InVivo Therapeutics Holdings Corp (NVIV) - NASDAQ
  • Tue, Jul. 12, 8:42 AM
    • Thinly traded micro cap InVivo Therapeutics Holdings (NASDAQ:NVIV) is up 6% premarket on light volume in response to its announcement that the 9th and 10th subjects have been implanted in its 20-subject Phase 3 clinical trial, INSPIRE, assessing the Neuro-Spinal Scaffold in patients with acute spinal cord injury.
    • The 10th patient died from a stroke several days post-implantation. The cause of death was determined to be unrelated to the Neuro-Spinal Scaffold.
    • The primary endpoint is the proportion of patients who achieve an improvement of at least one AIS grade level at month 6. According to ClinicalTrials.gov, the estimated study completion date 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, Jul. 12, 8:42 AM | 3 Comments
  • 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. 7, 9:11 AM
    | Mon, Mar. 7, 9:11 AM | 1 Comment
  • 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
  • Jun. 22, 2015, 9:16 AM
    • The USPTO grants a Notice of Allowance (NOA) to InVivo Therapeutics' (OTCQB:NVIV) patent application No. 14/496,742, titled "Methods and Compositions for the Treatment of Open and Closed Wound Spinal Cord Injuries." The patent covers its Neuro-Spinal Scaffold which has been implanted in three patients thus far. The patents also covers the company's Neuro-Spinal Scaffold Plus Stem Cells program, which is in early-stage development for the treatment of chronic spinal cord injury.
    • The new patent covers broader compositions for both products than the previously granted U.S. Patent No. 8,858,966, issued on October 14, 2014.
    • Shares are up 5% premarket on modest volume.
    | Jun. 22, 2015, 9:16 AM | 3 Comments
  • May 18, 2015, 12:46 PM
    | May 18, 2015, 12:46 PM | 11 Comments
  • Dec. 31, 2014, 10:25 AM
    • Thinly-traded nano cap Brainstorm Cell Therapeutics (BCLI +22.7%) jumps on a 6x surge in volume in response to CEO Tony Fiorino's positive comments about the final results from the Phase 2a study of NurOwn in ALS patients.
    • Management will host a conference call on January 5 at 8:30 am ET to discuss the data.
    • Previously: BrainStorm to start Phase 2 ALS trial (April 28)
    • Stem cell-related tickers: (CUR +3.8%)(STEM)(NBS +0.5%)(OTCQB:ISCO +1.4%)(PSTI +2.2%)(OTCQB:NVIV -1.5%)(FCSC +1.6%)
    | Dec. 31, 2014, 10:25 AM
  • Nov. 12, 2014, 4:56 PM
    • Nano cap InVivo Therapeutics (OTCQB:NVIV) continued its up move today with shares rising 38% on a 10x surge in volume. Prices have almost tripled in a month as investor interest builds over its Neuro-Spinal Scaffold for the treatment of acute spinal cord injury.
    • The first patient to receive the device is a 25-year old Scottsdale, AZ man who broke his back in a dirt bike accident last month. Although it's too early to gauge the success of the implant some researchers and clinicians believe it has great promise.
    • In late October, the FDA approved an expansion of clinical trial sites from six to 20 and broadened patient eligibility criteria.
    • After today's action, InVivo's market cap is $133M which is comparable to other regenerative medicine firms working on spinal cord injury therapies.
    • For comparison purposes, the market valuations of Neuralstem (NYSEMKT:CUR), Asterias Biotherapeutics (NYSEMKT:AST) and StemCells (NASDAQ:STEM) are $256M, $125M and $80M, respectively.
    | Nov. 12, 2014, 4:56 PM | 11 Comments
  • May 1, 2014, 3:59 PM
    • Shares of nano cap InVivo Therapeutics (NVIV +20.1%) are up again today on average volume. The up move began on Monday after the company announced the start of a Phase 1 clinical trial for its degradable polymer Neuro-Spinal Scaffold in spinal cord injury patients. Prices have popped over 40% since then.
    • Investors need to be both patient and cautious here. The clinical trial size is only five subjects and will begin at one site, The University of Arizona in Tuscon, AZ. Two additional sites should come on line in Q2. The regulatory process for this device will be long and arduous.
    | May 1, 2014, 3:59 PM
Company Description
Invivo Therapeutics Holdings Corp. is a medical device company, which develops and commercializes groundbreaking technologies for the treatment of spinal cord injuries. Its platform technologies focus on minimizing tissue damage sustained following acute injury and promoting neural plasticity of... More
Sector: Healthcare
Industry: Biotechnology
Country: United States