Why do surgeons participate so early in the R&D process?

Dr. Innovation to the R&D Lab, STAT  (ODT Mag written by Jeff Schell, CEO @ TranS1)
Surgeon-led innovation can improve and expedite medical advancements.
As bioscience and medical device companies strive to stay innovative, a trend is emerging. Surgeons are joining the front lines and helping companies innovate at the ground level to create better products. Coupled with the exponential rate at which new technologies are developed, surgeon-led innovation is changing the landscape for what is possible in healthcare.
Traditionally, medical research and development begins with medical device companies and ends with surgeons. Today, early collaboration between inventors, developers, and medical professionals is yielding the development of a number of amazing new technologies and eliminating much of the need for later redevelopment.
Who better to provide insight into creating unique solutions that fill a need while being financially viable than the medical professionals at ground zero in the operating room?
To read the full feature, see it at ODTmag – Dr. Innovation to the R&D Lab, STAT

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Surgeon who used Norian for treatment of a vertebral compression fracture is exonerated by jury 9 years later

SURGEON USING SYNTHES’ NORIAN EXONERATED BY JURY (Orthopedics This Week)
ALL Norian articles
Jens Chapman, M.D., a University of Washington surgeon, implanted Synthes, Inc.’s Norian bone cement in Reba Goldman’s spine after an accident in 2007.
Goldman reportedly died on the operating table. Cindy Wilson, Goldman’s daughter sued Chapman and Synthes, Inc. and four company executives. The company reached a confidential settlement with Wilson during the trial, but Chapman left his fate in the hands of the jury.
The jury, after a five-week trial, voted 10-2 in favor of Chapman, determining that the surgeon did not act below the standard of medical care. The jury, according to Wilson’s lawyer, Rick Friedman, also found that Chapman had failed to inform Golden about the risks associated with using Norian but concluded that an informed person would have opted to use the cement anyway.
Michael Madden, a lawyer representing Chapman and the university, reportedly told the jury that Goldman’s spine injury caused her extreme pain, and Chapman used a safe procedure to try to help her. He added Chapman did not use the Norian bone cement in a way that put Golden at risk.
Norian’s Rocky Road
Norian has been a sad story for Synthes ever since Synthes bought the California-based Norian Corporation in 1999.
By July 2003, adverse events began being reported and one patient death. Two more patients died in 2003 and 2004, and by January 2007, the FDA got involved and required labeling that said that Norian XR was not intended for use in the spine.
Sometime around June 2002 clinical investigators at the University of Washington told Synthes that they had found that the calcium contained in Norian SRS had a unique interaction with blood, providing both a surface on which clots could form and a chemical stimulus to clot formation. The pilot studies further showed dramatic clotting of a pig’s lung veins following injection of a small amount of SRS.
Six months later, December 19, 2002, the FDA cleared Norian XR as a general bone void filler with a label stating that XR was intended to fill only bony voids that were “not intrinsic to the stability of the bony structure” in the extremities, spine and pelvis, and further warning that XR was “not intended for treatment of vertebral compression fractures.”
One month later, January 13, 2003, a spine surgeon used Synthes’ Cavity Creation instruments on a patient who became immediately hypotensive and died on the operating table. The doctor could not rule out Norian as a cause of death.
Nine months after the first death, another spine surgeon used Norian XR with the Synthes Cavity Creation instrument. That patient also suffered a hypotensive episode and died. The doctor noted a cement leak and believed that it was the cause of the episode and could not rule out Norian XR as a cause of the death.
There were criminal and civil lawsuits and four former Synthes executives pled guilty in mid-2009 to a misdemeanor count of shipping adulterated and misbranded Norian XP in interstate commerce. Synthes paid a $23.5 million fine and was ordered to divest Norian.
More to Come
Friedman represented another client who sued Synthes, Chapman and the university for using Norian in a fatal surgery. All parties settled before trial.
After the Wilson trial started, Friedman said he was contacted by several other Chapman patients involving the use of Norian.
“We’re looking at those,” he said.
Norian continues to have a financial and moral impact on, now DePuy Synthes, but not in the way Synthes had hoped for back in 1999.

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SeaSpine acquires NLT Spine's MIS interbody technology for $53M

SeaSpine Holdings (SPNE) to Acquire NLT Spine; Updates FY16 Guidance (StreetInsider)
http://www.nlt-spine.com/        http://www.seaspine.com/
SeaSpine acquisition of NLT Spine could be worth $53m (MassDevice)
SeaSpine Holdings Corporation (NASDAQ: SPNE) announced that it is has entered into a definitive agreement to acquire substantially all of the assets of NLT Spine Ltd. (NLT), an Israel-based medical device company developing innovative spinal products for minimally invasive surgery (MIS).
NLT’s platforms include vertical, lordotic and footprint expanding interbody technologies for use in lumbar fusion procedures for the treatment of degenerative spinal conditions. By allowing surgeons to place smaller interbody implants that expand within the interbody space, these patented technologies are designed to enable smaller incisions and less nerve retraction, while achieving the same advantages of larger implants but with easier insertion and potentially less tissue disruption.
Acquisition terms include an upfront cash payment, issuance of common stock upon achievement of a near-term regulatory milestone, longer-term commercially-based milestone payments, as well as future revenue-based royalties.
“This transaction strengthens our future product offerings and broadens our growing portfolio of differentiated interbody solutions, one of the fastest growing market segments within spine, while demonstrating to distributors and the surgeon community our commitment to innovation, including through strategic acquisitions,” said Keith Valentine, President and Chief Executive Officer of SeaSpine. “The deal structure allows us to acquire differentiated assets with modest upfront investment, while deferring the majority of consideration to sales-based payments and commercially-based milestones. Equally important, it reflects the belief of NLT’s investors in both the potential of their technology and our ability to commercialize it successfully.”
“We’re pleased to add our line of products and technologies to SeaSpine’s comprehensive suite of offerings in the spine intervention market,” said NLT President and Chief Executive Officer, Didier Toubia. “We see SeaSpine as the ideal group to bring to market and drive adoption of our innovative interbody spine solutions, which we believe will benefit patients and our shareholders, now and in the longer-term.”
NLT’s broad intellectual property portfolio includes technologies that provide a robust pipeline of innovative MIS interbody solutions. NLT’s patent estate includes additional disruptive technologies with potential in other spinal applications. SeaSpine plans to further refine NLT’s existing products based on feedback from leading spine surgeons prior to full commercial launch and to evaluate NLT’s full intellectual property portfolio for additional product development opportunities.
Updated 2016 Financial OutlookThe transaction does not affect SeaSpine’s previously communicated 2016 revenue guidance. The Company expects to pay in 2016 up to $1.7 million for acquisition considerations, transaction costs and transition services fees.

