Impress3D Announces Launch of Commercial Operations

 

Flexible Partials Made Easier

Impress3D announced today the official launch of its commercial operations in North America, offering dentists a new way to treat the 138 million partially edentulous Americans. 

“Impress3D is the only solution that combines digital scanning technology with Valplast® materials, making removable partial dentures more efficient, comfortable, and accessible. 

After receiving an overwhelmingly positive response from the dentists already using Impress3D, we’re excited to now expand our service nationwide,” says CEO Jason Shelton. 

Impress3D’s exclusive partnership with Valplast®, the world’s #1 flexible partial denture material, enables dentists to easily upload a scan of the patient’s mouth via its online platform at impress3d.com or through their preferred scanner’s portal. The partial denture is then precisely fabricated and shipped back to the office within just a few days. The result is a 95% fit rate, leading to fewer visits and better patient comfort. 

For more information, visit the Impress3D website at impress3d.com. 

About Impress3D: As part of Reset Technology Corp., Impress3D was founded in 2020. Co- founder Justin Marks is the inventor of 3D printing using Valplast®, the gold standard in dentistry for removable partial denture materials. CEO Jason Shelton joined in early 2022 and brings over two decades of medical device leadership. 

Statement from NIH and BARDA on the Novavax COVID-19 Vaccine

 What follows for today's post is the lastest statement from the NIH and BARDA about the Covid Vaccine...

The Centers for Disease Control and Prevention (CDC) has recommended that Novavax’s COVID-19 vaccine be used as another primary series option for adults in the United States ages 18 years and older. The Food and Drug Administration (FDA) previously authorized for emergency use the protein-based vaccine, known as NVX-CoV2373.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health; the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response; the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND); and the Defense Health Agency supported the development of NVX-CoV2373 as part of the U.S. government’s rapid response to develop safe and effective COVID-19 vaccines.

DoD funded the early development of technology used in the NVX-CoV2373 vaccine, and NIAID, BARDA, JPEO-CBRND and DoD provided support for clinical trials evaluating its safety and efficacy. BARDA also provided funding and expertise to support manufacturing and procurement of the vaccine.

NVX-CoV2373 contains a stabilized form of the SARS-CoV-2 spike protein—a surface protein that facilitates entry to human cells. The approach for stabilizing the spike protein was invented by NIAID scientists and their collaborators. The spike proteins are organized in tiny protein particles called nanoparticles. The vaccine is formulated with a saponin‐based adjuvant. Saponins are naturally occurring compounds from soapbark trees. Adjuvants are sometimes added to vaccines to enhance immune responses.

The U.S. government supported the Phase 3 clinical trial known as PREVENT-19 that enrolled 29,960 adult participants in the United States and Mexico between Dec. 27, 2020, and Feb. 18, 2021. Participants were randomly assigned to receive two doses of the candidate vaccine 21 days apart or two injections of a saline placebo. Randomization occurred in a 2:1 ratio, with two volunteers receiving NVX-CoV2373 for each one who received placebo. Results published in the New England Journal of Medicine showed the candidate vaccine was 90.4% effective in preventing symptomatic COVID-19 among trial participants and 100% effective in preventing moderate-to-severe COVID-19. The trial was conducted before the Omicron variant of SARS-CoV-2 became dominant.

The PREVENT-19 trial expanded in May 2021 to enroll adolescents ages 12 to 17 years. Novavax has noted that the trial results in adolescents demonstrated comparability to those observed in the adult population. PREVENT-19 also is evaluating a third shot or booster dose in both adult and adolescent participants. In addition, NIAID is studying NVX-CoV2373 in the Phase 1/2 “mix & match” trial, in which adult volunteers who have been fully vaccinated against COVID-19 receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.

