NEW YORK, NY, June 24, 2024 – Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, announced the launch of Medidata Clinical Data Studio, a unified experience that unlocks the true power of clinical research data. This groundbreaking technology gives stakeholders greater control over the quality of data and the ability to deliver safer trials to patients faster.

Built on the Medidata Platform, Clinical Data Studio integrates data from both Medidata and non-Medidata sources, accelerating decision-making across the full clinical trial process and delivering holistic data and risk strategies that connect patients, sites, and sponsors. Through AI, study teams can more effectively identify potential data issues and safety signals, resulting in a more accurate understanding of the patient. This reduces the challenges posed by siloed data systems and enables action data review and reconciliation up to 80 percent faster.

“Clinical Data Studio unlocks the broad ecosystem of clinical data. Powered by embedded AI, we are democratizing access to data and revealing the signals, risks, and insights that matter most. Together this accelerates trial execution and creates rich data for new discoveries,” said Tom Doyle, chief technology officer, Medidata.

Clinical Data Studio offers a comprehensive workspace for data integration, transformation, and management. It includes AI-assisted data reconciliation and anomaly detection, self-serve data listings, robust risk-based quality management, and tools to implement a holistic data and risk strategy supported by workflows and visualizations.

“As data volume and sources grow exponentially, managing this data and garnering real-time insights is becoming increasingly complex. Not only is this impacting time-to-market, but it is also delaying the timely delivery of therapies to patients, thus impacting patients’ lives,” said Dr. Nimita Limaye, research vice president, Life Sciences R&D Strategy and Technology, IDC. “By enabling users to manage all their data, both Medidata and non-Medidata data, in one place, Medidata Clinical Data Studio has the potential to disrupt the industry by accelerating clinical trials and getting therapies to patients faster.”

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 33,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand, Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC.

For more information, visit www.medidata.com.

About Dassault Systèmes

Dassault Systèmes is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all –consumers, patients and citizens. Dassault Systèmes brings value to more than 350,000 customers of all sizes, in all industries, in more than 150 countries.

For more information, visit www.3ds.com.

EXTON, PA, June 5, 2024 – Ricoh USA, Inc. announced its flagship Point of Care 3D medical device manufacturing facility – the RICOH 3D for Healthcare Innovation Studio. Through its mission to innovate and improve clinical outcomes and quality of life, the on-site Innovation Studio provides clinicians with easy and immediate access to development, design, and manufacturing services for patient-specific, 3D-printed anatomic models, which can be used for surgical planning and patient education. Located in Innovation Quarter, in downtown Winston-Salem, NC, it is the first of many Point of Care 3D medical device manufacturing facilities that will be connected to a health system.

Patient care teams with limited access to 3D-printed anatomic models often see challenges related to workflow disruptions, lead time issues, resources, and regulatory compliance when attempting to acquire patient-specific anatomic models, which can impact the standard of patient care. The foundational mission of the RICOH 3D for Healthcare Innovation Studio aims to resolve these challenges by leveraging Ricoh’s HIPAA-compliant, ISO 13485-certified 3D medical device manufacturing center and Managed Services pedigree for the development, design, and production of 3D-printed anatomic models. Bringing patient-specific anatomic modeling directly into the hospital using Ricoh’s innovative technology ecosystem and quality management system provides clinicians with the availability and confidence of FDA-cleared devices.

The on-site center allows for faster production times, in-person access to clinical resources and 3D-printing expertise, as well as multidisciplinary team collaboration across national networks – providing clinicians and patients with a wider team of experts and support for enhanced care. In addition, the Innovation Studio helps to increase communication and feedback between the care team and Ricoh staff, drive innovation for personalized patient care, and focus on collecting data on the benefits of using 3D-printed anatomic models to help drive reimbursement.

“The RICOH 3D for Healthcare Innovation Studio is a foundational step in Ricoh’s long-term vision to lead the way in democratizing access to patient-specific, precision medical solutions in healthcare,” said Gary Turner, managing director, additive manufacturing, North America, Ricoh USA, Inc. “As we look to integrate and scale Point of Care facilities within health systems nationally, we’re extremely grateful that Atrium Health Wake Forest Baptist has partnered with us to make the first facility a reality, and we look forward to growing 3D production within their network and in other hospital systems across the country.”

