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SI-BONE Receives Transitional Pass-Through Payment Status for iFuse Bedrock Granite™
GlobeNewswire News Room· 2024-11-05 21:30
SANTA CLARA, Calif., Nov. 05, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for the iFuse Bedrock Granite™ (Granite) system, used for pelvic fixation and sacroiliac joint fusion in conjunction with lumbar spinal fusion procedures, under the Medicare Hospit ...
Strength Seen in Si-Bone (SIBN): Can Its 6.9% Jump Turn into More Strength?
ZACKS· 2024-10-30 16:35
Si-Bone (SIBN) shares rallied 6.9% in the last trading session to close at $13.11. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 12.2% loss over the past four weeks. Si-Bone scored a strong price increase, on investors' optimism surrounding its impending third-quarter 2024 financial results, which is slated to release on Nov. 12 post the closing bell. The Zacks Consensus Estimate for the third quarter reven ...
SI-BONE To Report Third Quarter 2024 Financial Results on November 12, 2024
GlobeNewswire News Room· 2024-10-23 04:09
SANTA CLARA, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving sacropelvic disorders, today announced it will report financial results for the third quarter of 2024 after market close on Tuesday, November 12, 2024. Management will host a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Investors interested in listening to the conference call may do so by registering at this link: https://edge.media ...
SIBN Stock Up After First-In-Patient Use of FDA Breakthrough Device
ZACKS· 2024-10-15 01:20
SI-BONE, Inc. (SIBN) announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT Implant System (TNT), on Thursday. TNT received the FDA's 510(k) clearance and was awarded Breakthrough Device Designation by the FDA in August 2024. Per SI-BONE, TNT, which has been designed to address the anatomic and biomechanical challenges of pelvic fragility fractures (particularly in patients with poor bone quality), is expected to offer a significant advancement over traditional can ...
SI-BONE, Inc. Announces First-In-Patient Procedures with FDA Breakthrough Device for Pelvic Fracture Fixation
GlobeNewswire News Room· 2024-10-10 20:30
SANTA CLARA, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT™ Implant System (TNT). Designed to address the anatomic and biomechanical challenges of pelvic fragility fractures, particularly in patients with poor bone quality, TNT offers a significant advancement over t ...
Wall Street Analysts Think Si-Bone (SIBN) Could Surge 40.3%: Read This Before Placing a Bet
ZACKS· 2024-08-26 22:55
Shares of Si-Bone (SIBN) have gained 2.4% over the past four weeks to close the last trading session at $16.55, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $23.22 indicates a potential upside of 40.3%. The mean estimate comprises nine short-term price targets with a standard deviation of $4.68. While the lowest estimate of $18 indicates an 8.8% increase from the current pric ...
SI-BONE (SIBN) Receives FDA Nod for Its TNT Implant System
ZACKS· 2024-08-26 21:20
文章核心观点 - SI-BONE公司最近获得FDA 510(k)认证,推出了新的iFuse TORQ TNT植入系统,这是专门针对骨质疏松性骨盆骨折的首个解决方案 [1][2][3][4] - TNT植入系统采用特殊设计,可以更好地满足骶骨和髂骨的解剖和骨密度需求,有助于提高早期固定和减少螺钉后移的问题,从而可以更早地让患者进行负重活动 [3][4] - 这一创新产品获得了FDA的突破性设备认定,有望成为骨盆脆性骨折固定和骶髂关节融合的下一代技术 [4] 行业前景 - 根据Grand View Research的报告,全球骶髂关节融合市场规模预计将从2023年的7.212亿美元增长到2030年以19.8%的复合年增长率 [5] - 市场增长的主要驱动因素包括下背痛、臀部痛、腹股沟痛和下肢疼痛的发病率上升,以及最小创伤手术技术的进步和保险报销的改善 [5][6] - SI-BONE公司推出TNT系统的时机正好抓住了这一市场机遇 [6] 其他近期动态 - 2024年5月,SI-BONE公司扩展了iFuse Bedrock Granite植入系统系列,推出了Granite 9.5型号,获得FDA 510(k)认证 [7] - Granite 9.5适用于较小体型的患者,可以更容易地在骶髂关节轨迹上放置多个植入物 [7] - 与同行业相比,SI-BONE公司股价在今年迄今下跌了21.2% [8]
SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
GlobeNewswire News Room· 2024-08-20 20:30
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation technology for pelvic fragility fracture fixation and sacroiliac joint fusi ...
Wall Street Analysts Believe Si-Bone (SIBN) Could Rally 64.45%: Here's is How to Trade
ZACKS· 2024-08-08 23:00
Si-Bone (SIBN) closed the last trading session at $14.12, gaining 4.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $23.22 indicates a 64.5% upside potential. The average comprises nine short-term price targets ranging from a low of $18 to a high of $32, with a standard deviation of $4.68. While the lowest estimate indicates an increase of 27.5% from the current price level, the ...
