Clinical study design

Cytokinetics Announces Upcoming Presentations at the 2022 Inaugural HCM Society Scientific Sessions and the HFSA Annual Scientific Meeting

Retrieved on: 
Monday, September 26, 2022

SOUTH SAN FRANCISCO, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced six upcoming presentations, including two presentations at the 2022 Inaugural HCM Society Scientific Sessions, held by this newly launched professional medical society in National Harbor, MD on September 30, 2022, and four presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting taking place in Washington, D.C. from September 30, 2022 to October 3, 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced six upcoming presentations, including two presentations at the 2022 Inaugural HCM Society Scientific Sessions, held by this newly launched professional medical society in National Harbor, MD on September 30, 2022, and four presentations at the Heart Failure Society of America (HFSA) Annual Scientific Meeting taking place in Washington, D.C. from September 30, 2022 to October 3, 2022.
  • Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM).
  • Cytokinetics expects to start a Phase 3 clinical trial of aficamten in patients with obstructive HCM in Q4 2021.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

EQS-News: PRECISIS GmbH: EASEE – ­­­World's first minimally invasive brain pacemaker for the treatment of epilepsy receives CE-certification and is available immediately

Retrieved on: 
Friday, September 23, 2022

Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.

Key Points: 
  • Heidelberg, 23.09.2022 after seven years of development work, Precisis GmbH, headquartered in Heidelberg, has received the CE certification for its minimally invasive brain pacemaker EASEE.
  • These drug-refractory patients wait an average of 22 years before they are offered further technical or surgical treatment options.
  • With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."
  • EASEE is an acronym for Epicranial Application of Stimulation Electrodes for Epilepsy.

ObvioHealth Introduces ObvioGo, a Next-Generation DCT Platform and Mobile Application Delivering Stronger Evidence

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Wednesday, September 14, 2022

NEW YORK, Sept. 14, 2022 /PRNewswire/ -- ObvioHealth, a pioneering virtual research organization (VRO), announces the launch of ObvioGo , a next-generation decentralized clinical trial platform and mobile application powered to deliver stronger evidence of therapeutic efficacy and safety.

Key Points: 
  • NEW YORK, Sept. 14, 2022 /PRNewswire/ -- ObvioHealth, a pioneering virtual research organization (VRO), announces the launch of ObvioGo , a next-generation decentralized clinical trial platform and mobile application powered to deliver stronger evidence of therapeutic efficacy and safety.
  • ObvioGo's powerful and flexible tech stack has been designed to capture and integrate more accurate multi-source data, providing a unified platform thatempowers clinical science teams to generate stronger therapeutic evidence.
  • Mobile Application: ObvioGo's intuitive user interface was designed with extensive insight into the digital behaviors of trial participants.
  • By automating low-value processes, we are enabling humansboth patients and cliniciansto focus on the added value efforts that deliver stronger outcomes."

FDA Approves Abbott's New Spinal Cord Stimulation Device; Provides Tailored Relief to Multiple Pain Areas and Adds More Treatment Options for Evolving Pain Conditions

Retrieved on: 
Tuesday, August 23, 2022

BurstDR therapy is Abbott's exclusive stimulation technology that delivers pulses or bursts of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain.

Key Points: 
  • BurstDR therapy is Abbott's exclusive stimulation technology that delivers pulses or bursts of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain.
  • Spinal Cord Stimulation for Chronic Pain Syndromes: A Review of Considerations in Practice Management.
  • Pain.
  • Utilizing intraoperative neuromonitoring to program multiple areas of Burst spinal cord stimulation for treatment of chronic pain.

NEW RESEARCH FINDS WEIGHTWATCHERS APPROACH RESULTS IN SIGNIFICANTLY GREATER WEIGHT LOSS THAN DO-IT-YOURSELF

Retrieved on: 
Monday, August 22, 2022

NEW YORK, Aug. 22, 2022 /PRNewswire/ -- A new randomized clinical trial published in JAMA Network Open found that those engaged in WeightWatchers, a commercially available weight loss program, lost more than twice the amount of weight than those who tried to lose weight on their own. Those randomly assigned to WeightWatchers were also more likely to achieve clinically significant weight loss of five percent at three and twelve months, which can help lead to health benefits - including improvements in blood pressure, blood cholesterol and blood sugar.1

Key Points: 
  • As a result, the findings also suggest that programs with lower demands for self-monitoring of nutritious foods can produce clinically significant weight loss.
  • However, despite this guidance, most people try to lose weight on their own rather than choosing scientifically proven approaches.
  • We're also encouraged that our new approach - where you don't have to track everything you eat and drink - leads to clinically significant weight loss."
  • Through our comprehensive tools, expert Coaches and community, members follow our proven, sustainable, science-based program focused on weight loss.

