Here, Teresa Wong, PT, Executive Director of the REHAB Innovation Center, reviews the challenge of “un-teaching” compensatory techniques that are part of routine stroke rehabilitation.

She explains how early sit-to-stand and gait therapy with the Tibion Bionic Leg is helping REHAB patients avoid dependence on their unaffected extremities – and thus, more quickly recover a safe, natural gait.

Three Arch Partners, Hambrecht & Quist lead financing, join board

Sunnyvale, CA – Tibion Corporation, the privately held Silicon Valley firm transforming stroke rehabilitation with its robotic Bionic Leg, announced today the successful closure of a $10.175 million financing round, a new board of directors, and a new board chairman.

“This new financing is an affirmation of our efforts to increase the availability of our technology to the more than 3 million stroke survivors who cannot walk or walk well after a stroke,” explains CEO Charles Remsberg, who assumed leadership of the Sunnyvale firm just over a year ago.

According to the CDC, more than 300,000 stroke survivors each year cannot walk or walk well, adding to a pool of more than 3 million chronically disabled by stroke. Therapists using the Bionic Leg claim unprecedented clinical benefits, often from the first session.

“The new financing will enable us to accelerate roll-out of the new interchangeable battery version of our wearable gait-rehabilitation robot, and to expand our sales and marketing programs,” Remsberg said.

Financing enables expansion of revolutionary stroke rehab device

Most stroke survivors experience upper and lower extremity weakness on the side of their body opposite the brain hemisphere in which the stroke occurred. The Tibion Bionic Leg provides the assistance and resistance required by a stroke survivor’s weakened leg, enabling the repetitive sit-to-stand, overground walking and stairclimbing exercises to promote the “brain re-wiring” believed necessary for gait recovery.

Leading the recent financing round were Three Arch Partners, Portola Valley, CA, and Hambrecht & Quist Capital Management, Boston.

“We ended 2010 with a significant surge in Bionic Leg placements, broadening our installed base to include innovative skilled nursing facilities and free-standing physical therapy clinics,” Remsberg noted.

“Several of our earliest customers, inpatient rehabilitation facilities, have ordered second and even third Bionic Legs, to handle the demand for its superior outcomes,” he said. “The new financing will enable us to ramp up production and support to help them meet that demand.”

Lindholm new board chairman, Wang and Omstead join board

In addition to reporting the new financing, Tibion announced appointment of board member Randy Lindholm as chairman of the board. Mr. Lindholm is a widely recognized advisor to and on the boards of numerous medical device companies. Mr. Lindholm has served as chairman, president and chief executive officer of VidaMed, Inc., which was sold to Medtronics.

“I’ve been pleased to participate in the past year’s reorganization of Tibion under new leadership, with the support of a very involved board and first-round investors,” Lindholm said. “With the new financing, we see the opportunity for Tibion to fundamentally change how stroke patients are rehabilitated worldwide.”

Joining Remsberg and Lindholm on the Tibion board will be Conrad Wang, principal at Three Arch Partners, and Daniel Omstead, PhD, CEO at Hambrecht & Quist Capital Management, as well as current investor John Steuart, managing partner at Claremont Creek Ventures.

Prior to joining Three Arch Partners, Dr. Wang completed his orthopedic surgery training in the Harvard Combined Orthopedic Residency Program. He also has a BS degree in mechanical engineering from the Massachusetts Institute of Technology. Dr. Omstead is president and chief executive officer of Hambrecht & Quist Capital Management, and president of H&Q Lifesciences Investors and H&Q Healthcare Investors. Prior to joining HQCM, he was president and CEO of Reprogenesis, Inc. a private development stage biotech company developing therapies in the field of regenerative medicine.

Tibion Corporation

Tibion is a privately held company developing innovative equipment that can help individuals recover physical function lost due to disease, trauma or aging.

Its first commercialized product, the Tibion Bionic Leg, actively assists therapists with the rehabilitation of individuals who present with lower extremity dysfunction that impairs function, mobility and gait. Primary candidates for the Tibion Bionic Leg include individuals disabled by stroke, and certain neurologic degenerative diseases such as multiple sclerosis.

