Musculoskeletal Injury

New study shows promising results for allograft from Regenative Labs PENSACOLA, Fla., July 31, 2024 /PRNewswire/ -- More than 350,000 hip replacements are performed in the U.S. each year. Typically, patients in need of hip cartilage repairs seek minimally invasive options first, making Wharton's jelly a promising alternative for musculoskeletal defects. Continue Reading Albert Lai MD A recent study, titled Retrospective Evaluation of Cryopreserved Human Umbilical Cord Tissue Allografts in the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis, showed that patients reported less pain and stiffness when receiving an application of a Wharton's Jelly allograft from Regenative Labs. The overall objective of this study was to evaluate the improvement of patient-reported pain, quality of life, and functionality scales after applying Wharton's jelly in hip defects. Dr. Albert Lai of Desert Pain Specialists and Centers of Rehabilitation and Pain Medicine in California and Dr. Conrad Tamea of Orthopedic Associates of Tampa Bay participated in the study. A double board-certified physician with specialties in physical medicine rehabilitation and pain medicine, Dr. Lai said the Wharton's jelly therapy was providing relief for their patients. "Incorporating Wharton's jelly into our practice has provided an effective conservative option for patients with hip defects that outperforms conventional therapies," said Dr. Lai. "Using the structural connective tissue allografts has allowed many patients to avoid surgery altogether and significantly improve their quality of life." The study follows 69 patients with hip defects from 26 private practices who received an application of a Wharton's jelly allograft from Regenative Labs. Prior to the study, these patients had failed at least 8 weeks of conservative treatment. Patient outcomes were tracked on a 90-day calendar using three scales including the Numeric Pain Rating Scale (NPRS), Quality of Life Scales (QOLS), and the Western Ontario and McMaster University Arthritis Index (WOMAC) covering pain, stiffness, and functionality. There were statistically significant differences between the initial application and day 90 for the NPRS and WOMAC scales. The application of Wharton's jelly allografts in this retrospective cohort was observed to promote decreases in patient-reported NPRS scores, pain and stiffness and to improve function. These improvements were consistent across age groups but were most notable for the elderly, who generally have a slower and less effective recovery rate after conservative treatment and surgical procedures. Because of the success shown by NPRS and WOMAC in decreasing pain in the elderly population, Regenative Labs CEO Tyler Barrett said more studies are warranted to evaluate the safety and efficacy of Wharton's Jelly, specifically in patients older than 65. "Total hip replacements by Medicare alone are estimated to make up somewhere between $7 billion to $10 billion in annual healthcare expenditures in the U.S. It's clear that the need for this type of research is necessary and quite frankly overdue," said Barrett. The positive results from this study and the current literature provide a foundation to study applications of Wharton's Jelly in other musculoskeletal injuries to ultimately improve the quality of life and reduce the economic burden of multiple conservative treatments or surgical procedures. Dr. Tamea said Wharton's jelly allografts have reduced pain and stiffness for his patients — and in some cases — reduced the need for surgery. "As a board-certified Orthopedic Surgeon with more than 25 years of operative experience, I can say after using Wharton's jelly allografts in more than 200 cases, I have found them to be extremely beneficial to my patients," said Dr. Tamea. "Orthopedic applications using Wharton's jelly — including in the knee, shoulder, hip, and spine — are more often than not preventing the need for surgery that results in a prolonged recovery time, lost wages and great financial cost." Barrett and the Regenative Labs' 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. Physicians can contact Regenative Labs to get their practice involved today. Read the full study here. Wharton's jelly explained: About Regenative Labs Regenative Labs produces regenerative medicine products to address the root cause of a patient's debilitating situation 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 effective and minimally 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 About Dr. Albert Lai A southern Californian native, Dr. Lai completed his medical training at Tufts University, where he subsequently served as a clinical instructor. He is board certified in Physical Medicine and Rehabilitation. He also holds board certifications in Pain Medicine and Independent Medical Examiners. Dr. Lai has served as the managing partner at the offices of Desert Pain & Rehabilitation Associates based in Rancho Mirage for the past 18 years and as medical director of Centers of Rehabilitation and Pain Medicine in Placentia, California. Learn more at the Centers of Rehabilitation website: Pain Clinic Orange County | Professional Pain Management in OC (ocpain.net) About Dr. Conrad Tamea Dr. Tamea is a board-certified Orthopedic Surgeon, who now focuses solely on regenerative medicine. He received his education from the College of William and Mary, Drexel University, Hahnemann Medical University, and the University of Kansas Orthopedic Residency Program. Dr. Tamea utilizes his knowledge and experience from over three decades as a surgeon and over a decade of regenerative medicine and combines this knowledge with state-of-the-art equipment at his clinic at Orthopedic Associates of Tampa Bay. SOURCE Regenative Labs