Lawrence A. Tabak, D.D.S., Ph.D., Senior Official Performing the Duties of the NIH Director; Anthony S. Fauci, M.D., NIAID Director; and Gary Disbrow, Ph.D., BARDA Director, released the following statements:

“This is the third COVID-19 vaccine available in the U.S. as a result of the unprecedented government research response to develop safe and effective COVID-19 vaccines, for which NIH spearheaded the clinical testing. This collaborative approach involving many public-private partners provides an important blueprint for pandemic preparedness now and into the future.” – Dr. Tabak

“People in the United States now have an additional COVID-19 vaccine available to them that offers protection against severe disease. The Novavax COVID-19 vaccine contains a SARS-CoV-2 protein and an adjuvant to boost the immune response. Other vaccines in routine use in the United States, including the hepatitis B vaccine, use this traditional protein-based platform. I continue to encourage all eligible adults and children to get vaccinated against COVID-19 and to stay up-to-date on boosters.” – Dr. Fauci 

“We are pleased to see this vaccine achieve FDA authorization, giving Americans another option for a vaccine to protect against COVID, particularly with cases on the rise again. Even with other FDA-approved vaccines available, we continue to support development of flexible vaccine technologies like this one so that we can respond more rapidly to future public health emergencies as well as the current health crisis.” – Dr. Disbrow

Lawrence A. Tabak, D.D.S., Ph.D., is performing the duties of the Director of the National Institutes of Health in Bethesda, Maryland.

Anthony S. Fauci, M.D., is Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Gary Disbrow, Ph.D., is Director of the Biomedical Advanced Research and Development Authority (BARDA), in the HHS Office of the Assistant Secretary for Preparedness and Response. 

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Methodist Hospitals Data Breach $425K Class Action Settlement

 By now, we all know that data breaches can be expensive.  When you factor in the services of experts, potential hardware replacement/reconfiguration, fines, and other costs, a breach can be *so* expensive as to stress the resources of large organization while driving some smaller ones out of business completely.

However, add onto that the potential costs associated with a lawsuit and a company can soon see their expenses spiraling way out of control.  Even if a lawsuit is successfully defended and no loss incurred as a result, there are still the serious expenses incurred by dealing with the litigation.

Recently, lawsuit brought against Gary, Indiana based Methodist Hospitals, Inc was settled for $425,000.  The amount was the announced settlement, but that number fails to include the amount of money spent on legal bills to simply get to the point of a negotiated settlement.

It all stems from a 90 day window in 2019 where Methodist Hospitals had their network compromised before the attackers released Ransomware to encrypt their network.  The attackers, before encryption,  made off with PHI (Protected Health Information) as well as a good deal of demographic information related to those patients.  Forensics point to a successful Phishing Attack on an employee's email account that allowed for the initial network access.  Once the criminals had gained this foothold it appears they siphoned off the data and then encrypted the network.

The lawsuit accused the hospital of failing to properly protect the purloined data.

I haven't been able to find info related to how many patients were affected or what other costs have been associated with this attack, however it is safe to say the costs have been substantial.

Full info on the lawsuit including how to fie a claim if you were affected can be found by following this link.  

New Molecule may Help Reduce and/or Slow Head and Neck Cancer Cell Growth

 First of all, thanks for allowing me to take a few days off last week.  I hope you enjoyed the post on my Roland adventure thus far...

Now we are on to other fascinating and potentially life changing tech topics.  I'm leading off this week with a post on  newly discovered molecule that might have incredible implications for oral and pharyngeal cancers.

It seems that researchers at the University of California - Los Angeles (UCLA) School of Dentistry have managed to isolate a molecule that might prevent the growth and spread of squamous cell carcinomas.  These cancers can be horribly devastating to the patient... often the surgery to remove the cancer results in visible scars and/or deformities for those unfortunate enough to be victims.  

Squamous Cell carcinomas can be incredibly invasive and grow incredibly fast.  This means that often by the time they are detected, the tumor is large and may well have undermined soft tissue or bone.  This means more aggressive and invasive surgeries to remove them which can be devastating for the patient.  By slowing or stalling the growth of these cancer cells, it is hoped to allow for more conservative treatment.

