Kuros Biosciences Announces Peer-Reviewed Publication Of MagnetOs MAXA Level 1 Study Outcomes in Spine, Indicating Superiority Over Autograft
Kuros Biosciences Announces Peer-Reviewed Publication Of MagnetOs MAXA Level 1 Study Outcomes in Spine, Indicating Superiority Over Autograft
ZURICH, SWITZERLAND / ACCESSWIRE / June 25, 2024 / Kuros Biosciences, a leader in next generation bone healing technologies, today announced the publication of a peer-reviewed manuscript that details the clinical data of its MAXA Level 1 prospective, multi-center, randomized, intra-patient controlled clinical study in Spine 1 .
瑞士蘇黎世/ACCESSWIRE/2024 年 6 月 25 日/下一代骨癒合技術的領導者 Kuros Biosciences 今天宣佈發佈了一份經過同行評審的手稿,該手稿詳細介紹了其 MAXA 1 級前瞻性、多中心、隨機、患者內部對照的脊柱臨床研究的臨床數據 1 。
Published clinical results of "Efficacy of Biphasic Calcium Phosphate Ceramic with a Needle-shaped Surface Topography Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Randomized Trial" include fusion data on 91 patients and 128 segments with 1-year follow-up after surgery. As previously reported and now detailed in the peer-reviewed publication, the data demonstrates:
已發表的 “具有針狀表面地形的雙相磷酸鈣陶瓷與自體移植在儀器化後外側脊柱融合術中的療效:一項隨機試驗” 的臨床結果包括91名患者和128個分段的融合數據,術後爲期1年的隨訪。正如先前報道的,現在在同行評審的出版物中詳細介紹的那樣,數據表明:
- MagnetOs TM effectiveness as a standalone* alternative to autograft in challenging posterolateral fusions (PLF);
- Nearly double the fusion rate as compared to autograft in PLF, showing a 79% overall fusion rate with MagnetOs as independently measured with fine-cut CT, compared to 47% for autograft, which included difficult-to-treat patients of current and former smokers (n=19 and 35 respectively); and
- Noninferiority of MagnetOs versus autograft per study design, with primary outcome analysis even indicating MagnetOs superiority.
- MagnetOS TM 在具有挑戰性的後外側融合(PLF)中,作爲自體移植的獨立*替代方案的有效性;
- 與PLF中的自體移植相比,融合率幾乎是自體移植的兩倍,使用精細的Ct進行獨立測量,MagnetOS的總融合率爲79%,而自體移植的融合率爲47%,其中包括當前和以前吸菸者的難以治療的患者(分別爲19和35);以及
- 每項研究設計的MagnetOS與自體移植相比不遜色,主要結果分析甚至表明了MagnetOS的優越性。
"We are extremely pleased to share the results of the MAXA study with the medical community," said Moyo C. Kruyt, MD, PhD, lead researcher in the MAXA study. "The MAXA study demonstrates for the first time that an advanced synthetic bone substitute likely performs better than the current gold standard autograft in a challenging posterolateral fusion location."
MAXA研究的首席研究員莫約·克魯伊特醫學博士、博士說:“我們非常高興與醫學界分享MAXA研究的結果。”“MAXA的研究首次表明,在具有挑戰性的後外側融合部位中,先進的合成骨替代品可能比目前的金標準自體移植效果更好。”
Chris Fair, Chief Executive Officer of Kuros, said, "Kuros is committed to supporting clinical research and providing evidence-based solutions for next generation bone healing technologies. This study's acceptance and publication in Spine is proof of that commitment." Fair continued, "We commend Professor Kruyt and his team for their independent efforts and their desire to provide the spine community and their patients with a robust level 1 study that supports the use of MagnetOs for difficult to treat patients and highlights a viable alternative to autograft."
