Thursday, February 28, 2013

Best Practices Marketing Case Study, Telemedicine Sector


The following case study, developed by one of my clients, Grey Matter Marketing, details how telemedicine solutions provider InTouch Health differentiated its brand. This Best Practices example illustrates how a category creator was able to devise a new brand platform to help the organization focus its strategy on the best opportunities to increase sales, achieve sustainable competitive advantage and win in the telemedicine market.
SOURCE: Grey Matter Marketing, www.greymattermarketing.com
Full case study follows.
REBOOTING THE TELEMEDICINE MARKET: 
InTouch Health Gets In Touch with Customers
The Challenge
InTouch Health develops, manufactures, and markets acute care remote presence telemedicine solutions for high acuity applications where doctors are required to take immediate clinical action. While InTouch Health was the “category creator” of this market, the challenge was to differentiate the brand beyond being known as the “remote presence robot company.” Unfortunately, market research showed there was a disconnect between the company’s brand aspiration and current brand image within the market. The company chose to partner with Grey Matter Marketing to rebrand the company to solidify its leadership position. The key outputs of the rigorous branding and messaging process were to confirm Intouch Health’s position as the category creator of the acute care telemedicine market and clear choice over competitors; launch powerfully and effectively visionary products that extend its thought leadership and enable hyper-growth and clear market share/penetration gains in targeted healthcare markets; and create a high degree of focused market awareness and competitive differentiation to achieve measurable increases in customer acquisition.
The Solution
Grey Matter Marketing led the company through a multi-step exercise to help develop the plan for how InTouch Health can create superior value for a specific set of customers in a competitively distinctive way.  Key steps included: Conducting a series of qualitative and analytical sessions to determine the current brand state in the marketplace; utilizing “illumination sessions” to uncover the most compelling audiences and key insights that would result in an ownable brand position; leveraging insights to create and validate a unique selling positioning and key messages; and building the brand strategy on a new, deeper understanding of the target audience and market.  This proven process yields a “charismatic brand,” which is any product, service or company for which people feel there is no substitute.
The Results
Grey Matter Marketing created a new brand platform to help the organization focus its strategy on the best opportunities to increase sales, achieve sustainable competitive advantage and win in the telemedicine market. Key outputs included: Identification and prioritization of core values and target audience segments that could solidify the company as the leader among its competitors; alignment of the brand strategy with the target audiences’ wants and needs; and development of a new brand vision and position that all key stakeholders could buy into. Additionally, Grey Matter Marketing identified  a courageous customer promise that provides a significant point of differentiation, moving the brand from being just a “robot company” and identifying opportunities to grow the client’s business and increase technology adoption by creating a platform to educate target audiences‑opening the door to further expand their brand as the preeminent telemedicine provider. The final deliverable of this exercise resulted in a comprehensive brand development document that presented a detailed roadmap for implementing and managing the InTouch Health brand, including key messaging, to be carried out by the in-house Marketing department.

Grey Matter Marketing is an award-winning integrated marketing agency comprised of marketing veterans
that can relate to your challenges, understand your budgets, and offer valuable insights.

Tuesday, February 26, 2013

Clinical Trial News, Heart Attack Patient Study


STENTYS to Present Final Results From 1,000 Heart Attack Patient Study at ACC.13. Educational Symposium at ACC.13, March 9-11, 2013 in San Francisco. Also to Highlight FDA-Approved U.S. Pivotal Study for Self-Apposing® Stent in STEMI Patients.

Full press release follows.

