EndoSound Vision System™ Granted Transitional CMS Pass-Through Code

Portland, OR, (June 18th, 2024) — EndoSound®, Inc., is thrilled to announce that the Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) code, effective July 1, 2024, for the companies EndoSound Vision System™, or EVS™, a revolutionary advancement in endoscopic ultrasound (EUS) technology.

The CMS TPT status is monumental as it provides outpatient facilities with an incremental Medicare payment for procedures in which the EVS is utilized. This status is granted to new and innovative medical devices that meet eligibility criteria. Pass-through payments are intended to help facilitate patient access to new technologies. Details on the TPT code, C1606, can be found in the July 2024 update of the hospital outpatient prospective payment system, which is accessible on the CMS website.

“We are incredibly proud to receive the TPT status from CMS for the EVS,” said Scott Aldrich, CEO of EndoSound. “This approval underscores the clinical value and innovative nature of our technology. It enables broader access to the benefits of EUS, which is critical for early detection and treatment of gastrointestinal diseases. Our goal is to improve patient outcomes while reducing healthcare costs, and this milestone brings us a big step closer to achieving that.”

The EVS is an innovative, cost-effective solution designed to enhance the capabilities of existing endoscopic equipment, providing high-resolution ultrasound imaging without the need for expensive and complex new scopes. This breakthrough technology promises to improve the accessibility and quality of care for patients undergoing EUS procedures.

EndoSound remains committed to advancing medical technology and improving patient access to care.

About EndoSound

EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms any flexible upper endoscope into a fully functional EUS scope. EndoSound is comprised of an experienced team of scientists and engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.

To learn more about the EVS, please visit endosound.com/endosound-vision-system

For media inquiries, please contact:

Patrick Hurley
VP of Marketing
pr@endosound.com

EVS™ Cart Receives 2024 iF Design Award

In partnership with Modo, Inc., we designed our EVSTM Cart to optimize convenience and stability. We are excited to share that this innovative design was recognized as a 2024 iF Design Award winner.

More than 10,000 entries were received from companies headquartered worldwide for the annual design competition. We hope this cart will play a valuable role in the endoscopy suite, saving time and maximizing workflow, and we are proud to be among this year’s selection of iF Design winners.

Past winners include Apple, Nikon, Siemens Healthineers, Philips, BMW Samsung, Google, and Canon Inc.

Learn more about the EVS cart and system.

EndoSound® Inc., appoints medical device commercial leader Scott Aldrich Jr as Chief Executive Officer

Aldrich’s proven commercial, operational and leadership expertise helps position EndoSound for EVS launch and sustainable growth

Portland, Feb 6, 2024—EndoSound®  Inc., a pioneering medical technology company dedicated to advancing patient care, is pleased to announce the appointment of Scott Aldrich Jr as Chief Executive Officer on February 1st, 2024. Mr Aldrich is joining EndoSound from MotusGI (Nasdaq: MOTS) where he served as Vice President of Commercial and Strategy. Stephen Steinberg MD will remain on the executive leadership team as Chief Medical Officer.

Mr Aldrich brings operational and commercial leadership abilities paired with extensive experience in interventional gastroenterology and medical device imaging. Furthermore, Mr. Aldrich is a seasoned executive with experience in startup organizations, as well as, small/mid cap companies that are both privately and publicly held. He has established a reputation as an authentic leader with the ability to drive execution through clear organizational vision.

 

Mr Aldrich remarked, “I am honored and humbled to be able to assume the role of CEO. Stephen has done a remarkable job in getting EndoSound so far in its journey. EndoSound EVS™ is a customer-focused product that can reduce aggregate healthcare costs and improve patient experience and lives. It is exciting to be bringing this technology that so clearly can transform the GI market and patient access to endoscopic ultrasound to market.  I look forward to working closely with the EndoSound Board of Directors, Stephen, and the rest of the EndoSound team in successfully launching EVS and making the company’s immense potential a reality.”

Stephen Steinberg, MD, commented, “We are thrilled to welcome Scott to the team. He brings a wealth of knowledge in areas that will be extremely important to EndoSound’s success. We believe his leadership style, business acumen and passion make him more than capable to build and grow a revolutionary medical device company.”

About EndoSound

EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms any flexible upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists and engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.

