2.25million/year
Estimated annual volume of core microsurgical procedures in China: approximately 1.1545 million neurovascular, 512,100 malignant brain tumor related, 300,600 ENT, and 283,800 ophthalmic (excluding cataract).
SPECTRA NAVIGATION
Intelligent navigation for microsurgeryLesion boundary, instrument tip and safe distance stay visible throughout the resection
Microsurgical navigation for neurosurgery and microsurgery. It mounts onto the microscope already in the room, combining split-path stereo imaging, micron-scale instrument tracking and dynamic registration.
Navigation has to keep answering “where am I”. Existing systems register once, before surgery, and fail the moment tissue deforms — continuous intraoperative registration remains unsolved.
- 0.164mm dynamic registration error±0.059, max 0.270 · measured in murine studies
- 0.009mm instrument tracking accuracy9 µm · fiber tracking point · bench measurement
- 15/15in vivo craniotomies succeededMurine · Univ. of Tokyo ethics approval A2023M042-07 · the in vivo subset of 74 animal studies
- 2028Q3 · NMPA Class III submission targetClinical evaluation 2027 · certification targeted 2029
The project remains in R&D and validation · Core technologies validated on the bench and in animal studies; end-to-end system navigation accuracy will be established by third-party testing after integrated prototype V1
PROJECT FILM
Spectra Navigation in one video
A full walkthrough of the operating principle, the prototype, and the experimental setup (with narration).
Clinical Need
Microsurgery lacks a quantitative reference for deep anatomy
The relative positions of lesion boundaries, instrument tips, and critical anatomy are difficult to judge directly. Critical boundaries and residual tissue are often below 0.5 mm — beyond the resolving limit of the human eye and the depth of field of an operating microscope — while conventional navigation accuracy of 1–3 mm sits orders of magnitude away from the 20–25 µm scale of microsurgery. As procedures move deeper and toward smaller structures, reliance on individual experience increases, along with training time and variability in risk.
+29.4months
Reported mean survival benefit of gross total versus subtotal resection for grade IV glioma.
0.78per 100,000 people
Density is about 30% of that in developed countries, with a 10–15 year training cycle. In microvascular free-flap surgery, for example, novice anastomosis patency is only 60–70%, and roughly 600 cases are needed before the success-rate curve plateaus. Navigation supports decision-making and shortens the learning curve.
Procedure-volume data: China Health Statistics Yearbook. Other clinical figures are drawn from public research; definitions, reference years, and indication scope may vary between sources.
Limits of existing solutions: why millimeter-scale navigation cannot enter the microscopic field
Limits of Existing Solutions
Why millimeter-scale navigation cannot enter the microscopic field
Conventional navigation is designed around rigid bony fixation, large reflective markers, and an open field. All three premises break down in the microscopic field — drift, scale, and features are the three limits that follow, and the left column of the next section, Product Concept, is where they are drawn together.
Intraoperative tissue drift
Effective only for preoperative planning
CSF release and resection continuously shift tissue position. Existing navigation cannot re-register in real time, so the on-screen position gradually diverges from the actual surgical field.
11 mm vs 0.3 mm
Physical scale mismatch
Existing navigation carries system error of roughly 1–3 mm, insufficient for microscale boundary judgment. Conventional reflective spheres are about 11 mm in diameter against 0.3 mm microsurgical instrument tips, and readily obstruct a narrow field.
No registrable features
Algorithms fail outright
A microscopic field spans only a few millimeters and offers very few stable, repeatable features. Glare, bleeding, occlusion, and soft-tissue deformation further alter the local image.
Product Concept
Keeping “where is the instrument” and “what is this tissue” true throughout resection
Navigation rests on two conditions: where the instrument is right now and what the tissue in front of it is. Both must hold throughout resection. A system that answers them once, before the incision, is providing a plan — not navigation.
