Monday, May 23, 2022

Physician Indicted in $10 Million Telemedicine Health Care Fraud Scheme



 In the years since the Covid shutdown in the spring of 2020, healthcare has seen a steady increase in the use of telemedicine.  It's actually been a bit exciting to see how patients can be helped with the need to actually have doctor and patient in the same room together.

As many of you know, the has also been an increase in teledentistry.  The best part of that, in my opinion, is the ability of hygienists to go into nursing facilities and communicate their findings to a dentist who can then help these patients by either prescription, delegation of treatment, or being able to go on site and know the patient's needs ahead of time.  As more and more people age and end up in skilled nursing facilities, these types of healthcare will become critical.

Of course any system that is created can be hacked or scammed and so it is with telemedicine.  Here is a recent release from the U.S. Department of Justice...

An indictment was unsealed today in federal court in Brooklyn charging Elemer Raffai, an orthopedic surgeon, with health care fraud in connection with a $10 million scheme involving the submission of false and fraudulent claims to Medicare and Medicare Part D plans. Raffai was arrested today and will make his initial court appearance this afternoon in United States District Court for the Northern District of New York.

Breon Peace, United States Attorney for the Eastern District of New York; Kenneth A. Polite, Jr. Assistant Attorney General of the Justice Department’s Criminal Division; Scott J. Lampert, Special Agent-in-Charge, U.S. Department of Health and Human Services, Office of Inspector General’s Office of Investigations (HHS-OIG); and Janeen DiGuiseppi, Special Agent-in-Charge, Federal Bureau of Investigation, Albany Field Office (FBI), announced the arrest and indictment.

“In exchange for kickbacks from telemedicine companies, Dr. Raffai allegedly submitted millions of dollars in false and fraudulent claims to Medicare on behalf of beneficiaries without even examining them or based on conversations on the phone that lasted less than three minutes,” stated United States Attorney Peace. “Dishonest doctors who think Medicare is a cash cow and connect with telemedicine companies to brazenly steal from this vital taxpayer-funded program, will find themselves arrested, prosecuted and their scheme disconnected.”

“These allegations describe a physician who is more motivated by personal enrichment than his duty to provide appropriate and necessary care to his patients,” stated HHS-OIG Special Agent in Charge Lampert. “Dr. Raffai is accused not only of disregarding proper patient care, but also of pilfering funds from a program upon which millions of citizens depend for health services. Our agency and law enforcement partners are dedicated to tracking down individuals who commit health care offenses, and their involvement in a fraud network does not insulate them from our pursuit.”

“Healthcare fraud is a serious crime that impacts every American. Dr. Raffai cheated the system for his own personal gain in the amount of $10 million. Like many others who commit healthcare fraud, Dr. Raffai’s crimes contribute to the rising cost of health care for everyone. The FBI, along with our partners, will continue to investigate healthcare fraud to ensure these individuals who willingly defraud the American people are brought to justice,” stated FBI Special Agent-in-Charge DiGuiseppi.

According to the indictment, Dr. Raffai purported to practice telemedicine with the AffordADoc Network and other telemedicine companies that paid the defendant for each consultation with a beneficiary. Between July 2016 and June 2017, Dr. Raffai allegedly participated in a health care fraud scheme in which he signed prescriptions and order forms via purported telemedicine services for durable medical equipment (DME), including orthotic braces, that were not medically necessary. Dr. Raffai caused the submission of these claims based solely on a short telephone conversation for beneficiaries he had not physically examined and evaluated, and that were induced, in part, by the payments of bribes and kickbacks. Dr. Raffai was paid by telemedicine companies approximately $25 or $30 per patient consultation. The indictment further alleges that Dr. Raffai, together with others, submitted or caused the submission of approximately $10 million in false and fraudulent claims to Medicare for DME on behalf of beneficiaries who were residents of the Eastern District of New York, and Medicare paid more than $4 million on those claims.

The charges in the indictment are allegations, and the defendant is presumed innocent unless and until proven guilty. If convicted, Dr. Raffai faces up to 10 years in prison.

The FBI and HHS-OIG are investigating the case, which was brought as part of the Medicare Fraud Strike Force under the supervision by the U.S. Attorney’s Office for the Eastern District of New York and the Criminal Division’s Fraud Section. Trial Attorneys Andrew Estes and Kelly M. Lyons of the Criminal Division’s Fraud Section are in charge of the prosecution.

The Fraud Section leads the Medicare Fraud Strike Force. Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,200 defendants who have collectively billed the Medicare program for nearly $19 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.


