Pearl Raises Largest-Ever Investment in Dental AI with $58 Million Round

July 24, 2024

Pearl, the global leader in dental AI, today announced that it has raised $58 million in Series B funding to accelerate its mission to elevate patient care in dentistry. Left Lane Capital led the round, with participation from Smash Capital, Alpha Partners, and existing investors, Craft Ventures and Neotribe Ventures. This funding marks the largest investment ever in dental artificial intelligence.

With this investment, Pearl will continue to advance innovation in technologies that enhance the health of dental patients around the world by expanding its line of dental AI products, broadening its regulatory and patent portfolio, and increasing global access to the transformative benefits of AI in dentistry. At present, Pearl’s machine learning and computer vision tools solve a core challenge in dentistry: inconsistency in diagnostic accuracy, which directly impacts the quality of patient care. The company’s AI serves as a real-time aid to help dentists read patient x-rays, deliver consistent, objective, and accurate diagnoses, and clearly communicate findings to patients with precision, clarity, and confidence.

Since receiving the first-ever FDA clearance for AI software to help dental professionals detect multiple different pathologies and other conditions in x-rays, Pearl’s clinical AI has gained regulatory authorizations for chairside use in over 120 countries and recognition among TIME’s Best Inventions. The company plans to use the funding announced today both to accelerate ongoing development of computer vision capabilities – including detection and tracking of disease in 3D and other imaging modalities – and introduce new AI tools to improve patient treatment planning, insurance claim approvals and dental education.

“In the field of healthcare, dentistry has become an AI standard-bearer, demonstrating the technology’s enormous utility and benefit in day-to-day patient care––and Pearl has led the AI charge in dentistry,” said Ophir Tanz, founder and CEO of Pearl. “This historic funding round underscores the impact of Pearl’s capabilities and supports our belief that high-quality, AI-powered dental care should be accessible to everyone. With this investment, Pearl will continue to push the envelope, providing pioneering machine learning to improve oral health outcomes and strengthen trust between the patient and dental professionals.”

This investment follows a period of significant growth for Pearl. The company grew its revenue by 458% in 2023 and remains the only dental AI company with a global market presence. Pearl’s technology is used in dental practices across six continents and is commercially available to over 500,000 dental practices and millions of dental professionals worldwide. The company has also integrated its AI into dozens of popular imaging and practice management systems and is the preferred radiologic AI provider for leading dental technology distributors.

“We have spent the past year evaluating this market and it is clear that Pearl stands above peers at the forefront of dental innovation,” said Vinny Pujji, Managing Partner at Left Lane Capital. “Pearl’s pioneering dental Al improves diagnostic accuracy and efficiency while transforming the provider-patient relationship. We’re confident in Pearl’s ability to continue setting new standards of care and are thrilled to support their next phase of growth.”

Pearl’s AI technology offers a seamless and less invasive approach to dental diagnostics. By accurately detecting disease and displaying clinical findings that are easy for patients to understand, the company’s FDA-cleared software enhances the efficiency, consistency, and precision of radiologic exams, while also facilitating patient education and engagement in their dental health. Leveraging its new funding, Pearl will enable dental professionals to continually raise the standard of care with more transparent, accurate and objective diagnoses, more effective individualized care, and deeper patient trust in dentistry.

Shoulder Innovations Further Strengthens IP Portfolio in Key Areas with Recent Patent Grants

July 24, 2024

Shoulder Innovations, a leader in shoulder replacement technology, today announced the United States Patent and Trademark Office (USPTO) has granted nine new patents over the past 18 months that significantly expand the Company’s intellectual property portfolio.

The newly granted patents cover key areas within shoulder replacement and less invasive surgical techniques, including, among others, glenoid preparation in a single step, total reverse shoulder systems and methods, and porous coated convertible glenoid.

“These recent grants further strengthen key patent families that are foundational to our technology, and we are pleased the USPTO continues to recognize our meaningful innovation in the shoulder arthroplasty segment,” said Rob Ball, CEO of Shoulder Innovations. “This noteworthy expansion of our IP position represents the culmination of over 10 years of research and development, and we are proud of our team for their continued dedication to creating practical solutions for shoulder surgeons and advancing patient outcomes.”

