|Over a week ago|
Vivos Therapeutics, Empower Sleep launch new cooperative relationship » 07:3808/2608/26/21
Vivos Therapeutics announced a new cooperative relationship with Empower Sleep, a company providing accessible and personalized telemedicine sleep care, to provide critical diagnostic and medical consultation services to people across North America who suffer from obstructive sleep apnea, OSA. "Vivos and Empower Sleep plan to leverage each company's core technologies to provide a user-friendly platform with personalized insights for patients who are being screened for OSA by North American dentists and other healthcare providers," the company said. Central to this collaboration is the Company's VivoScore product, powered by SleepImage, a biometric ring recording device that allows patients to readily take a sleep test in their own homes. The test results will be automatically uploaded and interpreted by independent physicians and personnel at Empower Sleep. From there, treatment or a telemedicine consultation may be recommended, or a consult with a medical doctor and dentist may be scheduled. "Our trained providers' VivoScore sleep test use has increased by more than 300 percent from just a few weeks ago," said Kirk Huntsman, Vivos Chairman and CEO. "What's more, about half of those patients are testing positive for OSA. Simply put, VivoScore is gaining traction, and we believe that this new cooperative relationship with Empower Sleep will add a vital medical diagnostic and consultative component to our patient-friendly sleep apnea treatment ecosystem. We believe that more screenings and confirmed diagnoses of OSA mean that more patients will seek what is often lifesaving treatment for their OSA, which may include using the Vivos System."
Vivos Therapeutics says FDA denies 510(k) application for DNA appliance » 07:3408/2308/23/21
The FDA has denied…
The FDA has denied Vivos' previously submitted, additional 510(k) application for its DNA appliance. The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly. Vivos expects to appeal the FDA's decision or resubmit the 510(k) application to the FDA in the coming weeks. This denial does not impact the existing use of the DNA appliance by licensed, trained dentists, and the Company does not believe that this development will have a near- or long-term impact on its operational results or future prospects.
Vivos Therapeutics receives 510(k) market clearance for mmRNA device » 07:3308/2308/23/21
Vivos Therapeutics announced the U.S. Food and Drug Administration has granted 510(k) market clearance to Vivos' mmRNA device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults. This FDA clearance paves the way for expanded insurance reimbursement coverage for the mmRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.
|Over a month ago|
Investor Summit Group to hold a virtual summit » 09:2708/1808/18/21
ZEN, VVOS, MEEC, PYPD, ANPC, FGF, VRAR, SAFE, ARTL, ARC, GET, VLON, HCDI, KULR, SPI, ABIO, BTN, DTSS, RESN
Q3 Virtual Investor…
Q3 Virtual Investor Summit to be held on August 17-18. Webcast Link
Vivos Therapeutics reports details of obstructive sleep Apnea study » 16:1308/1708/17/21
Vivos Therapeutics …
Vivos Therapeutics announced a more detailed summary of the national study results announced by the Company on July 13. As previously announced, one in four patients in the study treated with Vivos' FDA Class 1 DNA appliance for certain orofacial anomalies reported no remaining OSA symptoms, which is defined as patients having an Apnea Hypopnea Index score of less than five post-treatment. The more detailed study data now available reports that prior to treatment, 20 patients had severe OSA, which, from an AHI perspective, improved or is improving by 53%. Of these 20 patients, none have reported worsening of their OSA symptoms, while 3 patients still have severe OSA, 12 have moderate OSA, 4 have mild OSA and 1 has no OSA. The study data also reports that for the 18 patients who began the study with moderate OSA, the average percent improvement in AHI score is 64%. One patient's AHI score worsened by 1 category , while another slightly increased by 2.1. The balance of the patients had improved AHI scores by an average of 64%. After treatment or mid-treatment, 2 patients remained moderate, 10 have mild symptoms and 5 have resolved their OSA symptoms. In addition, 36 patients in the study had mild symptoms pre-treatment. Of these, 1 now has severe symptoms, 4 have moderate symptoms, 16 have mild symptoms and 15 have no symptoms of OSA. Commenting on the additional study data, Kirk Huntsman, Vivos' Chairman and CEO, stated, "By addressing maxillary palatal deficiencies, we believe Vivos' treatment protocols represent an improvement over CPAP and mandibular advancement devices with 27% of the study participants reporting a complete resolution of their OSA symptoms. These measurements are taken without a Vivos appliance in the mouth, whereas MAD measurements are taken with the appliance in place. The more detailed data now available from this study confirms that the Vivos device works well for many patients, with the study showing very strong and statistically significant evidence for an increase in airway volume and transpalatal width. We know the investment community and other interested parties have been looking for more real world data about our devices, so we are pleased to share this more detailed study summary and its positive results."
Vivos Therapeutics reports Q2 EPS (19c), two est. (18c) » 16:1908/1208/12/21
Reports Q2 revenue $4.5M,…
Reports Q2 revenue $4.5M, two est. $3.6M. Gross margin was 81% for the second quarter of 2021, compared to 83% for the second quarter of 2020, and remained consistent at 79% for the first six months of both 2021 and 2020, reflecting high margin service revenues.