Thursday, May 19, 2022

DENTSPLY SIRONA INC. INVESTIGATION ALERT: Bernstein Liebhard is Investigating DENTSPLY SIRONA Inc. For Violations of the Federal Securities Laws

 Dentsply Sirona has been in the news frequently as of late... and not for good reasons.  It seems that the behemoth company has potentially violated federal securities laws.  The CEO was terminated in a sudden and unanticipated move on April 19th, then the CFO Jorge Gomez left and was hired by vaccine maker Moderna.  One day after Moderna hired him, Gomez was terminated when the company learned that Dentsply Sirona had started an investigation that included him.  This is the kind of thing one expects in a novel, not in the real world.

Now comes a press release from a law firm that is looking to litigate over stock losses of Dentsply Sirona. Here is the press release:

Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, is investigating potential securities fraud claims on behalf of shareholders of DENTSPLY SIRONA Inc. ("Dentsply Sirona" or the "Company") (NASDAQ: XRAY) resulting from allegations that Dentsply Sirona might have issued misleading information to the investing public.

On April 19, 2022, the Company announced that Donald M. Casey Jr. ("Casey") had been terminated as the Company's Chief Executive Officer ("CEO") and had also ceased to serve as a member of the Board of Directors of the Company, effective that same day. Casey had served as the Company's CEO since joining the Company in February 2018. 

On May 10, 2022, the Company announced its preliminary financial results for the first quarter of 2022. Among other things, the Company reported first quarter net sales decreased 6.1% to $965 million, compared to $1,027 million in the first quarter of 2021. Additionally, net income for the first quarter of 2022 was $65 million, or $0.30 per diluted share, compared to $117 million, or $0.53 per diluted share in the first quarter of 2021. And adjusted earnings per diluted share decreased to $0.52 compared to $0.72 in the first quarter of 2021. 

On that same day, the Company also announced that it was unable to file its Quarterly Report on Form 10-Q for the period ended March 31, 2022.  The Company revealed that in March 2022, an internal investigation had commenced into allegations regarding certain financial reporting matters submitted by current and former employees of the Company.  The investigation was focused on the Company's use of incentives to sell products to distributors in the third and fourth quarters of 2021, whether those incentives were appropriately accounted for, and whether the impact of those sales was adequately disclosed in the Company's periodic reports filed with the SEC. Dentsply also revealed that the Company's Audit Committee was investigating allegations that certain former members of senior management directed the Company's use of these incentives and other actions to achieve executive compensation targets in 2021.  The Audit Committee retained independent outside counsel to assist in its investigation. The Company also announced that it had voluntarily contacted the SEC to advise it that an internal investigation was underway, and that it was unable to file the Form 10-Q on a timely basis.

On this news, the price of Dentsply Sirona stock declined over 7% to close at $36.38 per share on May 10, 2022.

If you purchased Dentsply Sirona securities, and/or would like to discuss your legal rights and options please visit DENTSPLY SIRONA Inc. Shareholder Investigation or contact Peter Allocco at (212) 951-2030 or pallocco@bernlieb.com.

Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal's "Plaintiffs' Hot List" thirteen times and listed in The Legal 500 for ten consecutive years.

ATTORNEY ADVERTISING. © 2022 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Contact Information:

Peter Allocco
Bernstein Liebhard LLP
https://www.bernlieb.com
(212) 951-2030
pallocco@bernlieb.com


Wednesday, May 18, 2022

LIGHTFORCE BRINGS ON FRANK QUINN AS CHIEF REVENUE OFFICER

 LightForce, makers of the world’s only fully customizable 3D

printed braces system, announced that Frank Quinn, former Vice President and General Manager of

US Commercial at Align Technology, has joined the LightForce team as their Chief Revenue Officer.

Frank brings over 13 years of experience in the orthodontics space, helping to drive growth,

revenue, and go-to-market strategies.


“Frank has been a trusted executive in the orthodontics space for over 13 years. He has a long

history of growing companies, and most importantly, scaling the customer-focused values that

make LightForce special,” said LightForce CEO and Co-Founder, Dr. Alfred Griffin, DMD, PhD,

MMSc.


Dr. Griffin continues, “Frank’s orthodontics knowledge, go-to-market expertise, and leadership

experience will be invaluable to both doctors and the LightForce team as the industry makes the

transition to fully digital treatment."

