Connect with us

News

OPTIMIZE Study Reports Lowest TLR Ever Achieved in an Investigational Device Exemption (IDE) Study With Svelte Medical System’s Bioresorbable Coated Drug-Eluting Coronary Stent

gbafNews28

The Svelte Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study. Primary and secondary endpoint outcomes of the OPTIMIZE IDE study, designed to assess the safety and efficacy of the Svelte DES Integrated Delivery System (SLENDER IDS) and Rapid Exchange (DIRECT RX) platforms, were presented today during the Late-Breaking Trials session at TCT Connect.

OPTIMIZE randomized 1,639 subjects (1:1 SLENDER IDS or DIRECT RX DES vs. Xience or Promus DES) at 74 investigative sites in the US, Japan and Europe in support of US and Japan regulatory approvals. Under the prespecified study statistical analysis plan, the threshold for non-inferiority of 1 year Target Lesion Failure (TLF) using an absolute non-inferiority margin was not quite met (p=0.034 with 0.025 the prespecified threshold for non-inferiority). Unprecedented Target Vessel Myocardial Infarction (TVMI) rates of 8.8% were observed across both treatment groups, driven by the frequent use of high-sensitivity troponin biomarkers during peri-procedural assessments, leading to overall TLF of 9.9%, nearly double the expected rate and effectively underpowering the study. Non-inferiority of the Svelte DES compared to the Xience and Promus DES was clearly established in independent analyses of the OPTIMIZE results using either a comparable relative non-inferiority margin with the protocol definition of MI (p=0.009), or the SCAI definition of MI (p=0.003), which specifically accounts for high-sensitivity troponin use in the assessment of peri-procedural TVMI.

Dean Kereiakes, M.D., F.A.C.C., the Medical Director at The Christ Hospital, Lindner Research Center in Cincinnati, Ohio and co-principal investigator of the OPTIMIZE study stated, The Svelte DES went head-to-head against the gold standard for DES and demonstrated exceptionally low TLR and stent thrombosis rates at 1 year. I regard the high TVMI rates observed in this study as artifact. When nearly 1 in 3 subjects assessed using high-sensitivity troponin assays is counted as TVMI across both treatment groups (including previously studied and highly regarded DES as the control), it is clear the protocol definition of TVMI, and not clinically meaningful TVMI, plagued this study.

The high TLF reported in both OPTIMIZE treatment groups is driven by the 25% of study subjects assessed peri-procedurally with high-sensitivity-troponin. These subjects accounted for 80% of all study TVMIs, yet 96% of them had no ECG changes and 88% were discharged post-procedure without delay, data that are not indicative of true clinical TVMI, added Sunil Rao, M.D., F.A.C.C., Professor of Medicine at Duke University in Durham, North Carolina and co-principal investigator of the OPTIMIZE study. With definition-driven TVMI placed into appropriate context, its exciting to see the exceptional clinical outcomes achieved in OPTIMIZE with 79% of subjects undergoing TRI. The low profile of the Svelte DES, and especially SLENDER IDS, facilitates TRI. The significantly lower access site hematoma rates and strong 1 year clinical results in TRI subjects should be of interest to radial specialists seeking to downsize catheters and improve patient care.

Direct stenting was undertaken in 30% of OPTIMIZE subjects, with 96% device success rates observed. Ronald Caputo, M.D., F.A.C.C., an interventional cardiologist at Levine Heart & Wellness in Naples, Florida and top-5 user of SLENDER IDS for direct stenting in the OPTIMIZE study stated, SLENDER IDS offers a unique low-profile option especially attractive to radial operators. It and DIRECT RX are extremely deliverable stents. I was very impressed with their performance during the study and exceptional 1 year clinical outcomes. Investigators with prior experience direct stenting with SLENDER IDS in Europe also realized significant reductions in procedure, device and fluoroscopy times, as well as radiation exposure, compared with direct stenting using control DES.

SLENDER IDS and DIRECT RX utilize the same low profile, highly conformable stent with a new class of bioresorbable sirolimus-eluting drug carrier designed to minimize inflammation and promote vessel healing. Both SLENDER IDS and DIRECT RX hold CE Mark certification and are commercially available in Europe.

