Evaluation dossier · Updated July 27, 2026

Quick read

SPHERA addresses a specific gap: when the pathology team identifies a positive or close margin in the resected surgical specimen, the surgical team must relocate that site in a surgical bed that has already changed. SPHERA is designed to provide a shared 3D reference across the two spaces to support visualization, communication, and case documentation.

TRL 5 Functional MVP. Declared target of TRL 7 by year-end 2026.

76 3D components inventoried: 36 specimen and 40 surgical bed. Not clinical cases.

10+ Target of new prospective pilot cases. Not a completed result.

What exists today

MVP with model loading, four co-registration modes, annotation, dual view, and reporting.
Local operation and a shared session over the institution's internal network.
3D acquisition protocol supported by an updated, auditable technical inventory.
Prospective pilot approved by a research ethics committee and reportedly underway with FALP.
Start-Up Chile Ignite grant awarded to strengthen the product, evidence base, and regulatory pathway.

What remains to be demonstrated

Prospectively measured and published clinical accuracy.
Impact on repeat resections, recurrence, or other oncologic outcomes.
Clinical safety and production-grade cybersecurity controls, including authentication, encryption, and audit logging.
Formal regulatory classification and pathway for each target market.
Pricing, sales cycle, retention, and unit economics validated with customers.

The solution
3D acquisition
Evidence
Status and risks
Pilot
Ways to engage

What SPHERA is

SPHERA is 3D software that supports intraoperative margin assessment in head and neck cancer surgery. It reconstructs the surgical specimen (the tissue removed with the tumour) and the surgical bed (the cavity left in the patient) in three dimensions, overlays them and aligns them so that surgeon and pathologist work on the same model.

It is developed by Altitud 100K together with Fundación Arturo López Pérez (FALP), a reference cancer centre, based on real cases and the real surgical workflow.

SPHERA is a support tool for visualization, communication and documentation. It is not a diagnostic device, it has no regulatory clearance, and it does not replace the clinical judgment of the medical team.

A partnership between engineering and oncology

SPHERA is developed by Altitud 100K —an applied science platform that turns technical knowledge into solutions— together with Fundación Arturo López Pérez (FALP), a reference cancer centre in Chile.

FALP brings the clinical context, the real cases and the surgical and pathology perspective; Altitud 100K brings the 3D engineering and the software. The clinical collaboration is reported by the team and can be verified against its institutional sources.

The clinical problem

The pathologic finding is identified on the surgical specimen, while any additional margin resection is performed in the patient. Between these stages, orientation is lost, tissue deforms, and the operative field changes. The challenge is not only to detect the finding, but to relocate it within anatomy that is no longer the same.

Four panels: the resected surgical specimen, the positive or close margin identified on it, the surgical bed in the patient, and the spatial relocation gap between them. — Figure 1. Conceptual representation of the relocation gap between the surgical specimen and the surgical bed. This is not a patient image and does not demonstrate SPHERA's performance.

49.7% of perpendicular-margin relocations were more than 1 cm from the true site.

10.2 mm mean observed relocation error.

13.8% of shave-margin relocations did not overlap the true margin.

Source: Miller et al., Head & Neck, 2024. Prospective multi-institutional study involving 32 specialists, 10 specimen models, and 640 margins. These figures describe the clinical problem; they are not SPHERA results.

Clinical relevance. In head and neck surgery, removing additional tissue at the wrong site may compromise structures involved in speech, swallowing, breathing, and appearance; leaving residual disease may also affect oncologic control. Head and neck cancer accounts for roughly 947,000 new cases per year across the included cancer sites —approximately 758,000 of the lip, oral cavity and pharynx plus 189,211 of the larynx—; not all are surgical cases or potential SPHERA candidates. SPHERA is intended to improve spatial referencing, not replace the judgment of the surgeon or pathologist.

Source: IARC, 2022 incidence data and GLOBOCAN 2022.

The solution

A shared 3D reference between the operating room and pathology

SPHERA loads 3D models of the specimen and surgical bed, co-registers them within a shared reference frame, supports margin annotation using real-world dimensions, and enables review from two synchronized workstations. The goal is to help surgical and pathology teams communicate an anatomic location with less ambiguity.

Intraoperative 3D protocol workflow: equipment setup, surgical-bed and surgical-specimen scanning, quality control, standardized export, import into SPHERA, and co-registration across the operating room, pathology and the platform. — Figure 2. End-to-end overview of the proposed workflow, from preparation and scanning through co-registration and communication. This is a product representation; adoption at each center requires local evaluation.

