Friday, September 19, 2014

MD Care Act Passage - Another Milestone Event

The MD CARE Act passage is quite important for all of us living with a muscular dystrophy related condition, including Kennedy's Disease (SBMA).  The following writeup from the MDA reflects this milestone event.  Follow the link to the article and check out the 'timeline' (2000-to-2014).  For example, NIH funding in 2000 was $14M. In 2014 it is $75M. 

If you have the opportunity, thank your Senators and Representatives for passage of this act.

MD CARE Act Update (2014)

The passage of the MD-CARE Act was a game-changer for MDA's muscular dystrophy community. The MD-CARE Act (Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments Act), originally passed in 2001 and reauthorized in 2008, provides the research and the infrastructure needed to accelerate discovery and bring drugs to market for all 9 forms of muscular dystrophy. Since its passage, research in muscular dystrophy has exploded, and the bill has led to scores of clinical trials and improved health care for people with muscular dystrophy.
MDA has actively continued to fight for the passage of amendments to the MD-CARE Act that are currently being considered by Congress. These would expand on research progress made and keep momentum robust and focused. Among the areas of emphasis within these amendments are cardiac and pulmonary research and an increased focus on resources for adults living with muscular dystrophy.

Every day, scientists in some of the world’s best research facilities are making exciting discoveries, developing new drugs for the treatment of muscular dystrophies and improving the quality of therapeutic treatment and clinical efforts — all at an unprecedented pace. Yet, tens of thousands of families living with muscular dystrophy are still waiting and counting on new treatments and cures. Increased federal support is needed to ensure researchers can continue making progress . A stronger commitment from the federal government will help ensure that MDA's life-changing momentum continues.

MDA is grateful to the muscular dystrophy community, as our combined voices and tireless fight helped ensure amendments to the MD-CARE Act passed in the House (H.R. 594) and Senate (S. 315) earlier this year. Next, the MD-CARE Act will go to the President's desk for his signature. Together, we will ensure the lifesaving research and clinical momentum put in place through this bill remains strong and focused.

MDA salutes our Congressional champions and their extraordinary staffs for their vision and leadership: Representatives Michael Burgess (R-TX) and Eliot Engel (D-NY) in the U.S. House of Representatives and Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN) in the U.S. Senate.

Wednesday, September 17, 2014

Bionic Suit cleared by FDA for home use

The below article by Bionics Research is a major step forward for individuals with spinal chord injuries.  It is also important for people living with a progressive neuro-muscular disorder like Kennedy's Disease.  The more of these units the hit the market, the lower the cost.  It also allows for even greater testing and generates interest in the for similar units that will support other uses.

ReWalk™ Bionic Suit

Personal Exoskeleton System Cleared by FDA for Home Use

Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S.

Marlborough, MA—June 26, 2014 — Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

The FDA has issued a marketing clearance for the ReWalk, which was granted via a rigorous de novo process that involved multiple clinical studies demonstrating safety and effectiveness of the technology.
“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics. “For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials,” he added. “This is truly the beginning of ‘ReWalking’ as a daily reality in the U.S.”

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