It seems that these cancers, especially along their outside, have a gene called CD276 that keeps the body from fighting it with T cells.  The newly discovered molecule blocks the CD276 gene and stops or greatly slows the growth of the cancer cells.

This could be a MAJOR breakthrough for the treatment of cancers in the head and neck.

For the full scientific paper, follow this link.  

The Shape of Things to Come...

 

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I am extremely enthusiastic about the next 3-5 years of dentistry!  The research and development part of the profession goes through a development cycle of what Darwin referred to as "punctuated equilibrium".  Basically meaning that changes go through peaks and valleys.  Sometimes great ideas come down like a spring rainstorm and sometimes there are droughts.

It seems that since 2020 when the pandemic changed everything, we've seen hesitations in the development of new products.  In the big picture that makes sense.  There was no need for companies to introduce a plethora of new products and/or technologies if the industry couldn't use them.

Now we are going to see some exciting changes in the industry!  One of the things that I am excited about is the ease of use in the category of in-office milling.  Milling has exploded on the lab side with many doctors receiving crowns that they don't even realize have been milled.  On the lab side of things one of the largest companies in the milling space is Roland DG’s DGShape.  The company is well known and trusted in dental labs for its precise and dependable milling solutions.

If you ask an experienced lab technician what mill they prefer, you will find that Roland is on a very short list.

The good news for doctors is that Roland is now bringing the same technology to the dental office.  Since late April, we have been working with the DGShape DWX-42W in our office with very good results.  As regular readers of this blog and my columns in DPR know, I like to keep things on the leading edge and occasionally on the bleeding edge.  Our work with DGShape is definitely leading edge kind of stuff.

I say that because DGShape has extensive experience in the milling market.  They have been providing mills to the dental labs for a very long time and have created devices that are durable, dependable, but most importantly they produce amazing results.  In fact, I'd be willing to bet that a lot of doctors out there have been placing restorations created by Roland mills and didn't even know it

The dental industry is currently riding the crest of a wave of science and technology that was created and fine tuned during the Covid layoff.  We are currently seeing, and will continue to see for the foreseeable future,  incredible changes in clinical practice.  The workflow is one of those categories that will be impacted for sure.

Our current digital workflow for many fixed restorative procedures is as follows:

• Diagnose
• Prepare - this is especially impacted by our Bien Air electric handpieces.  If you are in the market for electrics be sure to check out the Bien Air Nova.  You'll be impressed.
• Digital Scan - The scan is performed with our iTero units.  We have an iTero Element and are also using the new iTero Element 5D Plus.  Scan time for a a full mouth is less than 10 minutes.  It is normally in the 5-10 minute range.
• Download - the digital scan leaves our office and is stored in the iTero cloud.  We download the files from the cloud to our design computer.
• Design - using Exocad design software, our 2 designated Dental Assistant Design Specialists (affectionately known as D-Rey and Boo-boo) take turns doing the digital design part of the process.
• Mill - once the case is completed in Exocad, the file is sent to the DGShape DWX-42W and milled.
• Polish - once the milling process is done, the restorations are polished using Ultradent's Jiffy Porcelain system.  We are currently not firing any of our restorations in an oven.
• Deliver - the prosthesis is then tried in, adjustments done (if needed), and the case bonded into place.

The incredible ease of doing this type of dentistry is not something difficult to achieve.  The digital tools we all now have at our disposal make this much easier and much more predictable than you might imagine.  The ability to utilize open source hardware means you can basically bring any scanner you would like into the process.  I love not being locked into one manufacturer for every piece of the workflow.  I can find what I like best and what is easiest for me and my team, while delivering outstanding results.  The image at the top of this post came out of the DGShape DWX-42W this past Thursday.  THAT is the kind of result you can expect from this machine.  Done with no impression and no model.  

Darby Invests in onDiem to Bring Flexible Staffing Solutions to Customers

Darby Dental Supply, one of the nation’s largest dental distributors, is proud to announce a strategic partnership with onDiem, a national on-demand staffing platform that connects dental practices with verified dentists, dental hygienists, dental assistants and front office professionals. This collaboration merges two innovators in the dental space to provide a modern solution for everyday staffing, HR, and payroll needs. 