LEGACY · EXISTING MICROSURGICAL NAVIGATION
Registers once before the incision, never updates during it
- Intraoperative tissue drift: CSF release and resection keep shifting tissue, and the single preoperative registration cannot follow
- Physical scale mismatch: 1–3 mm system error and roughly 11 mm reflective markers against instrument tips on the 0.3 mm scale
- No registrable features: a field only millimeters across offers very few stable, repeatable features
- Together they reduce navigation to one-time preoperative planning
NAVIGATION · SPECTRA
Real-time intraoperative navigation
- Real-time sensing, dynamic registration, and quantitative cues
- Continuously reports lesion boundary, instrument tip, and distance to critical structures
- Updates the reference online as tissue deforms, so registration evolves with the deformation
- Keeps answering: where am I now | can I keep resecting | how much more can I safely remove
Objective: bring boundary, distance, and risk cues into the current view without disrupting the surgeon's core operating habits.Product value still requires continued validation in real clinical workflows, against defined baselines, and through surgeon feedback.
Core Technology · Product System
Three technologies, three components, one navigation that holds throughout surgery
Visualization reconstructs the 3D surgical field, precision tracking localizes the instrument tip, and intelligent registration updates the coordinate reference as tissue and the field change. These capabilities connect along a single navigation chain, each embodied in one component of the system.
Product System
Where each of the three components sits during an operation
The system mounts onto the operating microscope already in the room and changes neither staff positions nor equipment layout. The three components marked here, plus the overlay inside the surgical field, are all of it that is visible in the operating room.
Select a numbered point in the scene, or any component below, to mark its position and open the technology behind it, with its study records.
01VISUALIZATION
Split-path stereo operating microscope
Stereoscopic field and depth measurement
OpenNow showing
02PRECISION
Trackable fiber-optic instruments
Continuous instrument-tip tracking
OpenNow showing
03INTELLIGENCE
3D navigation workstation
Planning, localization, and model linkage
OpenNow showing
01 · VISUALIZATION
Visualization: split-path stereoscopic microscopic imaging
One optical path, two purposes. The three images show how visualization is implemented: coaxial split-path visible and near-infrared acquisition, a validation prototype that establishes 3D metrology, and final integration with an operating microscope. The split-path camera module has completed bench validation.
- Visible and near-infrared light share one optical path for simultaneous field visualization and tracking-signal acquisition.
- Stereo vision provides the 3D measurement foundation, converting microscopic images into depth and relative-position information.
- Once integrated with the microscope, the system supplies stable observations for instrument tracking and dynamic registration.
0.11 mmSystem error across a 20 mm microscopic field (bench validation)
The microscope platform combines imaging and metrology, preserving the live surgical field while providing structural, depth, and relative-position references.
02 · PRECISION
Ultrafine optical fibers enable continuous instrument-tip tracking
Ultrafine optical fibers are embedded in microsurgical forceps, scissors, and related instruments to form active tracking points while preserving the original dimensions, weight, and handling. Tracking remains available in deep and narrow fields, and tip position is linked to the preoperative model.
< 0.1 mmFiber diameter
0.009 mmTracking-point localization accuracy (9 µm, measured in R&D)
03 · INTELLIGENCE
Dynamic registration maintains a reliable reference at microscale
Vessel orientation and bone-surface texture serve as semantic alignment constraints, combined with a dynamic-landmark mechanism that continuously assesses confidence and updates the reference online. Core algorithm accuracy has been validated on a robotic platform and across 74 mouse craniotomy experiments (ethics approval A2023M042-07, the University of Tokyo).
15 / 15In vivo mouse craniotomies succeeded, zero failures
0.27–0.51 mmMeasured range of mouse-skull thickness
2–6 mmCranial-window size: circular, elliptical, square, and suture-crossing
01
Establish initial alignment
Extract constraints from recognizable structures such as vessels and bone-surface texture to align the preoperative model with the intraoperative view.
02
Continuously evaluate deviation
Under a small field, occlusion, glare, and tissue change, the system continuously checks whether the current reference remains reliable.
03
Update coordinates online
Dynamic landmarks update relative positions and return the instrument trajectory, model, and live image to a common spatial relationship.
