invenio-imaging

Background

Invenio Imaging, founded in 2012 and headquartered in Santa Clara, California, is a medical device company dedicated to enhancing cancer patient care through intraoperative histologic imaging combined with artificial intelligence (AI). Their flagship product, the NIO® Laser Imaging System, enables rapid, real-time microscopic imaging of fresh tissue specimens during surgical procedures, facilitating immediate and informed decision-making by surgeons and pathologists. This innovation aims to streamline intraoperative histology, reduce operating room downtime, and improve surgical outcomes.

Key Strategic Focus

Invenio Imaging's strategic focus centers on integrating advanced imaging technologies with AI to revolutionize intraoperative diagnostics. The company specializes in developing and commercializing the NIO® Laser Imaging System, which utilizes Stimulated Raman Histology (SRH) to provide high-resolution images of unprocessed tissue specimens without the need for physical sectioning or staining. This technology targets various surgical oncology applications, including neurosurgery, pulmonology, urology, and endoscopy, aiming to enhance the accuracy and efficiency of intraoperative tissue evaluation.

Financials and Funding

As a privately held company, Invenio Imaging has secured funding through multiple channels to support its growth and innovation initiatives. Notably, the company received a Medical Design Excellence Award in 2021 and was selected as a Rosenman Innovator, reflecting its commitment to advancing medical technology. Additionally, Invenio obtained CE Mark approval in 2021, enabling the commercialization of its products in the European market. The company has also engaged in research collaborations, such as the partnership with the Lung Cancer Initiative at Johnson & Johnson, to develop and validate AI-based image analysis algorithms for lung cancer detection.

Pipeline Development

Invenio Imaging's product pipeline includes the NIO® Laser Imaging System and its associated AI-based image analysis modules:

• NIO® Laser Imaging System: This system has been utilized in over 2,500 cancer treatment procedures at major cancer centers in the US and Europe. It provides rapid, real-time imaging of fresh tissue specimens, aiding in intraoperative decision-making.

• NIO® Glioma Reveal: An AI-based image analysis module designed to assist in the detection of gliomas during neurosurgical procedures. This module received CE Mark approval in May 2022, allowing its clinical use in Europe.

• NIO® Lung Cancer Reveal: Currently under development, this AI-based module aims to assist physicians in evaluating bronchoscopic lung biopsies. In August 2024, Invenio announced the enrollment of the first patients in a US pivotal study for this module, conducted in collaboration with Johnson & Johnson's Lung Cancer Initiative.

Technological Platform and Innovation

Invenio Imaging's technological platform is distinguished by its integration of Stimulated Raman Histology (SRH) and AI-driven image analysis:

• Stimulated Raman Histology (SRH): SRH is a spectroscopic technique that enables the acquisition of high-resolution, label-free images of fresh tissue specimens. This method allows for the visualization of tissue architecture and cellular features without the need for traditional histological processing, thereby expediting intraoperative diagnostics.

• Artificial Intelligence Integration: The company's AI-based image analysis modules, such as NIO® Glioma Reveal and NIO® Lung Cancer Reveal, leverage machine learning algorithms to assist in the rapid and accurate detection of cancerous tissues during surgical procedures. These modules are designed to enhance the diagnostic capabilities of the NIO® system, providing real-time decision support to clinicians.

Leadership Team

Invenio Imaging's leadership team comprises experienced professionals with diverse backgrounds in biomedical engineering, medical devices, and AI:

• Jay Trautman, PhD: Co-Founder, President, and CEO. With over 30 years of experience in pharmaceutical, medical device, and life-science R&D and commercialization, Dr. Trautman has co-founded five companies, four of which have successfully exited. His previous ventures include Vedere Bio, acquired by Novartis for $280 million, and Praelux, sold to Amersham/GE. He began his career at Bell Labs.

• Chris Freudiger, PhD: Co-Founder and Chief Technology Officer. Dr. Freudiger has over 18 years of experience in biomedical and medical devices. He is a world-renowned spectroscopist and AI expert, with over 10,000 citations and more than 10 publications on AI image analysis. He discovered SRH at Harvard and led the engineering of the NIO® Laser Imaging System and its AI components.

