CRY Has Reason To Smile, GILD Eyes Japan, ROSG Inks Deal, OxySure Breathes Easy

(RTTNews) - CryoLife Inc. (CRY) is all set to begin enrollment in its pivotal clinical trial of PerClot in the U.S. in the second quarter of 2014.

PerClot is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular and arteriolar bleeding by pressure, ligature and other conventional means is ineffective or impractical. PerClot has CE Mark designation, and has been distributed in several international markets since Q4, 2010.

If things pan out the way as planned, PerClot could potentially receive pre-market approval from the FDA by the end of 2015.

CRY closed Wednesday's trading at $10.56, up 2.42%.

Gilead Sciences Inc.'s (GILD) phase III clinical trial in Japan evaluating once-daily Sofosbuvir in combination with Ribavirin for the treatment of genotype 2 chronic hepatitis C virus infection has met its primary efficacy endpoint of superiority compared to a predefined historical control sustained virologic response rate.

The company is planning to file a New Drug Application for Sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency by mid-2014.

Sofosbuvir, marketed by Gilead Sciences under the brand name Sovaldi, for use in subjects with hepatitis C virus genotypes 1, 2, 3 or 4 infection was approved in the U.S. as recently as December 2013.

GILD closed Wednesday's trading at $73.96, up 0.43%. In after-hours, the stock gained 1.92% to $75.38.

Rosetta Genomics Ltd. (ROSG) and Marina Biotech Inc. (MRNA.PK) have established a strategic alliance, to identify and develop microRNA-based products designed to diagnose and treat various neuromuscular diseases and dystrophies.

Financial terms and other details of the agreement are yet to be revealed.

OxySure Systems Inc.'s (OXYS.OB) Model 615 portable emergency oxygen device has received CE Mark approval.

The OxySure Model 615 enables lay persons, from bystanders to family members, to administer medical oxygen easily and quickly in any medical emergency, while waiting for paramedics or first responders to arrive on the scene.

OXYS.OB closed Wednesday's trading at $0.74, up 7.10%.

Tetraphase Pharmaceuticals Inc. (TTPH) has been granted Fast Track designations for its intravenous and oral formulations of lead antibiotic candidate, Eravacycline.

The IV formulation of Eravacycline is under a phase III trial, dubbed IGNITE 1, for the treatment of complicated intra-abdominal infections. Another phase III trial, known as IGNITE 2 is evaluating Eravacycline IV-to-oral step-down therapy for the treatment of complicated urinary tract infections.

TTPH closed Wednesday's trading 2.48% higher at $11.58.