Vivos Therapeutics opens international training center in Denver » 08:2207/2907/29/21
Vivos Therapeutics announced that the company has opened The Vivos Institute training center in Denver, Colorado. The 15,000-square-foot facility was established to provide advanced post-graduate education and training to dentists, dental teams and other healthcare providers from around the world in a live and hands-on setting. "Part of our mission is to spread the word about OSA among healthcare professionals who can help treat it. This new facility can accommodate 300 to 400 healthcare professionals a day, which not only significantly increases our clinical training capacity but also enables us to leverage the technology that we've built into the center to provide the highest-quality training for dentists all over the country and the world," said Kirk Huntsman, Vivos Chairman and CEO. "The Institute's opening (which augments the online training we established over the last year and half) represents a critical milestone for us as we train independent dentists whose patients suffer from dentofacial malformations that may be associated with OSA and other debilitating health conditions. We are also proud that we are able to open our Vivos Institute as promised with the proceeds of our initial public offering that occurred just eight months ago."
Vivos Therapeutics announces results from national study on airway function » 08:1607/1307/13/21
Vivos Therapeutics announced results from a national study commissioned by the Company to assess patients' airway function and OSA symptoms after undergoing the Vivos treatment. In the study, 28 percent of the 74 adult patients treated with the Company's FDA Class 1 DNA appliance for certain orofacial anomalies reported no remaining OSA symptoms, which is defined as patients having an Apnea Hypopnea Index score of less than five post-treatment. This real world patient data was gathered from multiple sites and has been submitted to the U.S. Food and Drug Administration to be used as part of the Company's process for obtaining 510k clearance for the DNA appliance to treat mild-to-moderate OSA. Patients who experienced little to no OSA symptoms may no longer require CPAP, neuro-stimulation, or other lifetime interventions. Other company case studies suggest potential long-term stability in the outcomes, although a clinical trial will be required to confirm whether or not these changes remain stable. Most importantly, these AHI findings were recorded with no oral appliance in place during sleep tests. Typically, when sleep tests are performed to evaluate the impact of OSA treatment, they are conducted with the treatment modality in place-whether it is CPAP, oral appliances, or neuro-stimulation implants. Since treatment with the DNA appliance is typically complete after just 12-24 months, patients' post-treatment sleep tests are performed and evaluated in the patient's natural state, unaided by any device. Eighty-two percent of the patients in the study showed some improvement in AHI scores, with 64 percent improving by at least one full category, such as moderate to mild OSA. In 15 percent of patients, AHI scores worsened, and in 4 percent of patients there was no change. Average treatment time with the Company's Class 1 DNA appliance for certain orofacial anomalies was just 14 months. Not all of the patients in the study had completed treatment at the time this data was collected and a small percentage of patients required additional cosmetic orthodontia.
Vivos Therapeutics' dental tissue treatment shows 97% satisfaction in study » 08:0807/0707/07/21
Vivos Therapeutics has…
Vivos Therapeutics has unveiled new data from an independent patient survey related to its proprietary Vivos treatment for treating dental tissue anomalies and dentofacial malformations known to be associated with obstructive sleep apnea - OSA - and other debilitating health conditions. Key findings include: nearly all - 97 percent - of patients surveyed said that they had achieved their desired outcome from the Vivos treatment for their OSA. 29% of patients surveyed said that they searched for non-surgical alternatives to current standards of care for treating OSA. The Vivos treatment is typically completed in approximately 12 to 24 months, after which most patients no longer require ongoing intervention.
new option listings and one option delisting on June 30th » 08:3006/3006/30/21
ARKO, AXLA, BAB, BMTX, BTRS, CLXT, COGT, CTXR, DCRC, ELYS, FBRX, FVE, III, ISUN, NEGG, NOVN, NSPR, OCUP, PANL, RADI, SQZ, TBLA, TGLS, TLIS, VMD, VVOS, YQ, IACA
New option listings for…
New option listings for June 30th include iShares Agency Bond (AGZ), ARKO Corporation (ARKO), Axcella Health Inc (AXLA), PowerShares Build America Bond Portfolio (BAB), BM Technologies Inc (BMTX), BTRS Holdings Inc (BTRS), Calyxt Inc (CLXT), Cogent Biosciences Inc (COGT), Citius Pharmaceuticals Inc (CTXR), Decarbonization Plus Acquisition Corporation III (Class A Stock) (DCRC), Elys Game Technology Corporation (ELYS), Forte Biosciences (FBRX), Franklin FTSE Brazil ETF (FLBR), Five Star Quality (FVE), IQ S&P High Yield Low Volatility Bond ETF (HYLV), Information Services (III), iSun Inc (ISUN), KraneShares MSCI China Clean Technology Index ETF (KGRN), Newegg Commerce Inc (NEGG), Novan (NOVN), InspireMD (NSPR), Ocuphire Pharma Inc (OCUP), Pangaea Logistics (PANL), WisdomTree CBOE S&P 500 PutWrite Strategy Fund (PUTW), Radius Global Infrastructure Inc (Class A Stock) (RADI), Schwab 1 to 5 Year Corporate Bond ETF (SCHJ), SQZ Biotechnologies Company (SQZ), Taboola com Ltd (TBLA), Tecnoglass (TGLS), SPDR Barclays 1 to 10 Year TIPS (TIPX), Talis Biomedical Corporation (TLIS), VieMed Healthcare Inc (VMD), Vivos Therapeutics Inc (VVOS), Invesco S&P SmallCap Value with Momentum ETF (XSVM), 17 Education and Technology Group Inc (ADS) (YQ), and YieldShares High Income (YYY). Option delistings effective June 30th include ION Acquisition Corp 1 Ltd (Class A Stock) (IACA).