Temporomandibular Joint Dysfunction Syndrome

The homologous-use application validated by Dr. Ryan Robinson and NP Rachel Reynolds sets a precedent for non-surgical allograft application. PENSACOLA, Fla., Oct. 26, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces the publication of a case study demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Temporomandibular Joint (TMJ) defects. The case study titled "Single-Center Retrospective Study of Flowable Umbilical Cord Tissue Allograft Application in Temporomandibular Joint Defects: An Investigative Study," was published by Walsh Medical Media and can be accessed in its entirety here. Board-certified sleep medicine and craniofacial pain specialists Dr. Ryan Robinson and NP Rachel Reynolds of The Pain and Sleep Therapy Center presented a novel case series studying the application of Wharton's Jelly, an umbilical cord connective tissue, to the structural tissue defect of the temporomandibular joint. This homologous use application validated by Robinson and Reynolds sets a precedent for non-surgical allograft application. "We've seen a decrease in terms of healing time for patients when we've compared it to other types of injections that we've used previously for patients with temporomandibular joint dysfunction (TMD). We've also seen improvement in outcomes for patients who've been utilizing Wharton's Jelly in conjunction with other types of modalities that we've used for these patients," shared NP Rachel Reynolds. Nearly 10 million patients suffer from TMD in the United States each year. These patients often experience symptoms ranging from joint arthralgia, displacement, degenerative arthritis, limited and painful mouth opening, painful subluxation of the joint, joint clicking, and referred pain to the periauricular area or head and neck muscles. Although there are many treatments for TMD, therapy specific to degenerative pathology of the TMJ disc itself is limited in scope and therapeutic effect. Standard treatment includes simply resting the jaw muscles and avoiding use, massage, physical therapy, medication management, and, when all else fails, surgery. The rising annual number of surgeries and high out-of-pocket costs for patients, overall treatment costs ranging from 5,000-50,000 USD, are enough to implement conservative protocols alternative to invasive surgical repair of the TMJ. "Today, we see many physicians who are wary about treating TMJ and often revert to standard surgical treatments. Showing the outcomes that we have for patients will hopefully help to bolster more physicians to join us in using more conservative treatments. Our patients deserve more options," concluded Reynolds. The five patients in this case series presented with chronic refractory TMD, specifically from severe degeneration of the structural tissues within the joint, and had failed standard-of-care practices for at least three months. After one application of Regenative's Wharton's Jelly allograft, the patient's pain improved by an average of 75% after 90 days. "A few years ago, we started using PRF (platelet-rich fibrin) therapy in the jaw joint, and we thought that was revolutionary. We have seen amazing results; however, the protocol involves additional technology like a centrifuge and consists of multiple rounds of injections to get the desired outcome. It also subjectively eliminates some patients from treatment who are opposed to blood draws on themselves. With Wharton's Jelly, there is only one injection, which makes the application much easier, more convenient, and less invasive to the patient. What's most exciting is the results we are seeing! We're seeing much better patient outcomes than any other modality we've ever treated. We're really excited to continue the use of Wharton's Jelly in our Pain and Sleep clinic, and it soon becoming a routine standard for our patients who can benefit," shared Dr. Ryan Robinson. To advance the necessary research and fill the need for non-surgical alternatives, Regenative has been tracking data in its comprehensive retrospective data repository in which physicians across specialties submit patient data as they track patient outcomes up to 120 days after the patient receives an application of Regenative's products, like its Wharton's Jelly allografts. Regenative has collected data from clinics nationwide on Wharton's Jelly homologous-use applications around the body. Still, very few have documented data on the jaw joint, and Regenative is excited to highlight this unique procedure in the first of many publications on regenerative orthodontic medicine. "Given the high incidence rate and few effective treatment options for defects in the Temporomandibular Joint, this study aims to provide a new, promising alternative intervention for patients who have failed all other standard-of-care treatments. This is just one of many homologous-use applications in regenerative medicine to improve patient outcomes," shared Regenative Labs CEO Tyler Barrett. Barrett and his