Industry Insider News

Stryker Corp. to acquire Novadaq Technologies

Medical technologies firm Stryker Corp. has agreed to acquire Novadaq Technologies for about $701 million, Novadaq announced on Monday. Novadaq is a medical imaging solutions company. The deal is for all of the issued and outstanding shares of Novadaq, priced at $11.75, about 95.8% over the Friday closing price. The deal is pending approval of a number of groups, including Novadaq shareholders, who will have a special meeting on or about Aug. 4, 2017. Novadaq shares are halted in Monday premarket trading until 8:30 am. The company's stock is down more than 36% for the past year while the S&P 500 index SPX, -0.86% is up 17.5% for the period.

Organogenesis Attends Future Cell Therapy Summit

CANTON, Mass., June 26, 2017 /PRNewswire/ -- Cell therapy scientists, researchers and product developers will learn about advanced rapid sterility detection techniques employed by Organogenesis Inc. at the Future Cell Therapy Commercialization Summit held June 26-28 in Boston, Massachusetts. The summit brings together leading industrial cell therapy experts to discover, debate and discuss how to successfully commercialize personalized cell therapies. 

Zorina Pitkin, PhD, Senior Vice President of Quality for Organogenesis, will deliver a presentation titled, "Rapid sterility test method for an allogeneic cell-based therapy product" that will review challenges to ensure microbiological safety for cell-based products, highlight advantages of rapid sterility test methods for cell therapies, and describe an approach to rapid sterility method validation.

The presentation will also focus on best practices and lessons learned through the implementation of a rapid sterility test method for Apligraf®, a cell-based commercial product from Organogenesis. Apligraf is an FDA-approved Class III medical device indicated for the treatment of diabetic foot ulcers and venous leg ulcers.

"Ensuring sterility for a cell-based therapy can be challenging as the time required to perform a conventional sterility test may exceed the product's shelf life," said Pitkin. "As companies strive to adopt these new technologies, they must ensure through validation that these new rapid detection technologies are appropriate for their intended use and are capable of maintaining a high level of sterility assurance that is at least equivalent to the conventional 14-day USP sterility method."

Pitkin has more than 20 years of experience in the field of biotechnology, including the development of Quality System programs for autologous and allogeneic cellular therapies, biologic/device combination products, and for xenotransplantation.  Pitkin holds a Ph.D. in Biological Sciences from the Research Institute of Influenza, Russian Academy of Medical Sciences, and is Regulatory Affairs certified.