Mr. Charles Funk reports:

Vancouver, Canada - TheNewswire - December 9th, 2020 - Heliostar Metals Limited (TSXV:HSTR) (OTC:RGCTF) (FRA:RGG) ("Heliostar" or the "Company") is pleased to announce the appointment of Mr. Mahesh Liyanage to the Company’s executive team in the role of Chief Financial Officer (“CFO”). Mr. Liyanage takes over from Mr. Mark Brown who has stepped down from his role.

Heliostar CEO, Charles Funk, commented “I welcome Mahesh to Heliostar Metals as we continue to build a dynamic management team that can unlock the potential of our high-grade portfolio in Alaska and Mexico. We would also like to thank Mark for his excellent contribution, and his team’s service, to the company over the last two and half years.”

Mr. Liyanage is a Chartered Professional Accountant with more than 20 years of experience across diverse industries. He has strengths in Canadian public company reporting and regulatory compliance, business spin-offs/mergers and acquisitions, treasury management, Canadian and US tax compliance including extensive experience in US and Mexican operations. Mr. Liyanage worked most recently as CFO for Orogen Royalties and Mirasol Resources.

Summary
Show definitions

The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid duplex ultrasound study.

Description

Currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. this test is not considered suitable for screening for disease. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.

This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Medical. The CSS instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of arterial narrowing.

Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment either before or after the carotid duplex ultrasound.

Details
Treatment Carotid Stenotic Scan
Clinical Study Identifier NCT04057183
Sponsor Phillip J Bendick
Last Modified on 7 December 2020

IIROC Trading Resumption - CVM


June 10 2020 - 04:41PM
PR Newswire (Canada)

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VANCOUVER, BC, June 10, 2020 /CNW/ - Trading resumes in:

Company: CVR Medical Corp

TSX-Venture Symbol: CVM

Resumption (ET): 9:30 AM 6/11/2020

IIROC can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. IIROC is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) - Halts/Resumptions

Copyright 2020 Canada NewsWire


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Pluristem Reports Positive Top-Line Results from Its
Multinational Phase II Intermittent Claudication Study
PLX-PAD treatment reduced risk of revascularization and improved patients’ mobility.
Study validates the design of Pluristem’s ongoing Pivotal Phase III study in Critical Limb Ischemia (CLI)

