Vivos Therapeutics and Candid Announce Strategic Collaboration to Deliver A Comprehensive Sleep Apnea and Orthodontic Treatment Solution

At the recently concluded Smilecon that was held October 11-13, I had a chance to meet and speak with a company that I hadn't heard of before.  It's a clear aligner company called Candid.  One of the things about this company that intrigued me is the way they track progress of patients' treatment.  As part of the procedure, they give the patient a device that attaches to their smartphone and allows the patient to take fairly precise pictures of their teeth.  The patient places lip retractors so that the teeth are clearly visible and then take images of their teeth.  Those images can be evaluated and compared to make sure the case is progressing as planned.

I'm a big fan of clear aligners and as most of you know, I'm also a huge advocate of treating obstructive sleep apnea (OSA).  I was intrigued to read today that Candid has now partnered with Vivos Therapeutics to allow the companies to combine their expertise in orthodontics and OSA treatment.

Read on for all the details:

Vivos Therapeutics, Inc. ("Vivos" or "the Company") (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, and Candid Care Co. ("Candid"), a digital platform for oral healthcare, today announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose and treat OSA in adult patients and provide orthodontic treatment from the same provider network.

At the core of this collaboration, Vivos and Candid will market each company's products and areas of expertise to deliver a comprehensive sleep and oral health solution to patients in the United States and Canada. The focus of the collaboration will be Candid's CandidPro clear aligner for straightening teeth and the Vivos System for treating OSA. The two companies will also share educational resources, training, and key opinion leaders to bridge the gap between airway health and orthodontic therapy.

"By teaming with Candid, we are aiming to provide patients with access not only to our highly effective Vivos System, but also simultaneous access to CandidPro's novel orthodontic treatment. We believe the Vivos-Candid collaboration will provide for the first solution that seamlessly integrates sleep and orthodontic therapy to create better patient outcomes for treating OSA and enhance overall health and wellness across the board." said Kirk Huntsman, Vivos Chairman and CEO. "We are hopeful that this joint effort will increase market penetration and accelerate revenue growth for both companies as we each attract and expand our respective North American dental and healthcare networks."

Additionally, under the terms of the agreement, Vivos and Candid will join forces to explore new research and development opportunities for device development and other alliances related to orthodontics, OSA, and snoring. Candid will also conduct specialized training sessions at the Vivos Institute, the Company's new state-of-the-art international training center in Denver, Colorado, as well as semi-annual seminars for both dentists and medical doctors to provide additional learning opportunities.  The parties will act on a non-exclusive basis, although during the term of the agreement, Candid's aligners will become the official  clear aligner of Vivos and Vivos' oral devices and proprietary protocols will become the official sleep apnea therapy program of Candid. 

"Candid was built on a foundation of clinical excellence and has always put patient health first. Since launching Candid in 2017, my co-founders and I have strived to shine a light on the correlation between teeth alignment, oral health, and chronic illnesses, like obstructive sleep apnea. Vivos Therapeutics and Candid are where airway and sleep, oral health, and orthodontic therapy come together for the first time," added Nick Greenfield, Candid Co-Founder and CEO. "By combining Vivos' therapeutic protocol for OSA and its VIP doctor network with Candid's treatment methodology and CandidPro network, together we look forward to offering a full-service solution for patients suffering from OSA."

"As someone who focuses his practice on combining sleep-disordered breathing, orthodontics and comprehensive dentistry, I know how important it is to treat all oral health conditions as part of one comprehensive solution," concluded Dr. Ben Miraglia, DDS, Chief Clinical Consultant of Airway Health Solutions, Vivos Provider and recognized thought leader in sleep-disordered breathing, clear aligner therapy and craniofacial development. "The Vivos-Candid alliance is a true win-win for patients who are looking to improve their sleep, oral health and confidence all at the same time."

Cesar Sabates, DDS Takes Office as the 158th President of the American Dental Association

 

Almost everyone has had the experience of knowing someone who does great things, is incredibly successful, or garners fame and fortune.  At the recent Smilecon last week in Las Vegas, one of my hosts was from Seattle and she told me the story of how a good friend of hers was the person who wrote the code for the original Solitaire game in Microsoft Windows.

