Mazor Robotics Ltd. has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.
Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.
According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”
Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.
Stryker Corporation announced the commercial launch of the highly anticipated robotic-arm assisted total knee arthroplasty application for use with its Mako System at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Diego. This latest advancement distinguishes the Mako System as the first and only robotic technology that can be used across the joint replacement service line to perform total knee, total hip and partial knee replacements.
Mako Total Knee combines Stryker’s advanced robotic technology with its clinically proven Triathlon Total Knee System (“GetAroundKnee”), enabling surgeons to have a more predictable surgical experience with increased accuracy.1 Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient’s unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.
Total knee replacements in the United States are expected to increase 673 percent by 2030,2 yet studies have shown that approximately 30 percent of patients are dissatisfied after conventional surgery.3 As this procedural growth materializes, surgeons will continue to seek clinical solutions that leverage technological advancements to improve their patient’s satisfaction.
“We are excited to be leading the transformation of the orthopaedics industry with the commercial launch of the Mako Total Knee application,” said Bill Huffnagle, President of Stryker’s Joint Replacement Division. “We believe that pairing our Mako robotic-arm technology with our market leading implant systems will enable surgeons to have an improved surgical experience.”
More than 83,000 Mako robotic-arm assisted procedures, including total knee, partial knee and total hip replacements, have been performed through 2016. More than 350 Mako Systems have been placed in the United States with over 1,400 Mako Total Knee replacements performed to date.
Medrobotics Corp. received CE Mark regulatory clearance in Europe for colorectal applications with the Flex® Robotic System. Medrobotics is the first robotic company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures. With this expanded indication, the Flex® Robotic System becomes the first robotic surgical platform offering the ability to access hard to reach anatomy in both otolaryngology and colorectal procedures without the limits imposed by straight, rigid instruments.
Intuitive Surgical and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced a joint venture to research, develop, manufacture and sell innovative, robotic-assisted catheter-based medical devices.
The joint venture between Intuitive Surgical, the global leader in robotic-assisted minimally invasive surgery, and Fosun Pharma, a leading healthcare group strategically comprising the complete value chain, will initially produce products targeting early diagnosis and cost-effective treatment of lung cancer, one of the most commonly diagnosed forms of cancer in the world.
The technology will be used in robotic-assisted medical devices based on catheters, and incorporates proprietary intellectual property developed or owned by Intuitive Surgical. The joint venture will be registered in Shanghai, where it will perform research and development activities and manufacture catheter-based products for global distribution. Distribution in China will be conducted by the joint venture. Distribution outside of China will be conducted by Intuitive Surgical.
Mazor Robotics Ltd. announced the completion of the second tranche of the equity investment by Medtronic pursuant to a previously executed agreement between the parties. The Company issued new securities representing 3.40% percent of Mazor’s issued and outstanding share capital, on a fully diluted basis, at a price per ADS $21.84, which is equal to the volume weighted average price of the ADS’s for the trailing 20-day period ending on and including August 9, 2016, for an aggregate purchase price of $20 million. The triggering milestone for this second tranche investment was the July 12, 2016 unveiling by the Company of Mazor X, a transformative Surgical Assurance Platform to enhance predictability of spine surgeries for the benefit of patients and those who treat them.
“Since signing the agreements in May our two organizations have been working closely to ensure a successful partnership,” commented Ori Hadomi, Chief Executive Officer. “This investment by Medtronic reflects a key operating achievement – the unveiling of the Mazor X Surgical Assurance Platform – and in just a few short weeks we have received many inquiries from new surgeons, as well as interest from our existing Renaissance user base. The feedback is overwhelmingly positive and we plan to launch Mazor X at the NASS conference this October. I am confident it will advance and change the way spine surgery is performed.”
Following the completion of the second tranche investment, Medtronic has purchased a total of 1.96 million ADS’s, representing 7.27% of Mazor’s issued and outstanding share capital, on a fully diluted basis, for a total of $31.9 million.
As of June 30, 2016, cash, cash equivalents and investments totaled $47.5 million. Following the completion of the second equity investment, the Company’s cash, cash equivalents and investments will total approximately $65 million and the fully diluted share count will be approximately 53.9 million.