New Data for Abbott's Investigational High Sensitive Troponin Test Shows It May Help Doctors Predict Heart Attack Risk

New data for Abbott's Investigational High Sensitive Troponin Test shows it may help doctors predict heart attack risk. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the US) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.

Full press release follows.

SOURCE: Abbott

HOUSTON, July 30, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced today promising results from a study evaluating its High Sensitive Troponin-I (hsTnI) assay presented at this year's American Association for Clinical Chemistry (AACC) annual meeting in Houston, Texas. The study, conducted by researchers at Brigham and Women's Hospital, demonstrated that Abbott's hsTnI test (currently for research-use only in the United States) may help doctors predict which patients presenting with symptoms of a heart attack, such as severe chest pain, are at a higher risk for having a heart attack 30 days later.

A concern for patients who present with severe chest pain is that they are more likely to experience another cardiovascular event within a few weeks or months. Researchers at Brigham and Women's Hospital evaluated the performance of a hsTnI assay (Abbott, ARCHITECT) with the performance of a fourth generation troponin T assay (Roche, TnT) among 4,695 patients presenting with severe chest pain and found that the hsTnI assay identified more patients at higher risk of recurrent heart attack, even at very low troponin concentrations.

"The ability to identify patients at higher risk for another heart attack or cardiovascular death is an essential step in their prevention," said Dr. Petr Jarolim, M.D., Ph.D., one of the key authors of the study and Medical Director, Clinical Chemistry and Laboratory Control, Brigham and Women's Hospital. "This study demonstrates that the new high sensitivity cardiac troponin assays are efficient tools for classifying patients, allowing doctors to provide more aggressive treatment of those at higher risk."

Cardiac troponin, a protein found in the heart muscle, is considered the preferred biomarker used to identify suspected heart attacks, because it can detect injury to the heart.¹ Abbott's ARCHITECT STAT hsTnI assay can measure very low levels of the protein, which allows doctors to evaluate whether or not patients are having a heart attack within two to four hours after presentation.² This faster evaluation could allow doctors to reduce the time to diagnosis and treatment by several hours when compared to standard troponin tests.

"This study adds to the clinical evidence confirming the advantages of Abbott's high sensitive troponin test to provide more insight to clinicians about which patients are at greater risk for a future heart attack as compared to contemporary tests," said John Frels, PhD, divisional vice president, Diagnostics Research, Abbott. "This is important information for patient care because it may help doctors focus on the patients at greater risk for appropriate management."

The abstract for this study was selected as the first annual recipient of the Biomarkers of Acute Cardiac Disease Division Outstanding Abstract Award. The committee awarded a grant for outstanding abstract to one of the key authors of the study, Dr. Petr Jarolim (Brigham and Women's Hospital).

The ARCHITECT STAT hsTnI assay is commercially available in Europe and runs on Abbott's fully-automated ARCHITECT family of analyzers.

About Abbott Diagnostics

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 22,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness, and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

About Abbott

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

¹ Thygesen K, Alpert JS, Jaffe AS et al. Third universal definition of myocardial infarction. European Heart Journal. 2012; 33:2551-2567.

² Abbott ARCHITECT STAT High Sensitive Troponin-I Product Insert (PI), January 2013.

SOURCE Abbott

CONTACT: Media, Darcy Ross, (847) 937-3655 (office), (224) 475-7673 (mobile), or Jessica Masuga, (847) 935-0650 (office), (847) 970-1391 (mobile), or Financial, Tina Ventura, (847) 935-9390

Web Site: http://www.abbott.com

Reebok CHECKLIGHT™ New Impact Indicator for Athletes

Sports Brain Injury [SBI] has become a problem of national concern. CHECKLIGHT™, launched on July 25, 2013, features a head-impact indicator weighing less than an ounce, made of an ultrathin, bendable electronic sensor (developed by tech company MC10) fitted into a mesh cap, designed by Reebok. It senses when the wearer has been dealt a major blow to the head. A proprietary algorithm makes the call, i.e. the Reebok CHECKLIGHT™ is not a concussion diagnostic tool – it provides an objective measure of impact force and is designed to lead athletes on a pathway to assessment.

Full press release follows.

SOURCE: MC10, www.mc10inc.com AND Reebok, www.reebok.com

Keep Your Head in the Game with the Reebok CHECKLIGHT™: a New Impact Indicator for Athletes. Reebok CHECKLIGHT™ Provides Coaches, Athletic Trainers, Parents and Athletes with an "Extra Set of Eyes" to Help Determine Impact Severity

CANTON, Mass.[July 26, 2013]--Reebok, the global fitness brand, has launched the groundbreaking Reebok CHECKLIGHT™*, a sports activity impact indicator designed for athletes of all ages and skill-levels. The CHECKLIGHT™ skullcap is designed for use in all helmeted and non-helmeted contact sports and activities.

