Robotic Exoskeleton Market Ripe for Expansion

by Jennifer French, senior editor

January 2016 issue

The market for robotic exoskeletons is poised for significant growth in the years ahead as new vendors enter the market and existing players gain funding and momentum.

Exoskeletons are not new. In the 1960s, General Electric developed the first exoskeleton for military use called the Hardiman. It later proved to be impractical for its given purpose. In 2001, DARPA began phase I of the Exoskeletons for Human Performance Augmentation Program and in 2015 began testing mechanical exoskeletons for energy conservation and performance on soldiers at the Aberdeen Proving Ground. These external wearable brace support systems with computer-based integration and motion sensors have been used for industrial and military purposes but are also gaining momentum as components become smaller and more efficient.

In the recently released report The Market for Neurotechnology: 2016-2020, Neurotech Reports projects the exoskeleton market will be $44 million 2016 and grow to over $100 million by 2020. Neurotech Reports categorizes exoskeletons as neuroprosthetic devices since they restore lost function to an individual with a neurological condition. However, some vendors are marketing the devices as rehabilitation tools. Including neurorobotic systems used for rehabilitation purposes, the total market will reach $193 million by 2018, according to the report.

The current published research tends to agree with this. In a systematic literature review published in the journal NeuroRehabilitation in 2015, the authors reviewed 27 published studies involving 144 participants in more than a half dozen countries and spanning a 13-year timeframe. Of these studies, only 29 percent evaluated the rehabilitative effectiveness of exoskeletons for paraplegic patients. There is no doubt the systems increase mobility, improve function, and reduce the risk of secondary injury but demonstrative effectiveness compared to other rehabilitative techniques is still an open question. There is ongoing research in top rehabilitation facilities at the VA and around the world to address this question.

At the moment, the FDA categorizes exoskeletons as class II devices with special controls including a level of supervision and a training program. This has not deterred vendors. ReWalk Robotics, formerly Agro Medical Technologies, is the most aggressive in this space. The company gave a demonstration to President Obama in 2013 and launched an IPO in 2014. Led by CEO Larry Jasinski, ReWalk was the first to be FDA approved for home and community use for consumers with lower extremity paralysis and with defined health benefits of fat tissue loss, increased lean muscle mass, and improved bowel function. The company overcame a hurdle in the struggle for reimbursement in December when the Department of Veterans Affairs approved a National Coverage Policy for paralyzed veterans living with SCI, plus the VA will train staff at a dozen medical centers around the country.

On ReWalk’s heels is Ekso Bionics. The company was founded in 2005 when Homayoon Kazerooni, Russ Angold, and Nathan Harding partnered with members of the Berkeley Robotics and Human Engineering Laboratory at UC Berkeley and later gained a contract with the Department of Defense and Lockheed Martin for military applications. Ekso is exploring broader medical applications beyond ambulation for paralyzing neurological conditions like SCI, TBI, and stroke. The company is dabbling in the orthopedic, obesity, and COPD space and building the management team around this strategy. Ekso went public in 2014.

American vendors are not the only ones getting into this space. Cyberdyne out of Tsukuba, Japan offers the elegant HAL (Hybrid Assistive Limb) device. This cyborg type robot has a presence in the medical device space and is working its way through the complex Japanese reimbursement system, but also has medical center collaborators in northern Europe. Another competitor is REX Bionics, based in New Zealand with offices in the U.K. REX is much bigger than its rivals but it functions as a hands-free robotic mobility device and with the added stability opens the opportunity of a wider range of users in the paralysis space. The company was founded in 2003 and later acquired by Union Medtech in 2014. Much like ReWalk, REX offers a personal and a clinical use device. Bionik Laboratories in Toronto, ON is in early clinical development of their exoskeleton device, ARKE. The company is clearly positioning as a rehabilitation company and also has pipeline development for other ancillary devices for the rehab market.

A big player has entered this space in the form of Parker Hannifin and its partnership with Vanderbilt University researcher Michael Goldfarb. In October 2012, Parker Hannifin signed an exclusive licensing agreement with Vanderbilt for the right to develop and manufacture a commercial version of the exoskeleton, which it plans to release under the brand name, Indego. Unlike its competitors, the Indego has a slow and calculated release. With five trial sites in the U.S., the device looks like its rivals but can be compacted down to fit into a backpack. It is also clearly pursuing the rehabilitation space with predesigned integrated features for electrical stimulation. Parker Hannifin plans to capitalize on the manufacturing capabilities to bring the costs of the system down to compete on price in this crowded market.

Vendors have rushed into the market for lower extremity ambulation for diversified applications. With the projected growth potential over the next four years there is no sign of the expansion to slow.