What's New in the Total Joints Market?

In the market for Total Joint Replacement, companies continue to innovate with assistive technologies and new implants and instruments to advance clinical outcomes and increase efficiency of care. From new hip products optimized for the direct anterior approach to cementless knee solutions, companies are focusing on technologies that provide optimal outcomes whether surgeries are performed in a hospital, hospital outpatient or ASC setting. The following is a sample of SmartTRAK's recent Total Joints news and developments from around the world, compiled, curated and posted in real time by the expert analysts at SmartTRAK.

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• JNJ/DePuy Synthes*
  

  JNJ/DePuy Synthes did not discuss its new EMPHASYS hip implants during its Q322 earnings call. However, SmartTRAK would not be surprised to see the Company introduce the system at AAHKS 2022 with the EMPHASYS Cup* recently receiving 510(k) clearance to round out the platform.

• Exactech*

  Exactech announced the successful first surgeries and limited launch of the Novel Total Hip Arthroplasty System with the Spartan Stem* and Logical Cup* with full commercial US launch planned for H123. Exactech is a distributor of the implants supplied by Signature Orthopaedics*.

•  Zimmer Biomet

  ZBH noted its soon-to-be-launched Persona cementless knee, anticipated for H222, should provide additional momentum for cementless conversions especially heading into 2023. ZBH Q222 Earnings Transcript on Seeking Alpha

Patents:

• Anika*
  

  Arthrosurface was granted US Patent “Tibial Resurfacing System And Method” describing an implant resection system for preparing a patient’s bone for a tibial resurfacing component. 11,471,289

• X.NOV

  X.NOV was issued US Patent “Tibial Component And Tibial Insert Of A Knee Prosthesis Comprising A Promontory And Its Associated Cut-out” describing a knee arthroplasty tibial component where the tibial plate and insert are fixed together via snap-fit action. 11,464,642

• Smith & Nephew* 

  Engage Uni LLC’s US Patent Application “UNICOMPARTMENTAL KNEE ARTHROPLASTY” was published describing unicompartmental knee components and alignment guides. 20220304825

Studies:

• How Much Have Medicare Payments for TKA & THA Declined?

  From 2009 to 2019, inflation-adjusted Medicare payments declined by 11.5% and total hospital reimbursements (Medicare payments plus co-payments) declined by 6.5% for THA, while Medicare payments declined by 13.4% and total hospital reimbursements declined by 7.7% for TKA. JA 

• ANA.NOVA Alpha Stem* - ImplanTec*

  A study of 87 patients who underwent THA w/ ANA.NOVA proxy short stem reported an average migration of 2.0 mm in the first 3 years. Migration did not lead to stem loosening, instability, dislocation or revision surgery in any patient. SR

•  Saturne Acetabular Cup* - Amplitude*

  A 70-patient single-center retro review of robotic-assisted pedicle screw placements with open procedures using the Mazor X Stealth Edition concluded that robotics is especially useful for surgeons with less experience in spinal deformity surgery. Eur J Orthop Surg Traumatol
  

Deals/Financing:

• Moximed*
  

  Moximed announced it raised $40MM in Series C equity and debt financing led by Advent Life Sciences and returning investors. The round is in support of gaining regulatory approvals and establishing commercial infrastructure for the MISHA* Knee System, an implantable knee shock absorber.

• ConforMIS*
  ConforMIS announced entering into a multi-year agreement with Vizient, the largest US member-driven healthcare performance improvement company, that enables Vizient members to purchase ConforMIS personalized implants, including access to Image-to-Implant Platinum Services Program.

• Enovis Acquires Insight Medical Systems
  Enovis* acquired Insight Medical Systems* for an undisclosed sum. SmartTRAK believes Insight’s ARVIS, an FDA-cleared AR guidance system for THA and TKA, positions Enovis to address the growing number of total joint procedures in ASCs. ARVIS will be commercially available in Q322.
  

Clinical/Regulatory:

•   iNSitu Hip System* - Theken/NextStep*
  

  Theken received 510(k) clearance for Zirconia Mg-PSZ ceramic femoral heads as part of the iNSitu Hip System.

• Plasmafit System* - Aesculap*
  

  Aesculap AG has not begun recruiting for its 100-patient RCT to compare modular Plasmafit Dual Mobility Inserts with Ceramic Multilayer Coating to standard poly inserts for primary THA. Final end date for the study is September 2027. clinicaltrials.gov

• Episealer Patellofemoral System* - Episur*
  Brainlab AG is awarded 510(k) clearance for Spine and Trauma Navigation, Spine Navigation, Navigation Software Spine and Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System, which links a freehand probe to virtual computer image space on a patient's existing images.

Markets:

• Hip Replacement - US*
  

  SmartTRAK projects there will be greater than 4,000 hip resurfacing procedures in the US in 2022 comprising more than 1% of Hip Replacement Market revenue (~$29MM). SmartTRAK US Hip Replacement Market Overview*

• WFS: JNJ/DePuy Synthes Q322 Results Hint to Strong Quarter
  Based on JNJ/DePuy Synthes’ Q322 results, Wells Fargo expects SYK’s ortho growth to be in line or better than estimated and ZBH to be ahead. Currently, WFS is modeling +5.7% US Knee Market growth and +5.4% US Hip Market growth for the quarter. WFS JNJ Q322 Ortho Growth Report
  
  
• Could Reverse Hips Change the Total Hip Game?
  SmartTRAK believes Hip Innovation Technology may be facing high odds against commercialization of the Reverse HRS Hip based on the difficulty of gaining FDA approval for a new technology and current surgeon sentiment. SmartTRAK Could Reverse Hips Change the Total Hip Game?*

 Revenues:

• Medacta*
  

  For H122, Medacta confirmed its WW Hip revenue reached ~$103.6MM (€101.4MM), +14.7% (+11.1% CC) driven by AMIS anterior approach strategy, new product roll-outs and adoption of the Bikini technique. Medacta Final H122 Earnings Report

• JNJ/DePuy Synthes*
  

  Wells Fargo is projecting stronger sequential growth in Orthopedics for JNJ/DePuy Synthes for Q322. WFS predicts Ortho growth will be +5.4% adjusted organic and Ex-FX. WFS JNJ Q322 Preview

• ConforMIS*
  ConforMIS’ expects Q322 product revenue to land in the range of $13MM to $14MM and full year 2022 product revenue of $57MM to $61MM. CFMS Q222 Earnings Release

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