ScienCell Research Laboratories (http://www.sciencellonline.com) is a biotechnology company whose mission is the research and development of cell and cell-related products for experimental and therapeutic use. We currently have a new opening:
Well-developed research and critical thinking skills, and sound decision-making abilities, with attention to detail to produce consistently accurate work….From NIBR – Wed, 24 Aug 2016 21:02:29 GMT – View all San Diego jobs
Is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global…From DeviceSpace.com – Wed, 24 Aug 2016 19:10:33 GMT – View all San Diego jobs
Tenova Pharmaceuticals Inc is seeking a highly motivated synthetic chemist. Qualified candidates will possess a Ph.D. or M.S. degree in organic chemistry with synthetic chemistry laboratory experience. Specific skill requirements include designing an […
Designer Molecules, Inc. (DMI) is located in San Diego, CA and develops and manufactures unique organic molecules used by formulators in the electronic and other high tech markets. We have an immediate employment opportunity for a Production Supervis […
How often would you go to the doctor if you had to pay for a big chunk out of pocket—or how about if it was completely free? The amount of health care we consume depends on how good our health…
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A regular 5 day work week will include and require:. Proficient in data collection/documentation, either in electronic or hardcopy forms….From Indeed – Wed, 24 Aug 2016 15:39:31 GMT – View all San Diego jobs
ITHACA, N.Y., Aug. 24, 2016 /PRNewswire/ — Data from Vybion on a novel treatment for Huntington’s disease has been published in the Journal of Neurodegenerative diseases. The published study (http://www.hindawi.com/journals/jnd/2016/7120753/) links the ability of Vybion’s proprietary, novel Intrabody (INT41) blocking of cellular gene dysregulation to the delay of cognitive and motor function loss in the well-validated vR6/2 animal model.
INT41 interferes with direct binding of toxic N-terminal huntingtin fragments to DNA, as well as their transport into the nucleus. The data support a direct gain of function of N-terminal huntingtin protein fragments that may lead to neuron dysfunction and brain atrophy as well as a novel therapeutic modality. The data also demonstrate that Vybion’s platform may have broader application in generating Intrabody drug candidates to difficult-to-drug targets, including intracellular proteins in neurodegenerative disorders and other disease areas such as oncology. Further, the platform may be used to validate new targets of interest, particularly in intracellular signal transduction pathways, prior to generation of new therapeutic candidates.
“We believe that our therapeutic approach to the treatment of Huntington’s disease has provided a biological rationale linking Huntington’s disease progression and toxic N-terminal fragments. We look forward to completing our plans for human patient trials,” says Lee Henderson, PhD, CEO of Vybion.
About Vybion: Vybion, Inc. is a development stage Company with proprietary technologies for Intrabody discovery and development to treat neurodegenerative diseases such as Huntington’s, SBMA and SCA1, 3 and 7. The Company is currently in late pre-clinical development with INT41 in Huntington’s Disease. The Intrabody platform is applicable to target validation in intracellular signal transduction pathways and can be applied to multiple therapeutic areas.
About Inverness: Inverness Advisors LLC, based in San Francisco and a division of KEMA Partners LLC, is an investment bank that provides capital raising and mergers & acquisitions advisory services to clients in the technology, media and healthcare industries. Inverness Advisors conducts all securities business through KEMA Partners LLC, a FINRA member and SEC-registered broker-dealer.
Lee A. Henderson, Ph.D.
SOURCE Vybion, Inc.