I now have one of those stories too.  I went to dental school at the University of Missouri - Kansas City School of Dentistry.  My alma mater has a reputation of training outstanding clinical doctors, but we're not known for our leadership skills.  That simple fact means it is even more amazing that I can say with pride that I was, and am, friends with someone who has accomplished a lot in our field and has summited to the pinnacle of leadership.

On Saturday October 16, 2021 my friend Dr. Cesar Sabates was installed as the 158th president of the ADA.  He's not only the president, but he's also the only first president of Cuban-American decent.  His family came to the United States when he was a just a boy, but his family has made the most of the American dream.  They came to the U.S. in 1967 and ended up settling in the Kansas City area so that his father could attend UMKC and receive his dental degree.  Then his son followed in his footsteps.

I met Cesar in the mid-80s when I started at UMKC.  In my last two years of training, he and I were assigned to the same team which placed us in close proximity to each other on a regular basis.  He was a couple of years older than I was, plus he was married while I was single and considerably more prone to, ahem, "social exuberance".  However we struck up a bond and I always enjoyed talking with him.

We graduated and he moved to Miami to celebrate his Cuban heritage while I stayed in the KC area.  We drifted apart, but with the Internet came a chance to reconnect.  Also, we both enjoyed the benefits of organized dentistry and industry meetings.  I'd frequently see Cesar at meetings across the US.  I enjoyed teaching, lecturing, and writing.  Cesar enjoyed the political side of the profession as he worked to move it forward into a new and exciting future.

My friend has had a tremendous impact on dentistry.  He now leads the largest dental professional organization in the United States.  None of his success was given to him.  He has always worked hard.  I am so proud of what Dr. Sabates has accomplished.  He is the first Cuban American to ever lead the ADA and I could not have a greater sense of pride in what he has accomplished.  A little boy came from Cuba and went on to leave a footprint on a profession.  I don't think either of us envisioned how far he would go... but I have a feeling he's not done just yet!

Primescan and Atlantis Suprastructures: A Validated Workflow for Efficient Treatment of Edentulous Patients

Market penetration of intraoral scanners - intraoral acquisition systems - digital impression systems continues at a brisk pace.  The numbers that I am seeing are somewhere from 25-33% of general dental offices.   The profession has well surpassed the early adopter phase and is now heading into mainstream acceptance and use.

One of the great things about the current progression to all digital treatment planning and appliance design is the ability to merge data from different platforms to create a digital solution.  As things continue along this path I expect to see greater and greater integration.  Check out the newly announced digital workflow from Dentsply Sirona!

Dentsply Sirona has validated a new workflow for clinically-efficient and digitally-supported implant treatment that includes all components, from impression to prosthetics. An essential part of this workflow is taking the digital impression with Primescan, which is characterized by ease of use, speed and very high accuracy1 over the entire arch. All treatment steps are coordinated with each other and come together in an efficient implant dentistry workflow.

With the upgrade of Connect SW 5.2, dental professionals now have convenient access to high-quality, patient-specific Atlantis suprastructures, designed and manufactured using highly accurate digital impression taken by Primescan. New firmware makes the intraoral scanner twice as fast, provides a higher-performing scanning experience and gives users access to new workflows and even better usability*.

In the validated workflow with Atlantis, dentists benefit from a very high flexibility, as the individual steps can be carried out completely digitally and in collaboration with the laboratory. Dentsply Sirona offers the possibility of ordering prosthetic components, including a complete suprastructure for the partial or full-arch case, from the global Atlantis design and manufacturing sites, the company's own digital laboratory. 

Dentsply Sirona is the first to enable intraoral scans with Atlantis suprastructures for fixed multiple-unit implant restorations. Thanks to the proven accuracy1 of Primescan, it is the first and only intraoral scanner validated for the fully digital workflow for Atlantis suprastructures, which was previously only validated for laboratory scanners.

With Primescan, a digital impression can be taken for single teeth, quadrants, whole dentition and now also edentulous jaws with multiple implants placed based on the Atlantis IO FLO-S scanbody. Users can then transfer scan data to their preferred lab via the Connect Case Center. Based on the open data format, labs must be able to detect the IO FLO-S scanbody in their lab software and can start working on the case coming from Primescan, creating more efficiency between practice and lab. Once complete, the technician can upload all required data to Atlantis. 

