InVivo Therapeutics Retrenches, Cuts Most Hydrogel R&D

Spinal cord injury (SCI) treatment startup InVivo Therapeutics Holdings Corp. (Cambridge, MA) has announced what the company refers to as a "realignment" of its R&D strategy that amounts to a reconcentration on its core-competency SCI business and an end to its hydrogel drug delivery program which was, according to the company, "at an early stage of preclinical development."

In making the announcement, InVivo explained that "substantial financial and human resources would have been required to address technical and competitive challenges and to advance any drug delivery product to the partnering stage or into the clinic." The company indicated that one element of the hydrogel platform will be further explored, the potential of hydrogel for cell delivery, as part of an expanded biomaterials development program for the delivery of stem cells.

The company says its novel Neuro-Spinal Scaffold and Neuro-Spinal Scaffold Plus Stem Cells program has been approved by FDA for an Investigational Device Exemption (IDE); human studies began in May, and approval of the Humanitarian Use Device (HUD) designation request has been granted. This designation is reserved for devices designed to treat rare diseases or conditions fewer than 4000 individuals in the United States per year and is required, along with clinical study data, to support a Humanitarian Device Exemption (HDE) application to FDA.

The Neuro-Spinal Scaffold is a porous bioresorbable polymer scaffold designed to provide structural support to injured spinal tissue following implantation within a spinal cord contusion, thereby preserving more of the spinal tissue and increasing the chances for functional recovery. The Scaffold is designed for use in contusion injuries, the most common SCI, and degrades inside the body over time.

In announcing the refocusing of the company's R&D resources, InVivo further announced it is making a reduction in force (RIF) of 14 employees, or 28% of its workforce. The RIF and the shifting of R&D resources is expected to result in annualized savings of approximately $3 million and to reduce cash expenditures by approximately 23% compared to 2013 levels. With these savings, InVivo anticipates that existing funds will be sufficient to support its planned activities through March 2016.  

"Although reducing staff size and eliminating the hydrogel drug delivery program were difficult decisions, InVivo's focus will be even stronger on the company's core mission: developing meaningful treatments for spinal cord injury," CEO Mark Perrin said. "Going forward, all of the company's resources and efforts will be centered on the development of the Neuro-Spinal Scaffold for acute SCI and Scaffolds Plus Stem Cells for the treatment of chronic SCI."

Stephen Levy is a contributor to Qmed and MPMN.