At the core of this partnership is Darby and onDiem’s shared passion for helping dentists thrive through solutions that solve real problems. onDiem uniquely provides value to a two-sided marketplace – connecting dental professionals with flexible employment opportunities while giving hiring practices access to qualified, fully vetted, and on-demand employees. 

“The future of temporary staffing in the dental industry relies on a modern, flexible approach, which onDiem provides on a national scale,” said Michael Caputo, President of Darby Dental Supply. “With this partnership, Darby customers will have all the tools necessary to implement hiring workflows that they can grow with, not grow out of. Alongside the team at onDiem, we look forward to transforming the way dental professionals hire and look for work.” 

Now available to Darby customers at a discounted rate, onDiem makes it easy for practices to search for qualified, pre-vetted dental professionals within their community. Dentists can seamlessly hire temporary employees without having to worry about compliance, onboarding, payroll, and benefits – which is all handled directly by onDiem to save time and money. On the careers side, job seekers can use onDiem to find their next opportunity and enjoy the benefits of flexible work schedules at pre-determined hourly pay rates. 

“At onDiem, we are changing hearts and minds about how staffing and payroll get done,” said Joe Fogg, Founder and CEO of onDiem. “Our partnership with Darby reflects our shared entrepreneurial spirit and goal of proactively solving everyday problems for both dental practices and dental professionals. By taking the hassle and worry out of paying temporary staff, onDiem helps dentists stay compliant so they can focus on what’s most important to them – growing their business and ensuring patients have ready access to high quality care.” 

While paying temporary staff as independent 1099 contractors is not new to the dental industry, most dentists don’t realize the risk of this practice. onDiem ensures all temps are covered by malpractice and workers compensation insurance and meet local state requirements – protecting practices from any legal or compliance issues. The platform also offers free temp-to-perm conversion for those interested in retaining the temporary employees they hire. 

Just as dentistry is constantly evolving, so is the onDiem platform. By working closely with customers to understand their rapidly changing needs and pain points, onDiem is continuously tweaking their product and building upon their suite of offerings to grow with them. Among the platform’s latest innovations is ClearPay – a tool that gives transparency to the cost of temporary staffing. ClearPay eliminates the mystery of what it really costs you to hire a temp safely by providing a full breakdown of what you pay for each shift. The company also recently introduced the onDiem OneShift Guarantee, allowing practices to subscribe to the service risk-free. With the OneShift Guarantee, practices pay nothing until they have filled their first shift.

This partnership further enhances Darby’s growing suite of solutions from industry partners, all carefully curated to provide holistic value for dental professionals. 

About Darby Dental Supply:

Darby Dental Supply is where supplies meet solutions – for 75 years and counting. Darby provides dental practices of all sizes with convenient access to more than 50,000 products as well as technology services, equipment repair, a full line of private label products, and dedicated glove, specialty, and capital equipment divisions.

Darby began in 1947 as a single mail-order catalog in Brooklyn and has become one of the largest dental distributors in the United States, shipping over one million orders each year while never losing sight of what matters most – their customers. In celebration of the company’s 75th anniversary, Darby is thanking customers for their loyalty and support with special incentives throughout the year. 

Darby focuses not only on improving dental practices nationwide but improving communities as a whole. Through purposeful investments and thoughtful advocacy efforts, Darby is committed to making a positive environmental and social impact on the world for generations to come. For more information, please visit darby.com. 

About onDiem:

Founded in Portland, Oregon, in 2017, onDiem's staffing platform connects dental practices and dental professionals in all 50 states to meet real-time staffing needs. onDiem distinguishes itself from other staffing platforms by offering employees, not contractors for temporary shifts. They eliminate the burden of staffing compliance, so practices can focus on maximizing production and revenue. onDiem dental professionals enjoy health-care benefits, employer-paid taxes, and insurance coverage, along with the ability to set their own work schedule and hourly rates. 