SI-BONE(SIBN) - 2024 Q2 - Quarterly Report
2024-08-07 04:15
财务数据 - 公司第二季度收入为39,969,000美元,同比增长20.1%[20] - 第二季度毛利率为79.0%,同比增加1.5个百分点[20] - 第二季度销售和营销费用为28,970,000美元,占收入的72.5%[20] - 第二季度研发费用为4,352,000美元,占收入的10.9%[20] - 第二季度一般及行政费用为8,332,000美元,占收入的20.8%[20] - 第二季度净亏损为8,939,000美元,亏损同比收窄20.3%[20,21] - 截至6月30日,公司现金及现金等价物为25,577,000美元,短期投资为125,950,000美元[16] - 截至6月30日,公司存货为23,233,000美元,较上年末增加14.8%[16] - 截至6月30日,公司应收账款净额为24,796,000美元,较上年末增加12.9%[16] - 截至6月30日,公司总资产为223,843,000美元,较上年末减少2.8%[16] - 公司于2023年6月30日完成公开发行股票,募集资金净额为83.7百万美元[31] - 公司营业收入增加18%,达到77.8亿美元[159] - 毛利率为79%,较上年同期下降2个百分点[161] - 销售及市场费用增加6%,达到58.4亿美元[162] - 研发费用增加25%,达到8.7亿美元[164] - 一般及行政费用增加8%,达到16.5亿美元[165] - 利息收入增加64%,达到4.1亿美元[166] - 公司现金及可流动证券余额为151.5亿美元[170] - 公司累计亏损为420.3亿美元[171] - 公司获得8.37亿美元的公开发行股票净收益[172] - 公司已获得36.0亿美元的银行贷款[174][175][176] 新产品 - 公司于2023年1月推出新产品iFuse INTRA,这是一款可植入的骨科产品[31] - 公司于2022年推出新产品iFuse Bedrock Granite[31] - 公司于2021年推出新产品iFuse-TORQ[31] - 公司于2017年推出新产品iFuse-3D[31] - 公司自2009年推出首款iFuse产品以来,已陆续推出多款钛合金植入产品系列[31] 市场情况 - 公司主要产品在美国获得了广泛的适用范围,包括骶髂关节功能障碍和融合、成人脊柱畸形和退行性变、骨盆创伤等[31] - 公司主要业务集中在美国市场,国际市场收入占比不到10%[38,39] - 公司在美国市场的收入占总收入的95%,国际市场占5%[144] - 公司业务存在季节性,第四季度销售通常较高[131] - 公司持续扩大销售团队规模,截至2024年6月30日,美国销售团队包括84名区域销售经理、69名临床支持专员和204名第三方销售代理[115] - 公司积极拓展进入门诊手术中心市场,截至2024年6月30日,超过20%的骶髂关节功能障碍手术在门诊手术中心完成[116] - 公司通过多种培训方式,包括尸体实操和模拟器培训等,提高医生对产品的熟悉度和手术技能,截至2024年6月30日,已有约1,700名外科住院医生和研究生接受培训[118][119] 资产负债情况 - 公司于2024年1季度调整了仪器托盘的使用寿命估计,从3年延长至5年,这将减少折旧费用,提高利润[35] - 公司的可供出售的有价证券的摊余成本与公允价值基本相当[49] - 公司未确认任何与投资相关的信用损失[49] - 公司的现金等价物和短期投资主要包括货币市场基金和美国国债[44][45][47][48] - 公司的存货包括21.2百万美元的制成品和2.0百万美元的在制品及零件[57] - 公司的固定资产净值为19.1百万美元,主要包括手术器械托盘、机器设备和在建工程[57][58] - 公司的应计负债主要包括8.9百万美元的薪酬及相关费用和1.6百万美元的应计专利费[59] - 公司的应收账款坏账准备余额为1.3百万美元[60] - 公司有多项不可撤销的经营租赁,包括办公楼和研发仓储用房,租赁期限最长至2027年[62][63][64][65][66][67] - 公司有一些采购承诺,涉及金额为0.4百万美元[69][70] 融资情况 - 公司于2021年8月12日与Silicon Valley Bank签订贷款和担保协议,获得3500万美元的定期贷款[77] - 2023年1月6日,公司与Silicon Valley Bank签订第一次修订贷款和担保协议,获得3600万美元的新定期贷款,用于偿还原有贷款,并获得1500万美元的循环信贷额度[78] - 2023年3月,Silicon Valley Bank的所有资产和负债被First-Citizens Bank & Trust Company接管[80] - 2024年1月25日,公司与First-Citizens Bank & Trust Company签订第二次修订贷款和担保协议,修订了财务契约条款[81] - 截至2024年6月30日,公司符合所有债务契约,但需要将部分客户付款和现金管理账户余额转回First-Citizens,才能获得循环信贷额度[83] - 公司违反了修订贷款协议的某些条款,通过向另一家金融机构开设银行账户并从SVB转移资金[177] - 公司与Silicon Valley Bridge Bank签订了一份豁免执行该条款的协议,并获得在其他金融机构持有部分现金的权利[177] - 如果未来违反任何契约条款,可能会导致违约并限制公司进一步获取循环信贷额度和要求立即偿还任何未偿贷款[177,179] 股权激励 -