$NVIV - outstanding case for the future of spinal scaffolding device, from Factman777 on YMB:
Fact 1: Currently there is nothing approved that can restore function to patients with traumatic Spinal Cord Injury (SCI, paralysis). Each year $10 billion is spent on patients with acute SCI, so the market potential is huge.
Fact 2: InVivo’s polymer-based medical treatments have been successful in restoring, within three to five weeks, functional improvement in more than 40 paralyzed green monkeys. No other company has ever restored function to a single paralyzed monkey.
Fact 3: The DNA in green monkeys is a 98% match to the DNA in humans so there is an overwhelming chance that this will work just as well in humans. Clinical trials in humans will begin in 2013.
Fact 4: InVivo’s “scaffold” is a biopolymer material already approved by the FDA for other uses, such a sutures, that ultimately dissolve into CO2 and water.
Fact 5: In April 2012, the FDA confirmed that the Company’s biopolymer scaffolding device can indeed be considered a medical device (not a pharmaceutical) and therefore follow the pathway for an Investigational Device Exemption. The FDA will allow the device to proceed along the Humanitarian Use Device/Humanitarian Device Exemption pathway. This means that the Company might only have to try this on as few as 5 patients before receiving FDA approval for the device to be marketed for humanitarian use while testing continues.
Fact 6: On May 9, 2012, Frank M. Reynolds, the Chief Executive Officer of InVivo Therapeutics Holdings Corp., terminated his previously disclosed Rule 10b5-1 trading plan, which covered potential sales of up to 4,000,000 shares of common stock of the Company. No sales were made pursuant to the Rule 10b5-1 Plan. Frank has not sold a share since April 2012 and previous sales were due to a one-time personal reason and had nothing to do with future company performance.
Fact 7: On Sep 18, 2012, Brain Hess replaced Edward Wirth as Chief Science Officer. Edward Wirth’ s expertise was in stem cell research while Mr. Hess basically invented the materials used in InVivo’s scaffolding devices. Getting stem cell applications in humans through the FDA can take several years. Mr. Hess was instrumental in developing HydroSetTM, an injectable calcium phosphate based bone substitute, from concept to product launch. The product has become the market-leading bone scaffold, and Stryker awarded Mr. Hess and his team with “Best Technology” and “Best Team Synergy” for their work on this critical product. Mr. Hess also won several research and development awards during his tenure at Stryker. Most notably he was named "Co-Innovator of the Year" in 2010 within Stryker Orthopedics. So their new Chief Science Officer is now much more aligned with the company’s goals.
Fact 8: On Sep 25, 2012, InVivo opened their new Office and Labs in Cambridge, MA. The polymer-based scaffold material will be made in this new state of the art facility. This will also act as the new company’s headquarters.
Fact 9: Approval from the FDA to start the 5 patient human clinical trials has been delayed due to the approval of batches made in in this brand new facility. These batches are to be used in the upcoming 5 patient human clinical trials. The approval is expected very soon, with human clinical trials set to begin by mid-2013.
When dealing with the FDA, it always takes longer than expected. Three to nine months from now this will turn out to be a positive as it has allowed new investors to buy shares at ridiculously low prices and allowed other investors who bought over $2.00 a share to average down.
Fact 10: InVivo has begun discussions with the FDA about its second product, a drug releasing hydrogel for use as a long term pain management of peripheral nerve pain. There are millions of peripheral nerve procedures performed on patients every year, and the Company will leverage its technology by also submitting its injectable hydrogel drug releasing product for use on peripheral nerve injury.
Fact 11: InVivo has Bob Langer, Sc.D. on their team. Robert S. Langer is the David H. Koch Institute Professor at the Massachusetts Institute of Technology (MIT) (being an Institute Professor is the highest honor that can be awarded to a faculty member). Dr. Langer has written over 1,100 articles. He also has approximately 760 issued and pending patents worldwide. Dr. Langer’s patents have been licensed or sublicensed to over 220 pharmaceutical, chemical, biotechnology and medical device companies.
He served as a member of the United States Food and Drug Administration’s SCIENCE Board, the FDA’s highest advisory board, from 1995 — 2002 and as its Chairman from 1999- 2002.
His experience at the FDA should not be underestimated. He was instrumental in convincing the FDA to allow InVivo’s polymer-based medical treatments to proceed along the Humanitarian Use Device/Humanitarian Device Exemption pathway with just an initial 5 patient clinical trial. See Fact 5 above.
Fact 12: Frank Reynolds is an extremely driven CEO that is passionate about helping people with Spinal Cord injuries. Mr. Reynolds suffered a paralyzing injury to his spine in December 1992. He spent 5 years of his life in bed paralyzed, except for some small movement in his legs, but only when he laid down. He could not walk. While recovering from this injury he spent several years gaining subject matter expertise on the spine and spinal cord.
Fact 13: InVivo raised $20 million in early 2012 from a select group of institutional investors and has $18.0 million of cash on hand as of June 30, 2012. This is sufficient to fund operations well into 2014. Exercise of warrants also has the potential to raise an additional $16.7 million of cash.
Fact 14: National Medal of Technology and Innovation award received by Dr. Robert Langer from the Massachusetts Institute of Technology during a ceremony in the East Room of the White House in Washington, February 1, 2013.
Fact 15: InVivo management is confident human studies will begin in the next few months for their biopolymer scaffolding product. In an October 2012 letter to shareholders, Frank Reynolds noted that the FDA has confirmed the regulation of the scaffold product as a device. In December 2012, InVivo filed a request with the U.S. FDA for a Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product for the treatment of acute spinal cord injury. The request comes after an April 2012 meeting in which InVivo and the FDA discussed the requirements for the HUD designation and the potential for the device to be regulated and distributed under a Humanitarian Device Exemption (HDE). A HUD designation and a subsequent approved HDE would enable InVivo to commercialize the device in the U.S. faster than the Pre-Market (PMA) approval process. InVivo is guiding to start the 5-person human study in the next few months, with data rolling out two months later. If the trial works, InVivo could request HDE approval by the end of the year.
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