Align Tech files suit against Israeli competitor Strauss & Co

Align Technology

Align Technology (NSDQ:ALGN) has filed a suit against competitor Strauss Diamond Instruments, a subsidiary of Israel-based Strauss & Co, claiming that Strauss’s MagicSleeve product infringes upon Align’s own iTero Element sleeves, and that the company has engaged in “false and misleading advertising” of the product.

The suit was filed in the US District Court for the Northern District of California, San Jose Division and includes claims of unfair competition and false designation, patent infringement, federal trademark infringement, trademark counterfeiting, federal trademark dilution and other business code violations, according to court documents.

Strauss Diamond’s MagicSleeve is intended to cover the wand portion of Align Tech’s iTero Element scanner, a device designed to produce a computer-based 3D model of a patient’s teeth as an alternative to traditional teeth impressions.

Align produces its own sleeve for the iTero scanner which incorporates specific design elements the company said are made to allow the device to operate at maximum efficiency, and to prevent cross-contamination.

Align Tech said that the MagicSleeve “is a direct knock-off of Align’s own iTero Element scanner sleeve, except that [Strauss’s] MagicSleeve is significantly inferior in quality to Align’s genuine product,” according to court documents.

The suit goes on to claim that Strauss markets the sleeve across multiple platforms, and in its advertisements it “implies to consumers an association with Align and Align’s iTero Element scanner system.” Strauss also claims the sleeve will result in a “25% faster scanning time,” which Align claims is false.

Align lays out a number of ways in which it believes the MagicSleeve differs from its official product, and claims that use of the product could result in less-than-standard outcomes. Align also claims that the product infringes on the patents related to the official sleeve.

The suit seeks to stop Strauss from using any of Align’s trademarked products in their advertisements and to suspend and recall products sold “with the use of the Invisalign and/or iTero marks, or any other confusingly similar mark,” according to court documents. The company is also seeking reimbursement for profits from the sale or distribution of the system.

Last month, Align Technology saw shares tumble over 20% after the orthodontic device maker posted downbeat guidance alongside third quarter earnings that beat The Street.

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Philips board backs reappointment of CEO van Houten, CFO Bhattacharya | Personnel Moves – October 29, 2018

Philips CEO Frans van Houten

Royal Philips (NYSE:PHG) said today that its board of directors is backing the re-appointment of Frans van Houten as its president and CEO and Abhijit Bhattacharya as chief financial officer and board member.

CEO van Houten has been at the head of Philips since 2011, while Bhattacharya joined the company in 2015, Amsterdam-based Philips said.

During his time in the corner office, van Houten led the initial public offering for Philips Lighting in May 2016 and has increased R&D investments and led acquisitions including Volcano, Spectranetics, Wellcentive and VitalHealth.

Board members will officially vote on a new CEO and CFO next May at the company’s annual general meeting of shareholders.

“The supervisory board is very pleased that Frans van Houten and Abhijit Bhattacharya remain available as members of the board of management. We recommend their re-appointment in view of the fundamental progress of Philips’ transformation into a solutions-driven health technology company with an improved growth and profitability profile. We are impressed by their continuing drive to further unlock Philips’ potential to grow its market positions and expand margins, as the company aims to make the world healthier and more sustainable through innovation,” Philips supervisory board chair Jeroen van der Veer said in a press release.

 Fisher & Paykel taps York as CFO

Fisher & Paykel Healthcare (NZE:FPH) said last week that it appointed Lyndal York as its new chief financial officer, set to join the company next March.

Currently, York serves as CFO to Australian company Asaleo Care. Prior to working with Asaleo Care, York acted as Cochlear‘s(ASX:COH) head of group finance and group financial controller, serving with the company for 11 years. York has also held positions with Edwards Lifesciences (NYSE:EW), Fisher & Paykel said.

“I am looking forward to joining the Fisher & Paykel Healthcare team. The company is well respected and highly successful on the global stage and I am excited to help it continue to build its reputation for sustainable growth and innovation,” York said in a press release.

