Osteoboost is the first and only non-pharmacological prescription treatment to demonstrate reduced loss of bone strength in postmenopausal women

Osteoboost是第一个也是唯一一个证明绝经后女性骨强度损失减少的非药物处方治疗

Represents the first therapeutic mechanism specifically designed and cleared for intervention during the osteopenia stage

代表了第一个专门设计和清除骨质减少阶段干预的治疗机制

REDWOOD CITY, CA / ACCESSWIRE / January 18, 2024 / Bone Health Technologies today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for OsteoboostTM, the first non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density)..

加利福尼亚州红木市/ACCESSWIRE/2024年1月18日/Bone Health Technologies今天宣布，美国食品和药物管理局（FDA）已批准OsteoboostTM，这是第一种针对绝经后骨质减少症（低骨密度）女性的非药物处方药治疗。。

Osteoboost

骨增强剂

Osteoboost is the first FDA-cleared prescription medical device to treat osteopenia.

Osteoboost是FDA批准的第一款治疗骨质减少症的处方医疗器械。

Osteoboost is a wearable belt device, worn on the hips, that delivers targeted, calibrated vibration to the lumbar spine and hips. Osteoboost is indicated to reduce bone strength and density decline in postmenopausal women and is the first and only solution specifically designed to improve bone health during osteopenia.

Osteoboost是一种可穿戴的腰带装置，佩戴在臀部，可为腰椎和臀部提供有针对性的校准振动。Osteoboost被认为可以降低绝经后女性的骨强度和密度下降，是第一个也是唯一一个专门设计用于改善骨质减少期间骨骼健康的解决方案。

This breakthrough technology is safe, medication-free, and easy to use at home, making it suitable for a wide variety of patients with bone density loss..

这项突破性的技术安全、无需药物，并且易于在家中使用，使其适用于各种骨密度降低的患者。。

An estimated 52 million Americans have osteopenia, the precursor to osteoporosis, driving an addressable market of over $30 billion in the U.S. and $100 billion globally. Half of all women suffer from fractures during their lifetime, and most of these fractures occur during the osteopenia stage.

据估计，有5200万美国人患有骨质减少症，这是骨质疏松症的前兆，在美国和全球的可寻址市场分别超过300亿美元和1000亿美元。一半的女性在一生中都患有骨折，其中大多数骨折发生在骨质减少阶段。

'Today's groundbreaking decision represents the first non-pharmacological therapy approved to treat this widespread and serious condition. With Osteoboost, we have a new treatment option - free of serious adverse events - that taps into the body's natural mechanism to stimulate bone growth,' said Laura Yecies, CEO of Bone Health Technologies.

“今天的开创性决定代表了第一个被批准用于治疗这种广泛而严重疾病的非药物疗法。bone Health Technologies首席执行官劳拉·叶希斯（LauraYecies）说，有了Osteoboost，我们有了一种新的治疗选择，没有严重的不良事件，可以利用人体刺激骨骼生长的自然机制。

'Women's health has been underserved for too long, making this a huge step forward for older women who have lacked effective treatment options and are seeking an effective way to protect their bone health.'.

“长期以来，妇女的健康一直得不到充分的服务，这使得对于缺乏有效治疗选择并正在寻求保护骨骼健康的有效方法的老年妇女来说，这是一个巨大的进步。”。

Osteoboost was reviewed through the FDA's De Novo classification process and received Breakthrough Device Designation. The Osteoboost clearance creates an entirely new class of therapeutics for low bone density outside of pharmacological intervention. Notably, Osteoboost also represents the first therapeutic mechanism specifically designed and cleared for intervention during the osteopenia stage.

Osteoboost通过FDA的从头分类过程进行了审查，并获得了突破性的设备指定。Osteoboost清除为药物干预之外的低骨密度创造了一类全新的治疗方法。值得注意的是，Osteoboost还代表了第一种专门设计和清除骨质减少阶段干预的治疗机制。

Until now, patients with osteopenia have lacked effective therapeutic options. Before Osteoboost, the standard of care for osteopenia focused on regular weight-bearing exercise and calcium supplementation - neither of which have been proven to significantly slow the loss of bone density..

到目前为止，骨质减少症患者缺乏有效的治疗选择。在Osteoboost之前，骨质减少症的标准护理集中在定期的负重运动和钙补充上-这两种方法都没有被证明可以显着减缓骨密度的损失。。

'There are millions of American women with low bone density or osteopenia. This is often the precursor to osteoporosis. We have little to offer those women other than calcium and vitamin D supplements,' said David B. Karpf, MD, Adjunct Clinical Professor of Endocrinology, Gerontology & Metabolism, Stanford University School of Medicine and attending in the Osteoporosis & Metabolic Bone Disease Clinic.

