Redwood Pharma enters partnership with Nextec medical in preparation for European market clearance of RP501
Stockholm, Sweden, December 15, 2022. Redwood Pharma AB (publ) has entered a partnership with Nextec medical GmbH to act as the Legal Manufacturer for Redwood Pharma´s medical device RP501. The partnership is an important step to ensure a time and resource efficient pathway to obtain CE-mark and facilitate the market introduction of RP501 for the treatment of dry eye disease.
Redwood Pharma’s medical device RP501 is being developed as an effective over-the-counter tear substitute for temporary relief of dry eye disease, a medical condition affecting more than 300 million people around the world. RP501 is based on IntelliGel – a proprietary and unique formulation of polymers and water that has the consistency of water when dropped into the eye, where it immediately forms a viscous, protective and lubricating film that stays on for an extended period of time.
A clinical trial of RP501 is ongoing and based on the forthcoming results, which are expected in the first half of 2023, the company is aiming to apply for a CE-mark of the product. To secure that Redwood Pharma has the required Quality Management System (QMS) and other regulatory services necessary for regulatory approval according to the European Medical Device Regulation (MDR), the company has entered a partnership with Nextec medical, a German company specializing in legal responsibility for medical devices under MDR.
As Legal Manufacturer, Nextec medical will be responsible for Redwood Pharma’s technical documentation and all the regulatory aspects of the RP501 product and will serve as a critical link to the regulatory Notified body. This partnership will ensure a robust, time and resource efficient way of reaching CE-mark and facilitate the market introduction of RP501.
Nextec medical GmbH is an EN ISO 13485:2016 certified company. With over 25 years of experience in medical device regulatory affairs, the company is a trusted partner of choice when it comes to acting as Legal Manufacturer or European Authorised Representative as well as Contract Developer for Medical Device Software with or without the use of Artificial Intelligence. Nextec is part of a solid and well-established regulatory company group, initially founded in 1994 by Dr. Regenold. The company’s regulatory affairs experts can look back up to 20-40 years of experience and +1000 products supported.
“This is an important partnership to secure that we will meet all regulatory requirements in the upcoming activities and future marketing of RP501. With this support in place, we can focus on maximizing the commercial potential and prepare for a market introduction in Europe. RP501 has the potential to help millions of Europeans suffering from mild, but still debilitating, dry eye disease,” comments Martin Vidaeus, CEO of Redwood Pharma.
This disclosure contains information that Redwood Pharma is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on December 15 2022.
For further information
Martin Vidaeus – CEO, Phone: +46 70-232 29 29
Email: martin.vidaeus@redwoodpharma.com
About Redwood Pharma
Redwood Pharma AB (publ) (Nasdaq First North Growth Market: REDW) is developing next-generation treatments for dry eye disease. More than 300 million people suffer from dry eyes and today’s standard treatment provides only temporary relief and may need to be applied up to ten times a day. Redwood Pharma’s development projects are based on IntelliGel – a proprietary and unique formulation of polymers and water that has the consistency of a water when dropped into the eye, where it immediately forms a viscous, protective and lubricating film that stays on for an extended period of time. The company currently has two development projects: RP501 as a readily available medical device for the treatment of mild dry eye disease, and the drug candidate RP101 containing estrogen for the treatment of postmenopausal dry eye disease in women. The company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, Sweden (+46 8 463 80 00, certifiedadviser@penser.se). For more information, please visit www.redwoodpharma.se
2022-12-15