Simplified and improved workflow with Primescan*

The combination of Atlantis suprastructures and the full arch accuracy of Primescan assists in delivering an easier workflow for the dentist and the dental laboratory. Following this protocol, the clinician takes a digital impression using Primescan and Atlantis IO FLO-S Scanbodies. The partnering dental laboratory finalizes the order and sends it to Dentsply Sirona for design and manufacturing of the Atlantis suprastructure. The restoration is finalized by the lab technician and sent back to the clinician. 

Atlantis patient-specific solutions 

When function and esthetics are prioritized, a customized, patient-specific restoration probably is a natural choice. Atlantis patient-specific solutions are produced using state-of-the-art technologies and supported by computer based industrial and medical device expertise for a very high accuracy.

Moreover, additive manufacturing provides new possibilities for advanced geometries for fixed, screw-retained solutions in titanium or cobalt-chrome for all major implant systems. Atlantis includes a full range of dental implant suprastructures for fixed and removable splinted implant restorations.

“It is a big step forward to restore edentulous jaws using a digital workflow. This makes the process of planning, surgery and restoration between the clinician and the laboratory more coherent and offers very good esthetic results, while taking less clinical time,” explained Dr. Martin Wanendeya, dentist from London (UK). “Atlantis’ validation for Primescan gives us as practitioners the reassurance that it works reliably and consistently.”

This reliability was a major focus of the validation: Supporting implant restorations comprehensively with digital technology gives everyone involved peace of mind, ensuring that the planned treatment can be implemented predictably.

More information about Primescan can be found at www.dentsplysirona.com/primescan.

* Unless stated otherwise, all comparative statements in this press release refer to a comparison between Dentsply Sirona products.

Overjet's Dental Assist Receives FDA Clearance to Bring AI to the Dental Practice

 Over the last 5 or so years, I've had the good fortune to be able to evaluate more than a couple of dental AI systems for radiology.  It's been an interesting time doing that because reading x-rays requires nuance and, for lack of a better description, feel.  There is an "art" to looking at an image and being able to discern very subtle differences from one part to another and then basing your diagnosis on those nuances.  It is one of those things that is very difficult to explain.  There is no user's manual or IFU for understanding and interpreting radiographs.

That's why it's been so interesting to work with some of the problems.  AI can do amazing things, but it's one thing to discern a dog from a cat in a photograph to catching incipient lesions on a bitewing radiograph.  However, dental AI systems are evolving constantly and become better and better at what they do.

Now comes the announcement that Overjet Dental Assist™ has received FDA clearance.  The evolution of medical AI continues.  Here is the press release:

Overjet, the global leader in dental artificial intelligence, today announced that it received FDA 510(k) clearance for its Overjet Dental Assist^TM product. This Software as a Medical Device product applies artificial intelligence in real-time to aid dentists and hygienists. The clearance by the FDA will enable Overjet to market and sell the AI product directly to dental practices. The software supports dental professionals in measuring mesial and distal bone levels in bitewing and periapical radiographs for the diagnosis and treatment planning of periodontal disease. The condition affects an estimated 46 percent of U.S. adults, including 8.9 percent who have severe periodontitis. Left untreated, periodontitis can lead to tooth loss and painful chewing.

"Overjet's Dental Assist clearance by the FDA is a landmark moment for dental AI," said Dr. Wardah Inam, PhD, CEO and co-founder of Overjet. "All clinicians can now have at their fingertips highly accurate software to detect and measure serious dental disease and clear AI visualizations to communicate with patients. This is big for dentistry and moving toward evidence-based, patient-centric care." 

In clinical performance testing, Overjet Dental Assist^TM demonstrated automated measurement capabilities comparable to a team of highly skilled dentists. Overjet had three experienced dentists independently measure bone levels on dental radiographs using a measuring tool. These measurements were then further adjudicated by an oral radiologist to establish an official consensus ground truth. Overjet's AI-powered Dental Assist measurements were then compared against this dentist consensus and had an average difference of only 0.3mm.

"We're seeing dental AI software perform at the level of a team of trained dentists with accuracy closer than the width of a needle," said Dr. Chris Balaban, DMD, Clinical Director for Overjet. "These tools unlock the ability to track the progression of disease over time for each tooth and make the case for evidence-based treatment, supported by unbiased software and clear visuals for patients."

