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No Cement, No Screws , Yes Memory Metal Retention – RodoMedical

To cement or to screw – that is the question. Not anymore, startup RODO Medical has added a new option. Reversible retention using a shape memory metal dental retention system which uses one or more compression plates made from various shape memory materials, e.g., nickel-titanium alloys such as Nitinol. By applying energy via heat or electrical energy, the memory metal elements change shape. To remove a crown, energy is applied via a wand and the memory metal retentive element shape

Zimmer Acquires BioMet/3i for $13.35 billion USD

In a deal worth $13.35, which has been approved by both companies’ boards, positions Zimmer, based in Warsaw since 1927, to become the second largest company by revenue in the $45 billion global market for artificial knees, hips and other orthopedic and bone-mending implants. The acquisition price, which includes the assumption of debt, consists of $10.35 billion in cash and $3 billion in Zimmer shares. The Zimmer-Biomet merger is the largest in the medical-devices industry since Johnson & Johnson purchased

FDA proposes Blade Implant Reclassification

The FDA (US Food and Drug Agency) is proposing to reclassifying blade implants in a possible come-back for this type of implant. In a FDA press release they are proposing to change the classification from Class III devices to Class II devices because the benefits of blade-form implants “outweigh the risks enough to justify reclassifying the implants from class III, requiring premarket approval, to class II, requiring premarket notification with special controls,”. Class II medical devices are of “medium risk,”

Dental Implant Prices decline due to Pressure from Generics

Dental Implant Prices Decline by 3.3% in Europe as Practitioners Purchase Implants From Low-Cost Manufacturers, According to Millennium Research Group. Average selling prices of dental implant fixtures and final abutments have decreased 3.3% and 8.1%, respectively, over the past year. This occurred as dentists attempted to maintain profitability during the economic crisis by demanding greater discounts and increasingly purchasing implants from low-cost manufacturers.

Astra Tech for Sale : $2 billion

AstraZeneca is considering spinning off a Swedish business that makes dental implants and medical devices for $2bn (£1.25bn). The Anglo-Swedish drugmaker said today that it had hired JP Morgan Chase to help with a strategic review of the firm. In 2009 the industry suffered its weakest year, with sales falling by 3% to 5%. This year the market has been flat but it is slowly recovering. Potential suitors for Astra Tech include US rivals such as privately held Biomet, along

FDA MedWatch Filed on Nobel Biocare`s Replace Implant`s Package Sterility

A Las Vegas dentist has filed a FDA Med Watch report regarding the integrity and therefore sterility of Nobel Biocare Replace Implants. To quote from the report: “I have experienced substantial and unexplainable failures with Nobel Biocare`s (“Nobel”) Replace(TM) Implants. Of 88 consecutively placed implants,34 required removal due to pain or infection for a failure rate of 38.6% (Attachment #1). I doubt these failures are caused entirely by my case selection or surgical skill because I also recorded the clinical

Watch Sales Recovery May Be A Good Signal for Dental Implants

Dental implant makers lost their shine as a recession-proof investment during the global crisis, which turned fixing smiles into a luxury for consumers who struggled to pay for non-essential work on their mouths. “In spite of their rather functional nature, implants are similar to luxury goods in the sense that they are expensive, discretionary items,” Jefferies analyst Stephan Gasteyger said. The dental implant market earned a reputation for being recession-proof by maintaining double-digit growth rates in prior downturns, but the

Implant Wars : The Rise of the Clones

Numerous dental implant company`s have sprung up over the last 3 years that aim to deliver either very similar designs or almost direct copies of established company`s design. These clone implants are often substantially less expense i.e. 1/4 the cost of full service dental implant company`s implants. In addition to mimicking the implant, they have also expanded into compatible prosthetic parts and coverscrews. Especially prominent clone makers Blue Sky Bio (Clone: Straumann, Nobel Biocare and Zimmer) and Dr. Niznick`s Implant

Keystone Dental settles with Nobel Biocare for $2million

Keystone Dental, funded by private equity firm Warburg Pincus, has settled an unfair competition lawsuit from Noble Biocare for $2million. “The settlement terms provide for Keystone Dental to pay $2 million to Nobel Biocare and that Keystone Dental not hire or solicit any current Nobel Biocare employee through February 1, 2009,” the world`s largest maker of dental implants said in a statement. Nobel Biocare filed a lawsuit in late 2007, saying Keystone Dental systematically targeted and hired Nobel Biocare`s sales

Emdogain – Available in the USA again

The FDA has reinspected the BIORA facility and is satisfied with the improvements made. Because the focus of the observations was on the maintenance of quality system documentation and procedures, changes to Straumann® Emdogain, Straumann® PrefGel and Straumann® BoneCeramic were not needed in order to resolve the FDA issues. Straumann has changed the delivery mechanism of Straumann® PrefGel from a pipette to a syringe, which will help to ensure easier, more effective handling of the root conditioner.

