NOTTINGHAM, UK – May 2, 2012 – Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that its recombinant human albumin (rAlbumin), Albucult®, is being used by Neomend in the company’s Progel® Adhesion Barrier Sealant product which has recently received the European Union CE mark. Albucult, used as a key component in medical device applications, helps to facilitate regulatory compliance and enables a faster time to market due to its stable, safe and animal-free composition. The product’s high purity can help manufacturers manage and reduce both commercial and regulatory risk where source variability and safety profile are important considerations in the commercialization of drug and medical device products.
David Renzi, Neomend’s President and CEO, comments: “Novozymes has an extensive understanding of the regulatory pressures its customers are facing and its quality-assured, consistent biopharmaceutical components make the company an ideal partner for Neomend. The Progel Adhesion Barrier Sealant CE mark is a vital milestone as it will enable us to help surgeons in Europe effectively prevent adhesions and its associated complications.”
Neomend uses Novozymes’ Albucult in its Progel Adhesion Barrier Sealant, a product that has been developed as a hydrogel adhesion barrier sealant that can be sprayed onto general visceral organs during open and laparoscopic surgery to help prevent post-operative adhesions. The addition of a CE mark will help Neomend to expand the distribution of its latest sealant across Europe. This is the second Neomend sealant that incorporates Albucult with the product already being used successfully in the company’s ProGEL® PLATINUM surgical sealant.
“Novozymes is delighted that Albucult is being used as a key component in another CE marked medical device”, says Dermot Pearson, Marketing Director, Novozymes Biopharma. “It is a testament to the unique advantages conferred by the product and demonstrates our commitment to supporting customers throughout their regulatory process. We have a dedicated regulatory affairs team that monitors regulatory changes and trends, while working closely with relevant trade organizations to offer customers current, fast and efficient support for product registration.”
The use of Albucult as a key ingredient in medical devices offers a range of performance and quality benefits for medical applications not possible with animal-derived ingredients including an exceptional purity profile and sustainability of supply. Novozymes’ Albucult also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative.
To learn more about Novozymes’ Albucult, please visit www.biopharma.novozymes.com.
To find out more about Neomend, please visit www.neomend.com
About Neomend, Inc.
Neomend, based in Irvine, California, is a private company focused on the design, development and commercialization of surgical sealants and adhesion prevention products derived from the ProGEL technology platform. The company has a direct sales force of 30 people in the U.S. and holds 29 issued U.S. patents in chemical composition and delivery applicators. For more information, visit www.Neomend.com or call 949-916-1630.
Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries, we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources.
With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace. Read more at www.novozymes.com.