Mes: agosto 2020

FOSTER CITY, Calif., Aug. 4, 2020 /PRNewswire/ — ANA Therapeutics (ANA), a Silicon Valley-based biotech start-up announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ANA001 (niclosamide capsules) as a potential treatment for COVID-19, making it the first U.S.-based company to conduct a human clinical trial to determine the efficacy of niclosamide to treat COVID-19.

ANA Therapeutics clinical trial will seek to enroll at least 400 patients with COVID-19 at 10 centers across the U.S., specifically in states that are experiencing surges in coronavirus cases such as Florida and Texas and expects to enroll the first patient in August. ANA will evaluate both the safety of niclosamide as well as its ability to show a clinical improvement in hospitalized patients with COVID-19. This study will focus on patients with less severe symptoms who are not on ventilators. During the trial, patients will be given a seven-day course of niclosamide and monitored for 60 days. ANA Therapeutics plans to look at niclosamide’s effectiveness in treating outpatients in a later study.

«Safe and effective antiviral therapies are critically needed to treat COVID-19 now and treatments will continue to be necessary even if a vaccine is developed. This will be the first U.S.- based clinical trial to determine the efficacy of niclosamide in COVID-19,» ANA Co-Founder and CEO Akash Bakshi said. «Anticipating that niclosamide may prove to be effective against COVID-19, we are already laying plans to make the drug accessible to everyone.»

Niclosamide has been used for more than 50 years to safely treat millions of people worldwide with its primary indication being the treatment of tapeworm infections. Now, niclosamide has emerged as a promising candidate to combat COVID-19. In pre-clinical research, niclosamide has been shown to stop the virus that causes COVID-19 from replicating and to be more potent than remdesivir in the same assay.  Furthermore, niclosamide has documented anti-inflammatory properties. Therefore, ANA Therapeutics believes niclosamide has the strong potential to both stop viral replication and reduce symptoms in patients suffering from COVID-19.

«As a start-up and unlike large life science companies, ANA Therapeutics has already moved at lightning speed to get niclosamide into clinical trials,» said Sam Altman, former president of Y Combinator and now the CEO of OpenAI. «I’m thrilled to invest in the team’s critically important mission to develop a safe, effective, and widely available treatment for COVID-19.»

In early March, at the outset of the coronavirus pandemic in the U.S., ANA pivoted their business to determine the efficacy of niclosamide for COVID-19 and quickly raised over $5 million to lead the first U.S.-based clinical trial for niclosamide as a COVID-19 treatment. Investors in ANA’s seed round include former president of Y Combinator Sam Altman; Atomic fund founder Jack Abraham; Gmail creator and Y Combinator partner Paul Buchheit; Randi Zuckerberg’s On Air Investments; Refactor Capital; a Palo Alto based early stage VC, SV Tech Ventures; Incite.org and Nest co-founder Matt Rogers and Incite.org co-founder, Swati Mylavarapu; Ron Conway’s SV Angel; SOSV; and Neal Khosla co-founder of the health care start-up Curai.

«At Refactor Capital, we invest in health startups that creatively disrupt the status quo with visions for building great businesses that solve massive problems,» said Zal Bilimoria, founding partner of Refactor Capital. «We couldn’t think of a bigger problem to address right now than COVID-19, and we’re excited to see ANA Therapeutics bring their niclosamide treatment to patients.» 

For more information, visit: https://anatherapeutics.com/

ABOUT ANA THERAPEUTICS:

ANA Therapeutics, is a Silicon Valley-based biotech start-up working to develop niclosamide as a safe, widely accessible antiviral treatment for patients with COVID-19. A low-cost, scalable, and well tolerated compound, niclosamide has the potential to be a needed treatment to help individuals who contract the novel coronavirus to beat it. For more information, please visit https://anatherapeutics.com/.

MEDIA CONTACT:
Liz Squire
esquire@tridentdmg.com
202-617-4662

 

View original content:http://www.prnewswire.com/news-releases/ana-therapeutics-announces-us-fda-clearance-of-ind-application-to-initiate-clinical-trial-of-niclosamide-in-covid-19-patients-301105314.html

SOURCE ANA Therapeutics

PLEASANTON, Calif., Aug. 4, 2020 /PRNewswire-PRWeb/ — NeoTract, a wholly owned subsidiary of Teleflex Incorporated (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced that Daniel Arrison, M.D., Chesapeake Urology Associates in Bel Air, MD, has been designated as a UroLift® Center of Excellence. The designation recognizes that Dr. Arrison has achieved a high level of training and experience with the UroLift® System and demonstrated a commitment to exemplary care for men suffering from symptoms associated with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate.

Recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines, the FDA-cleared Prostatic Urethral Lift procedure using the UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to BPH. The UroLift permanent implants, delivered during a transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.

The UroLift Center of Excellence program is designed to highlight urologists who are committed to educating their patients on BPH and the UroLift System as a treatment option and consistently seek to deliver excellent patient outcomes and experiences.

«We are pleased to recognize Dr. Daniel Arrison as a UroLift Center of Excellence for his commitment to providing consistent care to BPH patients using the UroLift System treatment,» said Dave Amerson, president of the Teleflex Interventional Urology business unit. «This achievement has helped many patients experience durable, long- term relief from the burdensome symptoms of BPH while preserving sexual function*1,2.»

Over 40 million men in the United States are affected by BPH, a condition that occurs when the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. Symptoms of BPH often include interrupted sleep and urinary problems and can cause loss of productivity, depression and decreased quality of life.

Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra. While current surgical options can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction, and retrograde ejaculation.

About the UroLift® System

The FDA-cleared UroLift System is a proven, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function*1,2. Patients also experienced a significant improvement in quality of life. Over 100,000 men have been treated with the UroLift System in the U.S. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The Prostatic Urethral Lift procedure using the UroLift System is recommended for the treatment of BPH in both the American Urological Association and European Association of Urology clinical guidelines. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at http://www.UroLift.com.

About NeoTract | Teleflex Interventional Urology

A wholly owned subsidiary of Teleflex Incorporated, the Interventional Urology Business Unit is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function*1,2. Learn more at http://www.NeoTract.com.

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit http://www.teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch®, UroLift® and Weck® – trusted brands united by a common sense of purpose

For Teleflex Incorporated: Jake Elguicze, 610.948.2836
Treasurer and Vice President, Investor Relations

Media:
Nicole Osmer, 650.454.0504
nicole@healthandcommerce.com

*No instances of new, sustained erectile or ejaculatory dysfunction
1. Roehrborn, J Urology 2013 LIFT Study
2. McVary, J Sex Med 2016

MAC00968-01 Rev A

 

SOURCE NeoTract Teleflex

DOYLESTOWN, Pa., Aug. 4, 2020 /PRNewswire-PRWeb/ — Resilience, according to Manion, is all about «struggling well.» Conversations will focus on how the principle of struggling well relates to current events, the Travis Manion Foundation mission of empowering veterans and families of fallen heroes to serve, as well as personal trials guests have overcome. With all guests, Ryan’s goal will be to focus on sharing lessons that listeners can use to face adversity more effectively, while turning challenges into opportunities for growth.

The show will feature an array of guests, and the inaugural episode will launch on Tuesday, August 4th, with Ryan interviewing Chairman of the Board and CEO of Johnson & Johnson, Alex Gorsky.

«In the years since the loss of my brother Travis, I’ve learned that my life need not be defined by a tragic event, but it can be inspired by it,» said Ryan Manion. «My hope is that listeners will join us on this journey with some amazing guests, as we explore how to struggle well through life’s inevitable challenges.»

The Resilient Life Podcast will be available on all major podcast streaming platforms, including Apple Music, Spotify, Radio.com, and more, as well as a video version that will be available on YouTube. Listeners can subscribe to the podcast at http://www.ryanmanion.com/podcasts or subscribe to watch on YouTube at http://www.youtube.com/TravismanionOrg

About Ryan Manion
Ryan Manion is a wife, a mom, the President of Travis Manion Foundation, and the daughter of a retired Marine. Her brother, 1stLt Travis Manion, was killed in Iraq in 2007, and she lost her mother to breast cancer in 2012. Ryan also co-authored the book «The Knock at the Door» which tells the story of three women, bonded by grief and purpose, who turned loss into inspiration for others by channeling their grief through service. She has learned that responding to struggle well can not only help determine the course of your life; it can inspire others to change the course of theirs. Learn more about Ryan Manion here.

