Despite the looming shadow of the emergence of the COVID-19 Delta variant, the worldwide MedTech industry continues to focus on the future. SmartTRAK reports daily on the challenges still ahead, covering all aspects of the Orthopedic market: Extremities, OrthoBio, Spine, Computer Assisted Surgery, Total Joints, Trauma, Soft Tissue Fixation and EU Extremities and Trauma. We'll be at AAOS in San Diego, and if you would like to meet with us to see what SmartTRAK can do for you, just click here.
The following is just a small sampling of recent Orthopedic updates from around the world compiled, reviewed and posted in real time by our SmartTRAK analysts. We constantly monitor the worldwide MedTech industry, sifting through the noise to present to our subscribers the most relevant international news, patents, trends, new products, financial data and competitor developments in the global Life Sciences industry.
Patents:
KB Medical was granted US Patent “Robotic navigation of robotic surgical systems” describing robotic surgical systems with built-in navigation capability & ability to update registration in real time & obviating the need for a separate navigation system. 11,071,594
US Patent Application “Sutureless Repair of Soft Tissue” was published describing a sutureless method of repairing soft tissue defects in soft tissue including ligaments such as anterior cruciate ligaments (ACLs). 20210236130
Arthosurface’s US Patent Application “Humeral and Glenoid Articular Surface Implant Systems and Methods” was published describing a system that comprises a plug which is connectable to the glenoid implant w/ a releasable mechanical connection. 20210228370
New Products:
ATEC Management noted that though EOS is a big piece of capital, it’s not in the OR; its information can be brought into the OR with the tablet paper platform. Info about full body weight-bearing images and alignment is also integrated. ATEC Earnings Transcript* on Seeking Alpha
ROSA for Partial Knee was approved in April, w/ the first surgery early in Q221 & ongoing good traction & feedback. W/ a sizeable market share in partial knee, the Company is excited about both revenue & patient outcomes. ZBH Q221 Earnings Transcript* on Seeking Alpha
Upcoming launches for SPNE include a line extension of the Mariner platform w/ an alpha launch of an adult deformity system and the full launches of NorthStar OCT, Admiral Anterior Plating System, and the WaveForm C 3D-printed IBD. SPNE Q221 Earnings Transcript* on Seeking Alpha
Studies:
A study evaluated 104 novices at using MAKO to simulate bone shaving. Weekly duration of videogame playing was negatively related to performance. Men & women performed equally, but women who played videogames performed better than women who didn’t. J Robot Surg
A 69-pt retro study compared pedicle screw placement using a novel electromagnetic navigation (EMN) system vs conventional C-arm fluoroscopic (CF) guidance. W/ EMN, surgery duration & placement time/screw were lower & accuracy better (both P<.05). Euro Spine J
A systematic review of patient-specific instrument use in total ankle arthroplasty reported implant position and function outcome of TAA was similar between PSI and SI. Study stated current evidence is not strong enough to evaluate PSI TAA. Int Orthop
Deals/Financing:
OrthoPediatrics and Mighty Oak Medical, Inc. announced the continuation of their navigation partnership another 5 yrs to August 2027. Since 2017, OrthoPediatrics has been the exclusive distributor of Mighty Oak Medical’s FIREFLY Technology in US children’s hospitals.
SNN noted that its acquisitions of Brainlab, Atracsys & other digital assets have helped it build out its digital surg portfolio. SNN plans to bring Brainlab’s technology to the CORI platform to expand indications in the future. SNN’s Q221 Earnings Transcript* on Seeking Alpha
RTI Surgical entered into a long-term strategic agreement with Exactech related to the development and supply of biologic bone substitutes. As part of the agreement, RTI acquired Optecure bone matrix from Exactech.
Clinical/Regulatory:
In this overview, the authors describe a novel single-portal ECTR method, conceived to reduce the risks of iatrogenic complications by optimizing visual control and avoiding dilatation of the CT. Tech in Hand & Upper Extremity Surgery
In this study, researchers compare rate of donor site morbidity between patients who have their harvest sites bone grafted with autologous bone (BG) & those whose harvest sites remain unfilled (nBG). Est primary comp date Jun 2022, est study comp date Jun 2024. Clinicaltrials.gov
Zimmer Biomet will be sponsoring a 365-pt post-market clinical study at Washington Univ, St. Louis, MO on the safety, performance and clinical benefits including 10-year survivorship of Alliance Glenoids in primary or revision TSA. clinicaltrials.gov
Markets:
XTNT believe its platform for growth, including exceptional market access, high quality biologics, niche fixation products and improved bio production capabilities puts the company in a position to drive momentum going forward. XTNT Q221 Earnings Transcript* on Seeking Alpha
For FY22, FDA raised the Med Device user fees by +2.5% for a PMA. The base fee is $329,000, to apply from 10/01/21 to 9/30/22. The standard fee (adjusted base amount) for a PMA, incl a biologics license application, premarket report and a BLA efficacy supplement, is $374,858.
For Q221, OFIX reported Biologics portfolio net sales increased +$3.7MM or +33.5%, as multi-level complex procedure volumes have recovered from Q220, but they have not returned to historical levels prior to the pandemic. OFIX Q221 Form 10-Q
Revenues:
Revenue from Anika’s sole significant customer, JNJ/DePuy Synthes, as a percentage of total revenue was 46% and 54% for Q221 and Q220, respectively, and 44% and 54% for H121 and H120, respectively. ANIK Q221 Form 10-Q
OrthoPediatrics reported Q221 Scoliosis revenue of $7.7MM, +100% as compared to $3.8MM for Q220, reflecting increased patient volumes and growth in Response and Firefly procedures, as well as initial contribution from ApiFix.
Orthofix provided an update for the Company’s FY21 Financial Guidance, w/ total net sales now expected to be in the range of $468MM to $474MM (+15.1% to +16.6% YoY), compared to prior Financial Guidance of $455MM to $465MM. OFIX Q221 Earnings Release
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