NanoVibronix Provides Business Update in Letter to Shareholders

Retrieved on: 
Thursday, August 18, 2022

We continue to grow our business as exemplified by our 53% year-over-year growth in Q2.

Key Points: 
  • We continue to grow our business as exemplified by our 53% year-over-year growth in Q2.
  • Our PainShield family of products, which includes the original PainShield MD, and pending clearance of PainShield MD Plus, continues to comprise the majority of our business.
  • In each of these facilities, many of the clinicians support utilizing PainShield to address chronic pain and prevention of opioids.
  • There has been a high degree of communication and cooperation between CMS and NanoVibronix, including a recent on-on-one committee call.

Cytokinetics Reports Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 4, 2022

SOUTH SAN FRANCISCO, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2022. Net loss for the second quarter was $19.8 million, or $0.23 per share, compared to net loss for the second quarter of 2021 of $61.6 million, or $0.86 per share. Cash, cash equivalents and investments totaled $596.7 million at June 30, 2022.

Key Points: 
  • Advisory Committee Meeting to Review NDA for Omecamtiv Mecarbil Scheduled for December 13, 2022; PDUFA Target Action Date Set for February 28, 2023
    Company Revises 2022 Financial Guidance; Reduces Projected Spending for 2022
    SOUTH SAN FRANCISCO, Calif., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2022.
  • Net loss for the second quarter was $19.8 million, or $0.23 per share, compared to net loss for the second quarter of 2021 of $61.6 million, or $0.86 per share.
  • During the second quarter we made progress across regulatory, clinical and financial objectives.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Surgalign Announces Partnership with PRIA Healthcare to Improve Patient Healthcare Coverage

Retrieved on: 
Thursday, July 14, 2022

DEERFIELD, Ill., July 14, 2022 (GLOBE NEWSWIRE) -- Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, announced PRIA Healthcare will serve as a strategic partner in support of the recently launched Surgalign™ Patient Access Program.

Key Points: 
  • Terry Rich, President and Chief Executive Officer of Surgalign stated, Our vision at Surgalign is to drive optimal patient outcomes while advancing the standard of spine care.
  • We partnered with PRIA because of their extensive experience advocating for patients to receive favorable medical coverage.
  • Ultimately this program will expand patient access to procedures and devices such as the Coflex Interlaminar Stabilization and SImmetry SI Joint Fusion systems.
  • PRIA diligently works to influence payers to establish patient access to life changing devices, therapies, treatments, and procedures by leveraging clinical data, patient, and physician rights.

URBAN ALLIANCE RECEIVES $10 MILLION INVESTMENT TO CONNECT MORE YOUNG PEOPLE TO EQUITABLE CAREER PATHWAYS AND WORKFORCE TRAINING

Retrieved on: 
Tuesday, July 12, 2022

WASHINGTON, July 12, 2022 /PRNewswire/ -- Urban Alliance, a national nonprofit that connects young people to paid internships, workforce training and career pathways, received a $10 million investment from philanthropist MacKenzie Scott.

Key Points: 
  • WASHINGTON, July 12, 2022 /PRNewswire/ -- Urban Alliance, a national nonprofit that connects young people to paid internships, workforce training and career pathways, received a $10 million investment from philanthropist MacKenzie Scott.
  • With this funding, Urban Alliance will grow to reach thousands more young people, primarily from communities of color, and give them access to equitable opportunities that will put them on the path to economic mobility," said Elizabeth Lindsey, Urban Alliance CEO.
  • With this investment, Urban Alliance will expand to a fifth city, build out its career pathways internships in high-growth industries, and continue to improve the organization's capacity and infrastructure.
  • Since 1996, Urban Alliance has connected more than 6,000 young people to paid internships and 23,000 more with workforce training and professional development.

Clinical Trials Market Size, Share & Trends Analysis 2022-2028 by Phase (Phase I, Phase II, Phase III, Phase IV), & Indication (Pain Management, Oncology, CNS Condition, Diabetes, Obesity) - ResearchAndMarkets.com

Retrieved on: 
Monday, June 27, 2022

The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design, by Indication (Pain Management, Oncology, CNS Condition, Diabetes, Obesity), by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design, by Indication (Pain Management, Oncology, CNS Condition, Diabetes, Obesity), by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.
  • The global clinical trials market size is expected to reach USD 78.3 billion by 2030, registering a CAGR of 5.8%.
  • In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.
  • The phase III clinical trials segment dominated the market with a 53.4% share in 2021.