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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

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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

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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

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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

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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

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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

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Gates Ventures, Mayo Clinic Back Tiny Robot Created By $400M Apple Face ID Inventors To Treat Brain Disease

OurCrowd

By Matthew Kalman PrimeSense, the previous company founded by Michael Shpigelmacher, Aviad Maizels and Alex Shpunt, was acquired in 2013 by Apple (NASDAQ: AAPL) for around $400 million. It was a world leader in 3D sensors that helped power the Microsoft (NASDAQ: MSFT) Kinect for Xbox 360 and provided the technology behind Apple’s Face ID. Bionaut Labs, the medical startup founded by the trio, is on a very different journey – into the deepest recesses of the human brain. But the company is already making waves. This month, Bill Gates’ Gates Ventures joined its early funders, extending investment to $70 million from a blue-chip roster including the Mayo Clinic, Khosla Ventures, Upfront Ventures and OurCrowd, Fortune magazine reported. The company’s Bionaut, a tiny micro-robot smaller than a grain of rice, is guided through a patient’s central nervous system into a targeted spot in the brain where it can perform minor surgery, deliver therapeutic drugs or return with tissue for a biopsy. Not since Raquel Welch was shrunk and inserted into a patient’s bloodstream in the 1966 movie “Fantastic Voyage” have doctors come so close to targeting life-saving medication so precisely to reach the inaccessible recesses of the human body. The company is testing its technology at a Mayo Clinic facility and is poised to begin clinical trials with five top-tier U.S. medical centers as it applies for FDA approval. Investors can still join the Bionaut Labs funding round via the OurCrowd investment platform. Shpigelmacher, CEO of Bionaut Labs, says he realized that treatments for disease occurring at a specific point in the body – especially the brain – were not being accurately targeted. He likens the effect of existing treatments to “carpet bombing a patient’s body with drugs,” creating “widespread undesired side effects or damage to surrounding tissue and organs.” “There we were, flooding the whole body. It was like having one dirty dish in the sink and bringing out a fire hose that floods the whole house just to wash that single dish,” he says. The Bionaut, guided by a physician using a powerful magnet, can release a payload of targeted therapy directly into a tumor or any other localized target – even deep inside the brain – and head for home. “Surgeries to get to the brain tend to be relatively aggressive and fairly in depth and carry a lot of risks associated with them and a lot of recovery time,” says Dr Bill Loudon, VP of Neuroscience at Bionaut Labs. The blood-brain barrier creates “very significant problems to try to get drugs to where we want it to go. On the surgical side it’s hard to get into the brain and on the drug side it’s hard to get into the tissues.” “The Bionaut has specific advantages that circumvent these problems. It truly represents a whole new level,” Dr Loudon says. The company has developed several micro-robot prototypes, each designed for a different purpose. There is a capsule-shaped Bionaut designed to move through fluid, a corkscrew-shaped Bionaut designed to burrow through tissue and a sharp-pointed Bionaut that can perform microsurgery by slicing through the kind of cyst in the brain that causes hydrocephalus, or Dandy-Walker Syndrome. A Bionaut can carry a therapeutic payload and deliver it directly to the targeted area, which avoids flooding the entire central nervous system. Instead of drilling through several centimeters of brain tissue, the Bionaut can be guided through internal fluids to within millimeters of its target. “We minimize tissue penetration, doing it only for the safest and shortest distance possible. It opens a completely new way of treating brain diseases,” Shpigelmacher says. Each tiny Bionaut contains a powerful magnet that allows it to be remotely controlled from outside the body. The patient has an MRI or CT scan, which the physician uses to plan the safest route to the affected area and then loads the route onto a computer. The patient is sedated and the Bionaut is injected into the central nervous system at the entry point worked out in advance. Then, the computer takes over, guiding the probe to its destination while causing the least possible damage to surrounding tissue as the physician monitors its progress via X-ray. $130 Billion Market “The market for brain and CNS therapeutics is massive – over $130 billion today and estimated to grow to over $200 billion. Most of it is drugs,” Shpigelmacher says. Pharma giants are targeting a wide range of neuro-degenerative conditions including Parkinson’s, Huntington’s, Alzheimer’s, epilepsy, glioblastoma and many more, but they all face the challenge of getting the drugs to the point where they are needed inside the brain. “The problem is, even if you have the best drug how are you going to get it to the target?” Shpigelmacher says. “This is where Bionaut steps in. Bionaut does not aim to replace these drugs or replace these payloads. It aims to provide a way for the drug manufacturer to get their payload to the target. So even if we just focus on neuro-degeneration, brain cancer and epilepsy – that alone is over a $70 billion market today.” “We’re already in discussions with the FDA to take this to the clinic next year. The idea is that by the end of 2024 we will have early human data for the device, and in 2025 we will license it out for broader neurological indications,” Shpigelmacher says. The company hopes to emulate the success of other companies specializing in robotic surgery and the treatment of neurodegenerative diseases. Intuitive Surgical (NASDAQ: ISRG), a leader in surgical robotics, is worth more than $100 billion. Halozyme (NASDAQ: HALO), which partners with major pharma companies to reformulate drugs for precision use, earns millions of dollars each year and is valued at almost $5 billion. “When we started this research, many of the physicians we spoke to, specialists in cardiology, gastroenterology, ophthalmology and more, simply asked, ‘When can we sign up?’” Shpigelmacher says. For more information about joining Bionaut Labs’ extension round via the OurCrowd platform, click HERE. Featured photo courtesy of Bionaut Labs. OurCrowd was started in 2013, driven by the idea that the business of building startups grows bigger and better when the global ‘crowd’ gains access to VC-level investment opportunities.Today, OurCrowd is a global venture and alternative investing platform that empowers institutions and individuals to invest and engage in emerging companies. OurCrowd vets and selects companies, invests its capital, and provides its global network with unparalleled access to co-invest and contribute connections, talent and deal flow. OurCrowd builds value for its portfolio companies throughout their lifecycles, providing mentorship, recruiting industry advisors, navigating follow-on rounds and creating growth opportunities through its network of multinational partnerships. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Lisa Graston lisa.graston@ourcrowd.com Company Website http://www.ourcrowd.com