team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine. "We're doing the research at Regenative, and the results are very promising. We are calling on all physicians across the country to engage with us to advance the field of regenerative medicine," Barrett concluded. Contact Regenative to get your practice involved today. Read the full case study here. About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: About Dr. Ryan Robinson: Dr. Robinson is Delaware's first and only doctor triple-boarded in Craniofacial Pain and Dental Sleep Medicine. After many years of treating the airway in his general dental practice, Dr. Robinson decided to open up a specialty practice to address the needs of the community. This new practice, called The Pain and Sleep Therapy Center of Delaware Valley, focuses on finding the origin of the problem as opposed to treating it with medications and "band-aid" fixes that have become so routine in today's medical system. Learn more at Pain and Sleep Therapy Center's website: About Rachel Reynolds: Rachel is a Family Nurse Practitioner (FNP) who joined the Pain and Sleep team in July 2021. Originally, Rachel is from upstate New York, where she completed her Bachelor of Nursing and Master of Nursing at Binghamton University. Prior to completing her Master's, Rachel worked in Neurology as a registered nurse, focusing on patients who dealt with chronic pain and headaches. Upon moving to Delaware, Rachel completed a fellowship in Primary Care with Christiana Care. During her fellowship, she identified her passion for comprehensive patient care, which resulted in her devotion to identifying the root cause of her patient's issues. Upon identifying a need for nutritional guidance for our patient population, Rachel acquired a certification in nutrition from the University of Stanford. Rachel is also completing a second master's degree program in Psychiatry at this time to better assist patients and provide a more comprehensive scope of practice. Learn more at Pain and Sleep Therapy Center's website: SOURCE Regenative Labs

The homologous-use application validated by Dr. Ryan Robinson and NP Rachel Reynolds sets a precedent for non-surgical allograft application. PENSACOLA, Fla., Oct. 3, 2023 /PRNewswire/ -- Regenative Labs (Regenative), a leading HCT/P manufacturer, announces a retrospective case series demonstrating new care advancements using its Wharton's Jelly allografts in the supplementation of Temporomandibular Joint (TMJ) defects. Board-certified sleep medicine and craniofacial pain specialists Dr. Ryan Robinson and NP Rachel Reynolds of The Pain and Sleep Therapy Center have presented for publication a novel case series studying the application of Wharton's Jelly, an umbilical cord connective tissue, to the structural tissue defect of the temporomandibular joint. This homologous use application validated by Robinson and Reynolds sets a precedent for non-surgical allograft application. "We've seen a decrease in terms of healing time for patients when we've compared it to other types of injections that we've used previously for patients with temporomandibular joint dysfunction (TMD). We've also seen improvement in outcomes for patients who've been utilizing Wharton's Jelly in conjunction with other types of modalities that we've used for these patients," shared NP Rachel Reynolds. Nearly 10 million patients suffer from TMD in the United States each year. These patients often experience symptoms ranging from joint arthralgia, displacement, degenerative arthritis, limited and painful mouth opening, painful subluxation of the joint, joint clicking, and referred pain to the periauricular area or head and neck muscles. Although there are many treatments for TMD, therapy specific to degenerative pathology of the TMJ disc itself is limited in scope and therapeutic effect. Standard treatment includes simply resting the jaw muscles and avoiding use, massage, physical therapy, medication management, and, when all else fails, surgery. The rising annual number of surgeries and high out-of-pocket costs for patients, overall treatment costs ranging from 5,000-50,000 USD, are enough to implement conservative protocols alternative to invasive surgical repair of the TMJ. "Today, we see many physicians who are wary about treating TMJ and often revert to standard surgical treatments. Showing the outcomes that we have for patients will hopefully help to bolster more physicians to join us in using more conservative treatments. Our patients deserve more options," concluded Reynolds. The five patients in this case series presented with chronic refractory TMD, specifically from severe degeneration of the structural tissues within the joint, and had failed standard-of-care practices for at least three months. After one application of Regenative's Wharton's Jelly allograft, the patient's pain improved by an average of 75% after 90 days. "A few years ago, we started using PRF (platelet-rich fibrin) therapy in the jaw joint, and we thought