ANIK Anika Therapeutics Inc.

Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020

Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020

Innovative Products Designed to Meet Needs of Surgeons and their Patients in Joint Preservation and Restoration Procedures

BEDFORD, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- (NASDAQ: ANIK), a global, integrated joint preservation, restoration and regenerative solutions company with products across the orthopedic early intervention continuum of care, today announced U.S. Food and Drug Administration (FDA) clearance and the planned launch of multiple new product innovations that address the needs of orthopedic and sports medicine surgeons and their patients seeking to stay active by overcoming soft tissue damage. Six minimally invasive surgical devices and instruments have been cleared by the FDA to repair rotator cuffs, perform arthroscopic knee repairs and treat arthritis damage in the hand and wrist. The products will be commercialized through Anika’s recently expanded sales and marketing team throughout the third quarter of 2020 and mark the first products launched from the acquisitions of Parcus Medical and Arthrosurface, which were completed earlier this year.

“Anika has rapidly pivoted to become a dynamic, customer facing enterprise. The introduction of these innovative technologies is evidence that the Company is listening to its physician customers to identify surgeon and patient needs, and has the ability to develop, gain approvals for and launch a series of new devices and instruments, even during pandemic conditions,” said Cheryl R. Blanchard, Ph.D., President and Chief Executive Officer of Anika. “Commercial success and growth in the sports medicine and joint preservation and restoration market demands an evolving understanding of unmet patient needs and the ability to translate surgeon feedback into designs that are both meaningful and practical for today’s minimally invasive surgical ecosystem. Anika is well positioned to launch these exciting innovations, and we look forward to introducing these new products to our growing customer base as COVID restrictions ease and elective procedures resume in the U.S.”

The new products include:

  • Knotless AP Suture Anchors, a new family of knotless, drive-in suture anchors manufactured from a proprietary, bioabsorbable composite and available in four diameters. These products are used for rotator cuff repairs in the shoulder and tendon repairs in the foot and ankle.
  • ATLAS, a more anatomical and less invasive arthroplasty solution to treat arthritis of the CMC joint (thumb).
  • Synd-EZ Ti and Synd-EZ SS, knotless solutions to repair syndesmosis injuries in the ankle. These products are available in both titanium and stainless steel for compatibility with adjunctive fixation products.
  • Twist PEEK SST, a suture anchor design incorporating fixed suture tapes to facilitate reproducible knotless double-row rotator cuff repair.
  • 35 PEEK CF Push-In with Tape, a carbon fiber reinforced polymer anchor that incorporates high-strength suture tape to facilitate arthroscopic capsulolabral repairs of the shoulder.
  • GFS BTB Link, a ligament retention device used with the GFS Ultimate suspensory fixation device to provide the option to utilize bone-tendon-bone grafts in ACL and PCL reconstruction.

“Consistent incremental improvements to techniques, tools and materials are critical in joint preservation surgery, allowing surgeons to continually refine ways to keep their patients active and comfortable,” said Anil S. Ranawat, M.D., Hospital for Special Surgery. “Having worked closely with the Anika team in recent years, I am impressed with their ability to identify clinical problems and provide real time solutions for us as practitioners. Their growing armamentarium of new tools is the most recent example of this commitment, and I look forward to putting them into practice.”

About Anika Therapeutics

(NASDAQ: ANIK), is a global, integrated joint preservation, restoration and regenerative solutions company based in Bedford, Massachusetts. Anika is committed to delivering a diverse array of products to improve the lives of patients, with a focus on osteoarthritis pain management, sports medicine and joint preservation, restoration and regeneration. The Company has close to three decades of global expertise commercializing innovative products across the orthopedic early intervention continuum of care. For more information about Anika, please visit

Forward-Looking Statements 

The statements made in the first and third sentence of the first paragraph, which are not statements of historical fact, 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. These statements include, but are not limited to, those relating to the Company’s planned product launches. 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, especially in light of the evolving landscape around the COVID-19 pandemic. 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 failure to realize the anticipated benefits of its recently completed acquisitions; (ii) unexpected expenditures or assumed liabilities that may be incurred as a result of these acquisitions; (iii) loss of key employees or customers following the acquisitions or otherwise; (iv) unanticipated difficulties in conforming business practices, including accounting policies, procedures, internal controls, and financial records of the recently acquired companies; (v) inability to accurately forecast the performance of the recently acquired companies resulting in unforeseen adverse effects on the Company’s operating results; (vi) synergies between the recently acquired companies and the Company being estimates which may be materially different from actual results; (vii) 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; (viii) 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; (ix) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (x) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (xi) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (xii) 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.

Sylvia Cheung, 781-457-9000

Chief Financial Officer



 
For Media Inquiries:

W2O Group

Rachel Girard, 617-379-6760  

 

EN
20/07/2020

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Anika Therapeutics Inc.

 PRESS RELEASE

Anika Reports Third Quarter 2025 Financial Results

Anika Reports Third Quarter 2025 Financial Results Commercial Channel revenue up 22% with continued strong Integrity™ Implant System and Hyalofast® growth, and double-digit International OA Pain Management growth Third and final Hyalofast PMA module filed and data released Cingal® achieved commercial milestone of more than one million injections worldwide since 2016 Reaffirming Fiscal 2025 guidance and long-term outlook and commencing a $15 million 10b5-1 share repurchase BEDFORD, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (Nasdaq: ANIK), a global leader in the ...

 PRESS RELEASE

Anika Therapeutics Reports Filing of Final PMA Module for Hyalofast® C...

Anika Therapeutics Reports Filing of Final PMA Module for Hyalofast® Cartilage Repair Scaffold and Data from U.S. Pivotal FastTRACK Phase III Study BEDFORD, Mass., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global leader in joint preservation and regenerative solutions, announced that it filed the third and final module of its Premarket Approval application (PMA) for Hyalofast—its resorbable, hyaluronic acid-based scaffold used with autologous bone marrow aspirate concentrate (BMAC) for treating articular cartilage defects in the knee. The Company also re...

 PRESS RELEASE

Anika to Issue Third Quarter 2025 Financial Results on Wednesday, Nove...

Anika to Issue Third Quarter 2025 Financial Results on Wednesday, November 5, 2025 BEDFORD, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: ANIK), a global joint preservation company in early intervention orthopedics, announced today that it will issue its third quarter 2025 financial results before the opening of the market on Wednesday, November 5, 2025, followed by a conference call at 8:30 a.m. ET to discuss its results and business highlights. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) and providing the con...

 PRESS RELEASE

Anika Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Anika Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) BEDFORD, Mass., Sept. 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: ANIK), a global leader in the osteoarthritis pain management and regenerative solutions spaces focused on early intervention orthopedics, today announced that on September 2, 2025, Anika granted non-statutory stock options (“Options”) covering an aggregate of 2,500 shares of common stock at a per share exercise price of $9.15, which equaled the closing price of common stock on the Nasdaq Global Select Market on the grant date, to one newly hired non-executive e...

 PRESS RELEASE

Anika Reports Second Quarter 2025 Financial Results

Anika Reports Second Quarter 2025 Financial Results Regenerative Solutions revenue up 41% with Integrity™ Implant System ahead of expectations and continued strong Hyalofast® growth; Integrity surpasses full year 2024 performance and is on pace to more than double in 2025 Company released topline results for Hyalofast® clinical trial which did not meet pre-specified co-primary end points; Hyalofast demonstrated statistically significant improvements in pre-defined secondary endpoints and other measures; Company plans to file the final PMA module in second half 2025 Reaffirming Fis...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch