Our solution is a state of the art steerable drilling technology and a novel implant featuring advanced precision to ensure higher accuracy in complex orthopedics and neurosurgical procedures and improve patient outcomes.
As a spinoff from UT Austin, ARTS Surgical Inc. is pioneering a new era in orthopedic and neurosurgical procedures with our state-of-the-art steerable drilling robotic system. Our mission is to revolutionize minimally invasive surgeries by enhancing precision, safety, and efficiency in diagnosing and treating conditions involving complex hard tissue anatomies. A key limitation of current surgical tools lies in their rigidity, which restricts access to straight-line trajectories and prevents clinicians from reaching deep, intricate anatomical regions. This rigidity poses significant challenges when navigating hard-to-reach areas such as the spine, pelvis, shoulder, and knee, where conventional instruments and implants often fail to provide the flexibility needed for accurate and minimally invasive treatment. With ARTS Surgical’s intuitive solution, surgeons can overcome these barriers, safely and accurately steering through hard tissue to reach points of interest without disrupting existing surgical workflows or increasing operation times. By addressing these limitations, we aim to improve patient outcomes and transform the standard of care for orthopedic and metastatic bone tumor interventions.
Dr. Alambeigi, an Assistant Professor at UT Austin, is the founder and CEO of ARTS Surgical Inc. With over 15 years in medical and surgical robotics, he is the primary inventor of the technology, possessing expertise in both technical development and commercialization.
Dr. Jordan Amadio, a board-certified neurosurgeon, serves as the Chief Medical Officer and principal clinical advisor. He has been involved in the technology's development since its inception.
Dr. Susheela Sharma, the Chief Technology Officer, began working on this project during her Ph.D. at UT Austin, focusing on medical devices and surgical robotics.
Dr. Douglas Beall is the clinical advisor of company and renowned clinician in musculoskeletal imaging and interventional spine care.
Mr. Shane Johnson, with over 25 years in the medical device industry, serves as the Strategic Business Advisor. He has guided companies from startups to established organizations. Wilson Sonsini Goodrich & Rosati provides legal counsel to company.
We are finalizing a partnership agreement with a leading Japanese manufacturer specializing in mechatronic components and ball bearings. This company has over a century of experience in engineering and manufacturing, contributing significantly to various industries worldwide. Their expertise in precision manufacturing and commitment to quality make them an ideal partner to support the production of our steerable drilling device. With this partnership, our go-to-market strategy is structured in two main phases:
- Handheld Device Development and FDA Clearance (Years 1-5): We will develop a handheld version of our steerable drilling system and pursue 510(k) FDA clearance. Upon approval, we will commercialize this device in hospitals, providing a foundation for market entry.
- Partnership with Established Robotic Companies (Years 2-5): Concurrently, we will collaborate with leading medical robotic companies, such as Medtronic's Mazor robot and Globous, to develop an end-effector compatible with their existing systems. This partnership will leverage their established hospital networks, accelerating our entry into the robotic surgery market.
As we gain market traction and secure FDA clearance for our handheld device, we will expand our manufacturing capabilities to produce components for major robotic companies like Globus and Medtronic. This strategic move will position us as a key supplier in the robotic surgery industry. By executing this phased approach, we aim to establish a strong market presence, foster strategic partnerships, and drive the adoption of our innovative steerable drilling technology.
As previously outlined, our go-to-market strategy comprises two phases. In Phase 2, commencing in Year 2, we plan to establish partnerships with major manufacturers to enhance our revenue streams and increase the company's valuation, thereby reducing the need for additional capital raises. Simultaneously, we are pursuing FDA approval for our handheld device. Our primary revenue sources for both the handheld device and robotic end-effector include:
One-Time Actuation Components: Each use of our drilling system requires a one-time actuation component, generating immediate revenue with each procedure.
Consumables: We offer consumable items such as steering guides (designed for up to 10 uses) and single-use drilling instruments. These consumables provide a continuous revenue stream, as they need to be replaced after each use.
This dual revenue model—comprising both one-time sales and recurring consumable purchases—ensures a steady income flow, supporting sustainable business growth. By integrating these components into our product offerings, we aim to establish a robust financial foundation that will facilitate the successful commercialization of our innovative medical devices.
Considering the current progress of our technology and the significant non-dilutive funding invested to date, we are seeking $1M in funding to advance ARTS Surgical Inc. toward regulatory approval and the commercialization of our innovative steerable drilling device. Over the next two years, this funding will be strategically allocated to achieve key milestones essential for market entry and enhancing patient care: Establishing a Quality Management System (QMS): Implementing a robust QMS is essential for ensuring compliance with FDA regulations and maintaining consistent product quality. This will lay the foundation for successful device testing, validation, and eventual market entry. Expanding the Team: We plan to hire highly skilled engineers to conduct rigorous product testing and support QMS implementation. Their expertise will also accelerate the refinement of our device, ensuring safety, reliability, and effectiveness. Preclinical Studies and FDA Approval Preparation: We will conduct preclinical studies and testing to gather the necessary data for FDA 510(k) clearance, focusing on safety and efficacy. This is a critical step in bringing our device to market. Regulatory and Commercialization Advisors: Engaging experienced advisors in FDA regulatory pathways and commercialization strategies will help us navigate the 510(k) process efficiently and position us for a successful market launch. Operational and Development Needs: Additional funding will support other essential activities, including supply chain management, documentation, and preparing for scale-up. This funding will enable us to achieve FDA clearance, build commercialization infrastructure, and deliver a transformative solution to address unmet needs in orthopedic and neurosurgical procedures.
We have successfully developed and evaluated prototypes of the steerable drilling device at UT Austin. Our work has resulted in the publication of approximately 15 papers in prestigious conferences and journals, earning us numerous awards and recognitions. Additionally, we have filed an intellectual property (IP) through UT Austin, which has recently been published and licensed to ARTS Surgical Inc. Our next step is to secure funding to advance this technology toward FDA clearance and eventual commercialization.
So far, we have developed working prototypes of the steerable drilling technology and our implant with the support of NIH R21 Trailblazer award and UT Austin's internal commercialization awards and internal funding.
