Global Smart Pills Market to Surge at a CAGR of ~11% by 2030

May 29, 2024

Key Takeaways from the Smart Pills Market Report

As per DelveInsight estimates, North America is anticipated to dominate the global smart pills market during the forecast period.
Within the application segment of the smart pills market, the small bowel video capsule endoscopy category captured a substantial revenue share in 2023, driven by its inherent advantages and diverse applications.
Notable smart pills companies such as Medtronic, Capso Vision Inc., Olympus America, Hoya (Pentax Medical), etectRx, Check-Cap, INTROMEDIC, HQ, Inc., Koninklijke Philips N.V., Novartis AG, BodyCAP, Medisafe, Otsuka America Pharmaceutical, Inc., JINSHAN Science & Technology, Proteus Digital Health, Inc., AnX Robotics, Medimetrics S.A. de C.V., BioCam, BDD Limited, RF Co., Ltd., and several others, are currently operating in the smart pills market.
In February 2023, AnX Robotica Corp. (US) launched the NaviCam Small Bowel System in the US. The NaviCam SB System utilizes aspherical lens technology to reduce distortion and enhance the field of vision, a critical component in the diagnosis of small bowel disease.
In 2021, Check-Cap (Israel) expanded C-Scan’s manufacturing capacity and on-premises production line, while also remedying technical issues from a single source supplier. The company significantly expanded its production line to support its US pivotal study.
In June 2020, AnX Robotica Corp. was granted by the FDA De-Novo classification for its NaviCam Magnetically Controlled Capsule Endoscopy (MCCE) System. It is the first-of-its-kind system that allows complete, real-time visualization of the stomach utilizing a pill-sized capsule containing a camera and is remote-controlled by the physician using proprietary magnetic technologies.
In December 2020, CapsoVision Inc. achieved the International Standard Organization (ISO) 27001 security certification. The scope of the certification includes CapsoVision’s headquarters and the company’s CapsoCloud software. This certification validates the company’s long-term commitment to the protection of customer data.

To read more about the latest highlights related to the smart pills market, get a snapshot of the key highlights entailed in the Global Smart Pills Market Report

Smart Pills Overview

Smart pills, also known as digital pills or ingestible sensors, represent a breakthrough in medical technology by combining pharmaceuticals with digital monitoring capabilities. These pills are embedded with tiny sensors that communicate data about the body’s response to medication ingestion, such as vital signs or medication adherence, to external devices like smartphones or computers. By providing real-time insights into patient health and treatment effectiveness, smart pills enable healthcare professionals to tailor treatment plans more precisely and intervene promptly when necessary. However, their integration raises ethical concerns regarding privacy and data security, underscoring the need for robust regulatory frameworks to balance innovation with patient rights.

Moreover, smart pills hold promise beyond healthcare, with potential applications in fields like sports performance monitoring and workplace safety. Athletes could use them to track hydration levels and nutrient absorption during training, while employees in high-risk environments could benefit from real-time monitoring of vital signs to prevent accidents. Despite their potential benefits, widespread adoption of smart pills requires addressing technical challenges such as miniaturization, power management, and cost-effectiveness. As research and development continue to advance, smart pills are poised to revolutionize not only healthcare but also various aspects of human performance and safety.

Smart Pills Market Insights

In 2023, North America dominated the smart pills market due to several key factors highlighting the region’s importance. The high prevalence of chronic diseases, particularly gastrointestinal disorders and associated cancers, is a major driver of growth. This is supported by the 2021 report from the International Foundation for Gastrointestinal Disorders (IFFGD), which revealed that between 25 to 45 million individuals in the United States suffered from irritable bowel syndrome that year.

The region’s openness to advanced technologies aimed at improving patient care is crucial. The broad acceptance of such technologies is facilitated by a sizable and discerning consumer base, bolstered by the rapidly expanding elderly population. Regulatory approvals for innovative devices, along with increased awareness of disease diagnosis through smart pill technology, further contribute to the region’s promising prospects.

The IFFGD report also highlights the growing burden of Inflammatory Bowel Disease (IBD) in Canada, with projections indicating a rise from 322,600 affected individuals in 2023 to 470,000 by 2035. This trend underscores the increasing demand for smart pills for both diagnosing and treating gastrointestinal diseases.

