DOYLESTOWN, Pa., July 17, 2019 /PRNewswire/ -- OrthogenRx®, Inc., a medical device company focused on the development and commercialization of treatments for musculoskeletal conditions including osteoarthritis (OA) has announced that their CEO, Dr. Michael Daley, was awarded the 2019 Entrepreneur of the Year Award by the Pennsylvania Biotechnology Center (PABC) of Bucks County in Doylestown, PA. The company began at the PABC in 2013 before moving last year to a new office space location in Doylestown, to accommodate its growth.
More than 100 business leaders and biotech investors gathered at PABC last week for the 5th Annual "Entrepreneur Spotlight" where the award was announced. Dr. Daley, on hand to receive the award, commented, "It doesn't feel like that long ago that OrthogenRx was starting out here at PABC. I am grateful to the Pennsylvania Biotech Center and Dr. Timothy Block for their support back through the years. The Biotech Center plays an essential role in the life science entrepreneurial ecosystem in eastern Pennsylvania. I also want to take a moment to credit our great team, and especially Dr. David Toledo, for our recent success in obtaining the FDA approval of TriVisc™. Great things happen only when you have great people."
OrthogenRx's launch of TriVisc (sodium hyaluronate) in the first quarter of 2019 for the treatment of patients with osteoarthritic (OA) knee pain (who have failed to receive adequate relief from simple painkillers or from exercise and physical therapy) was officially recognized during the event as part of PABC's "Product Wall of Fame," which recognizes medical devices and drugs that were developed at the Center.
TriVisc is a solution of highly purified hyaluronic acid (sodium hyaluronate; HA) and helps supplement the viscous properties of the fluid in the knee joint. TriVisc is administered by a healthcare professional in 3 injections in the knee given at weekly intervals. In clinical studies TriVisc has been shown to provide patients with months of pain relief and can be repeated if the pain returns. The intra-articular HA market in the U.S. exceeds $1 billion.
TriVisc is the first product (Class III medical device) in over 20 years to secure FDA approval under Section 216 of the 1997 Food and Drug Administration Modernization Act. TriVisc is derived from a biofermentation process, which means that patients with allergies to chicken, eggs, feathers and other avian biproducts are not at risk for an avian reaction that might arise from some other products derived from chicken combs. The TriVisc formulation has had over 35 million doses administered worldwide outside the US. TriVisc is the second product to receive FDA PMA approval in the OrthogenRx portfolio in just 2 years. GenVisc® 850, which is a 5 weekly injection regimen of sodium hyaluronate, was previously approved by the FDA in September 2015.
TriVisc and GenVisc 850 were developed in collaboration with Meiji Seika Pharma Co., Ltd. (Japan) and its manufacturing subsidiary, Tedec-Meiji Farma S.A (Spain). The TriVisc formulation has been approved in over 63 countries (outside US) under the Adant® and related brands and distributed by Meiji Seika Pharma Group and partners.
OrthogenRx Inc. is a late stage development company headquartered in Doylestown, OrthogenRx, Inc. is focused on the development and commercialization of treatments for knee pain caused by osteoarthritis (OA). OA is the most common cause of knee pain, causing sufferers significant pain and disability. The management team has decades of industry experience in product development, commercialization, sales/marketing, and reimbursement of medical device products. To learn more please visit OrthogenRx.com.