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Lexaria Bioscience Corp. (NASDAQ: LEXX) Looking to Provide Bioavailable Oral Treatment for Hypertension, Mitigate Effects of High Blood Pressure

  • Lexaria is a biotechnology company pursuing the enhancement of the bioavailability of a diverse and broad range of active pharmaceutical ingredients (“APIs”)
  • The company has developed the patented DehydraTECH(TM) drug delivery technology, which has been shown to deliver more API at a faster rate than controls
  • Lexaria’s DehydraTECH pipeline includes DehydraTECH-CBD for the treatment of hypertension
  • Through pre-clinical studies, DehydraTECH-CBD has been shown to decrease systolic blood pressure among hypertensive volunteers
  • The company intends to file an Investigational New Drug (“IND”) application and has already received confirmation that the FDA agrees with its proposed abbreviated pathway under section 501(b)(2)
Oral delivery remains the preferred route of administering drugs among cooperating and conscious patients. But some drugs do not have the desired physicochemical and pharmacokinetic characteristics that favor oral administration, an issue that is linked to poor bioavailability. This has often led to the use of other routes or prompted the administration of higher doses, with the latter causing toxicity concerns and risks tied to erratic and unpredictable responses. These challenges, coupled with the fact that more than 90% of therapeutic compounds are known to possess oral bioavailability limitations, have necessitated research that explores ways to enhance oral drug bioavailability (https://ibn.fm/xQ0vX). The research has been spearheaded by scholars and scientists as well as companies such as Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms. A biotechnology company focusing its attention and resources on pursuing the enhancement of the bioavailability of a diverse and broad range of active pharmaceutical ingredients (“APIs”), Lexaria developed the patented DehydraTECH(TM) drug delivery technology. Designed to be incorporated into the formulation and manufacturing process of existing or new topical and ingestible products, the technology works with existing physiological systems to facilitate enhanced and more rapid absorption of drugs into the bloodstream and cells. In fact, the company has evidenced, through in vivo, in vitro and pre-clinical testing, that DehydraTECH delivers more API at a faster rate than controls, enabling more effective drug absorption. The testing has so far involved APIs such as cannabidiol (“CBD”), PDE5 inhibitors, antiviral drugs, and nicotine, each at different stages of product development. This DehydraTECH pipeline, Lexaria says, is addressing severe unmet patient needs. Its DehydraTECH-CBD compound, for example, specifically targets the hypertension space; in the U.S., about 47% of adults, or 116 million people, have hypertension, with only about 24% having the condition under control (https://ibn.fm/ZEKeM), while globally, hypertension affects more than 1 billion people, or about 30% of the adult population (https://ibn.fm/sdKDi). A person is considered hypertensive if and when their systolic blood pressure (when the heart is beating) exceeds 130 mmHg or their diastolic blood pressure (when the heart is at rest) is greater than 80 mmHg or if they are on hypertension medication. This heightened pressure has several consequences, including the fact that it makes arteries less elastic, effectively damaging them. This damage, in turn, decreases the blood flow and oxygen to the heart, leading to heart disease. The decreased blood flow also increases the risk of stroke. In extreme cases, hypertension causes death. In 2020, over 670,000 people died from hypertension in the United States, according to the Centers for Disease Control (“CDC”). Globally, the World Health Organization (“WHO”) reports, 7.5 million people die from high blood pressure annually (https://ibn.fm/HCtyI). Unfortunately, some of these deaths occur among patients who may not have noticed any symptoms, leading to the recognition of hypertension as a “silent killer.” The good news? There are several approved blood pressure medications, with scores still under development or evaluation, including Lexaria’s DehydraTECH-CBD. In its human pre-clinical studies, Lexaria has shown that DehydraTECH delivers 317% more CBD to the bloodstream. Its HYPER-H21-1 study demonstrated that DehydraTECH-CBD results in a rapid and sustained drop in blood pressure, particularly systolic pressure and especially in stage 2 hypertensive volunteers (those whose systolic pressure exceeds 140 mmHg). In addition, the company separately showed, through its HYPER-H21-2 study, that its drug candidate results in a 23% average reduction in overnight blood pressure and reduces arterial stiffness, while its HYPER-H21-3 study demonstrated attenuated pulmonary artery systolic pressure by -5 mmHg (https://ibn.fm/hCT43). Motivated by the positive results, Lexaria is marching toward filing an Investigational New Drug (“IND”) application, having already received confirmation from the U.S. Food and Drug Administration (“FDA”) that the agency had agreed with the company’s proposal to pursue the 505(b)(2) new drug application (“NDA”) abbreviated regulatory pathway (https://ibn.fm/NQaBK). For more information, visit the company’s website at www.LexariaBioscience.com. NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX

Freight Technologies Inc. (NASDAQ: FRGT) Using Technology to Help Customers Overcome Challenges of Cross-Border Logistics, Greatly Improving Efficiency