“The industry is shifting to being fully digital and LightForce, with their exponential growth and

buzz in the market, is clearly leading the movement. I’ve been especially impressed by their

community of doctors who are deeply invested and engaged with the LightForce team. There’s

a real shared desire to build something that improves practice efficiency and patient outcomes,”

said Mr. Quinn. “I’m excited to roll up my sleeves with this incredible team to help doctors

provide their patients with the very best orthodontic experience in the specialty.”


About LightForce Orthodontics

LightForce is a digital platform providing orthodontists with fully customized, 3D printed tooth-moving

tools. Founded in 2015 by Dr. Alfred Griffin, DMD, PhD, MMSc, along with Dr. Lou Shuman, DMD,

CAGS, LightForce is revolutionizing the specialty through advanced manufacturing and technology.

After five years of extensive research and development, LightForce launched its first product to the

Orthodontic market- the world’s only fully customized 3D printed bracket system and digital

treatment software. Learn more at www.lf.co.

Tuesday, May 17, 2022

Join Me Tonight for a Presentation on Advanced Digital Caries Detection

 





The good folks at Medidenta have been nice enough to allow me to present this evening.

If you are interested in learning more about devices that can make diagnosing caries easier,  join me for all the low down.

The best part?  It's FREE!

Follow this link to register.  

Monday, May 16, 2022

Keeping Personal and Practice Data Safe in the Wake of the American Dental Association Hack

 A very short post today because the real story is in the link.

A couple of weeks ago, the American Dental Association had their network compromised by cyber criminals.  The hack took the ADA offline for several days and caused a major disruption to not only ADA operations but also the operations of several state dental associations as well.

Even as I type this, their systems are still not back 100%.  This is a big deal and unfortunately it is a situation. that most individuals read or about or experience far too frequently.  It has almost gotten to the point where these situations happen so frequently that the public has become desensitized to them.  We think, 'Oh another data security incident.  Pass the salt." and we carry on our lives.

That's unfortunate, but it is also human nature.  What is *news* is what is not common.  Plane crashes are a big story because they are rare.  If there was 24 hour coverage of every auto fatality, that all the news we would hear, unfortunately.

To help doctors put this event in perspective and also to help them to be prepared, I turned to my friend Steve White.  He is the Senior Partner and Vice President of the cyber security firm DDS Rescue and also someone I've come to have a friendship with where we, once again unfortunately, have bonded over our interest in data security.

Steve's firm is one of my major vendors that helps with my cybersecurity, so when  he speaks, I listen.  I really feel that any doctor, or any individual, who wants to be more secure should listen to him as well.  He was kind enough to answer some questions for me which we've posted to Dental Products Report online.  

Also, if you'd like more info on the ADA incident, after reading the interview on DPR, simply scroll down the page for an article by my buddy Stan Goff dealing with this unfortunate situation.

Thursday, May 12, 2022

Patrick Wardle - From the DPRK With Love

 


If you are a Mac user and you are not yet familiar with Patrick Wardle, I'd highly recommend you check out his blog and his work.  He is a security consultant and pretty much the creme de la creme of Mac experts.  His blog can be found at this link.  

Patrick has devoted himself to the study of Mac malware, even going so far as to finding vulnerabilities in both applications and the Mac Operating System itself.  He also runs a 501(c)(3) foundation devoted to the study of and solutions to Mac problems and malware.

Through his foundation "Objective See" he also releases tools/applications that help Mac users monitor vital functions, locate unwelcome processes, and become aware of potential "bad things" happening in places most of us would never look.  Oh, and did I mention that he provides these tools for FREE?  

Patrick has a long history of working in the security arena and he's one of those individuals who, when he speaks, the industry listens... and rightly so.

On a personal note, I've never met Patrick face to face, but we've corresponded a bit and I've come away impressed.  It's a given that a guy like this is smart.  However, it's rare these days to find someone who is doing the right thing simply because it's the right thing to do.  Because of that, I highly recommend supporting Patrick through Patreon.  That allows him to continue the good fight and to help provide the community with high quality and effective tools.


Now on to the heart of today's post.  If you follow the security industry and read what's been going on the past few months, you've seen that North Korea has put forth a lot of effort in attempting to compromise security researchers in an attempt to learn better ways to break into systems.  North Korea is under an incredible number of sanctions that limit their ability to earn money that the country wants to spend in its nuclear weapons program.

The North Korean economy is floundering and because of that, their government sponsored hackers have been working hard to break into banks and basically find any way possible to bring money into North Korean coffers.