Minimally invasive procedure repairs injured spinal discs without surgery. SCOTTSDALE, Ariz., May 22, 2024 /PRNewswire/ -- Michael Wolff, MD, has been named the first Master Instructor for the Discseel® Procedure, a non-surgical outpatient treatment for chronic back pain resulting from damaged discs. Dr. Wolff, with more than 25 years of research in developing and safely performing intradiscal procedures, leads the Southwest as one of the few physicians certified by Discseel® founder, Kevin Pauza, MD, to offer the Discseel® Procedure to repair injured discs non-surgically. Continue Reading Michael Wolff, MD "Often people suffer from chronic back and leg pain as a result of degenerative discs that don't function properly and can become "leaky" due to tears in the disc wall. As chemical mediators leak out they can irritate the disc itself and surrounding nerves." Dr. Wolff explained. "Many patients treated with the Discseel® Procedure have experienced significant improvement of their low back and leg pain and are able to enjoy an active lifestyle again while avoiding surgery and its inherent risks and prolonged recovery time." Back pain often begins as small annular tears in disc walls, which, when left untreated, can lead to disc degeneration, bulging, and herniation. The Discseel® procedure, which is performed under fluoroscopic (X-ray) guidance, involves injecting fibrin into affected discs to immediately seal them. Fibrin promotes new tissue growth and healing both in the disc wall and inside the disc. Other biologic therapies, in addition to fibrin, can also be used during the procedure to further enhance and speed cellular regeneration. More than 7,000 Discseel® procedures have been performed, with data showing 82% of patients experiencing improvement in pain and function. About Michael Wolff, MD Dr. Wolff established Southwest Spine & Sports in Scottsdale, Arizona, in 1999 to help people with musculoskeletal injuries return to the life they love without surgery. He is double-board certified by the American Board of Physical Medicine and Rehabilitation in both Physical Medicine and Rehabilitation and Pain Medicine. Dr. Wolff's education includes Emory University, undergraduate; Georgetown University, medical school; The Ohio State University, residency; and Illinois Sports & Spine, interventional spine fellowship. Dr. Wolff taught an interventional spine fellowship for over 20 years. He is a passionate leader in the field of Regenerative Medicine and a trusted source for detailed examinations, accurate diagnoses, cutting-edge treatments, and honest advice. In his local community, he is honored to be the "doctor's doctor", often being referred the toughest cases by other physicians, as well as treating them and their families. About Southwest Spine & Sports Southwest Spine & Sports specializes in advanced regenerative and traditional treatments using state-of-the-art technologies to treat painful back, muscle, nerve and joint conditions and degenerative disc disease. Treatments include the Discseel® Procedure, platelet-rich plasma, biologic injections, IV wellness, and image-guided epidural and joint injections. Contact: Al Maag, [email protected] SOURCE Southwest Spine & Sports

Hands-on demonstrations will include the company's first single-use flexible ureteroscope CENTER VALLEY, Pa., April 30, 2024 /PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer and more fulfilling, will highlight a diverse urology portfolio that can help physicians treat bladder cancer, urinary stones and enlarged prostate during this year's American Urological Association (AUA) annual meeting May 3-6 in San Antonio. Continue Reading Olympus will highlight a diverse urology portfolio that can help physicians treat bladder cancer, urinary stones and enlarged prostate during this year’s American Urological Association (AUA) annual meeting Olympus will feature the recently FDA-cleared RenaFlex™ single-use flexible ureteroscope system, the company's first single-use ureteroscope, and the ESG-410™ Surgical Energy Platform which supports procedural approaches and efficiencies in the treatment of NMIBC (non-muscle-invasive bladder cancer), benign prostatic hyperplasia (BPH), as well as a wide variety of open and laparoscopic procedures. As the exclusive AUA2024 clinical practice guideline sponsor, Olympus will provide 2,500 copies of the AUA2024 Guidelines-At-A-Glance compendium books, which include the recommendation of Narrow Band Imaging™ (NBI™) technology for the diagnosis and treatment of NMIBC and the iTind™ procedure for the management of lower urinary tract symptoms attributed to BPH. The iTind procedure is reflected in the new procedure category, Temporary Implanted Prostatic Devices (TIPD).1 Stone management The RenaFlex single-use flexible ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.2 Visitors to the Olympus booth will have an opportunity for a hands-on skills challenge using the RenaFlex ureteroscope, which will be available in limited market launch in 2024. The RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible single-use. For safe and proper use, follow the manufacturer's instructions for use, handling, and operating of the RenaFlex Single-use Ureteroscope and the CV-S1 Video System Center. If used or handled in an improper manner, there is a risk of patient and/or operator injuries, burns, infections, bleeding, and/or perforation, and/or equipment damage. The RenaFlex system is part of a larger stone management portfolio of products that allow physicians to confidently approach every patient or procedure at any site of care. Included in that portfolio is the SOLTIVE™ Premium SuperPulsed Laser System (SOLTIVE Laser System). The SOLTIVE System's thulium fiber laser (TFL) technology allows physicians to dust kidney stones more quickly than advanced post-modulation Holmium:YAG technology.3 The SOLTIVE System will also be available for hands-on demonstrations. The SOLTIVE SuperPulsed Laser, powered by a novel energy source, is capable of dusting stones in half the time and fragmenting stones relentlessly with virtually no