Anika Reports Topline Results from U.S. Pivotal FastTRACK Phase III Study for 贬测补濒辞蹿补蝉迟庐 Cartilage Repair Scaffold and Provides Program Update
Anika Therapeutics (NASDAQ:ANIK) has reported topline results from its FastTRACK Phase III study for 贬测补濒辞蹿补蝉迟庐, a cartilage repair scaffold. While the treatment showed consistent improvements over microfracture, it missed the pre-specified co-primary endpoints for KOOS Pain and IKDC function statistical significance.
Despite this setback, Hyalofast demonstrated statistically significant improvements in secondary endpoints, including KOOS Sports and Recreation Function, Quality of Life, and Total KOOS. The product has been successfully used in over 35,000 patients across 35+ countries since 2009. Anika plans to file the final PMA module in H2 2025, incorporating additional post-hoc analyses and global data under its Breakthrough Device Designation.
Anika Therapeutics (NASDAQ:ANIK) ha comunicato i risultati principali del suo studio FastTRACK di Fase III per 贬测补濒辞蹿补蝉迟庐, un supporto per la riparazione della cartilagine. Sebbene il trattamento abbia mostrato miglioramenti costanti rispetto alla microfrattura, ha mancato gli endpoint co-primari predefiniti per il dolore KOOS e la funzione IKDC in termini di significativit脿 statistica.
Nonostante questo ostacolo, Hyalofast ha evidenziato miglioramenti statisticamente significativi negli endpoint secondari, inclusi la funzione sportiva e ricreativa KOOS, la qualit脿 della vita e il KOOS totale. Il prodotto 猫 stato utilizzato con successo in oltre 35.000 pazienti in pi霉 di 35 paesi dal 2009. Anika prevede di presentare il modulo finale PMA nella seconda met脿 del 2025, includendo ulteriori analisi post-hoc e dati globali nell鈥檃mbito della sua Designazione di Dispositivo Innovativo.
Anika Therapeutics (NASDAQ:ANIK) ha informado los resultados principales de su estudio FastTRACK de Fase III para 贬测补濒辞蹿补蝉迟庐, un andamiaje para la reparaci贸n del cart铆lago. Aunque el tratamiento mostr贸 mejoras consistentes en comparaci贸n con la microfractura, no alcanz贸 los puntos finales co-primarios predefinidos para el dolor KOOS y la funci贸n IKDC con significancia estad铆stica.
A pesar de este contratiempo, Hyalofast demostr贸 mejoras estad铆sticamente significativas en los puntos finales secundarios, incluyendo la funci贸n deportiva y recreativa KOOS, la calidad de vida y el KOOS total. El producto ha sido utilizado con 茅xito en m谩s de 35,000 pacientes en m谩s de 35 pa铆ses desde 2009. Anika planea presentar el m贸dulo final PMA en la segunda mitad de 2025, incorporando an谩lisis post-hoc adicionales y datos globales bajo su Designaci贸n de Dispositivo Innovador.
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Anika Therapeutics (NASDAQ:ANIK) a annonc茅 les r茅sultats principaux de son 茅tude de phase III FastTRACK pour 贬测补濒辞蹿补蝉迟庐, un 茅chafaudage de r茅paration du cartilage. Bien que le traitement ait montr茅 des am茅liorations constantes par rapport 脿 la microfracture, il n鈥檃 pas atteint les crit猫res co-primaires pr茅-sp茅cifi茅s pour la douleur KOOS et la fonction IKDC en termes de signification statistique.
Malgr茅 ce revers, Hyalofast a d茅montr茅 des am茅liorations statistiquement significatives sur les crit猫res secondaires, notamment la fonction sportive et r茅cr茅ative KOOS, la qualit茅 de vie et le KOOS total. Le produit a 茅t茅 utilis茅 avec succ猫s chez plus de 35 000 patients dans plus de 35 pays depuis 2009. Anika pr茅voit de soumettre le module final PMA au second semestre 2025, en int茅grant des analyses post-hoc suppl茅mentaires et des donn茅es mondiales dans le cadre de sa d茅signation de dispositif r茅volutionnaire.
