Stroke patients striving to walk normally may get a lift from a bionic leg developed by venture-backed Tibion Corp.
Many stroke survivors have weakness on one side that impairs their gait. Tibion’s device, worn around the leg during physical therapy, supplies the power needed to stand or walk, and may enable more intense therapy sessions. As strength and control returns, it assists the leg less.
Tibion, which has placed the device in 10 U.S. rehabilitation centers since launching it in January, soon intends to close a $15 million Series B round to expand the rollout, said Chief Executive Charles Remsberg. Previous backers include Claremont Creek Ventures and Saratoga Ventures.
The company’s product, the first of its kind, targets a large problem. Stroke, in which blood stops flowing to the brain, affects 795,000 Americans a year, according to the American Heart Association. A leading cause of long-term disability, stroke costs the U.S. about $70 billion annually in direct and indirect expenses, including health-care services, medications and missed work.
Early research suggests that Tibion’s device could reduce patients’ dependence on health services by helping them recover their ability to walk, drive and live independently. A study at New York Presbyterian Hospital could supply more hard evidence. The trial is comparing 12 patients receiving conventional therapy to 12 rehabbing with the bionic leg’s added boost, according to Remsberg, who said he is talking with universities and the U.S. Department of Veterans Affairs about additional studies.
The company’s product, which wraps around the leg and extends from the thigh to the ankle, amplifies a patient’s effort, adding just enough mechanical lift to enable him to stand or take a step. Sensors in the patient’s shoe detect weight distribution and trigger the robot to deliver the amount of assistance that a therapist has programmed in.
Stroke survivors with “hemiparesis,” or muscle weakness on one side of the body, initially have little movement in one leg, so therapists traditionally have done most of the work to get the limb moving. Tibion aims to shift the effort to the patient. “We’re making it possible for the patient to work more intensively with the affected leg,” Remsberg said.
On a recent morning at Whittier Rehabilitation Hospital in Bradford, Mass., patients performed sit-to-stand drills and other exercises with the robot’s help. One patient, a 63-year-old man, said he needed help to get out of bed shortly after his stroke, but has improved with therapy.
“I’m walking straight,” he said. “I’m not dragging my foot [any] more.”
How much the bionic leg contributed to his recovery is not entirely clear, but scientists suspect the device helps stroke survivors to form new neural connections to compensate for the ones they lost. By enabling them to work their leg more, the robot appears to help magnify afferent, neural signaling that reawakens the brain to the limb’s presence, Remsberg said.
COMMENTARY:
Tibion’s has developed the first ambulatory device that can rehabilitate stroke patients with gait impairment. And the stroke market is very, very large.
- In 2006, 890,000 Americans were discharged with a diagnosis of stroke – 606,000 in people over the age of 65, and 236,000 between the ages of 45 and 64. Average length of stay (LOS) ranged from 4.8 to 5.1 days.
- In 2005, approximately 5,839,000 Americans had a history of stroke, about 50% of whom suffer gait disturbances that limit their ambulation and place them at sharply increased risk of falls.
- Escalating rates of obesity and Type II diabetes have led many researchers to forecast a “stroke tsunami” in the coming decade.
- Only the Tibion Bionic Leg offers millions of chronic stroke survivors the potential to regain lost mobility – and a reason to return to therapy.
Prospective market
Rehabilitation hospitals. Tibion believes that approximately 2000 freestanding U.S. rehabilitation hospitals represent the greatest opportunity for its commercialization efforts.
Rehabilitation hospitals certified as stroke centers…
- Often admit acute-stroke patients directly from ambulance transport, when reimbursement can equal $15,000/day.
- Enjoy the highest reimbursement for post-acute rehabilitation, ranging from $1500-4000/day
- Justify their higher reimbursement and retain patients for post-acute inpatient rehab by acquiring and promoting the latest rehab technology.
- Enjoy a volume of managed care and Medicare stroke inpatients and outpatients that justify purchase of multiple Bionic Legs.
- Represent excellent prospects for encouraging patients to rent a planned home Bionic Leg.
Skilled nursing facilities. Roughly 15,000 skilled nursing facilities (SNFs) often compete with rehab hospitals for residential stroke rehabilitation – if they have technology like the Bionic Leg.
- When stroke patients leave an acute-care hospital for residential rehab, patient families often receive several qualified SNF referrals from a discharge planner or case manager – and the family must visit each and select a provider.
- SNFs often use technology as a competitive tool to persuade families to bring patients to their facilities.
- Medicare Part A fully pays for 20 days of residential rehabilitation at an SNF, after which patients can elect to pay a $137/day copayment for up to 100 additional days.
- SNF technology not available at local outpatient rehab clinics can persuade SNF patients pay to remain for many days beyond the 20 Medicare-paid days.
Other candidate Bionic Leg customers include 715 accredited U.S. stroke centers, 153 Veterans Administration hospitals with rehab facilities, and 895 smaller VA rehab clinics.
Tibion is now testing a new “pay-as-you go” billing system that holds the potential to make the Bionic Leg available to an even wider range of facilities, including thousands of small private clinics with only a few stroke patients a week, and even home care PTs.
Competitive landscape
Tibion is aware of no comparable, wearable robotic stroke rehab devices marketed or reported in development anywhere in the world.
The closest robotic device in use for stroke gait therapy is the Hocoma Lokomat, a $300,000 body-weight support system limited to treadmill use. Several exoskeleton devices – essentially, “vertical wheelchairs” – have been developed for spinal cord injured patients and for certain military applications.
The Bionic Leg is protected by a battery of patents and proprietary software technology.
In addition to planned enhancements and a home version of the Bionic Leg, Tibion anticipates development of upper extremity robotics that will consolidate its position as a robotic rehabilitation leader.
I have seen stroke victim's undergo lengthy and very painful rehabilitation. My mother had a stroke, and it was very painful for her just to bend her leg, let alone walk. Thankfully, she was able to walk again.
Tiobion's bionic assisted-walking device definitely fills a serious need in the healthcare industry, not just for stroke victim's, but for post-operative knee joint patients.
This one is a no-brainer for a VC.
Courtesy of an article dated October 8, 2010 appearing in The Wall Street Journal's Venture Capital Dispatch
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