Cerapedics宣布在美国首位患者接受PearlMatrix™ P-15肽增强骨移植治疗，此前已获FDA批准-动脉网

Cerapedics Announces First U.S. Patient Treated with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following FDA approval

CISION 等信源发布 2025-07-08 22:51



可切换为仅中文







AdventHealth Avista, an Orthopedic and Spine Center of Excellence, conducted the first lumbar fusion procedure with PearlMatrix Bone Graft, the first and only bone growth accelerator for lumbar fusion.

AdventHealth Avista，一家骨科和脊柱卓越中心，完成了首例使用PearlMatrix骨移植材料的腰椎融合手术，这是首个也是唯一一个用于腰椎融合的骨生长加速器。

WESTMINSTER, Colo.

科罗拉多州威斯敏斯特

，

July 8, 2025

2025年7月8日

/PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the successful completion of the first patient treated with PearlMatrix™ P-15 Peptide Enhanced Bone Graft following the recent U.S. Food and Drug Administration (FDA) approval.

/PRNewswire/ -- 全球商业化阶段的骨科公司Cerapedics Inc.致力于重新定义骨骼修复路径，今天宣布在近期获得美国食品药品监督管理局（FDA）批准后，已成功完成首位使用PearlMatrix™ P-15肽增强骨移植材料治疗的患者手术。

PearlMatrix Bone Graft is a Class III drug-device combination product for lumbar fusion. The first post-approval procedure on an adult patient with degenerative disc disease (DDD) was performed by neurosurgeon .

珍珠矩阵骨移植是一种用于腰椎融合的III类药械组合产品。首位接受该产品术后治疗的成年患者患有退行性椎间盘疾病（DDD），手术由神经外科医生完成。

Sharad Rajpal

沙拉德·拉杰帕尔

, M.D., Medical Director of the Advanced Spine Program at AdventHealth Avista in

，医学博士，AdventHealth Avista高级脊柱项目的医疗主任

Louisville, Colorado

路易斯维尔，科罗拉多州

。

继续阅读

(PRNewsfoto/Cerapedics Inc.)

PearlMatrix Bone Graft received

珍珠矩阵骨移植已收到

U.S. FDA premarket approval

美国FDA上市前批准

在

June 2025

2025年6月

and is the first and only bone growth accelerator proven to accelerate lumbar fusion based on data from the pivotal ASPIRE IDE study. Of the more than 350 spinal bone grafts in the U.S. market, Cerapedics has two of only three spinal bone grafts that have successfully gone through the PMA process.

并且是首个也是唯一一个基于关键的ASPIRE IDE研究数据证明可加速腰椎融合的骨生长加速器。在美国市场的350多种脊柱骨移植产品中，Cerapedics拥有仅有的三个成功通过PMA流程的脊柱骨移植产品中的两个。

'My goal is to bring my patients the most innovative and appropriate treatments specific to their needs, so they can regain their quality of life as soon as possible. I am proud to have performed the first post-approval procedure using PearlMatrix Bone Graft, a novel approach to treating degenerative disc disease,' said .

“我的目标是为患者带来最适合他们需求的最具创新性和适用性的治疗方法，以便他们能够尽快恢复生活质量。我自豪地完成了首个使用PearlMatrix骨移植材料的获批后手术，这是一种治疗退行性椎间盘疾病的新方法，”他说。

Sharad Rajpal M.D

夏拉德·拉杰帕尔医学博士

., FAANS, FCNS, with AHMG.* 'It's innovation like this that helps surgeons effectively treat patients, and it's particularly gratifying to be able to use a

., FAANS，FCNS，与AHMG.* “正是这样的创新帮助外科医生有效地治疗患者，能够使用这项技术尤其令人欣慰。

Colorado

科罗拉多州

innovation on a local resident.'

本地居民的创新。

TLIF is a complex surgical procedure aimed at reducing or eliminating pain in the lumbar spine as a result of degenerative disc disease by removing the damaged disc and then fusing the spinal vertebral bones above and below the damaged disc to create spinal stability, along with decompression of the affected nerves.

