Elutia's CanGarooRM: Pioneering Drug-Eluting Biologic for Secure Medical Implants
Elutia Inc.
Elutia CEO Randy Mills joined Steve Darling from Proactive to discuss the company's groundbreaking product, CanGarooRM, a drug-eluting biologic designed to safeguard implanted medical devices such as pacemakers. Founded by Mills and Kevin Rakin, both esteemed veterans in the biotech industry, Elutia aims to revolutionize healthcare by combining regenerative medicine with localized drug delivery. Mills shed light on CanGarooRM's unique formulation, which includes antibiotics to prevent infections and device migration, ultimately enhancing patient safety. With the FDA accepting their filing in December, Elutia is optimistic about receiving favorable results in the second quarter of this year. If approved, CanGarooRM has the potential to capture a significant share of the market, estimated to exceed $500 million. Mills further elaborated that Elutia has completed product development and is poised to commence commercial production by the late second quarter. A soft launch is planned for the third quarter, followed by full-scale deployment by the fourth quarter of this year. This strategic timeline positions Elutia for substantial growth pending regulatory approval, with CanGarooRM poised to address critical needs in the healthcare industry and improve patient outcomes. In summary, the interview underscored Elutia's promising trajectory and the transformative potential of CanGarooRM in enhancing medical device safety. With a strong foundation in regenerative medicine and localized drug delivery, Elutia is poised to make a significant impact in healthcare innovation, driving positive change and improving patient care globally. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:37 AM Eastern Standard Time
Video
CervoMed appoints drug development veteran Dr. Joshua Boger as Chairman of the Board
CervoMed
CervoMed Inc CEO John Alam joined Steve Darling from Proactive to announce a significant addition to the company's leadership team. CervoMed has appointed Joshua Boger to its Board of Directors as Chair, leveraging his wealth of experience in drug development and biopharmaceutical leadership to drive the company's strategic initiatives forward. Dr. Boger is a seasoned industry veteran with over 40 years of experience, renowned for his innovative approach to science and proven track record as a business executive. Currently serving as Executive Chairman of Alkeus Pharmaceuticals, Dr. Boger brings invaluable insights and expertise to CervoMed. Alam elaborated on the significance of Dr. Boger's appointment and the pivotal phase the company is entering, with topline data from the RewinD-LB Phase 2b clinical trial evaluating neflamapimod in dementia with Lewy bodies (DLB) expected in the second half of 2024. Neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha, holds immense promise in addressing synaptic dysfunction, particularly in the basal forebrain cholinergic system, which is most impacted in DLB. Drawing from preclinical studies and clinical trials involving over 300 participants, Alam highlighted neflamapimod's favorable safety profile and its significant impact on dementia severity as demonstrated in the AscenD-LB Phase 2a clinical study. These promising results underscore the potential of neflamapimod to address the unmet medical needs in DLB and pave the way for transformative treatment options. The appointment of Dr. Boger and the advancements in CervoMed's clinical trials signify a significant milestone in the company's mission to develop innovative therapies for neurodegenerative diseases. With a visionary leadership team and a promising pipeline of treatments, CervoMed is poised to make a meaningful impact on the lives of patients and caregivers affected by DLB and related conditions. Stay tuned for further updates as CervoMed continues its journey towards advancing neurological healthcare. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:22 AM Eastern Standard Time
Video
Cloud DX secures key partnership with Sanrai International for worldwide distribution
Cloud DX
Cloud DX CEO Robert Kaul joined Steve Darling from Proactive to announce a new Partnership Agreement with New York-based Sanrai International. Sanrai International, a leading medical device distribution company with a global presence, will now market and resell the Cloud DX Connected Health platform across more than 65 countries. Kaul highlighted the significance of this partnership, emphasizing Sanrai's extensive customer and sub-distributor network, which spans Latin America, Africa, the Middle East, Asia, and beyond. The focus of this collaboration will be on addressing chronic disease management and post-surgical recovery, leveraging Cloud DX's innovative Connected Health products and services. With the partnership in place, both Cloud DX and Sanrai aim to equalize access to innovative medical devices, particularly in the areas of chronic illness and post-surgical recovery. Kaul also mentioned that Cloud DX has already announced over $2.5 million CAD in new business in 2024, reflecting the company's continued growth and market expansion efforts. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:06 AM Eastern Standard Time
Video
Filament Health announces FDA opening of IND application for substance abuse disorder
Filament Health Corp