SI-BONE, Inc. Announces Two-Year Results from a Randomized Controlled Trial of the iFuse Implant System® vs. Non-Surgical Management for Some Causes of Sacroiliac Joint Dysfunction
Two-Year RCT Demonstrates Long-Term Durability of iFuse, Further Validation of Previous 3, 4 and 5 Year Published Results
SAN JOSE, Calif., Aug. 24, 2016 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a patented triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of two-year results from INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004) a landmark prospective, multicenter, randomized controlled trial (RCT) of MIS SI joint fusion with iFuse compared to non-surgical management (NSM). Results of this Level 1, high quality study were published in the International Journal of Spine Surgery titled: Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction1. The study showed that rapid improvements in pain, disability and quality of life for the iFuse group were larger than those seen for the NSM group and were durable to two years. This large, Level 1 RCT adds to the more than 40 peer-reviewed publications on iFuse and further reinforces positive outcomes and product durability demonstrated in previously reported 3 year, 4.5 year and 5 year publications.2-4
148 subjects were enrolled, randomized 2:1 (102 iFuse/46 NSM), and treated at 19 centers in the United States including both private practice and academic institutions. In the iFuse group, the mean SI joint pain score improved from 82.3 at baseline to 30.1 at 6 months, 28.6 at 12 months and 26.7 at two years, corresponding to improvements from baseline of 52.3, 53.7 and 55.4 points, respectively (all p<.0001, Figure 1). Disability, as measured using the Oswestry Disability Index (ODI), decreased from a mean 57.2 at baseline to 29.9, 28.3 and 28.7 at months 6, 12 and 24, representing mean improvements of 27.4, 28.9 and 28.4 points, respectively (p<.0001)
The revision surgery rate was low at 3.4% (3/89) consistent with previously reported long-term results for iFuse2,5 and roughly one-third that for lumbar fusion surgery6. Two-year results also showed a 29.7% decrease from baseline in the number of study subjects taking opioids (Figure 2) which is consistent with a 28% reduction in opioid use observed in a previously reported prospective multicenter two-year study5.
“These two-year results from the INSITE study illustrate the durability of SI joint fusion with iFuse and further validate previously reported 6- and 12-month results that showed rapid improvement in pain, function and quality of life in this highly debilitated patient population,” said Frank Phillips, MD of Rush University Medial Center in Chicago, IL. “This positive publication validates the consistency of the earlier publications on iFuse and will hopefully encourage health plans across the U.S. to establish coverage for this effective procedure.”
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants with a porous surface that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. iFuse is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 40 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse. It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9695.082416
- Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028.
- Sachs D, Kovalsky D, Redmond A, Limoni R, Meyer SC, Harvey C, Kondrashov D. Durable Intermediate- to Long-term Outcomes after Minimally Invasive Transiliac Sacroiliac Joint Fusion using Triangular Titanium Implants. Med Devices (Auckl). 2016;9:213-22. doi: 10.2147/MDER.S109267.
- Vanaclocha-Vanaclocha V, Verdú-López F, Sánchez-Pardo M, Gozalbes-Esterelles L, Herrera JM, Rivera-Paz M, Martínez-Gómez D. Minimally Invasive Sacroiliac Joint Arthrodesis: Experience in a Prospective Series with 24 Patients. J Spine. 2014;3:185. doi: 10.4172/2165-7939.1000185.
- Rudolf L, Capobianco R. Five-Year Clinical and Radiographic Outcomes After Minimally Invasive Sacroiliac Joint Fusion Using Triangular Implants. Open Orthop J. 2014;8:375–83. doi: 10.2174/1874325001408010375.
- Duhon BS, Bitan F, Lockstadt H, Kovalsky DA, Cher DJ, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-year Follow-up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. doi: 10.14444/3013.
- Martin BI, Mirza SK, Comstock BA, Gray DT, Kreuter W, Deyo RA. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine. 2007;32(3):382-7. doi: 10.1097/01.brs.0000254104.55716.46.
One or more of the individuals named herein may be a past or present SI-BONE employee, paid consultant, investor, clinical trial investigator, or grant recipient. Research described herein was supported by SI-BONE.
SOURCE SI-BONE, Inc.
SENIOR RESEARCH ASSOCIATE, IMMUNO-ONCOLOGY (IN VITRO MODELS) – Sorrento Therapeutics, Inc. – San Diego, CA
Strong work ethic, a desire to learn and contribute to the advancement of novel immune-based cancer therapies, attention to details, precision, flexibility and…From DeviceSpace.com – Wed, 24 Aug 2016 07:11:33 GMT – View all San Diego jobs