Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020
“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
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
carbonfiber 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
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
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Source: Anika Therapeutics Inc.