About Travis Manion Foundation
Travis Manion Foundation (TMF) unites communities to strengthen America’s national character by empowering veterans and families of fallen heroes to develop and lead future generations. In 2007, 1st Lt. Travis Manion (USMC) was killed in Iraq while saving his wounded teammates. Today, Travis’ legacy lives on in the words he spoke before leaving for his final deployment, «If Not Me, Then Who…» Guided by this mantra, veterans continue their service, develop strong relationships with their communities, and thrive in their post-military lives by serving as character role models to youth. As a result, communities prosper and the character of our nation’s heroes lives on in the next generation.

The story of 1st Lt. Travis Manion and his Naval Academy brother Lt. (SEAL) Brendan Looney have been publicized in the book Brothers Forever, and additional information about the Foundation can be found at http://www.travismanion.org.

For interview opportunities or additional information, please contact:
Derrick Morgan, Sr. Director of Marketing Derrick@travismanion.org (215) 622-2225

 

SOURCE The Resilient Life hosted by Ryan Manion

MORRISTOWN, N.J., Aug. 4, 2020 /PRNewswire-PRWeb/ — It’s a fund raiser, it’s a marathon, it’s a way to give back to local communities – all through the sport of golf. The 2020 ClubsHELP 100-Hole Challenge was announced this week as a vehicle to raise funds for local charities nationwide.

«With so many charity golf events being canceled this year due to social distancing and non-member play voiding large tournaments, we needed to create an event that adheres to social distancing protocols,» said Michael McCarthy, CEO of Addison Reserve Country Club and Chairman of the ClubsHELP 100-Hole Challenge. «Members and corporate sponsors can support players who are responsibly playing in these events.»

The main benefit of the 2020 ClubsHELP 100-Hole Challenge is that clubs across the country can pledge support for favored local charities.

How does this event work?

Amateur golfers, including club staff or teams from local charities (typically in groups of 2 or 3), play 100 holes of golf from sun-up to sundown raising money for select local charities. Pledges are received from friends, members, family and local businesses, with 90% of funds raised donated to the club’s designated local charity and the remaining 10% to ClubsHELP. Teams may represent the club, a corporation, or a charity, allowing tremendous flexibility to raise funds for multiple causes.

Member clubs receive promotional support from ClubsHELP national headquarters, including an app for receiving pledges, national leaderboard, and marketing tool kit.

The 100-Hole Challenges will run from now through October 31, 2020.

With support of the golf legends Ernie Els and Jack Nicklaus, plus the backing of the Club Managers Association of America and National Club Association, ClubsHELP has grown from a single club in March 2020 to a network of nearly 400 clubs supporting hospitals, food banks, emergency services responders, and nursing homes in their communities. Through this collective energy and support of golf and club members across the country, resources are being deployed where they are needed most—at the local level.

The 100-Hole Challenge is the ultimate demonstration of community support – and that’s the essence of ClubsHELP, a 501(c)3 foundation.

To enroll a club in ClubsHELP access the web site at http://www.clubshelp.org. To learn more about the 100-Hole Challenge, go to http://www.clubshelp.org/100holes/.

 

SOURCE ClubsHELP

SAN JOSE, Calif., Aug. 4, 2020 /PRNewswire-PRWeb/ — Reallusion is devoted to the digital human design pipeline and now adds another link in the chain of tools to design the ultimate digital human. Character Creator 3.3 features new realism tools that work with the already released Digital Human Shader and the Headshot plugin for rapid digital double creation for a total solution. Accompanying the release of Character Creator 3.3, the digital human workflow evolves with SkinGen – an intuitive, dynamic skin layer system, and CC 3 Base+, a greatly enhanced character topology for overall visual upgrades.

«SkinGen is a major breakthrough in the digital human workflow that introduces an ultra-realistic dynamic material system dedicated to human skin synthesis. » said John Martin, VP, Product Marketing, Reallusion. «The tools inside SkinGen are also empowered by the combination of industry leading partners like Texturing XYZ and Substance. SkinGen makes it possible for anyone to create a character with custom looks for age or appearance, and ultra-fine details down to the pores.

«Texturing.XYZ and Character Creator 3 is a dynamic combination for creating real-time digital humans. The partnership with Reallusion and Texturing.XYZ enables a pipeline to rapidly design detailed characters ready for animation.» – Jeremy Celeste, CEO, Texturing.XYZ

New CC3+ Character Base

Designing the best real-time Digital Human character is one of the core values of Character Creator 3. CC3 Base+ improves character mesh, UV, and skeletal rig; fulfilling the requirements of detailed sculpting and realistic animation.

