Thermo Fisher Scientific and University of California, San Francisco to Open Cell Therapy cGMP Manufacturing and Collaboration Center

- Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and the University of California, San Francisco (UCSF) today announced they have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies.

This is an aerial of the UCSF Mission Bay Campus. Credit: Matt Beardsley/UCSF (PRNewsfoto/Thermo Fisher Scientific)

Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, state-of-the-art cell therapy development, manufacturing and collaboration center in leased space on UCSF's Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support, to UCSF and other partners.

Expected to open in 2022, the facility will also serve as a central location where customers and UCSF researchers will have access to Thermo Fisher's broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, and fit-for-purpose instrumentation and compliant software. The CTS product portfolio is designed to work together, and seamlessly transition from research to clinical manufacturing to address cell therapy production workflow challenges.

"We are bringing together UCSF's leadership in the newest forms of cellular immunotherapy and Thermo Fisher's extensive capabilities in cell therapy instrumentation, manufacturing and distribution," said Mark Stevenson , executive vice president and chief operating officer of Thermo Fisher Scientific. "This powerful combination will provide customers – from emerging biotechs to large pharma companies – with integrated, end-to-end solutions to reduce costs and accelerate adoption of cell therapies, ultimately improving patient access to these transformative treatments."

Sam Hawgood , MBBS, chancellor of UCSF, said, "We expect breakthrough treatments for many different diseases and conditions to come from cell therapies. Establishing cell therapy manufacturing in such close proximity to our scientists, clinicians and patients will enable UCSF to catalyze innovation in living therapeutics and use the resulting discoveries to benefit our patients."

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion . Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

About UCSF

The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes UCSF Health, which comprises three top-ranked hospitals, as well as affiliations throughout the Bay Area. Learn more at https://www.ucsf.edu , or see our Fact Sheet .

About Innovation Ventures:

Innovation Ventures helps to translate the inventions of UCSF faculty into commercial offerings that can benefit patients. Supporting the development of these discoveries into more fully developed product candidates gives them a greater chance of success and brings greater value to the university.

Thermo Fisher Scientific logo (PRNewsfoto/Thermo Fisher Scientific)

UCSF logo (PRNewsfoto/Thermo Fisher Scientific)

Media Contact Information:
Ron O'Brien
Thermo Fisher Scientific
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com

Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone:  781-622-1356
E-mail: rafael.tejada@thermofisher.com

Laura Kurtzman
UCSF
Phone: 415-317-3760
Email: Laura.Kurtzman@ucsf.edu

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SOURCE Thermo Fisher Scientific

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

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