The latest efforts they've put forth are in the areas of cryptocurrency and the blockchain.  Obviously their hope is to make off with cash from different sources.  These attempts to steal crypto and hack the blockchain were publicized by the U.S. Cybersecurity & Infrastructure Security Agency (often abbreviated as CISA).  Objective See has analyzed the Mac parts of this and Patrick has posted his analysis.

He recently put up a blog post about this situation which is a fascinating read.  

Wednesday, May 11, 2022

Reward Offers for Information to Bring Conti Ransomware Variant Co-Conspirators to Justice

 


This is an interesting piece of news.  The US Department of State has decided to dial up the pressure on the Conti ransomware gang.  This group has been pretty prolific and in addition to making tons of money in ransom, they have also wrought havoc on a number of U.S. businesses and industries in general.  If you have any interest, just type "Conti" into Google and see the number of hits...


What follows is the Press Statement from the U.S. Department State:

The Department of State is offering a reward of up to $10,000,000 for information leading to the identification and/or location of any individual(s) who hold a key leadership position in the Conti ransomware variant transnational organized crime group.  In addition, the Department is also offering a reward of up to $5,000,000 for information leading to the arrest and/or conviction of any individual in any country conspiring to participate in or attempting to participate in a Conti variant ransomware incident.

The Conti ransomware group has been responsible for hundreds of ransomware incidents over the past two years.  The FBI estimates that as of January 2022, there had been over 1,000 victims of attacks associated with Conti ransomware with victim payouts exceeding $150,000,000, making the Conti Ransomware variant the costliest strain of ransomware ever documented.  In April 2022, the group perpetrated a ransomware incident against the Government of Costa Rica that severely impacted the country’s foreign trade by disrupting its customs and taxes platforms.  In offering this reward, the United States demonstrates its commitment to protecting potential ransomware victims around the world from exploitation by cyber criminals.  We look to partner with nations willing to bring justice for those victims affected by ransomware.

This reward is offered under the Department of State’s Transnational Organized Crime Rewards Program (TOCRP).

The Department manages the TOCRP in close coordination with our federal law enforcement partners as part of a whole of government effort to disrupt and dismantle transnational organized crime globally, including cybercrime.  More than 75 transnational criminals and major narcotics traffickers have been brought to justice under the TOCRP and the Narcotics Rewards Program (NRP) since 1986.  The Department has paid more than $135 million in rewards under these programs to date.

For more information on the group listed above and the TOCRP, please see Department of State INL Transnational Organized Crime Rewards.


Tuesday, May 10, 2022

VideaHealth Dental Artificial Intelligence Solution Receives FDA Clearance

  We are seeing a sudden influx of artificial intelligence platforms coming to dentistry.  Recently I posted about FDA Clearance for Pearl and their Second Opinion AI that can read radiographs.

Now comes news that VideaHealth, a dental artificial intelligence company has received FDA 510 (k) clearance for their AI powered caries detection algorithm called Videa Caries Assist.


Here is the press release:

VideaHealth, a dental AI pioneer, today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for Videa Caries Assist, an AI-powered dental caries (cavity) detection algorithm. VideaHealth surpassed the FDA’s exacting efficacy requirements by significantly aiding the analysis of radiographs instantly from the dentist’s chair.

In the FDA trial, the number of missed caries was 43% lower for dentists using Videa’s AI. Notably, the dentists using Videa’s AI also experienced a 15% average reduction in erroneous detections of caries lesions. All dentists in the trial, regardless of experience level, encountered caries detection capability improvements. These detection performance improvements enable more accurate diagnoses, better preventative care and substantial cost savings for patients by reducing unnecessary invasive treatments. A joint study with VideaHealth partner Heartland Dental revealed similar impacts on diagnostic improvements and treatment planning.

VideaHealth is disrupting a market that has remained largely unchanged for the past 30 years, providing greater transparency to patients, and is actively working to reduce AI bias in dentistry. The company’s breakthrough solution is built upon the Videa Factory, which houses the industry’s most diverse dataset with over 100 million data points from leading dental service organizations (DSOs), insurance companies, clearinghouses and universities. This helps the VideaHealth algorithms remain impartial and more fully represent the diversity of the U.S. population.

Florian Hillen, leading industry AI researcher and founder and CEO of VideaHealth, said, “Our biggest priority as a team is ensuring that our solution is effective across diverse patient populations and helps dentists deliver the most accurate diagnoses. This paves the way for more appropriate dental treatment recommendations and the opportunity for dentists to foster deeper patient engagement.”

