OrthogenRx Announces New TriVisc® Patient Programs

DOYLESTOWN, Pa., May 28, 2020 /PRNewswire/ -- OrthogenRx, Inc. a medical device company focused on the development and commercialization of treatments for knee pain caused by osteoarthritis (OA), today announced new pricing options relating to The TriVisc Direct Purchase Program™  and The TriVisc Patient Assistance Program™.

OrthogenRx core values are centered on preserving ethics and compassion, building greater transparency, and partnering to facilitate access to affordable healthcare products.  Essential to these values is the company's commitment to patient access.  OrthogenRx is pleased to offer enhanced patient access to their products by launching the following programs:

• The TriVisc Direct Purchase Program^[1] - provides a convenient solution for patients who don't have insurance coverage. The program enables patients to purchase product directly through an exclusive network of pharmacy partners, at a fair and consistent price.
• The TriVisc Patient Assistance Program^[1] - offers access to TriVisc for patients without the financial resources to pay for the treatment by providing TriVisc at no cost.

"OrthogenRx's mission has been to provide safe and efficacious treatment options to our patients for the treatment of OA knee pain while providing fair and consistent pricing to healthcare professionals and their patients," said Michael Daley, PhD, Co-President, Co-Chief Executive Officer, and Founder of OrthogenRx, Inc. "Our focus on optimizing patient care through greater access, combined with a strategic pricing model, will continue to create value for all patients. We are proud to supply these offerings through innovation and dedication to execution excellence."

TriVisc® (sodium hyaluronate) is the first and only medical device in over 20 years to secure FDA approval under Section 216 of the Food and Drug Administration Modernization Act (1997).  It is indicated for the treatment of OA knee pain in patients who have failed to respond adequately to conservative, non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).  TriVisc is a second-generation hyaluronic acid (HA) product, also known as a viscosupplement, that is derived from a bacterial fermentation process.  Due to this unique process, patients with allergies to any chicken-based products are not at risk for an allergic reaction with TriVisc. TriVisc should not be used to treat patients who have a known hypersensitivity to hyaluronan preparations.  Transient pain and/or swelling of the injected joint may occur after injections.  The TriVisc formulation is approved in 63 countries outside the US, with over 35 million doses administered worldwide^[2]

The efficiency of regulatory approval for TriVisc has allowed OrthogenRx to position the product as the lowest priced (based on Wholesale Acquisition Cost or 'retail' price), three injection regimen HA product derived from a biofermentation process on the US market.^[3]  Some patients with OA knee pain have failed to get adequate relief from conservative non-pharmacologic therapy and simple analgesics, e.g. acetaminophen. Industry research and customer feedback have indicated that these patients were unable to obtain viscosupplement products based on the lack of insurance coverage or a patient's ability to afford them.

Background

TriVisc is a solution of highly purified 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.  TriVisc has been shown, in clinical studies, to provide patients with months of pain relief and can be repeated if the pain returns.

TriVisc is the second product to receive FDA approval in the OrthogenRx portfolio in just 2 years.  GenVisc 850, which is a 5-injection regimen of sodium hyaluronate, was previously approved by the Agency in September 2015. TriVisc and GenVisc 850 were developed in collaboration with Meiji Seika Pharma Co., Ltd. (Japan) and subsidiary, Meiji Pharma Spain, S.A.

Important Safety Information

TriVisc is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).

TriVisc is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of infections or skin diseases in the area of the injection site to reduce the potential for developing septic arthritis.

The effectiveness of a single treatment cycle of less than 3 injections has not been established.

In a clinical trial of 297 patients, the frequency of adverse events in the first treatment cycle was 2.9%, which was identical to the frequency in the saline-control group.

The most commonly reported adverse events in the TriVisc group included injection site pain (6), allergic reaction (3), arthralgia (2), and bleeding at the injection site (2).

Please visit Trivisc.com for full prescribing and safety information

ABOUT OrthogenRx
OrthogenRx Inc. is a late stage development company headquartered in Doylestown, PA. It licenses, develops, and sells equivalent orthopedic medical devices at competitive pricing and efficient operating processes, thereby maintaining favorable margins. This reduced cost to the healthcare system maintains affordable access to quality healthcare. The management team has decades of industry experience in product development, commercialization, sales/marketing, and reimbursement of medical device products.

¹ Conditions apply, please contact the OrthogenRx for details 1-866-556-2259
² TriVisc formulation has been approved in over 63 countries (outside US) under the Adant® and related brands and distributed by Meiji Pharma Spain, S.A., and partners.
³ 2020 IBM Micromedex® RED BOOK® database on drug pricing.
  TriVisc is a registered trademark of OrthogenRx, Inc.

Contacts
OrthogenRx Inc.
c/o McDAY – Public Relations
Alison Guzzio, 484-459-3243
[email protected]
1515 Market St #1200
Philadelphia, PA 19102
ORTGEN-TRIVPR-0520

SOURCE OrthogenRx, Inc.

Related Links

http://Trivisc.com