Launched in the US, the TriVisc is claimed to be the first medical device in over 20 years to show clinical effectiveness and secure FDA approval under Section 216 of the Food and Drug Administration Modernization Act (1997).
TriVisc is a solution of purified hyaluronic acid (sodium hyaluronate; HA), which enables to provide viscous properties to the fluid of the knee joint.
Healthcare professional will administer TriVisc in three injections in the knee at weekly intervals.
According to the company, the new device has been demonstrated to offer patients with months of pain relief and can be repeated if the pain returns.
It is produced through biofermentation process, and its formulation secured approval in 63 countries outside the US.
For patients with allergies to chickens, eggs, feathers and other avian products, TriVisc helps to avoid the risk of an avian reaction that may cause due to products derived from chicken combs.
OrthogenRx founder, co-president and co-CEO Dr Michael Daley said: “This approval allows OrthogenRx to stay the course in continuing to provide fair and consistent pricing of our products to healthcare professionals and patients.
“It is our continuing mission to provide safe and efficacious treatment options to our patients for the treatment of osteoarthritis knee pain.”
TriVisc is the second product of the company to secure FDA approval within two years. In September 2015, the company received FDA approval for GenVisc 850 5-injection regimen of sodium hyaluronate.
OrthogenRx has worked with Japan’s Meiji Seika Pharma and its Spain subsidiary Tedec-Meiji Farma to develop TriVisc and GenVisc 850 products.
TriVisc formulation was approved in more than 63 countries under the Adant and related brands, and is supplied by Meiji Seika Pharma Group and partners.
OrthogenRx licenses, develops and markets equivalent orthopedic medical devices at competitive pricing.
The firm’s management team is engaged in product development, commercialization, sales/marketing, and reimbursement of medical device products.