We are deeply grateful to each and every one of the patients, investigative team members and support personnel contributing to the OPTIMIZE study. Our highly differentiated platforms bring a new and unique approach to coronary stenting which improves procedural efficiency while enhancing patient outcomes and comfort, delivering value to all constituents “ patients, physicians, providers and payers, said Jack Darby, President and CEO of Svelte Medical Systems.

About Svelte Medical Systems

Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the companys products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.

Jack Darby

President and CEO

Svelte Medical Systems, Inc.

[email protected]

(908) 264-2012

News

Embr Labs Continues Momentum as Leader in Thermal Wellness

gbafNews28

BOSTON, Dec. 3, 2020 /PRNewswire-PRWeb/ — Embr Labs, the breakthrough thermal technology company and creator of the Wave Bracelet, today announced a strategic investment by Joy Ventures and the appointment of Dr. Pamela Peeke as Embr Labs' Chief Medical Officer. Both moves help to solidify the company's leadership in women's health, wellness and digital therapeutics. The state of Massachusetts and the National Science Foundation recently recognized Embr Labs' role as a life sciences innovator by funding Artificial Intelligence for Menopause Symptoms, a collaboration between Embr Labs and UMass Institute for Applied Life Sciences that will produce the largest physiological dataset for natural menopause and advance the state of the art for detecting and predicting vasomotor symptoms, also known as hot flashes.

Dr. Pamela Peeke joins Embr Labs as Chief Medical Officer and will oversee clinical trials of the company's cutting-edge wearable that helps to improve women's stress, sleep and menopause symptoms. Dr. Peeke is a nationally renowned physician, scientist and expert in preventive and lifestyle medicine. She is also a Pew Foundation scholar in metabolism and a fellow of both the American College of Physicians and the American College of Sports Medicine, the latter of which she is a board member. As a three-time NY Times bestselling author and host of HER, the top women's health show on iTunes, Apple, and RadioMD, Dr. Peeke's message of health and wellness touches the lives of millions of women in the US and globally.

“As a physician and scientist, I am excited to be joining the Embr Labs' team. I look forward to creating clinical research opportunities and partnerships that will further the development and validation of this groundbreaking technology. At Embr Labs, we share a profound passion to improve people's health and wellbeing through our thermal digital technology. I'm honored and thrilled to be a part of this revolutionary new science,” noted Dr. Pamela Peeke, Embr Labs' Chief Medical Officer.

As Embr Labs solidifies its leadership as a digital therapeutic company, the company has attracted global investors such as Joy Ventures, who are committed to advancing the growing category of consumer products for wellbeing. Joy Ventures' investment insight reflects an understanding that today's complex world combined with intense lifestyles has created stress, anxiety and life challenges that demand accessible and holistic solutions.

“At Joy Ventures, our mission is to counterbalance today's challenges by advancing the science of everyday joy. We work to identify the world's most talented entrepreneurs, innovators and scientists to evolve their ideas into products that will help us all live more joyfully – and we see Embr Labs as a company that is succeeding in this area,” noted Miri Polachek, CEO of Joy Ventures.

Started in 2013 by three MIT materials science engineers, Embr Labs was founded upon a basic insight: temperature is an untapped pathway to the brain that can deliver therapeutic benefits. Embr's patented technology harnesses the power of thermal sensations to deliver safe, non-invasive, and beneficial therapies that leverage the body and mind's natural response to temperature to promote relief from hot flashes, manage stress, and improve sleep.

Embr Labs has sold tens of thousands of Embr Waves that have found their way into over 160 countries despite only being available through Embr Labs' US website. This digital thermal solution has also been clinically validated in partnership with Johnson & Johnson, and the Embr Labs' Science and Innovation team continues to explore new ways to enhance the efficacy and impact of Embr's technology for the nearly 1.1 billion women who will be experiencing menopause by the year 2025.

“The addition of Dr. Peeke to our leadership team and the investment from Joy Ventures, combined with our collaboration with UMass IALS and support from the Massachusetts Life Sciences Center/NSF have significantly accelerated our development and validation of innovative digital thermal solutions for women's health,” said Elizabeth Gazda, CEO of Embr Labs.

For more information, please contact Heather Ritchie or [email protected], or visit embrlabs.com.

