Craniomandibular Disorders

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

CARMEL, Ind., Aug. 24, 2023 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (NYSE American: NRXS), (“NeurAxis,” or the “Company”), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted the strength of its board of directors. “We are fortunate to have a board with a depth of experience in relevant areas to NeurAxis, including medical device commercialization, commercial insurance, and finance. Mitch Watkins has led several medical device companies from start-up through commercialization, Beth Keyser has served as President of Blue Cross Blue Shield Indiana at Anthem since 2020, and Tim Henrichs has been a finance executive across industries, including healthcare,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “We are excited to have this strength at the board level as we continue to develop and drive adoption of our IB Stim Therapy™,” concluded Mr. Carrico. The Company’s Board of Directors includes: Beth Keyser, DirectorMs. Keyser has more than 20 years of experience in executive roles in population health. Since 2020, she has been the President, BCBS of Indiana at Anthem, Inc. From 2018 to 2020, Ms. Keyser served as the President, Create at Brighton Health Plan Solutions. From 2015 to 2020, Ms. Keyser served as the Senior Vice President, International and Hawaii Markets at Sharecare, Inc. Bradley Mitch Watkins, DirectorBradley Mitch Watkins has overseen four companies through their early commercialization periods within the medical device sector over the last 20 years. Mr. Watkins has been the National Sales Manager of Terumo Interventional Systems since 2015, where he has led multiple new technology sales teams within the peripheral IV and Electrophysiology markets. He now manages corporate accounts and GPO contracts for the Cardiovascular line of products. Over his 18 years in a multitude of medical device markets, Mr. Watkins has overseen $410 million in company acquisitions in an array of leadership roles. Timothy Henrichs, DirectorTimothy Henrichs has been a finance executive for the last 14 years. Mr. Henrichs currently serves as the Chief Financial Officer of HomeRenew Buyer, Inc. (d/b/a Renovo Home Partners), a privately held short-term home improvement installer of bathrooms, kitchens, windows, doors, cabinets, roofing and siding across the United States. Prior to joining Renovo Home Partners, Mr. Henrichs served as the Executive Vice President and Chief Financial Officer from 2008 to 2022 of Follett Corporation, a privately held retailer and distributor of print and digital course materials, textbooks, trade books, library books and general merchandise and developer of software technology to the educational market including 80,000 schools. From 2005 to 2008, Mr. Henrichs served as the Global Controller of General Electric Company’s Healthcare Clinical Systems division responsible for the manufacture and distribution of patient monitoring, maternal and infant care, ultrasound, diagnostic cardiology and anesthesiology equipment. From 2003 to 2005, Mr. Henrichs served as the Financial Reporting Manager at Federal Signal Corporation. From 1995 to 2003, Mr. Henrichs served in various roles of increasing responsibility at Ernst & Young LLP in Chicago, Illinois and Frankfurt, Germany including Capital Markets and Mergers and Acquisitions Transaction Support, ultimately serving as a Senior Manager in the Audit and Assurance practice. Christopher Robin Brown, Director of Innovation, Founder and DirectorDr. Brown is a co-founder of the Company. He developed clinical protocol, initial practice guidelines, designed and implemented the practitioner certification program, initiated the company 401K, and personally financed the first two years of the Company. Dr. Brown is listed as the sole or principal inventor on all NeurAxis patents and is currently active in further device development working closely with compliance, product design and engineering. He also served as clinic chief in the United States Army Reserve (USAR) dental corps at Fort Benjamin Harrison in Indianapolis, Indiana. Dr. Brown started a private practice (current) concentrating in head, neck, and facial pain developing the first hospital based facial pain clinic in Indiana. He served on the Board of Directors of the American Academy of Pain Management for 15 years, helping grow the organization from 800 members to over 5000. He served on the national board of The Alliance of TMD practitioners, serving one term as president. Brian Carrico, President, Chief Executive Officer and DirectorBrian Carrico joined the Company in 2012. During his tenure, Mr. Carrico has held multiple leadership positions of increasing responsibility, including Vice President of Sales and President before becoming CEO on January 1, 2018. As an early employee in the Company’s life cycle, Mr. Carrico was instrumental in setting the strategic agenda for the Company, raising start-up capital, championing new product development, and bringing the Company’s technology to market. Prior to joining Neuraxis, Mr. Carrico worked selling in the operating room at Bard Medical and in the Cath lab at St. Jude Medical. Forward-Looking StatementsCertain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, as well as factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise. About NeurAxis, Inc.NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com. Contacts: CompanyNeurAxis, Inc.info@neuraxis.com Investor RelationsGilmartin GroupIR@neuraxis.com