Over the past 20 years, Shoulder Innovations has developed a robust intellectual property portfolio around the Inset Glenoid technology and brand that is marked by a continued long life prior to expiration. Specific patents among the newly granted awards adding to the Company’s existing strong IP foundation include:

Glenoid Preparation in a Single Step

This patent covers a groundbreaking method of implanting a glenoid implant, which involves reaming two cavities in the glenoid in a single step.

Total Reverse Shoulder Systems and Methods

This patent features a reverse shoulder system with a scapular glenoid baseplate and humeral stem, where the baseplate’s axis is angled relative to the stem’s axis.

Porous Coated Convertible Glenoid

This patent covers shoulder replacement components and methods utilizing porous fixation rings, enabling the switch from anatomic to reverse articulating surfaces without changing the fixation components.

“Shoulder Innovations‘ commitment to advancing shoulder replacement technology is further evidenced by these patents,” said Dr. David Fehnel. “As a shoulder surgeon, I’m thrilled to see these technological developments rapidly making their way into the marketplace, with the goal of helping us provide even more innovative surgical care for our patients.”

Samsung Ventures Among Top Investors Backing AI Imaging Acquisition Market Leader Subtle Medical – Bringing Total Series B to Over $30 Million

July 24, 2024

Subtle Medical Inc., the global market leader in AI-powered medical image acquisition, has raised close to $10 million in a Series B+ round. Investors include existing shareholders like Fusion Fund and top US and global investors, such as EnvisionX Capital, BRV Capital, Ignite Innovation, and Samsung Ventures. This latest funding round brings Subtle Medical’s Series B to over $30 million and total financing to over $50 million. The funds will primarily support accelerating US and global sales initiatives and expediting the launch of new AI-driven products.

Subtle Medical is currently leading its category with multiple times the revenue of its closest competitors and significantly higher adoption as the first mover in the market. Serving more than 600 sites globally and 2.5 million patients annually worldwide, the company has sustained a remarkable 2x year-over-year growth rate, a trend expected to continue throughout 2024.

Founded in 2017 by Dr. Enhao Gong, a serial entrepreneur with a PhD in Electrical Engineering from Stanford University, and Dr. Greg Zaharchuk, a radiologist and professor at Stanford University, Subtle Medical is headquartered in Silicon Valley with a globally distributed team. The company leverages AI and advanced generative models to accelerate the data acquisition stage of medical imaging exams, including MRI, PET, CT, SPECT, and angiography – several in the product pipeline. Their AI products aim to enhance image quality and efficiency while potentially reducing radiation and contrast agent dosages, thereby improving examination safety and accuracy.

The company holds exclusive licensing rights to technology developed by the founders at Stanford University in 2016, boasts over 30 global patents, and has more than 20 peer-reviewed publications validating their products worldwide. Subtle Medical has achieved seven FDA clearances to date, with major products also CE Mark (MDR) approved, along with other regional clearances globally. The company has earned multiple industry accolades, including the NVIDIA Inception AI award, multiple CB Insights Top AI 100 Company, and Top GenAI 50 Company.

Currently, Subtle Medical operates with multiple business models to commercialize its AI technologies globally. They primarily offer AI solutions as SaaS or software systems to hospitals and imaging centers in the United States, Europe, and Latin America. Recently, they have seen significant growth in the APAC region, including China and Southeast Asia, with plans to enter the Korean and Japanese markets in 2024. Additionally, Subtle Medical has been contracted by leading medical imaging equipment manufacturers, such as Siemens Healthineers, and pharmaceutical companies, such as Bayer and Bracco, leveraging Subtle’s AI solutions and platform to enhance workflow, quality, efficiency, and radiopharmaceutical applications in MRI and PET Imaging.

Subtle Medical leads its category with market-leading products and an expanding product line, including flagship products SubtleMR™ and SubtlePET™, which were the first of their kind to receive FDA approval in 2018 and 2019, respectively. With seven FDA clearances secured so far, Subtle Medical is one of the leading vendors in AI devices. This year, the company has announced new FDA clearances for SubtleREFORMAT™, a new AI product for MRI data harmonization and quality standardization, and SubtleSYNTH™, a new category-defining software solution that further improves quality and efficiency with AI-powered synthetic image generation, leveraging more data and resulting in greater acceleration.

