Company
Portfolio Data
Back to Company SearchINVENIO IMAGING INC
UEI: N8ADGJWND191
Number of Employees: 8
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2012
4
Phase I Awards
3
Phase II Awards
75%
Conversion Rate
$749,306
Phase I Dollars
$4,232,361
Phase II Dollars
$4,981,667
Total Awarded
Awards
A multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial intelligence for rapid lung cancer detection - The ON-SITE study
Amount: $2,000,000 Topic: NCI
Project Summary & Abstract Lung cancer accounts for about 25% of all cancer deaths in the US, as it is often caught at an advanced stage when treatment options are limited. This has led to the institution of screening programs with low-dose CT, resulting in ~1.6 million pulmonary nodules detected every year, most of them (~80%) in the periphery of the lung. Tissue biopsy is the standard of care for establishing a definitive diagnosis for treatment planning. Rapid on-site evaluation (ROSE) of tissue biopsies in the procedure room by cytopathologists or cytotechnicians can be used to establish that: 1. Diagnostic quality tissue has been procured; identifying malignancy by ROSE has been shown to reduce the number of biopsy tools and repeat procedures 2. An adequate number of cells have been obtained to allow molecular profiling by next- generation sequencing and molecular testing 3. The absence of metastatic disease in the lymph nodes justifies the more-invasive peripheral biopsy. Nevertheless, ROSE is not the standard of care despite its advantages, because its quality is highly variable across sites, it can increase procedure times, and its costs are unlikely to be fully reimbursed. We propose the development of an FDA-cleared medical device that allows microscopic imaging of fresh, unprocessed tissue biopsies in the treatment room and provides accurate, near real-time diagnosis based on deep learning. Specifically, the proposed system uses Stimulated Raman Histology (SRH), which was pioneered by the PI, translated for intraoperative diagnosis in brain tumors, shown to be suitable for automated diagnosis via deep learning with a performance that is non-inferior to pathologists, and resulted in the first CE-certified device for identification of brain tumor margins by the company. Here, we address an urgent clinical need in lung cancer, giving doctors confidence in their intraoperative decisions, and reducing unnecessary biopsies/procedures for patients and payers. Further, we will investigate the potential to provide accurate intraoperative diagnosis of molecular markers that could enable local delivery of pharmaceuticals, ablation, and other therapies, in the biopsy procedure.
Tagged as:
SBIR
Phase II
2023
HHS
NIH
Real time histopathology for intra operative tumor margin delineation
Amount: $1,499,797 Topic: 102
DESCRIPTION provided by applicant Surgical resection is the cornerstone treatment for the majority of the primary brain tumors and brain metastases diagnosed each year in the US Extent of resection is an important prognostic factor as most tumor recurrence is in or near the resection cavity Unfortunately safely maximizing the extent of resection remains a challenge in part due to the difficulty of differentiating tumor from normal brain tissue Consequently suboptimal surgical outcomes are common for brain tumor patients A recent study showed that among patients with safely resectable tumors complete resection was achieved in only of patients Stimulated Raman Scattering SRS microscopy co developed by the technical Co PI Dr Freudiger allows label free imaging of biological tissues based on the intrinsic vibrational spectroscopy of their molecular components Science In collaboration with clinical Co PI Dr Orringer we recently demonstrated SRS microscopy enables rapid histology with image quality and diagnostic accuracy comparable to gold standard Handamp E staining but without the time delay caused by tissue sectioning and dye staining Science Translational Medicine Compared to other techniques under investigation SRS produces the best image quality and consequently the highest sensitivity and specificity for detecting tumor infiltration The overall goal for this Phase grant is to develop the first FDA cleared clinical SRS instrument based on the validated prototype incorporating our custom fiber laser This innovation will lead to the introduction of a novel technology to improve the safety and accuracy of brain tumor surgery Specifically we will establish quality systems for design and assembly according to federal regulations CRF We will then design the clinical SRS instrument to overcome the limitations of the prototype i e improve the imaging speed for multi color mosaic imaging automate the sample loading scheme modify the form factor include design controls for compliance with electrical and laser safety