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SPHERA

Spatial Pathology for Head and Neck Realignment Assistance

3D spatial mapping for surgical margin relocation in cancer surgery.

Software that reconstructs the resected specimen and the patient's surgical bed in 3D, aligns them, and helps the surgical and pathology teams locate margins accurately in head and neck cancer.

  • TRL 5 · Functional software
  • On-premises by default
  • Not a diagnostic device
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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 software. Declared target of TRL 7 at the end of the Ignite program.
76 / 31 3D scans and clinical cases in the FALP series, across 33 operating days.
Sep 8, 2026 Start of the Start-Up Chile Ignite program (Corfo), already awarded.

What exists today

  • Software with model loading, four co-registration modes, annotation, dual view, and reporting.
  • Local operation and a shared session over the institution's internal network.
  • A series of 76 3D scans across 31 clinical cases and 33 operating days, with an acquisition protocol and an 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.
Download the dossierPDF · 13 pages · English Go to the clinical problem

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.

Altitud 100K Fundación Arturo López Pérez (FALP)

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.

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 in seven steps: equipment setup; surgical-bed and surgical-specimen scanning, carried out in parallel in two rooms; quality control and margin inking; standardized export; import into SPHERA; and co-registration and communication 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. Figure labels are in Spanish.
  1. 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.

  2. 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.

  3. 03
    Visualization

    Dual view

    Specimen and bed side by side, with overlay and transparency to see margins in depth.

  4. 04
    Collaboration

    Shared session

    The operating room and the frozen-section room work on the same model in real time over the local network.

  5. 05
    Documentation

    Structured PDF report

    Exports a PDF with a margin table, annotated snapshots and case measurements, inspired by synoptic pathology workflows.

  6. 06
    Privacy

    100% local

    Runs without the cloud: data never leaves the premises. Includes a de-identification mode for the report.

  7. 07
    Assistance

    Local software assistant

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

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 in four blocks: specimen preparation with washing, drying, landmark placement and positioning; 3D scanning of both specimen faces; surgical-bed scanning with lighting control; and quality control and export, with margin inking replicated in the same colour on the digital model before loading it into SPHERA.
Figure 3. Conceptual representation of the preparation, scanning, and quality-control procedure. Approval labels shown in the figure refer to operational input checks, not validation of clinical accuracy. Figure labels are in Spanish.
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 and scientific activity

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

763D scans
31Clinical cases
33Operating days
171.9 GBacross 1,142 files

Internal EXStar technical inventory, consolidated in August 2026: 36 specimen scans and 40 surgical-bed scans, with coverage from December 2024 through June 2026. These are aggregate operational counts: they do not identify patients and do not measure clinical performance.

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 and reports a retrospective series of 31 cases and 76 3D scans obtained with FALP, with seven coauthors. 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

Two international conferences

Altitud 100K reports participating in the SLAP 2025 Latin American Congress of Pathology and in the AHNS 12th International Conference on Head and Neck Cancer, held in Boston, United States, July 18–22, 2026, with the work Implementation of a 3D scanning workflow for accurate specimen–bed localization in head and neck cancer resections.

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.

Project timeline

From the founding of the company to commercial scale-up. What has been completed is marked; what follows are milestones the team anticipates, subject to results and to the relevant regulatory authority in each market.

2025

2025Startup

Altitud 100K founded

AI-native company.

2025Partnership

Partnership with FALP

Oncological medicine, with Fundación Arturo López Pérez.

2025Congress

Latin American Congress of Pathology

Altitud 100K + FALP paper presented at SLAP 2025.

2026

2026Congress

AHNS 12th International Conference on Head and Neck Cancer

Altitud 100K + FALP presentation and paper, in Boston.

2026Pilot MedTech + AI

Pilot program

Software for oncological surgery with Fundación Arturo López Pérez.

2026Incubator

3IE Escala Program

International Institute for Business Innovation, Universidad Técnica Federico Santa María.

2026Pitch

Shark Tank, Boston

1st place in the pitch competition.

2026Capital

Corfo funding

Start-Up Chile Ignite winners with the SPHERA project software.

2027

2027Regulatory

ISP approval

Authorization from Chile’s Public Health Institute (ISP).

2027Commercial

Software commercialization

SPHERA launch in Chile.

2028

2028Regulatory

FDA approval

U.S. Food & Drug Administration authorization.

2028Commercial

Commercial scale-up

SPHERA in clinics and hospitals across the United States and Europe.

The 2027 and 2028 milestones are team projections, not commitments. Meeting them depends on clinical results and on third-party decisions.

Team

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

Manuel Céspedes Araya, CFO and COO of Altitud 100K CFO and COO · Founder · Full-time

Manuel Céspedes Araya

Project Engineer with a BSc in Engineering Sciences (USM), an MBA, and international training in entrepreneurship and innovation at Babson College. Leads product, operations, technology projects, the business model, applied AI and the clinical relationship with FALP.

Meet the team → Valeria Alarcón Leiva, CTO of Altitud 100K CTO · Co-founder · Significant part-time

Valeria Alarcón Leiva

Electronics Engineer (USM), with experience in mission-critical engineering and involvement with Chile’s National Space Center. Contributes systems architecture, data analysis, 3D repository curation and methodological validation. Coauthor of the clinical and technical manuscript.

Meet the team → Sofía Galaz Meléndez, CEO of Altitud 100K CEO · Co-founder · Part-time

Sofía Galaz Meléndez

Engineering Physics student (USM) 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 and dissemination at SLAP 2025 and AHNS 2026.
  • Support from the 3IE Institute at Universidad Técnica Federico Santa María.

Ways to engage

SPHERA's next stage is to turn functional software 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.

After the pilot: how it is adopted

An institutional B2B thesis under validation: a paid pilot first and then a locally deployed annual clinical license. The commercial model still has to be proven with real customers.

Who buys and who uses it

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

The prices published in the dossier are list prices, not transacted prices. Procurement cycle, conversion, and retention remain to be validated with real customers.

The regulator sets the order

  1. Chile: evidence base, safety controls, the pilot proposition, and the ISP submission.
  2. