Shoulder Impingement Syndrome

ROSEMONT, Ill., Feb. 2, 2024 /PRNewswire/ -- The 2024 Kappa Delta Ann Doner Vaughn Award was presented to the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Group for shifting the way physicians treat patients with atraumatic, symptomatic rotator cuff tears. Their research determined that physical therapy (PT), is an effective treatment for over 70% of these patients to improve pain and patient-reported outcome measures (PROMs) followed for over 10 years. This award recognizes research in musculoskeletal disease or injury with great potential to advance patient care. Continue Reading The 2024 Kappa Delta Ann Doner Vaughn Award was presented to the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Group for shifting the way physicians treat patients with atraumatic, symptomatic rotator cuff tears. To read more about the award, please click here. According to the American Academy of Orthopaedic Surgeons (AAOS), each year, almost 2 million people in the United States visit their doctors because of rotator cuff tears. This type of injury creates a significant economic burden to the U.S. health care system, as the prevalence of rotator cuff tears accelerates with age, and more than two-thirds of patients who have surgery are of working age. "When I finished my training in 1994, we were taught that surgery was the preferred way to treat a rotator cuff tear," said John E. Kuhn, MD, MS, FAAOS, chief of shoulder surgery and director of Vanderbilt Sports Medicine and director of the MOON Shoulder Group. "As the approach to treating rotator cuff tears remained unclear, we wanted a more thorough understanding of the disease to help define the indications for rotator cuff repair surgery and determine which patients would benefit from nonoperative treatment." Over the course of 10 years, the MOON Shoulder Group used their multicenter outcomes network to prospectively collect data on patients with rotator cuff disease to answer clinically important questions and better understand the natural history and treatment of rotator cuff disease. To predict failure rates of nonoperative treatment of rotator cuff tears, the group developed a standard, evidence-based PT protocol that included a "gold standard" PT protocol, with elements derived from a systematic review. The cohort study enrolled patients aged 18 to 100 years with shoulder symptoms and MRI-documented, symptomatic, atraumatic, full-thickness rotator cuff tears (where the tendon is completely detached from the bone). Patients were given two instructive rehabilitation books—one for physical therapists and another for home-based PT written at the eighth-grade level—with an accompanying DVD. The specific exercises included daily range of motion (postural exercises, active-assisted motion, active training of scapular muscles and active range of motion); daily flexibility (anterior and posterior shoulder stretching); and strengthening three times per week (rotator cuff and scapula exercises). Therapists were instructed to provide manual mobilization exercises as needed based on evidence that supports their use in impingement and to progress the patient to a home therapy program when ready. Based on the systematic review, heat and cold were recommended as modalities, but ultrasound was not.i Patient outcome scores were tracked at entry into the study and during each follow-up visit at six weeks, 12 weeks, one year, and two, five, seven and 10 years. At the six-week mark, patients were given three options: no additional follow up if they considered themselves "cured"; continue PT for six more weeks if they were "improved"; and, if they were "no better", they could elect to have surgery. At any point during the study, patients could opt to have surgery. Results from the research include: At 10 years, PT was shown to be highly effective in over 70% of patients with atraumatic, symptomatic, full-thickness rotator cuff tears in reducing pain and improving PROMs. Most patients who decided to have surgery within six months were driven primarily by their expectations of the effectiveness of physical therapy. In other words, if they thought PT would work, it worked. If they didn't believe it would work, it didn't. When comparing those who had surgery before six months and those who had surgery between six months and 10 years, worker's compensation status and activity level were more important in predicting the need for surgery after 6 months. Structural factors (tear size, retraction), visual analog pain score and weakness were not predictors of having surgery and are likely not helpful in determining surgical indications. There was no correlation between rotator cuff tear anatomy and pain, the duration of symptoms, and patient activity level. "Our team was shocked when so many patients in the cohort improved with physical therapy, because it's not at all what we expected," said Kuhn. "We're also optimistic about the finding that low expectations for therapy drives patients to having surgery because we can modify this variable by educating patients that physical therapy can work." The MOON Shoulder Group and other surgeons are engaged in the Arthroscopic Rotator Cuff Trial, a multicenter, randomized trial funded by the Patient Centered Outcomes Research Institute, where patients with symptomatic, atraumatic full-thickness rotator cuff tears are randomized to either treatment with PT or surgical repair of their rotator cuff tear to help determine which treatment option might be best suited for a particular patient. In addition to Dr. Kuhn, the MOON Shoulder Group includes the following researchers: Warren R. Dunn, MD, MPH, FAAOS, Rosemary Sanders, BA, Keith M. Baumgarten, MD, FAAOS, Julie Y. Bishop, MD, FAAOS, Robert H. Brophy, MD, FAAOS, James L. Carey, MD, MPH, FAAOS, Brian G. Holloway, MD, Grant L. Jones, MD, FAAOS, C. Benjamin Ma, MD, FAAOS, Robert G. Marx, MD, MS, FAAOS, Eric C. McCarty, MD, FAAOS, Sourav K. Poddar, MD, Matthew V. Smith, MD, FAAOS, Edwin E. Spencer, MD, FAAOS, Armando F. Vidal MD, FAAOS, Brian R. Wolf, MD, MS, FAAOS, and Rick W. Wright, MD, FAAOS. About the Kappa Delta Awards In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the AAOS in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the AAOS to persons who have performed research in orthopaedic surgery that is of high significance and impact. The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier and Ann Doner Vaughn. The third is known as the Young Investigator Award. For more information about the manuscript submission process, please visit aaos.org/kappadelta. Learn more about the Kappa Delta Foundation, here. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal health care issues; and it leads the health care discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. Disclosure Funding and Conflicts of Interest For a list of disclosures, funding and conflicts of interest, email [email protected]. i Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. SOURCE American Academy of Orthopaedic Surgeons

Integrity marks Anika’s entrance into the fast-growing $150 million+2 U.S. rotator cuff augmentation market and expansion of its proprietary hyaluronic acid (HA) regenerative portfolio BEDFORD, Mass., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that the first surgeries using the Integrity Implant System were successfully performed by Dr. Christopher Baker at the Florida Orthopaedic Institute in Tampa, FL. Integrity, comprised of a hyaluronic acid-based scaffold with bone and tendon fixation components and single use arthroscopic delivery instruments, is designed to protect an injured tendon and promote healing in rotator cuff repair and other tendon procedures. The system was fully cleared by the FDA in August of 2023. This marks the beginning of the limited U.S. market release ahead of schedule that will ramp to a full market release during the first quarter of 2024. “The successful first surgeries using Anika’s new Integrity Implant System mark another key milestone in the build out of our regenerative product portfolio as we continue to provide differentiated solutions to surgeons for rotator cuff procedures,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “The HA-based scaffold, together with the instrumentation and fixation components, provide a seamless, efficient, and elegant rotator cuff repair solution. While having a strong implant at time zero is critically important in rotator cuff repairs, the instrumentation and delivery are just as important, and we believe we have nailed it. The feedback received after the procedure exceeded our expectations highlighting the system’s ease of use and strength of the HA-based scaffold. We believe that Integrity is truly a game changer for surgeons and their patients and look forward to extending this exciting technology to other tendon repairs, for example, in the foot and ankle.” The Integrity implant itself is a flexible, knitted, HA-based scaffold that provides improved dry and wet strength and regenerative capacity over first generation collagen patches1, and supports regenerative healing through improved cell infiltration1, tissue remodeling1, and tendon thickening1. In an independent head-to-head animal study1 comparing Anika’s Integrity system and the market leading collagen implant, fibroblast infiltration and regularly oriented new collagenous tissue formation had occurred within the Integrity repair, demonstrating greater regenerative capacity as early as 12 weeks post-implantation. At 26 weeks, within the resorbing Integrity structure, new collagenous tissue infiltration had occurred, forming a new network of tendon tissue. This resulted in an average repaired tendon thickness nearly three times greater than with the market-leading collagen device. The scaffold component of the Integrity system is a porous, knitted, flexible construct combining Anika’s proprietary HYAFF® fibers with polyethylene terephthalate (PET) and is designed to support cell infiltration and regenerative healing. