Business Tech & Wireless

CytoSorbents Launches Patient Enrollment for Pivotal U.S. Refresh 2-AKI Trial

CytoSorbents Corp. reported first patient enrollment into the pivotal U.S. Refresh 2-AKI trial.

According to a media release, focused on patients undergoing complex cardiac surgery, the Refresh 2-AKI trial is designed to evaluate the safety and efficacy of intraoperative CytoSorb use to reduce post-operative acute kidney injury (AKI), the primary endpoint of the study.

Dr. Eric Mortensen, Chief Medical Officer of CytoSorbents stated, "Achievement of the first patient enrolled is an important milestone that has occurred in parallel with the rapid expansion of our clinical operations team and final FDA Investigational Device Exemption (IDE) approval of the study. We anticipate an acceleration in the pace of the trial, with a key focus on enrollment, study execution, and onboarding new sites to our program."

Dr. Mortensen continued, "Postoperative AKI remains a common adverse event following cardiac surgery that has significant long-term health and cost consequences. It is associated with increased hospitalization, progression to chronic kidney disease requiring dialysis, and higher post-surgical mortality. At present, there are no approved therapies to reduce the incidence or severity of AKI in high risk cardiac surgery patients. We believe that intraoperative CytoSorb use has the potential to reduce factors that cause either direct and indirect kidney injury. If successful, we believe the data from the pivotal Refresh 2-AKI trial will provide the efficacy, safety, and cost-effectiveness data to support FDA approval, reimbursement, and adoption here in the U.S. and abroad."

The Company said that Refresh 2-AKI trial is a randomized, controlled, multi-center, clinical trial designed to evaluate intraoperative CytoSorb use as a therapy to reduce AKI, as measured by Kidney Disease Improving Global Outcomes (KDIGO) criteria, following complex cardiac surgery. The trial will enroll up to 400 patients undergoing elective, non-emergent open-heart surgery for either valve replacement, or aortic reconstruction with hypothermic cardiac arrest. Control patients will receive standard of care during surgery, while Treatment patients will receive standard of care with dual parallel CytoSorb cartridges in a heart-lung machine bypass circuit that are intended to reduce toxic inflammatory mediators and renal toxins such as plasma free hemoglobin and activated complement, during surgery.

Other secondary and exploratory endpoints include time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators, and mortality at 30 days, for example.

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  • Alexandra Scarborough
    Gilt and Sarah Jessica Parker Unveil SJP by Sarah Jessica Parker Bridal Collection for Spring

    Sarah Jessica Parker, in partnership with Gilt, kicked off the exclusive launch of SJP by Sarah Jessica Parker Bridal, Gilt’s first foray into bridal ready-to-wear that would have Carrie Bradshaw swooning.

    The collection includes dresses, skirts, bodysuits and other pieces, ranging in price from $295 to $2,395 and from sizes 0 to 14.

    "Collaborating with Gilt on my first bridal ready-to-wear collection was an opportunity I couldn't pass up," said Sarah Jessica Parker. "The team there is brilliant and allowed me to be imaginative and take risks as I was designing for the non-traditional bride. It has been quite fun to play around with colors, fabrics and details to create unique pieces for all kinds of brides." The collection, comprised of ten styles, is inspired by Parker's vision of a modern, non-traditional bride, and is designed to dress a woman for a variety of wedding milestone moments; from her bridal shower through her wedding reception. Styles offered are a unique mix of classic dresses and gowns, modern bodysuits, full skirts, and a jumpsuit. The color palette includes traditional bridal white, sleek black, plus pops of blush, poppy, light gray and blue.

    Designed in collaboration with Gilt, the collection was produced in New York City utilizing fabrics like cashmere and stretch crepe sourced from Spain, Italy and France.

    The pieces all feature carefully curated details like elegant bows, sophisticated cutouts, feathers, intricate embroidery and beautiful hand-stitched beading. 

    The actress and style icon is no stranger to chic bridal wear. Carrie Badshaw, famously played by Parker, took part in an elaborate bridal photo shoot in Sex and the City: The Movie. The shoot featured gowns from designers like Christian Lacroix and Lanvin. Parker famously wore a black wedding gown for her own wedding to Matthew Broderick in 1997.

    "Not only is Sarah Jessica Parker's style known around the world, her point of view is one-of-a-kind," says Tom Ott, Chief Merchant of Gilt. "Sarah Jessica brings her impeccable taste and fashion sensibility to life in this collection. We think our customers will be delighted with the offering which is stylish and well-priced in the bridal category."

    As part of the bridal launch, Gilt will also offer 15 exclusive styles from the SJP by Sarah Jessica Parker footwear line, each of which are complementary to the bridal collection. 

    To correspond with the bridal collection launch, Gilt City will present offers from some of Sarah Jessica Parker's favorite places in New York City.

    The offers were each chosen as a way to help brides plan for and celebrate the big day with highlights including, Leather Spa, Lars Nord Studio Tailoring, Mah-Ze-Dahr Bakery, among others.

    More Information:

  • Alexandra Scarborough
    Tea Forté Introduces ‘Matcha’ Collection

    Convenience meets tradition in Tea Forté’s new Ceremonial Matcha Bowl Set and the Matcha Single Steeps.

    The company said its spring harvested, shade grown, stone ground, organic matcha tea is best served in a centuries-old Japanese tea ceremony called chanoyu: a preparation technique known for its centering meditative qualities.

    "The launch of Tea Forté's Matcha collection represents our continued commitment to wellness and cultivating all the potential mental and physical health benefits of tea," says Tea Forté CEO Michael Gebrael. "In addition to our high quality Pure Matcha, we've also blended four distinct flavored Matcha varieties. Prepackaged in pouches measured out for a single serving, our Single Steeps Matcha is ideal for the office, travel, or to keep with you for a boost anytime."

    Tea Forté noted its handcrafted ceremonial tea bowl, handmade bamboo whisk and measuring ladle “encourages serene enjoyment of our premium Kosher, gluten-free and vegan matcha blends.” These include: Pure Matcha, Chocolate Matcha, Coconut Matcha, Ginger Matcha, and Chai Matcha.

    According to a release, in addition to its distinctive taste, matcha is prized for its health benefits. Steeped green tea contains only the antioxidants that can be extracted in water, while with matcha, the whole leaf is consumed.

    Available now in select stores and online at



QUICK 5 has released a year-end look at U.S. traveler behavior and trends for 2017, analyzing data to identify the most in-demand destinations, hotels, activities and more.

Among other insights, the roundup revealed:

  1. Labor Day was the busiest weekend for car rental
  2. Disney Theme Parks topped the list of things to do
  3. The average hotel stay was two nights
  4. Top destinations based on 2017 air travel included major global cities like New York, London and Bangkok
  5. Popular tourist destinations included Orlando, Cancun and Las Vegas