  • Freight Technologies is a technology company that develops solutions aimed at optimizing and automating the supply chain process
  • The company’s solutions include Fr8App Platform, Fr8FMS, cloud-based Fr8TMS, Fr8Radar, Fr8Data, and Fr8Fleet
  • Early this year, Freight Technologies unveiled Fr8Fleet, a technology solution for committed capacity planning, and announced it had secured its first contract for this product with Kimberly Clark de Mexico (“KCM”)
  • The company recently reported an expanded relationship with KCM following an agreement to include the Fr8App platform for cross-border logistics for shipments from Mexico to the U.S.
An insights report by multinational KPMG, entitled “The challenges of cross-border international trade,” lists logistics and supply chain as one of the major impediments businesses and suppliers must overcome to build effective and adequate cross-border trading capacity. “Tracking orders, determining liabilities for in-transit goods, and meeting promised delivery timeframes can all be more challenging in cross-border trade due to multicarrier handoffs and border delays,” the report underlines (https://ibn.fm/8qQPg). In addition to choosing between cross-border shipping or localized fulfillments – two core options to handle the complexity of international logistics – the report recommends the use of technology. “Technology can further simplify the challenges through multi carrier software platforms (also known as logistics control towers), which can select the most appropriate shipping partners and plan routes, prepare parcels for export, and pass on the exporter of record and liability elements to third parties,” the report explains. Freight Technologies (NASDAQ: FRGT) (“Fr8Tech”), a technology company that develops solutions aimed at optimizing and automating the supply chain process, has always understood the importance of integrating technology into logistics. Through its wholly owned subsidiary Freight App, Inc. (“Fr8App”), the company offers solutions such as the Fr8App Platform, a B2B cross-border shipping marketplace powered by artificial intelligence (“AI”) and machine learning; Fr8FMS, a solution that enables transportation companies and owners to handle their own fleet, thereby reducing operational costs; cloud-based Fr8TMS that allows users to manage fleet and request freight services on the marketplace; Fr8Radar; and Fr8Data. These technology solutions, the company holds, aim to contribute to its customers’ success by improving their efficiency and profitability. In a February 7 news release that further embodies this commitment, Fr8Tech unveiled Fr8Fleet, a technology solution that facilitates capacity planning by enabling corporate shippers to purchase fleet capacity over time – rather than on a trip-by-trip basis – in exchange for a flat fee (https://ibn.fm/g3FCv). According to CEO Javier Selgas’s comments on the new technology, Fr8Fleet affords participating carriers a steady stream of revenue while solving the need by shippers to secure capacity over time, particularly in the current tight market. As part of the unveiling, Fr8Tech also announced an agreement with the first corporate client for its Fr8Fleet technology, Kimberly-Clark de Mexico, S.A.B. de C.V. (“KCM”), a leading public company in Mexico that manufactures and commercializes branded consumer products. The initial arrangement was later expanded to include dedicated truck services on the Fr8App Platform for KCM as well as traditional spot services within domestic Mexico. Fr8Tech and KCM recently expanded their working relationship even further when the former announced that its Fr8App Platform for KCM would now support cross-border logistics for shipments from Mexico to the United States. As a result, Fr8Tech now supports three types of logistics services for the consumer products manufacturer (https://ibn.fm/RwjLn). “Pleased with the level of service and value KCM received from Fr8Fleet and domestic spot services, KCM logistics management chose the Fr8App platform to address their needs for the U.S./Mexico cross-border traffic,” commented Javier Selgas. “As KCM is one of the top consumer product manufacturers in North America, this important development validates Fr8Tech’s platform and services. KCM’s expanding relationship highlights our potential to increase business with existing customers as well as capture more transportation logistics trade from corporations of all sizes.” Fr8Tech aims to revolutionize logistics operations for brokers, carriers, and shippers by leveraging technology infrastructure to improve experiences and efficiency. The infrastructure combines everything in a single control center, optimizing logistics, making fleets more efficient, and reducing transportation costs. For more information, visit the company’s website at www.Fr8Technologies.com. NOTE TO INVESTORS: The latest news and updates relating to FRGT are available in the company’s newsroom at https://ibn.fm/FRGT Corporate Communications IBN (InvestorBrandNetwork) Los Angeles, California www.InvestorBrandNetwork.com 310.299.1717 Office Editor@InvestorBrandNetwork.com

Flora Growth Corp. (NASDAQ: FLGC) Agreement with Colombian Tribe Strengthens Cannabis Production Supply Chain