To learn more about the EVS, please visit endosound.com/endosound-vision-system

For media inquiries, please contact:

Patrick Hurley
VP of Marketing
pr@endosound.com

EndoSound® Receives 510(k) Clearance for Breakthrough EVS™ Innovation, a novel Endoscopic Ultrasound (EUS) technology

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  • 510(k) Clearance of first-of-kind Endoscopic Ultrasound (EUS) technology
  • Paves the way for safer and more accessible medical care
  • EndoSound will begin its controlled market release early in Q1 2024

Portland, Jan. 2, 2024—EndoSound® Inc., a pioneering medical technology company dedicated to advancing patient care, is pleased to announce it has received 510(k) clearance from the FDA for its EndoSound Vision SystemTM (EVSTM). This milestone achievement follows the company’s FDA Breakthrough Device designation in July 2021, emphasizing the technology’s safety features and its potential to enhance access to patient care.
The EVS is a novel endoscopic ultrasound (EUS) device that attaches to upper gastrointestinal endoscopes. It easily integrates into any endoscopy center’s existing ecosystem. The EVS is poised to revolutionize the landscape of EUS. With a more economical offering, the EVS can provide greater access to this critical imaging and therapeutic procedure than conventional EUS equipment. EndoSound expects the EVS will shift the site of care to more efficient settings like the ambulatory surgery center (ASC) preferred by patients, providers, and payers.

“We are thrilled to receive 510(k) clearance for our EVS, a testament to the dedication and innovation of the entire EndoSound team. This milestone underscores our commitment to advancing medical technology and improving patient outcomes. With the EVS, we aim to not only enhance the safety of endoscopic procedures but also contribute to expanding access to care for patients worldwide,” said Dr. Stephen Steinberg, President and CEO at EndoSound.

Breakthrough Technology

The FDA’s Breakthrough Device designation recognized the EVS for its groundbreaking approach to patient safety, cost reduction, and ability to increase accessibility to critical medical care. The EVS represents a significant leap forward in medical technology, specifically addressing the critical issue of infections associated with difficult-to-clean endoscope elevators. This clearance validates the system’s effectiveness and safety, underscoring EndoSound’s commitment to advancing healthcare through innovation.

Endoscopic Ultrasound Procedure

Endoscopic Ultrasound (EUS) is a minimally invasive procedure performed to assess diseases of the GI tract and other nearby organs and tissues. High-frequency sound waves produce detailed images of the pancreas, liver, and gallbladder. Currently, over 95% of patients who undergo EUS are seen in a hospital setting. A majority of those patients could be seen in a more efficient setting where patients prefer to be treated, an ASC.

 

About EndoSound

EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms any flexible upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists and engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.

To learn more about the EVS, please visit endosound.com.

For media inquiries, please contact:

Patrick Hurley
VP of Marketing
pr@endosound.com

EndoSound® and AdaptivEndo Partner to Revolutionize Endoscopy with Groundbreaking Technologies

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  • EndoSound® and AdaptivEndo sign letter of intent to expedite innovation in endoscopy.
  • Jointly completed first milestone animal trial including use of the first-ever simultaneous EUS/ERCP device.
  • Collaboration will provide even safer options and more accessible solutions for patient and healthcare providers.

PORTLAND, Ore.–(BUSINESS WIRE)–EndoSound, a pioneer in endoscopic ultrasound technology (EUS), and AdaptivEndo, a leader in single-use endoscopy solutions, are proud to announce their letter of intent to collaborate on a new groundbreaking project that aims to transform the landscape of endoscopy. These two innovative companies have come together to expand EndoSound’s novel ultrasound technology into the single-use endoscopy space, thus improving patient safety and increasing access to care.

“The successful in-vivo lab represents a significant leap forward in the field of endoscopy”

The collaboration between EndoSound and AdaptivEndo recently reached a significant milestone with the successful completion of an in-vivo porcine animal lab. During this trial, the teams demonstrated their ability to perform EUS with a single-use AdaptivEndo gastroscope and an AdaptivEndo duodenoscope. This achievement marked a historic moment as the first-ever simultaneous EUS/ERCP procedure using a singular EUS/ERCP device.