retropulsion. For effective dusting and fragmentation, the tip of the laser fiber should be directly in contact with the stone. Continuous irrigation should be used to wash away stone fragments and to provide cooling of the treatment site. The use of higher power settings should be avoided, especially when the fiber tip is in close proximity to the ureteral wall, as perforation of the ureter may result. As with non-laser surgery, the possibility of complications and adverse events, such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis, or infection may occur following treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or laser application. As with any conventional surgery, acute pain may occur immediately following laser therapy and may persist for as long as 48 hours.4 Drs. Ahmed Ghazi and Naeem Bhojani will offer "Ask the Experts" lectures regarding their experiences with the SOLTIVE System along with a "Tech Talk" by Dr. Mantu Gupta, who will highlight the versatility of the laser platform.5 Bladder Cancer The ESG-410 Surgical Energy Platform supports procedural approaches and efficiencies for the treatment of NMIBC. It is equipped with enhanced capacitors that allow for better plasma stability during ignition,6 and it powers the five modes of commonly used energy: monopolar, bipolar, advanced bipolar, ultrasonic and hybrid energy for use in endoscopic, laparoscopic and open procedures. The ESG-410 Surgical Energy Platform can be used in concert with Olympus' NBI™ technology that enhances visual observation of mucosal and vascular patterns by utilizing specific blue and green wavelengths absorbed by hemoglobin.7 NBI is not intended to replace histopathological sampling as a means of diagnosis. Recent data shows that the use of NBI technology with NMIBC patients led to a 37% less likelihood of recurrence over 12-35 months.8 Monitoring bladder cancer is critical. The American Cancer Society reports that bladder cancer has one of the highest recurrence rates9 with patients typically undergoing cystoscopy about every three months for years after treatment.10 BPH Olympus offers a variety of minimally invasive and surgical treatment options to treat men with an enlarged prostate (BPH). The iTind™ procedure is a novel minimally invasive BPH treatment option that involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. It remains in place for five to seven days while the patient is at home. Upon physician removal, patients experience rapid and effective relief of their symptoms.11 The iTind device is indicated in men age 50 and above. Implantation of the iTind device may cause pelvic discomfort, blood in urine, painful or urgent urination. In rare cases, the iTind device may cause urinary tract infection or a sudden difficulty to urinate. Olympus will host an iTind procedure "Tech Talk" to discuss how the iTind device was invented, how it works and which patients are ideal for treatment. Drs. Naveen Kella and Rahul Mehan will also offer "Ask the Experts" lectures in the Olympus booth regarding their experiences with the procedure.12 The ESG-410™ Surgical Energy Platform supports options for the treatment of BPH by providing an array of resection loops and vaporization buttons. The ESG-410 Surgical Energy Platform offers enhanced procedural efficiency in BPH resections due to faster tissue removal because of reliable ignition of larger resection loops.13 The ESG-410 electrosurgical generator, with its accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery and should only be used by a qualified physician in an adequate medical environment. Improper use or use of incompatible equipment with this electrosurgical generator can lead to excessive or incorrect HF and cause thermal or other injuries for the patient and/or operator. All plugs must be securely inserted to the corresponding sockets for proper use. Be aware that if the main plug is accidentally disconnected during a procedure, the electrosurgical generator immediately turns off and this can result in complications for the patient. Please refer to the instructions for use prior to usage. For more information about the urological portfolio, visit the Olympus booth, #311, during AUA or visit the RenaFlex™ system, ESG-410 Platform, SOLTIVE™ Laser System and iTind™ product pages for more information. About Olympus At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 4,500 employees throughout locations in North and South America. For more information, visit olympusamerica.com. 1 Sandhu JS, Bixler BR, Dahm P, et al. « Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023." J Urol. 2023;10. doi.org/10.1097/JU.0000000000003698 2 RenaFlex IFU 3 Benchmark study. Comparison of dusting and fragmenting using the new Super Pulse Thulium Fiber Laser to a 120W Holmium: YAG laser. AUA 2019. Dr. Ben Chew 4 For further information please refer to the SOLTIVETM Laser System IFU • PN001555 1_AE 5 Drs. Ahmed Ghazi, Naeem Bhojani and Mantu Gupta are paid consultants for Olympus Corporation of the Americas 6 When compared to the ESG-400 generator. Data on file 02/2023 7 Data on file with Olympus (D00489968) 8 Lai LY, Tafuri SM, Ginier EC, Herrel LA, Dahm P, Maisch P, Lane GI. "Narrow band imaging versus white light cystoscopy alone for transurethral resection of non-muscle invasive bladder cancer." Cochrane Database Syst Rev. 2022 Apr 8;4(4):CD014887. doi: 10.1002/14651858.CD014887.pub2. PMID: 35393644; PMCID: PMC8990285 9 American Cancer Society, "Cancer Recurrence Rates." Rev. December 2023 10 American Cancer Society, "Treatment of Bladder Cancer, by Stage." Rev. December 2023 11 Chughtai, B; Elterman, D; Shore, N; et al. "The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial." Journal of Urology, pub. July 2021 12 Drs. Naveen Kella and Rahul Mehan are paid consultants for Olympus Corporation of the Americas 13 When compared with competitive generator. Data on file 02/2023 SOURCE Olympus Corporation of the Americas