agency (ANVISA) to market its EOS system in Brazil. The clearance enables EOS to deploy its initial marketing and commercial activities in the coming months and enter the Latin American market.

Mazor Robotics received approval from the China Food & Drug Administration (CFDA) for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain procedures. Mazor plans to sell its system in China through its partner, Cicel, a Chinese medical device distributor with a focus on capital equipment utilized in orthopedic, spine, and neurosurgery procedures.

Trice Medical received 510(k) clearance from the FDA for its mi-eye fully disposable, single-use, streamlined visualization device, the company's lead product. Mi-eye utilizes a standard 14-gauge needle with an integrated camera and light source that allows doctors to perform diagnostic arthroscopies in their office during an initial consultation with a patient. The device aims to help doctors diagnose orthopedic injuries faster and less expensively, while also eliminating false reads that can occur in other types of diagnostic tests such as MRIs.

PRODUCT INTRODUCTION & UPDATE
Titan Spine announced it is offering a warranty for its Endoskeleton line of spinal interbody fusion devices. Titan’s line of Endoskeleton devices features the company’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. As outlined within the terms of the agreement, the warranty provides a one-time free replacement of any eligible Titan spinal interbody fusion device if revision surgery is required within the five year warranty period.

Tyber Medical launched the initial rollout of its headless cannulated trauma screw system, the latest addition to Tyber's product portfolio already consisting a full line of spinal interbody spacers featuring both standard sterile and non-sterile PEEK and TyPEEK, a proprietary titanium plasma sprayed PEEK. During this initial rollout, Tyber will make the new system available to select private label partners and surgeon advisors. The company is planning for a full product launch late in 4Q:14.

INTELLECTUAL PROPERTY
CartiHeal received four patents, three in the U.S. and one in Japan, for its Agili-C implant, a bi-phasic, cell-free, coralline-hyaluronate composite, off-the-shelf scaffold, intended for patients with injuries to the articular surface of joints. The four patents describe the use of modified coral scaffolds for the treatment of cartilage and bone defects and cover a wide range of claims including treatment of cartilage and osteochondral defects, osteoarthritis and a variety of joint disorders.

Ceterix Orthopaedics received a patent relating to its NovoStitch suture passer, used in the repair of meniscal tears and other soft-tissue joint injuries. NovoStitch allows the placement of a circumferential compression stitch in the knee meniscus, which is tightly surrounded by critical structures such as nerves, arteries and cartilage. Additionally, NovoStitch technology can also be utilized in minimally invasive hip and shoulder procedures. The patent further protects the NovoStitch methods allowing surgeons to arthroscopically pass suture through soft tissue in very tight joint compartments.

LEGAL
U.S. Federal officials filed complaints under the False Claims Act against Reliance Medical Systems and its distributorships, Apex Medical and Kronos Spinal, alleging that Apex and Kronos paid physicians to induce them to use Reliance spinal implants in the surgeries they performed. Each of Reliance’s distributorships sold spinal implants ordered by their physician-owners for use in procedures the physician-owners performed on their own patients. The complaints allege that Reliance used Apex to funnel improper payments to a neurosurgeon for using Reliance spinal implants in his surgeries. The government further alleges that Reliance operated a second distributor, Kronos, which made improper payments to two other physicians

Smith & Nephew agreed to pay $11.3 million to settle allegations that it sold the U.S. government devices it claimed were U.S.-made but actually came from Malaysia, violating the federal Trade Agreements Act. According to the lawsuit's allegations, in 2007 and 2008, Smith & Nephew sold the Department of Veterans Affairs orthopedic devices that it had bought from Malaysia-based Straits Orthopaedics while claiming they were made in the United States. The whistleblower lawsuit was brought about in 2008 by a former Smith & Nephew information technology manager.

CLINICAL
Cellular Biomedicine announced the completion of the twelve-month follow-up of patients from the Phase I/IIa trial, evaluating the safety and efficacy of its proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy ReJoin for Knee Osteoarthritis (KOA). Treatment was completed in 2013 and all patients have now undergone twelve-month follow-up tests, which includes knee articular cartilage volume assessment through quantitative magnetic resonance imaging (MRI) evaluation. The company expects the official report to be available in the fourth quarter of 2014.

IMPLANET published the study entitled, “Adolescent Idiopathic Scoliosis Treated by Posteromedial Translation Using Jazz Sublaminar Bands”. The study presents results of the company's JAZZ implant in the surgical treatment of adolescent idiopathic scoliosis by posteromedial translation, in particular in terms of the restoration of frontal and sagittal alignment. The study was conducted with 12-month follow-up of a consecutive series of 20 patients.