German Court Dismisses Materialise`s Injunction Against Nobel Biocare`s NobelGuide

A court in Germany has dismissed a request from Belgian dental implant software maker Materialise for an injunction against a Nobel Biocare software product, NobelGuide. Belgium software maker, Materialise had alleged the updated version of Nobel Biocare`s NobelGuide software infringed one of its patents, a spokesman for Nobel Biocare told Reuters on Wednesday. The Duesseldorf district court decided that the NobelGuide software does not infringe the Belgian company`s patent. The updated version had been introduced as a response to last

3M Buys IMTEC – Mini Dental Implant Manufacturer

3M announced that it will acquire Imtec Corp, a leading manufacturer of mini dental implants. “We are looking forward to the reputation, resources and worldwide reach that 3M brings to help us build this business,” said Ron Bulard, DDS and Chairman of the Board, IMTEC Corp. “Its overall strength in oral care with both the 3M ESPE and 3M Unitek divisions makes them a particularly good partner for us.” This acquisition gives 3M ESPE access to two of the fastest

Dubai Toughens Requirements to Practice Implantology

Tighter laws are on the cards for dentists wishing to practice implantology in Dubai. A proposed change in policy will require dentists to complete 100 hours of implantology study and to present completed case reports, before being permitted to sit for the oral licensing exam. The move is set to infuriate local product companies, who have previously complained of the United Arab Emirate`s excessive licensing requirements.Industry-led courses are likely to be most affected by the ruling, as most are structured

Denture Cleaner Warning Issued by FDA

Denture cleaners like Polident and Fixodent have caused serious and sometimes fatal reactions in some people. The Food and Drug Administration (FDA) announced Monday that one person died and at least 72 others were sickened as a result of allergic reactions to denture cleaners. In some cases, the reactions were a result of product misuse. The FDA report blamed a bleach called persulfate, an allergen used in most denture cleansers. Persulfates are used in these products as part of the

Nobel Biocare Aquires Alpha Bio for $ 95 million

Swiss company Nobel Biocare bought Israeli dental implant startup Alpha Bio for $95 million. Alpha Bio Implant was a one-man show: Dr. Ophir Fromovich, CEO, owner and dentist to the stars, not that he`ll say who his clients are. Fromovich founded Alpha Bio Implant in 1988. Alpha Bio created a new type of implant, the first generation of what became called the NobelActive, the implant with the novel thread pattern. The device Web site explains that it does not “cut

Dental Tourism on the Rise

Aspiring Mexican dentists are moving to border cities in droves and are luring American patients away from farther flung discount destinations such as Hungary and Thailand. A dental crown in the United States costs upward of $600 per tooth, compared to $190 or less in Mexico. Americans have long crossed the border for cheap medicines, flu vaccines, eye surgery or specialist doctors, but dentists are now in highest demand. “We`ve gone from a handful of patients when we started 2-1/2

Astra Tech Aquires Atlantis Components for USD 71 million in cash

The Swedish medical technology company Astra Tech AB is purchasing the US dental company Atlantis Components Inc. for USD 71 million in cash. This business deal is part of Astra Tech’s growth strategy. “The purchase of Atlantis gives us an even stronger product portfolio in the field of dental implants. We strengthen our position in the North American market and can introduce the latest digital CAD/CAM technology in Europe. This also gives us a leading position in the fastest growing

Nobel Biocare CEO Replaced

Nobel Biocare`s CEO Heliane Canepa has been replaced. Domenico Scala has been named its new chief executive, replacing Heliane Canepa, as of Sept 1, 2007. Nobel Biocare Chairman, Rolf Soiron, explained the decision to replace Canepa by saying: `An international company of this size should not be so greatly identified with a single person as has been the case at Nobel Biocare`. Swiss Sunday paper, SonntagsZeitung, reported Heliane Canepa has come under fire over allegations that the Swedish-Swiss dental implant

US ban on Biora Products costs Straumann 10 million Swiss Francs

The continuing FDA ban on importation of Biora`s Emdogain and Bone Substitute has cost parent company Straumann 10 million Swiss francs (8.14 million US$). Straumann chief executive Gilbert Achermann described the loss as `painful`. He furthermore stated that `The US FDA will reinspect our facility in Malmo, but we are not in a position to say when this will happen, If all goes well`, Biora products `could be reintroduced in the US in the first quarter of this year,` Additionally,

Novartis acquires 10% stake in Thommen Medical

Novartis, the Swiss pharmaceutical giant has taken a 10% stake in Swiss dental implant manufacturer Thommen Medical. According to a press release, Novartis`s stake will rise to 20% later in the summer. Andreas Stutz, Thommen Medical CEO says: “Novartis is a strategic partner for us. This opens completely new possibilities in the area of research. The understanding of soft-tissue and bone biology becomes more and more important for the producers of dental implants. Furthermore, we see the interest of Novartis

Controversy over the high price of Dental Implants

Dr. Gerald Niznick of Implant Direct sent a letter to the Editor of IJOMI taking issue with its recent Editorial (JOMI 2006; 21:6) that claimed a direct correlation between innovation and high prices for dental implants. Dr. Niznick`s letter analyzes the published financial statements of Nobel Biocare and Straumann showing their cost of goods at 16% to 20% with marketing expenses in excess of 40% and research costs of only 3.5% – 5% of gross revenues. The editor saw fit

Merrill Lynch`s Implant Industry Report

A Merril Lynch analyst`s report on the dental implant industry has been released. Issues discussed include: the risk of increasing regulation of implant placement, image guided surgery`s growing importance, Nobel Biocare`s sales strategy and various implant company`s product launches. As always, a very interesting read.