With a free account, dental professionals can look for temporary and permanent job opportunities, and practices can create posts for new temp shifts, search for professionals in their area, and communicate with candidates directly. Today the platform serves over 32,000 dental professionals and over 13,000 dental practices.

Experian Hacks Allow for Criminals to Take Over Legitimate Accounts - Thanks to Brian Krebs

 One of the best security websites on the Internet, in my opinion, is Krebsonsecurity.com

Brian Krebs is an investigative journalist who, at one time, worked for the Washington Post for 14 years.  He is probably one of the best computer security journalists on the planet.  I read his stuff frequently and I highly recommend his book Spam Nation.

I wanted to give Brian a bit of an introduction in today's post because the post today is actually short because he has done all the heavy lifting on this one.  It seems that there have been criminals hijacking legitimate customer accounts on credit bureau site Experian.

Of course, this is a pretty dangerous site to have a compromised account on.  I think most of you should give this article a definite read just to make sure you are well informed and aware of how this thing is happening.

A big thank you to Brian Krebs for all of his hard work on this & other issues and stories.  Follow this link to read the post.  

Supply Chain Attack of Professional Finance Co affects over 650 Dental Offices

 It's difficult for a small practice when it comes to cyber security, but now we have seen an  attack of a third party that affected data from dental practices.  It seems that Professional Finance Company,  a third party company that provides accounts receivable services for offices, suffered a ransomware attack.  

From what I've discerned, no dental offices were actually compromised, however because PFC had information dealing with collections, there was information on patients.  It's difficult to tell if any health information was compromised.  Since the company helped with collections, I suppose it is possible that  something like services billed might have been compromised.

Part of PFC's statement reads:

PFC found no evidence that personal information has been specifically misused; however, it is possible that the following information could have been accessed by an unauthorized third party: first and last name, address, accounts receivable balance and information regarding payments made to accounts, and, in some cases, date of birth, Social Security number, and health insurance and medical treatment information

If you are interested in reading the entire Notice of Cybersecurity Incident report from PFC, this link will take you there.   

3Shape Confirms Filing of US Patent Infringement Complaint Against Medit Related to Wireless Scanning, Scanning Software, and Shade Measurement

 

Intraoral scanning is continuing to increase in dentistry.  Because of that, acquiring customers and maintaining relationships is imperative to these companies.  We are saying lots of players in this market currently and companies are determined to keep the intellectual property safe as they work to attain market share.  Needless to say, some lawsuits will be occurring.  Here is the latest info on one such lawsuit.  This information was released on July 7, 2022 by 3Shape.

3Shape A/S confirmed today that it recently filed a complaint against Medit, asserting that Medit intraoral scanner systems infringe 3Shape patents related to wireless scanning, scanning software and tooth color shade measurement. 

3Shape filed the complaint in the United States District Court for the Western District of Texas. The complaint seeks monetary damages as well as injunctive relief. 

Regarding the infringement complaint, Thomas Kirkbak, Director, Litigation & Compliance at 3Shape said, “The innovation and scanner technology in 3Shape TRIOS are unique and fundamental to why we are the choice of doctors. 3Shape TRIOS has received the Best of Class award for intraoral scanners an unprecedented ten years in a row. We simply cannot allow other companies to copy our hard-earned technology and infringe on our patents.”

3Shape asserts that certain Medit intraoral scanner systems, including the i500, i600, i700 and i700 Wireless, infringe a number of 3Shape patents and, that the i700 Wireless scanner system infringes a 3Shape patent covering wireless scanning technology. 

The patents named in the Complaint are 3Shape U.S. Patent No. 9,629,551; U.S. Patent No. 10,064,553, U.S. Patent No. 10,695,151 and U.S. Patent No. 11,076,146.

