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Oct. 22, 2015

Zimmer acquires Biomet for an estimated $14 billion

Zimmer Holdings Inc. (Warsaw, Indiana; NYSE: ZBH) has completed the acquisition of Biomet in a cash and equity currently valued at approximately $14.0 billion following the receipt of US Federal Trade Commission clearance. In connection with the acquisition, Zimmer has changed its corporate name to Zimmer Biomet Holdings Inc. The company began trading on the New York Stock Exchange and the SIX Swiss Exchange under the ticker symbol ZBH on 29 June 2015.

The transaction is expected to be double-digit accretive to the company's adjusted earnings per share in the first year. Zimmer Biomet also expects to achieve net annual synergies of approximately $350 million by the third year following closing, with approximately $135 million anticipated in the first 12 months. The company anticipates leveraging its scalable platforms and achieving cross-selling opportunities.-Zimmer Biomet press release, 24 June 2015

SomnoMed receives FDA 510(k) approval for SomnoDent devices with wearable compliance microrecording

SomnoMed Ltd. (Sydney, Australia; ASX: SOM) received FDA approval to commercialize its wearable SomnoDent devices fitted with DentiTrac microrecorders. SomnoMed is the first company to receive FDA clearance to offer this advanced compliance-recording feature for oral devices in the United States.

SomnoMed has partnered with Braebon Medical Corp., maker of the DentiTrac, to introduce SomnoDent with DentiTrac, designed to capture and store compliance data in the cloud for patients undergoing continuous open airway therapy (COAT). The recorded compliance data is uploaded to a HIPAA-secure cloud and can be easily accessed by the treating physician.

The launch of the compliance control system in the US was prepared in anticipation of the FDA approval. SomnoDent devices fitted with DentiTrac became available in July 2015.-SomnoMed press release 22 June 2015

Nt-trading acknowledges Straumann patent, removes copied implant components from US market

Straumann (Basel, Switzerland; SIX: STMN) and nt-trading GmbH & Co. KG (Karlsruhe, Germany) have reached an out-of-court settlement in a patent dispute that was filed in Delaware District Court. As a result, nt-trading has agreed to remove its imitations of Straumann's implant abutments from the US market.

At the heart of the dispute was a patent that covers Straumann's CrossFit technology, which ensures that connecting abutments fit precisely into Straumann implants without jamming. The patent protects against copies of Straumann's original abutments for its Bone Level Implants.

nt-trading GmbH & Co. KG manufactures components for use in implant dentistry. In the settlement, the company acknowledged that Straumann's patent is valid and enforceable. It also agreed to remove its imitation abutments from the US market and to pay for Straumann's legal costs. nt-trading has also agreed not to permit any third party to sell, market, or import the respective products in the US.-Straumann press release, 30 June 2015

CareCredit supports ADA Foundation Give Kids A Smile Fund with $100,000 grant

For the ninth consecutive year, CareCredit (Coasta Mesa, California; NYSE: SYF) has donated $100,000 to the ADA Foundation (ADAF) Give Kids A Smile (GKAS) Fund. The $100,000 grant is designated to support GKAS through funding of three major initiatives: (1) GKAS NASCAR elementary-school oral-health education events for underserved children; (2) the ADA Mission of Mercy and GKAS oral-health education and treatment event; and (3) GKAS and TeamSmile collaborative oral health treatment events bringing sports and dental professionals together to improve children's oral health.

In addition to funding the ADA Mission of Mercy, the CareCredit donation will support several GKAS and TeamSmile collaborative events to be held in conjunction with professional sports teams.-CareCredit press release, 29 June 2015

Survey reveals consolidation of the average Canadian dental practice continues

The makeup of the typical Canadian dental practice continues to show consolidation, according to results from the Dental Industry Association of Canada (DIAC) 19th annual Future of Dentistry Survey. While the number of patients treated per day, per respondent has remained relatively consistent over the last eight years, there have been notable shifts in the practice profile appearing since the 2008 study.

As first reported in 2013, the trend towards recent Canadian dental graduates taking longer to set up their practices than those who graduated in past decades is continuing and appears to be accelerating. Established practices are also seeing major changes in their makeups. The 2015 survey confirms that there is a trend towards increasing numbers of dentists in the typical established practice.

Currently, dentists are seeing no more patients per day than on average over the past eight years. Overall, dentists treated 12.4 patients in an average day in 2015 (almost exactly the same as the average of 12.5 patients seen per day over the last eight years).-Dental Industry Association of Canada press release, 7 July 2015

Denteractive Solutions Inc. announces new dentist-patient communication mobile app

Denteractive Solutions Inc. (Newport Beach, California) recently announced its new mobile application built to enhance dentist-patient interaction. Denteractive is a mobile- and web-friendly dentist-patient communication platform designed to help dental professionals and patients engage with one another at any location. Secured with encryption protection (following HIPAA guidelines for privacy), Denteractive members can have live interactions by text, phone, and/or video for the purposes of introductory meetings, consultations and education, exchange of information and files, preventive treatment, tracking dental treatment history, and appointment bookings.

