Endoscopic ultrasound (EUS) has long been a valuable diagnostic and therapeutic tool in gastroenterology, traditionally confined to hospital settings due to high costs and technical requirements. This white paper introduces the EndoSound Vision System™ (EVS™), a groundbreaking solution that makes EUS accessible and profitable for Ambulatory Surgical Centers (ASCs) and smaller hospitals. By addressing traditional barriers to EUS adoption in outpatient settings, EVS is poised to transform the landscape of advanced endoscopy, improving patient care, physician satisfaction, and ASC profitability.

Background: EUS in Gastroenterology

Endoscopic ultrasound (EUS) has been a cornerstone of advanced gastroenterology for over three decades. This hybrid technique combines endoscopy with high-frequency ultrasound, allowing for detailed imaging of the gastrointestinal tract and adjacent structures. EUS has proven invaluable for:

  • Diagnosis and staging of gastrointestinal cancers
  • Evaluation of submucosal lesions
  • Assessment of pancreaticobiliary disorders
  • Guided fine-needle aspiration (FNA) and biopsy procedures
  • Therapeutic interventions such as pseudocyst drainage and celiac plexus neurolysis

Despite its clinical utility, EUS has primarily been confined to hospital-based settings due to several limiting factors.

Traditional Barriers to EUS in ASCs

Historically, several factors have prevented the widespread adoption of EUS in the ASC:

  1. High Capital Costs: Traditional EUS systems require substantial upfront investment, often exceeding $200,000 for the ultrasound hardware alone.
  2. Additional Scope Requirements: Conventional EUS systems necessitate the purchase of specialized echoendoscopes, which can cost over $80,000 each. This represents a significant additional expense beyond the ultrasound hardware.
  3. Extensive Training: The complexity of traditional EUS systems demands extensive training for endoscopy technicians, increasing operational costs and potential scheduling difficulties
  4. Space Constraints: Many ASCs lack the physical space to accommodate bulky EUS equipment, limiting their ability to offer this service.

These barriers have effectively relegated EUS to larger hospital settings, limiting access for patients and potentially increasing healthcare costs.

The EVS Solution

The EVS represents a paradigm shift in EUS technology, specifically designed to overcome the traditional barriers to ASC adoption. Key advantages include:

  1. Low Capital Cost: The EVS is offered at a fraction of the cost of traditional EUS systems, making it accessible to a wider range of healthcare providers. Furthermore, making the case for Echo-Endoscopy, the concept of combining upper endoscopy with EUS to maximize the diagnostic yield, is possible.
  2. Compatibility with Existing Endoscopes: Unlike traditional systems, EVS works with standard endoscopes already in use at ASCs. This eliminates the need for additional expensive echoendoscopes, allowing for immediate implementation regardless of the current scope vendor.
  3. High-Quality Imaging: Despite its cost-effectiveness, EVS provides high-resolution ultrasound images comparable to those produced by many traditional systems.
  4. Minimal Additional Training: The system’s user-friendly interface and compatibility with existing endoscopes minimize the learning curve for endoscopy technicians.
  5. Compact Design: The EVS’s small footprint allows for easy integration into existing ASC environments without requiring additional space. Additionally, it can be easily moved between room and can potentially be shared across facilities due to its compact size.

Financial Benefits for ASCs

Implementing the EVS can drive significant financial benefits for ASCs:

  1. Expanded Procedure Offerings: ASCs can now offer EUS procedures, attracting new patients and retaining existing ones who would otherwise be referred to hospitals.
  2. Increased Revenue: EUS procedures are reimbursed at the higher end of the EGD CPT code table, providing a new revenue stream for ASCs.
  3. Improved Utilization: The addition of EUS can help optimize underutilized ASC capacity, increasing overall procedure volume and profitability. As the EVS works directly with your existing equipment, setup and room turnover is minimal, allowing EUS exams to be performed within the standard block schedule without delay.
  4. Physician Satisfaction: By enabling gastroenterologists to perform advanced procedures in the ASC setting, the EVS can improve physician satisfaction and potentially attract new practitioners to the facility.