“With tens of millions of dollars worth of contracts secured from top radiology providers worldwide, Subtle Medical is poised to capture a significant market share of the $35 billion AI-powered radiology market,” said Sean Seoho Lee, Executive Director at Ignite Innovation. “Focusing on the image acquisition stage of radiology, rather than the crowded downstream diagnostics market, the company has established itself as a clear category leader. Subtle Medical stands out from its competitors by encompassing multiple imaging modalities beyond just MRI, tapping into a larger market, and enabling partnerships with pharmaceutical companies. Led by a world-class team of AI experts, clinical leaders, and experienced healthcare executives, the company is set to propel substantial growth and continue its impressive trajectory.”

“In addition to the advantage of expanding AI product lines, Subtle Medical further differentiates itself from others with solid partnerships built with top scanner manufacturers and top radiology pharmaceutical companies, ensuring its leading position in this vertical,” said Lu Zhang, Founder and Managing Partner of Fusion Fund.

“Subtle Medical boasts a proven suite of AI-powered SaaS products with a strong product-market fit,” added a representative from Samsung Ventures. “The company’s value proposition centers on improving efficiency, reducing costs, and enhancing patient care for hospitals. Subtle Medical’s AI-powered solutions deliver a clear return on investment for hospitals and imaging centers by doubling scanner throughputs. Subtle also continuously leads with new innovation, winning multiple awards to advance research and technology that potentially reduces radiation dosage and contrast dosage for patients by 90%. This impressive ROI has resulted in a growing base of satisfied customers and an expanding partnership network, driving strong market traction and solidifying the company’s leadership in the industry.”

“Improving the quality and efficiency of data generation can significantly optimize imaging workflows, helping serve more patients better and enabling better AI training for diagnosis and treatment,” said Dr. Enhao Gong, CEO at Subtle Medical. “The new funding and product line expansion distinguish us from any competitors, allowing us to continue leading and building a new era of AI-powered imaging acquisition and workflow solutions.”

Tampa General Hospital Researchers Develop Innovative Device That Expands Access to Heart Transplants

July 24, 2024

Tampa General Hospital (TGH) announced today the development of a new device that optimizes donor organs, making more donor hearts eligible for transplantation. Dr. Lucian Lozonschi, professor and director of the Division of Cardiothoracic Surgery and Transplantation at the USF Health Morsani College of Medicine, and Dr. Ruisheng Liu, professor in the Department of Molecular Pharmacology and Physiology in the USF Health Morsani College of Medicine, received $500,000 for two years from the Interdisciplinary Research Award at the University of South Florida. The project was one of just six awarded grants this year and the largest sum from the program that promotes innovative research.

“Our goal is to expand access to world-class care and save more lives,” said John Couris, president and CEO of Tampa General Hospital. “With innovative approaches to transplantation, we can extend the life of critical organs and improve patient outcomes. This grant will advance our research efforts, directly impacting the patients we serve.”

The Synchronization Modulation Electric Field (SMEF) device, developed by Dr. Wei Chen, Liu and Lozonschi can not only maintain the Na/K pump functions but also generate adenosine triphosphate (ATP) molecules. The pump molecules can effectively work in situations with a limited or lack of ATP supply, such as in hypoxia.

“The SMEF device has the potential to achieve optimal preservation and transport conditions by electrically inhibiting the ischemic damage in donor hearts and maintaining cellular functions, ultimately enhancing the success rates of heart transplantation,” said Lozonschi.

“Results obtained from earlier studies are expected to have high translational significance and could be readily applied to patients. However, due to the high technical demand for heart transplantation in our models, it will be impossible to perform this kind of surgery without strong support from a world-class cardiac surgeon such as Dr. Lozonschi,” said Liu. “We have a great opportunity to test this novel technique in a pre-clinical model. This is a typical example of synergistic collaboration between basic researchers and clinicians.”