HAIFA, Israel, June 12, 2018 - Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer
of placenta-based cell therapy products, today announced positive top-line results from its multinational
Phase II clinical study of PLX-PAD cells in the treatment of Intermittent Claudication (IC). PLX-PAD
treatment reduced Incidence of revascularization and improved patients’ mobility. Study results also
validate the design of Pluristem’s ongoing Pivotal Phase III study in CLI, a more severe stage of peripheral
arterial disease (PAD) and confirm Pluristem’s proprietary Bio-Therapeutic approach.
Pluristem's Phase II IC study was designed to evaluate the safety, efficacy and optimal dosing regimen for
PLX-PAD cells in patients with IC, Rutherford categories 2-3. Enrollment took place at 28 clinical sites in
the U.S., Germany, South Korea and Israel. The 172 patients in the study were randomized into four
treatment groups: two administrations of 300 million PLX-PAD cells (“main efficacy group”); two
administrations of 150 million PLX-PAD cells; two administrations of placebo; or one administration of 300
million PLX-PAD cells followed by placebo. In each of these study arms, the two administrations were
given intramuscularly (IM), 3 months apart. The primary efficacy endpoint was the change from baseline
in maximal walking distance (MWD) at 52 weeks compared to placebo. The key secondary endpoint was
the change from baseline in MWD at 52 weeks compared to placebo, in patients treated with 2 doses of
PLX-PAD originating from different placentas (Pluristem’s proprietary Bio-Therapeutic approach). Other
endpoints included risk of revascularization and other hemodynamic and clinical outcome measures.
Top Line Results:
• Patients treated with 2 administrations of 300 million PLX-PAD cells showed statistically significant
improvement (p=0.0008) in MWD as compared to baseline at 52 weeks.
• Key primary efficacy endpoint, improvement in MWD as compared to placebo, in analysis by
country, showed best results with statistically significant improvement (effect size= 51.1%,
p=0.015) in U.S patients (n=73) treated with 2 administrations of 300 million PLX-PAD cells.
• Key secondary efficacy endpoint, improvement in MWD following administration of 2 doses of
300 million PLX-PAD cells originating from different placentas, showed statistically significant
improvement at 52 weeks (effect size= 42.0%, p=0.043) as compared to placebo. These patients
also demonstrated a statistically significant improvement (effect size= 83%, p=0.0007) in MWD at
52 weeks as compared to baseline.
• Revascularization risk was reduced by 49% (Hazard ratio = 0.51) in the main efficacy group at week
65. Patients receiving 2 administrations of PLX-PAD cells originating from different placentas were
“revasc-free” (no revascularization events) at week 65.
• IM administration of PLX-PAD cells was safe and well tolerated.
Validation of study design in ongoing Pivotal Phase III study in Critical Limb Ischemia (CLI):
• Dose confirmation- Study results demonstrated dose of 300 million PLX-PAD cells as the optimal
dose for treatment of PAD
• Two administrations of 300 million PLX-PAD cells demonstrated a statistically significant superior
effect (p=0.0331) compared to a single administration of 300 million PLX-PAD cells in MWD at
week 52, suggesting that in chronic indications such as PAD a second treatment may be required
to significantly improve the clinical outcome.
• Pluristem’s proprietary Bio-Therapeutic approach of using cells originating from different
placentas for each administration, as implemented in the CLI pivotal Phase III clinical study, was
shown to generate a superior therapeutic effect.
“We are highly encouraged by the results seen in the study. The option of treating peripheral artery
diseases like IC and CLI through IM injections of PLX-PAD cells is promising, and an important outcome,
demonstrating the potential ability to implement regenerative medicine advanced technologies in
cardiovascular diseases. We look forward to the CLI pivotal study results that may demonstrate the ability
of Pluristem’s cell therapy to improve patient outcomes and create economic benefits for the healthcare
systems,” stated Dr. Manesh Patel, Chief of the Division of Cardiology at Duke University Health System,
and the lead principle investigator (PI) for the U.S. Phase II IC study.
“These promising results demonstrate a clinically meaningful treatment effect. Finding a non-surgical
medical solution for PAD, especially in patients who are unsuitable for revascularization, has proven to be
one of the biggest medical challenges in recent years. These study results are highly encouraging and
suggest that PLX-PAD cells may be the answer for both PAD patients and physicians seeking effective
medical solutions,” commented Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical
University of Dresden, Germany, and the lead PI for the European Phase II IC study.
“We are very pleased with the study results that may bring hope to millions of patients worldwide
suffering from peripheral artery diseases,” stated Pluristem Chairman and Co-CEO Zami Aberman. “These
results suggest that PLX-PAD cells may be efficacious in the treatment of PAD and could significantly
reduce the need for invasive procedures in these patients. Furthermore, these results provide
important validation to our ongoing pivotal Phase III study in CLI in terms of dose selection, dualdosing
administration regimen and the superiority of our proprietary Bio-Therapeutic approach we have
developed in the last few years of using different placentas when more than one treatment is required.
The unique PLX platform and manufacturing processes we developed enable us to confirm donor-todonor
and batch-to-batch comparability and achieve optimal clinical benefits.”
About Peripheral Artery Diseases (PAD)
Peripheral Arterial Disease (PAD) is caused by fatty deposits in leg arteries that obstruct blood flow. Risk
factors include smoking, diabetes, heavy weight, cardiovascular problems and hypertension. An earlier
stage of PAD is Intermittent Claudication (IC) with symptoms of leg pain and weakness brought on by
exercise, with resolution of the symptoms following rest. IC can progress to Critical Limb Ischemia (CLI)
when patients suffer from severe pain at rest, skin wounds, tissue necrosis and poor quality of life with a
high risk of leg amputation and death. PAD affects 4-12% of people aged 55-70 years and 15-20% of people
aged over 70 years. The frequency of lower extremity artery disease is strongly age-related, rising steeply
after 50 years of age. PAD afflicts about 20 million U.S. citizens, 28 million Western Europeans and 42 to
60 million Chinese citizens.
Pluristem’s Phase III study in Critical Limb Ischemia (CLI), was cleared by the U.S Food and Drug
Administration (FDA) and European Medicines Agency (EMA) and is recruiting patients (n=246) in the U.S.
and Europe.