EUS is a vital diagnostic and therapeutic tool in gastroenterology. Traditionally, EUS procedures have been performed with reusable endoscopes, which presents challenges related to infection control, sterilization, and access to care. Part of EndoSound’s mission is to make EUS safer and more accessible as exemplified in its elimination of difficult to clean moving parts (elevator) and delivering a product at a fraction of current costs. By integrating EndoSound’s cutting-edge ultrasound technology into single-use endoscopes, this collaboration aims to bring these efforts further and offer an even safer and more accessible solution for patients and healthcare providers.

“The successful in-vivo lab represents a significant leap forward in the field of endoscopy,” said Dr. Steve Steinberg, CEO of EndoSound. “We are thrilled to partner with AdaptivEndo, a company known for its dedication to innovation and patient safety. Together, we envision a future where healthcare professionals can perform EUS procedures confidently and conveniently with single-use equipment, further expanding patient access and ultimately improving outcomes.”

AdaptivEndo’s President, Ed Fancher, shared similar sentiments: “Our collaboration with EndoSound signifies our commitment to pushing the boundaries of endoscopic technology. By combining our expertise in single-use endoscopy with EndoSound’s revolutionary ultrasound technology, we aim to accelerate the time to market for both of our cutting-edge technologies. This partnership will reshape the endoscopy landscape, making advanced procedures more accessible and safer for patients.”

This collaboration is set to transform the field of endoscopy, addressing key challenges and bringing state-of-the-art technologies to healthcare facilities worldwide. With their shared vision of enhancing patient care and safety, EndoSound and AdaptivEndo are poised to make a lasting impact on the gastrointestinal community.

About EndoSound: EndoSound, Inc., is a privately held company based in Portland, Oregon. EndoSound is dedicated to expanding access to endoscopic ultrasound technology around the world. With its patented design, EndoSound transforms an upper endoscope into a fully functional EUS scope. It is comprised of an experienced team of scientists, engineers, clinicians, and seasoned business professionals with a track record of bringing new medical devices to market.

About AdaptivEndo: AdaptivEndo is a pioneer in single-use endoscopy solutions, offering a range of innovative products designed to improve patient safety and streamline medical procedures. The company is dedicated to making advanced endoscopic technology accessible to healthcare professionals worldwide, with a focus on enhancing patient outcomes and infection control.

Contacts

Josh Cohn for EndoSound
Cohn@endosound.com

Ed Fancher for AdaptivEndo
hfancher@adaptivendo.com

EndoSound® Announces Initial Closing of its Series A Financing

EndoSound® Inc., a privately held medical device company developing an endoscopic ultrasound platform to diagnose and treat diseases of the gastrointestinal tract, today announced the initial closing of its Series A round financing.

The round is being led by GEO Medtech Venture Fund, a leading healthcare venture capital firm that invests in transformative medical technology, and health solutions companies seeking to improve clinical outcomes, enhance quality of life, and drive efficiency of healthcare delivery.

The financing will support EndoSound’s ongoing research and development and preparations for commercial launch.

The EndoSound Vision SystemTM (EVSTM) is designed to eliminate the financial burden of expanding access to care for patients who require an endoscopic ultrasound (EUS) procedure.  By attaching the EVS Transducer to a standard upper endoscope found in all hospitals and GI surgery centers, this critical technology becomes available and affordable in more areas of care.

Our ability to complete a financing round with experienced, highly respected investors and our existing shareholders is a testament to our team, our strategy and the overall market opportunity ahead of us. It brings us closer to our goal of expanding patient and physician access to EUS in the US and around the world.

—Steve Steinberg, President and CEO of EndoSound, Inc.

EndoSound® included in Becker’s “5 GI device companies to watch in 2023”!

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From Beckers GI & Endoscopy

Claire Wallace –  

As the gastroenterology device market continues to grow, here are five companies poised to take over the market in 2023.

EndoSound®, Iterative Health, Medtronic, FujiFilm, and Motus GI

At the beginning of 2023, EndoSound, a newer player in the GI space, received an investment from the American Gastroenterological Association to improve its endoscopic ultrasound technology. In July 2021, EndoSound earned FDA breakthrough device designation for the device.

See Linked In post here.