Case Study: Realizing the EVS Advantage

To illustrate the real-world impact of the EVS, consider the following case study from a current user:

An established gastroenterologist implemented the EVS in his ASC practice, with the following results:

  • Pre-Implementation (2023):
    • 112 EUS cases performed over 8.5 months in a hospital endoscopy suite.
  • Post-Implementation (2024):
    • 96 EUS procedures performed at the hospital endoscopy suite
    • 88 EUS cases performed at the ASC using the EVS
  • Total EUS Volume:

With EUS now available at the ASC, more patients were scheduled for expanded indications including chronic abdominal pain and diarrhea, pancreatic cancer screenings, pancreatic cyst surveillance, dilated bile ducts, small gastric submucosal lesions, and others.

Case Study—Key Outcomes:

1. Practice Growth through Echo-Endoscopy:

  • The physician didn’t simply shift volume but significantly expanded his EUS practice.
  • This was accomplished by screening more patients with EUS, a term called Echo-Endoscopy meaning “Ultrasound-Enhanced Endoscopy”.
  • Using EUS in conjunction with regular EGD has the potential to enhance diagnostic yield and data from this case study confirms that result.

2. ASC Revenue Boost:

  • EUS procedures code with higher reimbursement
  • Increased volume of EGD and colonoscopy procedures on days allocated for EUS. When physicians schedule EUS exams, they will often perform additional EGD and colonoscopy cases to fill out their schedule.

3. Improved Efficiency:

  • The EVS allowed for efficient scheduling and performance of EUS procedures in the ASC setting.

4. Enhanced Patient Experience:

  • Patients benefited from the convenience and typically lower costs associated with ASC-based procedures.

This case study demonstrates that implementing EVS can be a win-win situation for gastroenterologists, ASCs, and patients alike.

A New Paradigm for EUS

The introduction of the EVS has the potential to create a new standard for EUS delivery, aligning it more closely with common procedures like EGD and colonoscopy. This shift promises several key benefits:

Conclusion

The EVS represents a significant advancement in making endoscopic ultrasound more accessible, efficient, and profitable in the ASC setting. By addressing the traditional barriers to EUS adoption, this innovative technology opens new possibilities for gastroenterologists, ASCs, and patients alike. As demonstrated in the case study, implementing EVS can lead to practice growth, increased ASC profitability, and improved patient care.  Furthermore, with Echo-Endoscopy the practice used ultrasound with a standard EGD to drive more clinical results and increase volume.

The future of EUS lies in its broader adoption in outpatient settings, aligning with the ongoing shift towards value-based care. The EVS is at the forefront of this transformation, promising to revolutionize the delivery of advanced endoscopic services in gastroenterology.

Further Information:

 

References:

1Procedure price lookup for outpatient services. Procedure Price Lookup for Outpatient Services. Accessed September 25, 2024. https://www.medicare.gov/procedure-price-lookup/cost/43259/.

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

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.

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

  • 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 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® 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.

From Beckers GI & Endoscopy

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.

Mr. Fraser is Founding Partner of Fraser Healthcare, LLC a consulting practice focused on growth strategy for leading med-tech, pharmaceutical and private equity firms.  Scott’s twenty-five years of successful commercialization of new technology and healthcare services uniquely position him to guide clients with growth strategies, new healthcare delivery models and market development opportunities.

Prior to Fraser Healthcare, Scott was President of Physicians Endoscopy (a Kelso Private Equity company).  Fraser successfully led the company’s growth plans through development of a successful business plan and MSO transaction to form a new practice management division of the company.

Prior to Physicians Endoscopy, Mr. Fraser was part of the founding executive team at EndoChoice Inc. (NYSE: GI).  He served as Vice President of Marketing from 2008 – 2012 and Global Vice President of Commercialization from 2012 – 2017. EndoChoice was a medical technology and service company that was recognized five consecutive years by Inc. Magazine as one of the fastest growing companies in America. EndoChoice was a Sequoia Capital backed start-up that completed a successful IPO in June 2015 before being acquired by Boston Scientific Corporation in 2016.

Before the founding of EndoChoice, Fraser served as Director of Marketing at Given Imaging (NASDAQ: GIVN). During his tenure, the company successfully launched the revolutionary PillCam Video Capsule.

Fraser’s healthcare career started at Boston Scientific Corporation where he served in expanding leadership roles in sales, marketing and market development during a rapid growth phase of the company.

Fraser is a board member of Pinnacle GI Partners, an HIG backed private equity sponsored gastroenterology platform group and holds a B.Sc. in management from Villanova University and has an MBA from Boston University.