BENCHMARK · REGISTRATION ERROR
Error magnitude against existing registration methods
Under microscopic deformation, the errors reported for existing registration methods differ from our measured values by an order of magnitude. The table places the three approaches side by side and labels the source of each figure.
| Registration method | Reported error | Microscopic deformation | Source |
|---|---|---|---|
| Bone-anchored registration | approx. 0.8–2 mm | Not applicable | Published literature |
| Conventional ICP surface matching | 2.7–5.3 mm | Not applicable | Published literature |
| This project · dynamic registration | 0.164 ± 0.059 mm (max 0.270 mm) | Applicable | Measured in mouse studies |
Literature values and our measured values come from different experimental conditions, sample sizes, and statistical definitions, and are not directly equivalent; the comparison is shown to indicate the difference in error magnitude. Project data come from mouse craniotomy studies; the full statistical definition and raw records are available in due-diligence materials.
FAIL-SAFE
Graceful degradation when features fail — never a silent correction
Bleeding, glare, and occlusion occur constantly in a microscopic field. The system degrades in three tiers according to confidence, and every tier returns judgment to the surgeon rather than continuing to present certainty once the reference is no longer trustworthy. Measured median registration translation error in mouse studies was 0.16 mm, against 1–3 mm typical system error for conventional optical navigation.
1
Single-point failure
Landmarks invalidated by bleeding, glare, or occlusion are discarded immediately; the remaining landmarks sustain registration.
2
Low overall confidence
The overlay is frozen and re-registration is prompted. The system does not keep correcting coordinates on an unreliable reference.
3
Insufficient valid points
The system reverts to the last trusted pose and waits for the surgeon to confirm before continuing.
These results demonstrate R&D-stage system capabilities. Medical use, performance claims, and clinical approval status remain subject to subsequent validation and public regulatory documents.
Clinical Workflow
One added step, and no change to established surgical habits
The system integrates with the existing operating microscope. Staff positions, instruments, and screen layout stay unchanged, and the surgeon receives boundary and distance cues inside the original microscopic view without shifting gaze.
Preoperative
Image import and planning
Same as current practiceImport MRI/CT, segment the lesion and critical structures, and plan the approach.
Intraop · Added
One non-invasive initial registration
Under 5 minutesPerformed once after the microscope is positioned, with no implanted bony markers. This is the only step the system adds.
Intraop · Continuous
Automatic tracking of tissue change
Zero extra actionsThe system continuously evaluates and updates the correspondence between the preoperative model and the live field, with no surgeon input.
Intraop · Decision
Boundary and distance cues
In-field overlayPresents lesion boundary, instrument tip, and relative position to critical structures inside the microscopic view.
Postoperative
Procedure recording and review
Added valueRetains process data for case review, training, and accumulation of clinical evidence.
Sterility and instrument handling follow existing practice: the camera module is covered with a single-use sterile drape without changing draping procedure, and fiber instruments are sterilized as conventional microsurgical instruments. Scrub staff add only drape placement and counting. Actual steps and per-stage timing are still being confirmed with collaborating clinicians.
Development and Intellectual Property
Development is progressing from prototype validation toward registration preparation
The product path includes research prototypes, animal studies, registration prototypes, clinical trials, and NMPA review. Timing remains dependent on experimental progress, regulatory consultation, and funding.
2021–23
Project R&D
CompletedCompleted method innovation and the core technical route, advanced human-machine interaction validation and first-generation prototype development.
2026.2
Method innovation and animal studies
CompletedCompleted animal studies and validation of the split-path camera module prototype.
2026.8
Product development
In progressEngineering iteration of the navigation software and instrument-tracking system, with testing and standards-conformity preparation underway.
2027
Clinical validation
PlannedAdditional animal studies, determination of the clinical evaluation pathway, and clinical-trial application.
2028 Q3
NMPA Class III submission accepted
TargetRegistration documentation submitted, entering technical review.
2029
Expected approval
TargetIncludes buffer for review deficiency responses. This target depends on regulatory consultation and trial progress; the final timeline will reflect actual development.