North America benefits from the presence of key industry players, creating an environment conducive to product development. Additionally, the FDA has played a significant role in shaping the market by approving innovative technologies. For instance, the FDA cleared etectRx’s ID-CAP System in December 2019—a pill embedded with sensors that wirelessly communicates with an external system, revolutionizing remote health monitoring without physical contact.

Given these factors, the smart pills market in North America is expected to experience substantial growth from 2024 to 2030. The combination of increasing disease prevalence, regulatory support, technological advancements, and a robust healthcare ecosystem positions the region as a significant driver in the advancement of smart medical solutions.

To know more about why North America is leading the market growth in the smart pills market, get a snapshot of the Smart Pills Market Outlook. Smart Pills Market Outlook

The smart pills market has been witnessing a surge in demand and innovation, driven by the growing need for advanced healthcare solutions. These pills, equipped with sensors and microelectronics, offer real-time monitoring of patients’ vital signs and medication adherence. The market dynamics are characterized by a blend of technological advancements, regulatory frameworks, and increasing healthcare expenditure globally. As more stakeholders recognize the potential of smart pills in improving patient outcomes and reducing healthcare costs, the market is poised for significant growth.

Furthermore, the rise of chronic diseases, aging populations, and the increasing adoption of digital health technologies are fueling the expansion of the smart pills market. Patients and healthcare providers are seeking more personalized and efficient treatment options, driving the demand for innovative solutions like smart pills. Moreover, the integration of artificial intelligence and machine learning algorithms with smart pill technology enhances data analytics capabilities, facilitating better diagnosis, treatment optimization, and preventive care strategies.

However, challenges such as data privacy concerns, regulatory hurdles, and limited reimbursement policies remain significant barriers to widespread adoption. Additionally, the high cost of smart pill technology and the need for specialized infrastructure for data management and analysis pose challenges for market penetration, particularly in developing regions. Overcoming these challenges will require collaboration among stakeholders, including pharmaceutical companies, technology developers, healthcare providers, and regulatory agencies, to ensure the safe and effective integration of smart pills into clinical practice while addressing concerns regarding privacy, accessibility, and affordability.

Get a sneak peek at the smart pills market dynamics @ Smart Pills Market Dynamics Analysis

Report Metrics	Details
Coverage	Global
Study Period	2021–2030
Smart Pills Market CAGR	~11%
Key Smart Pills Companies	Medtronic, Capso Vision Inc., Olympus America, Hoya (Pentax Medical), etectRx, Check-Cap, INTROMEDIC, HQ, Inc., Koninklijke Philips N.V., Novartis AG, BodyCAP, Medisafe, Otsuka America Pharmaceutical, Inc., JINSHAN Science & Technology, Proteus Digital Health, Inc., AnX Robotics, Medimetrics S.A. de C.V., BioCam, BDD Limited, RF Co., Ltd., among others

Smart Pills Market Assessment

Smart Pills Market Segmentation
- Smart Pills Market Segmentation By Product: Capsules and Software and Accessories
- Smart Pills Market Segmentation By Application: Capsule Endoscopy (Small Bowel Video Capsule Endoscopy and Colon Capsule Endoscopy), Patient Monitoring, and Drug Delivery
- Smart Pills Market Segmentation By Disease: Crohn’s Disease, Small Bowel Tumors, Inherited Polyposis Syndromes, GI Bleeding, and Others
- Smart Pills Market Segmentation By End User: Hospitals & Clinics, Diagnostic Centers, and Others
- Smart Pills Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World
Porter’s Five Forces Analysis, Product Profiles, Case Studies, KOL’s Views, Analyst’s View

Which MedTech key players in the smart pills market are set to emerge as the trendsetter explore @ Smart Pills Companies

Table of Contents

1	Report Introduction
2	Executive summary
3	Regulatory and Patent Analysis
4	Key Factors Analysis
5	Porter’s Five Forces Analysis
6	Smart Pills Market Layout
7	Global Company Share Analysis – Key 3-5 Companies
8	Smart Pills Market Company and Product Profiles
9	Project Approach
10	About DelveInsight

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Franck Mevellec Appointed Senior Director, Business Development at Asymchem

May 29, 2024

Asymchem, a leading global CDMO, is excited to announce the appointment of Franck Mevellec as senior director, business development. Franck brings over 20 years of experience in the pharmaceutical industry, working across various aspects of drug development from R&D to sales.