Acquisition

3D specimen and surgical bed

Scanning under a standardized procedure, followed by operational checks for coverage, texture, and anatomic landmarks.

Co-registration

Shared spatial reference

Four implemented modes combine automation and user guidance. Internal quality metrics still require prospective clinical performance evaluation.

Collaboration

Review and reporting

Dual view, annotations, a shared session over the local network, and structured PDF reporting inspired by synoptic pathology workflows.

Intended-use boundary

SPHERA is designed to support visualization, communication, and documentation. It does not diagnose or autonomously classify margins, make resection decisions, or replace clinical judgment. The final intended-use statement and applicable regulatory classification remain to be formally established.

01
Alignment
Specimen ↔ bed co-registration

Four implemented co-registration modes that combine automation and user guidance. Internal quality metrics still require prospective clinical performance evaluation.
02
Annotation
Colour-coded margins

Mark points or paint areas at real size in millimetres, with a colour code for positive, at risk or negative.
03
Visualization
Dual view

Specimen and bed side by side, with overlay and transparency to see margins in depth.
04
Collaboration
Shared session

The operating room and the frozen-section room work on the same model in real time over the local network.
05
Documentation
Structured PDF report

Exports a PDF with a margin table, annotated snapshots and case measurements, inspired by synoptic pathology workflows.
06
Privacy
100% local

Runs without the cloud: data never leaves the premises. Includes a de-identification mode for the report.
07
Assistance
Local software assistant

An assistant that supports use of the software, reportedly without access to case data.

3D acquisition

From tissue to 3D model

Co-registration quality begins with controlled acquisition. Preparation, lighting, and scan coverage must remain consistent for the models to be comparable. This page presents the general approach; acquisition parameters and complete operating procedures are agreed confidentially with each institution.

Scanning protocol: specimen preparation with washing, drying and marking; 3D specimen scanning side by side; surgical-bed scanning with lighting control; and quality control with standardized export to SPHERA. — Figure 3. Conceptual representation of the preparation, scanning, and quality-control procedure. Approval labels shown in the illustration refer to operational input checks, not validation of clinical accuracy.

01

Prepare

Washing, drying, and landmark placement under the institution-approved protocol.

02

Capture

Scanning of the specimen and surgical bed with checks for lighting, coverage, and anatomic orientation.

03

Verify

Review of mesh, texture, visible landmarks, and metadata before loading the models.

The repository contains meshes and textures, images, native scanner files, derived data, and process logs. The existence of a format in the inventory does not mean that SPHERA imports it directly.

OBJ
PLY
STL
3MF
GLB
ASC

Data and security. SPHERA is designed for on-premises operation by default. Any export of appropriately de-identified technical or clinical data for research or development would be optional, separate from software use, and subject to applicable ethics approval, contractual terms, and data-protection requirements. Each pilot must account for Chilean Law No. 20,584, Law No. 19,628, and Law No. 21,719, which takes effect on December 1, 2026.

Evidence

Evidence and scientific activity

SPHERA is being developed with clinical professionals. Its 3D acquisition work has contributed to a manuscript in preparation and to participation in an international conference. This activity supports the relevance of the problem but should not be interpreted as clinical validation of the product.

Manuscript

Intraoperative 3D correlation

The manuscript Beyond visualization: translational challenges and clinical opportunities of intraoperative 3D specimen–surgical bed correlation in head and neck cancer surgery is being prepared for submission to Oral Oncology. The journal is the intended venue; this does not imply acceptance or publication.

Thumbnail of the first page of the clinical and technical manuscript on 3D specimen–bed correlation. — Figure 4. Manuscript thumbnail. Wider distribution requires authorization from the coauthors and the relevant institutions.

International dissemination

AHNS 12th International Conference

Altitud 100K reports participating in the conference with the work Implementation of a 3D scanning workflow for accurate specimen–bed localization in head and neck cancer resections, held in Boston, United States, July 18–22, 2026.

Thumbnail of the scientific abstract presented at the American Head and Neck Society 12th International Conference. — Figure 5. Scientific abstract thumbnail. Presentation format, abstract number, and program listing are available for verification when applicable.

763D components

1,142Files

184.6 GBDecimal storage volume

Internal EXStar technical inventory, as of July 3, 2026. These are aggregate operational counts: they do not identify patients, establish specimen–surgical bed correspondence, or measure clinical performance.