Ricoh 3D for Healthcare produces patient-specific anatomic models via additive manufacturing, using segmented 3D print files created from medical images in FDA-cleared applications. These models are used for diagnostic purposes in various medical fields, including craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications. With the ability to manage 3D-print operations at the point of care, the RICOH 3D for Healthcare Innovation Studio gives providers access to a streamlined and efficient solution for producing and obtaining these models. The new facility enables Atrium Health Wake Forest Baptist and Wake Forest University School of Medicine to create a Medical 3D Printing Center of Excellence, in collaboration with Wake Forest Innovations and Innovation Quarter.

“As a leading academic learning health system, we are committed to leveraging technology that will benefit our patients, our faculty and staff, and our learners,” said Christopher T. Whitlow, MD, PhD, MHA professor and chair of radiology at Wake Forest University School of Medicine and a neuroradiologist at Atrium Health Wake Forest Baptist. “This partnership will allow our health system and medical school to continue to elevate our clinical, research and education capabilities, and will open up new opportunities to collaborate with other departments across our organization.”

In patient care, access to precision, anatomic 3D models from on-site facilities like the RICOH 3D for Healthcare Innovation Studio allows clinical teams to plan and provide timely and informed care plans. It may also lead to:

• Reduced operating times – Surgeons using 3D-printed anatomic models saw an average operation time savings of 62 minutes[i] and a 7.8% reduction in operative time[ii].
• Redefined surgical approaches – 50% of surgeons redefined their surgical approach when a 3D model was used during the planning stage[iii].
• Lowered costs – When used for diagnostic purposes, providers saw an average cost savings of $3,720 per caseⁱ.
• Educational opportunities – 3D-printed models offer cadaver-free training, clearer communication, and education for patients when discussing informed consent.
• Enhanced diagnostic support – Having accurate insights into a patient’s anatomy beforehand allows clinicians to better evaluate and understand complex conditions to effectively prepare a more informed approach to procedures and care.
• Decreased compliance concerns – With an on-site Point of Care 3D medical device manufacturing facility, regulatory and legal compliance requirements are met due to Ricoh’s award-winning Managed Services platform, 3D-printing expertise and FDA 510(k)-cleared anatomic models.

For more information about RICOH 3D for Healthcare, view the RICOH 3D for Healthcare webpage.

^{[i] https://www.academicradiology.org/article/S1076-6332(19)30418-0/pdf, “Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides” Academic Radiology, Vol 27, Issue 8.}

[ii] https://pubmed.ncbi.nlm.nih.gov/27486910/, “Cost-Benefit Analysis of Three-Dimensional Craniofacial Models for Midfacial Distraction: A Pilot Study”, Cleft Palate Craniofac J. 2017 Sep;54(5):612-617. doi: 10.1597/15-281. Epub 2016 Aug 3. PMID: 27486910.

[iii] https://pubmed.ncbi.nlm.nih.gov/28977423/, “Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study”, Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1139-1148. doi: 10.1093/ejcts/ezx208. PMID: 28977423.

About Ricoh

Ricoh is a leading provider of integrated digital services and print and imaging solutions designed to support digital transformation of workplaces, workspaces and optimize business performance.

Headquartered in Tokyo, Ricoh’s global operation reaches customers in approximately 200 countries and regions, supported by cultivated knowledge, technologies, and organizational capabilities nurtured over its 85-year history. In the financial year ended March 2024, Ricoh Group had worldwide sales of 2,348 billion yen (approx. 15.5 billion USD).

It is Ricoh’s mission and vision to empower individuals to find Fulfillment through Work by understanding and transforming how people work so we can unleash their potential and creativity to realize a sustainable future.

For further information, please visit www.ricoh.com.

NEW YORK, NY, June 3, 2024 – Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, announced that it has been selected by Lexicon Pharmaceuticals, Inc. to help advance PROGRESS, a Phase 2b study of LX9211 in diabetic peripheral neuropathic pain (DPNP), with the potential for LX9211 to become the first new, non-opioid drug approved for neuropathic pain in over two decades. Medidata will enable Lexicon to accelerate patient enrollment and clinical trials for Lexicon’s AAK1 inhibitor LX9211, improving the patient experience with a focus on addressing the high, unmet need for chronic neuropathic pain therapies.