Franck Mevellec boasts a proven track record of success, having held key positions at industry leaders like Bayer Healthcare (R&D), Teva Pharmaceuticals (portfolio director), Minakem (BD director), and most recently, Seqens (global head of sales). He joins Asymchem with a focus on expanding the company’s footprint across Europe.

“Franck’s extensive experience and deep understanding of the European pharmaceutical market make him a valuable asset to our team,” said Jon Brice, SVP of business development at Asymchem. “His leadership and entrepreneurial spirit will be instrumental in driving our growth and strengthening our presence in this region.”

In his new role, Franck will leverage his expertise to develop new business opportunities for Asymchem, focusing on a wide range of services including flow chemistry, oligo and peptides, drug product development, and biologics.

Tandem Mobi Insulin Pump Now Compatible with Dexcom G7 CGM

May 29, 2024

Tandem Mobi Insulin Pump

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) and Dexcom, Inc. (Nasdaq: DXCM), today announced that the Tandem Mobi insulin pump with Control-IQ technology is now fully compatible with both the Dexcom G7 and Dexcom G6 Continuous Glucose Monitoring (CGM) Systems. Tandem Mobi, the world’s smallest, durable automated insulin delivery (AID) system1, launched in the United States earlier this year.

Tandem is now the only company that offers people living with diabetes two insulin pump options that connect with both Dexcom G6 and Dexcom G7, providing more choice in how they manage their diabetes. Tandem’s #1-rated2 t:slim X2™ insulin pump was the first AID system to feature Dexcom G7 integration, as announced in late 2023.

Tandem will email all Tandem Mobi users in the United States over the coming weeks, when their software update is available, with instructions on how to add the new feature free of charge by remote software update. Tandem Mobi pumps pre-loaded with the updated software are now shipping to new customers.

“Choice is a hallmark of our offerings, and we’ve proven this commitment with the expansion of our insulin pump portfolio and extended CGM compatibilities,” said John Sheridan, president and chief executive officer of Tandem Diabetes Care. “With this integration, we’re providing more flexibility for our customers and continuing our decade-long partnership with Dexcom to bring innovative and discrete solutions to people living with diabetes.”

Tandem Mobi is small enough to be worn almost anywhere3, including a coin pocket, providing users with more discretion, comfort, and options for how they manage their diabetes. Powered by Control-IQ technology, which has demonstrated in real-world studies improved time in range overnight and during the day4, Tandem Mobi connects with Dexcom G7 or Dexcom G6 to predict glucose levels 30 minutes in advance and automatically adjusts insulin, if needed, to help prevent highs and lows.

With the integration of Dexcom G7, Tandem Mobi users can also experience:

More time in closed loop with Dexcom G7’s 30-minute sensor warm-up time – faster than any other CGM on the market.⁵
Additional discretion with Dexcom G7’s low-profile, all-in-one wearable.

“As the leader in connectivity, Dexcom has been the CGM of choice for the development of AID systems for over a decade,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “We are proud to offer people with diabetes the ability to use Dexcom G7, our smallest and most accurate CGM, with Tandem Mobi to create a seamless user experience.”

For more information about Tandem Mobi and how to start the order process, please visit www.tandemdiabetes.com/mobi.

As of May, 2024. Data on file, Tandem Diabetes Care.
dQ&A Q1 2024 US Diabetes Patient Voice Report.
The pump should not be placed more than 12 inches (30.5 cm) above the infusion site. Doing so may result in over delivery of insulin.
All published clinical trials and real-world studies of Control-IQ technology to date are based on use of Dexcom G6 CGM with the Tandem t:slim X2 insulin pump.
Dexcom G7 can complete warmup within 30 minutes, whereas other CGM brands require up to an hour or longer.

COTA, Baptist Health South Florida, and PreciseDx Announce Collaboration on the AI-Enabled Breast Cancer Recurrence Risk Assessment, PreciseBreast™

May 29, 2024

COTA, PreciseDx and Baptist Health South Florida announced a collaboration to assess and validate the performance of the artificial intelligence (AI) -enabled PreciseBreast™ (PDxBr) test that predicts the likelihood of invasive breast cancer (IBC) recurrence.

