Amsel Medical Corporation Announces Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Amsel Endo Occluder Device

The Amsel Endo Occluder device is an endoscopic ligating clip applier and clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amsel Medical Corporation today announced clearance of a Pre-Marketing Notification (510(k)) by the US Food and Drug Administration (FDA) for its Amsel Endo Occluder. The Pre-Market Notification is the third 510(k) clearance¹ received by the company for its family of Amsel Occluder Devices².

About the Amsel Endo Occluder
Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and tubular (ductal) structures. The device is a mechanical occlusion clip delivered through a fine needle that when deployed transfixes the target vessel while clamping it shut. The Amsel Endo Occluder device is an endoscopic ligating clip applier and clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, “We are thrilled to expand the Amsel Occluder family of single-use, site-specific vascular control devices into the endoscopic and minimally invasive surgery market with this recent Pre-Marketing Notification (510(k)) by the US Food and Drug Administration. The Amsel Occluder possesses the ability to transfix and ligate a selected vessel or duct. We anticipate significant clinical interest for this innovative technology in the markets where the Amsel Occluder Device is cleared for commercial distribution.”

About the Endoscopic Market
Conventional minimally invasive surgical systems includes techniques such as laparoscopy and endoscopy. Laparoscopy is a minimally invasive surgical procedure which is used to examine the internal organs inside the abdomen³. Endoscopy allows both operations on more fragile patients, notably the elderly, and the treatment of more complex diseases, such as cancer. Other benefits of endoscopy include reduced post-operative pain and risks of complications, rapid healing, lighter anesthesia and a shorter period of hospital stay. Surgery, interventional radiology, and advanced endoscopy have all developed minimally invasive techniques to effectively treat a variety of diseases to bring about a positive impact on patients' postoperative outcomes. The global market for specialty endoscopic surgery products totaled approximately $5.8B in 2016, with the US comprising 48.2% of sales (or $2.8B)⁴. The global market for specialty endoscopic surgery products is forecast to grow at a 4.6% CAGR, reaching $7.8B in 2021⁴. The global endoscopy equipment market was valued at USD 24.32B in 2016 and is projected to reach USD 34.82B by 2022, at a CAGR of 6.4% during the forecast period⁵.

About the Amsel Medical Corporation Family of Occluder Devices
The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as tubular structures) during surgical procedures. The Amsel Occluder Device is intended for use in general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter. The Amsel Occluder Device employs a proprietary mechanical design that enables a vessel clamp to be introduced during open or endoscopic surgery. The Amsel Occluder Device transfixes the target vessel with the clamp to provide closure.

About Amsel Medical Corporation
Amsel Medical Corporation, a development stage medical device company, founded in 2011, is developing The Amsel Occluder Device intended for simple and secure vessel or duct closure. The company has operations in Cambridge, MA, and Tel Aviv, Israel. The Amsel Occluder Device addresses an estimated 31 million^6,7, annual US surgical procedures where vessel closure is required.

Previous Announcements
On September 25, 2017, Amsel Medical Corporation announced Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Low-Profile Amsel Occluder Device.

On November 28, 2016, Amsel Medical Corporation announced Presentation of “A Novel Mechanical Closure Device for Left Atrial Appendage Orifice and Closure of Right Atrial Incision” at the International Conference for Innovations in Cardiovascular Systems (ICI) Meeting 2016 (Israel).

On October 27, 2015, Amsel Medical Corporation announced Filing of 2nd 510(k) Pre-Marketing Notification with the US Food and Drug Administration for the Amsel Occluder Device.

On February 2, 2015, Amsel Medical Corporation announced Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Amsel Occluder Device.

On July 25, 2014, Amsel Medical Corporation and the Mayo Clinic Announced Signing of a Patent License Agreement.

On May 20, 2014, Amsel Medical Corporation announced that it had successfully completed filing of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Amsel Occluder Device.

Publications
Miller A, Lilach N, Botero-Anug A, Willenz U, and Miller R: Comparison of a Novel Secure Transfixing Blood Vessel Occluder with the Hemoclip in the Porcine Model. Journal of Surgical Research 2017;209: 211 – 219.

Miller A, Lilach N, Miller R. and Kabnick L: A Novel, Simple, and Secure, Percutaneous Vessel Occluder for the Treatment of Varicose Veins. J. Vasc Surg; Venous and Lymphatic Disease 2017;5:114-20.

L. Kabnick and A. Miller. Ultrasound-placed clips will make CHIVA more widely applicable. Vascular and Endovascular Challenges Update. BIBA Publishing. Ed. Roger M Greenhalgh 2016; 529-534.

Szold A, Miller A, Lilach N, Botero-Anug A, Miller R and Schwaitzberg, S: A Preclinical Animal Study of a Novel, Simple, and Secure Duct and Vessel Occluder for Laparoscopic Surgery. Surgical Endoscopy 2018, 1-10, DOI: 10.1007/s00464-018-6052-0

Medical Society Poster Presentations

Miller A, Lilach N, Miller R. A Novel secure Vessel Occluder for Minimally Invasive and Percutaneous Treatments. Annual Meeting, The Society of Vascular Surgery, Boston, June 5-7, 2014.

A Novel Vessel and Duct Occluder for Laparoscopic Surgery. Arnold Miller, Nir Lilach, Raanan Miller and Steven Schwaitzberg. SAGES Annual Meeting, Boston, March 16-19, 2016.

Arnold Miller, Nir Lilach, Raanan Miller, and Hillel Laks. A Novel Mechanical Closure Device for Left Atrial Appendage Orifice and Closure of Right Atrial Incision ICI Dec 4-6, 2016 Tel Aviv, Israel

¹ Amsel Medical Corporation previously received FDA clearances of Pre-Marketing Notification (510(k)) on January 23, 2015 and September 14, 2017.
² Patents issued and pending
³ Global Minimally Invasive Surgical Systems Market: Detailed Analysis and Focus on Robotic, Endoscopic, and Laparoscopic Surgeries for 21 Countries - Analysis and Forecast (2018-2025), July 2018
⁴ Global Specialty Endoscopic Surgery Devices Market Report 2017: Market totaled $5.8Bn in 2016 and is Projected to Reach $7.8Bn by 2021 - ResearchAndMarkets.com, January 2018
⁵ Endoscopy Equipment Market by Product (Endoscope (Flexible, Rigid, Capsule) Visualization Systems, Endoscopic Ultrasound, Insufflator)), Application (GI Endoscopy, Laparoscopy, Cystoscopy, Bronchoscopy, Colonoscopy, Arthroscopy) - Global Forecast to 2022, December 2017
⁶ CDC/NCHS National Hospital Discharge Survey, 2010
⁷ Company Estimates