Orthopedic companies with digital products should engage InTouch now!

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Read also – Dear CEO, the future of orthopedics is software

InTouch Health
Intuitive Surgical Could Help Usher in a New Era for Medtech (MDDI Online)
InTouch Health is building an Internet of Medical Things for Intuitive Surgical that could also benefit other medical device companies and healthcare systems.
More than a decade ago Amazon recognized that it needed mass-cloud computing power, but didn’t believe there was a third party service available to meet their needs, so they built their own cloud computing infrastructure. The online retailer also realized early on that this problem that it had solved for itself was the same problem that people and organizations all over the world were also facing, so they created the Amazon Web Services (AWS) subsidiary.
Santa Barbara, CA-based InTouch Health is following Amazon’s example in an effort to offer medical device companies an ability to connect to their products after they’ve been installed within a highly secure healthcare network. The company has built a telehealth platform that allows it to tap into any of the 2,300 hospitals that its software is currently inside of in order to solve the challenge of interconnectivity between unaffiliated healthcare facilities. But rather than just keep this ability to itself, InTouch has started partnering with other medical device companies seeking a way to access data from their own devices and software systems that sit inside a healthcare environment.
This week the company announced it is working with Intuitive Surgical to build an Internet of Medical Things (IoMT) that will enable the surgical robotics company to access their surgical systems within hospitals or surgery centers.

“Intuitive came to us and said, ‘Hey InTouch, we have 4,000 surgical robots all over the world and we would like to be able to pull data off of those devices and push software into them in a very secure, reliable network’,” Joseph DeVivo, CEO of InTouch Health, told MD+DI.  “And because our network was built in a HITRUST certified, HIPAA-compliant manner for high-risk healthcare, it meets their requirements.”
Although the financial terms of the partnership were not disclosed, DeVivo characterized it as “not an insignificant deal,” that will enable InTouch to expand its capabilities. “And, like Amazon, we believe we will be building a separate business within InTouch, helping all medical companies who wish to have access to their devices in these secure environments to do so through our cloud,” he said.
For Intuitive, the agreement will expand its use of real-time data to support surgeons in the operating room and help them achieve better patient outcomes, said Brian Miller, PhD , Intuitive’s senior vice president of systems and vision.
InTouch has data centers around the world, and its network is proactively monitored and serviced on around the clock, much like an alarm company. The InTouch Health Network provides redundancy, low latency, and the ability to reach thousands of highly secure global medical locations with one click, the company said.
“Hospital firewalls and security requirements are purpose-built to keep outsiders outside, which makes in-facility telehealth between two unaffiliated institutions with separate security protocols and VPNs a major challenge,” DeVivo said. “Over the past 15 years, we solved this issue by creating the only telehealth network that reliably connects across secure provider networks. It’s because of our network that our customers experience a first-time connection success rate of over 95%. Today, healthcare companies, like Intuitive, which want to push and pull data to and from their devices are asking InTouch to help them build an equally secure, reliable, and scalable network for IoMT. As we look for new ways to maximize the impact technology has on healthcare and enable the increasing demand for data, I believe InTouch’s IoMT network will be as big of a market opportunity as our core telehealth business.”

Amanda Pedersen

Amanda Pedersen is MD+DI‘s news editor.  Contact her at [email protected].

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Medtronic acquires Mazor Robotics for $1.6B (25 X sales last year)

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Read press release
Medtronic strikes $1.6B takeover of Mazor Robotics (MedTechDive)

Dive Brief:

Medtronic is set to pay $1.64 billion to buy Mazor Robotics for its portfolio of guided spinal surgery technologies.
The takeover will give Medtronic control of technologies that enable robotic, guided spinal surgeries that deliver better outcomes than freehand procedures.
Medtronic will combine the technologies with its existing devices and technologies to create a portfolio of products covering each step in the planning and execution of spinal surgeries.

