LSI USA

In 2024, Diality secured FDA 510(k) clearance for its Moda-flx Hemodialysis System™. The Moda-flx Hemodialysis System is designed to empower kidney care professionals with a wide range of variable flow rate ranges, integrated reverse osmosis water filtration, and an intuitive, easy-to-use graphical user interface. The system provides clinicians the flexibility to easily customize each hemodialysis experience according to patient needs in one integrated system. The platform’s compact footprint and mobility enable integration and transportation within dialysis care settings. At LSI USA ‘24, we had the pleasure of sitting down with Diality’s CEO, Osman Khawar, to explore how their innovations are set to improve the lives of those affected by kidney disease. The full interview is available on our website and YouTube channel. You can also connect with Osman at LSI USA ‘25 next month in Dana Point, California. Want to join us for a Studio Interview at LSI USA ‘25 next month? Reach out to our team today while space is still available.

Xenocor (#LSIUSA25 Innovator) is developing a single-use laparoscopic video platform to address the costs, risks, waste, and hassles associated with legacy platforms that were largely designed in the 1980s. Their flagship product, the Saberscope®, is the world's first true HD, fog-free, articulating, single-use laparoscope. This 5mm device features a 90-degree articulating tip and offers both manual and auto-focus capabilities, addressing common challenges in minimally invasive surgery such as fogging and complex equipment setups. The Saberscope system includes a compact, reusable Xenobox video processor compatible with any HD monitor or existing tower system. The company has achieved many major milestones recently, including: • Raised a $10M oversubscribed Series A funding round led by GenHenn Venture Fund I. • Successfully redesigned the Saberscope® 2.0 Laparoscopic Video Platform to scale and meet market demand. • Granted an additional patent and submitted a new patent application. • Expanded its R&D team by 66%, strengthening its innovation capabilities. • Conducted its first wet lab with the Saberscope® 2.0, advancing clinical validation. We’re excited to announce that COO Antony Watson has been selected to present Xenocor at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Tony and learn more about Xenocor.

I’m looking forward to attending #LSIUSA25 in Dana Point, California this March! I’m excited for the opportunity to connect with others in the industry. A big thanks to LSI for hosting this amazing event. #LSIUSA #medtech #healthtech #ZeptoLife

Reach Orthopaedics Inc. (#LSIUSA25 Innovator) is developing a durable shoulder implant to treat middle-aged patients suffering from massive irreparable rotator cuff tears (MIRCT). Almost ten percent of the over-50 population has an MIRCT, but the middle-aged population is underserved by current treatment options. Designed by a team of orthopaedic surgeons and engineers with over 100 years of combined experience, Reach Orthopaedics’ novel implant restores shoulder alignment – increasing mobility and function, while reducing chronic pain. The company has achieved many major milestones recently, including: • Received FDA Breakthrough Device Designation • Cadaver studies and computational modelling completed, leading to design freeze • Advancing toward its first-in-human study, with an application in progress • Actively raising a seed round of financing We’re excited to announce that Co-Founder & CEO, Christina Goudy has been selected to present Reach Orthopaedics at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Christina and learn more about Reach Orthopaedics.

In 2024, RedDrop Dx received FDA 510(k) clearance for its RedDrop One blood collection device for prescription use. RedDrop One is a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system for Home Health, Point-of-Care, Centralized, and Remote Clinical Trials testing. RedDrop One offers several key advantages over traditional blood collection methods, including the ability to collect a larger volume of blood more easily, with increased reliability and reduced discomfort for the user. The device is designed to meet the needs of both patients and healthcare providers by offering a more efficient and less painful blood collection experience. The effectiveness of RedDrop One for self-collection of blood samples was supported by a clinical trial with 100 participants, demonstrating a 97% success rate when following the device's Instructions for Use. During LSI USA ‘24 we had the pleasure of sitting down with Kris Buchanan, CEO of RedDrop Dx, for a Studio Interview to discuss the key advantages that RedDrop One offers over traditional blood collection methods. The full interview is available on our website and YouTube channel. You can also connect with Kris at LSI USA ‘25 next month in Dana Point, California. Want to join us for a Studio Interview at LSI USA ‘25 next month? Reach out to our team today while space is still available.

