MEDICAL DEVICE INNOVATION - Medical Device Daily

More documents

Recommendations

Info

96 NovoCure brain cancer device gets backing from big pharmas By LYNN YOFFEE Medical Device Daily Staff Writer Privately held NovoCure (Haifa, Israel) is taking its cancer treatment device into a pivotal trial – squaring off against one of the most aggressive cancers: glioblastoma multiforme (GBM), the brain cancer that generally kills its victims in about a year. Apparently the early data are so promising that some heavyweight backers are now on board. The company just reported completing a new funding round with investors Pfizer (New York), Johnson & Johnson (New Brunswick, New Jersey) and Index Ventures. “We’re very happy to have them on our team of investors,” Mike Ambrogi, U.S. general manager for NovaCure, told Medical Device Daily. “Prior to this fundraising round they weren’t involved. Both companies have vast experience and we look forward to their input, but they are not directly involved in R&D. But we have the opportunity to draw upon their counsel.” NovoCure’s pilot study in Europe, which was the basis for its investigational device exemption approval, included 10 patients, of whom seven are still alive today, five years out. “If all of the patients were to expire now, we would have median overall survival of 62 months vs. 14.6 months for temozolomide (chemotherapy) alone,” Ambrogi said. “We continue to follow these patients and they continue to live. Five of 10 are progression free, meaning there’s been no recurrence and they aren’t on any treatment of any kind.” Although the amount of the investment that came from the pharma giants was undisclosed, Ambrogi said it’s enough to get the company’s promising treatment through trials and, if all goes well, into commercialization. The Novo-TTF device aims to zap solid tumors via specially tuned, low-intensity electrical fields known as tumor treating fields (TTF) to disrupt cell division. Rapidly dividing cancer cells are either broken apart or fail to divide properly when attacked by these electrical fields. Healthy surrounding cells aren’t affected, yielding a targeted treatment with minimal side effects. “To date, the only known side effect is a reddening of skin, dermatitis, where the electrodes are attached, which is to be understood, given that it’s warm and moist,” Ambrogi said. “Other than that, no adverse events have been attributed to the device.” The patient wears a cap on the scalp that’s embedded with non-invasive, insulated electrodes. Those electrodes, which look like bandages, are attached by wires to a battery operated, six-pound portable device – carried in an over-the-shoulder satchel – that generates the fields. Patients wear the cap for up to 24 hours a day MEDICAL DEVICE INNOVATION 2010 In the new 283-patient trial, investigators will study the efficacy of the Novo-TTF device for newly diagnosed GBM patients in combination with standard-of-care chemotherapy, temozolomide (made by Schering-Plough [Kenilworth, New Jersey]), compared with chemotherapy alone in patients with newly-diagnosed GBM. Two-thirds of the patients will receive treatment with the Novo-TTF device while the rest will receive only chemotherapy. “The primary endpoint is progression-free survival time,” Ambrogi said. “We are also expecting to show overall survival benefit.” Study centers are now enrolling patients in the U.S., Europe and Israel. The trial is expected to last two years with a one-year follow-up. If all goes well, the company will be ready for a PMA submission in 2012. NovoCure also recently completed enrollment for a 236-patient, multi-center, randomized pivotal trial studying the safety and efficacy of the Novo-TTF device treating patients with recurrent GBM compared to standard-of-care chemotherapy. Ambrogi pointed out that patients with newly diagnosed and recurrent GBM are treated quite differently, hence the separate trials. The results of this trial will be presented to the FDA as part of a PMA application planned for early next year. “The way the tumor reacts is different in newly diagnosed GBM vs. recurrent,” he pointed out. “Typically newly diagnosed patients have minimal disease. In recurrent cases the tumor is potentially more aggressive and responds differently to treatment.” The company’s device was invented by NovoCure’s founder, Yoram Palti, MD, PhD, who began testing the technology in the basement of his home more than a decade