There is a national shortage of donor organs to meet the needs of patients experiencing heart failure. Donor organs must be transplanted within just five hours, and they degrade in transit due to a lack of blood supply.

The SMEF device protects donor hearts in a way that lengthens the time available for transit from five hours to more than eight. This novel approach would directly address the shortage of available hearts for donation by extending the time donor hearts are available. The device also improves the organ’s function by protecting its cellular activity during transport.

“Drs. Lozonschi and Liu make an incredible team for this translational research project that is taking foundational bench science through the rigors of pre-clinical trials. This translational research represents an excellent example of the bench-to-bedside progress that can only be accomplished at academic health systems, such as ours,” said Dr. Charles J. Lockwood, executive vice president of USF Health and dean of the Morsani College of Medicine.

Lockwood is also the executive vice president and chief academic officer of Tampa General Hospital.

Lozonschi and Liu were one of more than three dozen teams applying for the Interdisciplinary Research Award at the University of South Florida, with just $1.5 million in funding available to support the work. The team was one of just six to earn awards, and the highest award granted from the program.

Doug Cassidy Appointed President of the Deep 6 AI Precision Research Ecosystem, the Largest Network of Sites and Sponsors Using AI To Accelerate Research

July 24, 2024

Deep 6 AI, the leader in AI-powered patient recruitment and real-world data (RWD), announced the appointment of Doug Cassidy as president of its Precision Research Ecosystem. The Deep 6 AI Ecosystem is the largest network of health systems and life sciences companies, enabling over 45 member organizations to de-risk and accelerate clinical trials, and next-generation RWE projects, while significantly reducing the workload for staff.

“Doug Cassidy, formerly our SVP and GM of healthcare organizations, has led the growth of our Ecosystem—from the first site, Cedars-Sinai in 2017, to the launch of our life sciences vertical in 2021, to now,” said Wout Brusselaers, founder and CEO of Deep 6 AI. “With over 25 years of diversified experience exclusively in the healthcare IT and clinical research technology sectors, Cassidy is poised to take on an expanded role as president of the Deep 6 AI Precision Research Ecosystem to drive its continued growth and improve collaboration between sites and sponsors.”

Cassidy’s distinguished career is marked by his leadership roles at industry giants such as GE Healthcare, Orion Health (New Zealand), Hyland Software, and Dedalus (Italy). As a biomedical engineer and computer scientist, Cassidy’s technical and subject matter expertise spans specialties including computer-aided detection (CAD), healthcare data interoperability, enterprise content management, disease management, and population health.

“Stepping into my new role is an exciting opportunity to increase collaboration between the sites, sponsors, and technology and services partners in our Ecosystem,” said Doug Cassidy, president, Deep 6 AI Precision Research Ecosystem. “Research is delayed when key stakeholders don’t have access to the crucial information they need. The Deep 6 AI precision research ecosystem connects all stakeholders by providing a platform for researchers to work together to match the right patients to the right studies at the right time.”

What distinguishes the Deep 6 AI Precision Research Ecosystem is that it gives all sites and sponsors transparency into the real-time availability of patients eligible for research. The software uses AI and NLP to query electronic medical record (EMR) data across entire health networks, including coded data, clinician notes, sequenced data, labs, pathology reports, and other clinical data to find patients. Healthcare organizations that become part of the Ecosystem use the company’s AI-powered software platform enterprise-wide for investigator-initiated, government-funded, and sponsored trials. Often, the technology is managed centrally (i.e., by the Clinical Trials Office) which makes it strongly integrated with healthcare workflows to create actionability and reduce site staff burden.

As part of the Deep 6 AI Precision Research Ecosystem, healthcare organizations can assess study feasibility faster, cut down on staff time screening patients, find more patients for trials, engage more physicians in research, and improve collaboration with sponsors. Pharmaceutical companies that participate can collaborate with an established network of sites that already have the platform embedded in their workflow. They help reduce site burden by delivering screen-ready, AI-matched patient ‘lists’ to IRB-approved staff who can easily identify and validate patients with evidence in the chart.

Trial Approval for New Pacemaker Aiming to Boost Recovery in Heart Failure

July 23, 2024

Cysoni-XT is a temporary cardiac pacemaker which aims to boost cardiac performance by resynchronisation of the heart and lungs, a natural phenomenon known as Respiratory Sinus Arrythmia (RSA).