About Embr Labs
Embr Labs is the first thermal wellness technology company, pioneering a new pathway to unlock the therapeutic power of temperature. Its first product, Embr Wave, is an intelligent bracelet that uses temperature to activate and balance the body and mind. Despite only being sold in the United States, the Wave is being used in over 160 countries. The company's patented technology harnesses the power of thermal sensations to deliver a brand new category of safe, non-invasive, and natural therapies that leverage the body and mind's natural response to temperature to help people feel more comfortable, fall asleep faster, and be less stressed. Embr Labs was founded by MIT-trained engineers and is backed by investors including DigiTx Partners, Joy Ventures, Bose Ventures and Joyance Partners.

Media Contact

Heather Ritchie, Embr Labs, +1 (323) 903-7063, [email protected]

Twitter, Facebook

 

SOURCE Embr Labs

Continue Reading

News

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Citigroup Inc. – C

gbafNews28

NEW YORK, Dec. 3, 2020 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of  Citigroup Inc. (“Citigroup” or the “Company”) (NYSE: C).  Such investors are advised to contact Robert S. Willoughby at  [email protected] or 888-476-6529, ext. 7980.

The investigation concerns whether Citigroup and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action] 

On September 14, 2020, reports surfaced that regulators were preparing to reprimand Citi for failing to improve its risk-management systems.  On this news, Citi's stock price fell $2.85 per share, or 5.59%, to close at $48.15 per share on September 14, 2020. 

Then, on September 14, 2020, post-market, an internal memo sent to Citi employees revealed for the first time the Company's disregard for adequate internal controls and regulatory compliance.  On this news, Citi's stock price fell an additional $3.34 per share, or 3.94%, to close $44.81 per share on September 15, 2020. 

Finally, on October 13, 2020, Citi reported earnings for the third quarter of 2020, and disclosed that the Company's expenses increased during the third quarter by 5%, to $11 billion, due to an increase in costs including a $400 million fine, investments in infrastructure, and other remediation costs related to control deficiencies.  On this news, Citi's stock price fell another $2.20 per share, or 4.8%, to close at $43.68 per share on October 13, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:

Robert S. Willoughby
Pomerantz LLP
[email protected] 
888-476-6529 ext. 7980

Cision View original content:http://www.prnewswire.com/news-releases/shareholder-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-citigroup-inc—c-301185451.html

SOURCE Pomerantz LLP

Continue Reading

News

Citycon has agreed to sell residential building rights to Hausia in the Lippulaiva urban development project

gbafNews28

HELSINKI, Dec. 3, 2020 /PRNewswire/ — Citycon and the construction company Hausia have entered into a preliminary agreement for Citycon to sell 8,750 square meters of residential building rights within the Lippulaiva development project. According to the current city plan, these building rights will enable the construction of two towers (approximately 150 units) consisting of a twelve storey and an eight-storey residential complex on top of the Lippulaiva shopping centre. In total, the plan is to develop eight residential towers consisting of 550 new apartments that will be built on the site. The remaining six towers will be developed by Citycon with at least four towers being planned for rental units, thereby diversifying the income stream of the project.

Citycon is currently carrying out a comprehensive re-development project for Lippulaiva; the previously demolished shopping centre is currently being replaced with a vibrant urban hub which includes a new and modern shopping centre along with the residential towers and a metro station. The new Lippulaiva will have a total of 30,000 square metres of residential building space in addition to 44,000 square metres of commercial space housing approximately 100 different units including grocery stores, cafés, restaurants, services and office spaces. 

“The sale to Hausia supports our strategy to create mixed use urban hubs. We will accomplish this by developing a portion ourselves and selling a portion to third parties. This new Lippulaiva will also contain a stop on the metro line allowing people to live and shop with the convenience of enhanced transportation”, says Erik Lennhammar, Chief Development Officer at Citycon. 