• Steven Pastore, MD: Vice President of Clinical Affairs. Dr. Pastore has over five years of experience in pathology and medical devices. He obtained his MD at the Zucker School of Medicine and completed 18 months of pathology residency at Northwell Health. He serves as an SRH pathology expert, leading clinical studies and acting as a liaison for commercialization and AI development.

• Adrian Ion-Margineanu, Dual PhD: Head of Artificial Intelligence Development. With over 10 years of experience in AI/machine learning and biomedical imaging, Dr. Ion-Margineanu holds dual PhDs in Machine and Deep Learning. As a Marie Curie Fellow, he has authored 19 peer-reviewed papers on AI/ML/DL. Previously at Philips, he developed deep learning algorithms for tumor cell detection in H&E and IHC microscopy images. At Invenio, he leads AI development for brain cancer (CE-marked), lung cancer, and prostate cancer applications.

• Geoff Maniago: Manager of Manufacturing. With over 20 years of experience in manufacturing and developing complex laser systems, Mr. Maniago has worked at Coherent (scientific & high-power lasers) and Enablence Technologies (telecom). He has expertise in ISO-13485 quality systems and leads in-house manufacturing of the NIO® Laser Imaging System, with over 20 systems completed.

Competitor Profile

Invenio Imaging operates in the competitive landscape of intraoperative imaging and AI-driven diagnostics. Key competitors include:

• CLINapps: Founded in 1999 and headquartered in San Diego, California, CLINapps specializes in application software for clinical trials and data management. While not directly competing in intraoperative imaging, their focus on clinical data solutions positions them as a player in the broader healthcare technology sector.

• ClinDatrix, Inc.: Established in 2002 in Irvine, California, ClinDatrix offers clinical research services, including data management and regulatory support. Similar to CLINapps, their services complement the clinical trial process but do not directly overlap with Invenio's intraoperative imaging solutions.

• Bayessoft: Based in Davis, California, Bayessoft provides software solutions for healthcare analytics. Their focus on data analysis tools places them in the broader competitive landscape of healthcare technology but not directly in intraoperative imaging.

Invenio's unique integration of SRH and AI in intraoperative imaging differentiates it from these competitors, offering a specialized solution for real-time tissue analysis during surgery.

Strategic Collaborations and Partnerships

Invenio Imaging has established significant collaborations to enhance its technological capabilities and market reach:

• Johnson & Johnson's Lung Cancer Initiative: In January 2023, Invenio entered into a research collaboration agreement with the Lung Cancer Initiative at Johnson & Johnson to develop and validate the NIO® Lung Cancer Reveal image analysis algorithm. This partnership aims to assist physicians in evaluating bronchoscopic lung biopsies, addressing a critical need in lung cancer diagnostics.

• Ambra Health: In July 2020, Invenio partnered with Ambra Health to integrate the NIO® Laser Imaging System with Ambra's Cloud PACS image management technology. This integration enables pathologists to instantly access SRH images exported from Invenio's device, facilitating remote consultations and enhancing collaborative diagnostics.

Operational Insights

Invenio Imaging's strategic positioning leverages its proprietary SRH technology and AI integration to offer a unique solution in intraoperative diagnostics. By providing rapid, real-time imaging without the need for traditional histological processing, the company addresses critical challenges in surgical oncology, such as reducing operating room downtime and improving surgical margins. The CE Mark approval and collaborations with industry leaders like Johnson & Johnson and Ambra Health underscore Invenio's commitment to expanding its market presence and technological capabilities.

Strategic Opportunities and Future Directions

Looking ahead, Invenio Imaging is poised to capitalize on several strategic opportunities:

• Expansion of AI Capabilities: The ongoing development of AI-based image analysis modules, such as NIO® Lung Cancer Reveal, positions the company to address a broader range of intraoperative diagnostic needs. Successful validation and regulatory approval of these modules could significantly enhance the utility of the NIO® system across various surgical disciplines.

• Market Penetration in Europe: With CE Mark approval obtained in 2021, Invenio is well-positioned to expand its market presence in Europe, leveraging its technological innovations to meet growing demand for advanced intraoperative diagnostic solutions.