The company began marketing the Bionic Leg in January 2010. Customers span the U.S. For additional information, visit www.tibion.com and www.onstroke.org.

Editors:

For photos of the Bionic Leg, click here: https://picasaweb.google.com/106483500727907874893/BionicLeg#

For videos of examples of patients successfully rehabilitated with the Bionic Leg click the links below:

Rehabilitation Hospital of the Pacific is the only acute-care medical rehabilitation organization serving Hawaii. For more than 56 years, the 100-bed, not-for-profit hospital and outpatient clinics on Oahu and the Big Island have been dedicated to providing comprehensive medical rehabilitation services.

Each year, Rehabilitation Hospital of the Pacific treats more than 5,500 patients recovering from strokes, brain injury, spinal cord injury, orthopedic injuries, sports injuries and those individuals requiring general rehabilitation. Services to patients include physical therapy, occupational therapy, and speech therapy.

Accepting the MDEA award on behalf of Tibion was Robert Horst, Chief Technology Officer. Dr. Horst is the principal developer of the Bionic Leg, and is named on the key patents.

The Tibion Bionic Leg is a wearable robotic device that therapists use to help those disabled by stroke and other diseases to recover their ability to walk without canes and walkers, and to reduce risk of falls. Claremont Creek Ventures (Oakland, CA) and Fogarty Research and Development (Portola Valley, CA) were cited by the awards committee for their contribution to the Bionic Leg development.

The MDEA competition is the premier awards program for the medical technology community.

The program is open worldwide to companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging. Awards are offered in 10 categories.

In announcing the winners, the MDEA said the awards recognize the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, clinicians and investors —who are “responsible for the groundbreaking innovations that are changing the face of healthcare.”

Tibion is a privately-held company developing innovative equipment that can help individuals recover physical function lost due to disease, trauma or aging. Its first commercialized product, the Tibion Bionic Leg, actively assists therapists with the rehabilitation of individuals who present with lower extremity dysfunction that impairs function, mobility and gait.

Stroke patients rehabilitating at Whittier Rehabilitation Hospital, Haverhill, MA are among the first in the nation to “walk their way to recovery” with the aid of a new bionic leg.
Whittier is the first U.S. rehabilitation hospital to offer patients the Tibion Bionic Leg, a sophisticated computerized device that provides the assistance and resistance that stroke survivors require to re-learn how to stand up, walk and climb stairs without the use of a walker, cane or even a stair railing.

The appearance of Whittier’s new Tibion Bionic Leg is reminiscent of that sported by the protagonist in the movie “Robocop.” But inside, Whittier’s new device contains a sophisticated computer and powerful small motors capable of helping a stroke patient weighing more than 200 lbs to regain lost ability to walk normally.

“We’re very enthusiastic about being the first rehabilitation hospital in the nation to offer this kind of robotic therapy to our patients,” said neurologist Joan Breen, MD, leader of Whittier’s stroke rehabilitation program.

“While we’ve just initiated therapy with a limited number of outpatients, we see the potential to apply the Bionic Leg to our inpatient population as well,” she said. “Perhaps we can help them avoid the troublesome stroke gait that is very physically exhausting, and places them at increased risk of falls and fractured hips.”

One of the first Whittier patients to benefit from Bionic Leg therapy is Merrick Teague, 62, of Georgetown, MA. Mr. Teague had a stroke a year ago, and says his doctors told him he’d never walk again. After just five one-hour sessions with Whittier’s Bionic Leg, he reports he’s much more mobile.

“I can now walk 30 feet without a cane, I can climb stairs with both legs, I can do the dishes – I can take out the garbage, just not drag the cans to the curb,” Mr. Teague reports. “My wife is amazed.”

According to Mr. Teague, the Bionic Leg “talks to him” – referring to the staccato pulsing sounds of its tiny motors when he doesn’t provide the effort necessary to perform some action he wants to do.

“At the beginning, it would talk to me all the time, telling me where I wasn’t stepping right. But now, as I make progress, it doesn’t talk to me much anymore. I’m very impressed by it.”

