MENLO PARK, CA – January 27, 2014 – AtheroMed, a developer of innovative catheter technologies for treating peripheral artery disease (PAD), today announced that it has received FDA clearance to market the Phoenix Atherectomy System®, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.
“Peripheral artery disease, especially lesions located below the knee, can be challenging to treat, even with currently available technologies,” said Dr. Thomas Davis, Director of the Cardiac Catheterization Lab and Director of Peripheral Interventions and Disease at St. John Hospital and Medical Center in Detroit, MI. “My experience with the Phoenix device during the EASE clinical study was extremely positive, and I am excited that the device is now available as it will allow me to debulk small vessels that I may not have been able to treat in the past.”

Read more: http://www.atheromedinc.com/atheromed-announces-fda-clearance-to-market-the-phoenix-atherectomy-system-for-treating-peripheral-artery-disease/

MALVERN, Pa., Jan. 21, 2014 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that it has entered into a research collaboration with the Walter and Eliza Hall Institute of Medical Research to examine TetraLogic's SMAC-Mimetic birinapant in viral infections. Preclinical studies performed at the WEHI have indicated that SMAC-Mimetics decrease the viral burden in mice with human Hepatitis B Virus (HBV) by inducing apoptosis of virally infected hepatocytes while sparing the non-infected cells.

TetraLogic has entered into a license agreement with WEHI for worldwide exclusive rights to a patent application filed by the institute relating to a method of treating intracellular infections involving the administration of an Inhibitor of Apoptosis (IAP) antagonist.

"Our work with TetraLogic, if successful, will provide a truly novel approach," said Professor Douglas Hilton, Director, WEHI. "This is further evidence of our commitment to perform research that has a direct impact on the lives of patients."

"We are very excited about this collaboration and look forward to further progress in the research program with WEHI," said Mr. Kevin Buchi, CEO of TetraLogic. "This is an opportunity to build on pioneering basic research to attack infectious disease with a completely novel therapeutic approach."

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 

Read more: http://ir.tetralogicpharma.com/releasedetail.cfm?ReleaseID=820211

SUNNYVALE, Ca., Jan. 13, 2014 /PRNewswire/ -- Silk Road Medical, Inc., a developer of advanced devices for the treatment of Carotid Artery disease, announced today the appointment of Sumaira  Macdonald, MD, PhD to the position of Chief Medical Officer effective immediately. In this new role, Dr. Macdonald will direct the company's scientific and technical agenda and lead research in ground breaking endovascular interventions for the prevention and treatment of stroke.

Prior to joining Silk Road Medical Inc., Dr. Macdonald was a Vascular Radiologist and Honorary Clinical Senior Lecturer atNewcastle University and the Freeman Hospital, Newcastle upon Tyne, UK. "To have attracted a clinician of Dr. Macdonald's significant caliber is a testament to the promise of our technology in preventing stroke resulting from carotid artery disease" saidErica Rogers, President and Chief Executive Officer. "Her leadership in clinical research and renowned medical skills will significantly contribute to the advancement of our products and company's growth. We are honored to have her on the team."

Dr. Macdonald is well regarded for her career-long efforts to improve endovascular interventions.  In addition to being the Co-Editor of the Springer "Carotid Stenting; A Practical Guide", Dr. Macdonald has authored over 70 medical publications  on vascular disease, is the recipient of many academic society honors, serves on the editorial boards of a number of scientific journals and  is highly sought after as a speaker, having given over 300 international lectures.

Read more: http://www.prnewswire.com/news-releases/silk-road-medical-appoints-world-renowned-physician-as-chief-medical-officer-239899971.html

Santa Clara, CA, January 13th, 2014 - ProteinSimple today launched Sally Sue and Peggy Sue, the next generation of high throughput Simple Western instruments. These instruments drive the sensitivity of the current high throughput Simple Western systems to performance levels well beyond any traditional Western.

The Simple Western is a Western with none of the hassle. No messy gels, no transfer tanks, no blots, no imaging and no manual analysis. In 2012, ProteinSimple introduced two high throughput instruments that surpassed the throughput of the traditional Western by 50 times. These systems allowed researchers to simply load up to 96 samples, push a button, walk away and come back to fully analyzed, truly quantitative data in less than a day.