Filament Health CEO Ben Lightburn joined Steve Darling from Proactive to share the groundbreaking news that the U.S. Food and Drug Administration (FDA) has given its approval for the Investigational New Drug application for PEX010, Filament Health's botanical psilocybin drug candidate designed for the treatment of Substance Use Disorders. This development paves the way for Filament Health to commence research activities in the United States, focusing on the potential use of their botanical psilocybin drug candidate in addressing substance use disorders, including those involving opioids. Lightburn went on to explain that the IND-opening protocol had previously been submitted to Health Canada and had received the department's no-objection status, underlining the company's commitment to adhering to rigorous regulatory standards on both sides of the border. Moreover, Lightburn highlighted the extensive scope of research and collaboration surrounding PEX010. Currently, a network of 24 research institutions and licensing partners across Canada, the USA, Europe, and Israel is actively studying PEX010 for various conditions. These include but are not limited to alcohol use disorder, depression, and coma, showcasing the versatile potential of this botanical psilocybin drug candidate in addressing a wide range of medical conditions. The acceptance of the IND application by the FDA marks a pivotal moment in Filament Health's journey, offering a pathway for innovative and potentially transformative treatments for substance use disorders. It also underscores the company's global reach and collaborative efforts in advancing the field of psychedelic medicine. This milestone is a testament to the commitment of Filament Health to research and develop solutions that hold promise for individuals struggling with these challenging conditions. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 09:40 AM Eastern Standard Time
Video
Communication Service for the Deaf Names Amanda Whyrick Division President of California Connect
Communication Service for the Deaf
Communication Service for the Deaf (CSD) today announced that Amanda Whyrick has been named the new Division President of California Connect. Whyrick previously served as CSD’s Vice President of Information Technology. In this new role, she will provide leadership support for all California Public Utilities Commission contracts held by Communication Service for the Deaf. California Connect, also called the Deaf and Disabled Telecommunications Program (DDTP), provides telecommunication access for Californians with hearing, vision, cognitive, mobility, and speech-related disabilities. The program of the California Public Utilities Commission (CPUC) includes accessible telecommunication equipment and devices, relay service, and Augmentative and Alternative Communication (AAC) devices. The California Connect Division President will provide strategic and operational support for the State’s marketing services, equipment distribution, and field operations contracts. Equitable and accessible communication solutions have been at the core of CSD’s work for the past fifty years. Bolstering our partnership with California Connect is a logical extension of our efforts to remove communication barriers for people with disabilities. “With the rapid advancement of communications technology, the person who fills this role must have extensive experience in accessible technology,” stated Chris Soukup, CEO of CSD. “Amanda is perfectly suited to lead the advancement of our California Connect division as they work towards their goal of providing communication equity for communities with disabilities.” Whyrick joined CSD in 2016 as a Systems Administrator and held various leadership roles until her promotion to Vice President of Information Technology in 2022. During this period, she successfully implemented accessible organizational-wide technology policies, including a transition to work-from-home call centers during the COVID-19 pandemic. Before joining CSD, Whyrick provided technology support to organizations including Southeast Community College and Dell Technologies. Now, as Division President for California Connect, Whyrick looks towards modernizing the program in a way that centers on the needs of various communities with disabilities and integrating the most up-to-date technological offerings. “As someone who personally benefits from accessible technologies, I know that access to them is crucial to the health and well-being of the user in all aspects of life. I look forward to extending this same privilege to Californians with different accessibility needs." shared Whyrick. Whyrick will assume the position of California Connect Division President on February 26, 2024. About Communication Service for the Deaf Communication Service for the Deaf (CSD) is the largest Deaf-led social impact organization in the world. For more than four decades, CSD has been a leader in creating and providing accessible and innovative solutions for the Deaf community. Today, CSD continues its work to create opportunities for personal and economic growth within the Deaf community, specifically addressing leadership and employment. For more information, please visit CSD and follow us on Facebook, Twitter, Instagram, and LinkedIn. Contact Details Communication Service for the Deaf Molly Miller +1 315-679-8948 leltouny@csd.org Company Website https://www.csd.org/
February 20, 2024 09:15 AM Eastern Standard Time
Hemogenyx Pharmaceuticals achieves breakthrough with HEMO-CAR-T program, CBR platform
HemoGenyx Pharmaceuticals