BioAro Inc. is a biotechnology company specializing in genomics, artificial intelligence, and blockchain technologies. The company offers whole genome sequencing, microbiome testing, and software solutions to support clinical testing offerings and improve the overall efficiency of healthcare practices. Through genetic data analysis, BioAro reveals inherited and acquired health risks, aiding decisions on diseases, pharmacogenomics, and nutrition. They ensure data security via blockchain, enabling global sample submission and breaking down international barriers for comprehensive health understanding and proactive lifestyle choices. Beyond diagnostics, BioAro operates precision clinics focused on longevity, gut health, dermatology, and hypertension, integrating genetic insights with personalized care. Their Genetic Monitoring Program continuously analyzes health data, providing proactive alerts and recommendations. Through these innovations, BioAro aims to empower individuals and healthcare providers with actionable insights for better health outcomes. We’re excited to announce that CEO, Dr. Anmol Kapoor has been selected to present BioAro at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Dr. Kapoor and learn more about BioAro.

EndoInnovate (#LSIUSA25 Innovator) is on a mission to revolutionize colon cancer prevention with a focus on innovative technology that enhances early polyp detection and colorectal cancer prevention. The company’s upcoming development, a new oral preparation for colonoscopy, is designed to stain subtle polyps, enhancing detection without adding time to preparation or procedural durations. This product has shown promising results in human pilot studies, successfully staining the colon and highlighting subtle polyps. With strong intellectual property protection and a strategic regulatory pathway via the FDA’s 505(b)(2) process, EndoInnovate is well-positioned to bring this transformative solution to market. EndoInnovate is supported by a formidable team of industry veterans and leading experts in polyp detection who bring a proven track record of bringing innovative solutions to the medical technology market. As they continue to advance their product development, they are actively seeking seed funding. We’re excited to announce that Founder, Toufic Kachaamy MD FASGE AGAF FACG has been selected to present EndoInnovate at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Toufic and learn more about EndoInnovate.

Restera Sleep is a clinical-stage medical technology company focused on developing an innovative treatment for sleep apnea.  This system works by delivering mild electrical pulses to the hypoglossal nerve, which controls tongue movements, thereby preventing the tongue from collapsing backward and obstructing the airway during sleep. This approach aims to maintain an open airway, reducing the occurrence of apneas and improving sleep quality. Want to learn more about Restera? Catch Rick O'Connor’s full video presentation from LSI USA ‘24 on our website and YouTube channel. Plus, don’t miss Rick’s return to LSI USA '25 this March, where he will present the latest updates from Restera. Want to get involved at LSI USA ‘25? We’re still accepting registrations to attend the event for a limited time. Apply today while space is still available.

Hy2Care® BV (#LSIUSA25 Innovator) is a clinical phase company pursuing a breakthrough therapy with its CartRevive® hydrogel implant. The company’s vision is to support patients in the fight against osteoarthritis. Its lead product, CartRevive, is a hydrogel implant composed of dextran and hyaluronic acid conjugates that form a resorbable scaffold when injected. The hydrogel enables the natural restoration of tissue defects by creating an environment conducive to cell regrowth that proceeds toward the restoration of smooth hyaline cartilage. In October 2024, Hy2Care® completed the second phase of its clinical trial, treating the 46th patient with the CartRevive® hydrogel implant. This phase was approved by the Medical Ethical Review Committee of UMC Utrecht following the successful completion of an initial safety group of 10 patients, which began in 2022. The second phase of the clinical trial was conducted in collaboration with Dutch hospitals UMC Utrecht, Elisabeth-TweeSteden Ziekenhuis (ETZ), Maastricht UMC+, and Martini Hospital Groningen. At the end of 2024, Hy2Care® submitted an Investigational Device Exemption (IDE), marking an important step in its preparations to enter the US market. The first patient treatment is expected in early 2026, aligning with Hy2Care’s European goals, as CE marking is also anticipated by that time. We’re excited to announce that CEO, Leo Smit and COO, Sanna Severins have been selected to present Hy2Care® at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Leo and Sanna to learn more about Hy2Care®.

QUANTiSCOPE® leverages deep learning and image-based innovation to pioneer PhenotypIQ® digital twin technology, transforming the sustainability, safety, and efficacy of drug discovery, bio-processing, and bio-manufacturing. By integrating cutting-edge imaging and NLP AI into user-friendly dashboards, Quantiscope® streamlines decision-making for researchers and regulators developing critical therapies. The platform offers a modern, reliable solution to replace outdated tools, accelerating the creation of safer and more effective treatments. In 2024 the company: • Represented MIT Startup Exchange in Japan and South Korea. • Was part of the Novo Nordisk Bio-Innovation Hub Greenhouse, NVIDIA Inception Program, Altitude Lab, and ARPA-H Catalyst Network. We’re excited to announce that Co-Founder, Kevin Christopher has been selected to present Quantiscope at LSI USA ‘25 this March 17-21. Join us in Dana Point, California to meet with Kevin and learn more about Quantiscope.