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US FDA Grants De Novo Application for Neurolutions Novel Brain Control Interface System

Updated: Sep 18



The technology utilizes brain-computer interactive technology to facilitate rehabilitation and improve functional outcomes for patients.

Santa Cruz, CA – Sept XXX, 2020 – Neurolutions, Inc., a medical company developing and commercializing technologies to improve stroke patient recovery, announced today that the U.S. Food and Drug Administration (FDA) has granted the De Novo application for its IpsiHand System, the first-ever Brain-Computer Interface technology proven to improve range of motion and recovery for stroke survivors. When used as part of traditional stroke rehabilitation therapy, the system can dramatically improve and expedite the rehabilitation process for stroke survivors. The system facilitates muscle re-education through its novel brain-computer interactive platform and can increasing range of motion for patients. The De Novo application follows the breakthrough device designation by the FDA earlier this year.

“The approval of the IpsiHand BCI System represents a revolutionary step forward in the care and rehabilitation of stroke patients. ,” said XXX, CEO of Neurolutions “For the first time we are now able to combine advanced robotics and brain computer interface technology to augment traditional stroke rehabilitation to allow patients to significantly improve function and quality of life after stroke.”

The Neurolutions System is a Brain-Computer Interface (“BCI”) device developed for rehabilitation of upper extremity disability in patients who have suffered a stroke. The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy. The device consists of three components: the Neurolutions Robotic Handpiece, a Tablet Computer, and a Biometric Headset that translates brain signals into movement of the robotic handpiece worn over the patient’s hand and wrist. The motion of the Handpiece, in turn, opens and closes the patient’s impaired hand. The combined action of these System components allows the stroke patient to retrain their brain to control their body in a way they would not otherwise have been able to perform without the system. With the De Novo application granted, the company intends to immediately begin commercialization of the Neurolutions IpsiHand System in the United States.

“The Neurolutions System represents the cutting-edge of medical technology and is a critical breakthrough for stroke survivors” said Dr. XXXXX. “Progress in improving rehabilitation outcome for stroke patients has historically been extraordinarily challenging but the development of the Neurolutions IpsiHand System promises to usher in a bright future for our patients and allow us to significantly improve their rehabilitation therapy and quality of life.”

There are approximately 6 million stroke survivors living in the United States. Approximately 800,000 American adults experience a stroke each year, of which approximately 300,000 are left with upper extremity movement dysfunction. Muscular weakness or partial paralysis frequently persists into the chronic stage of stroke with 65% of chronic stroke patients reporting reduced motor function 6 months after stroke. Substantial motor improvements beyond 3 months post-stroke are difficult and rare, as motor deficits effectively become steady-state. 12,13,14,15,16,17,18,19,20,21

About Neurolutions, Inc.

Neurolutions, Inc. is a medical technology company developing a revolutionary platform of devices, based on Brain Computer Interface (BCI) technology, which promise to restore function to patients who are disabled as a result of neurological injury. The company’s first product, the IspiHand System is a Brain-Computer Interface (“BCI”) device developed for rehabilitation of upper extremity disability in patients who have suffered a stroke. The Neurolutions System is designed for use in clinic or home settings as part of prescribed rehabilitation therapy. The device consists of three components: the Neurolutions Handpiece, a Tablet computer, and a Biometric Headset. Neurolutions received breakthrough status form the FDA for its technology earlier this year.


More information is available at http://www.neurolutions.com.


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Paul Ruelos

pruelos@neurolutions.com

(314) 266-8015

Investor Relations

Neurolutions, Inc

Info@Neurolutions.com

12 Center for Disease Control. (2018). Use of Outpatient Rehabilitation Among Adult Stroke Survivors. Morbidity and Mortality Weekly Report, May 25, 2018. 67(20);575–578 (https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a2.htm).

13 Center for Disease Control. (2018). Use of Outpatient Rehabilitation Among Adult Stroke Survivors. Morbidity and Mortality Weekly Report, May 25, 2018. 67(20);575–578 (https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a2.htm).

14 A. Sunderland, D. Tinson, L. Bradley, and R. L. Hewer, “Arm function after stroke. An evaluation of grip strength as a measure of recovery and a prognostic indicator,” J. Neurol. Neurosurg. Psychiatry, vol. 52, no. 11, pp. 1267–1272, Nov. 1989.

15 D. T. Wade, R. Langton-Hewer, V. A. Wood, C. E. Skilbeck, and H. M. Ismail, “The hemiplegic arm after stroke: measurement and recovery,” J. Neurol. Neurosurg. Psychiatry, vol. 46, no. 6, pp. 521–524, Jun. 1983.

16 P. W. Duncan, L. B. Goldstein, D. Matchar, G. W. Divine, and J. Feussner, “Measurement of motor recovery after stroke,” Stroke, vol. 23, no. 8, pp. 1084–1089, 1992.

17 H. S. Jorgensen, H. Nakayama, H. O. Raaschou, J. Vive-Larsen, M. Stoier, and T. S. Olsen, “Outcome and time course of recovery in stroke. Part II: Time course of recovery. The copenhagen stroke study,” Arch Phys Med Rehab, vol. 76, no. 5, pp. 406–412, 1995.

18 D. Lloyd-Jones et al., “Heart disease and stroke statistics - 2009 update. A report from the American heart association statistics committee and stroke statistics subcommittee,” Circulation, vol. 119, no. 3, pp. 480–486, 2009.

19 S. M. Hatem et al., “Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery.,” Front. Hum. Neurosci., vol. 10, p. 442, 2016.

20 G. Kwakkel, B. Kollen, and E. Lindeman, “Understanding the pattern of functional recovery after stroke: facts and theories.,” Restor. Neurol. Neurosci., vol. 22, no. 3–5, pp. 281–299, 2004.

21 J. W. Krakauer, “Motor learning: its relevance to stroke recovery and neurorehabilitation,” Curr. Opin. Neurol., vol. 19, no. 1, pp. 84–90, 2006.

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