Kuros Biosciences’s MagnetOs Flex Matrix Cleared by FDA for Spinal Indications

Kuros Biosciences AG / Key word(s): Miscellaneous

21-Apr-2022 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

• Clearance as a bone void filler for use in the posterolateral spine
• Third FDA clearance for MagnetOs in the last 7 months
• Product provides opportunity to de-risk U.S. commercialization plans

Schlieren (Zurich), Switzerland, April 21, 2022 - Kuros Biosciences ('Kuros' or the 'Company'), a leader in next generation bone graft technologies, announced today that its MagnetOs Flex Matrix has been cleared by the U.S. Food and Drug Administration (FDA) as a bone void filler for use in the posterolateral spine.

MagnetOs Flex Matrix is a new open matrix bone graft with a unique fibrillar and flexible structure that optimizes the effect of Kuros' established pro-healing NeedleGripTM surface technology for more predictable fusion. U.S. spine surgeons routinely mix their bone graft of choice with bone marrow aspirate and the MagnetOs Flex Matrix allows them to reap the benefits of MagnetOs' NeedleGripTM surface technology while continuing with their routine perioperative practice.

The clearance of MagnetOs Flex Matrix is the third new FDA clearance for the MagnetOs product family within the last 7 months and follows existing FDA clearances for the use of MagnetOs Granules, MagnetOs Putty and MagnetOs Easypack Putty in the spine.

Joost de Bruijn, Chief Executive Officer of Kuros, said: 'This latest clearance of a MagnetOs product rounds out the MagnetOs product family, giving us solutions to meet user needs in most perioperative surgical scenarios in posterolateral fusion and we are pleased to demonstrate again to our investors our success in achieving our strategic goals. It gives us the chance to de-risk our commercialization plans in the U.S. by targeting spine surgeons who mix their bone graft with bone marrow aspirate. It further also allows us to re-engage with surgeons who have previously indicated they are interested in the science of MagnetOs but have not so far used our products based on their handling properties.'

MagnetOs Flex Matrix is convenient to use with excellent granule retention. It has extremely high wickability and absorbs up to ten times as much BMA as other bone grafts, with the potential to deliver even greater bone healing1. It remains strong but flexible even when wet so it can be torn, molded and folded to fill bony spaces in any way required.

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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.*†‡2-4

U.S. Indications Statement

MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., posterolateral spine. In the posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate and used as an extender to autograft bone. The osseous defects may be surgically created or the result of traumatic injury to the bone that are not intrinsic to the stability of the bony structure. MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.

About Kuros Biosciences

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 over 5,000 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.

1. Data on file

2. Van Dijk, et al. eCM. 2021;41:756-73

3. Duan, et al. eCM. 2019;37:60-73

4. Van Dijk, et al. Clin Spine Surg. 2020;33(6):E276-E287

*Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com.

†MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.

‡MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.