One in eight women in the U.S. will be diagnosed with breast cancer in their lifetime. An accurate understanding of a patient’s prognosis is needed to inform treatment decisions. Risk assessment to determine the likelihood of breast cancer recurrence is a critical step in characterizing a cancer diagnosis. While breast cancer patients have benefited from numerous gene-expression tests in recent years, these tools have documented limitations and can be expensive. Often reporting within a two-to-four-week timeframe, gene-expression testing can lead to delayed treatment decisions that are critical to patient management.

“AI has the potential to augment human learning and improve the accuracy and precision of cancer diagnostics and treatments,” said Dr. C.K. Wang, chief medical officer, COTA. “It is critical that we evaluate these tools against the current standard of care to validate their efficacy and build trust in AI and new technologies.”

As long-term collaborators, COTA and Baptist Health South Florida will analyze the performance of PreciseDx’s clinical risk tool using curated real-world data. They will compare the results of PreciseBreast™ to traditional pathology reviews and to 21-gene assay results to validate its performance. If the validation study is successful, Baptist Health South Florida will offer this AI-enabled testing to patients with IBC with the goal of expanding access to innovations in cancer care. Additional benefits include access to results in 48 hours and an 80% reduction in cost.

Current pathology practices are manual and often subjective. The PreciseBreast™ test is designed to improve clinical decision-making with AI-derived insights that give physicians and patients a clear understanding of the risk of recurring IBC.

“AI has allowed us to take a giant leap forward in the accuracy, affordability and accessibility of tools to better understand and treat breast cancer,” said Gerardo Fernandez, M.D., co-founder and chief scientific officer of PreciseDx. “Access to COTA’s best-in-class, real-world data that provides comprehensive insights into the cancer journeys of diverse patient populations will power more advanced and accurate AI learnings.”

“This collaboration underscores our commitment to advancing cancer diagnostics with the latest AI-driven solutions,” said Manmeet S. Ahluwalia, M.D., MBA, FASCO, deputy director, Fernandez Family Foundation Endowed Chair in Cancer Research, chief of medical oncology, and chief scientific officer of Miami Cancer Institute, part of Baptist Health South Florida. “By combining state-of-the-art technology with real-world evidence, we are working to not only enhance our diagnostic precision but also improve accessibility that may ultimately empower both patients and physicians with timely, actionable insights.”

Veristat Appoints Dr Gabriela Rosu to Lead Growing Medical Affairs Team

May 29, 2024

Veristat, the Science-First Full Service CRO and Consultancy, is pleased to announce that Gabriela Rosu, M.D., has joined as Senior Director, Global Medical Affairs.

Dr Gabriela Rosu is a seasoned professional with over twenty years of experience in scientific and clinical fields, having significantly contributed to the planning and execution of pivotal activities that have led to the approval and commercialization of groundbreaking therapies.

Her appointment is timely, coming just before the American Society of Clinical Oncology’s (ASCO, #ASCO24) Annual Meeting, an event where Dr. Rosu has historically made impactful contributions through numerous abstracts.

Patrick Flanagan, CEO of Veristat, praised Dr. Rosu’s dedication, “Dr. Rosu’s fervent commitment to collaboration enhances our ability to make informed decisions, crucially improving patient experiences in clinical trials and ensuring favorable outcomes. Her profound insight into the nuances of oncology therapy development is invaluable, particularly as we continue to focus on optimizing treatment strategies in this area.”

Veristat’s Medical Affairs team is at the forefront of evaluating scientific data to address the increasing complexity of biotherapeutic compounds and diverse patient demographics in clinical trials. The team is instrumental in fostering communication and generating essential evidence to support patient safety and optimize treatment outcomes, especially for those with rare and complex diseases (#oncology, #cancer, #raredisease).

In her new role, Dr. Rosu will oversee the global expansion of the medical and safety/pharmacovigilance teams. Her extensive background includes senior medical affairs positions at leading global CROs, where she oversaw medical monitoring for various oncology trials, advised on protocol development, risk mitigation strategies, and strategic development with a focus on patient safety and patient outcomes. Dr. Rosu’s experience is particularly notable in immuno-oncology, focusing on managing compound toxicity.

