/PRNewswire/ -- Cerapedics Inc., a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair, today announced the U.S. Food and Drug Administration (FDA) premarket approval (PMA) of PearlMatrix™ P-15 Peptide Enhanced Bone Graft as a Class III drug-device combination product for use in single-level transforaminal lumbar interbody fusion (TLIF) surgery in adult patients with degenerative disc disease (DDD).

/PRNewswire/ -- 全球商业化骨科公司Cerapedics Inc.致力于重新定义骨修复路径，今天宣布美国食品药品监督管理局（FDA）已对PearlMatrix™ P-15肽增强骨移植产品给予上市前批准（PMA），该产品被归类为III类药械组合产品，用于成人退行性椎间盘疾病（DDD）患者的单节段经椎间孔腰椎椎体间融合术（TLIF）。

Despite the availability of over 350+ spinal bone grafts, none have demonstrated a substantial improvement in fusion speed until now. Powered by a proprietary P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator (BGA) proven to accelerate lumbar fusion..

尽管有350多种脊柱骨移植材料可用，但迄今为止，没有任何一种材料显示出在融合速度上有显著改善。PearlMatrix骨移植材料凭借其专有的P-15成骨细胞结合肽，是首款且唯一被证实能够加速腰椎融合的骨生长加速器（BGA）。

PearlMatrix P-15 Peptide Enhanced Bone Graft, the first and only bone growth accelerator

珍珠矩阵P-15肽增强骨移植材料，首个且唯一的骨生长加速器

TLIF is a complex surgical procedure aiming to reduce or eliminate pain in the lumbar spine because of degenerative disc disease (DDD) by removing a damaged disc and then uniting (fusing) the spinal vertebral bones above and below the damaged disc to create spinal stability along with decompression of the spine.

TLIF是一种复杂的外科手术，旨在通过移除受损的椎间盘，然后将受损椎间盘上下方的脊椎骨融合在一起，以减少或消除因退行性椎间盘疾病（DDD）引起的腰椎疼痛，同时实现脊柱的稳定和减压。

The fusion is achieved using a bone graft which, over time, grows together with the vertebrae to form one bone..

融合是通过骨移植实现的，随着时间的推移，骨移植与椎骨一起生长，形成一块骨头。

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

2023年，美国进行了大约465,000例使用骨移植替代物的脊柱融合手术。

Additionally, 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.

此外，尽管最近有了进展，但由于具有一个或多个风险因素的患者患病率增加，脊柱融合手术变得更加复杂。

'As it can take up to 12 months for bones to fully fuse following a TLIF procedure, there remains a critical unmet need for new treatment options that accelerate fusion, especially for high-risk patients who are more prone to complications following surgery,' said

“由于在TLIF手术后，骨骼完全融合可能需要长达12个月的时间，因此对于加速融合的新治疗方案仍存在关键的未满足需求，特别是对于术后更容易出现并发症的高风险患者，”

Michael Steinmetz

迈克尔·施泰因梅茨

, M.D., Chairman, Department of Neurosurgery, Cleveland Clinic and Study Investigator, ASPIRE Study.* 'The majority of patients included in the ASPIRE study had one or more comorbidities, which is rare for these types of trials, although it's more representative of the patients I see in daily practice.

医学博士，克利夫兰诊所神经外科主任兼ASPIRE研究调查员。* “ASPIRE研究中大多数患者有一种或多种共病，这在这些类型的试验中很少见，但更能代表我在日常实践中看到的患者。”

The efficacy data of the ASPIRE study demonstrate faster fusion compared to local autograft.'.

ASPIRE 研究的疗效数据显示，与局部自体移植物相比，融合速度更快。

FDA approval is supported by data from ASPIRE, a prospective, single-blinded, multi-center, randomized, controlled pivotal PMA IDE study, evaluating the safety and efficacy of PearlMatrix Bone Graft compared to use of local autologous bone graft and cancellous allograft when applied in TLIF surgery..

FDA的批准得到了ASPIRE数据的支持，ASPIRE是一项前瞻性、单盲、多中心、随机、对照的关键PMA IDE研究，评估了PearlMatrix骨移植材料在TLIF手术中应用时，与使用局部自体骨移植和松质异体骨移植相比的安全性和有效性。

The ASPIRE trial included 33 U.S. centers and 293 patients, including approximately 60 percent of patients that were considered high risk for non-union (i.e., patients with Type 2 diabetes, BMI ≥ 30 and/or nicotine users). The study met the primary endpoint of 24-month Composite Clinical Success (CCS) and further demonstrated statistical superiority versus local autograft in CCS which was comprised of five components: fusion, function (ODI), neurological, no serious device-related adverse events, and no index-level secondary surgical interventions.