  • Flora Growth is a global cannabis brand-builder focused on the cultivation of product at a central Colombian facility and marketing through a design-led international supply chain
  • Flora recently announced an agreement with Colombia’s Misak tribe for cooperative processing and distribution of cannabis, drawing on the tribe’s licensing advantage to accelerate the pair’s marketing capacity
  • Flora is headquartered in Canada, but its strength lies in its Colombian-based cultivation operations centered in Colombia, one of the largest licensed outdoor operations in the world
  • In recent years, Colombia’s government has been working to create a legalization framework for cannabis cultivation, processing and exportation to shake off its legacy of illegal drug trade violence
Canada-headquartered global cannabis brand-builder Flora Growth (NASDAQ: FLGC) is increasing the strength of its supply chain, centered in its 100-hectare (about 247-acre) cultivation facility located in the heart of Colombia’s green climate, by finalizing a distribution agreement with the Misak indigenous tribe’s pharmaceutical arm. “Through this partnership, we will collaborate with the tribe on the processing and distribution of their Colombian-grown cannabis while offering Manasr a powerful platform for product distribution,” Flora Growth Chairman and CEO Luis Merchan stated in an August news release announcing the arrangement (https://ibn.fm/UAD84). “In return, Flora will be able to leverage the tribe’s unique regulatory positioning to expedite exports and increase global market penetration of Colombian cannabis goods.” Pharma Indigena Misak Manasr Sas, referred to simply as Manasr, is the tribe’s pharmaceutical enterprise, which in 2020 became the first native community business to receive a license from the national Ministry of Justice for producing legal cannabis for medicinal and scientific use, according to Google’s English translation of a local news report (https://ibn.fm/qA8aR). Flora Growth will assist the tribe with regulatory advice, as well as technical and business support and market promotion for Flora Growth-branded products, particularly as the tribe enters the international supply chain, as Merchan indicated. The agreement is for three years, with the potential to become a lasting, long-term collaboration. Prior to the June elections that established Colombia’s current national administration, the country underwent progressive drug policy changes in an effort to cast off its reputation as a haven for illegal drug trade and related organized crime violence. The normalization of the economy and legalization of cannabis commerce for medical purposes with regulated foreign exports have led to a revolutionary new energy for Colombia’s trades, which continues to be supported under the new administration. Flora’s Cosechemos facility provides cultivation, extraction and isolation operations at the city of Bucaramanga, supplemented by GMP-certified processing at a facility in the nation’s capital, Bogotá. Flora has established exports to Mexico and Spain and opening doors to the United Kingdom and the United States. The company recently reported its financial results for the first half of 2022, showing a 604 percent YOY growth in revenues as its design-led product profile and capital acquisitions gain market attention. The revenue growth was also a 117 percent increase over the second half of the previous year (https://ibn.fm/xz0Vw). For more information, visit the company’s website at www.FloraGrowth.com. NOTE TO INVESTORS: The latest news and updates relating to FLGC are available in the company’s newsroom at https://ibn.fm/FLGC

Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Clinical Trial Marks ‘Tremendous’ Milestone as First Participants Receive Initial CYB003 Dose

  • First dose is administered as first-ever novel psilocybin analog enters clinical development
  • Cybin believes CYB003 has potential to successfully address the challenges and limitations of oral psilocybin
  • The high level of participant interest in the study indicates a significant unmet need for alternative treatment options for major depressive disorder (“MDD”)
Cybin (NEO: CYBN) (NYSE American: CYBN) has reached a milestone in its mission to create safe and effective therapeutics. The company is conducting a phase 1/2a trial evaluating CYB003, its lead investigational molecule and the first-ever novel psilocybin analog to enter clinical development. Late last month, the first two trial participants were dosed (https://ibn.fm/JXADp). “To commence dosing in our first-in-human phase 1/2a trial is a tremendous milestone for Cybin, especially having reached the clinic within just 18 months,” said Cybin CEO Doug Drysdale. “Our goal continues to focus on becoming a leader in creating the best psychedelic therapies for patients, and today we have moved one step closer. Through our rigorous preclinical work and ongoing clinical development of CYB003, we believe we have the potential to unlock the powerful benefits of psilocybin for the treatment of major depressive disorder (‘MDD’) without its well-known limitations.” The in-human trial is critical to the company’s continued development of CYB003, a deuterated psilocybin analog that Cybin believes has potential to successfully address the challenges and limitations of oral psilocybin. According to the company’s preclinical research, CYB003 achieved less variability in plasma levels, along with faster onset of action, improved brain penetration, and shorter duration of effect, compared to oral psilocybin. CYB003 has the potential to reduce time in the clinic, which could allow more scalability and access for this treatment. As a randomized, double-blind, placebo-controlled study, the current phase 1/2a trial will evaluate individuals with moderate to severe MDD. Those who qualify for the study are between the ages of 21 and 55, have a verified diagnosis of MDD and are unsatisfied with their current prescribed medication and treatment. Participants will be allowed to remain on their current medication throughout the trial. “The high level of participant interest in our study serves to validate the significant unmet need for alternative and better treatment options to improve mental health conditions,” said Drysdale. “We expect that this phase 1/2a trial will provide valuable insights and data. These findings will be critical in establishing a safe and efficacious treatment profile for CYB003 so we can continue to progress our mission to help revolutionize the treatment landscape for people suffering from depression.” Cybin is a leading ethical biopharmaceutical company working with a network of world-class partners and internationally recognized scientists on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, and novel formulation approaches and treatment regimens for mental health disorders. For more information, visit the company’s website at www.Cybin.com. NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://ibn.fm/CYBN

QSAM Biosciences Inc. (QSAM) Working to Halt, Regress Bone Tumors in Children Through Therapeutic Radiopharmaceuticals

