Tag Archives: SCI

InVivo Therapeutics' CEO Scheduled to Appear on WCVB-TV in Boston Tonight

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InVivo Therapeutics’ CEO Scheduled to Appear on WCVB-TV in Boston Tonight

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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 CEO Frank Reynolds is scheduled to appear on WCVB-TV in Boston tonight, April 10th during the 11:00pm EDT newscast.

InVivo Therapeutics has pioneered a treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after traumatic SCI.

Last week, the U.S. Food and Drug Administration (FDA) granted two approvals to the Company, the first for Humanitarian Use Device (HUD) designation, which the Company believes will expedite the product’s path to market, and the second to approve the Company to begin a first-in-man clinical trial of the technology.

“Our technology is a true platform that can be leveraged to create products for many neurotrauma conditions, and we look forward to beginning the study for our lead product to provide the first effective treatment option for acute SCI,” said Reynolds.

WCVB-TV is the ABC affiliate for the Boston market and airs locally on channel 5.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. 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

Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Announces Warrant Exchange Offer with Intent to Up-List to a National Securities

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InVivo Therapeutics Announces Warrant Exchange Offer with Intent to Up-List to a National Securities Exchange

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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 it has commenced an offer to exchange outstanding warrants issued in 2010 to purchase approximately 15.0 million common shares (“2010 warrants”) for new warrants. The 2010 warrants have exercise prices of $1.40 and $1.00 per share and expire in 2015. One of the primary reasons for the offering is to facilitate the Company’s plans to uplist its stock to a national securities exchange such as NASDAQ or NYSE MKT.

InVivo is offering new warrants with modified terms that extend the warrant expiration date for an additional two years in exchange for elimination of a provision in the 2010 warrants that provides anti-dilution protection if shares are sold at prices below the warrant exercise prices. The exchange offer will expire at 11:59 p.m. on May 6, 2013 unless extended.

The purpose of the exchange offer is to remove the weighted average anti-dilution provisions from the 2010 warrants so InVivo’s financial statements more closely reflect its operating results and financial condition and to facilitate a listing of the Company’s common stock on a national securities exchange. Under generally accepted accounting principles, the anti-dilution provisions require the 2010 warrants to be valued and classified as a warrant liability on the balance sheet, resulting in negative stockholders’ equity. In addition, InVivo is required to revalue the 2010 warrants quarterly and has recorded significant non-cash derivative losses and gains which are not reflective of its actual operating performance. Both the NYSE MKT and NASDAQ require as part of their initial listing standards that a company have a minimum of $4 million of stockholders’ equity, which InVivo would have exceeded at December 31, 2012 if the anti-dilution clause was removed from all 2010 warrants and the $14.6 million warrant liability was reclassified to stockholders’ equity.

“We believe that the warrant exchange offer is mutually beneficial for the 2010 warrant holders, InVivo and our shareholders,” said Frank Reynolds, InVivo’s Chief Executive Officer. “For the warrant holders, the two year extension represents a significant increase in the value of the warrant while the anti-dilution clause being relinquished is unlikely to come into play as InVivo has raised $23.0 million at over $2.00 per share, and the Company’s current $185 million market capitalization is significantly higher since becoming a public company in 2010. For InVivo and our shareholders, the warrant exchange would remove a key impediment to the …read more

Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomaterials for Traumati

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InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomaterials for Traumatic Spinal Cord Injury

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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 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 …read more

Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Receives Humanitarian Use Device Designation for Spinal Cord Injury Treatment

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InVivo Therapeutics Receives Humanitarian Use Device Designation for Spinal Cord Injury Treatment

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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.

HUD designation covers devices that treat rare, ‘orphan’ diseases or conditions. InVivo has received designation for the use of its biopolymer scaffolding 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.

Historically, companies that have received ‘orphan’ status have been able to expedite commercialization, bringing products to market several years faster than other regulatory paths would have allowed. The Company expects the device to be regulated and distributed under a Humanitarian Device Exemption (HDE) pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA. The trial will be conducted to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use.

HUD designation is important not only for speed-to-market, but it represents a benchmark in InVivo’s commitment to patients with SCI,” said Frank Reynolds, InVivo Chief Executive Officer. “We are pleased that the FDA has recognized ‘orphan’ status for this condition and acknowledges the urgent demand for new treatment options for SCI. We’ve built out the team and the facility to manufacture products for human studies, and we’re ready to go.

“We intend to leverage our platform to further develop treatments for chronic SCI, and expect 2013 to be a springboard year for our stakeholders as we have multiple 510(k) products targeted for market entry by the end of 2014,” continued Reynolds. “Our work in 2013 will be marked by clinical SCI data and by developing treatments for additional neurotrauma conditions in the arms and legs while we engage the FDA on multiple products.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. 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 …read more

Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Sponsors 2013 RISE Above Paralysis Gala

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InVivo Therapeutics Sponsors 2013 RISE Above Paralysis Gala

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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 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

InVivo Therapeutics Holdings Corp. 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 …read more
Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Reports 2012 Financial Results, Provides Business Update

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InVivo Therapeutics Reports 2012 Financial Results, Provides Business Update

CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported financial results for the year ended December 31, 2012 and provided a business update.

InVivo has pioneered a new treatment platform utilizing a variety of biocompatible polymer-based devices to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving functional recovery and prognosis after a traumatic SCI. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion.

“The year 2012 has quickly become our most productive. We grew our research and development teams to support a pipeline that now exceeds seven new treatment options for neurotrauma, and we’ve established a GMP manufacturing facility capable of manufacturing our scaffold and hydrogels for human use,” said Frank Reynolds, InVivo Chief Executive Officer. “We’re ready to start a first-in-man clinical trial of our biopolymer scaffolding in acute SCI patients, and we expect as many as five products to be either on the market or in clinical studies by the end of 2014. We have built an outstanding regulatory team to support our R&D capabilities in neurotrauma, and are poised to continue developing new applications for our hydrogels in other areas of the body.”

Recent Corporate Highlights

Biopolymer Scaffolding for SCI:

  • InVivo submitted an updated Investigational Device Exemption to the FDA in February 2013, requesting permission to begin a human study to test its biopolymer scaffolding to treat acute SCI. The study will be an open label study and will evaluate the safety and efficacy of the biopolymer scaffolding in five SCI patients with thoracic injuries. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device, a designation that InVivo expects will create a faster path to market.
  • InVivo is the first company to successfully demonstrate functional improvement in non-human primates paralyzed after a SCI model. Recent data compiled from InVivo’s 2011 non-human primate study confirm that the functional recovery observed in the treatment group was attributable to the biopolymer …read more
    Source: FULL ARTICLE at DailyFinance