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Small Biz Grant Funds Long-Term Spasticity Implant

Delpor implant device

Delpor implant device (Delpor Inc.)

16 Nov. 2021. A developer of treatments for neurological disorders received National Institutes of Health funding for an implant treating spasticity for up to six months. Delpor Inc. in Brisbane, California is receiving a $2.5 million award from National Institute of Neurological Disorders and Stroke, part of NIH, to continue development of its spasticity implant device through August 2022.

Delpor designed the device to treat spasticity, a chronic neuromotor condition where where muscles are continuously contracted, which interferes with normal speech and movements, and can be particularly harmful to growing children. Spasticity, marked by muscle tightness and involuntary movements, is a symptom of disorders including cerebral palsy, multiple sclerosis, traumatic brain injury, stroke, and spinal cord injury. According to Johns Hopkins University, some 12 million people worldwide have a form of spasticity, affecting as many as 80 percent of people with cerebral palsy or multiple sclerosis.

The company says two oral drugs, tizanidine and baclofen, are prescribed to treat spasticity, but both drugs work for short periods of time and require being given to patients three or four times a day. In addition, says Delpor, the drugs have unwelcome adverse effects at high plasma levels, such as muscle weakness, dizziness, and drowsiness. And while a surgically-implanted infusion pump can administer baclofen into the spinal canal, that surgery can take as long as three hours and require general anesthesia, as well as an overnight hospital stay.

10-minute outpatient procedure

Delpor develops long-term treatments for neurological conditions, with medications formulated into passive, non-mechanical reservoir implants that continuously administer the drugs for as long as 12 months. The small titanium devices — four to six millimeters in diameter, and four to five centimeters in length — are implanted under the skin of the abdomen in a 10-minute outpatient procedure using local anesthetics. The company says the procedures are reversible, if necessary, and the device is easily replaced after the drug runs out. Delpor’s lead product is an implant with the drug risperidone for 12-month schizophrenia maintenance therapy, now being evaluated in a clinical trial.

For spasticity, Delpor designed its implant code-named DLP-208 to continuously dispense tizanidine for three to six months. In April 2019, the company received a $225,000 Small Business Innovation Research or SBIR grant to assess the technical feasibility of an implant device to treat spasticity. The award funded preclinical proof-of-concept lab and animal studies of the device.

The new SBIR grant, awarded in September 2021, continues the preclinical research on DLP-208. The grant funds the work needed for Delpor to file an investigational new drug or IND application with Food and Drug Administration. An IND filing officially seeks permission from FDA to ship new drug candidates across state lines to clinical trial sites, in effect requesting permission for an early-stage clinical trial.

This and other SBIR grants at the agency are made under NIH’s small business programs that set aside a part of the agency’s research funding for U.S.-based and owned companies. SBIR grants fund work by research companies in the U.S., and in most cases are made in two parts: a first phase to determine technical and commercial feasibility, and a second phase to develop and test a working prototype or prepare for clinical trials.

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