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears. Integrity is fixated using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation, as desired, at the site of the rotator cuff repair. The fixation components and instrumentation are delivered single-use and sterile for added efficiency. Christopher Baker, MD, of the Florida Orthopaedic Institute commented, “The hybrid, multifilament structure provides superior implant handling and strength when compared to collagen-based products alone. This combination of materials is comprised of 80% HYAFF, a hyaluronic acid-based material in clinical use for more than 20 years, and 20% PET fiber, i.e. surgical suture, which also has a long and established clinical history. The material and knitted structure result in a compelling blend of strength and healing that stands out from other products. The suture material remaining after full resorption of the HYAFF component is less than 30% of the total amount of suture used in a typical double-row repair. Handling of the implant has met every expectation that I had for this new device.” Timothy Codd, MD, of the University of Maryland St. Joseph Medical Center stated, “Integrity’s instrumentation, delivery and surgical technique are a game changer. Securing the implant laterally first helps ensure proper coverage across the repair site and the rolling deployment tool provides consistent and repeatable implant placement.” The U.S. rotator cuff augmentation market is currently over $150 million2 and is estimated to grow at a nearly 7% CAGR2 over the next 5 years, representing one of the high opportunity spaces in orthopedics. The Integrity Implant System continues Anika’s focus on delivering new, differentiated shoulder solutions, with a specific focus on the intersection of regenerative solutions and sports medicine. The launch of Integrity continues Anika’s release of differentiated products to support shoulder surgeons and a portfolio built around rotator cuff disease. Integrity, combined with recent product launches including X-Twist™ Fixation System, RevoMotion™ Reverse Total Arthroplasty System, and Tactoset® Injectable Bone Substitute for hardware augmentation, provide a truly innovative and comprehensive rotator cuff solution portfolio that is unmatched in the industry. These solutions position Anika to be a compelling partner for surgeons and facilities when treating all types of rotator cuff pathologies. 1Data on File 22023 SmartTRAK About Anika Anika Therapeutics, Inc. (NASDAQ: ANIK), is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Leveraging our core expertise in hyaluronic acid and implant solutions, we partner with clinicians to provide minimally invasive products that restore active living for people around the world. Our focus is on high opportunity spaces within orthopedics, including Osteoarthritis Pain Management, Regenerative Solutions, Sports Medicine and Arthrosurface Joint Solutions, and our products are efficiently delivered in key sites of care, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston, Massachusetts. For more information about Anika, please visit . ANIKA, ANIKA THERAPEUTICS, ARTHROSURFACE, HYAFF, INTEGRITY, REVOMOTION, TACTOSET, X-TWIST, and the Anika logo are trademarks of Anika Therapeutics, Inc. or its subsidiaries or are licensed to Anika Therapeutics, Inc. for its use. Forward-Looking Statements This press release may contain 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, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements regarding the planned launch and future expansion of Integrity, the potential expansion of Integrity to treat other tendon repairs, and the potential growth of the rotator cuff augmentation market. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release. For Investor Inquiries: Anika Therapeutics, Inc. Mark Namaroff, 781-457-9287 Vice President, Investor Relations, ESG and Corporate Communications investorrelations@anika.com For Media Inquiries: Greenough Christine Williamson, 617-922-1289 Senior Vice President cwilliamson@greenough.biz