In the heat of competition, athletes aren't always aware of the severity of a blow to the head. Reebok has delivered a simple solution. The CHECKLIGHT™ design uses multiple motion sensors to provide actionable impact data to help assess an athlete before continuing to play. An easy-to-read display of red and yellow lights indicates the level of impact. The Reebok CHECKLIGHT™ is the first impact indicator that comfortably fits wearable electronics directly on the athlete - not on the athlete's protective equipment. Embedding flexible electronics into a closely fitting skullcap helps to accurately measure direct accelerations that the head is experiencing in real-time.

Head impact injuries, also known as traumatic brain injuries, are a serious public health issue according to the Centers for Disease Control and Prevention (CDC). Sports-related head injuries are a recognized problem in both contact and non-contact sports, and for athletes of all ages and skill levels – from the student athlete to the elite athlete. For this reason, the CHECKLIGHT™ is specifically designed for players of all ages and skill levels.

"At Reebok, we are dedicated to helping people be fit for life, no matter which sport or activity they participate in," said Paul Litchfield, Reebok's Head of Advanced Concepts. "The more we learn about head injuries, the more we understand the long term ramifications and we want to do our part to help ensure people can participate, compete and enjoy life. There is still much to be learned in this area, but we believe technology can play a significant role in improving the athletic experience and the CHECKLIGHT™ is a perfect example of this. We're very proud to introduce such an innovative and important product."

More than three years of lab and multi-sport field-testing with hundreds of athletes ranging from youth to professional have served in the development and validation of the CHECKLIGHT™. During the creation of CHECKLIGHT™, Reebok has worked with head trauma experts in the medical and academic fields and professional athletes, including Indianapolis Colts quarterback Matt Hasselbeck.

"As a professional athlete, I understand and assume the risks involved in playing a sport at the elite level," says Hasselbeck. "But as a professional athlete, I am also fortunate to have the very best, most experienced athletic trainers, doctors, coaches, even TV monitors, watching me at all times, providing immediate medical attention and really looking out for my safety. These resources just aren't available at the youth level, where one coach may be responsible for the health and safety of an entire team. With the extra set of eyes provided by the CHECKLIGHT™, athletic trainers, coaches, and parents have the actionable information they need to check up on the athletes they care about."

The Reebok CHECKLIGHT™ utilizes the award-winning conformal electronics technology platform developed by Cambridge, MA electronics company MC10 to help ensure the product is comfortable and non-distracting to the athlete. MC10 reshapes high-performance electronics into ultra-thin systems that stretch, bend and flex seamlessly with the body.

The CHECKLIGHT™ takes sophisticated impact data and simplifies it by providing easy-to-read, actionable LED lights. By providing an objective measure of impact force, the CHECKLIGHT™ takes the burden off the athlete alone to start a conversation about symptoms. The device also helps reinforce safer contact techniques by encouraging athletes to keep their heads up and out of impacts.

"I have no doubt this will help create a paradigm shift in the way the sport of lacrosse is played," says Philadelphia Wings (NLL) and Hamilton Nationals (MLL) all-star Brodie Merrill. "We need to teach athletes to not lead with their heads and to play the game as it is meant to be played; without the use of excess physical hits to the head. The effects these traumas can have on an athlete, in any sport, of any age, are dangerous, and the Reebok CHECKLIGHT™ is the first step towards creating a safe and smart game."

The Reebok CHECKLIGHT™ is available nationwide on reebok.com and at select Dick's Sporting Goods locations. For additional information or to purchase the CHECKLIGHT™, please visit http://shop.reebok.com/us/content/CheckLight

About Reebok

Reebok International Ltd., headquartered in Canton, MA, USA, is a leading worldwide designer, marketer and distributor of sports, fitness and casual footwear, apparel and equipment. An American-inspired global brand, Reebok is a pioneer in the sporting goods industry with a rich and storied heritage in running, training and fitness. A subsidiary of the adidas Group, Reebok operates under the multiple divisions of the Reebok brand, Reebok-CCM Hockey and the Sports Licensed Division. Reebok is the exclusive outfitter of CrossFit and the Reebok CrossFit Games and main event partner and official apparel and footwear supplier for the 2013 Red Bull X-Alps. For more information, visit Reebok at www.reebok.com. Or, discover Reebok at the following locations: http://reesha.re/plus;http://facebook.com/reebok; http://twitter.com/reebok; and http://youtube.com/reebok

*The Reebok CHECKLIGHT™ is not a concussion diagnostic tool – it provides an objective measure of impact force and is designed to lead athletes on a pathway to assessment.

CONTACT:

Melanie Baroni

M&C Saatchi Sport & Ent.