VideaHealth’s AI technology and seamless workflow integration radically accelerate and improve decision-making across the entire dental chain, unlocking the most economic and health value for providers, insurers and patients. With FDA clearance and funding from some of the world’s top-tier venture capital firms, VideaHealth is poised to support millions of patients through strategic partnerships with leading DSOs with the goal of ensuring every dental patient receives an accurate diagnosis and every provider captures efficiencies and faster reimbursements.

About VideaHealth

Founded in 2018 and born out of Harvard and MIT artificial intelligence (AI) research, VideaHealth is on the mission to improve dental patient health through the power of AI. VideaHealth’s platform drives the improved quality of care for patients by using AI to augment the diagnosis and treatment planning capabilities of providers. Partnering with leading DSOs across the country, VideaHealth is committed to helping usher in the age of preventative care in dentistry. Backed by leading venture capital firms Spark Capital, Zetta Venture Partners and Pillar VC, and angel investors, VideaHealth is headquartered in Boston. For more information, visit https://www.videa.ai. 

Monday, May 9, 2022

Roland DGA Opens New Atlanta Imagination Center

 

We have recently brought a new mill on board to supplement our entire line of digital dental offerings.  Our new DWX-42W has been online in our clinic for about 2 weeks now and things are progressing nicely as we ramp up using the device.  The restorations it is producing are *impressive*!


Now comes word from Roland that they have opened a new Imagination Center in Atlanta.  I cannot wait until I get a chance to see it in person!  Here is the latest:


Roland DGA Corporation, a leading provider of wide-format inkjet printers, vinyl cutters, 3D milling machines, and other innovative digital devices, has opened a new regional office in Atlanta, Georgia – the Atlanta Imagination Center – which will allow customers, prospects and partners to access Roland DGA’s latest technologies in this important and popular region of the country.

The Atlanta Imagination Center houses many of Roland DGA’s newest and best-selling products, including the recently launched third-generation TrueVIS Series printer/cutters, allowing visitors to see the impressive capabilities of these state-of-the-art devices firsthand through live product demonstrations. Staffed by experienced application specialists, the new 5,600 square-foot facility will also serve as a hub for both in-person and virtual training and events.

Roland DGA conducted a grand opening event for the new Imagination Center on May 3, in conjunction with the start of ISA International Sign Expo 2022 in Atlanta. The well-attended afternoon event allowed invited sign and graphics industry professionals, already in the area to attend the Expo, to be on hand for the festivities. The event included a welcome address by Roland DGA Vice President of Sales Amado Lara, an official ribbon-cutting ceremony and guided tours of the facility, plus a DJ, food and drinks.

“We are thrilled about the opening of our new Atlanta Imagination Center, and we were pleased that so many people could join us to mark the occasion and celebrate with us,” said Oransky. “In addition to this new Atlanta office, we have another in Boston that’s centrally located for those in the Northeast and one in the Toronto, Canada area as well, expanding Roland DGA’s reach beyond our California headquarters. These regional offices – alongside our network of world-class resellers, roadshow program, and strong online presence – ensure our customers and partners can engage with us and see Roland DGA products in any way that suits them best.”

For more information on the new Atlanta Roland DGA Imagination Center, visit rolanddga.com/company/contact. To learn more about Roland DGA Corporation, or the complete Roland DGA product line, visit https://www.rolanddga.com.

About Roland DGA Corporation

Roland DGA Corporation serves North and South America as the marketing, sales, distribution and service arm for Roland DG Corporation. Founded in 1981 and listed on the Tokyo Stock Exchange, Roland DG of Hamamatsu, Japan is a worldwide leader in wide-format inkjet printers for the sign, apparel, textile, personalization and vehicle graphics markets; engravers for awards, giftware and ADA signage; photo impact printers for direct part marking; and 3D printers and CNC milling machines for the dental CAD/CAM, rapid prototyping, part manufacturing and medical industries.

 

Thursday, May 5, 2022

Dentsply Sirona opens the gateway to a new digital universe with cloud-based solution DS Core

 



 Today in a virtual event, Dentsply Sirona has unveiled DS Core and other services and solutions, a new and open platform that integrates the whole workflow of digital dentistry – across its devices, services, and technologies. DS Core is developed in collaboration with Google Cloud and gives dentists the power to do more, so that they can focus on their patients and create easier ways to collaboratively work with labs, partners, and specialists.

Cord Staehler, Chief Technology Officer at Dentsply Sirona: "We are very proud that we are now ready to take the next step in our mission to make digital dentistry easy to integrate into dental offices. In line with our recently launched collaboration with Google Cloud, this enables seamless workflows and the highest level of connectivity with the ultimate goal in mind: the best treatment outcome for patients."

