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Back in 2015, when Ashton Tweed last talked with Dr. Michael J. Daley, he was leading OrthogenRx® Inc. to rapid success. The late-stage company based in Doylestown, Pa., not only gained the Food and Drug Administration’s pre-market approval (PMA) of a Class III medical device for its first product, GenVisc®850, an intra-articular hyaluronic acid (HA) indicated for the treatment of osteoarthritis (OA) knee pain, it also navigated the journey to PMA—which can take six to eight years—in an astonishing 20 months.
Dr. Daley recently updated us on whether OrthogenRx has been able to keep up the pace.
Our second product, TriVisc™, which is another Class III medical device injectable, was approved in November 2017. We just received our preliminary reimbursement code and will launch in January 2019. TriVisc is administered three times a week to treat OA knee pain; the three-injection regimen represents the largest addressable market, $500MM, the biggest class of HA injectable products for knee pain. We’ve become very collaborative and efficient in working with the FDA and gained approval for TriVisc in six months.
We have a great team that’s allowed us to get two products approved in two years. At the same time, the regulatory pathway has become faster and more efficient. It also helps that I’ve worked closely with the FDA for most of my career and we’ve fostered an excellent collaborative relationship.
The next product in our pipeline is a single-injection HA medical device and we anticipate filing for FDA approval this year. According to SmartTRAK®, an industry business intelligence service, in 2017 OrthogenRx was the fastest growing company in the HA class. We intend on keeping that designation for the foreseeable future.