Cartilage Regeneration Therapy Builds Upon Company’s Orthobiologics Experience, Representing Expansion into Field of Regenerative Medicine
BEDFORD, MA, USA I December 29, 2015 I Anika Therapeutics, Inc., (ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid technology, today announced the enrollment of the first patient in its pivotal HYALOFAST® FastTRACK Phase III clinical study.
The HYALOFAST FastTRACK study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. The study will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe.
HYALOFAST is a biodegradable scaffold that is used to enable cartilage regeneration in patients suffering from cartilage defects. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date.
“HYALOFAST is an exciting, emerging product in our pipeline, representing Anika’s expansion into the rapidly evolving field of regenerative medicine in the orthopedics space,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
“I congratulate the FastTRACK investigators for beginning enrollment in this trial,” said Dr. Alberto Gobbi, Global Principal Investigator. “We know from prior research that the HYALOFAST scaffold supports the adhesion, migration and proliferation of mesenchymal stem cells, and their differentiation into chondrocytes. We look forward to demonstrating the unique advantages of HYALOFAST in a randomized clinical trial.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
SOURCE: Anika Therapeutics
Post Views: 37
Cartilage Regeneration Therapy Builds Upon Company’s Orthobiologics Experience, Representing Expansion into Field of Regenerative Medicine
BEDFORD, MA, USA I December 29, 2015 I Anika Therapeutics, Inc., (ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid technology, today announced the enrollment of the first patient in its pivotal HYALOFAST® FastTRACK Phase III clinical study.
The HYALOFAST FastTRACK study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. The study will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe.
HYALOFAST is a biodegradable scaffold that is used to enable cartilage regeneration in patients suffering from cartilage defects. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date.
“HYALOFAST is an exciting, emerging product in our pipeline, representing Anika’s expansion into the rapidly evolving field of regenerative medicine in the orthopedics space,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
“I congratulate the FastTRACK investigators for beginning enrollment in this trial,” said Dr. Alberto Gobbi, Global Principal Investigator. “We know from prior research that the HYALOFAST scaffold supports the adhesion, migration and proliferation of mesenchymal stem cells, and their differentiation into chondrocytes. We look forward to demonstrating the unique advantages of HYALOFAST in a randomized clinical trial.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
SOURCE: Anika Therapeutics
Post Views: 37
