Market Newsdesk

NEW YORK, May 24, 2021 (GLOBE NEWSWIRE) — (via Blockchain Wire) –– Artifex (www.artifex.art), a new digital art project that represents the next evolution for NFT artists and collectors, today announced the launch of its NFT platform and auction of limited edition NFT artwork based on self-portraits of renowned artists. In a world of trends, Artifex is an NFT platform designed to showcase the work of innovative digital artists. The auctions commenced on May 20th  featuring original work from Billelis and toomuchlag, and on May 21st with pieces by FVUCKRENDER and Baeige. Auctions continue this week with works from Blake Kathryn and Jason Ebeyer (Tuesday, May 25), Aeforia and Maalavidaa (Wednesday, May 26), and Victor Mosquera, and XSULLO (Thursday, May 27) at www.artifex.art. 

“Following the success of our NYC NFT takeover in Times Square and around the city, where we showcased digital art from 23 top artists in the space, we feel it’s time to fully launch Artifex and auction single edition artwork as well as showcase limited edition sculptures honoring some of today’s most influential NFT artists,” said Roger Dickerman, Founder of Artifex. “The industry desperately needs a solid platform that filters through the noise to reveal this generation’s true artists, while also creating an opportunity for artists to represent themselves in their work; and we’re happy Artifex will meet this need.” 

Each Artifex auction is released in “waves” around specific themes. The first wave is “The Family,” which represents the spirit of the NFT space: the collaboration, the community, and the positivity. The group consists of talented artists who rose up on Instagram and beyond to forge digital and real-world relationships, and blaze trails both together and individually. Each artist will showcase their work as a metaphorical self-portrait– such as a humanoid, animal, or object representation of self. The artwork ultimately answers the question: how do you see yourself in a piece of art? 

Each original artwork is auctioned as a 1/1 NFT. The NFTs will feature an Artifex, or a 3D sculpture of each artist’s work, created by art director DurkAtWork. The Artifex is a /100 NFT, 67 of which are available as limited editions. Through the Artifex, the character steps out of the original artwork into 3D virtual immortality. The sculpture is timeless and has a roadmap for metaverse compatibility, AR filters, and more. 

The full schedule for the auction is as follows: 

• Thursday, May 20th at 7:00pm EST – Billelis & toomuchlag
• Friday, May 21st at 7:00pm EST – FVCKRENDER & Baeige
• Tuesday, May 25th at 7:00pm EST – Blake Kathryn & Jason Ebeyer
• Wednesday, May 26th at 7:00pm EST – Aeforia & Maalavidaa
• Thursday, May 27th at 7:00pm EST – Victor Mosquera & XSULLO

For more information and to participate in the auction, please visit https://artifex.art/. 

About Artifex

Founded in 2020, New York City-based Artifex is partnering with artists and art organizations to honor pioneering creatives in the burgeoning NFT space.  By curating original pieces for sale as single editions, limited editions, in 2D and in 3D, Artifex is committed to creating a destination where collectors can acquire NFTs on a platform that honors the artists and their work.  For additional information, please visit: www.artifex.art.
Twitter: @Artifex_Project
Instagram: artifex_project

Media Contact: 

Transform Group: [email protected]

CpG-STAT3siRNA is a Distinctive RNA Therapy and Immunotherapy Developed at City of Hope

A Phase 1 Clinical Trial Will be Initiated at City of Hope

NEW YORK, May 24, 2021 (GLOBE NEWSWIRE) — Scopus BioPharma Inc. (Nasdaq: “SCPS”) today announced the approval of an investigational new drug application (“IND”) by the United States Food and Drug Administration (“FDA”) for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers.

A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology.

About Scopus BioPharma

Scopus BioPharma Inc. is a biopharmaceutical company developing transformational therapeutics capitalizing on groundbreaking scientific and medical discoveries from leading research and academic institutions. The company’s lead drug candidate is a novel, targeted immuno-oncology RNA therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. The company is also developing additional new chemical entities to treat other serious diseases with significant unmet medical needs, including systemic sclerosis.   Receive updates by following Scopus BioPharma on Twitter here.

Forward-Looking Statements

This press release may include forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks (including those set forth in the company’s offering circular filed with the U.S. Securities and Exchange Commission) and uncertainties which could cause actual results to differ from the forward-looking statements. The company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Investors should realize that if our underlying assumptions for the projections contained herein prove inaccurate or that known or unknown risks or uncertainties materialize, actual results could vary materially from our expectations and projections.