Hemogenyx Pharmaceuticals PLC CEO Dr Vladislav Sandler and non-executive director Peter Redmond joined Proactive's Stephen Gunnion after the company pioneering breakthrough treatments for life-threatening diseases, including blood and solid cancers, achieved a number of significant milestones. Sandler highlighted the company's significant progress with its HEMO-CAR-T program after it received the green light from the US Food and Drug Administration (FDA) to enter Phase 1 clinical trials for acute myeloid leukaemia, marking its transition to a clinical-stage biopharmaceutical company. This development symbolises a pivotal milestone, offering potential life-changing treatments for patients with limited options. Additionally, Hemogenyx is advancing its proprietary Chimeric Bait Receptor (CBR) platform, announcing that it has demonstrated in vivo that the CBR can be delivered intranasally in the form of messenger RNA (mRNA) for the potential treatment of airborne viral infections. As 2024 unfolds, Hemogenyx anticipates starting clinical trials and advancing its CBR platform towards IND-enabling studies, signaling a landmark year with promising outcomes for investors and patients alike. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
February 20, 2024 08:09 AM Eastern Standard Time
Video
hVIVO chairman Cathal Friel says he remains committed to hVIVO following share sale
hVIVO PLC
hVIVO chairman Cathal Friel joined Proactive's Stephen Gunnion to discuss the sale of shares in hVIVO PLC by directors, including himself. Friel explained his decision to sell a portion of his shares in hVIVO was to accommodate the high demand from major institutions while emphasising his commitment to remain a long-term, supportive shareholder despite this sale. Friel, who co-founded hVIVO (formerly known as Open Orphan) in 2017, highlighted the company's significant growth and his active involvement in its operations and strategic direction. He mentioned his 25-year experience in mergers and acquisitions (M&A) and his confidence in the company's ability to surpass its medium-term revenue target of £100 million, partly through strategic M&A activities. Additionally, Friel talked about his new role as Executive Chairman at Poolbeg, a company associated with hVIVO, assuring that this would not diminish his involvement with hVIVO. He shared his enthusiasm for the future of both companies, underscoring his role in identifying market opportunities and assembling high-performing teams to capitalize on them. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
February 20, 2024 04:55 AM Eastern Standard Time
Video
Poolbeg Pharma chair discusses shift to executive role; hVIVO share sale
Poolbeg Pharma PLC
Poolbeg Pharma chairman Cathal Friel joined Proactive's Stephen Gunnion to discuss his new hands-on role at the company. Stepping up as the executive chairman at Poolbeg Pharma, Friel expressed his intention to replicate the success he achieved with hVIVO, another company he founded. With the addition of key former Amryt leadership team members to Poolbeg, Friel said he is optimistic about the company's aggressive growth prospects and is focused on share price appreciation. The chairman also explained the rational for the sale of shares in hVIVO PLC by directors, including himself. Friel, who has a rich background in mergers and acquisitions (M&A) and investment banking, said the decision was driven by strong institutional demand for hVIVO stock. Despite selling a small portion of his stake, he affirmed his long-term commitment to the company, highlighting its robust growth, profitability, and cash generation under current management. He also revealed plans to increase his stake in Poolbeg, indicating confidence in the company's potential and his commitment to driving shareholder value. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
February 20, 2024 04:40 AM Eastern Standard Time
Video
Roberts & Ryan Inc., America's first Service-Disabled Veteran-Owned (SDVO) broker-dealer, is pleased to welcome Andrew Reynolds as Senior Director of Equity Trading.
Roberts & Ryan, Inc.
Andrew Reynolds joins Roberts & Ryan as Senior Director of Equity Trading and has more than 30 years of experience in equity trading, capital markets, portfolio management, options & derivatives, sales & business development, investor relations, and corporate compliance. Prior to joining Roberts & Ryan, Mr. Reynolds was Head of Equity Trading and a Registered Principal at Tullett Prebon and KCCI Ltd. Before that, he was Head Trader and Floor Broker at Tradition North America and R.J. Murphy & Associates. Prior to that, he was Head Trader at Preferred Technology. Mr. Reynolds began his career as an Options Clerk at Pershing, LLC. “Andrew brings extensive experience in equity trading and represents Roberts & Ryan’s commitment to providing best in class service and execution,” said James McDevitt, Roberts & Ryan’s Senior Director of Equity Sales and Trading, Capital Markets. “He will be a tremendous advocate for our social mission of supporting veterans and their families. I’m very excited to have him join our team.” Mr. Reynolds is a member of the Securities Traders Association (STA), the Securities Traders Association of New York (STANY), Philadelphia Traders (ITAP), and the National Investor Relations Institute (NIRI). He holds SIE and FINRA Series 7, 24, 25, 55, 57 & 63 licenses. Mr. Reynolds served as a Technical Warfare Specialist, Team Leader, and Group Leader in the 25 th Infantry Division of the United States Army and is a graduate of Archbishop Ryan in Philadelphia. About Roberts and Ryan, Inc. Roberts & Ryan, Inc. is a Service-Disabled Veteran Owned (SDVO) broker-dealer with execution capabilities in the capital markets, equities, and fixed-income trading. The firm was founded in 1987 by a United States Marine Corps Vietnam combat veteran and Purple Heart recipient. With over $1.8 million in committed donations, Roberts & Ryan is active in donating to charitable foundations that make significant positive impacts in the lives of Veterans and their families, focusing primarily on general wellness, mental health, and career transition. To learn more about Roberts & Ryan, please visit www.roberts-ryan.com. Contact Details Michael C. Del Priore +1 646-859-4061 mdelpriore@roberts-ryan.com Company Website https://www.roberts-ryan.com
February 19, 2024 09:00 AM Eastern Standard Time
Image