Before transitioning to the CRO industry, Dr. Rosu held significant roles such as Chief Medical Officer at IMV Inc. and Global Medical Advisor at Novo Nordisk Healthcare, where she led clinical developments in oncology and coagulation disorders, among other responsibilities.

Dr. Rosu earned her Doctor of Medicine degree in Romania and has maintained active participation in prestigious organizations such as the American Society for Clinical Oncology (ASCO, #ASCO) and the European Society for Medical Oncology (ESMO, #ESMO).

Reflecting on her new position, Dr. Rosu stated, “I am honored to lead as Senior Director, Global Medical Affairs at Veristat, aligning with the company’s strategic vision to pioneer the development and commercialization of innovative treatments for rare diseases. My dedication to enhancing patient experiences in clinical trials and fostering the development of safe and effective therapies remains unwavering. I look forward to contributing to Veristat’s dynamic team and its noble mission.”

Pulmatrix Announces Cross License Agreement and Transfer of Laboratory to MannKind Corporation

May 29, 2024

Pulmatrix, Inc. (“Pulmatrix” or the “Company”) (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary diseases using its patented dry powder inhalation iSPERSE™ technology, today announced a series of transactions with MannKind Corporation.

Ted Raad, Chief Executive Officer of Pulmatrix, commented, “MannKind’s interest in iSPERSE™ validates the enablement potential of our innovative particle engineering dry powder technology. In addition, the assumption of our lease and laboratory by MannKind helps extend our cash runway further into 2026. We are able to build upon this agreement to further support development of PUR3100 and its potential application with MannKind’s Cricket® device to develop the 1st orally inhaled DHE treatment for acute migraine.”

The Company entered into a cross license with MannKind pursuant to which MannKind will grant Pulmatrix a perpetual, royalty free, exclusive license to use MannKind’s Cricket inhalation device for the inhaled delivery of PUR3100, our proprietary formulation of dihydroergotamine (DHE) with iSPERSE™, and a perpetual, royalty free, non-exclusive license to use MannKind’s Cricket inhalation device for the inhaled delivery of any dry powder formulation formulated for the treatment or prevention of neurological disease. As part of the cross-license, the Company will grant MannKind a perpetual, royalty free, exclusive license to formulate iSPERSE™ with clofazimine for inhalation by humans for the treatment or prevention of infection, for the treatment or prevention of nontuberculous mycobacteria lung disease in humans, and with insulin for inhalation by humans for the treatment or prevention of diabetes. We will also grant MannKind a perpetual, royalty free, non-exclusive license to formulate iSPERSE™ for inhalation for the treatment or prevention of endocrine disease and for inhalation for the treatment or prevention of interstitial lung diseases (including IPF, PPF and other related lung diseases) in humans (“ILD”).

As part of the transaction, MannKind will assume the lease of our Bedford, Mass., R&D facility along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory. To maintain continuity of iSPERSE™ platform knowledge, MannKind plans to hire some members of the Pulmatrix R&D staff.

The agreements are anticipated to close in July 2024.

Mira Pharmaceuticals Announces DEA Rules MIRA-55, a Novel Oral Pharmaceutical Marijuana Analog, Is Not Classified as a Controlled Substance

May 29, 2024

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that MIRA-55, has been determined by the U.S. Drug Enforcement Administration (DEA) not to be a controlled substance or listed chemical under the Controlled Substance Act and its governing regulations.

MIRA-55 is under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline often associated with early-stage dementia. Unlike THC (the principal psychoactive compound in marijuana), which can impair cognitive function, MIRA-55 has demonstrated in pre-clinical studies that it can improve memory by 100% in wild-type mice.