  • Overall incidence of childhood cancer is on the increase, averaging 0.8% increase per year since 1975, reports leading advocacy organization
  • QSAM developing therapeutic radiopharmaceuticals as safer, more efficacious alternatives to address unmet medical needs, underserved patient populations
  • Company creating pipeline of novel radiotherapeutics to serve multiple indications with its lead product, CycloSam
With the overall incidence of childhood cancer on the rise, the work of QSAM Biosciences (OTCQB: QSAM) is becoming increasingly important. QSAM Biosciences is a clinical-stage biotechnology company focused on developing and bringing to market targeted therapeutic radiopharmaceuticals and advancing the fight against cancer, including the underserved pediatric population. “The overall incidence of childhood cancer is on the increase, averaging 0.8% increase per year since 1975. Overall cancer incidence rates increased an average of 1% per year from 1997 to 2018,” reports Children’s Cancer Cause, the leading national advocacy organization for children’s cancer (https://ibn.fm/foz9V). According to Children’s Cancer Cause, in 2022 an estimated 10,470 children (from birth to 14 years) and 5,480 adolescents (aged 15 to 19 years) will be diagnosed with cancer. “It is estimated that there will be 13.7 million cases of childhood cancer between 2020-2050. Unless there are major improvements in diagnosis and treatments, of this, 45% will go undiagnosed and 11.1 million will die if no further investments in interventions are made. The vast majority, almost 85%, will be concentrated in developing countries.” The group went on to note that cancer in children and young adults is different from cancer that develops in adults. “Some of the unwanted side effects of cancer treatments cause more harm to children than they do to adults,” the report states. “This is because children’s bodies are still growing and developing, so cancer and its treatment are more likely to affect developing organs. “More than 95% of childhood cancer survivors will have a significant health-related issue by the time they are 45 years of age,” the report continued. “These health-related issues are side effects of either the cancer or, more commonly, the result of its treatment: one-third will suffer severe and chronic side effects, one-third will suffer moderate to severe health problems, and one-third will suffer slight to moderate side effects.” QSAM Biosciences is working to make a difference in this space, as well as in the adult cancer sector. The company is developing “targeted therapeutic radiopharmaceuticals as safer and more efficacious alternatives to current treatment modalities to address large unmet medical needs and underserved patient populations” (https://ibn.fm/gE7c6). With that in mind, QSAM is focused on creating a pipeline of novel radiotherapeutics to serve multiple indications. The company’s lead product, CycloSam(R), is a clinical-stage, bone-seeking radiopharmaceutical designed to deliver targeted radiation safely and precisely to tumors in the bone. “CycloSam delivers the beta-emitting radioisotope, Samarium-153, to areas of rapid bone formation through a superior chelant, DOTMP, emitting a potent yet controlled dose of radiation treatment directly to the tumor environment while minimizing radiation exposure to healthy tissue,” the company reports. “The results we seek are halting or regressing primary and metastatic tumors in bone for both children and adults. . . . CycloSam is the next generation of an already FDA-approved drug, with patented improvements to increase efficacy and utility, reduce toxicity, and streamline production.” For more information, visit the company’s website at www.QSAMbio.com. NOTE TO INVESTORS: The latest news and updates relating to QSAM are available in the company’s newsroom at http://ibn.fm/QSAM

EverGen Infrastructure Corp. (TSX.V: EVGN) (OTCQX: EVGIF) Expands Canadian RNG Projects, Achieves Key Milestones

  • Traditional natural gas extraction pollutes air, contaminates water, disturbs landscape
  • Renewable natural gas is derived from organic sources, compatible with existing traditional natural gas pipeline grid
  • EverGen operates projects in British Columbia and Alberta, recently acquired 50 percent stake in Ontario-based Project Radius located in Eastern Canada
  • Company recently signed $31 million senior term loan to help fund RNG facility upgrades and expand projects
Traditional pipeline natural gas is extracted by vertical or horizontal drilling, and hydraulic fracturing. Well-drilling activities pollute the air, disturb lands, and contaminate water, while hydraulic fracturing – widely referred to as “fracking” – has similar consequences in addition to causing earthquakes (https://ibn.fm/ldZri). In contrast, renewable natural gas (“RNG”) is derived from organic sources while still being compatible with North America’s existing gas pipeline grid. EverGen Infrastructure (TSX.V: EVGN) (OTCQX: EVGIF) is leading the movement in Canada by acquiring, developing, building, and operating a portfolio of RNG, waste-to-energy, and related infrastructure projects. “Renewable natural gas, in Canada and the U.S., is a market that’s really starting to pick up steam,” said EverGen’s CEO and Co-Founder Chase Edgelow on a recent episode of IBN’s Bell2Bell Podcast (https://ibn.fm/fJLS8). “The gas utilities on both sides of Canada – the West Coast and Quebec – have both set targets of 15-20 percent of their volume to come from RNG or renewable products by 2030.” As part of its national expansion, EverGen recently acquired a 50 percent interest in Project Radius, a portfolio of RNG development projects in Ontario that include three RNG projects collectively capable of producing approximately 1.7 million RNG GJ/year. Scheduled to be constructed throughout 2023 and 2024, the acquisition provides EverGen with a foothold in the East that the company can use to participate in the consolidation and growth of the Canadian RNG industry. “Working alongside Northeast to advance the projects, EverGen will deliver on our platform expansion commitments with the potential to exceed 1,000,000 GJ of RNG production annually,” said Edgelow (https://ibn.fm/lSObZ). “Ontario has an abundant amount of excess organic feedstock, and as a leader in the RNG industry, EverGen can develop the sustainable infrastructure that contributes to carbon-negative energy production and the greening of the province.” To support its West coast projects, EverGen recently signed a $31 million senior term loan to help fund RNG facility upgrades and expand projects. “We’re fully funded to take our core expansion projects from where they are today (we’re cash flow positive today) to north of $13 million in EBITDA from those core assets, which are located in British Columbia and Alberta now with our acquisition of GrowTEC,” said Edgelow in comments referring to the company’s acquisition of the Alberta-based renewable natural gas facility. “When you add it all together, we’ve got a business capable of delivering $30 million of EBITDA from the portfolio that we have in front of us, and we see 25+ projects in Canada that could deliver 4x growth beyond that. There’s a tremendous amount of opportunity in this space right now.” Based in Vancouver, British Columbia, EverGen is an established independent renewable energy producer that is committed to combating climate change and contributing to a sustainable future. The company currently focuses on Canada with the long-term goal of developing RNG infrastructure throughout North America and beyond. For more information, visit the company’s website at www.EvergenInfra.com. NOTE TO INVESTORS: The latest news and updates relating to EVGIF are available in the company’s newsroom at https://ibn.fm/EVGIF

