InVivo Therapeutics Announces Publication of 12- and 24-month Data for INSPIRE 1.0 Study in Peer-Reviewed Neurosurgery

Rhea-AI Summary

InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) announced the publication of a peer-reviewed manuscript in Neurosurgery, detailing patient outcomes from their 24-month follow-up in the INSPIRE 1.0 Study. This study evaluates the investigational Neuro-Spinal Scaffold™ for spinal cord injuries. The company is encouraged by the findings which support further investigation and has closed the INSPIRE 1.0 study. Enrollment for the INSPIRE 2.0 Study is complete, with topline data expected in Q1 2023, aimed at enhancing clinical evidence.

Positive

• Publication of peer-reviewed manuscript supporting Neuro-Spinal Scaffold™ efficacy.
• INSPIRE 2.0 Study enrollment completed; topline data expected in Q1 2023.

Negative

• None.

Manuscript details patient outcomes through 24-month follow up visit

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today announced the publication of a peer-reviewed manuscript in Neurosurgery describing the previously disclosed 12- and 24-month data from the Company's single-arm INSPIRE 1.0 Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). The publication is titled “Acute Implantation of a Bioresorbable Polymer Scaffold in Patients with Complete Thoracic Spinal Cord Injury: 24-Month Follow-up from the INSPIRE Study.”

Richard Toselli, M.D., InVivo’s President and Chief Executive Officer, said, “In addition to the previous six-month publication covering INSPIRE 1.0 data in the Journal of Neurosurgery: Spine, we are pleased to see the evaluation of patient outcomes through the 24-month follow up visit. We are encouraged that these data support further evaluation of the investigational Neuro-Spinal Scaffold™ and its potential benefit to patients in the ongoing INSPIRE 2.0 Study.”

InVivo has officially closed the INSPIRE 1.0 study and recently completed enrollment into a second pivotal clinical study of the investigational Neuro-Spinal Scaffold™ in patients with acute SCI (INSPIRE 2.0). InVivo anticipates presenting topline data from the INSPIRE 2.0 Study in first quarter of 2023. The INSPIRE 2.0 study is a 20-patient (10 subjects in each study arm), randomized, controlled trial that is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the INSPIRE 1.0 study. For more information about the INSPIRE 2.0 clinical trial, please visit ClinicalTrials.gov.

The publication is now available electronically at this link.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect” and similar expressions, and include statements regarding the company’s expectation regarding the timing for the announcement of topline data and ability to serve the spinal cord injury patient population. Any forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to: the company’s ability to obtain additional funding to support the ongoing clinical and potential commercialization program for the investigational Neuro-Spinal Scaffold™, the varied interpretation of clinical data, the timing, cost and expense of regulatory filings, the potential for regulatory authorities granting or delaying approval for our Neuro-Spinal Scaffold, and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and in other filings that the company may make with the Securities and Exchange Commission in the future. The company does not undertake to update these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220608005203/en/

Investor Contact:

Bret Shapiro, Managing Partner

CORE IR

brets@coreir.com

516-222-2560

Media Contact

Gina Nugent

Ten Bridge Communications

gina@tenbridgecommunications.com

617-460-3579

Source: InVivo Therapeutics Holdings Corp.

FAQ

What does the recent InVivo Therapeutics press release say about the INSPIRE 1.0 Study?

The press release details the publication of a peer-reviewed manuscript covering 24-month follow-up data from the INSPIRE 1.0 Study, supporting the Neuro-Spinal Scaffold™.

What are the expected outcomes from the INSPIRE 2.0 Study by InVivo Therapeutics?

InVivo anticipates presenting topline data from the INSPIRE 2.0 Study in the first quarter of 2023.

How does the publication in <i>Neurosurgery</i> impact InVivo Therapeutics and NVIV stock?

The publication potentially enhances the credibility of the Neuro-Spinal Scaffold™, which could positively influence investor sentiment and NVIV stock performance.

What are the characteristics of the INSPIRE 2.0 clinical trial?

The INSPIRE 2.0 Study is a randomized, controlled trial with 20 patients, designed to enhance clinical evidence for the Neuro-Spinal Scaffold™.