In addition, the app serves as a marketing tool that can boost dental professionals' digital presence. Denteractive helps with increased brand awareness, product and service exposure, patient engagement, and dental transactions.-Denteractive press release, 7 July 2015

3M announces new division: 3M Oral Care

Consistent with 3M's (Maplewood, Minnesota; NYSE: MMM) goal to increase customer relevance, the company has announced the formation of 3M Oral Care, combining the former 3M ESPE Dental and 3M Unitek Orthodontics into a single new division led by Vice President and General Manager James D. Ingebrand, effective immediately.

The Anaheim Group, publisher of Dental Fax Weekly, recently recognized 3M as the Most Innovative Dental Company for the 10th consecutive year. 3M's range of dental products and supplies includes restorative, crown and bridge, mini dental implants, preventive, infection control, and cosmetic. 3M also integrates advanced digital technology and materials science through CAD/CAM dentistry and digital impressions. 3M has brought a number of firsts to the dental industry, including the first tooth-colored restorative material; the first self-adhesive universal resin cement; the first nano ionomer; the first malleable, preformed temporary crown; and the automix impression materials.-3M press release, 8 July 2015

Guideline on gum disease treatment released by American Dental Association

Dentists treating patients with chronic periodontitis, a severe form of gum disease that can lead to tooth loss, are advised to use scaling and root planing (SRP) as initial treatment, according to new guidelines from the American Dental Association (ADA). The guidelines, based on a systematic review and meta-analysis of treatment of periodontitis, were published in the July issue of the Journal of the American Dental Association (JADA).

"This is the first time the various treatments of periodontitis have been compared side-by-side," said ADA President and periodontist Maxine Feinberg, DDS. "Dentists are often challenged with managing gum disease of varying severity; these guidelines will assist practitioners in their decision-making and ultimately help patients receive the right treatment at the right time."

According to the authors, chronic periodontitis is a prevalent condition affecting 47.2% of the adult US population aged 30 years or older. It is a major cause of tooth loss in adults. According to the Centers for Disease Control and Prevention and American Academy of Periodontology, the prevalence of moderate and severe periodontitis are estimated at 30% and 8.5%, respectively, among adults.

Other treatments combined with SRP were examined, including systemic subantimicrobial-dose doxycycline (SDD), systemic antimicrobials, and lasers. The sub-antimicrobial dose doxycycline (Periostat) was a stronger recommendation than other systemic antimicrobials/antibiotics because of concerns of side effects and overprescribing.-DentistryIQ.com, 1 July 2015

Secret FDA proposal to limit mercury fillings is rejected by the HHS

Officials at the US Department of Health and Human Services rejected an FDA proposal that would have recommended against the use of mercury amalgams in any patient when possible and dictated that dentists should not use such amalgams in "pregnant women, nursing moms, children under six, and people with mercury allergies, kidney diseases, or neurological problems."

FDA officials had approved the guidelines in late 2011 but had not released them to the public. The guidelines were rejected after a cost-benefit analysis.-McClatchyDC 21 July 2015

ADA joins task force to investigate opioid crisis

Recognizing the urgency and serious impact of opioid abuse, the American Medical Association (AMA) formed a task force that recently announced the first of several national recommendations to address the growing epidemic. The ADA joined this task force in August 2015.

The AMA Task Force to Reduce Opioid Abuse is comprised of 27 physician organizations, including the AMA, American Osteopathic Association, 17 specialty and seven state medical societies, and now the American Dental Association. The new initiative will seek to significantly enhance physicians' education on safe, effective, and evidence-based prescribing.-ADA press release, 13 August 2015

Convergent Dental's Solea laser gets upgrades, new enhancements

At the opening of the CDA North meeting in San Francisco, Convergent Dental (Natick, Massachusetts) announced a significant software upgrade to Solea, the first FDA-approved, CO2, 9.3-micron dental laser for hard and soft tissue.

The dental laser's new features include a 1.00-mm-XC ("coarse-cut") spot size, an improved 1.00-mm ("standard-cut") spot size, and an auto-upgrade software feature. The new spot sizes enhance Solea's performance and create versatility for dentists looking to limit their use of the traditional drill and deliver virtually anesthesia-free and blood-free procedures.

