InVivo Therapeutics Holdings Corp (NVIVQ)

[FactMan777]

A Year in Review: 2015

Jan 9 - InVivo announces the reopening of subject enrollment for the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury. To date, there have been no reported serious safety events with the study’s first subject.
Jan 21 - InVivo reports three-Month Update of First Acute Spinal Cord Injury Subject Implanted with Neuro-Spinal Scaffold - Motor, Sensory, Bowel, and Bladder Function Improvement with No Reported Serious Adverse Events.
Jan 22 - InVivo announces Enrollment of Second Subject in Pilot Spinal Cord Injury Trial.
Feb 5 - InVivo announces the appointment of Mark D. Perrin as Chairman of InVivo’s Board of Directors, effective immediately.
Feb 9 - InVivo today announced the appointment of Lorianne Masuoka, MD, as Chief Medical Officer (CMO), effective March 2, 2015. Prior to joining the InVivo team, Dr. Masuoka served as Senior VP and CMO at Cubist Pharmaceuticals from July 2013 until Jan 2015. Merck acquired Cubist in January for $102 a share ($9.5 billion buyout).
Feb 23 - Froedtert & the Medical College of Wisconsin (MCW) Froedtert Hospital in Milwaukee, WI has been added as the 7th clinical site in the company’s acute SCI pilot study.
Mar 11 - InVivo provides update on patient #1: In the months that followed, an appreciable improvement in the first subject’s motor and sensory function was reported (improved from AIS A to C) as well as complete recovery of bowel function and improvement in bladder function.
Mar 23 - Video of Jesi moving her leg posted on the “Jesi S - NVIV Investor's Give gofundme” website
Mar 24 - InVivo announces 1-for-4 reverse stock split in preparation for planned uplisting to NASDAQ.
Mar 25 - the Keck Hospital of University of Southern California (USC) in Los Angeles, CA has been added as the 8th clinical site
Mar 26 - InVivo announces the reopening of concurrent enrollment of subjects 3, 4 and 5 in the company’s acute SCI pilot study
Mar 30 - InVivo announces that the University of Kansas Medical Center in Kansas City, KS has been added as the 9th clinical site.
Apr 1 – InVivo announces the UC Davis Medical Center in Sacramento, CA has been added as the 10th clinical site
Apr 8 - InVivo announces the implementation of its previously disclosed 1-for-4 reverse stock split as of today, April 8, 2015, a key step in preparation for its planned uplisting to the NASDAQ Capital Market.
Apr 16 - InVivo today announced that its common stock has been approved to begin trading on The Nasdaq Capital Market. The company’s common stock will begin trading on Friday, April 17, 2015
May 19 – InVivo announces the Goodman Campbell Brain and Spine in Indianapolis, IN has been added as the 11th clinical site.
Jun 1 – InVivo announces the company’s investigational Neuro-Spinal Scaffold has received the 2015 Becker’s Healthcare Spine Device Award. It is one of 25 devices that received this distinction from Becker’s Healthcare.
Jun 5 – InVivo’s announces that a third patient has been enrolled in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute spinal cord injury at the Carolinas Medical Center, part of the Carolinas HealthCare System in Charlotte, NC. Dr. Coric, who enrolled the 2nd patient (Jesi Stracham) also performed this Neuro-Spinal Scaffold implantation
Jun 12 – InVivo makes the preliminary list to be added to the Russell 3000, Russell Global and Russell Micro Cap.
Jun 15 – InVivo announces that James Guest, M.D., Ph.D., has joined its Scientific Advisory Board. Dr. Guest is currently a Professor of Neurological Surgery at the Miller School of Medicine and the Miami Project to Cure Paralysis in Miami, FL
Jun 16 – InVivo holds annual meeting. InVivo stated: Expedited Access Pathway (EAP) may be an option for devices to treat SCI.
Jun 29 – InVivo makes it official and announces that the company has been added to the Russell Global, Russell 3000®, Russell 2000®, and Russell Microcap® Indexes on June 26, 2015.
Jun 30 – InVivo announces that Rutgers New Jersey Medical School in Newark, NJ has been added as the 12th clinical site.
Jul 6 – InVivo Reports Significant Improvement of second and third patients Implanted with Neuro-Spinal Scaffold. The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury.
Aug 12 - InVivo announces the Cooper Neurological Institute (CNI) in Camden, NJ has been added as the 13th clinical site in the company’s ongoing IDE pilot study
Aug 20 – InVivo announces that a fourth patient has been enrolled in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute thoracic spinal cord injury at the UC Davis Medical Center in Sacramento, CA.
Aug 24 - InVivo announces that the listing of the company’s common stock has been transferred to the Nasdaq Global Market. The company’s common stock previously traded on the Nasdaq Capital Market CEO Perrin stated: “:Being listed on the Global Market allows us to be considered for a broader array of indexes, including the NASDAQ Biotechnology Index.”
Sep 8 – InVivo announces that a fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
Sep 9 - InVivo announces that Mount Sinai Hospital in New York has been added as the 14th clinical site.
Oct 19 - InVivo announces that the U.S. Food and Drug Administration (FDA) has approved the expansion of the number of patients from five to ten in the company’s pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury.
Oct 23 - InVivo reports Significant Improvement of First Patient Implanted with Neuro-Spinal Scaffold. In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors. A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.
Dec 2 - InVivo announces - an innovative strategy for the treatment of chronic spinal cord injury (SCI). The company will focus its research efforts for chronic SCI on Bioengineered Neural Trails™. Bioengineered Neural Trails are injectable combinations of biomaterials and neural stem cells (NSCs) delivered using minimally-invasive surgical instrumentation and techniques to create trails across the chronic injury site.
Dec 3 - InVivo announces it has received conditional approval of a study protocol amendment from the U.S. Food and Drug Administration (FDA) that will convert its ongoing pilot study into a pivotal probable benefit study. The approval is conditional solely upon a minor change to the informed consent form that has already been submitted to the FDA. Full approval of the amendment is expected in the next 30 days. With this transition, the study will be known formally as “The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.” The INSPIRE Study is designed to enroll 20 implanted patients, inclusive of the five patients already enrolled.
The FDA has also agreed to increase the total number of allowable U.S. sites to 40. In addition to the U.S. sites, the company plans to initiate the study in Canada and the United Kingdom with the intent to include patients enrolled at ex-U.S. sites as part of the 20 patient study.
Dec 17 - CEO Perrin posts CEO’s Perspective on: InVivo in 2016: Looking Ahead. CEO stated: “It is extraordinary to think that just over a year after enrolling the first patient in our study, we are now running a pivotal trial with planned international expansion and the potential to file an application for HDE approval in just two years."

FactMan777: please see:
http://www.invivotherapeutics.com/about-invivo/ceo-perspective/
to read the full CEO Perspective: InVivo in 2016: Looking Ahead


Obviously, InVivo has accomplished a lot during the year 2015 (even though the current share price of $7.20 doesn't reflect this).

Looking forward to year 2016. I am betting the share price will increase and start to reflect the company many accomplishments. InVivo is well on their way of providing the standard of care for spinal cord injury (SCI) patients.

Just the facts,
-FactMan777