Lexicon will utilize Medidata’s Decentralized Clinical Trial (DCT) solutions, incorporating artificial intelligence and automation, to conduct real-time remote monitoring and data capture from patients in a real-world setting, regardless of where the trial participant is along their treatment journey.

“Our innovative technology is transforming how clinical trials are initiated and managed, and ultimately improving patient experience, supporting the development and approval for new treatments faster than ever before,” said Anthony Costello, CEO, Medidata. “We are honored to work with Lexicon to advance this novel therapy for diabetic peripheral neuropathy with the potential to positively impact the lives of patients suffering from this condition.”

According to the Mayo Clinic, diabetic neuropathy is a serious complication of diabetes that can affect as many as 50 percent of patients suffering from this chronic disease. Currently, existing treatments depend on opioids, which can have severe side effects, including addiction, to relieve pain.

“With no new, non-opioid drugs approved for the treatment of neuropathic pain in over two decades, we are excited about the potential for LX9211,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer, Lexicon. “We are at a critical juncture in our efforts to make this medication available to diabetic patients suffering from neuropathic pain, and our partnership with Medidata has been invaluable in advancing this trial expeditiously and enrolling our first patients in the PROGRESS study.”

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 33,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand, Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC.

Discover more at www.medidata.com.

About Dassault Systèmes

Dassault Systèmes is a catalyst for human progress. They provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, their customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all – consumers, patients and citizens. Dassault Systèmes brings value to more than 350,000 customers of all sizes, in all industries, in more than 150 countries.

For more information, visit www.3ds.com.

MIAMI, FL, May 28, 2024 – Ontrak Inc., a leading AI-powered and technology-enabled healthcare company, today announced the launch of its pioneering Mental Health Digital Twin (MHDT) technology. This innovative advancement in mental health care delivery seamlessly fuses human empathy with data-driven insights to provide personalized, precise, and effective care for individuals struggling with mental health challenges.

Ontrak’s MHDT technology creates a comprehensive virtual representation of each unique individual enrolled in the Ontrak Program, leveraging vast amounts of data from various sources, including claims data, clinical assessments, biometric data, patient-reported outcomes and social determinants of health. By processing millions of data points and utilizing advanced AI and machine learning models, the MHDT generates predictive insights and personalized recommendations, which are delivered through Ontrak’s Advanced Engagement System, enabling care teams to make informed decisions and deliver targeted interventions.

“We are thrilled to introduce our Mental Health Digital Twin technology, which represents a significant leap forward in the field of precision mental health care,” said Brianna Brennan, chief innovation officer at Ontrak. “By harnessing the power of data and advanced analytics, we are enabling care teams to deliver highly personalized, evidence-based care that adapts to each individual’s unique needs and circumstances. Our MHDT technology is not only transforming the way we approach mental health care delivery, but also profoundly impacting the lives of the individuals we serve.”

Key features and benefits of Ontrak’s MHDT technology include:

• Proactive identification of high-risk individuals through predictive modeling, facilitating early intervention and preventive care
• Hyper-personalized care planning based on the MHDT’s insights into each individual’s unique profile, needs, and preferences
• Continuous analysis of coach-patient interactions to enhance the quality and impact of coaching, strengthening the therapeutic alliance
• Integration with Ontrak’s care delivery workflows, providing care teams with real-time insights and recommendations to optimize treatment outcomes
• Acceleration of care innovation by leveraging MHDT data to test novel interventions and uncover best practices

To learn more about Ontrak’s Mental Health Digital Twin technology and its transformative potential in precision mental health care delivery, please visit https://ontrakhealth.com/white-papers/ontraks-mental-health-digital-twin-pioneering-personalized-care/.

About Ontrak Health

Ontrak Health is a leading AI and technology-enabled healthcare company, whose mission is to help improve the health and save the lives of as many people as possible. Ontrak identifies, engages, activates, and provides care pathways to treatment for the most vulnerable members of the behavioral health population who would otherwise fall through the cracks of the healthcare system. They engage individuals with anxiety, depression, substance use disorder and chronic disease through personalized care coaching and customized care pathways that help them receive the treatment and advocacy they need, despite the socio-economic, medical and health system barriers that exacerbate the severity of their comorbid illnesses. The company’s integrated intervention platform uses AI, predictive analytics and digital interfaces combined with dozens of care coach engagements to deliver improved member health, better healthcare system utilization, and durable outcomes and savings to healthcare payors.