ago. “He theorized how it could work and then verified it in the lab,” Ambrogi said. “We believe it’s a pretty strong platform.” That platform, he added, will be applicable to other cancers too. A small trial – 42 patients with non-small cell lung cancer is currently being conducted in Switzerland. “These are late-stage patients who failed first-line treatment,” Ambrogi said. “We’re seeing some promising early results.” But the company is focused on the GBM indication right now. “We started on brain cancer because it’s a pretty tall hurdle. Patients don’t have a lot of options. The prognosis for a GBM patient is fairly dire and we think we can have a pretty significant impact. We believe we can be successful and make a big difference to these particular patients,” he said. Ambrogi said he is not aware of any other company developing a device that uses alternating electric fields to arrest cell growth, making NovoCure a pioneer in this approach to cancer treatment. (This story originally appeared in the Oct. 15, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 NMT Medical moves up timetable on Closure I Clinical Trial By OMAR FORD Medical Device Daily Staff Writer NMT Medical (Boston) is on the path to bringing its StarFlex device closer to the market. The company said that it will commence data analysis for its CLOSURE I clinical trial – originally scheduled for the fall of 2010 – in April 2010. The trial is evaluating StarFlex’s effectiveness in treating patent foramen ovale (PFO) stroke and transient ischemic attacks. Bumping up the time table stems from an independent group of statistical advisors determining that a significant number of primary outcome events will be demonstrated in both treatment arms of the trial and will have occurred by next month, according to NMT. The company added that by April 2010, the data is expected to have statistical power to support a primary outcome result and thus it would be scientifically appropriate to begin the analysis at that time. At that time the company said that 99.4% of all patient follow-up months will have been completed and 95.1% of patients will have completed the two-year follow-up. The results of the analysis are anticipated during 3Q10 at which point the trial will be complete, with 100% of the randomized patient follow-up available. If the results prove positive for device closure, the company will be in a position to submit a PMA for its Starflex device for the stroke and TIA indication to FDA. “The Starflex is an implanted technology that is used through minimally invasive procedures to treat structural heart disease” NMT CFO Richard Davis told Medical Device Daily. “We’re going down the PMA approval [pathway].” CLOSURE I is the first clinical trial approved by the FDA that brings together stroke neurologists and cardiologists to compare two treatments for embolic stroke and determine which is the most effective. It is being led by Principal Investigators Anthony Furlan, MD, and Mark Reisman, MD. Furlan is Chairman, Department of Neurology, Neurological Institute University Hospitals Case Medical Center, and Case Western Reserve University School of Medicine (Cleveland). Reisman is Director, Cardiovascular Research and Director, Cardiac Catheterization Lab, Swedish Heart and Vascular Institute (Seattle). StarFlex will be compared against pharmaceutical treatments, in the trial, which will include 910 patients throughout more than 95 centers. Of the 910 stroke and TIA patients enrolled, half received treatment with NMT’s StarFlex implant and half were treated with drugs alone. Follow up for the device arm of the study will require patients to see the interventional cardiologist who implanted the STARFlex six months after the procedure. This visit 97 will involve a chest X-ray. Depending on the results of these tests, further visits may be required. Patients in the medical therapy arm taking warfarin will have to have their prothrombin (clotting time) rates checked weekly against international normalization ratios (INRs) until a therapeutic level of between 2 and 3 is established, then every month after that. This is a simple blood test measuring the number of seconds if takes for an individual’s blood to clot. Patients taking aspirin will not need any special testing. NMT’s President/CEO Frank Martin said, “Since completing enrollment in late 2008, we have worked closely with the CLOSURE I Executive Committee to address the delicate balance between the medical community`s desire for more effective treatment options and the value of maximizing the amount of data we will file with the FDA. Commencing the data review in April 2010 should allow NMT to submit a PMA during the third quarter of 2010, assuming a positive outcome.” If the results are less than favorable then the company would have to make adjustments. “I think that if you don’t hit the primary endpoint you have to analyze the results and then see where you go from there,” Davis said. (This story originally appeared in the Sept. 17, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