standards develop a simple graphical user interface and develop a sterile consumable We will work with an independent test laboratory to demonstrate safety according to the IEC standard for medical devices and the IEC standard for laser products The clinical Co PI will validate the effectiveness by performing a blind read study comparing SRS imaging to the gold standard Handamp E histopathology Biocompatibility of the consumable will be demonstrated by compliance with ISO As the final goal we will work with an experienced regulatory consultant to obtain FDA clearance for the product PUBLIC HEALTH RELEVANCE Brain surgery is the cornerstone for the treatment of most of primary brain tumors and many of the brain metastases diagnosed in the US each year Survival and quality of life depend strongly on the extent of tumor resection but brain surgeons tend to err on the side of lesser resection to avoid neurologic deficits leaving some tumor behind because tumor is not readily distinguished from uninvolved tissue by the bare eye This proposal aims to develop a novel microscope and an associated consumable that together will allow brain surgeons to accurately access the completeness of resection in real time during brain surgery and if successful will improve survival and quality of life for patient with this devastating disease
Tagged as:
SBIR
Phase II
2016
HHS
NIH
Fiber Scanning Stimulated Raman Scattering (SRS) Endoscope
Amount: $225,000 Topic: NCI
DESCRIPTION (provided by applicant): Achieving maximal tumor removal with minimal collateral damage to healthy tissue is a challenge in tumor surgery, because there are no reliable visual cues to indicate completeness of resection. In contrast, on a microscopic level, the differences between tumor and non-infiltrated tissues are clear. However, traditional histopathologic techniques require that the tissue be removed from the operative field, processed, and stained. Therefore, histopathology can neither beperformed in situ nor in real-time. Suboptimal surgical results are extremely common in brain cancer surgery (64,000 US cases/year). Tumor that could have been safely removed has been identified in the operative cavity in 76% of cases, by post-operative MRI. In most cases, tumor recurrence occurs near the resection cavity. An in vivo technique for real-time imaging of the resection margins at the time of surgery would be highly desirable. Stimulated Raman Scattering (SRS) microscopy combines the advant
Tagged as:
SBIR
Phase I
2014
HHS
NIH
TOPIC 331: Biopsy Guidance with Coherent Raman Spectroscopy
Amount: $224,308 Topic: NCI
Not Available
Tagged as:
SBIR
Phase I
2014
HHS
NIH
SBIR Phase I: High Throughput Cell Sorting with Coherent Raman Scattering (CRS )
Amount: $149,999 Topic: BC
This Small Business Innovation Research (SBIR) Phase I project proposes to develop a flow cytometer for sorting cells based on chemical phenotyping, which (1) provides quantitative analysis of specific molecular species, (2) has single cell sensitivity, (3) is high throughput, (4) label-free, and (5) non-destructive to living organisms. The proposed system uses coherent Raman scattering (CRS), a laser spectroscopy based on analysis of the vibrations of chemical bonds. Compared to conventional Raman scattering, the CRS signal is coherently amplified, which should achieve sorting speeds up to 10,000 cells/s, which is>10,000x faster than what can currently be achieved with spontaneous Raman. Reaching this goal requires development of (1) a spectrally multiplexed CRS system based on a narrowband pump laser and a broadband probe laser, and (2) a high-speed, high-sensitivity multichannel detection system to simultaneously probe multiple spectral components of the broadband pump laser. The broader impact/commercial potential of this project derives from the variety of potential applications of this novel phenotyping technology in basic and applied R & D. One example is in the field of products from biological organisms (e.g., algae or yeast) including fuels and specialty chemicals, where the organism synthesizes the target chemical using energy either harvested from sunlight or from a low-value feedstock, such as glucose. Genetic modification is used to improve yield and specificity for the target chemical species. The process of mutation and selection can be repeated until an optimized outcome is obtained. High-throughput chemical phenotyping is required to sample a large number of genetic mutations and speed up the directed evolution process. It would be advantageous to perform such biochemical analysis non-destructively, so that the fitness of candidates could be tested in growth and stress assays after selection. In addition to biofuel production, there are numerous applications in basic research, as well as medical applications in both diagnostics and treatment.