TLIF是一种复杂的外科手术，旨在通过移除受损的椎间盘并融合受损椎间盘上下方的脊椎骨来减少或消除因退行性椎间盘疾病引起的腰椎疼痛，同时减轻受影响神经的压力以恢复脊柱稳定性。

The fusion is achieved using a bone graft, which, over time, helps the vertebrae grow together to form one continuous bone..

融合是通过骨移植实现的，随着时间的推移，骨移植有助于椎体生长在一起，形成一块连续的骨头。

In 2023, an estimated 465,000 spinal fusion cases utilizing a bone graft replacement were performed in the U.S.

2023年，美国估计进行了465,000例使用骨移植替代物的脊柱融合手术。

Despite recent advances, spinal fusion procedures have become more complex due to an increase in the prevalence of patients with one or more risk factors.

尽管最近有所进展，但由于具有一个或多个风险因素的患者数量增加，脊柱融合手术变得更加复杂。

'This first surgery post-approval is a significant milestone for Cerapedics,' said

“这次批准后的首次手术是Cerapedics的一个重要里程碑，”

Valeska Schroeder

瓦莱斯卡·施罗德

, Chief Executive Officer of Cerapedics. 'Every single team member behind the development, approval, and distribution of PearlMatrix P-15 Peptide Enhanced Bone Graft worked tirelessly to get this unique drug-device into the hands of surgeons to help them safely and effectively treat their patients. We are proud of the innovation we bring to the market, and we look forward to seeing the positive impact of our devices.'.

Cerapedics首席执行官表示：“每一位参与PearlMatrix P-15肽增强骨移植材料的开发、审批和分销的团队成员都全力以赴，将这一独特的药械产品交到外科医生手中，以帮助他们安全有效地治疗患者。我们为带给市场的创新感到自豪，并期待看到我们的设备带来的积极影响。”

About PearlMatrix™ P-15 Peptide Enhanced Bone Graft

关于PearlMatrix™ P-15肽增强骨移植材料

PearlMatrix P-15 Peptide Enhanced Bone Graft is the first and only bone growth accelerator proven to accelerate lumbar fusion with demonstrated statistically superior fusion speed in single-level TLIF procedures. P-15 Peptide, the active component of PearlMatrix, provides a distinct and proven mechanism of action to attach and activate osteogenic cells to accelerate new bone formation.

珍珠矩阵P-15肽增强骨移植是首个且唯一被证实可加速腰椎融合的骨生长加速器，在单节段TLIF手术中展现出统计学上显著优越的融合速度。P-15肽作为珍珠矩阵的活性成分，提供了一种独特且经过验证的作用机制，能够附着并激活成骨细胞，从而加速新骨形成。

P-15 Peptide is a 15 amino-acid sequence found naturally in Type-1 collagen, the predominant protein in bone. It serves a crucial role in the bone regeneration process as a powerful cell attachment factor. Cerapedics' pharmaceutically manufactured P-15 Peptide is bound onto calcium phosphate particles, creating a P-15-enhanced scaffold that provides an abundance of attachment sites for osteogenic, bone-forming, cells.

P-15肽是天然存在于Ⅰ型胶原蛋白中的一种含15个氨基酸的序列，而Ⅰ型胶原蛋白是骨骼中的主要蛋白质。它在骨再生过程中作为强大的细胞附着因子发挥关键作用。Cerapedics公司通过制药工艺制造的P-15肽被结合到磷酸钙颗粒上，形成一种P-15增强型支架，为成骨、造骨细胞提供了大量的附着位点。

Cell attachment activates pathways that release cell-signaling growth factors and allow bone growth through natural cellular processes..

