24.04.2024 07:00:37 - dpa-AFX: EQS-Adhoc: Kuros reports Corporate Highlights as of Q1 2024 including increase in direct MagnetOsTM sales (english)

Kuros reports Corporate Highlights as of Q1 2024 including increase in
direct MagnetOsTM sales


   Kuros Biosciences AG / Key word(s): Quarter Results/Regulatory
   Approval
   Kuros reports Corporate Highlights as of Q1 2024 including
   increase in direct MagnetOsTM sales
   24-Apr-2024 / 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.
     ____________________________________________________________


   
   Financial Highlights
     * Direct MagnetOs sales rose by 155% to CHF 13.9 million in Q1
       2024 from CHF 5.4 million in Q1 2023; this corresponds to a
       sequential increase of 21.9% or CHF 2.5 million over Q4 2023
     * Total Kuros Medical Devices segment sales accelerated to CHF
       13.9 million in Q1 2024 from CHF 5.6 million in Q1 2023
     * Kuros Medical Devices segment achieved a positive EBITDA of
       CHF 3.9 million in Q1 2024 compared to CHF 0.5 million in Q1
       2023
     * Cash and cash equivalents amounted to CHF 13.7 million, funds
       available (including trade and other receivables) totaled CHF
       23.5 million as of March 31, 2024


   Regulatory, Clinical & Commercial Highlights
     * MagnetOs Putty is the fourth product in the MagnetOs
       portfolio to receive FDA 510(k) clearance to market for
       interbody use
     * A recently published independent clinical study utilizing
       MagnetOs Putty in lumbar interbody fusion procedures
       demonstrated 86% fusion rate, which included 49% of study
       subjects in a high-risk patient cohort
     * G. Joseph (Joe) Ross appointed as Senior Vice President
       Marketing and Business Development, expanding the Kuros
       Leadership Team and providing significant industry experience


   Schlieren (Zurich), Switzerland, April 24, 2024 - Kuros
   Biosciences ("Kuros"), a leader in advanced bone healing
   technologies, today announced its financial performance for the
   first quarter of 2024. Direct sales of MagnetOs rose 155% in the
   first three months of 2024, to CHF 13.9 million from CHF 5.4
   million, compared to the same period in 2023. Total product sales
   from all Kuros Medical Devices were CHF 13.9 million in Q1 2024,
   compared to CHF 5.6 million in Q1 2023. MagnetOs overachieved its
   commercial plan in the first quarter of 2024, and the overall
   Kuros Medical Devices segment achieved a positive EBITDA of CHF
   3.9 million in Q1 2024 compared to CHF 0.5 million in Q1 2023.


   Kuros announced 510(k) clearance from the U.S. Food and Drug
   Administration (FDA) for interbody use with MagnetOs Putty.*
   This significant milestone marks the fourth product from Kuros to
   receive 510(k) clearance for interbody use, showcasing a notable
   achievement in the pursuit to deliver advanced innovations for
   bone healing across broad indications.


   Kuros also reported the recent publication of an
   investigator-initiated clinical study that demonstrated the
   clinical application of MagnetOs Putty for lumbar interbody use.
   In the study, 63 subjects received MagnetOs for lumbar interbody
   fusion (ALIF/LLIF) with posterior instrumentation demonstrating
   86% fusion at 12 months as shown by fine-cut CTs. With 49% of
   patients having three or more comorbidities including heart
   disease, obesity and previous lumbar surgery, this study reveals
   high fusion rates with MagnetOs even in challenging high-risk
   populations.^1


   Kuros recently added to the Leadership Team naming Joe Ross as
   Senior Vice President of Marketing and Business Development.
   "With more than two decades of device and biologics experience in
   both public and private companies, this addition further
   strengthens our ability to continue to meet or exceed our
   objectives, and to increase access to Kuros technology for
   surgeons and their patients," mentioned Chris Fair, CEO of Kuros
   Biosciences.


   "We are extremely pleased with the Q1 performance. We experienced
   a strong 155% increase in direct MagnetOs sales coupled with
   another FDA 510(k) clearance for MagnetOs Putty and yet more data
   to support its superior performance," stated Fair. "In addition,
   the approximately 22% sequential revenue increase quarter over
   quarter is worth noting, particularly given that traditionally we
   see this time period as flat due to the high procedure volumes
   seen domestically in Q4," Fair continued. "The accelerated growth
   in revenue, incremental regulatory clearance and additional
   MagnetOs clinical publication further bolster our position as an
   emerging leader in advanced bone healing technologies."


   For further information, please contact:
   Kuros Biosciences AG
   Daniel Geiger
   Chief Financial Officer
   Tel: +41 44 733 47 47
   daniel.geiger@kurosbio.com LifeSci Advisors
   Sandya von der Weid
   Investor Relations
   +41 78 680 0538
   svonderweid@lifesciadvisors.com


   About MagnetOs
   MagnetOs is a bone graft like no other: thanks to its
   NeedleGrip^TM surface technology, it grows bone even in soft
   tissues. This surface technology 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
   predictable fusion. ^2-6§


   Indications statement
   Please refer to the instructions for use for your local region
   for a full list of indications, contraindications, warnings, and
   precautions.


   About Kuros Biosciences
   Kuros Biosciences is on a mission to discover, develop and
   deliver innovative biologic fusion technologies. 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^TM, is a unique advanced bone graft
   that has already been used across three continents in 25,000
   fusion surgeries. 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. Nunley, et al. Cureus. 2024; 16(4): e58218.
   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.
   5. Van Dijk, et al. JOR Spine. 2018; e1039
   6. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater.


   *When used in intervertebral body fusion procedures, MagnetOs
   must also be used with an intervertebral body fusion device
   cleared by the FDA for use with a bone void filler.
   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.


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   End of Inside Information
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   Language:    English
   Company:     Kuros Biosciences AG
                Wagistrasse 25
                8952 Schlieren
                Switzerland
   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: 1887029



   End of Announcement EQS News Service
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1887029 24-Apr-2024 CET/CEST

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