RESEARCH
The European Union (EU) created a €1.0 billion ($1.3 billion) fund for research on the use of graphene, a promising new biomedical material for surgical implants and instrumentation. Graphene is a metamaterial (a material artificially engineered to have unique properties not commonly found in nature) composed of a single layer of carbon atoms arranged in a 2-dimensional, regular hexagonal (honeycomb) lattice, and exhibits approximately 10x the strength of titanium.

According to a new Stericycle report, during 2Q:14, the medical device industry saw 275 medical device recalls affecting 148 firms, decreasing 17% to the lowest such number recorded since the 2Q:12. The number of individual units pulled during recalls in 2Q:14 was also down 47% compared to 2Q:13.

Geisinger Health System launched three new orthopedic programs ProvenCare Hip Fracture, Total Hip and Total Knee. They are evidence-based protocols aimed at reducing mortality rates, improving outcomes and reducing readmissions. The programs will have a 45-point checklist that patients go through from admission, surgery, discharge and follow up.

COLLABORATIONS
Proception Medical entered into worldwide exclusive license agreements with two physician inventors for the development of two medical devices for the orthopedic extremity market. Proception is a strategic medical device developer that bridges the gap between inventor and strategic acquirer.

OPERATIONS
VEXIM established VEXIM Inc., a legal entity that will serve as the company’s U.S. subsidiary for marketing VEXIM’s product portfolio in the United States and support its planned commercial launch in early 2015 of vertebroplasty and kyphoplasty solutions, such as SpineJack. The company plans to approach the U.S. market through a select network of agents and dealers.

APPOINTMENTS
Aurora Spine appointed Mike Wheelock as Vice President of Sales. Prior to Aurora, Mr. Wheelock served as Area Vice President of Sales, Midwest, for Spinal Elements. Additionally, the company appointed Mike Coupland as National Sales Manager in the United Kingdom. Prior to Aurora, Mr. Coupland served as National Sales Manager for QSpine.


Researchers Reveal Nasal Septum Cells’ Ability to Treat Articular Cartilage Defects

A team of researchers at the University and the University Hospital of Basel, revealed that cartilage cells extracted from the nasal septum, called nasal chondrocytes, not only are able to adapt to the environment of the knee joint, but also retain the ability to regenerate and repair human articular cartilage defects.

The study, designed to confirm the safety and feasibility of cartilage grafts engineered from nasal cells when transplanted into knee joint, is published in the scientific journal Science Translational Medicine. In the study, the research team takes small biopsies from the nasal septum of patients 55 and younger, isolates the cartilage cells, cultures and multiplies the cells, and finally applies them to a scaffold. Weeks later, researchers then remove the damaged cartilage tissue of the patients' knees and replace it with the engineered nasal cartilage graft.

The team believes the reason nasal chondrocytes possess the distinct capability to generate new cartilage tissue and can adapt to the articular cartilage environment is because of the cells' homeobox (HOX) gene arrangement.

HOX genes or homeotic genes, are a group of related genes that help build complicated organisms by controlling the body plan of an embryo. After the embryonic segments have formed, HOX proteins determine the type of segment structures (e.g. legs, spinal vertebrae and etc.) that will form on a given segment. Therefore, HOX proteins confer segmental identity and are critical for the proper placement of segment structures, but do not form the actual segments themselves.

Nasal septum cells are cultivated in the neuroectodermal germ layer during embryonic development, which gives them a HOX-negative profile, or lack of expression (gene information utilized in the synthesis of a functional gene product) of certain HOX genes. These specific HOX genes are expressed in articular cartilage cells however, which are formed in the mesodermal germ layer of the embryo.

Due to their HOX-negative phenotype (observable characteristic or trait), serially cloned nasal chondrocytes can be continuously reverted from differentiated to dedifferentiated states, preserving their ability to form other types of cartilage tissues in vitro and in vivo, a capability articular cartilage cells do not possess.

Therefore nasal chondrocytes can be reprogrammed to stably express the HOX genes synonymous with articular cartilage cells, making them compatible to the knee anatomy, and as HOX-negative cells are attributed with an enhanced capacity of tissue regeneration, they can directly contribute to cartilage repair once implanted into the defects.

As human nasal cells' capacity to grow and form new cartilage is conserved with age, the elderly age demographic, as well as patients with large cartilage defects, could benefit from this new method of cartilage regeneration.


Mazor Robotics' Renaissance Guidance System Receives Approval in China

Mazor Robotics received approval from the China Food & Drug Administration (CFDA) for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain procedures.

Mazor plans to sell its system in China through its partner, Cicel, a Chinese medical device distributor with a focus on capital equipment utilized in orthopedic, spine, and neurosurgery procedures. Cicel anticipates Renaissance's target market to be in the hundreds of hospitals within China, and has begun coordinating U.S.-based seminars and hands-on-lab experiences for Chinese spine surgeons to learn about system.

The company presently has seven Renaissance systems installed throughout Asia, in India, Hong Kong, Taiwan, Singapore, Vietnam and Australia.



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