InVivo Therapeutics Holdings Corp (NVIV) - NASDAQ
  • Tue, Apr. 26, 12:46 PM
    | Tue, Apr. 26, 12:46 PM | 2 Comments
  • Tue, Apr. 26, 11:27 AM
    • InVivo Therapeutics (NVIV +13%) heads north on almost double normal volume in response to its announcement of positive results in its 20-subject Phase 3 INSPIRE study assessing its Neuro-Spinal Scaffold in patients with complete (AIS A) thoracic spinal cord injuries at the time of enrollment.
    • A fourth patient (out of a total of six) has converted from AIS A status (complete spinal cord injury) to AIS B status (incomplete), implying a 67% response rate. The primary endpoint of the trial is the proportion of patients who experience an improvement of at least one AIS grade by month six. The Objective Performance Criterion (OPC), a measure of success for INSPIRE, is a minimum conversion rate of 25%, significantly better than the historical rate of ~16%.
    • The American Spinal Injury Association (ASIA) ranks spinal cord injury in five classes: A: Complete (no sensory or motor function); B: Sensory Incomplete (sensory but no motor function below the neurological level; C: Motor Incomplete (motor function preserved below the neurological level; D: Motor Incomplete (higher muscle function than "C"); E: Normal.
    • According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is June 2017.
    • The Neuro-Spinal Scaffold is a bioresorbable polymer scaffold that is designed to treat acute spinal cord injury. It is implanted at the injury site within a spinal cord contusion where it provides structural support to spinal tissue and a supportive matrix that facilitates endogenous tissue repair. It degrades over a period of several weeks.
    | Tue, Apr. 26, 11:27 AM | 7 Comments
  • Tue, Apr. 26, 9:16 AM
    | Tue, Apr. 26, 9:16 AM
  • Tue, Mar. 15, 12:49 PM
    | Tue, Mar. 15, 12:49 PM
  • Tue, Mar. 15, 9:28 AM
    • InVivo Therapeutics (NASDAQ:NVIV) is down 9% premarket on light volume in response to its public offering of 3,733,333 units at $7.50 per unit. Each unit consists of one share of common stock and 1/2 of a warrant to buy one share of common at $10.00 per share.
    • Underwriters over-allotment is an additional 560K shares of stock and/or warrants to purchase up to 280K shares. Closing date is March 18.
    | Tue, Mar. 15, 9:28 AM | 4 Comments
  • Mon, Mar. 14, 5:43 PM
    | Mon, Mar. 14, 5:43 PM | 2 Comments
  • Mon, Mar. 14, 4:44 PM
    • InVivo Therapeutics (NASDAQ:NVIV) announces plans to float a public offering of stock and warrants, packaged as units. Prices, volumes and terms have yet to be announced. Net proceeds will fund ongoing clinical trials and general corporate purposes.
    • Shares are down 9% after hours on light volume.
    | Mon, Mar. 14, 4:44 PM | 7 Comments
  • Mon, Mar. 7, 9:11 AM
    | Mon, Mar. 7, 9:11 AM | 1 Comment
  • Fri, Mar. 4, 4:36 PM
    | Fri, Mar. 4, 4:36 PM | 3 Comments
  • Tue, Mar. 1, 10:22 AM
    • The FDA has agreed to review InVivo Therapeutics' (NVIV +15.1%) application for a Humanitarian Device Exemption (HDE) for its Neuro-Spinal Scaffold on a modular basis. In other words, it will review each section of the application on a rolling basis as they are filed which should shorten the review clock by enabling the company to address deficiencies earlier in the process.
    • InVivo's application, called a modular shell, has three modules: preclinical studies, manufacturing and clinical data. After receiving each module, the FDA will typically review and provide feedback within 90 days. Upon receiving the last module, it will make a decision on the completeness of the filing which, if positive, will trigger a 75-day review clock for approval of the HDE.