Contact

Rodd Leeds/David Waldman
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: [email protected]

Initial
NYU
experience in 99 patients demonstrated
EsoCheck
and
EsoGuard
capable of
detecting
esophageal
precancer
in chronic heartburn patients

NEW YORK, May 24, 2021 (GLOBE NEWSWIRE) — PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, and its major subsidiary Lucid Diagnostics Inc. (“Lucid”), today announced that David M. Poppers, M.D. Ph.D., Clinical Professor, Division of Gastroenterology and Hepatology at NYU Grossman School of Medicine, presented data on his team’s initial experience using Lucid’s EsoCheck^® Esophageal Cell Collection Device with Collect+Protect^™ technology (“EsoCheck”) and EsoGuard^® Esophageal DNA Test (“EsoGuard”) at the Digestive Disease Week 2021 medical conference, in a presentation entitled EsoCheck/EsoGuard: A Novel, Simple, Outpatient Technology for the Early Detection of Esophageal Intestinal Metaplasia, Dysplasia, and Adenocarcinoma.

EsoCheck is an FDA-cleared swallowable balloon capsule catheter which allows a clinician to perform anatomically targeted and protected sampling of surface cells from the esophagus in a less than 5-minute non-invasive office procedure.

EsoGuard is a commercially available molecular diagnostic test which assesses DNA methylation at 31 sites on two genes. EsoGuard has been shown to be highly accurate at detecting esophageal precancer (nondysplastic or dysplastic Barrett’s Esophagus, or BE) and esophageal cancer (esophageal adenocarcinoma, or EAC), which are complications of chronic heartburn (gastroesophageal reflux disease, or GERD), in a 408-patient NIH-sponsored clinical trial published in Science Translational Medicine.

Each year, approximately 20,000 U.S. GERD patients develop EAC and over 80% will die within five years. EAC is nearly always invasive at diagnosis and is highly lethal even in its earlier stages. Unfortunately, less than 10% of at-risk GERD patients recommended for screening undergo traditional invasive upper gastrointestinal endoscopy (EGD). The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened according to guidelines and undergone surveillance and curative endoscopic esophageal ablation of dysplastic BE.

Dr. Poppers and his team at NYU Langone Medical Center in New York City used EsoCheck to obtain esophageal cell samples from 99 patients (age range 24-75, median age 50, 78.7% male) over a period of one month and submitted these samples for EsoGuard testing. Of the 79 samples for which results were available, 18 (22.8%) were positive, 54 (68.4%) were negative and 7 (8.7%) were not evaluable due to insufficient DNA. The patients who received positive tests were referred for EGD to confirm their diagnosis and receive the appropriate follow-up or treatment.

“The use of EsoCheck and EsoGuard represent a simple and straightforward technique to screen patients for BE and EAC,” according to Dr. Poppers. “The procedure is well tolerated and is typically accomplished in 3 to 5 minutes. It can be easily performed without sedation in an outpatient setting, even as part of an initial clinical visit if warranted. What is noteworthy in this study is that we found instances of patients with BE who might never have been referred for endoscopic screening.”

“We are grateful to Dr. Poppers for collecting and presenting these encouraging data from his team’s initial experience with EsoCheck and EsoGuard,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive Chairman. “These findings are consistent with our growing real-world clinical experience with EsoCheck and EsoGuard, the first and only commercially available diagnostic technologies capable of serving as a widespread screening tool to prevent deaths through the early detection of esophageal precancer and cancer in at-risk chronic heartburn patients. We believe these tools could have as great an impact preventing esophageal deaths as widespread Pap test screening has had in preventing cervical cancer deaths.”

Digestive Disease Week^® (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology. 

About PAVmed and Lucid

PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical technology company with a diversified product pipeline addressing unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its major subsidiary, Lucid Diagnostics Inc., markets the first and only commercial tools for widespread early detection of esophageal precancer and cancer – the EsoGuard^® Esophageal DNA Test and EsoCheck^® Esophageal Cell Collection Device. Its GI Health division also includes the complementary EsoCure^™ Esophageal Ablation Device with Caldus^™ Technology. Its Minimally Invasive Interventions markets its CarpX^® Minimally Invasive Device for Carpal Tunnel Syndrome. Other divisions include Infusion Therapy (PortIO^™ Implantable Intraosseous Vascular Access Device and NextFlo^™ Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, our ability to complete our strategic initiatives, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; the effectiveness of our marketing initiatives; the establishment of government and private payment insurance coverage; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

Contacts:
Investors
Mike Havrilla
Director of Investor Relations
(814) 241-4138
[email protected]

Media
Shaun O’Neil
Chief Commercial Officer
(518) 812-3087
[email protected]

Jim Heins / Katie Gallagher
LaVoieHealthScience
(646) 491-7042 / (617) 792-3937
[email protected]

GREENVILLE, Texas, May 24, 2021 (GLOBE NEWSWIRE) — EXOS Aerospace & Technologies Inc, today executed an MOU with a consortium of Whitefield International Ltd based in London, England and I & J International, LLC based in Atlanta, GA to lead their $200M Series A raise. John Quinn noted, ”We chose the I & J / Whitefield consortium because of their ability to leverage their extensive international network to connect people and projects globally with resources.”