The new 1.00-mm-XC spot size ablates dental tissue as fast as the currently available 1.25-mm-XC spot size but in a smaller, more precise pattern. The new 1.00-mm, standard-cut spot size replaces the original version and ablates faster and smoother than its predecessor. Solea's new spot sizes mimic bur sizes, making the transition from traditional drills increasingly easy.-Solea press release, 20 August 2015

Vigilant Biosciences announces agreement with Crown Dental + Medical Ltd. for distribution of OncAlert in New Zealand

Vigilant Biosciences Inc. (Fort Lauderdale, Florida), a developer of solutions that aid in the early detection and intervention of cancer, has announced that it has entered into a three-year exclusive sales and marketing agreement with Crown Dental + Medical Ltd. (Christchurch, New Zealand) for the distribution of the OncAlert Oral Cancer Risk Assessment System in New Zealand. The OncAlert Oral Cancer Risk Assessment System includes the OncAlert Oral Cancer Rapid Point-of-Care Risk Assessment Test (OncAlert POC Test) and the OncAlert Oral Cancer CD44 + Total Protein Lab Test (OncAlert LAB Assay).

Under the terms of the agreement, Crown Dental + Medical will exclusively market and sell the OncAlert POC Test and OncAlert LAB Assay to the dental and medical markets in New Zealand pursuant to New Zealand regulatory approvals of the products, which are expected by Q1 2016. Financial terms were not disclosed.-Vigilant Biosciences press release, 18 August 2015


Earliest evidence of dental caries manipulation in the Late Upper Palaeolithic: Abstract

Prehistoric dental treatments were extremely rare, and the few documented cases are known from the Neolithic, when the adoption of early farming culture caused an increase of carious lesions. This study reported the earliest evidence of dental caries intervention on a Late Upper Palaeolithic modern human specimen (Villabruna) from a burial in Northern Italy. Using scanning electron microscopy, the authors showed the presence of striations deriving from the manipulation of a large occlusal carious cavity of the lower right third molar. The striations had a "V"-shaped transverse section and several parallel micro-scratches at their base, as typically displayed by cutmarks on teeth.

Based on in vitro experimental replication and a complete functional reconstruction of the Villabruna dental arches, the authors confirmed that the identified striations and the associated extensive enamel chipping on the mesial wall of the cavity were produced antemortem by pointed flint tools during scratching and levering activities. The Villabruna specimen is therefore the oldest known evidence of dental caries intervention, suggesting at least some knowledge of disease treatment well before the Neolithic. The study suggests that primitive forms of carious treatment in human evolution entail an adaptation of the well-known toothpicking for levering and scratching rather than drilling practices.-Oxilia G, Persani M, Romandini M, et al. Sci Rep. 2015;5:12150. Published online 16 July 2015.

The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment: Abstract

The study's authors carried out metagenomic shotgun sequencing and a metagenome-wide association study (MGWAS) of fecal, dental, and salivary samples from a cohort of individuals with rheumatoid arthritis (RA) and healthy controls. Concordance [similarity] was observed between the gut and oral microbiomes, suggesting overlap in the abundance and function of species at different body sites. Dysbiosis was detected in the gut and oral microbiomes of RA patients, but it was partially resolved after RA treatment. [. . .] The results establish specific alterations in the gut and oral microbiomes in individuals with RA and suggest potential ways of using microbiome composition for prognosis and diagnosis.-Zhang X, Zhang D, Jia H, et al. Nat Med. 2015;21:895-905. Published online 27 July 2015.

3-D printer technology approved for dentures

In July, the FDA issued 510(k) approval for Dentca Inc.'s new 3-D printable denture base material. "The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates, which will eventually replace traditional heat-cured and auto-polymerizing conventional denture-making methods," said Dr. Jason Lee, creator of the material.

The fabrication of dental prosthetics with Dentca's denture base involves using a CAD/CAM system, specialized tray impression systems, and a digital denture file database. The system automates the denture-making process. Now, by also incorporating an optical impression system, a stereolithographic additive printer, and curing light equipment, it gives doctors a more complete denture-manufacturing process.

The material has passed all recent biocompatibility tests in accordance with FDA Blue Book Memorandum #G95-1, ISO 10993-1, and ISO 20795-1.-Dentca press release 27 July 2015


Colan Rogers named president of NSK Dental

Dental equipment manufacturer NSK Dental LLC (Hoffman Estates, Illinois) has named industry veteran Colan Rogers as its president.

Rogers, who brings over 20 years of experience in the dental industry, was most recently director of institutional sales for Henry Schein Special Markets. For the previous nine years, he was national sales manager for Brasseler USA. He started his career at KaVo Dental, working as a sales representative and regional manager for nine years. -NSK Dental press release 26 August 2015

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