• Topology & Mesh Enhancement: evenly-distributed quad surface and perfect edge-loops for smooth facial expressions and body animations.
• UV Optimization: Head UV includes neck area. High details for hand, nose, lips, and UDIM layout optimized for ZBrush, Substance Painter pipeline.
• Upgraded Skinning & Rigging: Supports both A-pose & T-pose, enhances skin-weights.

SkinGen – Intuitive Skin and Makeup Design

Basic SkinGen features are included as a free update in CC 3.3. Along with embedded sample Skins and Makeup assets, all users are able to enjoy the layer stack and rich slider adjustments. The new character base (CC3 Base+) is required to present the quality for SkinGen. All existing characters can be easily converted into CC3 Base+, and a Batch Converter is also provided in the CC3.3 release.

Free SkinGen features includes:

• Content Manager

Browse and manage skin and makeup content, drag-and-drop assets to the SkinGen layer editor for
compositing effects.

• Layer Editing

Show/hide, opacity level, layer order, merge, flatten, and blend modes (normal, multiply, overlay, soft-light)

• Dynamic Material Editing

Adjustable skin effects on each layer, change material attributes for color, transformation, tiling and distribution, etc.

• Up to 4K real-time editing for each body material

What’s Included in the Digital Human Design Solution

Structural Skin and Makeup Assets
Following the natural layered skin dynamics, the Realistic Human Skin library starts from the muscle layer, and then Skin Details, Blemish on-top, and Acquired Elements like tattoos, finally determine Body Hair on the outermost surface. The simplified layer structure corresponds to real skin and properties to achieve a targeted result.

Realistic Human Skin – Detail Every Aspect of Digital Human
Realistic Human Skin is made of 270 dynamic materials for skin, hair, nail, tattoo, and blemishes; all magically blended with authentic 3D scan-based elements. Create a wide array of skin ages and appearance options with unmatched flexibility and production quality.

Makeup and SFX – From Daily Look to Hollywood SFX

The Makeup and SFX is a complete layer based editing environment to build custom makeup looks and Special FX. 280 makeup varieties go from the everyday casual looks to glamorous styles, and on to creative looks like reptile scales, sci-fi cyberpunk, tattoos, or battle-scarred fighter and beyond.

SkinGen Premium plug-in
The SkinGen Premium plugin unlocks texture import capability, and extends the 15 layer editing limit. The 21 dynamic material tools provide full control over every skin & makeup detail for customized skin effects, and the UV Converter helps you directly bring in DAZ textures for Character Creator 3 characters.

Ultimate Morphs – Authentic Human Morphs CC3 Base+

With more than 480 morphs from head to toe designed for the superior new CC3+ topology, Ultimate Morphs adds another 12 authentic human shapes delivering a balanced mixture of body scale, age, gender and ethnicities.

The Best Package Under $500 for Users to Get Started

Special entry offer valid until August 31, 2020

The Ultimate Digital Human Creation Bundle gives you an all-in-one solution to create stunningly hyper realistic characters in no time. With brand new CC3+ Characters, Morphs, SkinGen Skin & Makeup assets, along with the full-featured SkinGen Premium plugins, you can easily level-up your studio projects to rival AAA visuals.

xclusive bonus for this bundle: Human Anatomy Set
12 ultra-value and highly-detailed avatars are introduced to present the visual standard of CC3+ characters. The perfect starting point to any animated character project.

Price information:

New to Character Creator:
https://www.reallusion.com/store/product.html?l=1&p=cc#ultimate-digital-human

For Character Creator users – Ultimate Digital Human 4-in-1 Bundle
https://www.reallusion.com/character-creator/digital-human-skin-morph.html

Learn more about Character Creator 3.3 : https://www.reallusion.com/character-creator/

Learn more about SkinGen: https://www.reallusion.com/character-creator/skingen.html

About Reallusion
Reallusion Inc., a 2D and 3D character generation and animation tools company that specializes in real time cinematic animation, virtual production, and motion capture tools. Reallusion is a platform to connect professional animation technologies, industry partners, and content developers for character creation, motion capture and digital human solutions that balance quick production with quality results.

 

SOURCE Reallusion Inc.