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  1. #1

    INVIVO Articles

    InVivo Therapeutics Calls for Papers for 2nd Annual Langer Summit on Neurotrauma
    Posted by iCELL News, on 11th February 2013, in Stem Cell Research.

    02/11 06:00 AM

    CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV:$2.03,00$-0.02,00-0.98%) , a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced the 2nd Annual Langer Summit on Neurotrauma, taking place on Cape Cod in North Falmouth, MA on July 12 – 14, 2013. The Company is inviting papers in the fields of neurotrauma and SCI, and will announce the recipient of a $50,000 grant that will be given to a researcher developing novel biomaterial treatments for neurotrauma at the Summit. The award is intended to stimulate innovation and cutting-edge ideas in the fields of neuroprotection and regeneration utilizing biomaterials.
    If you are a researcher in these fields, please submit your paper to InVivo Therapeutics (NVIV:$2.03,00$-0.02,00-0.98%) by April 15, 2013. Your submission will be evaluated by Robert S. Langer, ScD and a panel of experts. The top author will be invited to present at the invitation-only event.
    “We’ll continue what we started at the 2012 Summit, fostering a productive exchange of ideas between InVivo scientists and neurotrauma researchers with the objective of furthering the development of treatments for SCI and other neurotrauma conditions,” said InVivo CEO Frank Reynolds. Since the last Summit, we’ve been focused on advancing our scaffolding device into a first-in-man clinical trial. By the 2013 Summit, we expect to have the clinical study underway, so the Summit will focus on our growing portfolio of hydrogel technologies.”
    About the Event
    The Langer Summit on Neurotrauma was first held in 2012 and brought together researchers from across the world to address the challenges faced by interventions developed for spinal cord injury and other neurological conditions. The Summit is chaired by InVivo Therapeutics (NVIV:$2.03,00$-0.02,00-0.98%) co-founder Robert S. Langer, ScD, the David H. Koch Institute Professor at the Massachusetts Institute of Technology. At this year’s event, participants will focus on InVivo’s expanding pipeline of 510(k) devices as well as recent innovations and their translation to the clinic.
    Submissions
    Authors are asked to submit papers in PDF format to Lauren Mitarotondo, Vice President of Operations, at lmitarotondo@invivotherapeutics.com.
    Format: 8½”x 11” (letter size), 1-inch margins, single line spacing, full justification, 11pt Times New Roman, include page numbers. Submissions are limited to 1 page of abstract and 2 pages of body text including tables, figures and references.
    Abstract: The abstract should be less than page, preceded by “Abstract:” in bold.
    Authors: First name, middle initial(s), followed by the last name, should be used to identify authors. Underline the name of the presenting author. All affiliations should follow the author’s name in italics, 10 point font. If the authors come from more than one affiliation, superscript numbers should be used to indicate the correct affiliation. Each author should indicate institute, city, state, country, and email address.
    Making a reference: References in the text can be made to literature listed in the “reference” section at the end by numbering the literature in superscript. The format for references should be: name of authors (initials of all names then family name, authors are separated by commas), Title of book or journal name in italics, Vol. Number in bold, pp. numbers, and year in (brackets).
    Submission Deadline: April 15, 2013
    Notification by: May 31, 2013
    Final Version for Presentation Due: June 30, 2013
    For more information please contact Lauren Mitarotondo, Vice President of Operations, at lmitarotondo@invivotherapeutics.com.
    Key words: Neurotrauma, neuroprotection, regeneration, spinal cord injury
    About InVivo Therapeutics (NVIV:$2.03,00$-0.02,00-0.98%)
    InVivo Therapeutics Holdings Corp. (NVIV:$2.03,00$-0.02,00-0.98%) is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD. Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
    Safe Harbor Statement
    Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct human clinical trials for the Company’s products, the expected commencement date of any approved human clinical trials, the expected size of the pilot study, the expectation that the scaffold product will be regulated under a HDE pathway, and the expected acceleration of commercialization of the Company’s products resulting therefrom. These forward-looking statements are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to obtain FDA approval to conduct human clinical trials; whether the human clinical trials produce acceptable results; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2011 and subsequent filings with the SEC.
    Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.
    Source: InVivo Therapeutics Holdings Corp. (NVIV:$2.03,00$-0.02,00-0.98%)

    http://investorstemcell.com/stem-cel...n-neurotrauma/
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
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    <----Scott Weiland---->