ASPIRE 试验包括 33 个美国中心和 293 名患者，其中约 60% 的患者被认为具有骨不连的高风险（例如，2 型糖尿病患者、BMI ≥ 30 和/或尼古丁使用者）。该研究达到了 24 个月复合临床成功 (CCS) 的主要终点，并进一步证明在 CCS 上相对于局部自体移植物的统计优越性，CCS 包含五个组成部分：融合、功能（ODI）、神经学、无严重设备相关不良事件以及无指数水平的二次手术干预。

ASPIRE is the first study of its kind to show substantially higher fusion rates achieving statistically superior fusion speed at 24 months with more than twice as many patients fused at six months versus local autograft. Complete results of the ASPIRE study are expected to be published in the coming months..

ASPIRE 是首个展示在 24 个月内实现显著更高的融合率的研究，与局部自体移植物相比，在六个月时融合的患者数量超过两倍，融合速度在统计学上更优。ASPIRE 研究的完整结果预计将在未来几个月内发布。

'The FDA approval of PearlMatrix Bone Graft is a significant achievement for Cerapedics as we're the only company with two PMA-approved products for use in spinal fusion. This is a testament to our dedication to investing in high-quality clinical evidence in our pursuit to have a positive impact on the practice of spine surgery and the lives of patients,' said .

“PearlMatrix骨移植获得FDA批准对Cerapedics来说是一项重大成就，因为我们是唯一一家拥有两款获PMA批准用于脊柱融合术产品的公司。这证明了我们致力于在追求对脊柱外科手术实践和患者生活产生积极影响的过程中投资于高质量的临床证据，”他表示。

Valeska Schroeder

瓦莱斯卡·施罗德

, Chief Executive Officer of Cerapedics. 'Differentiated by its unique P-15 Osteogenic Cell Binding Peptide, PearlMatrix Bone Graft is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed, giving surgeons a new option to better meet patient needs and treat them more efficiently.'.

Cerapedics首席执行官表示：“凭借其独特的P-15成骨细胞结合肽，PearlMatrix骨移植是首个也是唯一一个被证明能显著提高腰椎融合速度的骨生长加速器，为外科医生提供了新的选择，能够更好地满足患者需求并更高效地进行治疗。”

PearlMatrix Bone Graft was approved through the FDA PMA pathway and was

珍珠基质骨移植材料通过了FDA的PMA途径批准，并且

granted a Breakthrough Device designation

授予突破性设备认定

April 2021

2021年4月

. This designation is offered by the FDA for a product that could provide more effective treatment of a life-threatening disease, is a novel technology or offers significant advantages over existing approved or cleared alternatives. Premarket approval is the most stringent type of device marketing application required by the FDA and approval is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use.

此指定由FDA提供，适用于可能对危及生命的疾病提供更有效治疗、采用新颖技术或较现有已批准或已清除的替代品具有显著优势的产品。上市前审批（Premarket Approval, PMA）是FDA要求的最严格的器械营销申请类型，其批准基于FDA对PMA申请中包含足够有效的科学证据的判定，以确保该器械在其预期用途上安全且有效。

Of the more than 350 spinal bone grafts in the U.S. market, Cerapedics has two of only three spinal bone grafts that have received PMA approval..

在美国市场上的350多种脊柱骨移植产品中，Cerapedics公司拥有仅有的三种获得PMA批准的脊柱骨移植产品中的两种。

About PearlMatrix

关于珍珠矩阵

P-15 Peptide Enhanced Bone Graft

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肽增强骨移植材料是首个且唯一被证实可加速腰椎融合的骨生长加速剂，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肽作为珍珠矩阵的有效成分，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肽是一种由15个氨基酸组成的序列，天然存在于Ⅰ型胶原蛋白中，这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公司通过制药工艺生产的P-15肽被结合到磷酸钙颗粒上，形成一种P-15增强支架，为成骨、造骨细胞提供了丰富的附着点。

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，并通过自然细胞过程促进骨骼生长。

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 批准可用于腰骶椎的 PEEK TLIF 融合装置及辅助内部脊柱固定系统配合使用。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) 部位的一个水平，用于治疗退行性椎间盘疾病 (DDD)，并可伴随最高至 I 级的脊椎滑脱。DDD 被定义为由椎间盘退变引起的背部和/或神经根疼痛，且通过病史、体格检查和影像学研究确认椎间盘退变。

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.

在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应力的情况下，禁止使用PearlMatrix。

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.

珍珠基质对孕妇或哺乳期患者的影响尚未评估。在治疗可能影响手术成功率的原有疾病患者时应谨慎，例如任何病因引起的出血性疾病、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.

珍珠矩阵应仅由有TLIF手术经验的医生使用，并且在能够充分将其固定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：

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，让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）每年在全球范围内的脊柱、骨科、创伤和介入手术中被使用超过四百万次。