Dive Insight:
Medtronic first showed an interest in Mazor when it bought a 15% stake in the Israeli company in 2016. The following year, Medtronic tightened its ties to Mazor by adding to its investment in a deal that gave it the right to distribute the Mazor X robotic guidance system.
This activity took place against the backdrop of a lull in acquisitions at Medtronic, which stepped away from the deal table after agreeing to buy Covidien for $42 billion in 2015. Medtronic CEO Omar Ishrak indicated the company was ready to start striking deals again last month, and has followed up with a big move into the robotic-assisted surgery sector.
Once Medtronic’s existing stake in Mazor and the cash included in the acquisition are factored in, the deal will cost the medtech major $1.34 billion. In return, Medtronic will take ownership of Mazor X and Renaissance. Mazor developed the two technologies to free surgeons from the need to perform spinal procedures freehand. Using Mazor’s technologies, surgeons can plan procedures in 3D modeling software and execute them with the assistance of robotic arms.
Clinical studies suggest the move from freehand to robotic-assisted surgery reduces the complication rate, length of hospital stay and need for subsequent revision procedures. Medtronic is convinced these benefits will ensure robotic surgical technologies proliferate in the years to come.
“Over the past two years it’s become clear to us that enabling technology like this is the future,” Geoff Martha, president of Medtronic’s restorative therapies group, told Bloomberg. “It improves outcomes in spinal surgery and reduces the variability. Once we realized this is clearly the future, we knew we had to integrate all this technology.”
The integration referred to by Martha will see Medtronic combine Mazor’s products with its existing spine implants, navigation tools and intra-operative imaging technology. By bringing the technologies together, Medtronic aims to offer a suite of products that span surgical planning, execution and confirmation.
Once integrated, Medtronic will set about growing the use of devices that have already gained some commercial traction. Mazor has installed more than 80 Mazor X systems since introducing the technology in 2016. When the older Renaissance system is factored in, more than 200 Mazor systems are in clinical use. These systems have guided the placement of more than 250,000 implants in around 40,000 procedures.
Demand for Mazor X and Renaissance have established Mazor as an emerging force in robotic-assisted surgery. However, while Mazor and others are moving robots into new surgical areas and creating competition, the sector remains dominated by Intuitive Surgical.

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Hanger is the first to create "network-connected" devices in orthopedics

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Hanger and AT&T create industry-first, network-connected device for prosthetic limbs (press release)