United Kingdom

melanie.baroni@mcsaatchi.com

 +44 207 544 3799

FDA Grants Fast Track to Adynxx Lead Compound AYX1

FDA Grants Fast Track Designation to Adynxx Lead Compound AYX1.

AYX1 Injection Designated as a Fast Track Development Program for Prevention of Chronic Pain.

Full Press Release follows.

SOURCE: Adynxx

SAN FRANCISCO, July 17, 2013 /PRNewswire/ -- Adynxx, a clinical-stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AYX1 Injection for the prevention of chronic pain. 

"Fast Track designation for the AYX1 program is an important acknowledgement by the FDA of the need for advancements in the prevention of chronic pain," said Rick Orr, CEO of Adynxx. "We will continue to advance the development of AYX1 as rapidly as possible for the benefit of patients who are in need of new treatment options for post-surgical pain."

"We are pleased to receive the Fast Track designation," added Scott Harris, vice president of regulatory affairs and product development at Adynxx. "The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs."

In September 2012 Adynxx completed a 30-subject, dose-escalating study of AYX1 in five cohorts of healthy volunteers.  AYX1 was well-tolerated at all dose levels, with no serious adverse events reported and no subjects withdrawing from the study.  Adynxx is currently enrolling a 90 patient placebo-controlled Phase 2 study to evaluate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce or prevent post-surgical pain.

"While many widely-used pain therapies require repeat dosing for symptom relief, a single administration of AYX1 has the potential to prevent the development of pain before it begins," said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. "The fact that the FDA has granted Fast Track designation for the prevention of chronic pain recognizes an important aspect of the unique profile of AYX1, which we believe will transform the treatment of post-surgical pain."

About Adynxx

Adynxx, located in San Francisco, California, is a clinical stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots - preventing the development of pain following surgery or trauma and resolving established chronic pain syndromes.  Adynxx's unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Adynxx's lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. 

Funded by Domain Associates, Adynxx has successfully completed a Phase 1 clinical trial of AYX1 and initiated a Phase 2 study of AYX1 in Q1 2013.  Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical discovery stage.

Media Contact:

David Schull or Ian Stone 
Russo Partners
(858) 717-2310
(619) 308-6541
david.schull@russopartnersllc.com  
ian.stone@russopartnersllc.com

SOURCE Adynxx

FDA Approval AlignMed Class 1 Medical Device

Wellness wear developer AlignMed secures FDA approval. Full press release follows. SOURCE: AlignMed, www.alignmed.com AlignMed's Breakthrough Garment Technology Gets a YES from the FDA! Garments Approved by the FDA Registration as Class 1 Medical Device Align Garments Help Reduce Pain, Recover From Injury, and Achieve the Health Benefits of Good Posture SANTA ANA, Calif., July 16, 2013 /PRNewswire/ -- AlignMed, the innovative developer of wellness wear that has been scientifically proven to reduce pain and improve posture, has received U.S. Food and Drug Administration (FDA) Registration for its line of breakthrough specialty garments. AlignMed products are in an elite category of garments approved by the FDA Registration process as a Class 1 Medical Device. The comfortable, form-fitting, non-restrictive Align garments feature patented Touch-Tension Neuroband™ technology that fires muscles and stimulates nerves to align the body's joints with each stride of the leg or movement of the hip, back, shoulder, chest and neck. This revolutionary concept has been vetted and tested by a panel of medical doctors and research clinics. "We are thrilled to get the thumbs up," said AlignMed Founder Bill Schultz. "We've worked hard to ensure that every product we put into the market truly does what we say it does, and we're on a mission to help people move better and reduce pain through aligning the body. Our garments are proven to do just that."  Primary applications include everyday wear for muscle balancing, joint unloading, injury prevention, and as a recovery tool for surgery or trauma to the upper and lower extremities. Computer users can wear the garments to fend off neck pain, back pain and poor posture prompted by excessive sitting and repetitive movements. "As we age, mobility and agility are rapidly reduced by poor posture," Schultz continued. "The garments we've created are based on a scientifically-proven biomechanical approach that mimics the body's kinetic energy to help shape alignment and balance automatically without having to concentrate or think about it. It's a deceptively simple solution. And it works." For information on AlignMed, visit www.alignmed.com. About AlignMedAlignMed is the creator of Align garments featuring the patented in-garment Touch-Tension Neuroband™ technology that has been scientifically proven to help people achieve better health and reduce pain through ensuring good posture, one of the most under-appreciated aspects of health and wellness. Ideal users include anyone with an active lifestyle, amateur and professional athletes, sports team managers and trainers, clinicians in orthopedics and physical therapy, and corporate wellness programs.www.alignmed.com Media Contacts:Rachel Reenders, KCOMM 949-294-5095 rachel@kcomm.com Debra Buxton, AlignMed 714-352-8777 dbuxton@alignmed.com SOURCE AlignMed Web Site: http://www.alignmed.com