Sally Sue and Peggy Sue enhance the value of these high throughput systems by delivering at least 10 times the sensitivity of the first generation instruments and require 80% less sample. Both systems separate proteins by size and Peggy Sue can also separate proteins by charge. Together, these systems offer biopharmaceutical researchers the highest throughput and the best sensitivity available today in an immunoassay-based separation platform.

Read more: http://www.proteinsimple.com/news_details.html?id=50&page=news.html

REDWOOD CITY, Calif., Jan. 13, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with nab-paclitaxel (Abraxane®) and gemcitabine in pancreatic cancer. This trial is the first of three Phase 1b trials for OMP-54F28 expected to begin patient enrollment in the next few months as part of OncoMed's collaboration with Bayer Pharma AG. This study follows on the recent initiation of OncoMed's Phase 1b program for the Wnt-pathway-targeting antibody vantictumab (OMP-18R5, Anti-Fzd7).

The Phase 1b clinical trial is a dose escalation study of OMP-54F28 in combination with nab-paclitaxel and gemcitabine in patients with first-line Stage IV pancreatic cancer. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with nab-paclitaxel and gemcitabine. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.

Colin Weekes, M.D. Ph.D., Assistant Professor at the University of Colorado, Aurora, CO, is the Principal Investigator who treated the first patient enrolled in this study. Dr. Weekes commented, "Metastatic pancreatic cancer is a devastating disease and these patients are in need of additional therapeutic options. OMP-54F28 has shown impressive combination efficacy with Abraxane and gemcitabine in preclinical models for pancreas cancer. We are looking forward to learning more about this novel investigational combination in pancreas cancer patients."

Read more: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=818852

SANTA CLARA, Calif., Jan. 8, 2014 , PRNewswire -- ProteinSimple today introduced Wes, another revolutionary re-invention of the Western blot. Wes is the bold evolution of the popular Simple Western family of instruments, delivering simplicity and performance like no product before it. With just 30 minutes of sample prep, Wes will analyze up to 25 samples in under 3 hours and he will do it all for less than the price of a high-end Western imager. Wes also introduces an innovative suite of consumables that streamline assay workflow and delivers sensitivity that is better than any traditional Western.

When the Simple Western launched in 2011, it changed the Western blot world forever. It eliminated the hassles of traditional Western blots — no more messy gels, no transfer tanks, no blots, no imaging and no manual analysis. All the steps of the Simple Western are automated, and quantitative data is delivered in a matter of hours.

Wes elevates the Simple Western platform to a stunning level of simplicity. Wes assay kits come with a microplate pre-filled with all the required reagents, fully prepared and ready to use. Researchers only need to pipette their sample and primary antibody into the microplate. Then, simply insert the plate and a disposable capillary cartridge into the instrument. From there, Wes runs the chosen assay and delivers fully analyzed data. The researcher can then dispose of the plate and cartridge and Wes is completely ready for the next experiment.

Read more: http://www.proteinsimple.com/news_details.html?id=48&page=news.html

Soft Tissue Regeneration, Inc. Announces Financing and Appoints New Members to Board of Directors

NEW HAVEN, Conn. – Jan. 6, 2014 – Soft Tissue Regeneration, Inc. (“STR”), a developer of regenerative
orthopedic devices for tendon and ligament repair, today announced the completion of a financing and the
addition of three new members to the company’s board of directors. The $5 million financing commitment will
permit STR to complete its European Phase I clinical study and continue the FDA regulatory process for the
Company’s L-C Ligament®, a bioresorbable, implantable scaffold for the repair and regeneration of an injured
or torn anterior cruciate ligament (“ACL”). In conjunction with this financing, Dane Miller, Ph.D., Charles Hart,
Ph.D., and Richard Emmitt are joining the STR board of directors, offering deep industry expertise in medical
devices and investments.

Current investors, Connecticut Innovations and Launch Capital, led the $5 million financing and Dane Miller and
The Vertical Group also participated. The financing allows STR to complete its 15-patient Phase I clinical study
of the L-C Ligament in Europe, which enrolled the first patient in June, 2013, in The Netherlands. The financing
will also support STR’s continued regulatory and clinical activities with the United States Food and Drug
Administration (FDA) in preparation for a global pivotal clinical trial. The first tranche of STR’s $5 million
financing closed on Nov. 19, 2013.

Read More: http://softtissueregeneration.com/wp-content/uploads/2013/05/1.6.14-STR-News-Release_FINAL.pdf