Outcomes

Energy Solutions International, Inc. Reports Third Quarter 2015 Outcomes

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Power Options International, Inc. Reports Third Quarter 2015 Final results
09, 2015 (GLOBE NEWSWIRE) — Power Options International, Inc. (Nasdaq:PSIX), a leader in the design and style, engineering and manufacture of emissions-certified option-fuel and conventional energy systems, right now announced its economic outcomes for the …
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Planet Patent Marketing Introduces The SnapBack Remote As China and India Drive …
six, 2015 (GLOBE NEWSWIRE) — through PRWEB – Planet Patent Marketing, a vertically integrated manufacturer and engineer of patented products, announces the Snap Back Remote, a technological invention that helps people discover their remote manage. &quotThe International …
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Can Multi-fineline Electronix Incorporated hit Expected Sales of 170M?
With facilities in Anaheim, California Suzhou, China Chengdu, China Cambridge, England Korea Taiwan, and Singapore, it provides a worldwide service and assistance base for the sale, design and manufacture of flexible interconnect solutions. The Firm …
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Smith &amp Wesson Holding&#39s (SWHC) CEO James Debney on Q1 2015 Outcomes …

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Smith &amp Wesson Holding&#39s (SWHC) CEO James Debney on Q1 2015 Benefits …
… terms of units and you do the math — we&#39ve provided you the elements of the formula, so we have 139,000 units. If 72% goes by means of two methods when it comes to the consumer channel, that helps you draw comparisons against other companies …
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Ethis Healthtech Announces Partnership with IROC Science and EyeKor to Provide Turnkey Solution for Meeting New European Regulatory Demands for Post-market Outcomes Data

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ZURICH, MADISON, WI, and NEW YORK (PRWEB) September 11, 2014

Three companies—one European, two American—have teamed up to allow European manufacturers of implantable ophthalmic devices to comply with anticipated regulatory demands for ongoing post-marketplace outcomes information.

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In 2015, manufacturers of implantable health-related devices sold on the European market will likely be essential to offer information on the security and efficacy of their products—both prior to and now soon after their devices achieve regulatory approval. This will call for careful post-market place clinical studies to create data and reports that meet European regulators’ precise specifications.

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To meet this need, a collaborative group has been formed amongst Zurich-primarily based IROC Science to Innovation AG, a major ophthalmic consulting service with specialized experience in ophthalmic clinical trials EyeKor, LLC, a firm of American clinical trial authorities that has created a cloud-primarily based application application, EXCELSIOR™, constructed specifically for supporting image data collection and management of ophthalmic clinical trials and Ethis HealthTech, LLC, an American business that serves firms in the fields of eyecare and digital healthcare by supplying marketplace-entry arranging and help, fundraising, and strategic communications.

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According to IROC’s Founder and CEO Michael Mrochen, PhD, “The burden that the proposed regulations will place on the makers of implantable devices is substantial, so it was important to generate an efficient way for organizations to receive post-marketplace outcomes information.”

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The outcome of the three-company collaboration is a turnkey resolution that provides European ophthalmic device producers a straightforward, expense-powerful way to meet the anticipated regulatory needs. This is produced possible by the joining of IROC’s in-depth understanding of the European regulatory landscape and experience in clinical trial design and operation with EyeKor’s unique clinical trial management software.

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EyeKor CEO Christopher J. Murphy, DVM, PhD, notes: “Excelsior™, EyeKor’s unique ophthalmic clinical trial software platform is developed to enhance speed and accuracy in the collection and interpretation of ophthalmological clinical trial data, creating it completely suited to the quickly-to-be-required phase IV clinical outcomes studies. It is particularly designed to enable efficient uploading and archiving of pictures collected utilizing diverse proprietary instrument software program to standardize the presentation format. Excelsior™ is a software platform that received FDA 510(k) clearance with distinct indications for use as a information management method for ophthalmic clinical trials.”

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As the person who engineered the collaboration, Luca Sergio, Managing Companion of Ethis HealthTech, notes: “We are pleased to join such a world-class team of recognized ophthalmic regulatory and clinical affairs experts and prime-notch ophthalmic imaging and reading center specialists to supply this robust, scalable, however easy-to-implement solution for our European business partners.”

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Discover more by going to booth A11 at the 2014 Annual Meeting of the European Society of Cataract &amp Refractive Surgeons, September 13-17, in London, or go to phaseiveyecarestudies.com.

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About IROC Science: IROC Science to Innovation AG provides consulting solutions for translational investigation projects in ophthalmology. The company’s multidisciplinary group has more than 15 years’ expertise in ophthalmic translational research projects and brings to the table in-depth knowledge with European regulatory bodies and the design and operation of clinical trials.

