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    KURN   CH0325814116


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Kuros Biosciences Announces FDA 510(k) Clearance for MagnetOs Easypack PuttyHeadline

09/09/2021 | 01:01am EDT

EQS Group-News: Kuros Biosciences AG / Key word(s): Miscellaneous Kuros Biosciences Announces FDA 510(k) Clearance for MagnetOs Easypack PuttyHeadline 2021-09-09 / 07:00


Schlieren (Zurich), Switzerland, 9 September, 2021 - Kuros Biosciences ('Kuros' or the 'Company'), a leader in next generation bone graft technologies, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for MagnetOs Easypack Putty, a soft and moldable formulation ideal for packing into voids of the skeletal system, particularly the posterolateral spine during spinal fusion surgery.

The clearance of MagnetOs Easypack Putty follows existing clearances by the FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.

Joost de Bruijn, Chief Executive Officer of Kuros, said: "The new formulation in the MagnetOs product family offers surgeons a broader set of options for perioperative properties. This latest successful regulatory milestone continues our track record of market clearances with the FDA and strengthens our position on the market. "

Human-derived products, such as cell-based allografts, and recombinant protein products, such as bone morphogenetic proteins, need to be stored in freezers and then carefully thawed under strict protocol prior to or during surgery.

To the benefit of surgeons and their patients, MagnetOs Easypack Putty is provided in an open-ended dispenser and is ready to use with no need for thawing or mixing with blood or bone marrow aspirate. It can be stored at room temperature and used immediately from the packaging, which can save Operating Room staff vital time during procedures.

For further information, please contact:

Kuros Biosciences AG         LifeSci Advisors 
Michael Grau                 Mary-Ann Chang 
Chief Financial Officer      Investors 
t: +41 44 733 47 47          t: +44 7483 284 853 
e: michael.grau@kurosbio.com e: mchang@lifesciadvisors.com 

About MagnetOs MagnetOs isn't like other bone grafts. It grows bone even in soft tissue thanks to its unique NeedleGrip surface technology which provides traction for our body's vitally important 'pro-healing' immune cells (M2 macrophages). This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more efficient and predictable fusion. Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. MagnetOs is not cleared by TGA or FDA as an osteoinductive bone graft.

US indications statement MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

About Kuros Biosciences AG Kuros Biosciences is a fast-growing leader in the development of spinal fusion biologics that ease the burden of back pain. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company's first commercial product, MagnetOs, is a unique synthetic bone graft that has already been used successfully across three continents and in some 4,000 spinal fusion surgeries. The next candidate in the Kuros pipeline is Fibrin-PTH - the first drug-biologic combination for interbody spinal fusions, currently undergoing a Phase 2 clinical trial in the US. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words 'will' or 'expect' or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.


End of Media Release


Language:     English 
Company:      Kuros Biosciences AG 
              Wagistrasse 25 
              8952 Schlieren 
Phone:        +41 44 733 4747 
Fax:          +41 44 733 4740 
E-mail:       info@kurosbio.com 
Internet:     www.kurosbio.com 
ISIN:         CH0325814116 
Valor:        32581411 
Listed:       SIX Swiss Exchange 
EQS News ID:  1232217 
End of News   EQS Group News Service 

1232217 2021-09-09

Image link: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1232217&application_name=news

(END) Dow Jones Newswires

September 09, 2021 01:00 ET (05:00 GMT)

09/28KUROS BIOSCIENCES : Press Release, 28 September 2021
09/28KUROS BIOSCIENCES : to showcase new MagnetOs products at NASS 2021 Annual Meeting
09/28KUROS BIOSCIENCES : to Showcase New MagnetOs Products at NASS 2021 Annual Meeting
09/28Kuros Biosciences to Showcase New Magnetos Products At Nass 2021 Annual Meeting
09/09KUROS BIOSCIENCES : Wins US FDA Clearance For Skeletal System Formulation
09/09KUROS BIOSCIENCES : Press Release, 9 September 2021
09/09Kuros Biosciences Announces FDA 510(k) Clearance for MagnetOs Easypack PuttyHeadline
09/09Kuros Biosciences Announces FDA 510(k) Clearance for MagnetOs Easypack PuttyHeadline
08/11KUROS BIOSCIENCES : Interim Results, 2021
08/11KUROS BIOSCIENCES : Narrows H1 Loss as Revenue Soars
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Sales 2020 4,04 M 4,41 M 4,41 M
Net income 2020 -11,5 M -12,6 M -12,6 M
Net cash 2020 26,0 M 28,3 M 28,3 M
P/E ratio 2020 -4,26x
Yield 2020 -
Capitalization 71,5 M 77,9 M 78,0 M
EV / Sales 2019 14,3x
EV / Sales 2020 9,97x
Nbr of Employees 51
Free-Float 78,8%
Duration : Period :
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Managers and Directors
Joost D. de Bruijn Chief Executive Officer & Director
Michael Grau Chief Financial Officer
Clemens A. van Blitterswijk Chairman
Pascal Longlade Chief Medical Officer
Jason M. Hannon Independent Non-Executive Director
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