that was revolutionary. We have seen amazing results; however, the protocol involves additional technology like a centrifuge and consists of multiple rounds of injections to get the desired outcome. It also subjectively eliminates some patients from treatment who are opposed to blood draws on themselves. With Wharton's Jelly, there is only one injection, which makes the application much easier, more convenient, and less invasive to the patient. What's most exciting is the results we are seeing! We're seeing much better patient outcomes than any other modality we've ever treated. We're really excited to continue the use of Wharton's Jelly in our Pain and Sleep clinic, and it soon becoming a routine standard for our patients who can benefit," shared Dr. Ryan Robinson. To advance the necessary research and fill the need for non-surgical alternatives, Regenative has been tracking data in its comprehensive retrospective data repository in which physicians across specialties submit patient data as they track patient outcomes up to 120 days after the patient receives an application of Regenative's products, like its Wharton's Jelly allografts. Regenative has collected data from clinics nationwide on Wharton's Jelly homologous-use applications around the body. Still, very few have documented data on the jaw joint, and Regenative is excited to highlight this unique procedure in the first of many publications on regenerative orthodontic medicine. "Given the high incidence rate and few effective treatment options for defects in the Temporomandibular Joint, this study aims to provide a new, promising alternative intervention for patients who have failed all other standard-of-care treatments. This is just one of many homologous-use applications in regenerative medicine to improve patient outcomes," shared Regenative Labs CEO Tyler Barrett. Barrett and his team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field of medicine. "We're doing the research at Regenative, and the results are very promising. We are calling on all physicians across the country to engage with us to advance the field of regenerative medicine," Barrett concluded. Contact Regenative to get your practice involved today. About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative's website: About Dr. Ryan Robinson: Dr. Robinson is Delaware's first and only doctor triple-boarded in Craniofacial Pain and Dental Sleep Medicine. After many years of treating the airway in his general dental practice, Dr. Robinson decided to open up a specialty practice to address the needs of the community. This new practice, called The Pain and Sleep Therapy Center of Delaware Valley, focuses on finding the origin of the problem as opposed to treating it with medications and "band-aid" fixes that have become so routine in today's medical system. Learn more at Pain and Sleep Therapy Center's website: About Rachel Reynolds: Rachel is a Family Nurse Practitioner (FNP) who joined the Pain and Sleep team in July 2021. Originally, Rachel is from upstate New York, where she completed her Bachelor of Nursing and Master of Nursing at Binghamton University. Prior to completing her Master's, Rachel worked in Neurology as a registered nurse, focusing on patients who dealt with chronic pain and headaches. Upon moving to Delaware, Rachel completed a fellowship in Primary Care with Christiana Care. During her fellowship, she identified her passion for comprehensive patient care, which resulted in her devotion to identifying the root cause of her patient's issues. Upon identifying a need for nutritional guidance for our patient population, Rachel acquired a certification in nutrition from the University of Stanford. Rachel is also completing a second master's degree program in Psychiatry at this time to better assist patients and provide a more comprehensive scope of practice. Learn more at Pain and Sleep Therapy Center's website: SOURCE Regenative Labs

Revenue increased 6% Year-Over-Year; Operating Expenses Decreased 20% as Cost Cutting Initiatives Take Hold Management to Host Conference Call Today at 5:00 pm ET LITTLETON, Colo., June 08, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company'') (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from a variety of health conditions, many of which are associated with breathing related sleep issues arising from certain dentofacial abnormalities, today reported financial results and operating highlights for the first quarter ended March 31, 2023. First Quarter 2023 Financial Highlights Revenue was $3.9 million for the first quarter of 2023, compared to $3.6 million for the first quarter of 2022, mainly due to higher Vivos Integrated Provider (“VIP”) enrollments as well as increased revenue from seminars conducted at the Vivos Institute (readers should note that Vivos’ reported financial results for the three months ended March 31, 2023 and 2022 reflect the application of Vivos’ previously announced updated ASC 606 revenue recognition policies, including