Page 1 and 2:
MEDICAL DEVICE DAILY MEDICAL DEVIC
Page 3 and 4:
MEDICAL DEVICE INNOVATION 2010 1 AB
Page 5 and 6:
MEDICAL DEVICE INNOVATION 2010 3 Ta
Page 7 and 8:
MEDICAL DEVICE INNOVATION 2010 5 In
Page 9 and 10:
MEDICAL DEVICE INNOVATION 2010 A ti
Page 11 and 12:
MEDICAL DEVICE INNOVATION 2010 9 do
Page 13 and 14:
MEDICAL DEVICE INNOVATION 2010 Hear
Page 15 and 16:
MEDICAL DEVICE INNOVATION 2010 ARS
Page 17 and 18:
MEDICAL DEVICE INNOVATION 2010 15 b
Page 19 and 20:
MEDICAL DEVICE INNOVATION 2010 17 T
Page 21 and 22:
MEDICAL DEVICE INNOVATION 2010 Avan
Page 23 and 24:
MEDICAL DEVICE INNOVATION 2010 Body
Page 25 and 26:
MEDICAL DEVICE INNOVATION 2010 Came
Page 27 and 28:
MEDICAL DEVICE INNOVATION 2010 25 t
Page 29 and 30:
Page 31 and 32:
MEDICAL DEVICE INNOVATION 2010 29 2
Page 33 and 34:
MEDICAL DEVICE INNOVATION 2010 Coru
Page 35 and 36:
MEDICAL DEVICE INNOVATION 2010 33 s
Page 37 and 38:
MEDICAL DEVICE INNOVATION 2010 Surg
Page 39 and 40:
MEDICAL DEVICE INNOVATION 2010 Chee
Page 41 and 42:
Page 43 and 44:
MEDICAL DEVICE INNOVATION 2010 Cohe
Page 45 and 46:
MEDICAL DEVICE INNOVATION 2010 FDA
Page 47 and 48: MEDICAL DEVICE INNOVATION 2010 45 c
Page 49 and 50: MEDICAL DEVICE INNOVATION 2010 Enfa
Page 51 and 52: MEDICAL DEVICE INNOVATION 2010 Drex
Page 53 and 54: MEDICAL DEVICE INNOVATION 2010 Ekos
Page 55 and 56: MEDICAL DEVICE INNOVATION 2010 53 I
Page 57 and 58: MEDICAL DEVICE INNOVATION 2010 55 w
Page 59 and 60: MEDICAL DEVICE INNOVATION 2010 Exmo
Page 61 and 62: MEDICAL DEVICE INNOVATION 2010 Endo
Page 63 and 64: MEDICAL DEVICE INNOVATION 2010 Broa
Page 65 and 66: MEDICAL DEVICE INNOVATION 2010 Heal
Page 67 and 68: MEDICAL DEVICE INNOVATION 2010 Stud
Page 69 and 70: MEDICAL DEVICE INNOVATION 2010 ExAb
Page 71 and 72: MEDICAL DEVICE INNOVATION 2010 69 J
Page 73 and 74: MEDICAL DEVICE INNOVATION 2010 71 c
Page 75 and 76: MEDICAL DEVICE INNOVATION 2010 Hybr
Page 77 and 78: MEDICAL DEVICE INNOVATION 2010 Tru-
Page 79 and 80: MEDICAL DEVICE INNOVATION 2010 77 L
Page 81 and 82: MEDICAL DEVICE INNOVATION 2010 Lumi
Page 83 and 84: MEDICAL DEVICE INNOVATION 2010 81 t
Page 85 and 86: MEDICAL DEVICE INNOVATION 2010 MTI
Page 87 and 88: MEDICAL DEVICE INNOVATION 2010 Micr
Page 89 and 90: MEDICAL DEVICE INNOVATION 2010 Nano
Page 91 and 92: MEDICAL DEVICE INNOVATION 2010 89 s
Page 93 and 94: MEDICAL DEVICE INNOVATION 2010 91 A
Page 95 and 96: MEDICAL DEVICE INNOVATION 2010 93 m
Page 97: MEDICAL DEVICE INNOVATION 2010 NiTi
Page 101 and 102: MEDICAL DEVICE INNOVATION 2010 Tran
Page 103 and 104: MEDICAL DEVICE INNOVATION 2010 New
Page 105 and 106: MEDICAL DEVICE INNOVATION 2010 Paci
Page 107 and 108: MEDICAL DEVICE INNOVATION 2010 105
Page 111 and 112: MEDICAL DEVICE INNOVATION 2010 Non-
Page 113 and 114: MEDICAL DEVICE INNOVATION 2010 Pros
Page 117 and 118: MEDICAL DEVICE INNOVATION 2010 Sanu
Page 119 and 120: MEDICAL DEVICE INNOVATION 2010 Clos
Page 121 and 122: MEDICAL DEVICE INNOVATION 2010 Once
Page 123 and 124: MEDICAL DEVICE INNOVATION 2010 SFC
Page 125 and 126: MEDICAL DEVICE INNOVATION 2010 Mayo
Page 127 and 128: MEDICAL DEVICE INNOVATION 2010 C-Pu
Page 129 and 130: MEDICAL DEVICE INNOVATION 2010 supe
Page 131 and 132: MEDICAL DEVICE INNOVATION 2010 Syne
Page 135 and 136: MEDICAL DEVICE INNOVATION 2010 Ther
Page 137 and 138: MEDICAL DEVICE INNOVATION 2010 Gold
Page 139 and 140: MEDICAL DEVICE INNOVATION 2010 Nano
Page 143 and 144: MEDICAL DEVICE INNOVATION 2010 Pilo
Page 145 and 146: MEDICAL DEVICE INNOVATION 2010 US E
Page 149 and 150:
MEDICAL DEVICE INNOVATION 2010 147
Page 151 and 152:
MEDICAL DEVICE INNOVATION 2010 A ti
Page 153 and 154:
MEDICAL DEVICE INNOVATION 2010 VisE
Page 155 and 156:
MEDICAL DEVICE INNOVATION 2010 New
Page 157:
MEDICAL DEVICE INNOVATION 2010 155
show all

MEDICAL DEVICE INNOVATION - Medical Device Daily

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?