SOURCE: STENTYS

02/26/2013| 12:40pm US/Eastern -- STENTYS to Present Final Results From 1,000 Heart Attack Patient Study o. Educational Symposium Also to Highlight FDA-Approved U.S. Pivotal Study for Self-Apposing® Stent in STEMI Patients


PRINCETON, N.J. and PARIS - February 26, 2013 - STENTYS (FR0010949404 - STNT), a medical technology company commercializing in Europe the world's first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), announced today that results for the primary endpoint in the APPOSITION III study (MACE at one year on 1,000 STEMI patients) will be presented during ACC.13, the American College of Cardiology's Scientific Session & Expo, March 9-11, 2013 in San Francisco. Prof. Gilles Montalescot, M.D., Ph.D, Head of the Cardiac Care Unit at Pitié-Salpêtrière Hospital (Paris), will present "One Year Clinical Results on 1,000 STEMI Patients Treated With a Self-Expanding Coronary Stent (APPOSITION III)" during Session #2667 of the Featured Clinical Research I: Interventional session on Saturday, March 9, 2013 at 3:00 p.m.

STENTYS is also hosting an educational symposium during ACC.13 that will provide an overview of the Self- Apposing Stent clinical results to date and the U.S. IDE trial in STEMI, APPOSITION V. The event, "STENTYS IDE Trial in STEMI: The Self-Apposing Stent Revolution is Coming to the U.S.," is being held Sunday, March 10, 2013 from 6:45 a.m. to 7:45 a.m. at the InterContinental San Francisco Hotel and features a panel discussion and presentations relating to the Self-Apposing technology by prominent cardiologists:
• Maurice Buchbinder, M.D., of the Foundation for Cardiovascular Medicine (San Diego) will present "Better
Stent Sizing Leads to Better Outcomes: The Self-Apposing Stent Technology."
• Karel Koch, M.D., of the Academic Medical Center, University of Amsterdam will present "Real-world
Experience: Case Studies and APPOSITION III One-Year Results on 1,000 STEMI Patients."
• Roxana Mehran, M.D., of Mount Sinai Hospital (New York) will present "STENTYS Randomized IDE Trial in STEMI, the APPOSITION V Study in the United States and Worldwide."
• Timothy D. Henry, M.D., of the Minneapolis Heart Institute Foundation will also be participating in panel discussions.

About the STENTYS Self-Apposing® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients. It fits into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase, thus reducing the risk of malapposition and complications associated with conventional stents in this setting.

About the APPOSITION III Study
APPOSITION III is a prospective, single-arm, multi-center (50 hospitals across Europe) post-market trial to assess the long term performance of the STENTYS Self-Apposing stent in routine clinical practice in 1,000 patients suffering from ST-Elevation Myocardial infarction (STEMI). The trial's primary endpoint is Major Adverse Cardiac Events (MACE) at 12 months. MACE is defined as cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR by percutaneous or surgical methods at 12 months. The trial's secondary
endpoints are MACE at 30 days and 24 months post-procedure. The MACE rate at 30 days was 3.5% for the full study population and 2.5% when post-dilation was performed. Mortality rate at 30 days was 1.2% for the full study population. An interim analysis conducted on the first 600 patients at the one-year time point showed a death rate of 1.7% where conventional stents average 3.9% (pooled analysis from ACTION Study Group, Prof. G. Montalescot at Pitié-Salpêtrière Hospital).

About the APPOSITION V Study
APPOSITION V is a prospective, multi-center, randomized, two-arm clinical trial to evaluate the safety and effectiveness of the STENTYS Self-Apposing® Stent in the treatment of de novo stenotic lesions in coronary arteries in 880 patients undergoing primary revascularization due to ST-elevation myocardial infarction (STEMI) as compared to the Multi-Link Vision™ coronary system (Abbott Vascular, Inc.). The trial's primary endpoint is target vessel failure (TVF), which is defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target vessel revascularization (TVR) at 12 months post-procedure. The powered secondary endpoint is acute
stent malapposition and will be assessed by intravascular ultrasound (IVUS) on the first 225 patients. All patients will undergo clinical follow up at 30 days, six months, nine months and 12 months, with an annual checkup through three years. Fifty sites are expected to participate in the U.S. and worldwide. Enrollment is expected to begin in H1 2013.

About STENTYS

STENTYS is developing and commercializing innovative solutions for the treatment of patients with acute myocardial infarction (AMI, or heart attack) and complex coronary artery disease. STENTYS's Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters, particularly in the post-infarction phase, in order to prevent the malapposition problems associated with conventional stents. In the APPOSITION III clinical trial, STENTYS stents demonstrated a very low 30-day mortality rate among 1,000 high-risk AMI patients when compared to recent studies with conventional stents.

