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

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 ,"New clinical-pathological classification of intraspinal injury following traumatic acute complete thoracic spinal cord injury: postdurotomy/myelotomy observations from the INSPIRE trial", Neurosurgery | 2017 | 2017

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Abstracts

2016 Working 2 Walk Science & Advocacy Symposium
Alex A. Aimetti, Ph.D.
Translation of Biomaterial-based Therapies for the Treatment of Spinal Cord Injury: The Neuro-Spinal Scaffold™ and Bioengineered Neural Trails™
2016 Working 2 Walk Science & Advocacy Symposium; 2016 October 28-29, Minneapolis, MN
Society for Neuroscience 46th Annual Conference
Simon Moore, Ph.D.; Richard Layer, Ph.D.; Artem Kutikov, Ph.D.; Pamela Podell; Alex Aimetti, Ph.D.; Thomas Ulich, M.D.; James Guest, M.D., PhD.
The Neuro-Spinal Scaffold Promotes Tissue Remodeling, Axonal Sprouting, and Schwann Cell Myelination Following Acute Spinal Cord Contusion Injury in Rats
Program No. 383.09. 2016 Neuroscience Meeting Planner. San Diego, CA: Society for Neuroscience, 2016. Online
2016 Symposium on Biomaterials Science
Alex A. Aimetti, Ph.D.
Translation of Biomaterial-based Therapies for the Treatment of Spinal Cord Injury: The Neuro-Spinal Scaffold™ and Bioengineered Neural Trails™
2016 Symposium on Biomaterials Science; 2016 October 24-25, Iselin, NJ
2016 Cell & Gene Meeting on the Mesa
Thomas R. Ulich, M.D.
InVivo Therapeutics Developing Innovative Products for Spinal Cord Injury
2016 October 5-7, La Jolla, CA
Congress of Neurological Surgeons 2016 Annual Meeting
Robert Heary, M.D.; Maureen Barry, M.D.; Domagoj Coric, M.D.; Kee Kim, M.D.; Patrick Hsieh, M.D.; Wilson Z. Ray, M.D.; Nicholas Theodore, M.D.
MR Neuroimaging Does Not Accurately Identify Intraparenchymal Cavities in the Spinal Cord Following AIS A Thoracic Spinal Cord Injuries
Presented at 2016 CNS Annual Meeting; 2016 September 24-28, San Diego, CA
Congress of Neurological Surgeons 2016 Annual Meeting
Michael Fehlings, M.D., Ph.D.; Rick Layer, Ph.D.; Domagoj Coric, M.D.; Paul Arnold, M.D.; James Guest, M.D., Ph.D.; Robert Heary, M.D.; Patrick Hsieh, M.D.; Arthur Jenkins, M.D.; Kee Kim, M.D.; Stuart Lee, M.D.; Lorianne Masuoka, M.D.; Kristin Neff, M.Sc.; Wilson Zachary Ray, M.D.; Thomas Ulich, M.D.; Nicholas Theodore, M.D.
Clinical-Pathological Assessment of Severe (AIS A) Traumatic Acute Thoracic Spinal Cord Injury: Post-Durotomy/Myelotomy Observations from the INSPIRE Trial
Presented at 2016 CNS Annual Meeting; 2016 September 24-28, San Diego, CA
Congress of Neurological Surgeons 2016 Annual Meeting
Nicholas Theodore, M.D.; Kee Kim, M.D.; Patrick Hsieh, M.D.; Wilson Z. Ray, M.D.; Maureen Barry, M.D.; Rick Layer, Ph.D.; Simon Moore, Ph.D.; Domagoj Coric, M.D.
High ASIA Impairment Scale Conversion Rate Following Scaffold Implantation in Acute Thoracic Complete AIS A Spinal Cord Injury (SCI): Potential Mechanisms
Presented at 2016 CNS Annual Meeting; 2016 September 24-28, San Diego, CA
55th International Spinal Cord Society (ISCoS) Annual Scientific Meeting
Kristin M. Neff, M.Sc.
Clinical Trials Update for 2016 The INSPIRE Study: Neuro-Spinal Scaffold™
55th International Spinal Cord Society (ISCoS) Annual Scientific Meeting; 2016 September 14-16, Vienna, Austria
32nd Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves – Spine Summit 2016
Nicholas Theodore, M.D.; Domagoj Coric, M.D.; Patrick Hsieh, M.D.; Kee Kim, M.D.