 

North Korean State-Sponsored Cyber Actors Use Maui Ransomware to Target the Healthcare and Public Health Sector

 

Here is an interesting bit of news.  Security in healthcare is a tremendously important issue.  The speed and efficiency of digital data, as we all know, makes decision making and treatment orders of magnitude easier.  Yet, for every up there is a down.  That means security needs to be a serious focus.  Unfortunately as you will read in just a bit, there is a nation state that is now entered into that fray.  How can small offices keep up with APTs?  There is a ton of info at this page as well as in the links scattered through the info below.

Summary

The Federal Bureau of Investigation (FBI), Cybersecurity and Infrastructure Security Agency (CISA), and the Department of the Treasury (Treasury) are releasing this joint Cybersecurity Advisory (CSA) to provide information on Maui ransomware, which has been used by North Korean state-sponsored cyber actors since at least May 2021 to target Healthcare and Public Health (HPH) Sector organizations.

This joint CSA provides information—including tactics, techniques, and procedures (TTPs) and indicators of compromise (IOCs)—on Maui ransomware obtained from FBI incident response activities and industry analysis of a Maui sample. The FBI, CISA, and Treasury urge HPH Sector organizations as well as other critical infrastructure organizations to apply the recommendations in the Mitigations section of this CSA to reduce the likelihood of compromise from ransomware operations. Victims of Maui ransomware should report the incident to their local FBI field office or CISA. 

The FBI, CISA, and Treasury highly discourage paying ransoms as doing so does not guarantee files and records will be recovered and may pose sanctions risks. Note: in September 2021, Treasury issued an updated advisory highlighting the sanctions risks associated with ransomware payments and the proactive steps companies can take to mitigate such risks. Specifically, the updated advisory encourages U.S. entities to adopt and improve cybersecurity practices and report ransomware attacks to, and fully cooperate with, law enforcement. The updated advisory states that when affected parties take these proactive steps, Treasury’s Office of Foreign Assets Control (OFAC) would be more likely to resolve apparent sanctions violations involving ransomware attacks with a non-public enforcement response.

For more information on state-sponsored North Korean malicious cyber activity, see CISA’s North Korea Cyber Threat Overview and Advisories webpage. 

  Download the PDF version of this report: pdf, 553 kb.   

 

Ultradent Introduces JiffyTM One Single-Use Polishers

 

For years now I have been a fan of Ultradent.  The company makes really good products that do what they are supposed to do.  It is a privately owned company and because of that simple fact, they are not beholding to investors or stock holders.  That means they can develop products are their own time table and only bring them to market when they are absolutely sure the products are ready.  I have been fortunate enough to work with them on some projects over the years and I am always impressed with their commitment to quality.  I have seen them work on a product for over 7 years before releasing it to the market simply because didn't feel it was up to their quality standards.

The company also has a tremendous sense of ethics.  I have always been impressed by their focus on doing what is right regardless of profits.  In my time in dentistry I have worked with a lot of great companies.  In all of those, I would say that many are incredibly ethical and Ultradent ranks up with the best in that list.

Now on to the post.  Ultradent makes a lot of unique and "better mousetrap" products.  One of my favorites is the Jiffy Polisher System.  It is a kit of different abrasive rubber polishers that allow you to get a terrific shine to your composite restorations.  Their latest addition to that line is the Jiffy™ One.  Read on for all the details...

Ultradent Products, Inc., a leading developer and manufacturer of high-tech dental materials and equipment, is launching the newest extension to its popular Jiffy™ Polishers line—Jiffy™ One single-use polishers. 

For clinicians looking for a disposable, easy-to-use polishing system that delivers beautiful, natural shine on dental composite with minimal patient chair time, Ultradent’s new Jiffy One single-use polishers check every box without compromising end-result quality. With Jiffy One polishers, dentists reduce the chance of cross-contamination, while also eliminating the worry of accidentally throwing out expensive multi-use polishers. 

The Jiffy™ One single-use polishing system can be used on patients in one or two steps—with dentists starting with the medium grit polisher for a beautiful finish, with the added option of following up with the fine grit polisher for extra luster. The system is available in cups, points, and disks to best fit clinician and patient needs. 

Click here to learn more about or purchase Ultradent’s new Jiffy One single-use polishers.