Cerberus Cyber Sentinel Corp. (NASDAQ: CISO) Ranked in Top 10 of Cybersecurity Startups

  • The UK’s fastest-growing platform for startups, TechRound, named Cerberus in the top 10 cybersecurity startups and companies
  • Cerberus Sentinel is a nationwide provider of cybersecurity consulting and managed services, with offices and resources across the country
  • Company believes culture is the foundation of every successful cybersecurity and compliance program
Cerberus Cyber Sentinel (NASDAQ: CISO) was named in the top 10 cybersecurity startups and companies by TechRound, the voice of UK startups and the UK’s fastest-growing platform for startups (https://ibn.fm/cHuEr). Chosen by TechRound’s internal team, the companies were ranked based on “the experience of the team, founders and staff; how the companies have generated success through funding rounds, concept or generating revenue; and the companies’ abilities to overcome issues and help social issues.” Cerberus Sentinel is a “nationwide provider of cybersecurity consulting and managed services, with offices and resources all across the U.S,” reported TechRound. “They specialize in building a security-centric culture for their clients using an education-based approach. To support the ever-expanding list of needs from their clients, they focus on acquiring top cybersecurity talent who specialize in key areas that complement the services offered.” The announcement called out Cerberus Sentinel founder David Jemmett as a leader in the industry. “David has more than 30 years of executive management and technology experience with telecommunications, managed services, and consulting services,” the article noted. “He has specialized expertise in healthcare, HIPAA and governmental regulations, and has been intimately involved in designing, building, revamping, and/or managing networks and data centers worldwide.” The announcement also observed that Jemmett has spoken before the U.S. Congress and Senate subcommittees on Telecommunications and Internet Security. “He has [also] shared his expertise on broadband networking technologies as guest speaker on CBS, CNN, MSNBC and CSPAN,” TechRound stated. As part of CISO’s mission, the company is committed to demystifying and accelerating its clients’ journeys to cyber resilience, empowering organizations to securely grow, operate and innovate (https://ibn.fm/0mHKl). “We believe culture is the foundation of every successful cybersecurity and compliance program,” the company states. This key differentiator sets Cerberus apart from providers who offer their services traditionally, with each solution providing more than just security or compliance improvement. Cerberus designs their services to go beyond delivery to impact an organization’s culture, and the services all work in tandem to achieve this objective. “We are industry leaders who work collaboratively to solve complex cybersecurity challenges, meet strict compliance requirements, and educate your team on the role they play in the cybersecurity and compliance of your organization. This is the Cerberus Sentinel Solution.” For more information, visit the company’s website at www.CerberusSentinel.com. NOTE TO INVESTORS: The latest news and updates relating to CISO are available in the company’s newsroom at https://ibn.fm/CISO

HeartBeam Inc. (NASDAQ: BEAT) Is ‘One to Watch’