细胞附着激活释放细胞信号生长因子的途径，并通过自然的细胞过程促进骨生长。

Indications for use

使用指征

PearlMatrix™ Bone Graft is indicated for intervertebral body fusion of the spine in skeletally mature patients. PearlMatrix is intended to be used in conjunction with a PEEK TLIF Fusion Device and supplemental internal spinal fixation systems cleared by the FDA for use in the lumbosacral spine. The system is to be used in patients who have had at least six months of non-operative treatment.

PearlMatrix™ 骨移植材料适用于骨骼成熟的患者进行脊柱椎体间融合。PearlMatrix 旨在与经 FDA 批准的 PEEK TLIF 融合装置和补充性内部脊柱固定系统联合使用，用于腰骶椎部位。该系统适用于已接受至少六个月非手术治疗的患者。

PearlMatrix is intended for use at one level in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back and/or radicular pain of discogenic origin with degeneration of the disc confirmed by history, physical exam, and radiographic studies..

PearlMatrix 适用于腰椎 (L2-S1) 某一水平的治疗，用于治疗退行性椎间盘疾病 (DDD)，且伴有最高 I 级的脊椎滑脱。DDD 的定义是：由椎间盘退化引起的背部和/或神经根性疼痛，并通过病史、体格检查和影像学研究确认椎间盘退化。

PearlMatrix is contraindicated in situations where there is an absence of load-bearing structural support at the graft site, sensitivity to components or the product, active infection at the operative site, or an operative site subject to excessive impact or stress.

珍珠矩阵在以下情况下禁用：移植部位缺乏承重结构支撑、对成分或产品敏感、手术部位有活动性感染，或手术部位受到过度冲击或压力。

The effect of PearlMatrix on pregnant or nursing patients has not been evaluated. Care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure such as individuals with bleeding disorders of any etiology, long-term steroidal therapy, immunosuppressive therapy or high dosage radiation therapy.

尚未评估珍珠基质对孕妇或哺乳期患者的影响。在治疗可能影响手术成功的原有疾病的个体时应谨慎，例如任何病因的出血性疾病、长期类固醇治疗、免疫抑制治疗或高剂量放射治疗的个体。

PearlMatrix in a TLIF procedure was associated with a higher rate of secondary surgical interventions compared to local autograft..

在TLIF手术中，与局部自体移植物相比，使用PearlMatrix与较高的二次手术干预率相关。

PearlMatrix should only be used by physicians who are experienced with TLIF procedures and in surgical procedures where it can be adequately contained at the bony void or defect.

PearlMatrix 应仅由熟悉 TLIF 手术程序的医生使用，并且在可以将其充分容纳于骨缺损或缺陷的外科手术中使用。

To learn more about PearlMatrix, its indications, contraindications, warnings, precautions and potential adverse events, visit our website at

要了解更多关于PearlMatrix的信息，包括其适应症、禁忌症、警告、注意事项以及潜在的不良事件，请访问我们的网站

www.Cerapedics.com

or refer to the PearlMatrix Instructions for Use for complete safety and risk information.

或查阅 PearlMatrix 使用说明书以获取完整的安全和风险信息。

About Cerapedics

关于Cerapedics

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide.

Cerapedics是一家全球性的商业阶段骨科公司，致力于通过更快、更高效的骨愈合重新定义骨修复的路径，使所有患者都能恢复到最充实的生活状态。骨移植材料，包括Cerapedics的产品，每年在全球范围内用于超过四百万例脊柱、骨科、创伤及介入手术。

Cerapedics has two products approved by the FDA: PearlMatrix™ Bone Graft for single-level transforaminal lumbar interbody fusion (TLIF) in the lumbar spine and i-FACTOR.

Cerapedics有两种产品获得FDA批准：用于腰椎单节段经椎间孔腰椎椎体间融合术（TLIF）的PearlMatrix™骨移植材料和i-FACTOR。

Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in

用于单节段颈椎前路椎间盘切除融合术（ACDF）的骨移植。Cerapedics 总部位于

Westminster

威斯敏斯特

, CO.

，二氧化碳。

For more information, visit us at

欲了解更多信息，请访问我们

www.cerapedics.com

and follow us on

关注我们