Neurologic Outcome following Implantation of a Neuro-Spinal Scaffold™ into the Lesion Cavity in Acute Thoracic Complete Spinal Cord Injury: Results of a Pilot Study
Presented at Spine Summit 2016; 2016 March 16-19, Orlando, FL
34th Annual Symposium of the National Neurotrauma Society
Richard T. Layer, Ph.D.; Simon W. Moore, Ph.D.; Artem Kutikov, Ph.D.; Pamela Podell; Alex A. Aimetti, Ph.D.; Thomas R. Ulich, M.D.
Biodegradable Neuro-Spinal Scaffold Promotes Neuropermissive Remodeled Tissue Following Spinal Contusion Injury in Rats. Presented at 34th Annual Symposium of the National Neurotrauma Society
2016 June 26-29, Lexington, KY
Congress of Neurological Surgeons 2015 Annual Meeting
Lorianne Masuoka, M.D.; Kristin Neff; Thomas Ulich, M.D.; Alex Aimetti, Ph.D.
Novel Surgical Procedure to Implant an Investigational Neuro-Spinal Scaffold Following Myelotomy for Treatment of Acute Traumatic Spinal Cord Injury: A Safety and Feasibility Study
Presented at 2015 CNS Annual Meeting; 2015 September 26-30, New Orleans, LA
2015 Tissue Engineering & Regenerative Medicine International Society (TERMIS) World Congress
Alex A. Aimetti, Ph.D.; Richard T. Layer, Ph.D.; Simon W. Moore, Ph.D.; Thomas R. Ulich, M.D.
Biodegradable Neuro-Spinal Scaffold Preserves Macroscopic Spinal Cord Architecture and Allows For Neural Regeneration at the Epicenter of Spinal Cord Injury
Presented at 2015 Tissue Engineering & Regenerative Medicine International Society World Congress; 2015 September 9, Boston, MA
17th Annual Spinal Research Meeting
Alex A. Aimetti, Ph.D.; James D. Guest, M.D., Ph.D.; Nicholas Theodore, M.D.; Domagoj Coric, M.D.; Lorianne Masuoka, M.D.; Simon W. Moore, Ph.D.; Richard T. Layer, Ph.D.; Thomas R. Ulich, M.D.
Benefits of Surgical Implantation of an Investigational Biodegradable Neuro-Spinal Scaffold in Various Animal Models of Acute Spinal Cord Contusion Injury: Clinical Translation
Presented at 17th Annual Spinal Research Meeting; 2015 September 4-5, London, UK
2015 National Neurotrauma Society Symposium
Richard T. Layer; Alex A. Aimetti; Pamela Podell; Simon W. Moore; Thomas R. Ulich
Biodegradable Neuro-Spinal Scaffold Preserves Spinal Cord Architecture Following Spinal Contusion Injury in Rats
Presented at National Neurotrauma Society 2015 Symposium; 2015 June 28 – July 1, Santa Fe, NM
83rd American Association of Neurological Surgeons Annual Scientific Meeting
Alexander E. Ropper, M.D.; Randall Hlubek, M.D.; Jill Danielson, R.N.; Lou Vaickus, M.D.; Kristin Neff; Thomas R. Ulich, M.D.; Nicholas Theodore, M.D.
First Human Implantation of a Polymer Scaffold for Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility
Presented at 2015 AANS Annual Scientific Meeting; 2015 May 2-6, Washington, DC
83rd American Association of Neurological Surgeons Annual Scientific Meeting
James D. Guest, M.D., Ph.D.; Christoph Hofstetter, M.D., Ph.D.; Alex Aimetti, Ph.D.; Richard Layer, Ph.D.; Jianwei Hou, M.D., Ph.D.; Simon Moore, Ph.D.; Thomas Ulich, M.D.
Reduction of Intraparenchymal Pressure after Porcine Acute Spinal Cord Contusion Injury by Neuro-Spinal ScaffoldTM Implantation. Presented at 2015 AANS Annual Scientific Meeting
2015 May 2-6, Washington, DC
4th International Neural Regeneration Symposium
Richard T. Layer, Ph.D.
Development and Clinical Translation of Biomaterial Technologies for Spinal Cord Injury
Presented at: 4th International Neural Regeneration Symposium; 2014 Sep 6-8, Nanjing, China
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