“At Whittier, we’re committed to bringing the latest rehabilitation technology to this region,” explains Robert Iannaco, PT, administrator of the Bradford, MA facility. “We believe our combination of staff and technology makes us New England’s rehab provider of choice for patients and insurers.”

Stroke patients interested in being evaluated for Bionic Leg therapy should ask their physicians to refer them to the Whittier Bradford outpatient department at (978) 469-1425, or contact the department directly.

About Whittier Rehabilitation Hospital

Whittier Rehabilitation Hospital, Bradford is a long term acute rehabilitation hospital located at 145 Ward Hill Avenue, Bradford, MA 01835, serving patients throughout New England. It is part of a family-owned network of healthcare facilities spanning hospitals, skilled nursing facilities, home care and pharmacy. It is accredited by the Commission for Accreditation of Rehabilitation Facilities (CARF) and the Joint Commission for the Accreditation of Healthcare Organizations. The Bradford facility’s team of interdisciplinary rehabilitation professionals provides inpatient, outpatient, and home health services. It accepts admissions from emergency rooms, acute care hospitals, physician offices, and home. It accepts Medicare, most Medicaid, workers compensation and insurance plans, including a wide range of major HMOs and PPOs.

Allentown, PA – Good Shepherd Rehabilitation Network recently became the first health-care organization in the country to utilize the Tibion Bionic Leg in the inpatient and outpatient setting. The Tibion Bionic Leg is a new rehabilitation technology that uses robotics to help patients regain movement and function in a leg impacted by a stroke, spinal cord injury or brain injury.

Preliminary studies show that patients with lower limb impairments who are 5 to 10 years post-stroke benefit from the use of this robotic technology. Those patients’ walking speed, gait pattern and endurance improved in four weeks of therapy with the Tibion Bionic Leg.

The robotic leg provides sensor-based assistance and resistance to the affected leg to match the capabilities of the unaffected leg. The Tibion is “intention based,” which means that when a patient applies a force that is pre-set by a therapist, the Bionic Leg turns on a motor that provides the percentage of assistance set by the therapist. This provides “training” for the stance phase of gait (when the patient stands on the affected leg during walking).

“Patients using this new therapy tool will improve functional activities such as standing, walking and climbing stairs,” says Susan Golden, P.T., director of neurorehabilitation for Good Shepherd Rehabilitation Network. “We have patients with gait impairment who used the Tibion Bionic Leg and then walked without assistance and without pain for the first time since having a stroke.”

Good Shepherd is using the Tibion Bionic Leg at Good Shepherd Rehabilitation Hospital in Allentown and at its outpatient neurorehabiltation program in the Good Shepherd Health & Technology Center, 850 S. Fifth Street, Allentown. Many of Good Shepherd’s therapists are specially trained in using rehabilitation technologies to help patients regain function as quickly as possible.

“As soon as the Tibion Bionic Leg was ready for regular clinical use, we contacted Good Shepherd because it has been a national leader in bringing rehabilitation technology to its patients,” says Charles Remsberg, chief executive officer of Tibion. “We’re delighted that the Bionic Leg is quickly proving effective, and we believe many patients in the Lehigh Valley region will benefit from it.”

See an MS patient’s impressions of the program and the Bionic Leg.

Four years ago, neurologist Conrado J. Estol, writing in International Journal of Stroke, drew a powerful analogy between the December 26, 2004 tsunami that swept through Southeast Asia, leaving more than 280,000 dead or missing, and what he forecast as a “stroke tsunami” threatening the industrialized societies.

The analogy fails, of course, because, as Estol noted, the Southeast Asian tsunami came with no recognizable warning. By contrast, the stroke tsunami has been preceded by decades of escalating statistics of known stroke risk factors. Fewer than half of all patients under treatment for hypertension have their blood pressure under control. Almost a third of Americans are clinically obese, and almost the same fraction have pre-diabetic insulin resistance.

The stroke tsunami might be expected to hit with full force as the baby-boomer generation hits retirement age. But statistics suggest it might come earlier: Almost a third of all strokes occur in people between the ages of 45 and 64, at the peak of their earning years. The challenge to handle this tsunami’s acute victims will severely tax our ICUs and post-acute care facilities.