RevoMotion Reverse Shoulder Arthroplasty System significantly expands Anika’s shoulder arthroplasty portfolio and provides a bone conserving and innovative solution in the $1 billion1 U.S. reverse shoulder market RevoMotion adds to a growing, highly differentiated portfolio to treat the full continuum of rotator cuff disease including our recently launched X-Twist™ Fixation System and newly cleared Integrity™ regenerative hyaluronic acid (HA) based patch system launching in Q1-2024 BEDFORD, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company, today announced the full market release of their RevoMotion Reverse Shoulder Arthroplasty System (RSA) at the 2023 Orthopaedic Summit (OSET) Annual Meeting on September 20-23 in Boston, MA. Throughout the event, Anika will feature the RevoMotion RSA as well as the recently cleared Integrity Implant System and the recently launched X-Twist Fixation System at Booth #304 and during various educational opportunities throughout the conference. “We’re excited to participate in this year’s OSET Annual Meeting, where we are showcasing our breakthrough new products focused on early intervention orthopedics, including the launch of our RevoMotion Reverse Shoulder Arthroplasty System, designed specifically to address clinical needs through a truly bone preserving design with simple and efficient instrumentation,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “We are also thrilled to preview at OSET our recently cleared Integrity regenerative HA-based rotator cuff patch system, which is uniquely strong, versatile, and easy-to-use. Integrity has an innovative delivery and fixation system and has greater regenerative capacity compared to first generation collagen patches. Anika’s cutting-edge shoulder portfolio, which also includes our recently launched X-Twist suture anchors, Tactoset HA-enhanced injectable bone substitute cleared for hardware augmentation, and OVOMotion with Inlay Glenoid Total Shoulder Arthroplasty, is further reinforced by the full market launch of RevoMotion. Based on the very positive surgeon feedback during our successful limited market release, we are confident that RevoMotion and our expanding rotator cuff portfolio meaningfully enhances the value that we can provide to surgeons and their patients in both the ASC and hospital settings.” Key benefits of RevoMotion include: Industry’s smallest diameter threaded glenoid baseplate: RevoMotion features the industry’s smallest diameter threaded baseplate2, which preserves bone, provides flexibility in positioning, and maximizes fixation of the glenoid components, all while achieving substantial fixation via a central compression screw. RevoMotion™ Reverse Shoulder System showing smallest diameter threaded glenoid baseplate Mid-lay Humeral Implant: Partially in-lay and partially on-lay, with seven humeral tray sizes providing a more precise fit and are designed for optimal range of motion and reduced risk of scapular notching. The humeral tray and bone preparation are designed to decrease stress shielding on the proximal humerus with forces evenly distributed across entire proximal humerus. Bone preservation and patient personalization: The system includes bone preserving glenoid and humeral designs intended to provide patient personalization via numerous humeral tray offerings which match the native anatomy, similar to other implant system designs in Anika’s Arthrosurface Joint Solutions portfolio including the flagship OVOMotion® with Inlay Glenoid Total Shoulder Arthroplasty System. Enhanced efficiency for surgeons and facilities: With its two streamlined instrument trays, RevoMotion appeals to both surgeons and facilities looking to optimize efficiency. The consolidated instrumentation is both Ambulatory Surgery Center (ASC) and hospital friendly, reducing back table footprint, limiting sterile reprocessing, and reducing relative costs associated with more complex designs currently on the market. “The RevoMotion Reverse Shoulder Arthroplasty System fills a vital place in Anika’s shoulder arthroplasty portfolio, which now offers the full line of solutions to meet my patients’ needs,” said Christopher Baker, M.D., Florida Orthopaedic Institute, Tampa, Florida. “RevoMotion offers significant advantages, including a 23mm diameter baseplate, the smallest threaded baseplate on the market. This allows the potential to save glenoid bone-stock and provides flexibility in positioning, allowing me to treat a variety of glenoid morphologies. With short term follow-up we are seeing tremendous satisfaction from our patients and improving pain and function.” Additionally, Anika will be showcasing its other compelling products like the OVOMotion with Inlay Glenoid TSA System, the only system that offers a true Inlay Glenoid, with data demonstrating that inset performance does not equal inlay, X-Twist Fixation System, and Tactoset™ Injectable Bone Substitute which is indicated for both hardware augmentation and use with Bone Marrow Aspiration (BMA). Integrity™ Implant System Furthermore, Anika will have the newly cleared Integrity Implant System available for preview and demonstration at the booth. Integrity is a highly anticipated regenerative hyaluronic acid-based patch system for augmentation of rotator cuff repairs and is comprised of the HA-based patch implant, fixation implants, and single use arthroscopic delivery instruments. In a pre-clinical head-to-head animal study, Integrity demonstrated greater regenerative capacity at both 12- and 26-week endpoints2. Additionally, Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a unique and differentiated solution. The Integrity Implant System was fully cleared by the FDA in August 2023 with market launch targeted for Q1-2024, view press release here. Christopher Baker, M.D., of the Florida Orthopedic Institute also commented, “I’m excited to see Anika working to improve the biologic augmentation market starting with rotator cuff repair. While some collagen products on the market are showing promising results with biological incorporation, in animal studies, Integrity facilitated improved biological healing without the use of animal collagen, while also providing a scaffold that can add strength to the construct at the time of implantation. In addition to improving the patch itself, they have also identified a more streamlined surgical technique. This product could improve patient outcomes and reduce the likelihood of future failures of rotator cuff repair.” There will be multiple opportunities throughout the 2023 OSET Annual Meeting in Boston to learn more about Anika’s compelling products at the Anika Booth, #304, as well as during other educational sessions: RevoMotion Moderated Live Surgery Wednesday, September 20th at 8:30AM during the main program. Watch as Stephan Pill, M.D., from Steadman Hawkins performs RevoMotion RSA surgery while Anthony Miniaci, M.D., moderates on site. RevoMotion Educational Dinner Symposium, Wednesday, September 20th at 6:00 PM where faculty will present and walk attendees through hands-on RevoMotion training. Join us as Anthony Miniaci, M.D., and Wasik Ashraf, D.O., present data and case studies demonstrating the benefits of our new bone-preserving, patient-centric RSA solution. Contact your Anika distributor if interested in attending this dinner event. Various Ask the Surgeon sessions at the Anika Booth #304. Schedule of events will be posted on the Anika LinkedIn page leading up to the conference. For those surgeons not attending OSET, RevoMotion is now widely available in the United States. Please contact your Anika distributor for additional information, including training opportunities. 1 2023E SmartTRAK Data 2 Data on > About Anika Anika Therapeutics, Inc. (NASDAQ: ANIK), is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Leveraging our core expertise in hyaluronic acid and implant solutions, we partner with clinicians to provide minimally invasive products that restore active living for people around the world. Our focus is on high opportunity spaces within orthopedics, including Osteoarthritis Pain Management, Regenerative Solutions, Sports Medicine and Arthrosurface Joint Solutions, and our products are efficiently delivered in key sites of care, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston, Massachusetts. For more information about Anika, please visit ANIKA, ANIKA THERAPEUTICS, INTEGRITY, OVOMOTION, REVOMOTION, TACTOSET, X-TWIST, and the Anika logo are registered trademarks of Anika Therapeutics, Inc. Forward-Looking Statements This press release may contain 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, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements regarding the planned launch and future expansion of Integrity, the potential success of Integrity in improving the treatment of rotator cuff disease, the potential growth of the rotator cuff augmentation market, the anticipated adoption of RevoMotion RSA, and specifics around planned educational sessions . These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at . Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release. For Investor Inquiries: Anika Therapeutics, Inc. Mark Namaroff, 781-457-9287 Vice President, Investor Relations, ESG and Corporate Communications investorrelations@anika.com For Media Inquiries: Greenough Christine Williamson, 617-922-1289 Senior Vice President cwilliamson@greenough.biz RevoMotion™ Reverse Shoulder System showing smallest diameter threaded glenoid baseplate RevoMotion™ Reverse Shoulder System showing smallest diameter threaded glenoid baseplate Integrity™ Implant System Integrity™ Implant System