The US Food and Drug Administration (FDA) has awarded regulatory clearance for the Arcuro Medical’s (Arcuro) SuperBall meniscus repair system.
A Trendlines Group portfolio company, Arcuro Medical has developed the all-suture meniscus repair system to maintain knee functionality.
Recently, the company also secured patent for this system in the US.
Arcuro CEO Lee Ranon said: “We are very excited to have achieved FDA clearance in addition to the news of receiving our US patent.
“These two important milestones will enable the company to begin its clinical evaluation phase straight away.”
Meniscus tears are common among various population groups but are predominant among sportspersons, ageing people or patients with cartilage problems.
The standard treatment avoids the removal of the meniscus and involves arthroscopic repair techniques, which may result in rigid implants and inconvenient delivery systems.
It may also lead to long-term damage to the meniscus, poor repair and higher chances of intraoperative failure.
Stated to be secure and effective, the SuperBall meniscus repair system underwent a series of pre-clinical studies in the US and Israel.
Arcuro expects that this easy-to-use system will enable the surgeons to repair the meniscus instead of removing it.
The Trendlines Group chairman and CEO Steve Rhodes said: “We are very proud of the progress that the Arcuro team has made towards bringing their SuperBall meniscus repair system to market.
“We look forward to following their progress in improving patient outcomes and reducing surgeries in a market seeking a solution to this common and painful problem.”
Arcuro has already submitted a patent application at national phase in China, Israel and Europe.