Progress indicators

Technical inventory of 76 3D components, 1,142 files, and 184.6 GB of decimal storage.
Nominal coverage from December 2024 through June 2026; 63 of 76 components retain the six primary 3D exports.
Prospective pilot approved and reportedly underway with FALP.
Seven coauthors and an institutional letter signed in May 2026.

Correct interpretation

The 76 entries are technical components; they cannot be used to infer patients, unique cases, or complete specimen–surgical-bed pairs.
Volume and formats document available material, not SPHERA's accuracy or performance.
No published performance metrics or demonstrated oncologic outcomes are available.
Verify the pilot, manuscript, abstract, and institutional support against primary sources.

Status

Roadmap and risks

A clear distinction between what is in place, what remains under development, and what depends on third parties.

Current
MVP · TRL 5

Status and maturity as reported by the team. The inventory confirms 3D technical assets and EXStar project files, but does not independently validate the TRL, MVP functionality, or co-registration accuracy.
2026 target
Pilot-ready version · TRL 7

Version-controlled build, manuals, improved stability, prospective evidence, and a preliminary regulatory pathway. This is a target, not an achieved result.
Later stage
Production readiness and expansion

Enhanced clinical safety and cybersecurity controls, formal regulatory assessment, initial licenses, and multicenter pilots, subject to evidence, procurement processes, and approvals.

Development and dependencies

AI-based automatic detection of anatomic landmarks.
Non-rigid registration to compensate for tissue deformation.
Performance optimization for high-density meshes.
Authentication, encryption, and audit trails for production use.
Quality documentation, risk matrix, and regulatory strategy.
Standardization gap: 13 of 76 components do not contain the full set of six export formats, and 17 do not include an EXStar project file.

Risks a potential partner should assess

Clinical

Prospective evidence remains pending; no oncologic outcomes have been demonstrated.

Technical

Tissue deformation, acquisition quality, and variable file completeness.

Regulatory

No applicable regulatory authorization; classification and timelines remain undetermined.

Execution

Product knowledge and the clinical relationship are concentrated in one founder.

The current stage is funded by the Start-Up Chile Ignite grant (Corfo), awarded to strengthen the product, the evidence base and the regulatory pathway. It does not cover multicenter expansion, the full regulatory pathway, or a sustained commercial organization.

Pilot

How to evaluate a pilot

The proposed pilot is a controlled evaluation of feasibility, workflow, and technical performance. It does not, in itself, authorize diagnostic use or autonomous clinical decision-making. The final protocol must be approved by the institution and adapted to its infrastructure, clinical team, and applicable ethics and governance requirements.

01

Preparation

Review of the clinical service, scanner, local network, accountable parties, and pilot use case.

02

Agreements

Ethics, data governance, support, rights in results, and stopping criteria.

03

Training

Installation, workflow simulation, and operational verification before the first case.

04

Pilot conduct

Prospective pilot targeting 10–15 eligible cases, subject to the approved protocol.

05

Decision

Joint report: continue, adjust, expand to multiple centers, or conclude the pilot.

Suggested metrics

Preparation and scanning time, percentage of usable acquisitions, loading and co-registration time, technical issues, session completion rate, ease of use, perceived usefulness, and completeness of the file package. Any clinical-accuracy metric requires a dedicated protocol and analysis plan.

Data, cost, and close-out

Data remain on-premises by default, and each acquisition is accompanied by a de-identified manifest. Any secondary use is optional and subject to a separate agreement. Pricing and hardware requirements are defined after assessing the site. Deliverables, rights in results, data-retention rules, and continuation or close-out terms are agreed before the pilot begins.

Adoption

How it is adopted

An institutional B2B thesis under validation. The commercial model still has to be proven with real customers.

Proposed model

Locally deployed annual license

Buyer: hospital, clinic, or cancer center.
Users: head and neck surgery and pathology teams.
Revenue: institutional license, implementation, and training.
Future modules: automation, advanced registration, reporting, and support.

Pricing and scope are defined after assessing each site. Pricing, margin, procurement cycle and retention remain to be validated; pilot pricing may differ from commercial license pricing.

Market-entry strategy

Evidence first, expansion second

Chile: strengthen the evidence base, safety and cybersecurity controls, the pilot proposition, and the regulatory pathway.
Initial institutions: pilots and early licenses with close implementation support.
Regional expansion: Peru and Colombia as learning markets; Mexico and Brazil through partners.
Future extensions: assess other solid tumors in which spatial margin localization is relevant.

