– ISRAEL, Kfar Saba – CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured an additional $15 million equity investment from Bioventus, a global leader in orthobiologics.
The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeal’s investigational device exemption multinational pivotal study. An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.
This new round of funding is expected to enable CartiHeal to complete all patient follow-up in the study and submit the first application for premarket approval to the FDA. Bioventus made an initial $2.5 million investment in the Agili-C IDE study in January 2018, as part of a previous financing round.
Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company shortly after FDA approval of the Agili-C implant.
“We are pleased Bioventus continues to see value in the Agili-C implant and is making a greater investment to support the completion of the IDE study,” said Nir Altschuler, founder & CEO, CartiHeal. “We look forward to the work ahead and a successful application for PMA approval.”
“The successful enrollment and outcome at the interim analysis of CartiHeal’s pivotal study for Agili-C implant is an important milestone,” said Ken Reali, CEO, Bioventus. “It is a testament to the strength of its continuing development program and more importantly the future potential of the Agili-C technology in addressing the large unmet need in patients with joint surface lesions. This investment underscores our belief in the novel technology and we look forward to working with the team at CartiHeal in the years to come.”
CartiHeal, a privately held medical device company headquartered in Israel, is a pioneer in the field of regenerative medicine, providing simple and effective solutions for both degenerative and non-degenerative articular cartilage lesions. The company was founded by Nir Altschuler and Ben-Gurion University of the Negev.
Backed by extensive clinical evidence, its flagship product – Agili-C, has shown to promote regeneration of true hyaline cartilage and its underlying subchondral bone, simultaneously, without the use of cells, growth factors or other exogenous agents. The CE marked implant is a rigid bi-phasic scaffold composed of biocompatible and biodegradable materials.
For more information: https://www.cartiheal.com
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