Further information:

Risto Seppo, Property Development Director
Tel. +358 45 657 8990
[email protected]

Kari Kiviluoma, CEO, Hausia
Tel. +358 45 8533 533
[email protected]

Citycon is a leading owner, developer and manager of urban grocery-anchored shopping centres in the Nordic countries. The total value of the property portfolio managed by Citycon is approximately EUR 4.4 billion. Citycon is the leading shopping centre owner in Finland and among the market leaders in Norway, Sweden and Estonia. Citycon has also established a foothold in Denmark.

www.citycon.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/citycon-oyj/r/citycon-has-agreed-to-sell-residential-building-rights-to-hausia-in-the-lippulaiva-urban-development,c3248540

The following files are available for download:

Continue Reading
Editorial & Advertiser disclosureOur website provides you with information, news, press releases, Opinion and advertorials on various financial products and services. This is not to be considered as financial advice and should be considered only for information purposes. We cannot guarantee the accuracy or applicability of any information provided with respect to your individual or personal circumstances. Please seek Professional advice from a qualified professional before making any financial decisions. We link to various third party websites, affiliate sales networks, and may link to our advertising partners websites. Though we are tied up with various advertising and affiliate networks, this does not affect our analysis or opinion. When you view or click on certain links available on our articles, our partners may compensate us for displaying the content to you, or make a purchase or fill a form. This will not incur any additional charges to you. To make things simpler for you to identity or distinguish sponsored articles or links, you may consider all articles or links hosted on our site as a partner endorsed link.
gbafNews28 gbafNews28
News17 mins ago

Citycon has agreed to sell residential building rights to Hausia in the Lippulaiva urban development project

HELSINKI, Dec. 3, 2020 /PRNewswire/ — Citycon and the construction company Hausia have entered into a preliminary agreement for Citycon...

gbafNews28 gbafNews28
News17 mins ago

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Citigroup Inc. – C

NEW YORK, Dec. 3, 2020 /PRNewswire/ — Pomerantz LLP is investigating claims on behalf of investors of  Citigroup Inc. (“Citigroup” or...

gbafNews28 gbafNews28
News17 mins ago

Embr Labs Continues Momentum as Leader in Thermal Wellness

BOSTON, Dec. 3, 2020 /PRNewswire-PRWeb/ — Embr Labs, the breakthrough thermal technology company and creator of the Wave Bracelet, today announced...

gbafNews28 gbafNews28
News18 mins ago

Linqto Announces New Speakers For Global Investor Conference 2020

SILICON VALLEY, Calif., Dec. 3, 2020 /PRNewswire/ — Linqto, a leading digital trading platform for private market securities, today announced...

gbafNews28 gbafNews28
News18 mins ago

Thailand unveils measures and promotion packages to revive safe and successful international MICE at IBTM World Virtual

BANGKOK, Dec. 3, 2020 /PRNewswire/ — Leading a 30-member Thai Team to this year's IBTM World Virtual, TCEB highlights Thailand's variety...

gbafNews28 gbafNews28
News18 mins ago

Knock Home Swap™ Now Available in Miami, Fort Lauderdale and West Palm Beach

NEW YORK, Dec. 3, 2020 /PRNewswire/ — Homeowners in Miami, Fort Lauderdale, West Palm Beach and other parts of southeast...

gbafNews28 gbafNews28
News18 mins ago

Global Net Lease Announces Fourth Quarter To Date Rent Collection Success And Acquisition Of Four Industrial Properties For $153 Million, $140 Million Pipeline

NEW YORK, Dec. 3, 2020 /PRNewswire/ — Global Net Lease, Inc. (NYSE: GNL) (“GNL” or the “Company”) announced today that 97%...

gbafNews28 gbafNews28
News18 mins ago

States Where Residents are Most Likely to Accept a COVID-19 Vaccine

SEATTLE, Dec. 3, 2020 /PRNewswire/ — QuoteWizard®, a LendingTree company, and one of the nation's leading online insurance marketplaces released a...

gbafNews28 gbafNews28
News18 mins ago

American Finance Trust provides Rent Collection Update

NEW YORK, Dec. 3, 2020 /PRNewswire/ — American Finance Trust, Inc. (Nasdaq: AFIN) (“AFIN” or the “Company”) announced today that 95%...

gbafNews28 gbafNews28
News18 mins ago

Macerich Earns Bureau Veritas SafeGuard™ Certification For Key Retail Properties

NEW YORK, and SANTA MONICA, Calif., Dec. 3, 2020 /PRNewswire/ — Macerich (NYSE: MAC), one of the nation's leading owners, operators...