Kuros首席執行官克里斯·費爾表示:“Kuros致力於支持臨床研究,爲下一代骨癒合技術提供循證解決方案。這項研究的接受並在Spine上發表,證明了這一承諾。”費爾繼續說:“我們讚揚克魯伊特教授及其團隊所做的獨立努力,以及他們希望爲脊柱界及其患者提供一項強有力的1級研究,該研究支持對難以治療的患者使用MagnetOS,並強調自體移植的可行替代方案。”
The publication, which includes additional details such as study design, patient demographics, inclusion/exclusion criteria, and complications reported in the study, can be accessed on the Spine website and is also available on the Kuros Biosciences website.
該出版物包括研究設計、患者人口統計、納入/排除標準以及研究中報告的併發症等其他細節,可以在Spine網站上訪問,也可以在Kuros Biosciences網站上查閱。
1. Stempels, H. et al., "Efficacy of biphasic calcium phosphate ceramic with a needle-shaped surface topography versus autograft in instrumented posterolateral spinal fusion: A randomized trial." Spine. June 17, 2024.
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.
*MagnetOs was mixed with venous blood
†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.
1。Stempels,H. 等人,“具有針狀表面地形的雙相磷酸鈣陶瓷與自體移植在儀器化後外側脊柱融合術中的功效:一項隨機試驗。”脊柱。2024 年 6 月 17 日。
2。Van Dijk 等人。eCM. 2021;41:756-73。
3.段等。eCM. 2019;37:60-73。
4。範·迪克,等臨床脊柱外科。2020;33 (6):E276-E287。
5。範·迪克,等JOR Spine。2018;e1039
6。範·迪克,等。J Biomed Mater Res.B 部分:Appl Biomater。
*MagnetoS 與靜脈血混合
†體內實驗室測試的結果可能無法預測人類的臨床經驗。有關重要的安全和預期用途信息,請訪問 kurosbio.com。
‡ Magnetos 未被美國食品藥品管理局或 TGA 批准爲骨誘導性骨移植物。
在綿羊後外側融合模型中,事實證明,與兩種市售替代方案相比,MagnetOS能夠產生更可預測的融合。
About the MAXA Trial
關於 MAXA 試用版
The MAXA study is a 100-patient multicenter, observer blinded, randomized, intra-patient controlled, non-inferiority trial with intra-patient comparisons. Adult patients qualifying for instrumented posterolateral spinal fusion of one to six levels in the thoracolumbar and lumbosacral region (T10-S2) with the use of autograft were included and posterolateral lumbar/thoracolumbar fusion was assessed by fine-cut CT-scan 12 months after surgery. According to a randomization scheme, MagnetOs was implanted on one side of the spine and the gold standard autograft (consisting of at least 50% bone harvested from the iliac crest mixed with local bone) was implanted on the other side of the spine. The investigators were blinded to the side assigned to the grafts until just prior to graft application. Thereby, each patient serves as its own control. More details can be found at (NCT03625544). Fusion performance of MagnetOs was tested with a noninferiority margin of 15%.
MAXA研究是一項100名患者的多中心、觀察者盲視、隨機、患者內部對照、非劣勢試驗,採用患者內部比較。符合使用自體移植術在胸腰椎和腰骶部位進行一至六個水平的儀器化後外側脊柱融合術(T10-S2)的成年患者包括在內,並在手術12個月後通過精細的CT掃描對後外側腰椎/胸腰椎融合術進行了評估。根據隨機分組方案,將MagnetOS植入脊柱的一側,金標準自體移植體(由至少50%的骨頭從骶骨中採集的骨頭與局部骨頭混合而成)被植入脊柱的另一側。直到移植申請之前,調查人員才對分配給移植物的一側失明。因此,每位患者都是自己的控制者。更多細節可以在以下網址找到 (NCT03625544)。測試了MagnetOS的融合性能,非劣勢範圍爲15%。
The MAXA clinical trial was funded via an unrestricted research grant from Kuros Biosciences. Unrestricted research grants provide funding to clinical investigators with an interest in advancing the knowledge and understanding of certain technologies. These grants are donations in the form of flexible funding that can be directed toward whatever program, project, or expense the investigator chooses.