  • HeartBeam is a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere
  • In September 2022, the company announced it was granted a patent for its 12-lead ECG Patch Monitor, opening a pathway to ischemia and arrhythmia detection innovation in ECG Patch products
  • In August 2022, the company announced it was seeking FDA approval for its HeartBeam AIMI platform technology used to detect and diagnose heart attacks
  • On November 15, 2021, HeartBeam had its IPO on the Nasdaq under ticker symbol ‘BEAT’
  • The company’s management team has significant experience in software and medical device product development, with over $1 billion in successful exits over the past 18 months
  • HeartBeam was selected as a winner at the annual Cardiovascular Innovations (“CVI”) 2022 Innovation Summit, which recognizes state-of-the-art cardiac technologies
HeartBeam (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector 12-lead electrocardiogram (“ECG”) platform for heart attack detection anytime, anywhere. The company’s proprietary ECG telehealth technology aims to redefine the way high risk cardiovascular patients are diagnosed in ambulatory and acute care settings. HeartBeam’s initial focus is on providing diagnostic data to help physicians with care management of patients with cardiovascular disease. In August 2022, HeartBeam announced that it submitted its HeartBeam AIMI(TM) software for approval from the U.S. Food and Drug Administration (“FDA”). HeartBeam AIMI is a platform technology to improve the speed and accuracy of heart attack detection in acute care settings. The company expects FDA approval by the end of 2022, and a full commercial roll-out of HeartBeam AIMI is targeted for Q1 2023. HeartBeam sees submission of its first product based on its platform technology as an important milestone toward commercialization, which underscores the company’s continued progress toward making the HeartBeam AIMI platform widely available to help emergency department physicians quickly and accurately identify a heart attack. While the FDA conducts its regulatory review, HeartBeam will focus on executing key components of its commercialization plan and subscription revenue model. It will also continue to engage in discussions with strategic institutions, including academic centers, regional healthcare systems and regional community hospital systems that can utilize HeartBeam products. The company is based in Santa Clara, California. Products HeartBeam’s development portfolio includes two products:
  • HeartBeam AIMI is software that provides a 3D comparison of baseline and symptomatic 12-lead ECG to more accurately identify a heart attack in acute care settings and, as noted above, has been submitted for FDA approval; and
  • HeartBeam AIMIGo(TM), the first and only credit card-sized 12-lead output ECG device coupled with a smartphone app and cloud-based diagnostic software system for remote heart attack detection.
HeartBeam is developing AIMIGo, a medical-grade detection and monitoring technology for use in remote heart attack detection, thereby allowing physicians to diagnose a patient’s heart attack as it occurs, even if the patient is not at a medical facility. The company’s system, once approved by the FDA, can be used by patients at home or almost anywhere and anytime to help their physicians assess whether chest pain is the result of a heart attack or another cause. While approximately 82% of chest pain ED visits are unnecessary, patients delay approximately 3 to 4 hours after symptoms begin, increasing mortality rates by 40%. The company’s goal is to shorten the time to treatment outside of the medical facility to improve patients’ well-being. HeartBeam’s AIMIGo is a powerful, portable and easy-to-use prescription-based product. It comprises a smartphone app, a credit card-sized ECG device placed on a patient’s chest, the HeartBeam cloud platform, and a digital portal for the physician to view ECG results and direct patient action. For the first time outside of a medical setting, HeartBeam AIMIGo enables patients and their clinicians to determine if symptoms are due to a heart attack, quickly and easily, so care can be expedited, if needed. Pending FDA clearance, AIMIGo is initially intended to be available by prescription, and is reimbursable under existing remote patient monitoring codes (RPM codes). This provides a new revenue stream to physicians who before did not have a way to monitor these high-risk patients. The RPM codes provide a monthly reoccurring revenue stream to the company, as well. On average, at current reimbursement rates, the practice will receive $1,300+ per year per patient they monitor, and the company will receive $600 per year per patient from this RPM reimbursement. Market Overview Adoption rates of telehealth services increased dramatically in recent years, with the COVID-19 pandemic serving as a major driver of growth. Among the areas seeing the greatest expansion are cardiology, radiology, behavioral health and online consultation. Encouraging this growth, governments are actively developing new policies and reimbursement guidelines to promote the use of digital health platforms. The U.S. Centers for Medicare & Medicaid Services (“CMS”), for example, has recently expanded reimbursement for telehealth services. U.S. market growth is also being driven by the rising prevalence of chronic conditions and the growing geriatric population. Remote heart attack detection is a previously unsolved problem with a massive and underserved market that is several times larger than the $2 billion total addressable market (“TAM”) in the U.S. for ECG cardiac arrhythmia monitoring. Approximately 8 million Americans have suffered at least one heart attack, and a total of 18 million have been diagnosed with coronary artery disease (“CAD”). Based on these figures, HeartBeam projects a total addressable U.S. market TAM valued at $10 billion annually for its AIMIGo solution for remote heart attack monitoring of CAD. Management Team Branislav Vajdic, Ph.D., Chief Executive Officer and Founder of HeartBeam, Inc, combines over 30 years of experience in technology development and senior management positions. Dr. Vajdic has been deeply involved with the development of HeartBeam’s technology to fit his vision for the company. Prior to HeartBeam, from 2007 to 2010, Dr. Vajdic was CEO and Founder of NewCardio, a publicly traded company in the cardiovascular devices space. From 1984 to 2007, Dr. Vajdic was at Intel, where he held various senior management position. At Intel, Dr. Vajdic was the designer of first Flash memory and two key inventions that enabled Flash as a product and led engineering groups responsible for Pentium 1 through Pentium 4 designs. Dr. Vajdic was awarded two Intel Achievement Awards, the highest level of award for outstanding contributions to Intel. Dr. Vajdic is author of numerous patents and publications in the fields of cardiovascular devices, as well as chip design. Dr. Vajdic holds a Ph.D. in Electrical Engineering from the University of Minnesota. Jon Hunt, Ph.D., has over 35 years’ experience in the medical/medical device industry with extensive domestic and international experience in general management, clinical/regulatory, sales and marketing. He also has diverse experience in Fortune 500 companies, as well as start-up environments. Dr. Hunt was the Vice President of Clinical Science and Technology, Medical Device Innovation Consortium, from July 2019 to July 2021, and Vice President of Clinical and Regulatory Affairs, Cryterion Medical from January 2018 to June 2019 (acquired by Boston Scientific Corporation in July 2018 for $202M). Dr. Hunt was the Founding President and CEO of Bardy Diagnostics, Inc. from October 2013 to November 2017 (acquired by Hill-Rom Holdings, Inc.). Prior to joining Bardy Diagnostics, Dr. Hunt spent the previous 11 years as the Vice President of Clinical & Regulatory Affairs with Cameron Health, Inc. (acquired by Boston Scientific Corporation). Dr. Hunt spent the previous 10 years with Cardiac Pacemakers, Inc., St. Jude Medical and Cardiac Pathways Corporation. Dr. Hunt began his career with Cardiac Pacemakers, Inc. (now Boston Scientific Corporation) as the Director of Clinical Programs. He subsequently held positions at St. Jude Medical in Clinical Affairs and as the Business Unit Director for the Cardiac Rhythm Management division for Europe, the Middle East and Africa. At Cardiac Pathways Corporation, Dr. Hunt held various executive positions as Vice President of International Sales and Marketing and Vice President of Worldwide Sales and Marketing (acquired by Boston Scientific Corporation). Dr. Hunt received his Ph.D. in Motor Control from The Pennsylvania State University, his Master’s from California State University, Long Beach and his undergraduate degree from Keele University in the United Kingdom. Rick Brounstein, HeartBeam’s Chief Financial Officer, combines over 30 years of experience in health technology senior management. Since 2017, Mr. Brounstein has been and is currently a partner of Hardesty, LLC, a financial services firm, and Mr. Brounstein is currently a managing director of CTRLCFO, LLC, a firm Mr. Brounstein founded in 2016 to support funded start-ups in life science and technology. From 2008 to 2011, Mr. Brounstein was Chief Financial Officer of NewCardio, Inc., a microcap public company in the cardiology space, and, over his career, he has been with nine other companies in life science or technology, holding positions including Chief Financial Officer, Chief Operating Officer, Treasurer and Accounting Manager. From June 2001 through November 2007, Mr. Brounstein held several positions at Calypte Biomedical Corporation, a publicly traded medical device company, including Chief Financial Officer and Executive Vice President. In January 2007, Mr. Brounstein was appointed as the National Member Representative for the 2007 COSO Monitoring Project, which published new guidelines for monitoring internal financial controls in February 2009; Mr. Brounstein subsequently was a member of the FEI task force that issued the updated COSO Internal Control Framework in 2013. In March 2005, Mr. Brounstein was appointed to the SEC Advisory Committee on Smaller Public Companies. Mr. Brounstein earned his Certified Public Accountant (“CPA”) certification while working at Arthur Andersen LLP, formerly a public accounting firm. Mr. Brounstein holds a B.A. in accounting and an M.B.A. in finance, both from Michigan State University. Ken Persen, HeartBeam’s Chief Technology Officer, combines over 28 years of experience in the medical device and digital health industries in engineering and senior management positions. Mr. Persen has been involved in several companies in Cardiac Rhythm Management, holding positions including Chief Executive Officer, Chief Technology Officer, Executive Vice President and Director of Engineering. Since 2016 and prior to joining HeartBeam, Mr. Persen was the Chief Technology Officer at LIVMOR, Inc., a digital health company. In addition, from 2016 through November 2021, he was also Chief Executive Officer of LIVMOR. Prior roles included Director of Engineering at Cameron Health (acquired by Boston Scientific), a late-stage medical device start up, and engineering and management positions at Guidant Corp. (acquired by Boston Scientific), a large medical device manufacturer. He has an undergraduate degree from University of Minnesota, Duluth, with a BA in Computer Science. For more information, visit the company’s website at www.HeartBeam.com. NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT

