Our Technology

Aiming to promote neural regeneration after spinal cord injury

Aiming to promote neural regeneration after spinal cord injury

Caution: Investigational device. Limited by federal law to investigational use.

Our investigational Neuro-Spinal Scaffold™ is implanted at the site of damage within one week of spinal cord injury with the goal of supporting neural regeneration and cell growth.

If left untreated, a cavity will typically develop at the injury site, cutting off transmission of neural signals from the brain to all body parts below the injury. The scaffold is designed to encourage functional cells to fill in that cavity. If achieved, this structural change within the spinal cord has the potential to improve sensory and motor function and lead to a better quality of life for patients.


Our investigational Neuro-Spinal ScaffoldTM

Our proprietary and investigational Neuro-Spinal Scaffold technology is composed of two biocompatible and bioresorbable polymers which together form a highly porous framework that is conducive to cellular attachment and growth.

The scaffold is surgically implanted into the gap in the spinal column that arises at the site of injury, aiming to create a neuropermissive matrix that allows cells which are critical to neuronal health to respond to the injury site and begin filling the cavity. The scaffold breaks down in the body over several weeks and is resorbed.


How the scaffold is designed to facilitate recovery

If achieved, a robust response can lead to improved outcomes for spinal cord injury patients by:

Preventing
development of an empty cavity at the injury site

Creating
an environment conducive to neural regeneration and tissue remodeling

Preserving
white matter and allowing for potential remyelination of axons

Visualizing improvement in an animal model

This image shows the effect of the investigational Neuro-Spinal Scaffold implanted after acute spinal cord injury in an animal model.

An empty cavity develops at the site of an untreated injury, cutting off communication from the brain.

Treatment with the scaffold has encouraged tissue remodeling and neuronal growth.

The architecture of the spinal cord has not been restored to pre-injury status. However, the cyst is now filled with a neuropermissive matrix that allows cells, which are critical to neuronal health, to respond to the injury site and begin filling the cavity.


Existing Clinical Results

In its first human clinical study (INSPIRE 1.0), the Neuro-Spinal Scaffold was studied in 19 patients with acute thoracic spinal cord injury.

For more information on our clinical data, please see our corporate deck here.


Clinical trial underway

Based on the INSPIRE 1.0 data, InVivo has initiated the INSPIRE 2.0 clinical study. INSPIRE 2.0 is a 20-patient clinical study designed to assess the potential benefit of the Neuro-Spinal Scaffold in comparison to current standard of care by measuring improvement on the American Spinal Injury Association (ASIA) Impairment Scale (AIS Scale) at six months post-injury.

Visit clinicaltrials.gov for more information on our INSPIRE 2.0 Study.

 


Strong support in scientific literature

A robust collection of scientific publications, posters and presentations support the efficacy of the Neuro-Spinal Scaffold

Publications

Guest JD, Moore SW, Aimetti A, Kutikov AB, Santamaria AJ, Hofstetter CP, Ropper AE, Theodore N, Ulich TR, Layer RT | Internal decompression of the acutely contused spinal cord: differential effects of irrigation only versus biodegradable scaffold implantation | Biomaterials | 2018

Layer RT, Ulich TR, Coric D, Arnold PM, Guest JD, Heary RH, Hsieh PC, Jenkins AL, Kim KD, Lee KS, Masuoka LK, Neff KM, Ray WZ, Theodore N, Fehlings MG | Relationship of American Spinal Injury Association Impairment Scale grade to post-injury hospitalization and costs in thoracic spinal cord injury | Neurosurgery | 2017

Slotkin JR, Pritchard CD, Luque B, Ye J, Layer RT, Lawrence MS, O'Shea TM, Roy RR, Zhong H, Vollenweider I, Edgerton VR, Courtine G, Woodard EJ, Langer R | Biodegradable scaffolds promote tissue remodeling and functional improvement in non-human primates with acute spinal cord injury | Biomaterials | 2017

Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE | First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury: A clinical pilot study for safety and feasibility | Neurosurgery | 2016

Pritchard CD, Slotkin JR, Yu D, Dai H, Lawrence MS, Bronson RT, Reynolds FM, Teng YD, Woodard EJ, Langer RS | Establishing a model spinal cord injury in the African green monkey for the preclinical evaluation of biodegradable polymer scaffolds seeded with human neural stem cells | J Neurosci Methods | 2010