Vancouver, British Columbia--(Newsfile Corp. - May 22, 2018) - CVR Medical Corp. (TSXV: CVM) (FSE: B3BN) (OTCQB: CRRVF) ("CVR Medical") announces it has retained BUYINS.NET, www.buyins.net, a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on CVR Medical (OTCQB: CRRVF) (TSXV: CVM) (FSE: B3BN) after releasing the latest short sale data through May 17, 2018. The total aggregate number of shares shorted since January 2017 is approximately 14.37 million shares. Approximately 45.60% of daily trading volume is short selling. The SqueezeTrigger price for all CRRVF shares shorted is $0.38. A short squeeze is expected to begin when shares of CRRVF exceed this level.

CVR Medical Enters China, Executes Preliminary LOI To Launch Its CSS Device In World’s Largest Market
Hamza Ghaznavi - January 17th, 2018
Potential To Bring Innovation, Sweeping Change To Healthcare In China






CVR Medical Corp. (TSXV:CVM) (FRANKFURT: B3BN) (OTCQB: CRRVF) (“CVR Medical”) is pleased to announce the signing of an official Letter of Intent with Guangzhou LangRun Equity Investment Management Co., Ltd. (GLR), a professional equity investment fund management platform company headquartered in Guangzhou, China. GLR plans to create the “LangRun Asset Fund” focused on investment in medical devices specific to senior care and healthcare optimization, and which will fund a proposed 35% (CVR) / 65% (GLR) joint venture to market, assemble and distribute CVR’s patented carotid stenotic scan (CSS) device throughout Mainland China.
The Letter of Intent puts CVR in a position to achieve its goal of further expansion into the Asian-Pacific market upon the intended launch of the CSS in 2018. By working in unison with GLR, CVR will enter the Chinese market with the financial resources, stability and guidance necessary to build necessary infrastructure, grow brand awareness and reach a population of nearly 1.5 billion. GLR’s breadth of business experience in the region, mixed with commitment to fund the project in its entirety, will ensure that all operational and clinical requirements are substantiated and every effort is made to achieve approval by the Chinese FDA for market entry.
“We are excited about this proposed equity JV with Guangzhou LangRun to develop the Mainland Chinese market for our CSS medical device, which will leverage the strength of GLR’s strategic partners in government, political, financial and healthcare circles. The agreement we have in place with Guangzhou LangRun will pave the way to one of CVR’s primary goals, entrance into the Chinese market through an equity-based joint venture,” CVR CEO Peter Bakema states. “CVR sees this as a turnkey moment in our evolution into a globally recognized company within the medical device industry. It is a point of great pride for us, and we look forward to working with GLR and its partners to bring our technology to the people of China. This joint venture will act as the framework of future global opportunities for CVR’s patented CSS device. With a significant investment of tens of millions of dollars dedicated to the funding of operational infrastructure, which includes manufacturing, marketing and sales, CVR is effectively able to work with GLR and bring this project to profitability. In addition, the joint venture also calls for the payment of advance royalties and altogether is expected to be dwarfed by the ROI generated by the Joint Venture. CVR is currently negotiating several similar opportunities globally.”
GLR and CVR are working diligently to define the final terms of the Joint Venture Agreement.
For additional information on the organization, leadership and current news, please visit the newly launched company website www.CVRMed.com.