EndoSound® Receives Investment From AGA’s GI Opportunity Fund

Read more

EndoSound® is the Winner of the 2022 Shark Tank Competition at the AGA Center for GI Innovation and Technology

Endosound awarded AGA Shark Tank winner 2022

May 5th, 2022.  In April in San Francisco, CA, home to inventors, innovators, and investors, the 2022 AGA Center for GI Innovation and Technology (CGIT) Summit got underway.  There was a lot of great interaction among medical providers, investors and industry and one of the highlights was the Shark Tank style competition among start-up companies in the GI space.

Twenty companies applied for 6 spots to compete live in San Francisco and EndoSound® was selected among the 6 finalists.  Competitors each presented a 5-minute elevator pitch to a panel of GIs and investors, followed by 5-10 minutes of questions. Our founder, Steven Steinberg, MD, did a fabulous job pin-pointing the important details the panelists were seeking.

Without further delay,…

We won!

https://www.linkedin.com/company/endosound/posts/?feedView=all&viewAsMember=true

This win further validates that our technology is ready to disrupt the EUS market. Along with the award recognition, we will also receive guidance from the AGA CGIT committee, providing access to additional funding and partnering opportunities.  We could not be more excited!

As the 2022 AGA CGIT Shark Tank winner, we will represent the AGA CGIT in the Shark Tank competition at Digestive Disease Week (DDW) on May 21st, 2022, in San Diego, CA.  Once again Dr. Steinberg will be there to demonstrate our disruptive product and business plan.

Stay tuned for more information as we get closer to realizing our goals and more collaboration between the professional societies, strategic partners, and the GI community.

FDA Grants Breakthrough Device Designation for Innovative EndoSound Vision Ultrasound System

PORTLAND—August 31, 2021—Endosound, Inc., an Oregon-based medical device innovator developing technologies that enhance access, reduce cost, and increase the safety of endoscopic ultrasound procedures, announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

 

The EndoSound Vision System is an add-on device that consists of a compact ultrasound beamformer, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal (GI) video endoscope to convert it into an endoscopic ultrasound (EUS) system. Its unique distal attachment allows the endoscopist to perform advanced procedures, such as fine needle biopsy, with precision, but without the controversial elevator mechanism found on all other linear echo-endoscopes.

 

In recent years, multi-use endoscopes that feature an elevator mechanism have faced scrutiny due to their association with patient infection risk. In a July 2020 Safety Communication published by the FDA, it was stated that “FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components”1 to address the challenges presented by the elevator mechanisms on these endoscopes. Major device manufacturers have consequently responded with new disposable duodenoscope models, but the similarly designed ultrasound endoscopes have been overlooked. The innovative EndoSound Vision System addresses this oversight by eliminating the need for the elevator mechanism while still maintaining the precision and imaging that is necessary for complex EUS procedures.

 

“The EndoSound Vision System removes significant patient safety concerns that have been connected with the elevator mechanism over the last several years,” stated Dr. Shyam S. Varadarajulu, MD, Medical Director of the Digestive Health Institute at Orlando Health.“In addition to reducing risk, the system features a disruptive price point that gives it the potential to dramatically expand the availability of this critical modality in the United States and around the world.”

 

“The Breakthrough Device Designation is evidence of the transformative potential the EndoSound Vision System presents,” stated Dr. Stephen Steinberg, MD, EndoSound Founder and President. “There is a clear need for a resolution to the patient safety risk presented by traditional ultrasound endoscopes. Also, for many healthcare facilities, the high cost of conventional systems creates a barrier to entry into the use of endoscopic ultrasound. With Breakthrough Device Designation, we are on an accelerated pathway to eliminating these obstacles.”

 

The FDA Breakthrough Device Designation expedites the development and evaluation of novel devices that offer the potential to enhance patient outcomes through more effective treatment or improved diagnosis of life-threatening conditions. Under the program, the FDA will provide EndoSound with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.

 

About EndoSound

Endosound, Inc., is a privately held company based in Portland, Oregon that is dedicated to expanding access to endoscopic ultrasound technology around the world. The company comprises an experienced team of scientists, engineers, clinicians, and business professionals with track records of commercializing new medical devices.

 

www.endosound.com

 

1.     U.S. Food and Drug Administration. (2020). The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication [online]. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication [Accessed 13 Jul. 2021].