The SimpleStitch™ Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue (e.g., closure and healing of ESD/EMR sites and closing of fistula, perforation, or leaks).
Rx only. Refer to the Instructions for Use (IFU) for indications, contraindications, warnings, and precautions.
Large GI defects needed a better endoscopic answer.
The problem
Clips are generally limited to mucosal closure and small defects. Currently available endoscopic suturing devices are often cumbersome to operate, require substantial training due to their steep learning curves, and are associated with high costs that limit their adoption and widespread clinical use.
Our approach
A single-use, disposable suturing device that works with standard flexible endoscopes. The handle and circular needle are designed to be easy to operate and to support an intuitive suturing technique, with the ability to deploy running and interrupted stitches.
How the SimpleStitch™ Suturing System works
Mounted on the distal end of a standard endoscope
Set up
Easy setup: the single-use device attaches to a standard flexible endoscope, either a gastroscope or a colonoscope.
Stitch
The easy-to-operate handle and circular needle allow for an intuitive technique, deploying running or interrupted stitches.
Cinch
A unique cinch design secures the suture with knotless fixation at any location along the suture.
Preclinical evidence
In a porcine survival study, the SimpleStitch™ Suturing System closed 100% of gastric and colonic mucosal defects, with closure times similar to a commercially available suturing system and significantly lower endoscopist workload scores.1 In a randomized ex-vivo study of pursestring suturing, endoscopists achieved higher simulator scores and reported lower workload with SimpleStitch™, with the largest difference among participants without prior suturing experience.2
Features
Options for both gastroscope and colonoscope
Single-use and disposable
Designed to be simple and intuitive
Procedure video
POEM closure in a porcine model using the SimpleStitch™ Suturing System. Preclinical footage; not a human clinical procedure.
Aggarwal M, AbiMansour JP, Matar R, et al. Evaluation of the Envision Endoscopy SimpleStitch suturing system for closure of gastrointestinal defects in a porcine model. Surg Endosc. 2026;40:3510–3518. doi:10.1007/s00464-026-12718-4
Walradt T, Szvarca D, Jirapinyo P. Comparison of a novel endoscopic suturing device to a conventional endoscopic suturing device for pursestring transoral outlet reduction in an ex-vivo model: a randomized, controlled study [abstract Su2026]. Gastrointest Endosc. 2024;99(6S):AB750.
Milestones
2018Company foundedDr. Azadeh Khanicheh and Dr. Christopher Thompson launch EnVision Endoscopy in Massachusetts.
2019MassNextGen awardMassachusetts Life Sciences Center names Dr. Khanicheh an inaugural awardee.
2019MassChallenge BostonFinalist and Platinum winner.
2019NSF SBIR Phase INational Science Foundation Small Business Innovation Research funding.
2020MedTech InnovatorSelected for the MedTech Innovator Accelerator program.
2021NSF SBIR Phase IIContinued National Science Foundation funding for product development.
2025FDA clearanceThe SimpleStitch™ Suturing System receives FDA clearance.
2026Limited market releaseThe SimpleStitch™ Suturing System launches in a limited market release in the U.S.
Leadership & Board of Directors
Our team combines decades of device development and launch experience with leadership in therapeutic endoscopy.
Founders
Azadeh Khanicheh, Ph.D.
Co-Founder, President & CEO
Dr. Azadeh Khanicheh has over two decades of experience leading innovation programs and bringing medical devices to market. Throughout her career, the teams she has led have advanced multiple products from initial concept through development and commercial launch. Her roles in the medical device industry, including at Pentax Medical and BD Medical, have given her extensive experience collaborating with physicians and a deep understanding of clinical needs in endoscopic surgery. Driven by these unmet needs, she founded EnVision Endoscopy to develop solutions that address challenges in endoscopic procedures.
Dr. Khanicheh earned her Ph.D. from Northeastern University, then completed a postdoctoral research fellowship and served as a visiting research scientist at the Athinoula A. Martinos Center for Biomedical Imaging at Harvard Medical School. She is an inventor on more than 20 patents.
Christopher C. Thompson, MD, MSc, FASGE, FACG, AGAF
Co-Founder & Director
Dr. Christopher Thompson is Professor of Medicine at Harvard Medical School, Chief of Interventional Gastroenterology at Mass General Brigham, and principal investigator of its Developmental Endoscopy Lab. He is an internationally recognized leader in Natural Orifice Transluminal Endoscopic Surgery (NOTES) and bariatric endoscopy, and a founding member of NOSCAR, the SAGES/ASGE consortium shaping NOTES guidelines.
Dr. Thompson co-founded Beacon Endoscopic (acquired by Covidien), GI Windows, Enterasense, and Everself, and has advised Fortune 500 companies, venture firms, and startups. He received his MD from Penn State College of Medicine and completed clinical and research fellowships at Harvard Medical School.
Board of Directors
Azadeh Khanicheh, Ph.D.
Director
EnVision Endoscopy
Christopher C. Thompson, MD
Director
Chief of Interventional Gastroenterology, Mass General Brigham Professor of Medicine, Harvard Medical School
Jordan Milford
Director
Olympus Corporation of the Americas
Vice President of Business Development at Olympus Corporation of the Americas, where he leads acquisitions, venture investments, licensing and partnerships for the GI, urology and respiratory device businesses. He joined Olympus in 2013 after developing spine and trauma devices at DePuy Synthes and Biomet, and holds an MBA from Villanova University and a BS in biomedical engineering from Virginia Tech.
Vinit Nijhawan
Board Observer
MassVentures
Managing Director of MassVentures, the Massachusetts public venture capital fund for early-stage companies. A serial entrepreneur who has built five startups, he previously led Boston University’s Office of Technology Development, launching eight venture-backed spinoffs, and teaches entrepreneurship at BU’s Questrom School of Business.
Amit Hazan
Director
Puma Venture Capital
Founder and Managing Partner of Puma Venture Capital, which invests across the digital and robotic surgery ecosystem. He previously spent many years as a medical technology equity research analyst on Wall Street, most recently at Goldman Sachs, and holds a JD/MBA from Santa Clara University.
Yousif A-Rahim, MD
Board Observer
Gastroenterologist specializing in interventional endoscopy and minimally invasive treatment of GI disease, and a Lecturer in Medicine at Harvard Medical School. He co-founded Pacific Endoscopy Center in Hawaii, served as Chief Medical Officer of Covenant Physician Partners, and earned his MD and PhD at Penn State before training at Beth Israel Deaconess Medical Center.
Hiroaki Kobayashi, MD
Director
UTEC Ventures
Partner at UTEC Ventures (The University of Tokyo Edge Capital Partners), focusing on seed and early-stage investments in healthcare, medtech and life sciences. A former emergency and ICU physician with medtech business development experience, he earned his MD from the University of Tokyo and an MBA from the University of Michigan’s Ross School of Business as a Fulbright Scholar.
Our Investors
Contact us
Contact our team to learn more about the SimpleStitch™ Suturing System, place an order, or discuss partnership opportunities.