The system has shown a remarkable ability to boost performance and induce cardiac repair mechanisms in subjects with heart failure.

RSA-pace will be the first time RSA therapy has been evaluated in patients.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ceryx Medical’s clinical trial authorisation application for the pilot RSA-pace study of the Cysoni-XT system for post-cardiac surgery patients.

The trial will enrol patients with heart failure with reduced ejection fraction who have undergone a coronary artery by-pass procedure.
The study will evaluate up to 10 days of therapeutic pacing in 32 participants in the UK.
The trial’s primary objectives are to assess safety and feasibility, with the aim of evaluating initial efficacy.

The RSA-pace trial is due to begin in the UK later this year, recruiting patients from University Hospital Wales, Cardiff; Morriston Hospital, Swansea and the Bristol Heart Institute.

Ceryx Medical’s Chief Executive Officer Dr Stuart Plant:

“We believe Ceryx’s technology has the potential to transform the lives of patients with heart failure. This approval is a significant step on our journey towards a new therapy to support patients in their recovery and boost cardiac performance.”

Professor Zaheer Yousef, Consultant cardiologist at University hospital Wales and PI for the study:

“Patients with heart failure are at an increased risk of prolonged cardiac dysfunction following cardiac surgery. I am excited by the potential benefits of RSA pacing in post-surgical patients”.

About Ceryx Medical

Ceryx Medical is an innovative medical technology company developing a revolutionary therapy for the treatment of heart failure that treats both the symptoms and the underlying disease process. Their approach offers hope to the 30 million people across the world who are currently living with this incurable condition. For more information, please visit our website: https://www.ceryxmedical.com

Novo Holdings Leads $105 Mil Financing of Magenta Medical | To Support FDA Approval for World’s Smallest Heart Pump

July 23, 2024

Novo Holdings, a leading life science investor, today announces that it has led a $105 million financing in Magenta Medical (Magenta), developer of the Elevate™ System, the world’s smallest heart pump. The financing will be used to advance the company’s US clinical programs in multiple mechanical circulatory support (MCS) indications and to secure the first FDA approval for the Elevate™ System in patients undergoing high-risk percutaneous coronary interventions (HR-PCI).

MCS is one of the fastest growing markets in interventional cardiology. It encompasses devices designed to mechanically unload the failing heart and augment cardiac output in the setting of dangerously low blood pressure, providing a bridge to recovery over a period of hours to days.

The widely recognized unmet clinical needs in MCS revolve around the ability to provide full cardiac support with a single device and a truly percutaneous and minimally-invasive placement procedure. Magenta’s Elevate™ System is designed to meet those needs, while overcoming the significant limitations of existing temporary MCS devices. Because of these potential advantages, the Elevate™ System was granted Breakthrough Device Designation by the US FDA for two clinical indications: high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock (CS).

Eric Snyder, Partner, Venture Investments, Novo Holdings US said:

“Magenta’s technology stands at the forefront of innovation in the MCS field and has the potential to significantly improve outcomes in patients with severe cardiovascular conditions. We look forward to supporting Magenta’s team and bringing better care to even more patients in need of mechanical circulatory support.”

In connection with the financing, Eric Snyder will join the Magenta Medical Board of Directors.

Dr. David Israeli, Chief Executive Officer of Magenta Medical, added:

“Magenta is thrilled to add Novo Holdings and these exceptional MedTech investors to its mission of disrupting the MCS space. Together with our existing partners, we are fortunate to have brought together a world-class group of investors that has both the resources and expertise to shepherd Magenta through regulatory approvals and commercial growth. Magenta’s technology will potentially enable physicians to rely on a single device to treat the full spectrum of MCS indications and is expected to eliminate the need to escalate therapy to a different device and subject patients to unnecessary and invasive replacement procedures.”

Magenta completed a US Early Feasibility Study with the HR-PCI indication in 2023. The results were presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco by Dr. Perwaiz Meraj of North Shore University Hospital. Building on this study, Magenta is now preparing to launch a pivotal study in the U.S.

