Flexadyne: Revolutionizing ACL Braces Using 3D Printing

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"She was a superstar field hockey player, a forward, scored all of our goals." Alexa Guittari, the CEO of Flexadyne, describes one of her teammates who suffered an ACL injury. "She was finally able to play her junior spring again, but her brace slid, and she ended up tearing her PCL." After this, Alexa knew the current ACL braces on the market were not doing enough. 

Flexadyne is a company that utilizes 3D printing technology to create customizable medical braces for patients recovering from ACL injuries. Custom fitting each patient provides a more comfortable and durable brace, and for a fraction of the price. These braces also include sensors which differentiate Flexadyne from any other ACL brace currently on the market. These sensors connect to an app that helps the patient monitor their progress in rehabilitation.

Alexa, Ramiz Akhtar, Mia Pergola, and Brendan Berkel make up the Flexadyne team and are all rising third-year Biomedical Engineering Students at the University of Virginia. From collegiate field hockey to ice skating, cheerleading, soccer, basketball, tennis or track, each member of the Flexadyne team has participated in athletics throughout their lives.

While none of the members have suffered an ACL injury themselves, they have all experienced a friend or teammate who has. The Flexadyne team resonates with the desire for injured players to return to the game, and have set out to revolutionize ACL recovery. 

"Originally, Flexadyne's goal was to have an implantable graft." Alexa describes their initial idea, "A surgeon would put this graft into your ACL during surgery to speed up the time spent in surgery as well as the recovery." Flexadyne even obtained a patent for their biomaterial graft. However, after taking their patent to I-Corps for customer discovery, they encountered their first roadblock: the graft was deemed to be a FDA class III medical device. Class III devices are considered to be high risk to the patient and have stringent regulations. The Flexadyne team was thus forced to redirect their company.

Now, Flexadyne is creating a smart ACL brace that is a FDA class I medical device. Such devices are considered to have low to moderate risk to the patient and are much easier to meet regulations. 

Over the next ten weeks of the i.Lab, the Flexadyne team is hoping to file a PPA (Provisional Patent Application) for their smart brace. 

As a collegiate lacrosse player myself, I think that Flexadyne has the potential to revolutionize ACL recovery. One of the best players on my team this year partially re-tore her ACL after rehabbing it for over a year. I watched her struggle with her brace as it would often fall when she ran, clearly hindering her performance on the field. The ability for Flexadyne to create customizable braces that won't fall, as well as track rehab progress far surpasses the current braces on the market.