  2. #2

    InVivo Therapeutics Sponsors 2013 RISE Above Paralysis Gala

    InVivo Therapeutics Sponsors 2013 RISE Above Paralysis Gala

    CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV:$2.23,00$-0.01,00-0.45%) , a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has renewed its support for the Greater Boston Chapter of the National Spinal Cord Injury Association (NSCIA), a non-profit organization that offers programs and services to those with spinal cord injury and disease.
    InVivo will serve as a Premier sponsor at the RISE Above Paralysis Gala this Saturday, March 16, 2013, an annual event hosted by the Greater Boston Chapter of the NSCIA. The evening will bring together individuals with SCI, family members, healthcare professionals, and benefactors for a silent auction, dinner and dancing. This year’s gala marks the 21st anniversary of the Greater Boston Chapter.
    “We’ve worked for years to be ready to begin human studies and as we await word from the FDA regarding our application we’re proud to once again be a part of the RISE Above Paralysis Gala,” said Frank Reynolds, InVivo Chief Executive Officer. “This is the fourth year that we’ve been a premier sponsor, and we look forward to another evening celebrating the lives of those living with SCI.”
    Said David Estrada, Director of the Greater Boston Chapter, “From the day InVivo was founded, it has reached out and supported the SCI community via corporate philanthropy. We depend on generous donors like InVivo to support our mission, and we look forward to hearing the progress they’ve made on acute and chronic SCI technologies.”
    About InVivo Therapeutics (NVIV:$2.23,00$-0.01,00-0.45%)
    InVivo Therapeutics Holdings Corp. (NVIV:$2.23,00$-0.01,00-0.45%) is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
    Safe Harbor Statement
    Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct human clinical trials for the Company’s products, the expected commencement date of any approved human clinical trials, the expected size of the pilot study, the expectation that the scaffold product will be regulated under a HDE pathway, and the expected acceleration of commercialization of the Company’s products resulting therefrom. These forward-looking statements are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to obtain FDA approval to conduct human clinical trials; whether the human clinical trials produce acceptable results; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2012 and subsequent filings with the SEC.
    Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.
    Source: InVivo Therapeutics Holdings Corp. (NVIV:$2.23,00$-0.01,00-0.45%)

    http://investorstemcell.com/stem-cel...aralysis-gala/
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  3. #3
    If they achieve something for chronics , i´ll swim across the sea with my wheelchair if I have to!!

  4. #4
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    InVivo Therapeutics Receives Humanitarian Use Device Designation for Spinal Cord Inju

    CAMBRIDGE, Mass. --
    InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the Company has received approval for its request filed with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product.
    http://www.fortmilltimes.com/2013/04...anitarian.html
    KB

  5. #5
    Senior Member muskie's Avatar
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    ok now lets, start moving forward and start getting thing to cross the bridge and make connections in chronics
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  6. #6

    InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomateria

    InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomaterials for Traumatic Spinal Cord Injury
    Posted by iCELL News, on 05th April 2013, in Stem Cell Research.