DS Core gives dentists the power to do more

DS Core, an open, cloud-based platform operated by Dentsply Sirona, is transforming digital dentistry. It is designed around the needs of dentists and modern dental practices and with a focus on security.   

The digital platform is efficient, cost-effective, and easy-to-use – with automatic software updates that give dentists access to the latest version and features. DS Core makes running a dental practice easier, because it seamlessly connects to Dentsply Sirona equipment and is accessible across multiple devices. For dentists it means they can maximize the productivity of their practice by simplifying workflows and easily adding and integrating new ones. Practitioners can use DS Core to store different types of patient files and making them accessible from multiple locations, while collaborating with partners and colleagues outside their practice. DS Core supports GDPR and HIPAA-compliant file sharing and cloud storage for patient case files.

DS is also introducing two services that help dentists to get the most out of digital dentistry: DS Core Create and DS Core Care.

DS Core Create – with a few clicks to high-quality expert designs

DS Core Create is an excellent tool for next-level dental design services. With just a few clicks, dental practitioners can gain access to high-quality expert designs that are tailored for each patient's needs across a broad range of indications without having to use the software themselves. The cloud-based platform makes it easy to delegate the design workflow, which saves valuable time in the dental practice. The service integrates smoothly with Dentsply Sirona's new Primeprint Solution and will grow in the future.

DS Core Care – seamless service and support solution

DS Core Care is a comprehensive, integrated, and easy-to-understand equipment service and support solution that harmonizes equipment with service offerings to provide a seamless customer experience. This helps to increase equipment uptime and give dentists peace of mind so that they can focus on their patients.

Cord Staehler said: "By launching this digital universe with DS Core at its center and services like DS Core Create and DS Core Care, as well as solutions like Primeprint, we are positioning Dentsply Sirona at the forefront of digital dentistry. Most importantly, we help dental practitioners to unlock the full potential of their work so that they can focus on what matters most: treating patients and giving them healthy smiles."

Primeprint Solution – A medical-grade 3D printing system

Primeprint Solution is a highly automated, end-to-end, medical-grade 3D printing system for dentists and dental technicians who want to expand their treatment and service offerings. It is a smart hardware and software solution that is optimized for dental applications and can run the entire printing process including post-processing. The high level of automation helps reduce handling times, allows delegation, and enables maximized productivity. Primeprint Solution enables practitioners to print biocompatible applications with reproducible and accurate results*. The printing process has been developed in line with FDA guidelines for Additive Manufacturing (AM) medical devices and outputs from the device are medical products.

Dr. Mike Skramstad, dentist from Orono (Minnesota, USA), said: "3D printing has just taken the next leap forward with Primeprint. With the combination of complete integration, enclosed automated workflow, and industry defining efficiency, Primeprint gives me and most importantly my staff confidence that we are delivering very good and safe 3D printed parts to our patients. Furthermore, the automation supports that every application we 3D print is processed, cleaned and cured to a very high standard."

Due to various certification and registration periods, not all products are immediately available in all countries. In order to ensure an excellent customer experience DS Core will be launched in a phased rollout.


Wednesday, May 4, 2022

Align Technology Announces First Quarter 2022 Financial Results

 


When I started in dentistry, orthodontics required wires, years of treatment, sometimes extractions, AND a referral to a specialist.  my how times have changed.  Into that orthodontic process stepped Align Technologies and their product Invisalign.  The entire process rocked the tooth moving world and proved an incredible concept of healthcare.  Suddenly computer simulation could create a product that moved teeth and didn't involve wires.  Today the market for orthodontic services is higher than ever and more general dentists, like me, are treating a large percentage of patients.  And yet, orthodontists are busier than ever.  Align was a disrupter, but also an instigator or progress...

Now their numbers continue to prove every year just how successful the are...