Anika Therapeutics (NASDAQ:ANIK) hat die Hauptergebnisse seiner FastTRACK Phase-III-Studie f眉r 贬测补濒辞蹿补蝉迟庐, ein Ger眉st zur Knorpelreparatur, ver枚ffentlicht. Obwohl die Behandlung im Vergleich zur Mikrofrakturierung konsistente Verbesserungen zeigte, wurden die vorab festgelegten ko-prim盲ren Endpunkte f眉r KOOS Schmerz und IKDC Funktion nicht statistisch signifikant erreicht.
Trotz dieses R眉ckschlags zeigte Hyalofast statistisch signifikante Verbesserungen bei sekund盲ren Endpunkten, einschlie脽lich KOOS Sport- und Freizeitfunktion, Lebensqualit盲t und Gesamt-KOOS. Das Produkt wurde seit 2009 erfolgreich bei 眉ber 35.000 Patienten in mehr als 35 L盲ndern eingesetzt. Anika plant, das finale PMA-Modul in der zweiten H盲lfte 2025 einzureichen, wobei zus盲tzliche Post-hoc-Analysen und globale Daten im Rahmen der Breakthrough Device Designation einflie脽en werden.
- Statistically significant improvements achieved in key secondary endpoints including KOOS Sports, Recreation Function, and Quality of Life
- Favorable safety profile compared to microfracture
- Successful track record with over 35,000 patients treated globally since 2009
- Product has Breakthrough Device Designation status with FDA
- Failed to meet pre-specified co-primary endpoints for KOOS Pain and IKDC function
- Study impacted by high subject dropout rate and missed visits during COVID
- Reduced evaluable sample size complicated statistical analysis
- FDA approval uncertainty despite planned additional post-hoc analyses
Insights
Anika's Hyalofast missed primary endpoints but showed secondary benefits; FDA submission planned despite mixed results.
Anika's pivotal FastTRACK Phase III study for Hyalofast delivered mixed results that investors should carefully evaluate. The cartilage repair scaffold failed to meet its co-primary endpoints of percent change in KOOS Pain and IKDC function versus microfracture, which is a significant regulatory setback. However, several encouraging secondary signals emerged that management believes could still support FDA approval.
The product demonstrated statistically significant improvements in key secondary endpoints including KOOS Sports and Recreation Function, Quality of Life, and Total KOOS scores. These specific measures have previously supported FDA approvals for other cartilage repair products, providing Anika with a potential regulatory pathway despite the primary endpoint miss.
Study execution challenges likely impacted results, including higher dropout rates in the control arm and missed visits during COVID, which reduced evaluable sample size and complicated statistical analysis. This creates some uncertainty around the data's interpretability.
The regulatory strategy now involves filing the final PMA module in H2 2025 with additional post-hoc analyses and incorporating real-world evidence from Hyalofast's use in over 35,000 patients across more than 35 countries since 2009. The product's Breakthrough Device Designation could give the FDA flexibility in its review approach.
Importantly, the safety profile was comparable to microfracture, supporting a favorable benefit-risk assessment. While approval remains uncertain, the company is proceeding with its submission based on the totality of evidence, though investors should recognize the elevated regulatory risk following the primary endpoint miss.
Hyalofast consistently demonstrated improvements over microfracture, but missed on statistical significance of the pre-specified co-primary endpoints of percent change in KOOS Pain and IKDC function
Hyalofast showed statistically significant improvements over microfracture in pre-defined secondary endpoints and other measures that align with prior FDA approvals for cartilage repair products
Hyalofast has been used to treat over 35,000 patients in more than 35 countries outside the U.S. since 2009; data from independent studies performed outside the U.S. will be filed with FDA submission
Based on the totality of the data, Anika plans to file the final PMA module in H2 2025
BEDFORD, Mass., July 30, 2025 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (Nasdaq: ANIK), a global leader in osteoarthritis pain management and regenerative solutions, today announced topline results from its U.S. pivotal clinical trial of Hyalofast, a resorbable, hyaluronic acid scaffold used in conjunction with autologous bone marrow aspirate concentrate (BMAC) for cartilage repair. Enrollment for this trial was completed in 2023 and the results announced today follow the recently completed, evaluator-blinded two-year follow-up period post-treatment.