    04/05 06:00 AM

    CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV:$2.75,00$0.39,0016.53%) , a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) to begin human studies to test its biopolymer scaffold product, a technology developed to treat patients with acute, traumatic SCI.
    With this approval, InVivo intends to commence a first-in-man clinical study in the next few months that will test safety and performance of its biopolymer scaffold in five patients. The Company expects the study to occur over approximately 15 months. There are currently no treatment options approved by the FDA, or in clinical trials, to intervene directly in the spinal cord following SCI. The trial will be conducted at multiple U.S. hospitals, and work to gain Institutional Review Board (IRB) approval at Massachusetts General Hospital in Boston is already underway.
    “It’s heartbreaking for all of us for it to take even a minute longer than necessary to begin human studies, and we’ve all heard of, or experienced, treatments that have proven to be unsafe, but when conducting a first-in-man study, it is imperative to take the time to get it right, because any mistakes can lead to years of lost time for the scientists and patients that follow,” said Frank Reynolds, InVivo Chief Executive Officer.
    “I want to thank my team for their years of dedication and hard work, and the FDA for its diligence, careful consideration and engagement during the stringent review of our technology, a true platform that we believe is capable of being leveraged into new treatments for a wide range of acute and chronic neurological conditions. Many of these neurological problems have limited options for care, and for the patients and families of those with lower incidence conditions, often called ‘orphan’ conditions, every day life can feel like there is no way out. We expect a successful safety study to provide not only the first treatment for acute SCI, but also a safe platform for next generation treatment options for conditions such as ALS, MS and Parkinson’s Disease. At InVivo we live by the mantra ‘What a drug or cell can do…We can optimize,’ and we believe that these treatments will include combination therapies that will be optimized with long-term release and localized delivery of agents or cells.”
    Continued Reynolds, “Everyone knows my obsession with safe FDA studies. Over the next month or so, we plan to finalize the details of our study, and we expect to have all data to the FDA by the end of 2014. We will be conducting an open label study, and so we look forward to keeping the public aware of its progress. As a historical first-in-man study, this trial marks the next phase in our corporate growth and begins our mission to maintain a collaborative relationship with the FDA. We’ve built a framework to optimize speed-to-market for our pipeline of technologies, and we’ll be working to commercialize over fifteen products in the next five years while remaining focused on mitigating patient risk and maximizing patient safety and benefit.”
    The Company was also recently granted approval from the FDA on its Humanitarian Use Device (HUD) designation request. HUD designation is reserved for devices designed to treat rare diseases or conditions. InVivo has received this designation for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord. The HUD designation and clinical trial data are required to support a Humanitarian Device Exemption (HDE) application to the FDA with the goal of commercializing the scaffold in the United States sooner than a Pre-Market (PMA) approval would allow.
    About InVivo Therapeutics (NVIV:$2.75,00$0.39,0016.53%)
    InVivo Therapeutics Holdings Corp. (NVIV:$2.75,00$0.39,0016.53%) is utilizing polymers as a platform technology to develop treatments to improve function in individuals paralyzed from traumatic spinal cord injuries. The company was founded in 2005 based on proprietary technology co-invented by Robert S. Langer, ScD, Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Massachusetts General Hospital. In 2011, the company earned the prestigious David F. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
    Safe Harbor Statement
    Certain statements contained in this press release that are not historical facts may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, and the Company intends that such statements are subject to the safe harbor created thereby. These statements include, but are not limited to, those relating to the expected approval of the FDA to conduct human clinical trials for the Company’s products, the expected commencement date of any approved human clinical trials, the expected size of the pilot study, the expectation that the scaffold product will be regulated under a HDE pathway, and the expected acceleration of commercialization of the Company’s products resulting therefrom. These forward-looking statements are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to obtain FDA approval to conduct human clinical trials; whether the human clinical trials produce acceptable results; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our Annual Report on Form 10-K for the year ended December 31, 2012 and subsequent filings with the SEC.
    Forward-looking statements contained in this press release speak only as of the date of this release. Subsequent events or circumstances occurring after such date may render these statements incomplete or out of date. The Company undertakes no obligation and expressly disclaims any duty to update such statements.
    Source: InVivo Therapeutics Holdings Corp. (NVIV:$2.75,00$0.39,0016.53%)

    Get more news on:SYMBOLS: NVIVNEWS TYPE: Top News, Top Stories: InvestingSECTORS: Health Care, Health Care Equipment and Supplies, Pharmaceuticals, Health Care Providers and Services, Industrials, Electrical Equipment, Information Technology, Electronic Equipment and Instruments

    http://investorstemcell.com/stem-cel...l-cord-injury/
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  7. #7
    To get the orphan status is very important to get investors to look at SCI.

    http://seekingalpha.com/article/1329..._article_title

    "Approval under HUD allows for commercialization under a Humanitarian Device Exemption (HDE) rather than a Pre-Market Approval (PMA) pathway, saving InVivo an estimated two to three years and tens of millions of dollars in clinical trials.We note devices eligible for HUD designations are developed to treat rare diseases or conditions that affects fewer than 4,000 individuals in the U.S. per year. According to the National Spinal Cord Injury Statistical Center (NSCISC), an estimated 12,000 individuals will become fully or partially paralyzed each year due to spinal cord injury. NSCISC data show that approximately 22% of these individuals will have complete tetraplegia and 25% will have complete paraplegia. That would bring the proposed population down to 5,640 individuals. If we assume that half of this population does not have a penetrating injury or the complete severing of the spinal cord, investors can see that InVivo is well below the 4,000 maximum eligible population. On a side note, we fully expect that if approved with the proposed label, InVivo's device will be used, and could even be approved, for a much wider patient population than just the medically plausible subset outlined in the HUD request.


    To be noted that they have used the statistical numbers of NSCISC

    https://www.nscisc.uab.edu/

    NOT the ones provided by CDRF which would make it impossible to get the orphan status

    http://www.christopherreeve.org/site...s__Figures.htm


    Cosidering the chronic population the numbers are bigger so to still get the orphan status will require an even smarter numbers break down.


    Paolo

  8. #8

    Human trials offer hope those with paralysis will walk again

    Human trials offer hope those with paralysis will walk again
    InVivo Therapeutics develops new technology


    Read more: http://www.wcvb.com/health/Human-tri...#ixzz2Q9yV9Nq8

  9. #9
    Quote Originally Posted by Vike View Post
    Human trials offer hope those with paralysis will walk again
    InVivo Therapeutics develops new technology


    Read more: http://www.wcvb.com/health/Human-tri...#ixzz2Q9yV9Nq8
    Well Im afraid my cord is full of this scare tissue %&/$......but anyway this are some good news!

  10. #10
    Wouldnt they be able to remove scar tissue in chronics and re apply as an acute?

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