Not only will this tsunami challenge our already overburdened healthcare system, it will hit our economic system. It will move hundreds of thousands of taxpayers per year onto the rolls of the disabled and unemployed. Our current epidemic of post-recession unemployment will soon pass, and when it does, the loss of these seasoned and experienced workers/taxpayers will be painfully obvious.

However, as the economic impact of the Southeast Asian tsunami was most painful in the reconstruction period that followed, the most challenging period of the stroke tsunami will be in the post-acute rehabilitation period. Already today, approximately 50% of the nearly 6 million Americans living with a history of stroke struggle with a hemiparetic gait (CDC).

It would be nice to believe we could do something to halt the hypertension, Type 2 diabetes, obesity, and other diseases that precipitate stroke. But even if all the obese went on diets, the hypertensives took their meds, and the pre-diabetics started serious jogging, the stroke tsunami would not recede for 20 or more years. The stroke tsunami would continue – as would the need for much-improved stroke rehabilitation.

Advances in thrombolytic therapy and other acute stroke interventions show evidence of increasing the survival of stroke patients after a CVA. What is needed – and what Tibion has focused on – is improving the efficacy of rehabilitation in the post-acute and chronic periods.

Kollen and colleagues, after thorough analysis of many studies of Bobath and other stroke rehabilitation techniques (Stroke. 2009;40:e89), concluded that no form of conventional stroke therapy may actually impact functional gait recovery. Early experience with the Tibion Bionic Leg suggests it may be the first to do so. On this website, and in succeeding blogs, my team and I will discuss examples of that impact.

Tibion is pioneering the design and development of “wearable” bionic technologies that combine rehabilitation and enhanced function for patients impaired by stroke, neuromuscular disease, surgery, or aging.

Mr. Remsberg joins Tibion after serving for 3 years as CEO of Hocoma Inc., the U.S. sales and marketing arm of the privately held Swiss company Hocoma AG, best known for its clinic-based Lokomat® robotic gait orthosis that has helped thousands of American patients with spinal cord, stroke, traumatic brain injury and cerebral palsy to recover their ability to walk.

Prior to that position, Mr. Remsberg was head of worldwide sales for Hocoma, and for more than 10 years, an executive of Biodex Medical Systems, Shirley, NY. At Biodex, he rose from product development manager to head of worldwide sales for the nation’s leading supplier of balance, gait, and joint rehabilitation systems to private clinics, rehabilitation hospitals, professional sports teams, and skilled nursing facilities.

Tibion’s first commercialized product is its Bionic Leg, a powered, assistive device that enhances rehabilitation therapy, supplements muscle strength and function, and provides mobility assistance for activities of daily living. The Bionic Leg is in limited sales and clinical trials in the U.S., and scale-up and global marketing will begin in 2010. Unlike clinic-based fixed robotic systems, the Bionic Leg provides wearable, sensor-based, assistance and resistance as the patient engages in rehabilitation activities allowing function of the afflicted leg. The first clinical tests have been with stroke patients in both the inpatient and outpatient settings.

“I joined Tibion because I am impressed with the impact its technology can have on the rehabilitation of millions of handicapped patients worldwide,” Mr. Remsberg said. “I look forward to the opportunity to accelerate acceptance of the Bionic Leg, and the application of its technology to other unmet patient needs.”

“Tibion has reached the stage where its first product is ready for clinical evaluation and marketing, and follow-on products are in development,” explains Claremont Creek’s John Steuart, a member of the Tibion board of directors. “We looked for a leader who understood the skills needed to deliver leading-edge equipment, and had the confidence of rehabilitation academia, clinicians and major providers. We are excited by the potential of the company under his leadership.”

Tibion is a privately held company located at 247 Santa Ana Court, Sunnyvale, CA 94085. The company’s mission is to develop smart medical devices and therapies that address the needs of neuromuscular and musculoskeletal deficiencies. Tibion’s products are enabled by patented innovations encompassing a broad range of disciplines, including orthotics, biomechanics, robotics, and embedded control systems.