The financing was led by Novo Holdings, with additional new investment from Viking Global Investors and RA Capital Management, alongside participation from existing investors, OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE – Israel HealthTech Fund.

Asensus Surgical Receives FDA 510(k) Clearance for Senhance Surgical System in Urology

July 23, 2024

Asensus Surgical, Inc. (NYSE American: ASXC), a global leader of innovative digital solutions for the operating room, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for an expanded indication to treat adult and pediatric Urology patients with the Senhance® Surgical System.

“This FDA clearance marks another milestone for Asensus Surgical and represents an additional indication expansion in the U.S. market,” said Anthony Fernando, Asensus Surgical President and CEO. “The Senhance System’s precision and advanced digital capabilities make it uniquely suited for urological procedures, offering surgeons the benefit of digital tools and smaller instrumentation. We are excited to bring this technology to urologists and their patients across the United States.”

Healthcare providers perform upwards of 185,000 urological surgical procedures each year in the United States.* While the Senhance System has been successfully utilized for Urology procedures outside the U.S. for several years, this expanded indication will open the door to this important specialty to leverage the advantages of the Senhance System in the U.S. patient population.

Chester Koh MD, MBA, FACS, FAAP, a pediatric urologist and director of the Pediatric Robotic Surgery Program and Professor at Baylor College of Medicine in Houston, Texas noted that, “With a full suite of 3mm and 5mm instruments and digital integrations, the Senhance Surgical System combines the benefits of robotics and minimally invasive surgery. This is an exciting step in the evolution of Urological surgery for both adult and pediatric patients.”

The Senhance Surgical System is designed to increase surgeon control and reduce variability through Augmented Intelligence and deep learning capabilities.

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

July 23, 2024

Radical™ Catheter Technologies, a medical device company pioneering the next generation of endovascular access and delivery products, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Radical Catheter, the first significant advance in catheter technology in more than three decades.

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery (SNIS) 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors (NTI), which will be used to scale the company and expand the Radical platform.

“While catheters are the foundation of every neurovascular procedure I perform, current gaps in catheter technology fundamentally limit complex life-saving procedures. The operators in this pilot experience consistently commented on a number of advantages to the Radical Catheter, including greater flexibility to access targeted areas, more stability and increased durability,” said Christopher Kellner, MD, cerebrovascular neurosurgeon, Mount Sinai Health System, while presenting the initial clinical analysis. “In our initial case series, the Radical catheter consistently reached further territories of the brain than we are accustomed to with conventional catheters. With this dramatically better performance, I expect to be able to more easily address complex procedures.”

The analysis evaluated a wide array of neuroendovascular procedures including treatments for aneurysms and stroke that were performed by 14 operators across six hospitals in four institutions, consisting of Cleveland Clinic, Mount Sinai Health System, Prisma Health and University at Buffalo. Findings indicate that Radical Catheter demonstrated best-in-class performance, including:

Catheterization of the target vessel 100% of the time
Ability to reach an intracranial position in all anterior circulation treatment procedures
No device failures or device-related adverse events
Elimination of the need for and use of intermediate catheters in the majority of procedures in which one would have typically been used, due to ease of distal access with the Radical Catheter

In total, this retrospective analysis of 85 neuroendovascular procedures included 72 trans-arterial and 13 trans-venous cases. Of these procedures 62 were elective and 23 emergency cases, with various treatments, including stenting, flow diversion, embolization, and revascularization. This initial experience represents the full range of complex neurovascular cases, including several procedures where other catheters first failed to reach the targeted vessel.

The design features of Radical Catheter’s patented ribbon technology aim to deliver best-in-class flexibility, stability and durability, and also have additional benefits of reducing procedural time and associated risks and costs.

The co-founders of Radical Catheter Technologies, Brian Martin and Martin Dieck are serial entrepreneurs who together have been developing technologies for neurosurgeons for 30 years. During that time they participated in and witnessed the dramatic and rapid advancements of minimally invasive therapies, while the catheters required to deliver these devices only made minor improvements. They set out to develop a novel “radical” design to disrupt the status quo and reset the bar on performance.

The company plans to use the $20 million raised through NeuroTechnology Investors and other investors who have backed the core group over many ventures to expand the Company’s platform and leverage the strong post-clearance clinical data. In parallel, the Company is scaling operations to build a world-class manufacturing organization to support the advanced design of its Radical technology platform and commercial expansion.

Radical Catheter Technologies will be exhibiting their new technology at the SNIS 21st annual meeting, together with other innovative NTI portfolio companies, including Synchron, Serenity Medical and Borvo Medical.

Flagship Pioneering Unveils Abiologics to Pioneer Supranatural Biologics, A New Biotherapeutic Class

July 23, 2024

Flagship Pioneering, the bioplatform innovation company, today unveiled Abiologics, a company reimagining biologics with the creation of a new class of supranatural and programmable medicines, called Synteins^™. Synteins are computationally-generated and synthesized with novel building blocks, endowing them with extraordinary properties to bring life-changing treatments to patients across a wide range of diseases. Flagship has initially committed $50 million to advance the company’s platform and develop a diverse pipeline of medicines, with an initial focus on oncology and immunology indications.

“Biologics have transformed medicine in the past forty years, but only a fraction of their potential has been realized because we’ve been limited by the boundaries of nature,” said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and Chairman of the Strategic Oversight Board of Abiologics. “With the convergence of advancements in generative artificial intelligence, automated polymer synthesis and chemical functionalization coupled with a vision to develop more powerful medicines with unprecedented diversity, we asked, what if we could design biologics entirely from new building blocks that could overcome the most critical limitations of today’s medicines?”

The Abiologics platform is a fully integrated digital and automated wet-lab infrastructure to create supranatural biologics with powerful, desirable pharmacological properties. The platform leverages state-of-the-art generative artificial intelligence (AI) to computationally-design Synteins de novo using a broad set of artificial building blocks, far beyond the 20 naturally occurring amino acids that form the basis of today’s biologic medicines. These include biologics built with D-amino acids, chemically identical mirror images of standard amino acids. Once designed, Abiologics chemically synthesizes its digitally-optimized Synteins with pioneering new technologies. As a result, Synteins can be programmed to interact with virtually any therapeutic target while evading the body’s natural defenses. By surpassing the limitations of traditional biologics discovery tools, Abiologics is the first to discover, prototype and scale-up polymers composed solely of artificial building blocks, and to date has successfully generated Synteins made entirely of D-amino acids that bind a diversity of therapeutically relevant targets while remaining ultrastable.

“For the first time, we are able to imagine and generate chemically synthesized biologics at scale and with increasing programmability, offering a new class of medicines with transformative potential,” said Avak Kahvejian, Ph.D., Co-Founder and CEO of Abiologics and General Partner at Flagship Pioneering. “Creating protein biologics with artificial building blocks rather than naturally occurring amino acids allows Synteins to go unrecognized by the immune system, offering significant advantages compared to today’s biologics such as less frequent dosing, oral delivery and the ability to reach parts of the body that were previously impossible to access and treat. With Synteins, Abiologics is poised to bring boundary-breaking medicines to patients across a range of diseases.”

In addition to Afeyan and Kahvejian, Abiologics’ founding team includes Mike Hamill, Ph.D., Chief Innovation Officer of Abiologics and Senior Principal at Flagship Pioneering, Kala Subramanian, Ph.D., Founding President of Abiologics and Operating Partner at Flagship Pioneering, Jaclyn Dunphy, Ph.D., Senior Director of Strategy and Research Operations at Abiologics, and Alicia Kaestli, Ph.D., Senior Associate at Flagship Pioneering. Bradley Pentelute, Ph.D., Professor of Chemistry at MIT, is an Academic Co-Founder of Abiologics.

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Shoulder Innovations, a leader in shoulder replacement technology, today announced the United States Patent and Trademark Office (USPTO) has granted nine new patents over the past 18 months that significantly expand the Company’s intellectual property portfolio.

Cysoni-XT is a temporary cardiac pacemaker which aims to boost cardiac performance by resynchronisation of the heart and lungs, a natural phenomenon known as Respiratory Sinus Arrythmia (RSA).

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