Commercialization does not hinge on this milestone: OEM modules and software licences generate revenue before approval. The two-stage path is set out in the Market, Competition and Current Needs section below.
Patent portfolio in detail
IP PORTFOLIO
The team holds 8 patents — 6 granted and 2 pending — filed across China, Japan, and WIPO
Counted by patent family (the Chinese and WIPO force-feedback filings count as one). The Japanese application for a navigation system, algorithm, and instruments, together with the Chinese application for a 3D calibration board and performance-evaluation method for stereo microscopic imaging, are most closely aligned with the current product. The barrier is structural: split-path imaging × intraoperative registration × micron-scale instrument tracking, combined in one hardware-software system. The remaining patents reflect prior technical work; ownership, licensing scope, and freedom to operate require item-by-item confirmation during investment and partnership due diligence.
Team
A team spanning clinical practice, optics, algorithms, automation, and commercialization
Core members have research and academic experience at the University of Tokyo, Tsinghua University, Harvard University, Yale University, the University of Chinese Academy of Sciences, and Harbin Institute of Technology. Their disciplines span clinical medicine, computer science, and biomedical engineering, with R&D backgrounds in surgical robotics, medical imaging, and navigation systems.
FOUNDER & CEO
Dr. Xiaofeng Lin
Researcher in medical devices, Faculty of Medicine, the University of Tokyo
Experience
- Researcher in medical devices, Faculty of Medicine, the University of Tokyo
- PhD in biomedical engineering, the University of Tokyo
- Master's degree, Shenzhen Institutes of Advanced Technology, University of Chinese Academy of Sciences
- Former co-founder of Hengle Medical Technology, a Series B+ company
Achievements
- Global Medical Robotics Innovation Design Competition: Silver Award
- 6th China International Internet+ College Student Innovation and Entrepreneurship Competition: Gold Award
- IROS Workshop Best Poster Award in surgical robotics
- Multiple publications in leading journals and conferences on surgical navigation
- Eight patents in surgical robotics and surgical navigation
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Yuhan Song
Computer Vision
-
Enduo Zhao
Automation
-
Shenghao Jiang
Clinical Research
-
Guanhao Lin
Tech Transfer & Fundraising
-
Zenghui Yu
Market & Operations
-
Gina Quan
Tech Transfer & Partnerships
-
Jian Lu
Chief Advisor
Yuhan Song
Computer Vision
- PhD candidate in biomedical engineering, the University of Tokyo; JSPS Research Fellow
- Former Project Researcher at a Japanese national university
- Four journal and conference papers in medical image processing
Enduo Zhao
Automation
- Postdoctoral researcher in biomedical engineering, Tsinghua University
- PhD in mechanical engineering, the University of Tokyo
- Seven journal and conference papers on surgical robotic systems
Shenghao Jiang
Clinical Research
- MD candidate, UNSW Sydney
- Master's degree in computer science and engineering, Harvard University
- Several years of R&D experience in AI vision algorithms for autonomous navigation
- Eight journal and conference papers in medicine and robotics
Guanhao Lin
Technology Transfer & Fundraising
- Project manager and systems engineer at an AI company
- Master's degree in systems innovation, the University of Tokyo
- Several years as a consulting associate in venture capital
Zenghui Yu
Market & Operations
- Core member of a Japan AI programme at a leading internet company
- Master's degree in commerce, Komazawa University
- Several years as a manufacturing investment liaison at an investment institution
- Several years leading overseas business development at a Japanese manufacturer
Gina Quan
Technology Transfer & Partnerships
- PhD candidate, Faculty of Medicine, the University of Tokyo
- Master's degree in biomedical engineering, Yale University
- Former hardware and software developer at a medical robotics company
CHIEF ADVISOR
Jian Lu
Appointments
- Associate Chief Physician, Young Chief Professor, and PhD supervisor at Zhongda Hospital, Southeast University
- Young Chang Jiang Scholar
- Director of the Talent Office, Zhongda Hospital, Southeast University
- Deputy Director of Interventional and Vascular Surgery, Zhongda Hospital, Southeast University
