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Classified in: Health, Science and technology
Subject: FDA

cultivate(MD) Capital Funds Portfolio Company SentiAR Announces Second FDA Clearance for CommandEPtm Interface


GRAND RAPIDS, Mich., Oct. 23, 2023 /PRNewswire/ -- cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that one of their portfolio companies, St. Louis, Missouri-based SentiAR, Inc., a pioneer in using Augmented Reality (AR) visualization technology for cardiac ablation procedures, has received their second FDA 510K clearance for CommandEPtm, adding a new integration.

cultivate(MD) is focused on partnering with medical device companies to deliver truly innovative solutions to market.

CommandEPtm integrates existing 3D cardiac mapping systems to create a real time 3D holographic interface that provides physicians with an interactive, 360-degree view of the patient's specific anatomy to allow them to deliver cardiac ablation therapy with more precision. The CommandEP system utilizes a specially designed headset worn by the physician allowing hands-free manipulation of the patient's data for the first time, in addition to real-time heart anatomy and catheter locations inside the heart. This technology provides physicians control of their digital tools during cardiac ablation procedures.

Berk Tas, CEO of SentiAR said, "We are excited to have gained our second 510K clearance for our innovative CommandEPtm technology with a new integration. This new clearance allows us to continue expanding our clinical and industry partnerships. Our physicians have been looking for a tool that can provide full 3D visualization in real-time while allowing hands-free control of images. We are honored to be able to provide this to our physicians." 

Gregory Michaud, MD, Clinical Director, Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias at Massachusetts General Hospital said "Our initial clinical experience with the CommandEP system has been promising. Being able to see patient anatomy in full 3D visualization with contact force allows us to identify targets and navigate more efficiently. We look forward to continuing our use of the system as new features are developed."

R. Sean Churchill, MD, MBA, Managing Director, cultivate(MD) Capital Funds and SentiAR Board Member said, "cultivate(MD) is focused on partnering with early stage medical device companies to deliver truly innovative solutions to market. This is why cultivate(MD) Capital Funds took the opportunity to lead SentiAR's series A round and become the company's largest stakeholder. We are excited for SentiAR's latest 510K clearance that allows the physician unmatched visibility and precision with their cardiac ablation procedures."

CommandEP is the first application of its kind in the world and SentiAR anticipates completion of new clinical studies later this year.

About SentiAR:

SentiAR, Inc., based in St. Louis, MO, was founded by Dr. Jennifer Silva, MD, FHRS, FACC, FAHA, Dr. Jonathan Silva, PhD of Washington University in St Louis and Mike Southworth, MS. SentiAR received an SBIR award from NIH alongside support from BioGenerator and Cultivation Capital to start its journey alongside support from cultivate(MD), TechWald Holdings, Medventure Partners, Cultivation Capital Biogenerator and Harmonix. Following the founding team's vision SentiAR has created the first application of Mixed Reality technology for use during interventional procedures, starting with cardiac ablation procedures, including the treatment of atrial fibrillation. The SentiAR platform provides an immersive command center for the clinicians by presenting a 3D hologram of the patient's electro-anatomic data in real-time. This solution gives the clinician unprecedented control via SentiAR's patent-protected, intuitive gaze interface and provides invaluable insight to guide physician diagnosis and catheter navigation. Learn more about SentiAR at https://sentiar.com.

About cultivate(MD) Capital Funds

As a medical device venture capital fund, cultivate(MD) is dedicated to bringing emerging health care innovations to market, with a special focus on medical device and orthopedic technologies. cultivate(MD) is focused on investing in early stage healthcare companies with innovative technologies that have demonstrated evidence of effectiveness. For more information, visit: https://cultivate-md.com

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations, assumptions, and other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only as of the date on which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions.

SOURCE cultivate(MD)


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