February 16, 2024 08:35 AM Eastern Standard Time

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Kadimastem advances towards Nasdaq: Company Signs a Memorandum of Understanding to Merge with a Company traded on the Nasdaq

Kadimastem

Kadimastem Ltd. (TASE: KDST), a leading cell therapy company in the clinical development stages of breakthrough products for the treatment of ALS and diabetes, announces that the company has signed a non-binding agreement in principle (“MOU”) for a merger with a public company traded on the NASDAQ. pursuant to the MOU Kadimastem shareholders are expected to hold 88% of the shares of the combined company post -merger upon which Kadimastem will no longer be trading on the Tel Aviv Stock Exchange. The MOU is in line with the company's strategic plan, to approach the target markets of its field of activity and the US capital markets. As part of the terms of the MOU, Kadimastem undertook to have approximately $5 million in funds, including capital raised simultaneously with the completion of the transaction and the commencement of trading from existing shareholders and additional investors. Ronen Twito, Executive Chairman of the Board said, "Listing Kadimastem on the NASDAQ is an important and necessary goal for Kadimastem’s development and its progress to the company's target markets in the U.S., as we have stated in the past. The MOU is an important step in that direction. It follows the Company's report of receipt of FDA approval for a Phase IIa multi-site clinical trial in the US for the treatment of ALS, and the joint development agreement signed with iTolerance Inc., a Florida based company with a product in the field of diabetes which we recently reported to have a successful joint INTERCT meeting with the FDA.” We believe that the exposure to the U.S. capital markets will assist Kadimastem in the development of the company's clinical assets and preparations for the planned multi-site clinical trial for the US, and as a result will create value for the company's shareholders." About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). Social Media: LinkedIn, Twitter, Facebook Kadimastem (TASE:KDST) is a clinical stage biotechnology company, with a unique platform for cell therapy that enables the production of off-the-shelf cell-based products for the treatment of unmet medical needs. Kadimastem was founded in 2009 based on patent protected technology that was developed at Prof. Michel Revel’s laboratory at the Weizmann Institute of Science. Forward Looking Statement This document may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. Contact Details Kadimastem Ltd. Asaf Shiloni +972 73-797-1613 s.bazak@kadimastem.com Company Website https://www.kadimastem.com/

February 16, 2024 07:00 AM Eastern Standard Time

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RapidClaims uses AI to help US healthcare providers address $250b in denied claims