Commemorates 25 years of smiles and innovation through doctor-directed care with major milestones including 217K Invisalign trained doctors, 12.8M Invisalign patients, 73K iTero scanners, and 49K exocad software licenses


  • Q1'22 total revenues of $973.2 million, compared to $894.8 million in Q1'21
  • Q1'22 Invisalign volume of 598.8 thousand cases, compared to 595.8 thousand cases in Q1'21
  • Q1'22 Invisalign cases for teenage patients of 175.2 thousand cases, 29.3% of total volumes, compared to 165.3 thousand cases, or 27.7% of total volumes in Q1'21
  • Q1'22 Clear Aligner revenues of $809.7 million, compared to $753.3 million in Q1'21
  • Q1'22 Imaging Systems and CAD/CAM Services revenues of $163.5 million, compared to $141.5 million in Q1'21
  • Q1'22 diluted net income per share of $1.70; Q1 non-GAAP diluted net income per share of $2.13
 Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today reported financial results for the first quarter of fiscal 2022 ("Q1'22"). Q1'22 total revenues were $973.2 million, down 5.6% sequentially and up 8.8% year-over-year. Q1'22 Clear Aligner revenues were $809.7 million, down 0.7% sequentially and up 7.5% year-over-year. Q1'22 Imaging Systems and CAD/CAM Services revenues were $163.5 million, down 24.2% sequentially and up 15.6% year-over-year. Q1'22 Clear Aligner volume was down 5.1% sequentially and up 0.5% year-over-year. For the Americas, Q1'22 Clear Aligner case volume was down 4.3% sequentially and down 1.5% year-over-year. For our International region, Q1'22 Clear Aligner case volume was down 6.1% sequentially and up 3.0% year-over-year. Q1'22 Clear Aligner case volume for teens was down 3.6% sequentially and up 6.0% year-over-year. Q1'22 operating income was $198.1 million resulting in an operating margin of 20.4%. Q1'22 net income was $134.3 million, or $1.70 per diluted share. On a non-GAAP basis, Q1'22 net income was $168.7 million or $2.13 per diluted share.

Commenting on Align's first quarter results, Align Technology President and CEO Joe Hogan said, “Overall, the first quarter proved to be a tougher than expected operating environment globally and we believe our results primarily reflect three factors: the continued impact of COVID-19 waves in every region and especially in China with its restrictions and lockdowns under their zero-COVID policy; a weaker economic environment and waning consumer confidence driven by increasing inflationary pressures and supply chain disruptions; and the military conflict in Ukraine and fallout across Europe. In addition, with approximately half our business occurring outside of the U.S., unfavorable foreign exchange rates negatively impacted our revenues, margins, and EPS. Notwithstanding these headwinds, Q1’22 total revenues of $973.2 million were up 8.8% year-over-year. This is compared to Q1’21 revenues of $894.8 million which had year-over-year revenue growth rate of 62.4% from Q1'20 to Q1'21. Our Q1’22 operating income was $198.1 million and operating margin was 20.4%.”

Continued Hogan, “We know that COVID lockdowns, weaker consumer confidence, inflationary pressures, and the Russia/Ukraine conflict have created headwinds, but we remain excited and are committed to realizing the enormous opportunity in front of us to lead the evolution of digital orthodontics and comprehensive dentistry. With less than 10% share of the 21 million orthodontic case starts each year, and with over 500 million people globally who can benefit from a healthy beautiful smile, our market is as large as ever. No other company is as well positioned as us to take advantage of that potential as the environment improves and growth trends return. We will continue focusing on the relentless execution of our strategic growth drivers while managing investments in the near term to account for the headwinds and uncertainty and we remain confident in our long term revenue growth target of 20-30%.”

Financial Summary - First Quarter Fiscal 2022


  Q1'22 Q4'21 Q1'21 Q/Q Change Y/Y Change
Invisalign Case Shipments 598,835 631,145 595,820 (5.1)% +0.5%
GAAP  
Net Revenues $973.2M $1,031.1M $894.8M (5.6)% +8.8%
Clear Aligner $809.7M $815.3M $753.3M (0.7)% +7.5%
Imaging Systems and CAD/CAM Services $163.5M $215.8M $141.5M (24.2)% +15.6%
Net Income $134.3M $191.0M $200.4M (29.7)% (33.0)%
Diluted EPS $1.70 $2.40 $2.51 ($0.70) ($0.81)
Non-GAAP  
Net Income $168.7M $224.5M $198.4M (24.9)% (15.0)%
Diluted EPS $2.13 $2.83 $2.49 ($0.70) ($0.36)
As of March 31, 2022, we had $1.1 billion in cash, cash equivalents and short-term and long-term marketable securities, compared to $1.3 billion as of December 31, 2021. We also have $300.0 million available under a revolving line of credit. In February 2022, we purchased approximately 143.6 thousand shares of our common stock at an average price of $522.61 per share through open market repurchases, for a purchase price of $75.0 million. We have approximately $650.0 million remaining available for repurchase under our May 13, 2021, $1.0 Billion Repurchase Program.

