InVivo Therapeutics Announces Topline Data from Pivotal INSPIRE 2.0 Study in Acute Spinal Cord Injury

Rhea-AI Summary

InVivo Therapeutics announced that its INSPIRE 2.0 study did not meet its primary endpoint of improving spinal cord injury outcomes, as defined by the American Spinal Injury Association (ASIA) Impairment Scale. The study compared treated patients with a control group receiving standard care but failed to show significant differences at six months. InVivo plans to evaluate the complete data set and explore strategic options for future endeavors.

CEO Richard Toselli expressed disappointment over the results, emphasizing the urgent need for advancements in spinal cord injury treatments and acknowledging the contributions of patients and clinical sites.

Positive

• Potential for valuable insights upon full data set assessment
• Continued commitment to development of spinal cord injury treatments

Negative

• INSPIRE 2.0 study did not achieve primary endpoint
• Failure to demonstrate improvement compared to standard care could hinder future investments

Study did not achieve primary endpoint of defined improvement on standard impairment scale

InVivo to evaluate full data set and strategic options for the company

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries (SCI), today announced topline results from the company’s INSPIRE 2.0 study, which was designed to evaluate the safety and probable benefit of InVivo’s investigational Neuro-Spinal Scaffold™, a bioresorbable scaffold-based device in development for patients with acute SCI. The study did not meet its primary endpoint, which was assessed by the proportion of treated patients achieving an improvement of at least one American Spinal Injury Association (ASIA) Impairment Scale (“AIS”) grade at six months post-scaffold implantation, versus a control group that received standard of care surgery.

“We are disappointed by the outcome of this study as treatments for spinal cord injury are so urgently needed and we know many in the SCI patient and advocate community wait in hope for therapeutic options. We have rigorously pursued the science and believe that, upon full assessment, the INSPIRE 2.0 data set will provide a significant addition to the clinical literature around the treatment of SCI,” said Richard Toselli, M.D., InVivo’s President and Chief Executive Officer. “I extend our deepest thanks to our patients and clinical sites who have supported InVivo’s work to bring our science to patients, and the InVivo team who have tirelessly pursued our mission.”

InVivo management will conduct a full assessment of the study data set and plans to share its findings in full in a peer-reviewed medical venue at a later date. The company will also evaluate its strategic options and provide an update on corporate direction when appropriate.

About InVivo Therapeutics

InVivo Therapeutics is a clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., and Joseph P. Vacanti, M.D. InVivo 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 assessment of the full INSPIRE 2.0 data set and evaluation of strategic options. 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 its ability to identify strategic options and other risks identified and described in more detail in the company's Annual Report on Form 10-K for the year ended December 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.

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Investors:

Bret Shapiro, Managing Partner

CORE IR

brets@coreir.com

(516) 222-2560



Media:

Tyler Reilly

Ten Bridge Communications

tyler@tenbridgecommunications.com

(617) 640-3595

Source: InVivo Therapeutics Holdings Corp.

FAQ

What were the results of the INSPIRE 2.0 study conducted by InVivo (NVIV)?

The INSPIRE 2.0 study did not meet its primary endpoint of improving outcomes on the ASIA Impairment Scale.

What will InVivo Therapeutics do after the INSPIRE 2.0 study results?

InVivo plans to assess the complete data set and evaluate strategic options for the company.

What is the primary endpoint of the INSPIRE 2.0 study by InVivo Therapeutics?

The primary endpoint was the proportion of treated patients achieving at least one grade improvement on the ASIA Impairment Scale at six months.

What is the significance of the results from the INSPIRE 2.0 study for InVivo (NVIV)?

The failure to meet the primary endpoint may impact InVivo's future investments and the advancement of its spinal cord injury treatments.