Three-year-old Overjet was founded by a team of PhDs and dentists from MIT and Harvard. They built the company around the mission of improving oral healthcare for all. To date, the company has raised over $10.5 million in venture funding and built artificial intelligence models to detect a variety of dental conditions such as cavities, gum disease, tartar and impacted teeth. Overjet's software is already in daily use by multiple large dental insurance companies to automate and improve the accuracy of dental claims review. The company has numerous partnerships with research institutions, dental support organizations and large dental practices.

Some Things are More Important

 Things like SmileCon.

In case you haven't noticed, I've just taken a few days off to attend the ADA Smilecon in Las Vegas.

I'll be back with more reportings and ramblings starting next Monday.  Thanks for your patience!

CareQuest Institute Commends WHO For Adding Three Minimally Invasive Oral Health Care Medicines to Essential Medicines Lists

Here is some good news for individuals with kids in need of dental treatment.  I was happy to learn that WHO has authorized these materials as "essential".  For those of us who are lucky enough to live in areas where we can receive state of the art care, these materials are easily available and make a tremendous difference.  However, for those who live in areas where care is not so easily found, have access to these materials can make a real difference.  Here is the info courtesy of CareQuest:

The World Health Organization (WHO) published the new edition of its Model Lists of Essential Medicines (EML) and Essential Medicines for Children on Oct. 1, 2021, in which it recommended the establishment of a new section for children and adult dental preparation. The WHO's Expert Committee added three new oral health medicines — fluoride toothpaste, silver diamine fluoride, and glass ionomer cement — to the lists aimed at addressing global health priorities. These medicines provide the greatest benefits, according to WHO, and should be available and affordable for all. 

 These medicines are central to minimally invasive care, a care philosophy of decreasing and even eliminating the need for a dental drill and local anesthetic. They empower more oral health providers to treat tooth decay because they don’t require advanced skills such as drilling or numbing. This approach to care for tooth decay improves access, outcomes, and experience for many patients. 

 Jeremy Horst Keeper, DDS, PhD, director of clinical innovation at CareQuest Innovation Partners, a subsidiary of CareQuest Institute for Oral Health, led the proposal for glass ionomer cement to be a WHO Essential Medicine. He applauded the committee for their acknowledgement of oral health care's impact on the global public health problem and addition of these medicines:

 "This is a huge milestone in ensuring that billions of people will gain access to simple, non-invasive treatments for the most common disease in the world. The WHO has recognized that these three medicines, and not fillings, are the first-line treatment for tooth decay.”

 Keeper also explained why this shift in treatment is so important for children. 

 “Traditional dental procedures can be difficult for children, so providers often use sedation and anesthesia, which is expensive and can have adverse health effects on the overall body. Adding silver diamine fluoride and glass ionomer cement to the WHO EML for both children and adults eases the management of disease for all, but especially kids. We thank the WHO for taking this step toward a more person-centric and accessible approach to oral health care and helping millions of children in the process. Oral health care is health care. We are encouraged by this news and must continue to improve access to dental medicines and support additional innovations that allow us to improve health outcomes for all.”

 

Ellume issues voluntary recall of specific lots of Ellume COVID-19 Home Tests

As a bit of a public service, I thought I'd post this info today.  I receive regular updates from the CDC (Centers for Disease Control) and occasionally, things come via that route that I feel deserve a blog post.  Today's is about a home test for Covid-19.  The company has issued a voluntary recall and there is the possibility consumers may have affected products in their medicine cabinets.

If you happen to have one of these kits, follow this link to find out whether your product is part of the affected lots.  It will also provide instructions on how to proceed. 

Recall Notice

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert


On October 1, 2021, the digital diagnostics company Ellume announced a voluntary recall on specific lots of the Ellume COVID-19 Home Test, the company’s rapid, self-administered COVID-19 antigen test, because there is an increased chance that tests from the affected lot numbers may give a false positive result.


Ellume advises consumers to visit their website to check whether their product is part of the affected lots and, if affected, to receive further instructions.


The voluntary recall is being taken after specific product lots reported false positive test result rates higher than was observed in clinical testing. Ellume has investigated the issue, identified the root cause, implemented additional controls, and is working on resolving the issue that led to this recall. Information relating to the action to be taken by distributors and retailers for the affected lots is also provided on the company’s website.