Teng YD, Lavik EB, Qu X, Park KI, Ourednik J, Zurakowski D, Langer R, Snyder EY | Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells. | Proc Natl Acad Sci U S A | 2002

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Abstracts

Kim KD, Lee KS, Chang JJ, Toselli RM | Neuro-Spinal Scaffold™ implantation in patients with acute traumatic thoracic complete spinal cord injury: twenty-four month results from the INSPIRE study | CNS Annual Meeting; October 19–23, San Francisco, CA | 2019

Kim KD, Lee KS, Coric D, Theodore N, Toselli RM | Twelve month results from the INSPIRE study of the investigational Neuro-Spinal Scaffold™ in acute thoracic complete spinal cord injury | AANS Annual Meeting; April 13–17, San Diego, CA | 2019

Lee KS, Coric D, Theodore N, Kim KD | Complete 6-month primary endpoint results from the INSPIRE study of the investigational Neuro-Spinal Scaffold™ in acute thoracic complete spinal cord injury | AANS Annual Meeting; October 6–10, San Diego, CA | 2018

Lee KS, Boyer PJ, Hsieh PC, Hurth KM, Guest JD, Hofstetter CP, Aimetti A, Layer RT, Moore SW, Ulich TR | Histopathology of necrotic spinal cord tissue exudate collected during surgical implantation of a biodegradable scaffold following acute spinal cord injury: pre-clinical and clinical findings | CNS Annual Meeting; October 7–11, Boston, MA | 2017

Aimetti AA | Translation of biomaterial-based therapies for the treatment of spinal cord injury: the Neuro-Spinal Scaffold™ and bioengineered neural trails | Working 2 Walk Science & Advocacy Symposium; October 28–29, Minneapolis, MN | 2016

InVivo Therapeutics developing innovative products for spinal cord injury | Cell & Gene Meeting on the Mesa; October 5–7, La Jolla, CA | 2016

Heary RF, Barry M, Coric D, Kim KD, Hsieh PC, Ray WZ, Theodore N | MR Neuroimaging does not accurately identify intraparenchymal cavities in the spinal cord following AIS A thoracic spinal cord injuries | CNS Annual Meeting; September 24–28, San Diego, CA | 2016

Neff KM | Clinical trials update for 2016 – the INSPIRE study: Neuro-Spinal Scaffold™ | International Spinal Cord Society (ISCoS) Annual Meeting; September 14–16, Vienna, Austria | 2016

Layer RT, Moore SW, Kutikov AB, Podell P, Aimetti AA, Ulich TR | Biodegradable Neuro-Spinal Scaffold promotes neuropermissive remodeled tissue following spinal contusion injury in rats | National Neurotrauma Society (NNS) Annual Symposium; June 26–29, Lexington, KY | 2016

Aimetti AA, Layer RT, Moore SW, Ulich TR | Biodegradable Neuro-Spinal Scaffold preserves macroscopic spinal cord architecture and allows for neural regeneration at the epicenter of spinal cord injury | Tissue Engineering & Regenerative Medicine International Society (TERMIS) World Congress; September 9, Boston, MA | 2015

Layer R, Aimetti A, Podell P, Moore S, Ulich T | Biodegradable Neuro-Spinal Scaffold Preserves Spinal Cord Architecture Following Spinal Contusion Injury in Rats | National Neurotrauma Society (NSS) Symposium; June 28–July 1, Santa Fe, NM | 2015

Ropper AE, Hlubek R, Danielson J, Theodore N | First human implantation of a polymer scaffold for traumatic spinal cord injury: a clinical pilot study for safety and feasibility | AANS Annual Meeting; May 2–6, Washington, DC | 2015

Guest JD, Hofstetter C, Aimetti AA, Layer R, Hou J, Moore S, Ulich T | Reduction of intraparenchymal pressure after porcine acute spinal cord contusion injury by Neuro-Spinal ScaffoldTM implantation | AANS Annual Meeting; May 2–6, Washington, DC | 2015

Layer RT | Development and clinical translation of biomaterial technologies for spinal cord injury | 4th International Neural Regeneration Symposium (INRS); September 6–8, Nanjing, China | 2014

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