InVivo surges 56% on news of impending U.S. trial, search for strategic partnerships

InVivo surges 56% on clinical trial news for spinal scaffold

Massachusetts-based InVivo Therapeutics (OTC:NVIV) saw a major surge on Wall Street on Friday after the market reacted to news that it will soon begin enrolling patients in a U.S. clinical trial of its 1st investigational product, diverting development efforts from its hydrogel drug delivery platform.

The study is taking top priority over other efforts, InVivo said, and the company is searching for strategic partners rather than further developing its hydrogel product on its own. InVivo’s already in talks with "a number of prospective corporate partners," but said it’s too soon to discuss time lines or therapeutic areas.

InVivo plans in the 1st quarter of 2014 to launch a clinical study of its degradable polymer scaffold, evaluating the device in treatment of acute spinal cord injuries. More than 10 clinical sites have already signed confidentiality agreements signaling their interest in participating in the human safety trial and members of an independent data safety monitoring committee have already been selected and have agreed to participate, InVivo reported.

The device maker has already begun pouring resources into its spinal scaffold division, taking engineers and other personnel away from hydrogel product development. By February InVivo expects to have enough scaffold inventory on hand to supply the clinical trial and to be able to better "control the quantity, quality and cost of its scaffold."

"For the scaffold trial, InVivo will submit a filing containing proposed changes to its FDA-approved protocol and supporting documents within the next 10 days," the company reported. "The company believes that approval of the proposed changes would accelerate the progress of its trial by eliminating barriers to enrollment and by expanding the number of sites from at least 3 to as many as 6. For instance, the proposed changes would eliminate a substantial amount of burdensome paperwork and other requirements unnecessary for a safety study."

The FDA has 30 days to respond to InVivo’s new filing, according to regulation.

NVIV shares jumped 55.7% by the end of the day Friday, closing at $1.79, but they’re still far from regaining what they lost. In August NVIV shares sank more than 43% in a single day after the company announced new hurdles in negotiations with the FDA. InVivo announced that, under the terms of its FDA investigational device exemption, each patient enrolled in the upcoming spinal scaffold trial must be followed for 3 months and the company must win agency approval before enrolling the next, meaning it will take InVivo an estimated 21 months to enroll its 5 patients. The delays could push back commercialization for years, analysts warned at the time.

That news had come just a day after InVivo announced the sudden departure of chairman, CEO & CFO Francis Reynolds, who resigned suddenly citing a "medical condition." The company watched its shares drop even further following the sudden resignation of interim CFO Sean Moran, who quit after just 2 weeks in the role. Shares regained a few points after InVivo appointed Gregory Perry as the new CFO, but remained 60% lower than they’d been prior to the C-Suite shuffle.

NVIV shares are up about 3% on the year, but down about 38% on the last 6 months.

RSS From Medical Design & Outsourcing

  • Vicon captures a new development in motion capture (mocap)
    Vicon announced the launch of its new flagship camera platform, the Vicon Vantage. Drawing on over 30 years’ of motion capture (mocap) experience, the Vantage platform combines innovative technology with accessible design to open up motion capture to a broader audience. Vicon is a motion capture technology specialist company for science and life industries. Advances in […]
  • Satel’s latest product sets a new milestone in radio manufacturing
    The new Satelline TR4, from the Finnish manufacturer of radio data transmission systems, Satel sets a new milestone. The compact UHF transceiver with transmitting power of 1,000 mW is compatible with the protocols of Pacific Crest, Trimble and Satel. The type certifications in all important regions of the world make the TR4 ideal for integration […]
  • SCHURTER announces retirement of founder and management changes
    SCHURTER announced the retirement of founder Bruno H. Schurter on June 29, 2015. The company, founded in 1982 in Petaluma, California, will change management effective July 1, 2015. Bruno H. Schurter, president and CEO will retire after 33 years of heading up the privately held company, which is a subsidiary of SCHURTER Holding AG, founded in […]
  • Silicone: Expanding the horizon for modern medical devices
    Editor’s note: This article comes from Albright Technologies a manufacturer of custom silicone prototypes and provides volume production for medical, pharmaceutical, industrial, and other applications. Silicone materials have been around for more than 70 years. Beginning in the 1960s, silicones have played an important and evolving part in products designed for the medical field. Since that time, […]
  • DeNovo Sciences appoints a molecular diagnostics veteran as new CSO
    DeNovo Sciences, a producer of  liquid biopsy products, announced the appointment of Dr. Yixin Wang as Chief Scientific Officer (CSO). Dr. Wang is a veteran in molecular diagnostics where he has played significant R&D roles at large, multi-national companies including Parke-Davis/Pfizer, Veridex/Johnson & Johnson and Ventana/Roche. He will lead strategic initiatives for clinical development of DeNovo’s […]
  • Albright Technologies expands their silicone offerings
    Albright Technologies, a rapid silicone prototyper, has added silicone injection molding tooling and services to its product lineup. Liquid silicone injection molding became a suitable product offering as Albright expanded its offerings to better serve the silicone molding market. While silicone prototypes are commonly manufactured with low volumes in mind; injection molded liquid silicone rubber parts are […]
  • Applied Silver launches SilvaClean, silver treatment for textiles
    Applied Silver, Inc, is launching SilvaClean, a state-of-the-art silver treatment for textiles, at the Association for Professionals in Infection Control and Epidemiology’s (APIC) forty-second Annual Conference taking place at the Music City Center in Nashville, from June 27 through June 29. Hospitals have invested significantly in reducing the potential of infection through products and processes designed […]
  • Two-Component technology for improved quality of life
    In the field of injection molding and mold making, toolcraft covers all processes within the added value chain–from the design and selection of materials through to the creation of finished and qualified products. Complete solutions offered include injection molding for parts in the small and extremely small component areas, e.g. for medical technology. Utilizing two-component […]
  • GDS security protects medical devices from hackers
    As data breaches become more commonplace with serious consequences to personal, corporate and national security, it is clear that there is no shortage of accomplished and effective hackers ready to steal data and trade it on the open market. Global Data Sentinel (GDS) has the ability to provide retroactive security to remove access to email […]
  • BRAEBON and SomnoMed combine products to combat sleep apnea
    BRAEBON Medical Corporation announces that the DentiTrac oral appliance compliance system has passed a regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device. BRAEBON congratulates SomnoMed for being the first company to achieve this milestone. “We are pleased DentiTrac is launching in the US market. Accurate oral appliance […]
  • For advanced shielded plastic connector solution, ODU delivers with latest product
    ODU, a company which designs and manufactures connector solutions and cable assemblies, is announcing ODU MEDI-SNAP EMC, the advanced shielded plastic connector solutions, to the US market. ODU MEDI-SNAP EMC is the latest addition to ODU’s Push-Pull circular connectors. The advanced medical connector solution is lightweight, autoclavable, sterilizable and it offers a touch proofed housing and reliable […]

Leave a Reply