What's New In the Spine Market: SmartTRAK at NASS 2022

With the North American Spine Society (NASS) 2022 annual meeting next week in Chicago, anticipation builds to see if some of the top players' product launches are unveiled at the event, including potential new offerings from Medtronic and NuVasive. Meanwhile, SmartTRAK expects to see bright spots from some of the pure-play companies like Centinel, Alphatec and Astura Medical. The event will surely be a pick-me-up from sluggish market performance plagued by budget constraints and supply chain issues. 

Our spine experts will be roaming the floor, bringing our subscribers real-time news direct from the show. We'll also be on the show floor at booth #2341, ready to answer your questions, share insights on the latest in the spine market and discuss how SmartTRAK can help you Be the Expert in your market. To make sure you’re up to speed before the meeting, here is a sample of recent spine news collected and curated by the expert analysts at SmartTRAK. If you would like to book a meeting with us at NASS, please click the button below.

New Products:

• prodisc C* - Centinel Spine*
  

  Centinel Spine announced expansion of the prodisc cTDR portfolio. Currently, Centinel has 510(k) clearance for 1-level indications for prodisc C Vivo, prodisc C SK and prodisc C Nova giving them the broadest global offering in cTDR.

• SiLO* - Aurora Spine*

  Aurora Spine received 510(k) clearance for the patented SiLO TFX MIS SI Joint Fixation System. SmartTRAK notes that this clearance is one long awaited by Aurora, after multiple interactions with FDA on guidance for this new tech. More details TBA by Aurora on October 6th.

• Ghost* - Life Spine*

  LifeSpine announced that it has received 510(k) clearance for the GHOST 3D-Printed Titanium Spacer family, expanding on Life Spine’s interbody portfolio, which offers PEEK, titanium and now 3D-printed titanium. The new 3D printed line includes solutions for ALIF, PLIF/TLIF and LLIF.

Patents:

• JNJ/DePuy Synthes*
  

  DePuy Synthes Products was granted US Patent “Intervertebral Implants, Systems, And Methods Of Use” describing an implant frame which includes a pair of expandable arms that extend substantially around a spacer body to hold the body to the frame. 11,458,027

• NeuroPro*

  NeuroPro was issued US Patent “Bone Fusion System, Device And Method Including A Measuring Mechanism” describing a device configured to couple to an insertion instrument which allows for implantation of the device with minimal risk of slippage. 11,458,029

• NuVasive* 

  NuVasive was issued US Patent “Vertebral Body Replacement” describing an implant with an expandable core to which endplates of various shapes, sizes and angles can be attached in a plurality of positions.11,458,025

Studies:

• Dynamic Change of Pelvic Incidence After Long-construct Fusion

  A retrospective study of 82 adult scoliosis patients reviewed change in pelvic incidence at follow-up for patients who had S2AI fixation and aimed to identify factors associated with  the change and found that PI decreased in > 50% of ASD patients immediately postop when using S2AI screws. Eur Spine J

• Learning Curve for MIS TLIF: a Systematic Review

  A review of 9 articles, representing 753 patients aimed to discuss the cutoff point at which technical proficiency is reached to potentially enhance the learning process and concluded that the plateau point in MIS TLIF adoption differs based on variable outcome measures. Eur Spine J

• Spontaneous Lumbar Curve Correction Post-VBT

  A retrospective study of 218 scoliosis patients treated with thoracic AVBT were evaluated to assess the response of compensatory thoracolumbar/lumbar curve(s) following AVBT and concludes greater postop improvement was only observed in patients with continued growth modulation of the thoracic curve. JBJS
  

Deals/Financing:

• Precision Spine*
  

  Precision Spine and HippoFi (FKA ORHub) announce a strategic agreement to drive growth and revenue by cross-selling the PUR Biologics line and future HippoFi innovations. Immediately, due to Precision’s strong market presence, HippoFi expects a sizable increase in revenue. LinkedIn

• RevBio*
  SmartTRAK has learned that RevBio has received another Small Business Innovation Research grant of $375K from the National Institute on Aging allowing them to pursue the tx of vertebral compression fractures with Tetranite*. RevBio has received more than $5.3MM in grants to study Tetranite.

• Elevation Spine
  Elevation Spine announced completion of its Series B Preferred Stock financing, totaling $11MM, led by Technology Venture Partners and included Mutual Capital Partners and existing investors. The company plans to use the funds to further commercial production of Saber-C and other R&D.

Clinical/Regulatory:

• 5G-based Telerobot-assisted Spine Surgery 
  

  A 192-patient retro study in China has evaluated pedicle screw placement using a remote surgery service platform based on accuracy according to the Gertzbein and Robbins scale. Study completion was July 2022. clinicaltrials.gov

• Matisse* - CTL Amedica*
  

  The Taiwan Food and Drug Administration granted CTL Amedica Corporation a license for the MATISSE Anterior Cervical Interbody Fusion Cage System. The official license, DHA 05603556709, enables CTL Amedica to market the MATISSE System in Taiwan, a key OUS spinal technology market.

• Scarlet AC-T/Scarlet AL-T* - Spineart*
  Spineart enrolls the 100th patient, completing enrollment for the SCARLET AL-T study tracking the clinical performance of the company’s 3D-printed integrated hyperlordotic ALIF device. The protocol calls for subjects to be followed for 24 months post-device implantation. LinkedIn

Markets:

• SmartTRAK US Spinal Interbody Market Overview
  

  The SmartTRAK US Interbody Market Overview contains pricing and ASP information for competitive interbody devices by approach, by material and comparing expandable interbody devices with static. SmartTRAK US Spinal Interbody Market Overview*

• Adjusted Spine Growth Model Aligns with SmartTRAK
  Post closing of Q222, Needham’s adjusted 2022 forecast indicates +3% overall Spine market growth, while SmartTRAK predicts +2.4%. Needham Sep MedTech Monthly
  
  
• SpineGuard*
  SpineGuard upcoming priorities include boosting commercial activities with the launch of the DSG-Connect visual interface and partnership with WishBone Medical, developing a Smart Universal Drill embedded with DSG AI and signing other strategic agreements. SpineGuard H122 Earnings Release

 Revenues:

• Medtronic* 
  

  For Q1FY23 ending June 2022, Medtronic reports that Spine and Biologics revenue decreased in the low-single digits, reporting mid-teen declines in Bio, partially offset by +4% core spine growth. MDT Q1FY2023 Earnings Press Release

• Bioventus*
  

  For Q222, Bioventus reported +17% organic growth within its bone graft substitute segment, driven by a recovery in elective spine procedures. BVS noted continued receptivity for OsteoAMP* Flowable, consistent with prior quarters. BVS Q222 Earnings Transcript on Seeking Alpha.

• Medacta*
  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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