Announcing the limited market release of X-Twist™ Fixation System with biocomposite suture anchor for rotator cuff and other soft tissue repair at AAOS
Focusing on its full Regenerative, Sports Medicine and Arthrosurface Joint Solutions portfolio addressing the over $2.0 billion U.S. rotator cuff market1
BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company, today announced it is highlighting recently-launched products in high growth segments of joint preservation and restoration from its Regenerative Solutions, Sports Medicine and Arthrosurface Joint Solutions businesses during the 2024 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting on February 13-15 in San Francisco, CA. Throughout the event, Anika will feature its differentiated shoulder portfolio including the recently launched Integrity Implant System for rotator cuff repair, RevoMotion Reverse Shoulder Arthroplasty (RSA) System with newly launched AIMTM (Anika Implant Management) surgical planning software, X-Twist Fixation System with biocomposite suture anchor, OVOMotion® with Inlay Glenoid Total Shoulder Arthroplasty (TSA) System, and many more of its early intervention orthopedic solutions, in booth #5145.
“We’re thrilled to once again participate in the AAOS 2024 Annual Meeting and to showcase our advanced portfolio of regenerative, sports medicine and bone preserving implant solutions designed to meet the evolving needs of surgeons across the orthopedic continuum of care,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “Anika is excited to highlight our recently launched Integrity Implant System, our newest regenerative hyaluronic acid (HA)-based scaffold for rotator cuff repair, and our X-Twist Fixation System with biocomposite suture anchor. We have also enhanced our shoulder arthroplasty offerings with the launch of AIM, Anika Implant Management, for 3-D preoperative planning which is now available with both the RevoMotion Reverse Shoulder and OVOMotion Total Shoulder arthroplasty systems. These new products, and the continued combination of Anika’s advanced HA-based regenerative technology with our bone preserving implants and sports medicine solutions, provide surgeons with powerful tools and options to support their patients and help them return to active living.”
The Integrity Implant System, comprised of a hyaluronic acid-based and PET reinforced scaffold with bone and tendon fixation components and single-use arthroscopic delivery instruments, is designed to protect an injured tendon, promote healing, and support cell infiltration and regenerative healing in rotator cuff repair and other tendon procedures. The Integrity implant is inherently strong both when hydrated and dry and can be confidently manipulated arthroscopically. Integrity offers a differentiated solution for shoulder surgeons to treat rotator cuff tears. The flexible, knitted, porous HA-based scaffold provides greater regenerative capacity compared to first generation collagen patches2 and supports regenerative healing through improved cell infiltration, tissue remodeling, and tendon thickening2. Early usage during the limited market release indicates high levels of interest and excitement for this product. Surgeon feedback supports the value of Integrity in their practice. The implant strength, staple and tissue tack fixation capabilities, unique “lateral first” implant technique, and ability to manipulate the implant are standout features of the Integrity system. In combination with surgeon reported early patient follow up, Integrity is well positioned to take share in this high opportunity space.
The RevoMotion Reverse Shoulder Arthroplasty System, with the industry’s smallest diameter threaded baseplate, offers surgeons and patients the ability to restore motion and preserve bone. Anika’s newly launched 3-D preoperative planning software, AIM (Anika Implant Management), allows surgeons to personalize and pre-plan each surgery, including assessing erosion depth and bony defects, determining optimal implant position, and assessing the implant’s impact on range of motion.
AIM, formally launching at AAOS this year and now available in the U.S., was developed in partnership with Materialise NV, a market leader with over 30 years of experience revolutionizing personalized solutions. AIM 3-D preoperative planning software enables surgeons to generate powerful insights with both glenoid and humeral planning for Anika’s OVOMotion with Inlay Glenoid TSA and RevoMotion RSA Systems.
“Nearly a year into our experience with RevoMotion RSA, we are consistently seeing significant improvements in patient reported outcome measures and function,” said Christopher Baker, M.D., Florida Orthopaedic Institute, Tampa, Florida. “With the addition of AIM, a 3-dimensional preoperative planning program, Anika is now able to offer a cutting-edge planning option for the system. This will allow physicians to more accurately manage difficult anatomic deformities of the glenohumeral joint in reverse shoulder arthroplasty.”
With our focused commitment in expanding shoulder preservation solutions along the continuum of care, Anika is excited to announce the limited launch of the X-Twist Fixation System with biocomposite suture anchor. X-Twist’s suture anchors enable fast and strong insertion into bone, requiring only 3 ¼ turns and offering significant torsional strength. The launch of the X-Twist Fixation System with biocomposite suture anchors now expands the X-Twist family portfolio with both permanent and resorbable material options.
Several new Sports Medicine products will also be available in early 2024, including the ProPass™ Suture Passer, and other new shoulder instrumentation. The ProPass Suture Passer provides surgeons with an intuitive operation and consistent control that reliably passes suture through thick rotator cuff tissue and is offered with or without an auto-capture window. All are expected to launch in 2024.
AAOS attendees can learn more about Anika’s compelling products at the Anika booth, #5145, as well as during two Innovation Theater sessions held in booth #4003:
“A New Revolution in Reverse Shoulder Arthroplasty,” presented by David Weinstein, MD, an orthopedic surgeon at the Colorado Center of Orthopedic Excellence, who will discuss the RevoMotion System features, benefits, clinical insights, and early patient outcomes at 9:30 AM PST on Tuesday, February 13th.
“Integrity: The Next Generation of Rotator Cuff Augmentation,” led by David Porter, MD, with Progressive Spine & Orthopedics in NJ, will discuss the Integrity Implant System, animal study data and significant histology, patient selection criteria, early case experience, and initial patient outcomes at 3:40 PM PST on Wednesday, February 14th.
1 SmartTrak 2023 data
2 Data on file
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 www.anika.com.
ANIKA, ANIKA THERAPEUTICS, AIM, ARTHROSURFACE, INTEGRITY, PROPASS, OVOMOTION, REVOMOTION, 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 launch, adoption and future expansion of Integrity and X-Twist Fixation System with biocomposite suture anchors, the potential impact of the launch of AIM, and comments related to the planned launch of the ProPass Suture Passer and other Sports Medicine products in 2024. 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 file and 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 www.sec.gov. 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.
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