Q1'22 Announcement Highlights

April 3, 2022 marked the 25th anniversary of the founding of Align Technology and 25 years of smiles and innovation in digital orthodontics and restorative dentistry. Align is commemorating this significant milestone of doctor-directed care with over 217 thousand Invisalign trained doctors, 12.8 million Invisalign patients, 73 thousand iTero scanners, and 49 thousand exocad software licenses.
On March 18, 2022, we announced the new Cone Beam Computed Tomography ("CBCT") integration feature for ClinCheck digital treatment planning software, a user-friendly tool that combines roots, bone, and crowns into a single three-dimensional model that enables doctors to visualize patients' roots as part of the digital treatment planning process. The CBCT integration feature helps doctors confidently expand diagnosis and treat a broader range of cases with Invisalign clear aligners by increasing visibility and control of a patient’s underlying anatomical structures during the digital treatment planning process.
On February 2, 2022, we announced Invisalign system innovations for the Align Digital Platform, a proprietary combination of software, systems, and services designed to provide a seamless experience and workflow that integrates and connects all users – doctors, labs, patients, and consumers. These Invisalign system innovations include ClinCheck Live Update for 3D controls, the Invisalign Practice App, Invisalign Personalized Plan ("IPP"), and Invisalign Smile Architect, and will revolutionize digital treatment planning for orthodontics and restorative dentistry by providing doctors with greater flexibility, consistency of treatment preferences, and real-time treatment plan access and modification capabilities. Each of these innovations is designed to enhance Invisalign treatment planning quality, efficiency, and scale, and contribute to a better doctor-patient engagement and treatment outcomes.
Q2'22 Stock Repurchase

During Q2'22, we expect to repurchase up to $200.0 million of our common stock through either, or a combination of, open market repurchases or an accelerated stock repurchase agreement.

Tuesday, May 3, 2022

Ultradent Unveils New Temporary Dental Cement

 


Ultradent Products, Inc., a leading developer and manufacturer of high-tech dental materials, is announcing UltraTempTM REZ II temporary dental cement for temporary crowns, bridges, inlays, onlays, and small temporary fillings. 

UltraTemp REZ II temporary cement is a hydrophilic, resin-based chemistry that helps ensure low irritation and a quality seal. It was developed for longer retention needs (2-4 weeks) and comes in a dual-barrel syringe with mixing tips for easy delivery. The solution features a non-eugenol formula that will not interfere with resin bonding. 

With its innovative mixing-tip delivery system, UltraTemp REZ II temporary cement provides a highly convenient, time-saving application method that delivers an even cement mix for reliable strength. 

Once set, UltraTemp REZ II temporary dental cement provides optimal sealing capabilities. In addition to withstanding normal biting and chewing forces, it is radiopaque, fluoresces under a black light, and is easily removed. Available in Fast Set (1–2 minutes) and Regular Set (2–3 minutes). 


Monday, May 2, 2022

American Dental Association Cybersecurity Incident Update


Here is the latest communication from the ADA regarding the cyber security incident that occurred about 10 days ago.  My biggest piece of advice here is that if your ADA login password was used for anything else, change those NOW.  This may turn out to be a bigger problem than it appears currently.
  Needless to say, if and when I find out more, it will be available here... 


Dear Colleagues:

By now, you’re likely aware of the cybersecurity incident that impacted the American Dental Association last week. It has been a very challenging few days for our community, especially for those of you who have needed to access our online services and resources. I want to assure you that the ADA’s IT personnel, with additional guidance from third-party cybersecurity specialists, have been working tirelessly to restore our systems safely. We are making progress, and I thank you for your patience and understanding.

As valued members, your questions and concerns are important to us. It is also important that we provide timely and accurate updates as the situation evolves. However, because the incident is under an active investigation, we are limited in the information we can share at this time. Know that we hear you, and we will provide answers as we are able in the near future.

There is reasonable expectation that our system’s information is intact, but our investigation continues. In the meantime, if you’re looking for information on protecting your own computer systems, the Cybersecurity and Infrastructure Agency (CISA.gov) offers tips and resources.

As a precautionary measure, the ADA is reviewing service providers that can offer privacy protection and credit monitoring support for members. We will share more information as soon as it is available. In the meantime, please remain vigilant and know that the ADA will never contact you for your username and password information.

If there’s one thing I can say for certain, it’s that our ADA community is resilient. We have navigated the difficulties of a pandemic together, and I know that we will make it through the current situation as well.

If you have any questions, please send them to us at questionsada@gmail.com.  


Sincerely,


Cesar R. Sabates, D.D.S.

President, American Dental Association