More information is available at www.stentys.com 
STENTYS
Stanislas Piot, CFO
Tel.: +33 (0)1 44 53 99 42
Europe: NewCap.
Axelle Vuillermet / Pierre Laurent Tel.: +33 (0)1 44 71 94 93 stentys@newcap.fr
STENTYS is listed on Comp. C of the NYSE Euronext Paris
ISIN: FR0010949404 - Ticker: STNT

US: MacDougall Biomedical Communications
Kari Watson, Tel.: +1 781 235 3060
Christine Labaree, Tel.: +1 650 339 7533 stentys@macbiocom.com



Monday, February 25, 2013

Thermo Fisher Scientific New Group-B Strep Test, CE Marked


Thermo Fisher Scientific Announces New Group-B Strep Test.
Thermo Scientific Brilliance GBS Agar reduces Group B streptococcus testing in pregnancy to a simple four-step process for faster confirmation and patient treatment.
The test is CE marked for clinical testing, and has not received FDA clearance in the United States.
Full press release is below.
SOURCE: Thermo Fisher Scientific

Monday, February 25, 2013 5:00 pm EST
BASINGSTOKE, United Kingdom--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of Brilliance GBS Agar for the testing of Group B streptococci (GBS) during pregnancy. The new agar is designed to reduce the number of test steps for clinical technicians, give more reliable results, and enable faster patient treatment by featuring proprietary Inhibigen™ technology.
The test is CE marked for clinical testing, and has not received FDA clearance in the United States.
GBS is a bacterium that can be passed from mother to baby during labor, and is the most common cause of severe, sometimes fatal, infection in newborns. According to the World Health Organization (WHO), early onset of the disease shows a case fatality rate of up to 29%. Screening women for GBS colonization between weeks 35-37 of pregnancy may allow hospitals time to prescribe eradication therapy prior to labor, eliminating the GBS that is a potential cause of pneumonia, sepsis and meningitis if passed on to the infant prior to, or during birth. The UK GBS Support Group currently believes that timely intervention can reduce GBS infection in newborn babies by 60% and deaths from GBS in babies by 70%.
The new Brilliance GBS Agar differs from traditional GBS screening methods by eliminating the need for a pre-enrichment step that can take up to 18 hours, and thus delivers final results in less than 24 hours. In addition, Inhibigen technology selectively prevents the growth of enterococci that can sometimes lead to false positives and a need for additional confirmation tests.
“The implications of GBS disease include significant threat to patient morbidity and mortality and the additional costs associated with high-dependency baby care”, says Sumi Thaker, Global VP Marketing, Microbiology, Thermo Fisher Scientific. “Screening programs are proven to reduce the risks, but offer a challenge to the laboratory as they have to process a huge number of samples, many of which will be negative.
“With the introduction of Brilliance GBS Agar, we offer the laboratory a streamlined workflow and reduced turnaround time from swab to result, making handling the high throughput easier and more cost effective. Identification of GBS is made easier with a medium formulation that colors GBS colonies a bright pink, whilst non-GBS colonies are either inhibited, or grow a dark blue or purple. The inhibition in this product is more powerful than anything we’ve seen before. In trials, up to 99% of the negatives show no growth, greatly simplifying interpretation. And because the product requires only a single inoculation, it is also ideal for those laboratories who are already automating their test procedures. Screening for GBS can now be as simple as screening for MRSA”.
Brilliance GBS Agar is designed for hospital laboratories that are already routinely screening for GBS, but are looking for a more streamlined approach, and for the increasing number that recognize the benefits of screening and need an easy to use test that technicians of all skill levels can confidently adopt.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.
Contact:
Thermo Fisher Scientific Inc.
Nicola Scott, 01256 694318
nicola.scott@thermofisher.com