    • The company plans to submit the preclinical module this year and the remaining two in 2017.
    • The Neuro-Spinal Scaffold is a bioresorbable polymer scaffold that is designed to treat acute spinal cord injury. It is implanted at the injury site within a spinal cord contusion where it provides structural support to spinal tissue and a supportive matrix that facilitates endogenous tissue repair. It degrades over a period of several weeks.
    • HDE is designed to help patients with diseases or conditions that affect less than 4,000 Americans. It is similar to a Premarket Approval (PMA) application but is not required to contain clinical data proving effectiveness. The price of an HDE-classified device is supposed to be restricted to cost recovery (including development costs), not a certain level of profit.
    | Tue, Mar. 1, 10:22 AM | 17 Comments
  • Dec. 4, 2015, 12:44 PM
    | Dec. 4, 2015, 12:44 PM | 2 Comments
  • Dec. 4, 2015, 9:16 AM
    | Dec. 4, 2015, 9:16 AM
  • Dec. 3, 2015, 9:25 AM
    • Thinly traded micro cap InVivo Therapeutics Holdings (NASDAQ:NVIV) is up 8% premarket on increased volume in response to its announcement that the FDA granted conditional approval to convert its ongoing pilot study of its Neuro-Spinal Scaffold in acute spinal cord injury into a pivotal probable benefit study. The clearance is conditional because of a minor change to the informed consent form that has already been submitted to the agency. Full approval should happen in the next 30 days.
    • The pivotal study, which is formerly named The INSPIRE Study, will enroll up to 20 patients following the review of six-month safety data from the first five. The company expects to submit the data in Q2. The inclusion criteria have been broadened to include patients with T2 injuries (range: T2-T12/L1). The primary endpoint is the proportion of patients achieving an improvement of at least one ASIA Impairment Scale (AIS) grade at six months post-implantation.
    • The FDA also approved an increase in U.S. trial sites to 40.
    • The company will discuss the development this evening at 5:15 pm ET during its KOL Event and Company Update webcast.
    • Previously: Third patient receiving InVivo's Neuro-Spinal Scaffold shows encouraging progress, shares up 10% premarket (July 6)
    • Previously: First patient responds well to InVivo Spinal Scaffold (Jan. 21)
    | Dec. 3, 2015, 9:25 AM | 4 Comments
  • Nov. 4, 2015, 7:05 PM
    • InVivo Therapeutics (NASDAQ:NVIV): Q3 EPS of -$0.09
    | Nov. 4, 2015, 7:05 PM
  • Aug. 5, 2015, 6:03 PM
    • InVivo Therapeutics (NASDAQ:NVIV): Q2 EPS of -$0.21 misses by $0.01.
    | Aug. 5, 2015, 6:03 PM
  • Jul. 6, 2015, 9:26 AM
    • InVivo Therapeutics (NASDAQ:NVIV) is up 10% premarket on light volume in response to its announcement of encouraging results in the third acute spinal cord injury patient implanted with its Neuro-Spinal Scaffold. At a one-month post-injury assessment, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B injury, with the regaining of sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurological injury covert this quickly in the first month following injury.
    • The company also reports positive progress in the second person implanted. At an assessment at three months, the patient regained partial sensation in her right side from the lower ribs to the hip and continues to make meaningful progress in daily activities.
    • The Neuro-Spinal Scaffold is a bioresorbable polymer scaffold that is designed for implantation at the injury site within a spinal cord contusion. It provides structural support to spinal tissue and a supportive matrix that facilitates endogenous tissue repair. It degrades over a period of several weeks.
    • Previously: First patient responds well to InVivo Spinal Scaffold (Jan. 21)
    | Jul. 6, 2015, 9:26 AM | 22 Comments
Company Description
Invivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. Its platform technologies focus on minimizing tissue damage sustained following acute injury and promoting neural plasticity of the spared... More
Sector: Healthcare
Industry: Biotechnology
Country: United States