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About EyeKor: EyeKor, LLC, provides a complete spectrum of integrated ophthalmic clinical trial services with a network of established reading centers and clinical trial authorities. EyeKor’s proprietary application for supporting image data collection and management of ophthalmic clinical trials, EXCELSIOR™, enables image and data accessibility and progress tracking online any time, any location, as nicely as harmonization of image evaluation and grading in spite of differing instrumentation.

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About Ethis Healthtech, LLC: Ethis Healthtech serves firms in the fields of eyecare and mobile/digital healthcare by supplying industry-entry organizing and support, fundraising, and strategic communications. Ethis Healthtech supports all elements of its clients’ development activities.

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Media Inquiries: &#13

Luca Sergio&#13

+1-212-791-1440 (workplace)&#13

+1-201-744-3364 (mobile)&#13

lsergio(at)ethishealthtech(dot)com

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New Study: Exceptional Outcomes at 5 Years with SAVI Breast Brachytherapy Remedy for Early-Stage Breast Cancer

New Study: Exceptional Outcomes at 5 Years with SAVI Breast Brachytherapy Remedy for Early-Stage Breast Cancer

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Aliso Viejo, CA (PRWEB) September 04, 2014

Cianna Healthcare, Inc., a women’s health business, nowadays announced the release of lengthy-term data supporting the efficacy and safety of breast brachytherapy with the SAVI® applicator. Researchers reported 5-year outcomes for the 1st 100 sufferers treated with strut-based brachytherapy, which includes favorably low prices of local recurrence and toxicities, as well as excellent cosmetic outcomes.

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SAVI is a strut-primarily based applicator that delivers a type of accelerated partial breast irradiation (APBI) recognized as a breast brachytherapy, a 5-day course of targeted radiation for early-stage breast cancer. The 5-year actuarial rate for ipsilateral breast tumor recurrence (IBTR) was three.3%, and good/excellent cosmesis was reported in far more than 94% of patients, according to the study.

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“Five-year final results is a important milestone for any medical technology, and physicians ought to be confident offering SAVI as a protected, powerful therapy for patients with early, reduced risk breast cancers,” stated radiation oncologist Robert Kuske, MD, co-principal investigator of the SAVI Collaborative Investigation Group. “It’s encouraging to have an additional option to deliver very targeted, precise radiation, as it enables physicians to treat just the area most at threat for recurrence, whilst minimizing side effects and improving overall high quality of life for our patients.”

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To date, this is the longest comply with-up reported by the SAVI Collaborative Study Group, which was created to study the long-term outcomes of ladies treated with strut-based brachytherapy. The 5-year results will be presented at the 2014 Breast Cancer Symposium, September four-six, 2014,

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“Based on our study, nearby manage is comparable to published outcomes for entire breast irradiation with equivalent stick to-up, whilst toxicity rates and cosmetic outcomes are frequently superior with the strut-primarily based device due to its ability to deliver precisely targeted radiation,” Dr. Kuske added. “Better cosmetic outcomes, along with the shortened course of treatment, can lead to larger levels of patient satisfaction, which is an important good quality measure in today’s altering healthcare environment.”

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Strut-based brachytherapy is used as portion of breast conservation therapy (BCT), which consists of a lumpectomy followed by radiation therapy. Entire breast irradiation (WBI) radiates the entire breast, like healthier tissue and underlying structures, even though breast brachytherapy delivers targeted radiation to the area quickly surrounding the lumpectomy cavity. The clinical advantages of targeted radiation like brachytherapy incorporate decreased radiation exposure to healthy tissue, much better cosmetic results, fewer extended-term side effects, and preserving a lot more treatment options in the future in the occasion of a recurrence or new principal cancer.

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Patient eligibility for breast brachytherapy contains reduced danger cancers, as nicely as a quantity of other elements, which includes tumor size, age, margin status and lymph node involvement. The strut-primarily based, open architecture design and style of SAVI allows physicians to sculpt radiation primarily based on patient-specific anatomy, which may increase the number of girls eligible for breast brachytherapy.

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About Cianna Medical, Inc.&#13

Cianna Healthcare, Inc. is a healthcare device business focused on women’s wellness and devoted to the innovative therapy of early-stage breast cancer. The firm manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation soon after lumpectomy surgery. The applicator allows precise sculpting of the radiation dose, and is made to make the advantages breast brachytherapy offered to a higher number of females. To date, more than 20,000 females have been treated with the SAVI applicator.

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For more information, contact (toll-totally free) 866-920-9444 or go to http://www.ciannamedical.com.

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