- Vice Chair, Interstitial Tumor Implantation Committee, Chinese Anti-Cancer Association
- Member, Youth Committee of the Interventional Physicians Branch, Chinese Medical Doctor Association
Achievements
- Principal investigator for ten provincial- and ministerial-level projects, including the Jiangsu Distinguished Young Scholars Fund, a National Key R&D Program subproject, and National Natural Science Foundation grants
- More than 50 SCI papers as first or corresponding author, including work in Lancet Gastroenterology & Hepatology (cover), Nature Communications, and Journal of Hepatology
- Sixteen granted or pending patents
- First Prize, 2022 Jiangsu Science and Technology Award
- Young Investigator awards from leading interventional societies in North America, Europe, and Asia-Pacific
- ASCO GI Conquer Cancer Merit Award
- Outstanding Young Scholar, Interventional Physicians Branch of the Chinese Medical Doctor Association
- National Distinguished Physician: Emerging Young Talent
Market · Competition · Current Needs
Targeting the intersection of microscopic-field fit, dynamic registration, and instrument tracking, entering the market through modules and software
The project remains in R&D and validation. Revenue starts before approval through OEM modules and software licences, so commercialization need not wait for full-system approval; after registration the business moves to proprietary systems, software, and consumables.
- 01PositionHow it differs from existing routes: continuous registration and tracking at microscopic scale
- 02MarketOf 2.25 M procedures a year, the first cut is 512 K brain-tumor resections
- 03RevenueModules and software licences bring revenue before approval
- 04Risks and needsThree risks, each with a mitigation already under way
01 · Position
Navigation has to keep answering two questions throughout resection: where is the instrument and what tissue is this. Existing routes each have their strengths, but all were designed for the open field; what this product does differently is to answer both questions at microscopic scale, continuously during surgery.
Soft-tissue compensation
YesNo
Not microscope-ready, with compensation
Intraoperative imaging stacked on tracking
Proprio ParadigmUnited States
CompareComparing
Microscope-ready, with compensation
Coaxial beam-split dual camera
Spectra Navigation Intelligent Microsurgical Navigation SystemThis product · fixed in the right column
Not microscope-ready, without compensation
NDI-class infrared optical tracking
Brainlab Microscope NavigationGermanyMedtronic StealthStation S8United States / IrelandHuake PrecisionChina
CompareComparing
Structured-light surface registration
SeaSpine / Orthofix 7D FLASHUnited States
CompareComparing
Microscope-ready, without compensation
Digital visualization, no registration
Beyeonics OneIsrael, operating microscope
CompareComparing
Not fitFit
Microscope-field fit →
Select any route in the chart to compare it line by line with this product; on a phone, swipe left or right to switch.
NDI-class infrared optical trackingBrainlab · Medtronic · Huake Precision
TrackingContinuous; what is tracked is an array of reflective spheres about 11 mm across, from which the tip position is derived.
RegistrationRegistered once preoperatively against a bone-fixed reference frame; after tissue shifts, registration must be repeated to update.
Microscopic fieldDoes not register or track at microscopic scale. Reflective spheres are sized for the open field, an order of magnitude away from 0.3 mm tips and a field a few millimeters wide.
HardwareSeparate infrared camera (NDI Polaris class) + reference frame + reflective spheres.
A route established in the 1990s and still the mainstream: strong at “where is the instrument”, while “what tissue is this” holds only at the moment of registration.
Structured-light surface registration7D FLASH
TrackingInstrument tracking still uses reflective spheres.
RegistrationNo implanted markers; registration is based on one surface scan and is repeated by rescanning after tissue shifts.
Microscopic fieldDoes not register or track at microscopic scale. Surface scanning is designed for the open field; a field a few millimeters wide offers limited stable features.
HardwareStructured-light projector + camera, with instrument tracking added separately.
It removes implanted markers, but each registration is still a static step rather than continuous updating as tissue deforms.