The FastTRACK study, started in 2015, is a prospective, randomized, active treatment-controlled evaluator-blinded multicenter study to establish superiority of Hyalofast with autologous BMAC in the treatment of articular knee cartilage defect lesions in comparison to a microfracture control (an active comparator). Superiority between the groups was to be determined with two pre-specified co-primary endpoints: percent change from baseline to two years in both Knee injury and Osteoarthritis Outcomes Score (KOOS) pain and International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score (a measure of function).
While Hyalofast demonstrated consistent improvements in treated patients across all measures of pain and function relative to microfracture, the study did not meet its pre-specified co-primary endpoints. The study was likely impacted by both a higher subject dropout rate in the microfracture arm and missed visits during COVID. This resulted in missing data, which reduced the evaluable sample size and complicated the statistical analysis. Hyalofast exhibited a comparable safety profile when compared to microfracture following the initial effects of the differences in surgical procedure, supporting a favorable benefit-risk profile for Hyalofast.
Based on the totality of the clinical data the company has collected on Hyalofast, Anika plans to file the final PMA module by the end of the year. Hyalofast showed statistically significant improvements in key pre-defined secondary endpoints including KOOS Sports and Recreation Function, and Quality of Life. In addition, Hyalofast demonstrated statistically significant improvement in Total KOOS, a composite pain and function measure. These additional measures have supported prior FDA approvals for cartilage repair products. Hyalofast has been used outside the U.S. to successfully treat more than 35,000 patients since its launch in 2009 and is currently available in more than 35 countries. Hyalofast has demonstrated a favorable safety and effectiveness profile from this real-world clinical experience across multiple independent studies performed outside the U.S. including positive 15-year outcomes published last year.
鈥淲hile we are disappointed that the co-primary endpoints were not achieved under the original statistical framework, we are encouraged by the consistency and robustness of our results on pain and function measures including achieving significance on measures used for prior FDA cartilage repair approvals and the published global evidence supporting the safety and effectiveness of Hyalofast. We believe the totality of evidence presented in this study and the data from outside the U.S. demonstrates the true clinical value of Hyalofast, a single stage procedure, for patients who suffer from cartilage lesions in the knee,鈥� said Cheryl Blanchard, President and CEO of Anika Therapeutics.
Anika plans to file the third and final PMA module in the second half of 2025 and seek approval from the FDA. The third module will include ongoing additional post-hoc analyses including consideration of additional endpoints previously accepted by the FDA for cartilage repair product approvals. Anika expects that the FDA will consider these additional post-hoc analyses and the additional data from outside the U.S. as part of its review of the PMA submission under its Breakthrough Device Designation, but whether these analyses are sufficient to support approval will be a review issue.
About Hyalofast
Hyalofast is Anika鈥檚 single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair.聽It supports the regeneration of hyaline-like cartilage and is currently marketed in over 35 countries outside the U.S., with multiple clinical trials demonstrating its safety and effectiveness. Hyalofast has been designated as a breakthrough device by the FDA, allowing prioritized interaction and review.
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 about the clinical effectiveness of Hyalofast, the timing of the planned submission of a third PMA module for Hyalofast, the timing of FDA鈥檚 review of the PMA submission and the likelihood of approval. 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鈥檚 ability to timely complete regulatory submissions, including the third PMA module for Hyalofast, (ii) the FDA鈥檚 ability to timely review any such submission, and (iii) that the FDA may not approve the Hyalofast PMA because of the failure to achieve the pre-defined primary endpoints or because the FDA may determine that achievement of secondary endpoints and/or post hoc data analyses are not sufficient to support approval. 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
About Anika
(NASDAQ: ANIK), is the global leader in the design, development, manufacturing, and commercialization of hyaluronic acid innovations. In partnership with clinicians, our sole focus is dedicated to delivering and advancing osteoarthritis pain management and orthopedic regenerative solutions. At our core is a passion to deliver a differentiated portfolio that improves patient outcomes around the world. Anika鈥檚 global operations are headquartered outside of Boston, Massachusetts. For more information about Anika, please visit .
ANIKA, ANIKA THERAPEUTICS, HYALOFAST, and the Anika logo are trademarks of Anika Therapeutics, Inc. or its subsidiaries or are licensed to Anika Therapeutics, Inc. for its use.
For Investor Inquiries:
Anika Therapeutics, Inc.
Matt Hall, 781-457-9554
Director, Corporate Development and Investor Relations
FAQ
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