Key Advantages of MIRA-55 Over Marijuana:

Non-Controlled Substance: The DEA’s ruling confirms that MIRA-55 is not a controlled substance, offering a significant regulatory advantage over marijuana, which is currently classified as a Scheduled drug. This status facilitates more accessible research and development processes and reduces legal and logistical barriers to further studies and eventual commercialization.
Cognitive Enhancement: MIRA-55 has shown promising results in enhancing memory and cognitive performance in preclinical models. This is in stark contrast to marijuana, which is known to impair cognition and memory. Long-term marijuana use can impair thinking, memory, and learning functions, particularly when usage begins in adolescence. Studies have shown that heavy marijuana users can experience significant I.Q. declines and cognitive deficits.
Stable Anti-Anxiety Effects: Unlike THC found in marijuana, which exhibits a biphasic effect (anti-anxiety at low doses and pro-anxiety at high doses), MIRA55 demonstrates a monophasic dose-response in pre-clinical models, indicating a more stable and consistent anti-anxiety effect across its dosage range. Furthermore, marijuana use has been linked to mental health problems such as depression, anxiety, and an increased risk of psychosis and schizophrenia. Higher THC levels in modern marijuana strains increase the risk of addiction, heart problems, and lung issues.
Reduced Intoxicating Effects: MIRA-55 exhibits lower potency at the CB1 receptor, which is responsible for the psychoactive effects of THC, while maintaining higher activation of the CB2 receptor. This suggests that MIRA-55 may deliver therapeutic benefits with minimal intoxicating effects. Unlike marijuana, MIRA-55 aims to provide these benefits without the associated adverse effects such as temporary hallucinations, paranoia, and exacerbating symptoms in patients with schizophrenia.

“We are thrilled with the DEA’s decision, which underscores the potential of MIRA-55 as a groundbreaking therapeutic candidate,” said Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals. “This ruling allows us to focus on MIRA-55’s unique cognitive and anxiety benefits. With access to $90B traditional neurological and $30B cannabis markets, MIRA-55 represents a significant value proposition for our company. We remain committed to advancing it through the development pipeline for treating these diseases from which so many currently suffer.”

“Anxiety disorders affect around 40 million U.S. adults, causing excessive apprehension, worry, fear, nervousness, physical symptoms like sweating, shortness of breath, and palpitations,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals. “Current treatments such as SSRIs and SNRIs can take weeks to work and are associated with side effects. Cognitive impairment, affecting 16 million people (about the population of New York) in the U.S., similarly lacks effective treatments. MIRA-55 offers a promising alternative

Matter Bio Successfully Closes $7M Seed Funding Round

May 29, 2024

Matter Bio, a pioneering biotech company dedicated to preserving genome integrity and extending healthy human lifespan, today announced the successful close of its seed round funding, raising $7 million to advance its groundbreaking work in longevity research.

The seed round was led by Lifespan Vision Ventures, with participation from quadraScope Ventures and others, and includes grant support from NIH, NCI, and NIEHS. The funds will be utilized to conduct further research into the information theory of aging at a genomic level, which Matter believes contributes significantly to the aging process. The funds will also enable the filing of an IND and the start of a Phase 1/2a clinical trial in solid cancer.

Matter Bio tackles the problem of genome instability holistically, addressing the issue through a multi-pronged approach:

Reading Mutation: Detecting and identifying loss of genomic information.
Reversing: Correcting integrated mutations and reintroducing original genetic information.
Removing: Eliminating cells that are too damaged to be repaired, such as cancerous, clonal, and senescent cells.

Matter Bio has assembled a world-class team of scientists and executives, including co-founders such as George Church, PhD, a pioneer in genome sequencing and gene editing, Jan Vijg, PhD, an expert in genome instability and somatic mutations, and Claudia Gravekamp, PhD, a world authority in attenuated bacterial therapeutics. The company operates at the forefront of longevity biotechnology, leveraging cutting-edge science and innovative approaches to address the complexities of aging.

“Genomic integrity is a cornerstone of longevity and healthspan extension,” said George Church, Professor of Genetics at Harvard Medical School. “Matter Bio is pioneering a crucial approach in the fight against aging by focusing on the preservation of our genetic blueprint. I am excited to see the impact of their work on enhancing human health.”

“Our investment in Matter Bio furthers our mission of supporting the cutting-edge interventions that promote longevity and combat aging,” said Andrew Worden, Founding Partner of LifeSpan Vision Ventures. “Matter Bio’s strong team, cutting-edge genomic preservation technologies, and early-stage partnerships give the company excellent prospects to succeed with its vision.”