Hillcrest Energy Technologies Ltd. (CSE: HEAT) (OTCQB: HLRTF) (FRA: 7HIA) Works Towards Potential Breakthrough Solution for Electric Vehicle and Clean Energy Industries

  • Power electronics, especially those found in the traction inverters used in EVs, are key to achieving better range, safety, and lifetime; still, improving inverter efficiency has been relatively slow
  • Hillcrest stepped up to the challenge of developing a high-efficiency inverter — a new class of clean technology designed to help today’s electric power systems overcome their common limitations
  • Hillcrest’s unique inverter architecture can be deployed across different applications, providing opportunities for diversification and de-risking of the company’s revenue streams
Although the popularity of electric vehicles continues to grow amid the ongoing push for energy transition, their design challenges, such as range increase and cost reduction, remain. With aspirations to become an early leader in the electrification of North America and beyond, Hillcrest Energy Technologies (CSE: HEAT) (OTCQB: HLRTF) (FRA: 7HIA.F) strives to make an impact where it matters most by offering bold solutions to these key industry challenges. The company develops clean energy technologies intended to unlock electrification efficiencies and enhance the performance of electric systems across various applications, including electric vehicles, and grid-connected renewable energy generation, energy storage and EV charging. While EV technologies have transformed during the past decades, several challenges still impede further proliferation and commercial success. Innovation in this space often means a delicate balancing act between conflicting goals such as range, performance, and cost — which are typically bound by the limitations of power devices. Power electronics, a focus of innovation in electric powertrains, control and convert power and are central to three critical devices: the onboard charger, the traction inverter, and a DC-DC (direct current) converter. Of these three components, the most critical is the traction inverter, which operates at the highest available power and facilitates traction, so any efficiency gains here can increase vehicle range without changing the battery capacity (https://ibn.fm/fSrUD). But although inverters have been around for years, this critical technology has been slower to improve in terms of efficiency. That’s where Hillcrest steps in. Possibly the first company to successfully develop a new class of inverter technology that deploys Zero Voltage Switching (“ZVS”) capabilities. Compared to hard switching, ZVS — also called soft switching — can reduce stress caused during switching and lower switching losses. What differentiates Hillcrest inverter technology is efficiency that surpasses 99%; a design that enables smaller, lighter, and more powerful system capabilities; as well as systems that offer enhanced reliability and performance at lower costs. In addition, Hillcrest’s inverter technology eliminates inverter losses and reduces the thermal management needed across the entire powertrain system (https://ibn.fm/AGaT8). By benefiting from higher operating frequencies at higher voltage, Hillcrest’s solution could overcome historic technology trade-offs and offer improved efficiency, thermal control, and system reliability. This flexible inverter architecture can be deployed across various applications, providing an opportunity for value creation through co-development and collaboration efforts with EV manufacturers and beyond, potentially allowing the company to diversify and de-risk its revenue sources across different sectors and grid-connected energy systems (https://ibn.fm/Jpg9H). With a potential customer base that includes a number of automotive OEMs and tier 1 suppliers and an impeccable reputation across the EU auto, electrical and electronics network, Hillcrest remains focused on balancing short-term revenue maximization with long-term business disruption risk. Leveraging a business model centered around a blend of distinctive, application-specific hardware and software solutions, the company is confident that its new inverter technology will lead to meaningful revenue opportunities in the near future (https://ibn.fm/hfUbS). For more information, visit the company’s website at www.HillcrestEnergy.tech. NOTE TO INVESTORS: The latest news and updates relating to HLRTF are available in the company’s newsroom at https://ibn.fm/HLRTF