RapidClaims

Healthcare organizations are turning to automation with “revenue cycle management” to protect operating margins and the increasing claim denials from the payors. Every year, close to $265B in claims made by US healthcare organizations are denied because of the way claims are coded on payor documentation and delayed submissions are two chief reasons for the denials. Coding errors account for over 40% of claim denials, while untimely submissions contribute to 35% of denials; eligibility and prior authorization being some of the other aspects playing a significant role. Addressing this pain point, RapidClaims has today emerged from stealth with a $3.1 million funding round to tackle the claims denial problem head-on with its medical coding automation module. The seed round was led by Together Fund, a $250 million global SaaS fund, with participation from Better Capital, Neon Fund, Peercheque, DeVC with angels and advisors coming from prominent US healthcare organizations including Oscar Benavidez (Executive Director, Mass General), Ankit Jain (Founder & CEO of Infinitus), and Sachin Jain (President & CEO of Scan Health) among others. RapidClaims is led by Dushyant Mishra (CEO), Jot Sarup Sahni (CPTO), and Abhinay Vyas (CDO), each bringing a nuanced understanding of healthcare, data science, and scaling tech products. The idea for RapidClaims originated in 2018 during Dushyant Mishra’s tenure at Abbott Healthcare when he observed the challenges faced by hospitals while interacting with multiple hospital owners and physicians. Since then, he has closely monitored the space, which gained significant momentum in 2022 as two key trends emerged: an increase in claim denial rates across the US and the effective demonstration of large language models (LLMs) as a solution to these challenges. RapidClaims recognizes the diverse challenges inherent in revenue cycle management. With a strategic focus on tackling medical coding initially, the company aims to simplify the rising complexity of coding processes and leverage the potential for AI to drive efficiencies over time. In recent years, coding complexity has surged significantly with diagnosis codes like ICD codes rising from 19,000 (ICD 9) to nearly 120,000 (ICD 11). Adherence to guidelines is becoming increasingly challenging due to rapid changes encompassing NCCI edits, NCD/LCD guidelines, Medicare policies, payor rule sets, among others. RapidClaims has achieved success with six pilots within two months of its beta product launch in June 2023 and is poised to enhance product robustness even further with an additional five pilots already in the pipeline. Dushyant Mishra, Founder & CEO of RapidClaims commented: "We are just beginning to witness tangible benefits in terms of cost savings, speed, and revenue enhancement through AI utilization. While automation is pivotal, we recognize the indispensable role of coders with their nuanced understanding of intricate rules and edge cases. This is the driving force behind our significant investment in the RapidAssist product, which has the transformative potential to elevate medical coding operations for coder-managing teams." AI holds immense potential for introducing exceptional efficiencies into this domain. Beyond identifying the right code, AI's current state allows for precise context interpretation, adding a layer of sophistication to the coding process. RapidClaims has unveiled three multi-specialty products aimed at alleviating coding administrative overload: RapidCode: Fully autonomous medical coding, streamlining the process with end-to-end automation. RapidAssist: A tailored tool for medical coders designed to improve productivity by auditing charts and identifying documentation gaps, which includes a query builder and rule-set engine. RapidRisk: Advanced AI for risk-adjusted coding that calculates HCC and RAF scores while pinpointing opportunities for documentation improvement based on a comprehensive rule set developed in collaboration with prominent CDI leaders. More healthcare organizations are recognizing the need for revenue cycle automation to overcome workforce challenges, handle increasing claim volumes, mitigate revenue losses, and navigate the complexities of healthcare administration. This urgency is further fueled by the rise in claim denials from payors, which puts significant pressure on healthcare providers and exacerbates the already high administrative costs. A recent study conducted by Bain & Company and KLAS reveals that 80% of U.S. healthcare providers are increasing their investment in IT and software, with a specific focus on prioritizing AI technologies. Revenue cycle transformation and automation are the top areas of focus for healthcare executives. Manav Garg, Co-founder of Together Fund added: "We are thrilled about the transformative potential of AI in optimizing administrative processes within the revenue cycle. We are confident that the RapidClaims team embodies the perfect blend of expertise, showcasing an in-depth understanding of the complexities within the U.S. healthcare system coupled with exceptional proficiency in artificial intelligence." About RapidClaims RapidClaims is automating medical coding to help health organizations reduce claim denials from payors. About Together Fund Together Fund is an enterprise software-focused, operator-led fund started by Girish Mathrubootham (Founder, Freshworks ), Manav Garg (Founder, Eka ) and Shubham Gupta (ex Matrix Partners). Together invests in Seed and Series A opportunities across AI, Devtools, Cloud Infra, Security, Horizontal & Vertical SaaS applications. With a “for-founders, by-founders” DNA, Together is joined by 150+ global founders & operators in this endeavor to help build global products. Contact Details RapidClaims Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://www.rapidclaims.ai/

February 16, 2024 06:00 AM Eastern Standard Time

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