September 25, 2017 9:18 PM ET

Chemicals

Company Overview of W. L. Gore & Associates, Inc.

Company Overview

W. L. Gore & Associates, Inc. manufactures electronics, fabrics, industrial, and medical products. It provides consumer products, including waterproof, windproof, and breathable garments, footwear and accessories, guitar strings, and vacuum cleaner bags; cables and cable assemblies; electronic and electrochemical materials, such as EMI shielding and grounding solutions, fuel cell components, and electrochemical device components; fabrics, including public safety, military, and fire and safety service fabrics; and fibers, such as sewing threads, weaving yarns, and rope fibers. The company also offers filtration products; medical products, including implantable medical devices and medical OEM ...

555 Papermill Road

Newark, DE 19711

United States

Founded in 1958

Phone:

410-506-7787

Fax:

410-506-7633

Key Executives for W. L. Gore & Associates, Inc.

Chief Executive Officer and President
Media Relations Manager
Compensation as of Fiscal Year 2017.

W. L. Gore & Associates, Inc. Key Developments

W. L. Gore & Associates, Inc. Receives FDA Clearance for GORE® SYNECOR Preperitoneal Biomaterial Hernia Repair Device

W. L. Gore & Associates, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its GORE® SYNECOR Preperitoneal Biomaterial hernia repair device. The device is being launched June 8 at the Abdominal Wall Reconstruction (AWR) Conference in Washington, D.C. The Gore SYNECOR portfolio now offers treatment options for the full range of hernia cases, with configurations for both intraperitoneal and preperitoneal placement. GORE SYNECOR Preperitoneal Biomaterial is a hybrid, biosynthetic hernia repair solution intended for single-stage preperitoneal, onlay, and retromuscular placements through open, laparoscopic, and robotic applications. It is comprised of three layers: A macroporous knit of dense, monofilament polytetrafluoroethylene (PTFE) fibers provides strength for a durable single-stage repair and minimizes harboring of bacteria, while two surrounding layers of GORE® BIO-A® Web, a bioabsorbable copolymer scaffold, facilitate tissue ingrowth and vascularization on both sides of the device. Some common applications include: Transversus abdominis release (TAR) procedure, component separation technique, preperitoneal ventral hernia repair, and high-risk ventral hernia repair. Preclinical studies of GORE SYNECOR Preperitoneal Biomaterial demonstrated that the tissue-building scaffold promoted vascularity within seven days and tissue ingrowth within one month. Vascularity within the device and the PTFE fiber design enable treatment options in the presence of contamination, minimizing the need for device removal.

W. L. Gore & Associates, Inc. Announces Positive Results from REDUCE Clinical Study for PFO Closure

W. L. Gore & Associates, Inc. (Gore) announced positive results from its REDUCE Study assessing closure of patent foramen ovale (PFO) for the reduction of recurrent ischemic stroke and new brain infarct. The data were shared May 16 at the European Stroke Organisation Conference (ESOC) in Prague, Czech Republic. Gore plans to submit the positive data to the U.S. Food and Drug Administration (FDA) to seek a PFO indication for the GORE® CARDIOFORM Septal Occluder by year-end 2017. The controlled, open-label REDUCE study assessed the efficacy and safety of PFO closure using Gore Septal Occluder Devices in 664 randomized subjects, ages 18 to 59 with a history of cryptogenic stroke, across 63 investigational sites in seven countries. The trial met its primary endpoint by showing a statistically significant, 76.6% (p = 0.001), reduction in recurrent ischemic stroke in patients that underwent PFO closure in conjunction with antiplatelet therapy versus those who underwent antiplatelet therapy alone after an average of 3.4 years follow-up. In addition to the primary endpoint of reduction of recurrent stroke, the study also met its co-primary endpoint of reduction of new brain infarct, inclusive of silent brain infarct (SBI), through PFO closure. An increased risk of clinical stroke, dementia, and cognitive dysfunction has been associated with SBI. This marks the first time a study assessed the relationship between PFO closure and reduction of new brain infarct. Patients underwent baseline and two-year follow-up MRI scans to determine if new brain infarct occurred. New brain infarct was present in 5.7% of test arm subjects and 11.3% of control arm subjects, yielding a 49.6% (p = 0.024) relative risk reduction for PFO closure on new brain infarct. The data showed no difference in the subject-based rate of serious adverse events between test and control groups. Device- and procedure-related serious adverse events occurred in 1.4 and 2.5%, respectively, of test patients. Patients experienced low rates of bleeding, deep vein thrombosis, and pulmonary embolism, with no significant difference between test and control groups. There was a significantly higher rate of serious atrial fibrillation in the test group (2.3% versus 0.4%) but the majority of atrial fibrillation was peri-procedural (80% had onset within 30 days of the closure procedure) and had rapid resolution (70% with resolution within two days of onset).

ViaCyte, Inc. and W. L. Gore & Associates, Inc. Announce Collaborative Research Agreement to Develop Novel Implantable Delivery Technologies for Cell Therapies

ViaCyte, Inc. and W. L. Gore & Associates, Inc. announced a collaborative research agreement whereby the two companies will work together to develop novel implantable cell therapy delivery device technologies that provide protection from immune rejection. For more than a decade, ViaCyte has been developing innovative stem cell-derived cell replacement therapies with a focus on the treatment of insulin-requiring diabetes. In the case of patients with type 1 diabetes, ViaCyte's product candidates have the potential to provide a functional cure. The company was the first to describe directed differentiation of human pluripotent stem cells into pancreatic cells, and the first to demonstrate the differentiation of stem cell-derived pancreatic progenitor cells into glucose-responsive insulin-producing cells, both in vivo and in vitro. In addition, ViaCyte launched the first clinical trial for stem cell-derived islet replacement therapy for type 1 diabetes. An important aspect of the therapy is the effective delivery of the cells to the patient. To accomplish this, ViaCyte has been developing encapsulation technologies including devices that protect the cells from the host immune system. ViaCyte is developing the PEC-Encap™ (also known as VC-01™) product candidate designed to deliver stem cell-derived islet replacement therapies to patients with type 1 diabetes as well as patients with type 2 disease that require insulin. The PEC-Encap combination product comprises PEC-01 pancreatic progenitor cells delivered in an immune-protective device called the Encaptra® Cell Delivery System. Based upon early, preliminary clinical evaluation, the PEC-Encap product appears safe, the Encaptra device is providing immune protection as designed, and evidence of vascularization, engraftment, and differentiation of the PEC-01 cells into insulin-producing beta cells has been observed. Further product development work remains to improve engraftment of PEC-Encap, and non-clinical and clinical results have indicated the potential for improvement through modifications to the Encaptra Device. Building on the observations with the PEC-Encap product candidate, ViaCyte is initiating clinical development of the PEC-Direct product candidate. The PEC-Direct product also delivers PEC-01 cells, but in a device that allows for direct vascularization of the cells. Used with immunosuppression as with other transplants, PEC-Direct has the potential to be a functional cure for patients suffering with type 1 diabetes who are at high risk for life-threatening acute complications.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
May 22, 2017
ViaCyte, Inc.
Merger/Acquisition
April 25, 2017
W. L. Gore & Associates, Inc., Water and Chemical Filtration Product Line
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