York will replace long-time CFO Tony Barclay, who retired in May. Andrea Blackie will remain as acting CFO until York joins next year, the company said.

“We are delighted to welcome Lyndal to the Fisher & Paykel Healthcare team. Lyndal has strong international experience within the medical device industry, and as such, possesses a good understanding of its unique characteristics. We have a high performing and aspirational team in place and are very much looking forward to Lyndal joining us next year. I would also like to acknowledge Andrea Blackie, who has been performing the role of acting chief financial officer since 1 June 2018,” CEO & managing director Lewis Gradon said in a prepared statement.

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 Harvard Biosciences names Unninayar as CFO

Harvard Biosciences (NSDQ:HBIO) said last week it named Kam Unninayar as its new CFO, effective November 26, replacing Robert Gagnon who resigned on August 31.

Prior to joining Holliston, Mass.-based Harvard Biosciences, Unninayar served as CFO at clinical stage biopharmaceutical company Tetraphase. Unninayar also spent 11 years at Thermo Fisher Scientific, holding positions as finance VP for the customer channels group, laboratory products and services division and other businesses.

“Maintaining a competitive position within the global laboratory instrumentation industry requires insightful and experienced financial management. Kam Unninayar has proven herself to be an outstanding individual in this regard with a distinguished track record. Kam brings her deep knowledge of our industry, including overseeing growth strategies, operational excellence, and acquisitions while in financial leadership positions for various business segments at public companies. I look forward to partnering with Kam as we advance the company through the next phase of growth and profitability,” Barvard Bioscience CEO Jeff Duchemin said in a prepared statement.

“Harvard Bioscience has brought life science innovations to market for more than a century. I am excited to be joining during what is a transformative phase in the company’s evolution. I look forward to being a member of the executive team to help the company deliver on its strategy, accelerate its growth trajectory, and enhance value for customers and shareholders,” Unninayar said in a press release.

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 RenovaCare appoints Yan-Klassen as CFO

RenovaCare (OTC:RCAR) said last Friday that it appointed Steve Yan-Klassen as its new chief financial officer.

Prior to joining RenovaCare, Yan-Klassen has held positions with a number of accounting firms, including 5 years at BDO Canada LLP, the Scottsdale, Ariz.-based company said.

“We’re thrilled to have Steve join our roster of experienced clinical, regulatory and bioengineering professionals who have worked so hard to advance our SkinGun technology over the years. To date, over 70 patients have been experimentally treated, with many leaving the hospital in a matter of days, avoiding painful and expensive skin graft surgery. These results, along with other important factors, are why we were able to report positive outcomes from our pre-submission meeting with the U.S. FDA,” prez Thomas Bold said in a prepared release.

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 Sight Sciences taps Brown as chief medical officer

Sight Sciences said last week that it tapped Dr. Reay Brown, inventor of trabecular microbypass stenting, as its new chief medical officer.

Brown has published 90 peer reviewed articles on glaucoma and cataract surgery and has served as chair of the American Society of Cataract and Refractive Surgery’s glaucoma committee and as the glaucoma editor for EyeWorld magazine.

“We are extremely proud to add someone who I consider to be one of the true pioneers in the history of modern ophthalmology to our executive team. Dr. Brown’s vast experience both as a practicing surgeon and as a prolific product innovator aligns perfectly with our company’s core competencies and, on behalf of everyone at Sight Sciences, we could not be more thrilled about Dr. Brown joining the company and furthering our mission,” CEO Paul Badawi said in a press release.

“Dr. Brown has been a major force in the surgical glaucoma space for many years and he is uniquely capable of accelerating Sight Sciences’ mission to transform ophthalmology and optometry by addressing the underlying causes of the world’s more prevalent eye diseases. We’re looking forward to working closely with Dr. Brown to bring the OMNI Surgical System to cataract surgeons and glaucoma specialists around the world and to disrupt the dry eye market with TearCare, while keeping an eye on developing new products that address marketplace needs,” chief commercial officer Shawn O’Neil said in a prepared release.