Along with AT&T*, Hanger, Inc. (OTC PINK: HNGR) today announced the two companies have developed a trailblazing proof of concept for the industry’s first standalone, network-connected device for prosthetic limbs. The prototype, designed to attach to below-the-knee prostheses, is simple and highly mobile as it syncs directly to the cloud via AT&T’s network without relying on Wi-Fi, Bluetooth, or a separate mobile device. This connectivity allows Hanger Clinic, the patient care subsidiary of Hanger, to receive data on patients’ prosthetic usage beyond the clinical setting. Equipped with these insights, Hanger Clinic clinicians can proactively contact patients to address potential issues impacting prosthesis usage, such as fit and comfort, to in turn increase mobility.
Physical mobility is intrinsic to our everyday lives – running, bathing, dressing, driving. Now imagine losing a limb. When professional acrobat Andrew “AJ” Montgomery underwent a below-the-knee amputation following a motorcycle accident three years ago, he didn’t just have to re-learn once-instinctual movements. He also faced the uncertainty of continuing his acrobatic career with a prosthesis.
“After my amputation, I wasn’t sure how to tackle my life – where I’d left off, where I’d be going,” Montgomery said.
Those experiencing limb loss face an unfamiliar journey to finding their way to restored mobility. Some who don’t know where to begin might not communicate their challenges with their prosthetic clinicians, potentially leading to lack of use of their prosthesis.
But what if the prosthesis could talk directly to the patients’ caregivers? If this data feed could be relevant, automated and more detailed, caregivers could provide patients with better, targeted assistance. The AT&T Foundry, which is designed for collaborative innovation projects just like this, was the ideal venue for this venture with Hanger. The resulting prototype is designed to collect data on prosthetic usage and mobility in near-real time. The device is connected via AT&T’s LTE-M cellular network, and has an accompanying interactive mobile app.
“Becoming an amputee can be an emotional, traumatic experience,” said Aaron Flores, PhD, Hanger Clinic Vice President, who is responsible for the company’s fabrication network. “Transitioning from living with a fully functioning leg to a prosthesis requires re-learning how to walk entirely. Unfortunately, not everyone knows when or how to talk to us about potential challenges. This device will give us a window into patients’ daily experiences and equip us with a level of connectivity we’ve never had before, and in turn, provide even better patient care.”
Getting to an intuitive, seamless prototype required a flexible and nimble design process, collaboration and rapid iterations, which is how the AT&T Foundry approaches all its projects. In this case, combining an accelerometer, gyroscope, magnetometer and an LTE-M modem into a compact device resulted in multiple test versions of the prototype. With each version we provided new information – where to install the different components, how to balance the weight to make the prosthetic device comfortable with the prototype, the best way to capture and transmit data about speed of motion, impact force, direction, rotation, and more. In the span of just a few months, we’d gone from a concept to a prototype that was ready for real-world testing.
To put this data into action, we also prototyped an iOS app equipped with patient and clinician portals. The app will allow patients to view their day-to-day progress, such as number of steps taken. It also includes a video calling feature so patients can talk with Hanger Clinic providers about potential issues with their device. Likewise, clinicians can view their patients’ activity levels and contact those whose user data shows low activity or irregularities.
“Because this device is intended to become a physical part of Hanger’s patients, the technology driving it needed to be intuitive and seamless while providing benefits to both the patient and the caregiver,” said Vishy Gopalakrishnan, vice president of AT&T Ecosystem & Innovation. “The AT&T Foundry is uniquely suited to help customers like Hanger quickly solve these types of challenges. Through close customer collaboration, a proven ability to rapidly prototype the test solutions, and our advanced knowledge of connectivity, we’re able to move these revolutionary concepts to market faster than once possible.”
What’s next Hanger is currently trialing five of these devices with existing patients. In the coming months, Hanger and AT&T will continue to take the best components of this proof of concept to create a fully functional product for the next phase of this project.
“At Hanger, we know to best meet our patients’ needs, we need to be the most digitally connected company in O&P, so we can connect with our patients wherever they may be,” said Vinit Asar, Hanger President and Chief Executive Officer. “Collaborating with AT&T on this prototype not only allows us to equip our patients with the tools they need to get their lives back on track faster, but also helps us solidify our life-long commitment to them.”
About Hanger, Inc. Built on the legacy of James Edward Hanger, the first amputee of the American Civil War, Hanger, Inc. (OTC PINK: HNGR) delivers orthotic and prosthetic (O&P) patient care, and distributes O&P products and rehabilitative solutions to the broader market. Hanger’s Patient Care segment is the largest owner and operator of O&P patient care clinics with approximately 800 patient care locations nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions. With over 150 years of clinical excellence and innovation, Hanger’s vision is to lead the orthotic & prosthetic markets by providing superior patient care, outcomes, services and value. For more information on Hanger, visit www.hanger.com.
*About AT&T Communications We help family, friends and neighbors connect in meaningful ways every day. From the first phone call 140+ years ago to mobile video streaming, we innovate to improve lives. We have the nation’s largest and most reliable network and the nation’s best network for video streaming.** We’re building FirstNet just for first responders and creating next-generation mobile 5G. With DIRECTV and DIRECTV NOW, we deliver entertainment people love to talk about. Our smart, highly secure solutions serve over 3 million global businesses – nearly all of the Fortune 1000. And worldwide, our spirit of service drives employees to give back to their communities.
AT&T Communications is part of AT&T Inc. (NYSE :T ). Learn more at att.com/CommunicationsNews.
AT&T products and services are provided or offered by subsidiaries and affiliates of AT&T Inc. under the AT&T brand and not by AT&T Inc. Additional information about AT&T products and services is available at about.att.com. Follow our news on Twitter at @ATT, on Facebook at facebook.com/att and on YouTube at youtube.com/att.
© 2018 AT&T Intellectual Property. All rights reserved. AT&T, the Globe logo and other marks are trademarks and service marks of AT&T Intellectual Property and/or AT&T affiliated companies. All other marks contained herein are the property of their respective owners.
**Coverage not available everywhere. Based on overall coverage in U.S. licensed/roaming areas. Reliability based on voice and data performance from independent 3rd party data.
For more information, contact:
Krisita Burket Hanger, Inc.  Phone: 904-239-4627 Email: [email protected]
Katie Franklin AT&T Corporate Communications Phone: 469-203-0729 Email: [email protected]
SOURCE Hanger, Inc.
Related Links
http://www.hanger.com

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Histogenics gambles on an FDA clearance with a missed end point

