Tag: FDA

BALDWIN PARK, Calif., Jan. 3, 2019 /PRNewswire/ — StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury.

Thirteen years ago, just as the United States began what was to become its longest war, a futuristic wheelchair hit the market.

The iBOT allowed paralyzed people, including many veterans of Iraq and Afghanistan, to stand up by rising to eye level. It also did something no wheelchair ever had: climb stairs.

But even though users loved it, the iBOT went out of production in 2009 when Johnson & Johnson discontinued it.

Adapta Medical, Inc. to Expand Catheter Product Line

COLORADO SPRINGS, Colo., Oct. 6, 2016 /PRNewswire/ — Adapta Medical, Inc. has received FDA market release for the PerfIC Cath® intermittent touchless urinary catheter. The sterile catheter system was designed by J. Glen House, MD, a C7 quadriplegic with limited finger dexterity.

FDA clearance for the PerfIC Cath® will result in Adapta expanding the PerfIC Cath® product line and launching the new mPower Cath™ series catheter product line. Both product lines feature hydrophilic and gel lubricants for straight and coude-tipped catheters. The PerfIC Cath® catheters have an attached urine collection bag while the mPower Cath™ products have a urine collection bag that is not attached to the catheter.

Company will Collaborate with The University of Pittsburgh to Develop an Implantable Device for Spinal Cord Injury Patients

SAN ANTONIO, May 24, 2016 /PRNewswire/ — InCube Labs, a multi-disciplinary life sciences R&D lab, today announced that it has been awarded a subcontract from the University of Pittsburgh to help develop an implantable neuromodulation therapy to restore bladder function for spinal cord injury (SCI) patients.

First robotic exoskeleton cleared for use with stroke and spinal cord injury levels to C7

RICHMOND, Calif., April 04, 2016 (GLOBE NEWSWIRE) — Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Ekso GT robotic exoskeleton for use in the treatment of individuals with hemiplegia due to stroke, individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of T3 to C7 (ASIA D), in accordance with device’s labeling. The Ekso GT is the first exoskeleton cleared by the FDA for use with stroke patients.

State-of-the-Art Device Allows Individuals with Spinal Cord Injury to Stand and Walk; Regulatory Clearances in USA and Europe Pave the Way for Commercialization

CLEVELAND, March 10, 2016 (GLOBE NEWSWIRE) — Parker Hannifin Corporation (NYSE: PH), the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration (FDA) has given clearance to market and sell the Indego® exoskeleton for clinical and personal use in the United States. The company intends to commercially launch the device in the United States in the coming months.

A Big Opportunity – For Everyone

Spinal Cord Injury (SCI) refers to an injury to the spinal cord that is caused by direct trauma or secondary damage to the surrounding bone, tissue, or blood vessels. Classification of the extent of the injury is based on neurological responses, touch and pinprick sensations tested in each dermatome (an area of the skin supplied by a single spinal nerve), and strength of ten key muscles on each side of the body, including the hip flexion (L2), shoulder shrug (C4), elbow flexion (C5), wrist extension (C6), and elbow extension (C7). The four categories of SCI classification and their respective percent of the market are: Complete Tetraplegia (16%), Incomplete Tetraplegia (41%), Complete Paraplegia (22%), and Incomplete Paraplegia (21%)

NSI-566 to be tested in patients with chronic spinal cord injury

ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ — Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment,  between one and two years after injury. AIS A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.

The FDA’s go-ahead makes The Miami Project’s clinical trial to aid against spinal cord injury the only one in the United States.

The Miami Project to Cure Paralysis said Tuesday it has received federal approval to conduct “revolutionary” human trials to transplant a patient’s own Schwann cells, found mainly in the nervous system, to the site of recent spinal cord injuries in the hope that the trials may bring researchers closer to finding a cure for paralysis.