Intraoperative imaging stacked on trackingProprio Paradigm
TrackingContinuous.
RegistrationRepeatable intraoperative registration with soft-tissue deformation compensation.
Microscopic fieldDoes not register or track at microscopic scale. Designed for the open field; its published indication is spine.
HardwareMulti-camera intraoperative imaging array + instrument tracking, two optical systems.
The closest approach to this product and the benchmark we take most seriously: intraoperative registration, deformation compensation, and tracking are all present. The difference is that it addresses the open field, while this product brings all three into the single optical path of the microscope.
Digital visualization, no registrationBeyeonics One
TrackingNo instrument tracking.
RegistrationNo registration to preoperative imaging.
Microscopic fieldWorks within the microscopic field. It is itself a digital operating microscope, positioned as visualization enhancement.
HardwareDigital microscope imaging + head-mounted or screen display.
It addresses “seeing more clearly”, a different product category from the two questions navigation must answer; it sits outside this divide.
Criteria: “microscope-field fit” means whether intraoperative registration and instrument tracking are performed within a field a few millimeters wide at sub-millimeter accuracy; “soft-tissue compensation” means whether registration updates automatically after tissue shifts. Both axes are read straight off the two columns of the same name in the comparison table; no other criteria are introduced. Per-product values and sources are in the table below.
Competitive landscape table
| Product / Country | Product | Technical route | Registration method | Microscopic-field fit | Soft-tissue compensation | Closed-loop capability | Standard indications |
|---|---|---|---|---|---|---|---|
| Proprio Paradigm (United States) |  | Multi-camera intraoperative imaging + tracking | Bone-fixed | Not compatible | Yes | Registration + tracking | Spine |
| Brainlab Microscope Navigation (Germany) |  | NDI-class infrared optical tracking | Bone-fixed | Not compatible | No | Registration + tracking | General orthopedics or spine |
| Medtronic StealthStation S8 (United States / Ireland) |  | NDI-class infrared optical tracking | Bone-fixed | Not compatible | No | Registration + tracking | General neurosurgery / general orthopedics |
| Beyeonics One (Israel, operating microscope) |  | Digital visualization, no registration | No registration | Compatible | No | Visualization enhancement only | General ophthalmology |
| Huake Precision (China) |  | NDI-class infrared optical tracking | Bone-fixed | Not compatible | No | Registration + tracking | General neurosurgery / general orthopedics |
| SeaSpine / Orthofix 7D FLASH (United States) |  | Structured-light registration + optical tracking | Non-invasive fixation | Not compatible | No | Registration + tracking | Neurosurgery (brain tumors) |
| Spectra Navigation Intelligent Microsurgical Navigation System (This product)Meets all three of microscopic-field fit, deformation compensation, and instrument tracking within this table |  | Coaxial beam-split dual camera | Non-invasive fixation | Compatible | Yes | Registration + tracking | General neurosurgery / ENT / ophthalmology / reconstructive surgery |
Compiled in September 2026 from each manufacturer’s public materials. Competitor specifications and approval status change over time; current specifications, indications, and registration status are subject to each manufacturer’s own disclosures. Product names and trademarks belong to their respective owners and are used here for identification only. Globally, the closest approach is Proprio Paradigm; in China, Huake Precision also targets neurosurgery but uses NDI-class infrared optical tracking, a different technical route from this product.
02 · Market → 03 · Revenue
-
ADDRESSABLE
2.25Mprocedures/yr
Core microsurgical procedures in China
Neurovascular, malignant brain tumor related, ENT, and non-cataract ophthalmic procedures combined.
-
LAUNCH INDICATION
512Kprocedures/yr
Launch wedge: brain-tumor resection
Boundary judgment directly determines the extent of resection and survival benefit, the clearest value proposition.
-
FIRST SITES
Leading tertiary
Neurosurgical centers install first
Then ENT, ophthalmology, and reconstructive surgery.
