NinePoint Medical, Inc.

Who NinePoint serves

• Gastroenterologists and endoscopists using volumetric laser endomicroscopy (VLE)
• Hospitals and clinics that use the NvisionVLE Imaging System
• Academic and medical research groups studying tissue microstructure and OCT imaging

Address

NinePoint Medical, Inc. 401 Congress Ave, Suite 2650 Austin, TX 78701 United States

General contact

• Email: info@ninepointmedical.com

Collaboration

NinePoint Medical works with the academic and medical research communities and can provide access to anonymized OCT imaging datasets and associated tools. For collaboration discussions, use the contact details above.

• A swept‑source laser for rapid wavelength tuning
• High‑speed optical signal acquisition
• Innovative engineering and information technology

It is used in the NvisionVLE Imaging System to generate comprehensive, volumetric digital images of the esophagus and other tissue microstructures.

How Advanced OCT works (high‑level description)

As summarized from the website:

1. A swept‑source laser produces light at a single wavelength at any given instant, but rapidly changes ("sweeps") its wavelength over time.
2. The light beam is split into two paths:

• A reference beam that remains inside the console
• A sample beam that is delivered through the catheter and focused into tissue

3. Light reflected from structures within the tissue is collected by the catheter and returned to the console.
4. Inside the console, the reflected sample beam and the internal reference beam are recombined, creating an interference signal.
5. Signal processing converts this interference pattern into an axial line (an "A‑line") that represents reflectivity versus depth.
6. Many adjacent A‑lines are combined to form cross‑sectional images; multiple cross‑sections form a volumetric dataset of the scanned tissue.

Clinical and research context

According to the website:

• OCT was first developed and explored in the late 1980s for biological tissue imaging.
• Over time, sub‑categories such as swept‑source OCT were developed and evaluated in various biomedical applications.
• Commercial OCT systems are now an established imaging standard in areas such as ophthalmology, cardiology, dermatology, and general research.
• NinePoint's Advanced OCT technology, licensed from the Wellman Center for Photomedicine at Massachusetts General Hospital, focuses on esophageal and broader tissue microstructure imaging.

Filling an imaging gap

The site notes that Advanced OCT is intended to help fill an imaging gap in esophageal surveillance by combining:

• High‑resolution scanning
• Depth penetration
• Volumetric coverage

These properties are described as supporting more comprehensive visualization than surface‑only imaging modalities.

The website lists the following Current Procedural Terminology (CPT) codes in connection with VLE procedures:

• 43206 – Esophagoscopy, flexible, transoral; optical endomicroscopy
• 43252 – Esophagogastroduodenoscopy, flexible, transoral; optical endomicroscopy
• 0397T – Endoscopic retrograde cholangiopancreatography with optical endomicroscopy
• 88375 – Optical endomicroscopic image(s), interpretation and report, real‑time or referred, each endoscopic session

These codes are provided for informational purposes only. The website notes that CPT codes and descriptions are copyrighted by the American Medical Association (AMA).

Important reimbursement notes (as stated on the site)

• Coding, coverage, and payment information are subject to change.
• NinePoint Medical cannot guarantee success in obtaining third‑party insurance payment.
• Many factors influence whether a payer will reimburse for a given service.
• It is always the provider's responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered.
• Providers should contact their third‑party payers for specific information on coding, coverage, and payment policies.

Reimbursement support contact

For more detailed information or to request the NvisionVLE Imaging System Reimbursement Guide, the website directs users to:

• Email: reimbursement@ninepointmedical.com

Additional instructions or request forms may be available directly on the NinePoint Medical website.

The video section described on the site includes resources such as:

• NvisionVLE Imaging System with Real‑time Targeting™ animation
• Volumetric Laser Endomicroscopy (VLE) image recognition training

Additional videos may be listed on the website's Resources page.

