In a successful week for the medical technology companies in the LSI Alumni community, we saw the LSI Alumni raise a Series C funding round, receive FDA Breakthrough Designation, add new board members, and much more on the road to LSI Europe '24 in Sintra, Portugal (Sept 16-20).
Raised a $180M Series C extension and growth debt expansion round. The company is transforming surgery by implementing a scalable, end-to-end software and AI platform, allowing the capture and use of novel data and applications to improve precision and safety.
Received FDA Breakthrough Device Designation for its Intraluminal Bypass Device. The CG-100 Intraluminal Bypass Device is a single-use, temporary intraluminal bypass device, intended for patients with colorectal cancer requiring an anastomosis and are to receive a protective stoma under routine clinical practice.
Joined Kidney Care Partners, a leading kidney care multi-stakeholder coalition representing patient advocates, physician organizations, health professional groups, dialysis providers, researchers, and manufacturers. The Moda-flx Hemodialysis System provides clinicians the flexibility to easily customize each hemodialysis experience according to patient needs in one integrated system.
Announced first patients enrolled in US pivotal study of its AI-based image analysis module for lung cancer. The company is dedicated to advancing the care of cancer patients by combining intraoperative fresh tissue imaging and artificial intelligence.
Successfully completed the Stage 2 audit under the EU Medical Device Regulation for the company's mobility analysis and fall prevention technology. The company specializes in advanced AI-based 3D motion tracking and analysis solutions using ubiquitous smartphone cameras to address the critical challenge of fall prevention in the aging population.
Completed clinical study enrollment of 508 patients well ahead of schedule at The Ohio State University Wexner Medical Center. The company's patented and FDA cleared sensor provides a predictive (vs. responsive) respiratory profile including Respiratory Rate (RR), relative Tidal Volume (rTV) and Seconds Since Last Breath (SSLB) that are all delivered continuously and in real time.
Raised $2.5M as it pursues a new type of artificial artery for bypass surgery. The company is reshaping cardiac bypass surgery through its less-invasive, innovative artificial graft technology.
Received FDA clearance of its Investigational New Drug (IND) application for PTM-101 to treat pancreatic cancer patients, a population with challenging diagnoses and limited treatment options. PTM-101, has successfully been evaluated in a Phase 1 clinical trial in treatment naïve, localized non-metastatic pancreatic cancer patients.
Announced the appointment of LSI Alumni Paul LaViolette to its Board of Directors. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.
Announced its strategic expansion into the field of robotics and navigation through the appointment of seasoned leaders, Larry Hazbun, Senior Vice President of Robotics, and Kirstin Widding, Senior Vice President of Hip & Knee. The company holds proprietary expertise and intellectual property in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions to provide seamless data-backed care to optimize individual patient outcomes.
Awarded a $500K SBIR Phase IIb grant from the National Science Foundation. With this new grant, Samay’s total funding reaches $4.9 million, with over half of that amount being non-dilutive capital.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in our Weekly Recap, and follow our blog for the latest medical device news and advancements.
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