-
STAGE 01 · PRE-APPROVAL
Modules + licences
Revenue during research / OEM validation
Hardware module delivery; software licences bundled with hardware and billed annually; engineering services for microscope OEMs only, one-off per model. Serving university laboratories, microscope manufacturers, and navigation-system vendors to validate real demand, interface specifications, and willingness to pay.
-
STAGE 02 · POST-APPROVAL
Systems + consumables
Own brand at scale
Complete-system installations build scale; enhanced software licences renew annually; dedicated consumables launch after approval, forming recurring revenue.
04 · Risks and Current Needs
The next priority is converting technical performance into clinical evidence and a registrable product. Clinical workflow, funding, procurement logic, and the regulatory path must converge in parallel; delay in any one area will affect productization. All three risks have mitigations already under way, so none rests on a single assumption.
RISK 01Clinical workflow validationReal-world workflows and clinical-value endpoints still require validation, and the product definition may undergo several iterations.Response: focus on brain-tumor resection as a single entry point and run joint validation through a research and clinical network spanning several university and tertiary hospitals in China and Japan, building an evidence package of usage workflow, surgeon feedback, and comparison baselines to support procurement and payment decisions.
RISK 02Cash flow and financing windowEarly hardware integration requires concentrated investment, while animal studies, prototypes, and registration preparation create continuous funding needs.Response: use a modular OEM path and combine project funding with collaborative research to reduce upfront investment.
RISK 03Registration and clinical evaluation pathwayEquivalence comparison may be redirected to a clinical trial, and review deficiency responses extend timelines and raise costs. The paying entity, departmental budget, and ROI evidence must also be established through demonstration cases.Response: pre-submission consultation with review authorities and parallel preparation of quality-system documentation, with deficiency-response buffer already built into the 2029 approval target. Commercialization does not depend on approval: OEM modules and software licences generate revenue first.
Resources and deliverables for the next stage
RESOURCE PRIORITIES
Three resource groups must be secured in parallel
Clinical validationAnimal studies, close clinician collaboration, data collection, and staged reviews.
Product engineeringHardware and software optimization, systems integration, industrial design, and prototype iteration.
Operations and complianceIntellectual-property strategy, regulatory planning, quality systems, manufacturing, and supply-chain management.
Key hires and external advisorsClinical program leads, hardware and software engineers, quality and regulatory staff, plus advisors for animal studies, legal matters, and manufacturing scale-up.
NEXT MILESTONES
Five deliverables for the next stage
Intellectual property and patent strategyPatent drafting and prosecution, FTO searches, and entry into China, Japan, and PCT.
Integrated prototype V1Hardware and software integration and commissioning, producing units suitable for demonstration and third-party testing.
Third-party testing and registration groundworkPhantom accuracy, electromagnetic compatibility, and biocompatibility evaluation, plus classification consultation.
Hospital PoC and OEM interfacesJoint validation with clinicians, data collection and review, and interface discussions with microscope manufacturers.
Operations and quality-system foundationCore hires, quality-system development, and manufacturing readiness.
The basis and sources for procedure volumes are given in the Clinical Problem section above. Market size and commercial path illustrate the commercial logic; actual performance will depend on installation ramp, gross margin, channel discounts, and the post-registration launch schedule. Each deliverable maps to a defined milestone; specific pricing, installation plans, the financing requirement, detailed use of funds, and schedule are calculated against the milestone budget, cash flow, and registration plan, and are not disclosed on this page. They are available in formal due-diligence materials.
CONTACT
Clinical, industry, and investment enquiries
We welcome direct contact from neurosurgical and microsurgical teams, microscope and instrument manufacturers, and investors following early-stage medical device programs.
Full due-diligence materials — covering the clinical validation plan, registration pathway detail, financial projections, and use of funds — are available on request. Please state your organization and intended use.
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SPECTRA NAVIGATION
Give microsurgery a quantitative intraoperative reference
Spectra Navigation aims to bring navigation into smaller, deeper, and more dynamic microscopic fields. The next stage requires clinical, industry, and investment partners to advance validation, registration, and scalable deployment.