Mike Harling, Whitefield International managing director, said, “There is a rapid growth of interest in aerospace development among major funding sources worldwide. We look forward to introducing appropriate funders to EXOS Aerospace.” I & J International managing director Dr. Ian Bond added, “I am highly impressed with the incredibly talented team of engineers and entrepreneurs at EXOS Aerospace. They are dedicated to making space accessible and affordable to a wide range of commercial, government and defense customers.”

The next phase of the Exos Business Plan is to develop, fabricate and fly the Jaguar orbital vehicle, an air-launched two stage rocket designed to put 500-kg payloads into SSO. Not only are elements of the Jaguar vehicle reusable, but the intent is also to recover payloads after a predetermined period in orbit. John Quinn, Chief Executive Officer, stated, “Many successful research experiments have been conducted on the International Space Station (ISS), but it is impractical for development and manufacturing in space because the ISS simply was not designed or manned to support manufacturing. Jaguar will enable routine access to and from space on the customer’s terms on what amounts to an unmanned micro-ISS. Reusable Air-launch not only increases the capability of the vehicle, it also adds to flexibility by using commercial air launch provider solutions.”

About EXOS Aerospace

EXOS is a developer of reusable space vehicles with offices in Greenville, Texas, Torino, Italy, and Adelaide, Australia. Exos Aerospace is a DDTC registered privately-owned space hardware and operations company. Our team has developed hundreds of rocket engines, over a dozen flying vehicles and has even developed manned propulsion systems used on Rocket Racers that flew manned competitive sorties. Our team has developed technology for NASA and is presently working on a Hypersonic Reusable Launch Vehicle prototype under a Phase II AFWERX contract. We look forward to bringing our Design-Build Test Iterate approach to your Space hardware project. Exos Aerospace is making SPACEavailable.

Contact:

John Quinn
office: (844) 289-2773 x101
cell:1-972-740-8355

Richland WA, May 24, 2021 (GLOBE NEWSWIRE) —
Vivos Inc. (OTCQB: RDGL), During the past few months Vivos has made significant enhancements to the manufacturing process for Radiogel^™. These enhancements are crucial in aligning with FDA requirements for future clinical trials and licensing to international markets.

Our hydrogel and Y-90 particle production processes are safe and efficient and are being used to produce IsoPet^® for animal therapy. Full FDA pedigreed pre-clinical testing and clinical trials require Good Manufacturing Practice (GMP) protocols described in detail in FDA regulations. The production improvements for Radiogel^™ discussed were identified as part of establishing the GMP protocols for the IDE submission to the FDA.

This has been a substantial effort, including fifteen polymer runs to bound our design specifications, incorporation of more than fifty new Quality Management System documents, installation of new precision process control equipment, and a new Y-90 particle sterilization process. We are also assessing a contract with an international company that has the potential to produce a substantial amount of GMP RadioGel^™ and IsoPet^® both domestically and internationally.

This effort has strengthened our internal proprietary intellectual property. We discovered non-obvious and novel polymer/hydrogel production techniques that are significant and not published or mentioned in any patents. We are currently evaluating whether to keep these discoveries as a proprietary trade secret or to file additional patents. These manufacturing details have been incorporated in revisions to our Standard Operating Procedures for Hydrogel and Particle Production. With the essential elements of these enhancements now completed, we will accelerate our pre-clinical testing and now anticipate filing the IDE with the FDA in the next 90-120 days. Submitting the IDE after these manufacturing process enhancements were completed creates a much stronger submission with FDA and greatly reduces the risk and expense of having to do repeat testing.

Dr. Korenko stated “This effort has been substantial over the last several months, and is an invaluable investment necessary to transform our company into a serious commercial entity that has the potential to treat both animal and humans both domestically and internationally. We are confident that these manufacturing enhancements improve our proprietary technology and significantly strengthen our upcoming IDE submission.”

About Vivos Inc. (OTCQB: RDGL)

Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet^®) and in humans (RadioGel^™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.

RadioGel^™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.

RadioGel^™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.

The IsoPet^® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.

In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet^® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet^® to University animal hospitals and private veterinary clinics.

IsoPet^® for treating animals uses the same technology as RadioGel^™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.

CONTACT:

Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
MKorenko@RadioGel.com

Safe Harbor Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words “may,” “will,” “should,” “plans,” “expects,” “anticipates,” “continue,” “estimates,” “projects,” “intends,” and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company’s ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company’s control.

CONTACT:

Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
[email protected]