MAXA臨床試驗由Kuros Biosciences的無限制研究撥款資助。無限制的研究補助金爲有興趣提高對某些技術的知識和理解的臨床研究人員提供資金。這些補助金是以靈活資金形式提供的捐款,可以用於調查人員選擇的任何計劃、項目或費用。
About 'Spine'
關於 “Spine”
As the leading international journal in spine surgery, Spine publishes high-impact, peer-reviewed original research manuscripts. Spine is one of the top referenced journals in the field and is recognized for featuring new technology and innovative procedures and techniques.
作爲脊柱外科領域領先的國際期刊,Spine出版了具有高影響力、經過同行評審的原創研究手稿。Spine 是該領域引用率最高的期刊之一,因其以新技術和創新的程序和技術爲特色的期刊而受到認可。
About MagnetOs
關於 MagnetOS
MagnetOs is a bone graft like no other: thanks to its NeedleGrip TM surface technology, it enables bone formation without added cells or growth factors. 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†‡§
MagnetOS 是一款與衆不同的骨移植物:這要歸功於它的 NeedleGrip TM 表面技術,它可以在不添加細胞或生長因子的情況下形成骨骼。這種表面技術爲我們身體至關重要的 “促癒合” 免疫細胞(M2 巨噬細胞)提供牽引力。這反過來又釋放了以前尚未開發的刺激幹細胞的潛力,並在整個移植物中形成新骨骼。NeedleGrip 背後越來越多的科學體系被稱爲骨免疫學。但是對於外科醫生及其患者來說,這意味着一件事:更可預測的融合。 2-6†‡ §
Indications statement
適應症聲明
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.
有關適應症、禁忌症、警告和注意事項的完整列表,請參閱您所在地區的使用說明。
About Kuros Biosciences
關於 Kuros 生物科學
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 and its products, visit kurosbio.com.
Kuros Biosciences的使命是發現、開發和提供創新的生物融合技術。該公司在美國、瑞士和荷蘭設有分支機構,在瑞士證券交易所SIX上市。該公司的第一款商用產品MagnetOS TM ,是一種獨特的先進骨移植物,已在三大洲的25,000例融合手術中使用。有關該公司及其產品的更多信息,請訪問 kurosbio.com。
Forward Looking Statements
前瞻性陳述
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.
本新聞稿包含某些前瞻性陳述,這些陳述涉及風險和不確定性,可能導致實際業績與歷史業績或此類前瞻性陳述所表達或暗示的任何未來業績存在重大差異。我們敦促你將包含 “將” 或 “期望” 一詞或這些詞語的否定詞語或其他類似詞語的陳述視爲不確定和具有前瞻性的陳述。可能導致實際業績與任何前瞻性陳述所表達或暗示的任何未來業績存在重大差異的因素包括科學、商業、經濟和財務因素。在這些不確定性的背景下,讀者不應依賴前瞻性陳述。公司對更新前瞻性陳述或使其適應未來事件或事態發展不承擔任何責任。
For further information, please contact:
欲了解更多信息,請聯繫:
Kuros Biosciences AG Daniel Geiger Chief Financial Officer Tel +41 44 733 47 41 daniel.geiger@kurosbio.com |
Investors Gilmartin Group Vivian Cervantes Tel: +1 332.895.3220 vivian.cervantes@gilmartinir.com |
庫羅斯生物科學股份公司 丹尼爾·蓋格 首席財務官 電話 +41 44 733 47 41 daniel.geiger@kurosbio.com |
投資者 吉爾馬丁集團 薇薇安·塞萬提斯 電話:+1 332.895.3220 vivian.cervantes@gilmartinir.com |
SOURCE: Kuros Biosciences AG
來源:庫羅斯生物科學股份公司