Tagged as:
SBIR
Phase I
2013
NSF
SBIR Phase II: Dual-Wavelength Picosecond Fiber Laser Source for Label-Free Microscopy
Amount: $732,564 Topic: EI
This Small Business Innovation Research (SBIR) Phase II project aims to develop a novel research microscope based on coherent Raman scattering (CRS). In contrast to other techniques, CRS is a label-free method that requires excitation with two synchronized laser pulse trains (ultra-short pulse duration) with precisely tunable wavelengths (<1nm). The key innovation of the Phase I proposal was the realization that the difference frequency of the two major gain media used in the telecommunication industry, Erbium and Ytterbium, corresponds to the wavelength range where most CRS imaging is performed. This provided a path to an economical laser source for CRS based on a robust all-fiber implementation of low-cost telecom components. Following successful proof-of-concept in Phase I, the Phase II proposal aims to complete the development of the laser system and integrate it into an easy-to-use and environmentally stable solution for CRS microscopy. The broader impact/commercial potential of this project is in the area of biological and material science research, and ultimately medical diagnostics. CRS allows microscopic imaging with chemical contrast based on intrinsic spectroscopic properties of the sample. It circumvents the issues associated with fluorescent labeling or dye staining, which can be especially problematic for imaging molecules that are smaller than typical labels or for use in vivo in patients. Wide ranging applications including studying lipid metabolism, trans-dermal drug delivery, biomass conversion to biofuel, and tumor margin delineation during cancer surgery, have been demonstrated. Current laser systems for CRS are expensive, require experienced personnel for operation, and are not robust. This greatly limits access to this exciting new technology and prevents use in medical diagnostics. The proposed integrated CRS microscopy solution aims to overcome these limitations.
Tagged as:
SBIR
Phase II
2013
NSF
SBIR Phase I: Dual-Wavelength Picosecond Fiber Laser Source for Label-Free Microscopy
Amount: $149,999 Topic: BC
This Small Business Innovation Research (SBIR) Phase I project aims to develop a laser source for label-free microscopy technique, in particular coherent Raman scattering (CRS) microscopy. In contrast to other techniques, CRS requires excitation with two synchronized laser pulse trains (picosecond pulse duration) with a difference frequency that can be tuned to the precision of a typical line width of Raman spectra (<1nm). The key innovation of the proposal is the realization that the difference frequency of the two major gain media used in the telecommunication industry, Erbium (Er) and Ytterbium (Yb), corresponds to the high-wavenumber region of Raman spectra, where most CRS imaging is performed. Based on recent advances in robust all-fiber design, the application proposes to develop a novel dual-color Er-Yb-laser-system based on optical synchronization of two picosecond power amplifiers using super-continuum generation. While this could provide an elegant, economical laser source for CRS, the physics associated with the required high peak powers in fibers is challenging. The broader impact/commercial potential of this project is in the area of biological and material science research, and ultimately medical diagnostics. CRS allows microscopic imaging with chemical contrast based on intrinsic spectroscopic properties of the sample. It circumvents the issues associated with fluorescent labeling or dye staining, which can be especially problematic for imaging of molecules that are smaller than typical labels or for use in vivo in patients. Wide ranging applications include studying lipid metabolism, trans-dermal drug delivery, biomass conversion to biofuel, and tumor margin delineation during cancer surgery has been demonstrated. While laser systems have come a long way and different approaches exist at various degrees of commercialization, they are expensive (~$300,000), require experienced optics personnel for operation, and are not robust. This greatly limits the access to this exciting new technology and prevents use in medical diagnostics. The light-source proposed in this SBIR application aims to overcome these limitations, as it is based on a all-fiber design from robust and low-cost telecommunication components.
Tagged as:
SBIR
Phase I
2012
NSF