Tele: 561.316.3330
Breaking Medical Device News

Tuesday, September 21, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeMedCisionAthersys Partnering With MedCision on High-Volume ThawSTAR Cell Thawing Systems for Use in Clinical Trials

Athersys Partnering With MedCision on High-Volume ThawSTAR Cell Thawing Systems for Use in Clinical Trials

 

Companies collaborating on 6 mL AT-Closed Vial and a larger-scale cell thawing solution

“The use of the ThawSTAR Cell Thawing System allows us to remove variability and subjectivity associated with traditional methods,” stated Gil Van Bokkelen, Chairman and CEO of Athersys. “Together, our companies plan to implement a novel cell thawing solution for use in future trials, including automated thawing of larger-volume vials for indications where IV delivery is appropriate.”

MedCision, LLC., (automation of cell thawing), and Athersys, Inc., (clinical-stage biotechnology company developing proprietary cell therapies), announce the formation of a strategic partnership to include the use of the ThawSTAR® Cell Thawing System in Athersys’ clinical trials.

In the first stage of the partnership, Athersys adopted MedCision’s ThawSTAR AT6 Transport and Thawing System for 6 mL AT-Closed Vial® (Aseptic Technologies S.A.) to de-risk the cell thawing process and optimize cell efficacy in their Phase 2 trial using MultiStem® cell therapy to treat subjects with Non-ST Elevation Acute Myocardial Infarction (NSTEMI).

“The use of the ThawSTAR Cell Thawing System allows us to remove variability and subjectivity associated with traditional methods,” stated Gil Van Bokkelen, Chairman and CEO of Athersys. “Together, our companies plan to implement a novel cell thawing solution for use in future trials, including automated thawing of larger-volume vials for indications where IV delivery is appropriate.”

Large-volume cell thawing is particularly challenging because considerations must be given to osmotic imbalances, thermal gradients and varying intra-vessel phase states. An industry first, MedCision’s proprietary cell thawing technology is able to overcome these biophysical challenges and ultimately ensure that optimal, post-thaw cell health and efficacy is achieved.

“Thawing is a vital and frequently overlooked step in the cold chain,” said Rolf O. Ehrhardt, MD, Ph.D., MedCision CEO. “The ThawSTAR high-volume system is an automated and reproducible thawing platform that will allow Athersys to improve the overall handling of its cell therapies and further ensure the high quality and integrity of its investigational cell-based product.”

The proprietary ThawSTAR thawing system for 6 mL AT-Closed Vials has been recently launched and utilizes a novel adaptive algorithm specific to each unique cell therapy product. The algorithm operates on an understanding that cell size, volume and choice of cryopreservative affect the thawing rate needed to preserve optimal function in a given cell type. Additionally, the algorithm customizes the thaw for each fill volume, ensuring consistent and reproducible endpoints. Vials can be inserted directly from liquid nitrogen storage (below -150°C) or dry ice/ultra-low freezer storage (-80°C).

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

FDA Authorizes Software that Can Help Identify Prostate Cancer

The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.

Shannon Lantzy MedCrypt New VP of Consulting

"I met Shannon at a healthcare-related event several years ago and was immediately impressed with her passion and drive to move healthcare into a digital future," said Mike Kijewski, CEO of MedCrypt.

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

By using this website you agree to accept Medical Device News Magazine Privacy Policy