What's New in the Spine Market? SmartTRAK at ISSAS

The ISASS 2023 annual meeting is taking place this week in San Francisco, and SmartTRAK is excited to be in attendance. Our team of spine experts will be roaming the event, providing our subscribers with up-to-the-minute news directly from the show floor. To ensure you're well-informed ahead of the meeting, below is a selection of recent spine news meticulously curated by our expert analysts at SmartTRAK.

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New Products:

• Orthofix*
  

  Orthofix noted that the Company launched the Lattus Lateral Access System and the Fathom Pedicle-Based Retractor System during Q123, which both address what the Company estimated to be a $1.8B MIS spine market.
  

• REFLECT Scoliosis System* - Globus*

  Globus Medical has announced FDA approval of REFLECT Scoliosis Correction System, the company's first humanitarian device. The non-fusion system, using a flexible cord instead of rigid metal rods, corrects scoliosis in young pts while preserving motion and allowing for growth.
  

• ulrich medical*

  Ulrich Medical announced the first Momentum MIS case in the West w/ Dr. Patrick Maloney at Travis Air Force Base and noted Dr. Maloney’s positive review of the new, tab-based screw system that delivers the same surgical versatility and ease of use as Momentum Deformity. LinkedIn

Patents:

• NuVasive*
  

  NuVasive was issued US Patent “Method And Apparatus For Performing Spine Surgery” describing hyper-lordotic lateral implants along with associated methods for implantation and instruments. 11,647,999F

• Globus*

  Globus Medical’s US Patent Application “IMPLANTABLE SYSTEMS, DEVICES AND RELATED METHODS” was published describing a low profile frame and spacer system for inserting into a disc space. 20230149181

• JNJ/DePuy Synthes*

  DMedos Int’l SARL was granted US Patent “Implant Receivers And Connectors With Grip Grooves For Rod Fixation” describing implant receivers and connectors w/ grip grooves for improved rod fixation. 11,653,953

Studies:

• Influence of the Preop L5-S1 Disc State on Lateral L2 -L5 Outcomes

  A study 105 pts investigated the influence of the preoperative L5-S1 disc status on the clinical outcome of LLIFs, concluding that preop L5-S1 disc degeneration does not seem to impact the final clinical outcomes after LLIF. Eur Spine J

• Trends in Treatment of Adult Deformity Surgery by Specialty

  This 12K-pt review analyzed adult spinal deformity surgery performed by neuro or ortho surgeons. Neurosurgeons operated on older, more comorbid patients, utilizing shorter-segment fixation and navigation and robotics techniques. Both specialties had similar complication rates. SJ

• After Spine Surgery, Elderly Spine Patients Can Return to Sports

  At one yr f/up, a 53-pt study found 43% of elderly patients achieved a return to sports (RTS) after spinal surgery. More than half of patients returned to sports activities less than 2x/wk and reported high satisfaction. The RTS rate was 50% for lumbar and 35.3% for cervical spine. OJSM
  

Deals/Financing:

• CarboFix*
  

  CarboFix recently announced it has been awarded a national pricing agreement w/ CHRISTUS Health which spans 60+ hospitals and 175 clinics in the South Central and Western US. Under the agreement CHRISTUS Health will have access to CarboFix's entire trauma product portfolio.

• Assure Holdings - Underwritten Public Offering
  Assure Holdings, a provider of intraop neuromonitoring, announced an underwritten public offering of 5MM shares of its common stock at a public offering price of $1.20 per share. The pre-funded warrants will be immediately exercisable at $0.001 or on a cashless basis.

• Globus*
  DePuy Synthes mgmt announced it entered into a distribution agreement to bring GE HealthCare’s OEC 3D Imaging System to more US locations. The system is a 3D and 2D high-def mobile imaging system images, and the C-arm has the ability to enable intra-op 3D imaging. LinkedIn
  

Clinical/Regulatory:

• Multicenter Trial on Degenerative Spine Diseases in China
  

  A multi-center observational study of 10,000 patients that aimed to understand, analyze and compare the treatment and prognosis of pts w/ degenerative spine diseases and to construct a risk warning model and a decision-making system was completed on May 22, 2023. Clinicaltrials.org

• DEXA-C* Aurora Spine*
  

  Aurora Spine reported that its Dexa-C received IRB approval to commence a multicenter, multi-year study in Q123. Aurora Q123 Earnings Statement

• LDGraft* - Locate Bio*
  Cresco Spine announced that it has received Breakthrough Device designation for its Spring Distraction System, a new approach to growth modulation in the treatment of scoliosis. The BDD will allow for greater WW adoption of the system for those w / early-onset scoliosis. LinkedIn

Markets:

• Spine Market Drivers 
  

  CG views spine as a customer-centric market driven by surgeon preference, which offers an arena where focused pure-play operators keyed in on innovation and clinical solutions can continue to drive share gains and thus predicts growth for players like ATEC. CG Flash Update

• Medtronic
  MDT mgmt indicated promise in core spine trends and highlighted the normalization of procedures contributing to multiple quarters of growth and indicated growth to be due to the R&D of its broad-based ecosystem. MDT Q4FY23 Earnings Transcript on Seeking Alpha
  
  
• Thoughts on Spine Post-Q123 Reporting
  CG noted that US spine results were strong for Q123 and that its recent survey indicated that volumes were expected to decrease about -2% in Q123 (same as the -2% dip from Q422) w/ improvement predicted in Q223 at rates of +1% in April, +4% in May, and +3% in June. CG Flash Update

 Revenues:

• Medtronic* 
  

  For Q4FY23, MDT reported US Cranial & Spinal Technologies (CST) revenue of $855M, up +1.5 % as reported. FY23 CST US revenue totaled $3.26B, up +2.8% as reported. MDT Q4FY23 Earnings Release

• Orthofix*
  

  For Q123, Orthofix reported WW Spinal Implant and Enabling Technologies revenue to be $60.9MM, up +128% from Q122, driven largely by the company’s merger with SeaSpine. OFIX Q123 Form 10-Q

• Aurora Spine*
  In its final H122 report, Medacta reported Spine revenue increased +19.4% to ~$19.9MM (€19.8), +16% CC driven by the expansion of MIS Platform and MySpine offering. Medacta Final H122 Earnings Report

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