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Mazor Robotics has big expectations as it leverages the Medtronic partnership

Mazor Expects Record Year As Medtronic Helps It Launch Mazor X Robot (MedDeviceOnline)
Mazor Robotics and Medtronic are gearing up for the launch of the robotic spine surgery platform Mazor X as part of their multi-phase deal.
Ori Hadomi, CEO of Mazor, told analysts that the company by late August will start educating Medtronic sales reps at training centers on Mazor X, which is slated for commercial launch this October at the Annual Meeting of the North American Spine Society. During this ramp-up period, Medtronic will be focused on generating demand and interest from surgeons and hospitals, while Mazor will build it client list and take responsibility for closing sales. The Mazor X launch is part of the first phase of the agreement signed by the two companies in May, which includes milestones and conditions.
In the second phase in 2018, Medtronic will assume exclusive global sales and distribution rights for the Mazor X, specifically for the spine (but not brain) market. It will up its stake in Mazor to 10 percent and target annual quotas, with a cumulative potential of hundreds of Mazor X systems by 2021.
Medtronic already has ordered 15 Mazor X systems to be delivered during the second half of 2016. Five robots will be placed in unspecified facilities while 10 will be installed in leading clinical centers, according to Hadomi.
Unveiled in mid-July, the Mazor X platform includes pre-operative analytics to help surgeons plan their operations, intra-operative guidance with robotically placed tools, real-time 3D verification through proprietary fluoroscopy-based technology, and connectivity features, reported MDO.
Hadomi said surgeon feedback so far has been overwhelmingly positive, especially with regard to the system’s pre-op analytics “with all the capabilities of being able to plan and stimulate alignment and then execute it.” The system has been used in over 130 cases to place approximately 1040 implants.
“I believe it will transform and redefine the standard of care for spine surgeries and once again demonstrate our vision of savings reservation. We intend on remaining the market leader and other will be measured by our success. I remain confident about the remainder 2016 being a record year in system sales and utilization and our profits well beyond simply put Mazor is in the right place at the right time with the right technology and the right partner to be the global leader of spine robotics,” Hadomi told analysts during the call, according to Seeking Alpha.
Although Mazor X has different software and hardware components, the new system’s guidance technology is said to have been leveraged from experience with Mazor’s older Renaissance guidance system, which has been used in over 18,000 procedures globally.
Mazor received orders for 11 Renaissance systems during the second quarter, six of which were installed in the United States, including two systems with brain modules, the company reported through a press release. Five systems were delivered internationally. Mazor touted positive data from two studies using Renaissance robots for minimally invasive spine surgery at the 23rd International Meeting on Advanced Spine Techniques in Washington, D.C. held recently.
Hadomi believes that Mazor has tapped only a fraction of the addressable market for Renaissance, which is estimated at over 2,000 facilities which perform over 400,000 procedures.
Mazor reported revenue of $8.3 million for the second quarter, ending June 30, 2016. For the first half of 2016, revenue increased 20 percent to $14.7 million compared to $12.3 million for the same period last year.

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Medtronic buys another piece of the Mazor robot-assisted spine surgery startup

Mazor X unveiling triggers another $20m from Medtronic (MassDevice)
Medtronic paid $20 million for a 3.4% stake in Mazor at $21.84 apiece, the trailing 20-day average for MZOR shares, the Caesarea, Israel-based company said. It’s part of a 2-stage deal struck with the world’s largest pure-play medtech maker back in May.
The 1st phase of the deal calls for Medtronic to acquire 15 Mazor systems in 2016 and makes Medtronic Mazor’s sole partner for developing and commercializing robot-assisted spine surgery devices.
The 2nd phase is a 3-step equity investment in Mazor; including the payment announced today, the 2nd step in the equity phase, Medtronic has spent $31.9 million acquiring a 7.27% stake in Mazor.
“Since signing the agreements in May our 2 organizations have been working closely to ensure a successful partnership,” CEO Ori Hadomi said in prepared remarks. “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 [North American Spine Society] conference this October. I am confident it will advance and change the way spine surgery is performed.”
The 2nd equity investment was triggered by the launch of the Mazor X system in July, Mazor said.
When the deal was announced in May, Mazor said the 3rd step in the equity stage would be at its discretion, after the 2nd investment and a global distribution agreement, for up to 5% more at the same trailing-20-day price. As with the 2nd tranche, Medtronic can cap the 3rd tranche at $20 million.
Mazor, which had $47.5 million in cash and equivalents as of June 30, said that amount would swell to about $65 million after Medtronic’s 2nd investment.
MZOR shares ticked up 0.3% to $23.93 today in early pre-market trading.

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