Markets, timing, and product extensions remain working hypotheses subject to results and regulatory requirements.

Team

Three founders, clinical collaboration, and a recognized concentration risk.

CFO and COO · Founder · Full-time

Manuel Céspedes Araya

Project engineer and MBA. Leads product, operations, technology projects, the business model, applied AI and the clinical relationship with FALP.

Meet the team → CSO · Co-founder · Significant part-time

Valeria Alarcón Leiva

Electronics engineer with experience in mission-critical engineering. Contributes systems architecture, data analysis and 3D repository curation. Coauthor of the clinical and technical manuscript.

Meet the team → CEO · Co-founder · Part-time

Sofía Galaz Meléndez

Engineering physics student and captain of the USM CubeSat Team. Responsible for general management and the institutional adoption model.

Meet the team →

Reported support

Clinical collaboration with FALP/OECI teams.
Prospective pilot approved by a research ethics committee.
Institutional letter of recommendation signed in May 2026.
Clinical coauthorship of the manuscript in preparation.
Support from the 3IE Institute at Universidad Técnica Federico Santa María.

Risk and mitigation

A substantial portion of product knowledge and the primary clinical relationship is currently concentrated in one founder.
Proposed mitigations include documentation and version control.
Additional computer-vision capabilities.
Clear assignment of installation and support responsibilities.
Distribution of critical knowledge across multiple team members.

Collaboration

Ways to engage

SPHERA's next stage is to turn an MVP and an initial clinical collaboration into multicenter clinical evidence, production readiness, regulatory clarity, and a repeatable commercial model. Stakeholders can contribute in different ways.

01

Invest

Capital to expand validation to additional centers, strengthen the product, accelerate computer-vision capabilities, and fund regulatory and quality-management work.

Before deciding

Review the corporate and financial data room.
Verify source-code ownership and clinical agreements.
Review the evidence, regulatory plan, safety, and cybersecurity.
Agree on milestones, governance, investment amount, and deal structure.

02

Become a partner or pilot site

Clinical centers, healthcare teams, manufacturers, and distributors can contribute a real-world environment, hardware, support, institutional access, or complementary capabilities.

Before starting

Define the objective, scope, and accountable parties.
Review infrastructure requirements.
Agree on ethics requirements, data governance, costs, and rights in results.
Define metrics, support, and pilot close-out criteria.

03

Share expertise

Specialists in medical software, cybersecurity, computer vision, regulation, quality, and technology transfer can make a valuable contribution. Introductions to clinical networks are equally valuable.

Concrete contributions

A targeted introduction to a relevant clinical leader.
Expert review of a specific gap.
Access to manufacturers or distributors.
Mentoring on regulation, healthcare procurement, or scaling.

Initial meeting

30–45 minutes to assess fit, interest, constraints, and the appropriate next step. No sensitive information needs to be shared at this stage.

Second stage

Guided demo, technical session, or site-readiness assessment, depending on the type of collaboration.

Due diligence

Corporate, financial and technical documentation available under a confidentiality agreement, with staged access to what is needed for an informed decision.

Main sources

Miller A. et al. How far are we off? Analyzing the accuracy of surgical margin relocation in the head and neck. Head & Neck. 2024;46(11):2709–2716. PMID 38702976 · DOI 10.1002/hed.27793.
IARC. Global incidence of lip, oral cavity and pharyngeal cancers by subsite in 2022; GLOBOCAN 2022 data for laryngeal cancer.
American Head and Neck Society. AHNS 12th International Conference on Head and Neck Cancer, Boston, July 18–22, 2026.
Library of the National Congress of Chile. Law No. 21,719, effective December 1, 2026.
FALP institutional letter, Start-Up Chile Ignite award, pilot documents, and EXStar inventory as of July 3, 2026: internal supporting materials available for verification subject to authorization.
SPHERA evaluation dossier, Altitud 100K SpA, July 27, 2026 (Spanish and English editions).

Notice. This page is provided solely for informational and preliminary evaluation purposes. It does not constitute an offer to sell or a solicitation of an offer to purchase any security, nor does it constitute investment advice. Forward-looking statements reflect working assumptions and are subject to risks and uncertainties. SPHERA has not received applicable regulatory authorization and does not replace clinical judgment. Third-party names and logos are the property of their respective owners and are used subject to applicable authorizations.

SPHERA