Tuesday, February 12, 2013

Clinical Trial Enrollment News, Mirasol system to prevent bleeding in a variety of patient populations


Terumo BCT announces first patient enrolled in North American clinical trial of Mirasol® pathogen reduction technology system. This international study is designed to compare the effectiveness of standard platelets versus platelets treated with the Mirasol system to prevent bleeding in a variety of patient populations.
Full press release below.
SOURCE: Terumo BCT
BusinessWire · Feb. 12, 2013 | Last Updated: Feb. 12, 2013 1:10 PM ET -- Terumo BCT announces that the first patient, in the ongoing PREPAReS (Pathogen Reduction Evaluation & Predictive Analytical Rating Score study) trial, has been enrolled in Canada. Sponsored by the Sanquin Blood Supply Foundation, Netherlands, this international study is designed to compare the effectiveness of standard platelets versus platelets treated with the Mirasol system to prevent bleeding in a variety of patient populations.
While blood donations are commonly screened for specific pathogens to minimize risks for transmitting infectious disease, the Mirasol system is designed to further enhance the safety of platelet and plasma transfusions by using a combination of riboflavin (vitamin B2) and ultraviolet (UV) light to inactivate viruses, bacteria, parasites and white blood cells that might be present in collected blood products. The system is intended to produce a treated product to benefit patients receiving platelet and plasma products worldwide.
KEY FACTS:
   The PREPAReS trial is a non-inferiority, single-blinded study designed to compare the clinical efficacy of Mirasol (riboflavin/vitamin B2)-pathogen-reduced platelet concentrates with standard platelet concentrates using clinically relevant end points.
                      The first patient was enrolled in Canada in January 2013
                      The study began patient accrual in November 2010 in the HAGA hospital (the Hague, Netherlands) and currently has 173 participating patients.
                      In addition to Canada, four Dutch transfusion centers are participating in the study.
                      The study is estimated to complete enrollment by late 2013 or early 2014.
   An estimated 10 million platelet units are transfused to patients in North America, Europe and Asia each year.
   Experts estimate that as many as one in every 2,000 units of platelets collected could contain bacteria. Inactivating bacteria that might be present in collected platelets may be of benefit to patients receiving platelet transfusions, as bacterial contamination in platelets represents the single greatest infectious risk in transfusion medicine today.
KEY QUOTES:
Ray Goodrich, Ph.D., Terumo BCT, Vice President of Scientific and Clinical Affairs
“We have worked very closely with Sanquin, Canadian Blood Services and Health Canada on the Canadian arm of the PREPAReS Trial. The trial has been designed to establish that Mirasol-treated platelets are comparable to untreated platelets, in terms of efficacy for patients requiring platelet transfusion support. The study is also designed to determine if the use of Mirasol-treated platelets reduces the risk of HLA-alloimmunization in patients who require transfusions.”
Jean-Louis Kerkhoffs, Sanquin Blood Supply Foundation
“Safe and effective platelet transfusions are essential in the supportive care of hematology patients. Scientists, hematologists and transfusion specialists as well as numerous other dedicated colleagues are collaborating on the PREPAReS study, a unique transatlantic experience to further improve the safety of platelet transfusions and the care for hematology patients.”
Dana Devine, Vice President, Medical, Scientific & Research Affairs, Canadian Blood Services
“Canadian Blood Services is very pleased that this trial is under way. We look forward to the day that pathogen reduction technologies for treatment of cellular blood products are available for use in Canada. This trial is a first step toward licensure of this technology in Canada.”
KEY RESOURCES:
Note: The Mirasol system is not FDA-approved for sale in the United States.
About Terumo BCT:
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
About Sanquin Blood Supply Foundation:
The Sanquin Blood Supply Foundation ensures the safe and efficient blood supply in the Netherlands. Sanquin also develops and produces pharmaceutical products, conducts high-quality scientific research, and develops and performs a multitude of diagnostic services.
Contacts
Terumo BCT
D. Nikki Wheeler, +1-303-205-2828
Global Corporate Communications
press@terumobct.com