For more information, visit https://ontrakhealth.com/.

SAN DIEGO, CA, May 1, 2024 – Boston Micro Fabrication has introduced BMF Biotechnology Inc. Headquartered in San Diego, CA, BMF Biotechnology Inc. is dedicated to developing and commercializing innovative BioChips (organ-on-a-chip platforms) through cultivating large-scale tissues in vitro, helping accelerate new drug and cosmetic development.

The A10 BioChip (Photo: Business Wire)

BMF is known for its innovative and unique high precision micro-printing platforms for product designers and engineers in fields like medical device, electronics, optic/photonics and life sciences who require a high level of feature resolution and demanding dimensional tolerance.

BMF Biotechnology’s BioChips offer a powerful platform for studying health and disease biological mechanisms, evaluating drug and cosmetic safety and efficacy, and predicting patient responses. Robust tissue models, such as tumor models for assessing drug efficacy, kidney models for evaluating drug safety, and skin models for cosmetic assessments have been consistently cultivated.

“Building on success that BMF has had with other self-driven innovations such as the UltraThineer veneers, the launch of BMF Biotechnology Inc. represents a significant leap forward in our ability to harness the potential of 3D BioChip technology,” remarked Dr. Jennifer Sun, chief scientific officer of BMF Biotechnology Inc. “With our innovative technology and approach, we aim to empower researchers with the tools they need to translate scientific discoveries into tangible therapeutic solutions that improve patient outcomes.”

To help fully realize the power of the BioChips, BMF Biotechnology is now recruiting collaboration Partners.

About Boston Micro Fabrication

Boston Micro Fabrication (BMF) enables highly precise, micro-scale 3D printing across healthcare, the life sciences, electronics, and machining industries. Using the company’s proprietary PμSL (Projection Micro Stereolithography) technology, the microArch system printers produce the industry’s most accurate and precise high-resolution 3D prints for product development, research, and industrial short run production. Founded in 2016, BMF has offices in Boston, Shenzhen, Chongqing and Tokyo with a research and development center in San Diego.

For more information on BMF, please visit www.bmf3d.com.

SOUTH SAN FRANCISCO, CA, Apr 23, 2024 – Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, today unveiled Cell Q, the first automated quality control (QC) workcell for cell therapy manufacturing. Cell Q addresses a critical challenge: the manual, labor-intensive, low-throughput, and expensive nature of cell therapy QC. Exclusive to Cellares’ industry-first IDMO Smart Factories, Cell Q will offer a substantial improvement in throughput, cost, and reproducibility compared to existing manual QC methods.

First cGMP Cell Q system for automated in-process and release QC of up to 6,000 cell therapy batches per year.

As Cellares Cell Shuttles have addressed upstream bottlenecks in cell therapy manufacturing, Cell Q resolves the downstream QC capacity challenges. Cell Q is engineered to automate the vast majority of cell therapy QC assays for up to 6,000 batches per year. To accelerate analytical method transfer and shorten the time to clinical readout for new IDMO clients, Cell Q includes a pre-qualified set of the most common assays. Additionally, each Cell Q utilizes a modular platform that can be expanded with new instruments providing the flexibility needed to meet varying IDMO client needs.

Setting a new standard in the industry, Cellares is the only IDMO to offer the same unprecedented capacity for upstream cell therapy manufacturing as well as downstream QC via its South San Francisco Center of Excellence and Smart Factory in Bridgewater, NJ. Additional Smart Factories will be coming soon to the EU and Japan.

“Cell Q was designed to match the throughput of our Cell Shuttle platform. This enables the Cellares IDMO to offer a real end-to-end solution for our customers, providing 10 times higher capacity and up to 50% lower batch price,” said Fabian Gerlinghaus, CEO of Cellares. “Our proprietary platform technologies support our mission of becoming the de facto standard for cell therapy manufacturing, accelerating access for patients, and meeting the total patient demand for cell therapies globally.”

To learn more about how Cell Q enriches Cellares’ IDMO ecosystem and how it alleviates the QC bottleneck for cell therapies, please visit cellares.com/technology.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttles integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, CA with its commercial-scale IDMO Smart Factory in Bridgewater, NJ. The company is backed by world-class investors and has raised over $355 million in financing.

For more information about Cellares, please visit cellares.com.