“I am thrilled to join Sight Sciences as chief medical officer. I have known the leadership team for many years and have become intimately familiar with the company’s product portfolio as an active user of OMNI in my own practice. Having innovated and worked clinically within Schlemm’s canal for many years, I believe the OMNI System has tremendous potential given its unique ability to comprehensively target all three sources of resistance in the conventional outflow pathway using a single clear corneal incision. I look forward to making improvements to the existing product portfolio whenever possible, developing new products, assisting the clinical and commercial teams in the market with OMNI and TearCare, and contributing to the growing success of the company,” Brown said in prepared remarks.

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Align Tech shares tumble despite Q3 EPS beat

Align Technology

Shares in Align Technology (NSDQ:ALGN) have tumbled over 20% today after the orthodontic device maker posted downbeat guidance alongside third quarter earnings that beat The Street.

The San Jose, Calif.-based company posted profits of approximately $100.9 million, or $1.24 per share, on sales of approximately $505.3 million for the three months ended September 30, seeing profits grow 22.2% while sales grew 31.2% compared with the same period during the previous year.

Earnings per share were ahead of the $1.19 consensus on Wall Street.

“I’m pleased to report third quarter results with revenue and earnings above our outlook driven by higher than expected Invisalign volume — offset somewhat by lower ASPs and foreign exchange. We also had another record quarter for the iTero scanner business with revenues up 79.1% year-over-year. Q3 Invisalign volume increased 5.5% sequentially and up 35.3% year-over-year reflecting strength across regions and customer channels, as well as strong growth from both teen and adult patients. From a product perspective, we saw strength across the Invisalign portfolio with growth from both comprehensive and non-comprehensive products, reflecting an acceleration in the non-comprehensive category related to expansion of our product portfolio, as well as new sales programs and promotions intended to increase adoption and utilization. We also saw continued strength from international regions, especially Asia Pacific, which was our 2nd largest region after the Americas in Q3,” prez & CEO Joe Hogan said in a prepared statement.

For its fourth quarter, Align Technologies said that it expects to post sales of between $505 million and $515 million and diluted earnings per share of between $1.10 and $1.15.

Shares in Align have fallen 21.9% so far today, at $227.15 as of 10:35 a.m. EDT.

The drop comes after the company reported lower than expected average selling prices, according to  Leerink partner Richard Newitter. Despite the drop in ASPs, Newitter said that they didn’t see the issue as long-term.

“Most of the ASP impact in 3Q is not structural (some self-inflicted in fact), and we believe ALGN can sustain at least 20-30% top- & bottom-line growth for the foreseeable future as it penetrates an underpenetrated WW $12B+ clear aligner market,” Newitter wrote in a letter to investors.

In August, a federal appeals court found that a U.S. patent board erred when it invalidated portions of a patent covering the Align Technology (NSDQ:ALGN) Invisalign orthodontic device.

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Medical device companies: These 15 performed the best in 2017

[Image from Unsplash]

Updated Jan. 5, 2018

Among the most successful medical device companies of 2017, there were two themes: innovation and breadth of services.

That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world.

What does innovation mean? Think Align Technologies (Nasdaq:ALGN) and how it brought 3D printing to bear on a dental product screaming for better customization: braces. Or there’s Abiomed (Nasdaq:ABMD) and its tiny Impella heart pump, which is meant to help restore blood flow and allow the heart to rest after a heart attack.

For breadth of services, look no farther than Integer (NYSE: ITGR). Created out of the 2015 merger of Greatbatch and Lake Region Medical, Integer is a giant medical device contract manufacturer that could theoretically do almost anything for an OEM.

Most – about four-fifths – of the world’s 100 largest medical device companies saw their stock price increase this year. But Align, Abiomed, Integer and other top companies enjoyed an especially exceptional performance.

Here are the 15 best-performing medical device stocks of 2017, ranked by their stock growth percentage.

Next>>

And click here to download a performance spreadsheet of the 100 stocks>>

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Align Technology expands iTero distro, integration deal with Glidewell

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Align Technology

Align Technology (NSDQ:ALGN) said today it expanded a distribution deal with Glidewell Dental to distribute Align’s iTero Element intraoral scanning system in North America.