deferral of a portion of revenue into future periods); During the first quarter of 2023, Vivos enrolled 38 VIPs and recognized VIP revenue of approximately $1.3 million, an increase of 42% in enrollment revenue, compared to 32 VIPs and approximately $0.9 million for the first quarter of 2022; Gross profit was $2.3 million for the first quarter of 2023, compared to gross profit of $2.6 million for the first quarter of 2022, attributable to higher costs associated with increased VIP training as well as the sale and leasing of SleepImage® home sleep test rings; Gross margin was 61% for the first quarter of 2023, compared to 70% for the first quarter of 2022, reflecting higher costs associated with VIP training and new incentives deployed to increase VIP enrollments; Operating expenses decreased by a significant amount ($1.8 million, or 20%) versus the first quarter of 2022, reflecting Vivos’ previously announced cost-cutting initiatives. These initiatives, when combined with a $3.2 million non-cash derivative gain associated with Vivos’ outstanding warrants, led to a significant year-over-year reduction of net loss for the quarter; In January 2023, Vivos completed a private placement for net proceeds of approximately $7.4 million to augment its liquidity position; and Cash and cash equivalents were $7.0 million at March 31, 2023. First Quarter 2023 and Recent Operating Highlights As of March 31 2023, patients treated with The Vivos Method totaled over 35,000, compared to approximately 28,000 as of the first quarter of 2022. Vivos has also trained over 1,750 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to more than 1,600 as of the first quarter 2022; In February 2023, Vivos acquired certain U.S. and international patents, product rights, and other miscellaneous intellectual property from Advanced Facialdontics, LLC (“AFD”), a company holding propriety technology with FDA 510(k) clearances for Temporomandibular Joint Dysfunction (“TMD”) and Bruxism (unconscious teeth grinding and clenching). With this asset purchase transaction, Vivos acquired recently issued U.S. patents, provisional patent applications as well as international patents, Patent Cooperation Treaty patents and patent applications. One of Vivos’ key strategic goals for the remainder of 2023 is to initiate and grow sales of the AFD products, notably the Preventive Oral Device® (known as The POD®); and In May 2023, Vivos announced the results of a clinical observational study on the application of the POD® in the treatment and prevention of migraine headaches. The study demonstrated statistically significant results, with ninety-two percent (92%) of study patients reporting their migraine symptoms were completely resolved following completion of treatment. Migraine headaches affect over 39 million people in the United States alone according to the American Migraine Foundation. “Vivos is evolving into a more scalable and sustainable growth company with a clear path to cash flow positive operations. By broadening and diversifying our core product offerings and giving potential new providers easier and less costly options to enroll and become Vivos-trained, we believe we are positioning ourselves to become the comprehensive go-to source for dental treatments for OSA and other debilitating conditions like TMD and Bruxism. No other company in our market has the evidence-based technologies, or the regulatory clearances, or the clinical and technical expertise, or the full complementary product line, or the strong brand equity that Vivos has with healthcare providers and patients,” stated Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer. “We continue to believe our latest rounds of cost cutting, the impact of which can be seen in our first quarter results, coupled with an intense focus on creating accretive new revenue streams, will allow us to achieve our stated goal of achieving positive cash flow in the first quarter of 2024.” “During the first quarter, we continued to make substantial progress towards realizing our potential. Our focused sales and marketing efforts are gaining traction and our organizational changes have made Vivos a more efficient, streamlined organization. With our expanded products and services offering, we are well positioned to continue attracting more dentists and medical professionals to utilize the Vivos Method, as well as larger organizations, including Durable Medical Equipment (known as DME) companies and Dental Service Organizations (known as DSOs), to market and distribute our products. As we seek to drive revenue growth, Vivos now has new or active pilot programs with eight different DSO organizations, representing over 1,000 dental practices, as well as a new pilot program we will be launching shortly with a nationally regarded DME to distribute our devices. We are pleased with what we have achieved so far in 2023, and look forward to continuing this momentum during the rest of the year and into 2024,” Mr. Huntsman concluded. Vivos encourages