FundamentalVR Revolutionizes Surgical Training with Advanced AI Capabilities

May 29, 2024

FundamentalVR, global leader in immersive surgical training, announces groundbreaking advancements in its Fundamental Surgery platform, integrating cutting-edge artificial intelligence (AI) capabilities to drive predictive insights, enhance surgical proficiency, and accelerate skills acquisition. The company leverages this data to drive valuable insights for customers, fostering advancements in surgical training and beyond.

Harnessing the power of AI, FundamentalVR’s real-time data assessments can now predict surgical behavior and performance with unprecedented accuracy. By leveraging AI algorithms, the platform is able to track and analyze user gestures through telemetry data, in some cases achieving an impressive predictive accuracy rate of 98.5%. This predictive modeling empowers medical device companies and educators with analytics and data science techniques for more informed decisions around product design, training efficacy, and user skill levels, ultimately enhancing surgical techniques and improving patient outcomes.

“Our AI-driven approach marks a transformative shift in surgical training,” said Richard Vincent, Co-Founder and CEO at FundamentalVR. “By providing real-time insights and personalized guidance, Fundamental Surgery is revolutionizing how surgeons acquire and refine their skills, ultimately leading to safer and more effective patient care.”

The platform’s AI capabilities extend beyond performance prediction to offer the potential of expert guidance throughout the virtual reality (VR) experience. Through advanced machine learning (ML) models, FundamentalVR calculates users’ risk levels of harming patients in real time, allowing for immediate intervention and correction within a training experience. This proactive approach ensures safer training environments, ultimately leading to better training results.

With the ability to rapidly evolve designs and leverage data with each iteration, FundamentalVR is driving innovation in both training simulations and product designs. This approach results in continuously improved training experiences and better products, furthering the advancement of surgical proficiency and patient outcomes.

“Our AI Tutor empowers learners by providing intuitive mentoring, driven by an expert knowledge base, providing navigation and interaction cues within the simulation,” said Vicky Smalley, Chief Technology Officer at FundamentalVR. “By focusing on learner autonomy and personalized, adaptive learning support, we are able to cultivate user engagement while fostering a culture of continuous improvement.”

FundamentalVR remains committed to advancing surgical training and elevating performance standards globally. Selected as a partner by or accredited by leading institutions such as the American Academy of Ophthalmology, American Academy of Orthopaedic Surgeons, and the Royal College of Surgeons of England, FundamentalVR continues to lead the industry in digital surgery training.

Sedana Medical Completes Patient Recruitment for its Clinical Program in the US

May 29, 2024

Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 2 phase III clinical trial in the United States. Earlier this spring, Sedana Medical reported the completion of enrolment to the parallel phase III clinical trial INSPiRE-ICU 1. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025.

“The completion of INSPiRE-ICU 2 concludes Sedana Medical´s clinical trials in the United States. Running this study together with esteemed clinical investigators from highly ranked academic centers such as Columbia, the Harvard-affiliated medical center Beth Israel Deaconess Medical Center and many others has been very exciting and rewarding. Many investigators from the participating sites have been excited to be part of our pioneering studies. The bedside experience in the studies has generated a lot of interest in using inhaled sedation in US practice, which we hope will be possible soon,” said Peter Sackey, Chief Medical Officer of Sedana Medical.

Peter Sackey further elaborated: “We now enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months are being collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results for the 30-day outcomes in both studies a few months´ apart before the end of this year, and a swift regulatory submission in Q1, 2025.”

“The inhaled sedative isoflurane, studied in this trial, is a mainstay of general anesthesia during surgery because of its unique and straightforward pharmacokinetic and pharmacodynamic profile, properties that may potentially also benefit ICU patients. We are very excited to complete enrolment in this trial and eagerly await results evaluating its potential use as a sedative for ventilator-dependent adult ICU patients in the US,” said Jeremy Beitler, MD, MPH at Columbia University and Senior Lead Investigator for the INSPiRE-ICU 2 study.

Johannes Doll, President and CEO of Sedana Medical, stated: “Completing enrolment of our clinical program marks an important milestone on our journey towards making inhaled sedation accessible to intensive care patients in the United States. I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards launching our inhaled therapy on the US market.”

INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical’s unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021.

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