Forma Medical launches inaugural product; treats hammertoe

Camp Hill-based Forma Medical announced Wednesday that it has launched its OptimalHT, the world’s first instrumented Minimally Invasive Surgery (MIS) Hammertoe Arthrodesis procedure. 

The medical device manufacturer said OptimalHT received Federal Drug Administration (FDA) approval in July as its inaugural product launch. 

The device has been used to treat more than 50 hammertoe deformities to date, Forma Medical said. 

“It’s no secret that minimally invasive surgery is the future of foot and ankle care,” said Dr. Noman Siddiqui, LifeBridge Health, Baltimore, Maryland. “The novel OptimalHT approach for digital correction is ideal for less invasive surgery in the foot to reduce edema, expedite recovery, and achieve the results my patients demand.” 

 Less invasive than other hammertoe-specific products on the market, OptimalHT is a uniquely instrumented procedure designed to provide repeatable outcomes with minimal incisions, Forma Medical said. It is also more cost effective and scalable than other attempts at hammertoe-specific products. 

 “Receiving our first FDA approval and launching the OptimalHT system represents a pivotal moment for Forma Medical,” said James Gault, vice president of Forma Medical. “With this FDA approval, we now have a platform to launch life-changing systems across multiple anatomies. We are continuing to push the envelope and expand our portfolio to advance patient care.” 

 According to the US Census Bureau, the country is seeing unprecedented growth in the active aging population. With the number of people experiencing painful hammertoe deformities at an all-time high, and expected to rise, the need to better meet patient expectations is imperative. 

“Retrograde k-wire fixation has been an acceptable treatment for decades, yet I’ve recently come to appreciate that some patients are returning to my practice years later with recurrent toe deformities. When I give them the choice, they also seem to be less tolerant of the pins sticking out of the toe and more inclined to pursue a quicker return to standard footwear,” said Dr. Jesse Doty, Erlanger Health System, Chattanooga, Tennessee. “With OptimalHT, it’s been seamless for me to incorporate the proven results of a k-wire or to take it a step further with more reliable fixation in a repeatable way that my patients find less inconvenient.” 

Forma Medical will debut OptimalHT at the American Orthopedic Foot & Ankle Society (AOFAS) Annual Meeting Sept. 20 to 23 in Louisville, Kentucky.