Clinical spotlight library

The Clinical Spotlight section highlights how VLE is used in various clinical scenarios, including topics such as:

• VLE for pre‑treatment planning
• VLE for pre‑treatment planning using Real‑time Targeting
• VLE for identification of subsquamous disease
• VLE for post‑treatment assessment
• VLE for surveillance and emerging applications

These spotlights reference work by individual physicians and are intended as educational examples.

Technical resource library

Technical resources mentioned on the website include:

• VLE image atlas
• VLE system brochure
• Bibliography of published work

These materials provide technical background and further reading on VLE and Advanced OCT.

Image library

The image library lists example assets such as:

• Animation and physician screen images
• Images of a hand holding the VLE probe

For the latest versions of videos, documents, and images, users should refer directly to the Resources section of the NinePoint Medical website.

Key characteristics described on NinePoint Medical's website include:

• Imaging depth: up to approximately 3 mm beneath the mucosa
• Scan length: approximately 6 cm of tissue per scan
• Resolution: approximately 7 microns
• Imaging speed: real‑time cross‑sectional and longitudinal views
• Marking capability: ability to place small laser marks in tissue that are visible under white light endoscopy to help target biopsies

Intended use and indications (per labeling on the website)

The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two‑dimensional, cross‑sectional, real‑time depth visualization and may be used to mark areas of tissue.

The safety and effectiveness of this device for diagnostic analysis (for example, differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.

Clinical role described

According to the website, the system is designed to:

• Provide a more thorough evaluation of the esophageal tissue microstructure during a standard endoscopy procedure
• Help clinicians identify areas of interest that may not be visible with conventional imaging modalities such as white light endoscopy
• Potentially improve biopsy targeting for histopathologic diagnosis
• Provide additional information that may assist in clinical decision‑making about therapy

Imaging views

The system provides multiple views of the targeted esophageal segment:

• Cross‑sectional view:
• Collects around 1,200 cross‑sectional images across an approximately 6 cm segment
• Images penetrate approximately 3 mm into tissue
• Allows zoomed‑in evaluation of regions of interest

• Longitudinal view:
• Shows the esophageal wall along its axis
• Provides over 4,000 longitudinal images for review

• Linked views:
• Cross‑sectional and longitudinal views are linked so that navigation in one updates the other in real time

Console, workflow, and probes

The website describes several workflow and hardware features:

• Touch‑screen monitor and hand‑controller for clinician‑controlled scanning and tissue marking
• Active, clinician‑controlled workflow that can be tailored to each patient
• Single and double laser mark options
• Balloon catheter designs (for example, 14 mm, 17 mm, and 20 mm) to facilitate probe positioning and centering
• Balloon‑less low‑profile probe option to accommodate different anatomies
• Compatibility with endoscope channels that are 2.8 mm or larger

Reimbursement overview

For reimbursement and coding information related to VLE procedures using the NvisionVLE Imaging System, see the dedicated reimbursement and CPT coding document in this agent, or contact NinePoint Medical at reimbursement@ninepointmedical.com as indicated on the website.

The NinePoint Medical website states that the company maintains a large dataset of anonymized clinical OCT scans. These scans are:

• Enhanced by NinePoint's IRIS machine‑learning / AI solution for pattern detection
• Hosted in the public cloud for easier access by qualified users

The dataset is intended to support the academic and medical research communities working in areas such as:

• Esophageal imaging
• Volumetric laser endomicroscopy (VLE)
• Optical coherence tomography (OCT)–based tissue microstructure analysis

IRIS ML/AI solution

According to the website, NinePoint's IRIS solution:

• Applies machine‑learning / AI techniques to OCT imaging data to assist with pattern detection
• Can be made available to clinics that own NvisionVLE consoles to support data analysis workflows

Collaboration and access

The site invites collaboration from:

• Academic research groups
• Medical research institutions
• Clinics that use the NvisionVLE Imaging System

For discussions about collaboration, data access, or the IRIS solution, the website directs users to contact NinePoint Medical using the general contact details (for example, info@ninepointmedical.com).

Ask anyway — the agent will say plainly that it is not published rather than guess.