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STRONG DATA FROM DISAPPOINTING NEOCART TRIAL (Orthopedics This Week)
So close, they were … Histogenics Corporation, that is. When it comes to biologics, you want high standards—and that is where the Waltham, Massachusetts company started.
Recently, they announced that their Phase 3 clinical trial of NeoCart—a restorative cell therapy—did not meet the primary endpoint of a statistically significant improvement in pain and function in a study one year after treatment as compared to microfracture.
But the silver lining is in the details, says the company.
President and CEO Adam Gridley told OTW, “This is the largest and first prospectively designed, randomized clinical trial in North America evaluating the safety and efficacy of a restorative cell therapy to treat knee cartilage damage.”
“Ten years ago, we set an extremely high bar for success with a dual threshold responder analysis (and this was before FDA guidance). On top of that, we chose what was at the time the highest meaningful clinical difference threshold. Our scientists designed an elegant endpoint, but at the time they didn’t appreciate the robust nature of what it took to hit those endpoints.”
“Not only is cartilage the Holy Grail of orthopedics, but this is one of the most challenging regulatory environments in which to conduct clinical trials. The fact is that we missed hitting the trial’s primary endpoint by only two microfracture responders out of the 249 patients that participated in the trial.”
“We had incredible data, and we are already demonstrating clinically meaningful results. Rapid recovery is important in orthopedics, and at six months, we saw statistically superior results, which is unheard of with currently available treatment options. At one year, we missed the mark by two patients.”
“The data showed that in patients with a body mass index (BMI) higher than 28 and with larger lesions NeoCart did extremely well. If we had enrolled a lot of patients with a BMI of 35 for and with previous failures, then people would say we had stacked the deck. We went to the other extreme, which is what the FDA asked. While microfracture did better than we had anticipated, in no case did it do better than NeoCart.”
“As for our investors, they are saying, ‘Just file it because this data is so good compared to what has been approved or what is in development.’ And we hope the FDA appreciates the data because clinicians ‘get it.’ As for surgeons, they are frustrated because they have so few options, they are saying, ‘We hope this data puts microfracture in the grave where it belongs.’”
“Our next step is to engage with the FDA immediately and then file a Biologics License Application (BLA) at the end of this year or early next year. The FDA has been great to work with, so we want to sit down with them as soon as possible.”
“In the end, it is all about the patients … they are the ones who keep us going. It is genuinely heartening to hear stories about NeoCart giving people their lives back.”
 

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Globus acquires Surgimap, a surgical planning software startup

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Read Tiger’s wake-up call about Software 

Globus Medical (GMED) Acquires Surgimap (press release)
Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced the acquisition of Nemaris Inc., a privately held company that markets and develops Surgimap®, a leading surgical planning software platform. Surgimap® allows healthcare professionals to simulate potential surgical outcomes and share medical imaging globally to improve procedural workflow and patient care.
“The acquisition of Surgimap® bolsters Globus Medical’s efforts to advance the future of computer-assisted surgery with the goal of improving patient outcomes,” said Chief Executive Officer Dave Demski. “Software-enhanced solutions are critical components of the future of computer-assisted surgery, and Surgimap® is the leading surgical planning software technology in the spine market today. We are very excited about the strategic fit of this acquisition, which will allow us to further enhance the capability of our ExcelsiusGPS® navigation and robotic system to assist surgeons in planning complex spine procedures and placing screws more accurately and less invasively.”
Surgimap®’s intuitive, patient specific surgical planning and cloud-based infrastructure, with predictive algorithms and visual guides, is licensed to most of the leading spine implant manufacturers today to enable these customers to plan and simulate potential surgical outcomes in the course of treating complex deformities. The addition of Surgimap® will further strengthen Globus Medical’s ExcelsiusGPS® platform by streamlining workflow and enabling superior data analytics. These existing platform features, in addition to the deep software expertise of the Surgimap® team, are also expected to accelerate the launch of new products in Imaging, Navigation, and Robotics.
“The acquisition will enable Globus to combine Surgimap®’s best-in-class spine surgery planning technology with the best-in-class robotic and navigation technology of ExcelsiusGPS®,” said Dr. Frank Schwab, Chief of Spine, New York City, and co-founder of Nemaris. “We think the synergies bring enormous benefit to the entire spine community and particularly surgeons who are interested in less invasive robotic and navigation based procedures.”

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