Through the deal, San Jose, Calif.-based Align’s said its iTero Element scanner will feature Glidewell’s fastdesign.io software which serves to auto-design restorations for clinician approval and to communicate with a lab’s digital design technicians as needed.

“This is an exciting opportunity to join together to deliver a restorative work flow driven by digital precision and enabling the growth of digital dentistry. This collaboration makes same-day restorations more efficient and accessible for our joint customers, and also introduces the benefits of iTero scanning to the more than 50,000 dentists using Glidewell services,” Align chief marketing officer Raphael Pascaud said in a prepared statement.

Align Technology said it expects the iTero Element with Glidewell’s technology to be available during the 1st quarter of 2018.

“Align has long been at the forefront of digital dental technology. Their pioneering spirit and drive for continued innovation are very much in line with Glidewell Dental’s goal to remove barriers to patient treatment, and I couldn’t be more excited about this dynamic pairing,” Glidewell Dental founder & prez Jim Glidewell said in a press release.

In late October, Align saw shares rise over 15% after the orthodontic device maker beat expectations on Wall Street with its third quarter results.

Align Tech-backed SmileDirectClub levies lawsuits against critical dentists, orthodontists

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Smile Direct Club

The Align Technology (NSDQ:ALGN) backed SmileDirectClub is reportedly sending cease-and-desist letters to dentists who criticize its products, according to a BuzzFeed report.

The company sent at least 2 cease-and-desist letters last month, threatening lawsuits if dentists did not remove videos they’d posted criticizing the practice of do-it-yourself clear teeth aligners, according to the report.

The cease-and-desist letters join a lawsuit from late October that the company levied against a group of New York and New Jersey orthodontists who posted a similar video, and a suit against a Michigan affiliate of the American Dental Association over a publication the group published in a monthly journal, BuzzFeed reports.

The claims vary but centrally argue that the dentists are part of a “well-funded lobbying and public relations effort” trying to shut it down, according to the report.

“Several dentists and orthodontists have made publicly false, disparaging and misleading statements on various social media websites regarding SmileDirectClub all in an effort to protect their traditional business model and to limit access of care to keep prices for orthodontic care artificially inflated. SmileDirectClub has pursued legal remedies to prevent these dentists and orthodontists from making false, disparaging and misleading statements regarding SmileDirectClub,” a Smile Direct Club spokesperson said in an emailed statement to BuzzFeed.

According to the report, the dentists claim to be merely expressing their professional opinions on the clear orthodontic devices.

BuzzFeed originally broke the story on the cease-and-desist letters in mid-October, detailing the story of orthodontist Jeffrey Miller. Miller also received a cease-and-desist letter, which he ignored, and was followed by a letter declaring the company’s intent to sue him and his practice for damages of more than $34 million, “plus punitive damages of not less than three times that amount,” according to the report.

The report detailed a number of other groups and private practices that received cease-and-desist letters, as well as organizations which have presented opposition to SmileDirectClub.

Earlier this month, the ADA released its own resolution which “strongly discourages” the practice of do-it-yourself orthodontics, referencing potential harm to patients from delayed and reduced visits to dentists.

In the resolution, the ADA states that it “believes that supervision by a licensed dentist is necessary for all phase of orthodontic treatment including oral examinations, periodontal examinations, radiographic examinations, study models of scans of the mouth, treatment planning and prescriptions, periodic progress assessments and final assessments with stabilizing measures.”

“Patients are being inundated with direct marketing campaigns encouraging them to initiate and manage their own orthodontic treatment. These campaigns are operating in multiple media outlets, including online, billboards and television ads. This year’s ADA House of Delegates recognized the need for the ADA, as America’s leading advocate for oral health, to take steps to educate patients about the potential pitfalls of self-managed orthodontic treatment. This new policy supports the importance of dentists being in charge of diagnosing and treating patients to ensure the safe delivery of appropriate care,” ADA council on dental practice chair Dr. Craig Ratner said in an ADA release.