“有数百万美国女性骨密度低或骨质减少。这通常是骨质疏松症的前兆。斯坦福大学医学院内分泌、老年学和代谢副临床教授、骨质疏松症和代谢性骨病诊所的主治医生大卫·B·卡普夫（DavidB.Karpf）说，除了钙和维生素D补充剂外，我们几乎没有其他东西可以为这些女性提供。

'The field of bone health right now is missing innovative approaches - there are no new agents in clinical trials for osteoporosis and nothing for women who have osteopenia. With the aging of our population, we need new ways to effectively prevent the decline in bone mass and strength that affects all women in the peri-menopause or post-menopausal stage.'.

“目前骨骼健康领域缺少创新方法-骨质疏松症的临床试验中没有新药，骨质减少症女性也没有。随着人口老龄化，我们需要新的方法来有效防止骨量和力量的下降，这会影响围绝经期或绝经后阶段的所有女性。”。

Osteoboost was granted clearance based on data from an NIH-funded double-blinded, sham-controlled study conducted at the University of Nebraska Medical Center. The data, which were shared at the 2023 ENDO and ASBR conferences, demonstrate the efficacy of Osteoboost in directly stimulating bone growth and preserving bone mineral density and strength by sending low-frequency vibrations directly to the lumbar spine and hips..

根据美国国立卫生研究院（NIH）资助的内布拉斯加州大学医学中心进行的一项双盲，假对照研究的数据，Osteoboost获得了批准。这些数据在2023年的ENDO和ASBR会议上共享，证明了Osteoboost通过将低频振动直接发送到腰椎和臀部来直接刺激骨骼生长并保持骨矿物质密度和强度的功效。。

The primary outcome measurement was the change in vertebral strength measured by CT scan. Per Protocol (PP) - subjects (those who used the device a minimum of three times per week) in the Active Treatment group lost, on average, 0.48% bone strength while those in the Sham group lost 2.84%, with a relative difference of 2.36% (P=0.014).

主要结果测量是通过CT扫描测量的椎体强度的变化。按照方案（PP）-积极治疗组的受试者（每周至少使用该装置三次的受试者）平均失去0.48%的骨强度，而假手术组的受试者失去2.84%，相对差异为2.36%（P=0.014）。

Additionally, CT measurement of vertebral bone density was conducted and showed a 1.68% relative benefit for those using the Osteoboost (P=0.008). These results represent a dramatic reduction in the loss of bone strength and density. Zero serious adverse events were reported..

此外，进行了椎体骨密度的CT测量，结果显示使用Osteoboost的患者相对获益1.68%（P=0.008）。这些结果表明骨强度和密度的损失显着减少。报告的严重不良事件为零。。

'The well-being and ability of postmenopausal women to maintain an active lifestyle is threatened when loss of estrogen causes rapid loss of bone,' said Laura Bilek, Ph.D., Associate Dean for Research and Associate Professor at the University of Nebraska and principal investigator for this study. 'Although lifestyle interventions such as exercise and diet are beneficial to bone, the effect is small.

内布拉斯加州大学（University of Nebraska）研究副院长、副教授、本研究首席研究员劳拉·比莱克（LauraBilek）博士说：“当雌激素的缺乏导致骨骼迅速流失时，绝经后妇女的健康和维持积极生活方式的能力受到威胁。”虽然运动和饮食等生活方式干预对骨骼有益，但效果很小。

The Osteoboost shows promise in slowing the loss of bone density and strength and may fill the treatment gap.'.

Osteoboost有望减缓骨密度和强度的损失，并可能填补治疗空白。”。

About Bone Health Technologies

关于骨骼健康技术

Bone Health Technologies (BHT) is a Redwood City-based company that applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and associated bone fractures. The company's first FDA-approved device, Osteoboost, is poised to become the new standard of care in treating post-menopausal osteopenia.

Bone Health Technologies（BHT）是一家总部位于红木市的公司，它应用科学和医学专业知识，为有患骨质疏松症和相关骨折风险的女性和男性创造更好的健康结果。该公司的首款FDA批准的设备Osteoboost有望成为治疗绝经后骨质减少症的新标准。

BHT is backed by leading investors, including Esplanade Ventures, Ambit Health Ventures, Good Growth Capital, Portfolia, Astia Angels, and Golden Seeds. For more information about BHT and Osteoboost, including the full Indications for Use, please visit www.bonehealthtech.com..

必和必拓得到了领先投资者的支持，包括Esplanade Ventures、Ambit Health Ventures、Good Growth Capital、Portfolia、Astia Angels和Golden Seeds。有关BHT和Osteoboost的更多信息，包括使用的全部适应症，请访问www.bonehealthtech.com。。

Contact Information

联系方式

Colin Sanford

科林·桑福德

colin@bioscribe.com

colin@bioscribe.com

1-203-918-4347

1-203-918-4347

Related Files

相关文件

Osteoboost FDA Clearance - Infographic.pdf

Osteoboost FDA批准-Infographic.pdf

SOURCE: Bone Health Technologies

资料来源：Bone Health Technologies

View the original press release on newswire.com.

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