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Participates in H.C. Wainwright 24th Annual Global Investment Conference, Presenting Key Investor Highlights on Novel Anthracycline Berubicin for GBM Treatment

  • Glioblastoma multiforme (“GBM”) is one of the most aggressive, deadly, and treatment-resistant forms of cancer within the brain, with an average life expectancy of 12-18 months and more than 50,000 new cases each year
  • The current standard of care for GBM is ineffective for approximately 60% of patients
  • Initial Phase 1 trial information for Berubicin (approximately 14 years ago) resulted in one patient surviving cancer-free to present and two experiencing significant tumor reduction of up to 80%
CNS Pharmaceuticals (NASDAQ: CNSP), a clinical stage biotechnology company specializing in the development of novel treatments for brain tumors, recently participated in the H.C. Wainwright 24th Annual Global Investment Conference held on September 12-14, 2022, in New York and online in a hybrid virtual conference. During the event, CEO John Climaco presented the company’s investor presentation and participated in one-on-one investor meetings. An audio recording of Climaco’s presentation is currently available on the company’s News & Events page, through December 11, 2022 (https://ibn.fm/RP8cj). The company’s presentation includes key investor highlights on the efforts being pursued by CNS Pharmaceuticals to develop anti-cancer drug candidates for the treatment of primary and metastatic brain and central nervous system cancer. Berubicin, the company’s lead drug candidate, is a novel anthracycline in an ongoing, potentially pivotal international trial in glioblastoma treatment. The interim analysis data from this potentially pivotal trial is expected in mid-2023. Glioblastoma multiforme (“GBM”) is one of the most aggressive, deadly, and treatment-resistant cancers forming within the brain. Per the company presentation, GBM has an average life expectancy of 12-18 months, with more than 50,000 new cases each year (includes US, France Germany, Italy, Spain, UK, Japan and urban China), accounting for approximately 48% of all primary malignant brain tumors in the US. Unfortunately, the current standard of care for GBM is ineffective for approximately 60% of patients. Anthracyclines are among the most effective anti-cancer treatments. Berubicin was the first to provide scientific data which appears to demonstrate its ability to cross the blood-brain barrier and was designed with a molecular target of topoisomerase II enzymes responsible for cleaving and recombining double-stranded DNA during cellular replication. As tumors are rapidly growing compared to healthy tissues, the anthracycline effects tumor tissues much more than healthy neurons within the brain. The Phase 1 safety trials of Berubicin were conducted around 2006-2007 by Reata Pharmaceuticals, Inc., with one person surviving cancer-free to present and two others showing significant reduction in tumor size by up to 80%. CNS Pharmaceuticals, founded in 2017, entered a collaboration agreement with Reata and has used the initial Phase 1 trial information as the foundation for subsequent trials and to receive FDA Orphan Drug Designation in 2020 and FDA Fast Track Designation in 2021 for Berubicin. The current U.S. Orphan Drug Designation provides CNS Pharmaceuticals with U.S. marketing exclusivity for 7 years post-NDA approval. The company is pursuing Orphan Drug Designation in the EU, which will provide 10 years of protection following European approval. Since the beginning of 2022, CNS Pharmaceuticals has completed pivotal milestones with Berubicin, receiving approval from Switzerland Ethics Committee (“EC”) and Competent Authority (“CA”), France EC, and CA, and Spain EC and CA to open sites. The company’s next steps include pivotal trial expansions into additional countries, expected completion of enrollment, interim analysis/data, and target topline results from the potentially pivotal study. The company offers a strong balance sheet to execute its strategy with cash to progress toward key clinical and regulatory milestones within its development goals. CNS Pharmaceuticals is leveraging its ongoing clinical trial for Berubicin, and the novel anthracycline remains the only competitor to cross the blood-brain barrier to drive value for shareholders. “We are at the point where the finish line is within sight, and that is: ‘Is this drug performing in a clinical setting the way we want it to?’ And if it is, there is nothing to compete with it,” Climaco commented. “We believe this will be an absolute knock-it-out-of-the-park opportunity for neuro-oncology, but we have to prove that carefully, and that’s what we do on a day-to-day basis. That’s how we continue to build that [shareholder] value over time.” For more information, visit the company’s website at www.CNSPharma.com. NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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Nightfood Holdings Inc. (NGTF) Builds Robotic Coordination Layer as Autonomous Fleets Scale

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As robotics adoption accelerates, the challenge is shifting from building individual machines to making increasingly diverse robotic fleets work together. A cleaning robot, delivery robot, industrial arm and laboratory system may each perform its assigned task autonomously, but coordinating those machines across a facility can still require significant human oversight. That creates an opportunity for […]

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