Atlas Endoscopy is revolutionizing gastrointestinal diagnostics with a groundbreaking robotic system that performs painless, unsedated colonoscopies using magnetic guidance and an ultra-flexible endoscope. Our innovative technology eliminates the need for sedation, decontamination, and lengthy recovery times, allowing patients to complete procedures in just 30 minutes. Designed for both upper and lower GI applications, our solution enhances accessibility, reduces healthcare costs, and increases capacity by enabling satellite center,out-of-hospital use in clinics and GP surgeries worldwide
Atlas Endoscopy is addressing critical inefficiencies in colorectal cancer screening and diagnosis, where traditional colonoscopy faces significant limitations. Over 80 million colonoscopies are performed annually worldwide, yet accessibility remains a challenge due to the need for sedation, risk of cross contamination due to the reusable colonoscope, and specialized facilities. Our groundbreaking robotic colonoscopy system (Ren System) combines magnetic guidance technology and an ultra-flexible endoscope Easyflec single use colonoscope) to eliminate the need for sedation and decontamination processes. This innovation enables procedures to be performed in 30 minutes from arrival to exit, compared to the traditional 2-3 hours. Patients can immediately resume daily activities without requiring an escort, making screening more accessible and appealing. Designed for scalability, our solution targets both large public endoscopy centers and small private clinics. The device is built on a cost-effective 'razor blade' model, where single-use components ensure sterility while maintaining affordability. This approach addresses the urgent need to expand capacity and reduce costs in healthcare systems. With colonoscopy as our first application, our system directly tackles the pressing issue of colorectal cancer, the second leading cause of cancer deaths globally. By streamlining workflows and enabling out-of-hospital procedures, Atlas Endoscopy is redefining GI diagnostics, with the potential to reduce costs, improve access, and save lives.
Our team combines exceptional expertise in medical technology, clinical research, and regulatory strategy to revolutionize Colonoscopy. Executive-team includes:
- Donato Mazzeo, CEO, a seasoned med-tech entrepreneur with a proven track record of scaling innovative technologies.
- Pietro Valdastri, CTO, an internationally renowned expert in medical robotics and magnetic guidance systems.
- Alberto Arena, RA/QA/Clinical Director, who secured regulatory approvals for robotic colonoscopy devices at Era Endoscopy in Europe, US, and Japan.
- Bruno Scaglioni, VP of Engineering, a specialist in medical device design, ensuring safety and performance.
- We are guided by a Medical Advisory Board, chaired by Keith Obstein of Vanderbilt University, providing critical clinical insight.
- Our Board of Directors, including Timo Hercegfi, former CEO of Invendo Medical, adds strategic oversight. Timo led Invendo’s development of Robotic-single-use endoscopic technologies, acquired by Ambu for$250million in 2017.
This unique blend of expertise and leadership positions us to redefine Colonoscopy and scale globally.
Our go-to-market strategy focuses on the U.S. colonoscopy market, leveraging a phased commercialization plan post-FDA approval. From 2026-2027, we will prioritize controlled product launches and field testing in 3-5 key metropolitan areas with high adoption potential. Pilot programs will be launched in 2-3 leading institutions, such as Vanderbilt University Medical Center, Mayo Clinic, Cleveland Clinic, or Johns Hopkins, to collect clinical data and refine the product. Additionally, we aim to expand into GI clinics, including Veterans Clinics and private equity-backed groups like GI Alliance, Gastro Health, and United Digestive. To drive adoption, we plan to collaborate with the American Society for Gastrointestinal Endoscopy (ASGE) through seminars and publications. Building credibility through patient and clinician testimonials, case studies, and reports will further demonstrate the clinical effectiveness of our REN robotic platform. From 2027-2028, we aim to scale commercially by establishing distribution partnerships with prominent U.S. suppliers, including Medtronic, Johnson & Johnson, Olympus, Boston Scientific, Ambu, Cook Medical, and Nissha Medical, leveraging their strong presence in the endoscopy market. This comprehensive strategy is designed to maximize adoption, refine the technology, and ensure a successful scale-up in the competitive endoscopy landscape.
Our revenue model follows a razor blade strategy, combining upfront sales, recurring fees, and disposable usage to optimize long-term profitability.
Core System Sales: The REN System is priced at $350,000, offering a cutting-edge robotic colonoscopy platform. This one-time purchase supports high-throughput procedures and long-term use.
Annual Maintenance Fees: A yearly fee of $35,000 ensures system updates, servicing, and support, providing consistent performance and compliance.
Disposable Components (EasyFlex): Each procedure requires a single-use EasyFlex component priced at $600. With over 80 million colonoscopies performed globally each year, this creates substantial recurring revenue. For example, a facility conducting 1,000 procedures annually generates $600,000 in disposable sales per system. This model aligns with the operational needs of healthcare providers, ensuring affordability while maximizing revenue. By eliminating sedation and decontamination, the REN System increases procedure throughput, making it a cost-effective choice for high-volume GI centers. As adoption scales, recurring revenue from disposables and maintenance fees grows proportionally, ensuring sustained profitability and maximizing clinical and financial impact in the global colonoscopy market.
We are seeking $10 million in funding to advance the development and commercialization of our REN robotic colonoscopy platform. These funds will be allocated to achieve the following critical milestones:
- Obtain FDA Approval (by the end of 2025): Conduct a 20-patient clinical trial to demonstrate non-inferiority to current colonoscopy procedures, providing the data required for FDA approval.
- Obtain CE Mark: Finalize the necessary steps to secure regulatory approval for commercialization in the EU.
- Validate Financial Viability: Prove our pricing model, cost of goods sold (COGS), profit margins, and overall cost structure. Controlled Product Launch and Field Testing: Launch our product in a controlled setting to collect feedback and refine the platform for broader adoption.
- Select Distribution Partners (2026): Identify and secure distribution partners in the US and EU to accelerate market penetration. Post-regulatory submissions, we plan to raise a Series A round in Q4 2025, ideally led by a US-based investor. This funding will support additional clinical applications, advanced product features, and execution of our US and EU go-to-market strategy. We will also evaluate strategic options, including M&A opportunities with major endoscopy companies operating in the US market. Our targeted and scalable strategy ensures that this investment not only accelerates product commercialization but also positions us for rapid growth and potential market leadership.
After completing the first generation of our technology, we are now focused on finalizing our clinical strategy. In October 2024, we submitted a Q-Submission to the FDA and are expecting written feedback by January 2025. This feedback will provide critical confirmation of our clinical strategy and enable us to initiate human studies at one or more of our partner clinical centers in the US and EU.
$4.6 million seed round financed by Innovate UK Grant and investments by management and private angel investors