investors and other interested parties to join its conference call today at 5:00 p.m. Eastern time (details below), where management will discuss further details on topics including: (i) the acquisition of product rights and patents from AFD and Vivos’ expanded product line and revenue potential, (ii) the potential significant impact of Vivos’ recent discussions with DME companies on Vivos’ near-term growth, (iii) an update on Vivos’ DSO and DME sales and marketing efforts; (iv) additional programs for dentists to enroll with Vivos, and (v) Vivos’ current cash position and actions taken to reduce cash burn. In addition, further information on Vivos’ financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Vivos’ financial performance are provided in the Vivos’ Quarterly Report on Form 10-Q for the three months ended March 31, 2023, which will be filed with the Securities and Exchange Commission (“SEC”). The full 10-Q report will be available on the SEC Filings section of the Investor Relations section of Vivos’ website at . Conference Call To access Vivos’ investor conference call, please dial (877) 451-6152, or for international callers, (201) 389-0879. A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671. The passcode for the live call and the replay is 13739119. The replay will be available until June 22, 2023. A live webcast of the conference call can be accessed on Vivos’ website at . An online archive of the webcast will be available on the Company’s website for 30 days following the call. About Vivos Therapeutics, Inc. Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA. It has proven effective in over 35,000 patients treated worldwide by more than 1,750 trained dentists. The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and associated protocols that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-moderate OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method. For more information, visit . Cautionary Note Regarding Forward-Looking Statements This press release, the conference call referred to herein, and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, particularly with respect to the public offering described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, the results of Vivos’ sales, marketing and cost cutting initiatives as described herein) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Vivos Investor Relations Contact: Julie Gannon Investor Relations Officer 720-442-8113 jgannon@vivoslife.com -Tables Follow- VIVOS THERAPEUTICS INC. Unaudited Condensed Consolidated Balance Sheets (In Thousands, Except Per Share Amounts) March 31, 2023 December 31, 2022 Current assets Cash and cash equivalents $ 7,046 $ 3,519 Accounts receivable, net of allowance of $672 and $712, respectively 321 457 Prepaid expenses and other current assets 1,346 1,448 Total current assets 8,713 5,424 Long-term assets Goodwill 2,843 2,843 Property and equipment, net 3,157 3,082 Operating lease right-of-use asset 1,621 1,695 Intangible assets, net 458 302 Deposits and other 308 374 Total assets $ 17,100 $ 13,720 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,495 $ 1,411 Accrued expenses 1,940 1,912 Warrant liability 1,333 - Current portion of contract liabilities 2,647 2,926 Current portion of operating lease liability 433 419 Other current liabilities 127 145 Total current liabilities 7,975 6,813 Long-term liabilities Contract liabilities, net of current portion 250 112 Operating lease liability, net of current portion 1,882 1,994 Total liabilities 10,107 8,919 Commitments and contingencies - - Stockholders’ equity Preferred Stock, $0.0001 par value per share. Authorized 50,000,000 shares; no shares issued and outstanding - - Common Stock, $0.0001 par value per share. Authorized 200,000,000 shares; issued and outstanding 29,928,786 shares as of March 31, 2023 and 23,012,119 shares as December 31, 2022 3 2 Additional paid-in capital 88,161 84,267 Accumulated deficit (81,171 ) (79,468 ) Total stockholders’ equity 6,993 4,801 Total liabilities and stockholders’ equity $ 17,100 $ 13,720 VIVOS THERAPEUTICS INC. Unaudited Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Amounts) Three Months Ended March 31, 2023 2022 Revenue Product revenue $ 1,772 $ 2,049 Service revenue 2,085 1,595 Total revenue 3,857 3,644 Cost of sales (exclusive of depreciation and amortization shown separately below) 1,520 1,093 Gross profit 2,337 2,551 Operating expenses General and administrative 6,537 8,275 Sales and marketing 630 753 Depreciation and amortization 175 162 Total operating expenses 7,342 9,190 Operating loss (5,005 ) (6,639 ) Non-operating income (expense) Other expense 51 (38 ) PPP loan forgiveness - 1,287 Excess warrant fair value (6,453 ) Change in fair value of warrant liability, net of issuance costs of $645 9,628 - Other income 76 59 Net loss $ (1,703 ) $ (5,331 ) Net loss per share (basic and diluted) $ (0.07 ) $ (0.25 ) Weighted average number of shares of Common Stock outstanding (basic and diluted) 24,764,041 21,233,485