种植体 材料(美国公司RevBio开发了一种用于种植牙科的骨粘合生物材料)

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RevBio 开发了一种用于种植牙科的骨粘合生物材料的更快速吸收配方，该配方将用于本研究

RevBio has Developed a More Rapidly Resorbing Formulation of its Bone Adhesive Biomaterial for Implant Dentistry which will be Used in this Study

上图是兔子股骨远端体内三周后临界尺寸缺损内骨形成的组织学图像。在左边，原始的 Tetranite 配方几乎没有被新骨取代，并且呈白色，这表明生物材料的存在。在右侧，更具促骨作用的配方显示出显着的骨内生长，红色和粉色区域表明新骨取代了 Tetranite 生物材料。（照片：美国商业资讯）

Above are histological images of bone formation within a critical size defect after three weeks in vivo in a rabbit distal femur. On the left, the original Tetranite formulation shows very little substitution with new bone and appears white, which indicates the presence of the biomaterial. On the right, the more osteopromotive formulation shows significant bone in-growth with the red and pink areas indicating new bone substituting the Tetranite biomaterial. (Photo: Business Wire)

马萨诸塞州洛厄尔--(美国商业资讯)--RevBio, Inc.宣布，它已获得美国食品和药物管理局的批准，开始一项有20名患者参与的临床试验，以检验一种更快速替代的药物的安全性和有效性，该公司骨粘合剂生物材料 Tetranite® 的 pH 值调节多孔配方可在拔牙后立即稳定牙种植体。这种新配方已显示出具有更具生物活性的骨替代的证据。虽然不具有骨诱导性，但这种正在申请专利的 Tetranite 版本已显示出可被描述为“骨质促进”的特性。

LOWELL, Mass.--(BUSINESS WIRE)--RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient clinical trial to examine the safety and efficacy of a more rapidly replaced, pH modified porous formulation of the company’s bone adhesive biomaterial called Tetranite® to immediately stabilize dental implants following tooth extractions. This new formulation has shown evidence of a more biologically active bone substitution. While not osteoinductive, this patent-pending version of Tetranite has shown characteristics which may be described as “osteopromotive.”

该临床试验将由来自马萨诸塞州的世界著名牙周病专家 Paul A. Fugazzotto（DDS）和 Kanyon Keeney（DDS）进行，他是一位来自马萨诸塞州的世界知名牙周病专家，拥有超过 30 年的种植牙经验，而 Kanyon Keeney 是一位来自弗吉尼亚州的口腔颌面外科医生，他的临床研究实践专注于牙种植手术。“这个产品确实具有变性，”Fugazzotto 博士说。“Tetranite 将彻底改变牙科种植的实施方式。这种材料的粘合性能和操作特性是市场上任何产品都无法比拟的。”

The clinical trial will be conducted by Paul A. Fugazzotto, DDS, a world-renowned periodontist based in Massachusetts, who has over 30 years of experience placing dental implants, and Kanyon Keeney, DDS, an oral and maxillofacial surgeon based in Virginia whose clinical practice focuses exclusively on dental implant surgery. “This product is truly transformational,” said Dr. Fugazzotto. “Tetranite will revolutionize how implant dentistry will be performed. The adhesive properties and handling characteristics of this material are incomparable to any product on the market.”

牙齿因外伤、蛀牙或牙龈疾病而被拔除。目前的护理标准包括多阶段外科手术，通过由牙种植体支撑的假牙冠来恢复患者的牙列。通常，拔牙部位对于牙种植体来说太大，无法通过传统的机械接合实现初步稳定性。相反，患者必须经历昂贵、复杂且漫长的过程，包括在接受牙种植体之前进行初步骨移植手术。根据公司调查，美国每年约有 210 万颗种植体最终被植入最初不稳定的拔牙部位，这些部位首先必须接受骨移植。使用 Tetranite 来稳定不稳定的种植体将允许立即植入牙种植体，否则在最初的骨移植物愈合形成新骨之前无法放置牙种植体。因此，Tetranite® 生物材料将有助于减少这些牙种植手术的持续时间和复杂性，减轻患者疼痛和恢复时间，并降低总体护理成本，从而为患者提供更多的牙齿缺失治疗机会。

Teeth are extracted due to damage from traumatic injuries, tooth decay, or gum disease. The current standard of care consists of multiple staged surgical procedures to restore a patient’s dentition with prosthetic crowns supported by dental implants. Frequently, extraction sites are too large for dental implants to achieve primary stability through conventional mechanical engagement. Instead, patients must undergo a costly, complex, and lengthy process including a preliminary bone grafting surgery before receiving a dental implant.

Based on company surveys, each year in the U.S. approximately 2.1 million implants are eventually placed into initially unstable tooth extraction sites that first must receive a bone graft. The use of Tetranite to stabilize an unstable implant will allow for the immediate placement of dental implants which otherwise could not be placed until the initial bone graft has healed to form new bone. As a result, the Tetranite® biomaterial will help reduce the duration and complexity of these dental implant procedures, lessen patient pain and recovery time, and reduce the overall cost of care thereby providing greater patient access for the treatment of tooth loss.

RevBio 牙科临床运营高级总监 Alan Pollack 表示：“我们非常高兴能够与 Fugazzotto 博士一起开展这项研究，Fugazzotto 博士将启动这项研究，并与 Keeney 博士一起招募第一批病例。” “我们对技术所做的改进加速了骨替代方案和产品的粘合强度。最近刚刚获得 IRB 批准，我们期待在未来几周内招募第一批患者。”

“We are truly excited to conduct this study with both Dr. Fugazzotto, who will initiate this study enrolling the first cases, along with Dr. Keeney,” said Alan Pollack, RevBio’s Senior Director of Dental Clinical Operations. “The improvements we have made to the technology have accelerated both the bone substitution profile and the product’s adhesive strength. Having also just recently received IRB approval, we look forward to enrolling our first patients in the coming weeks.”

关于 RevBio , Inc .

RevBio, Inc. 是一家临床阶段医疗器械公司，致力于开发和商业化名为 Tetranite® 的专利合成、可注射、自凝固和骨传导性骨粘合剂生物材料。该公司最初正在开发这项技术，用于牙科、颅骨和更广泛的骨科市场以及动物健康市场的应用。RevBio 的 Tetranite 技术尚未批准用于商业用途。

关于RevBio , Inc .

RevBio, Inc. 是一家临床阶段医疗器械公司，致力于开发和商业化名为 Tetranite® 的专利合成、可注射、自凝固和骨传导性骨粘合剂生物材料。该公司最初正在开发这项技术，用于牙科、颅骨和更广泛的骨科市场以及动物健康市场的应用。RevBio 的 Tetranite 技术尚未批准用于商业用途。

About RevBio, Inc.

RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The company is initially developing this technology for use in the dental, cranial, and broader orthopaedic markets as well as applications in the animal health market. RevBio's Tetranite technology is not yet approved for commercial use.

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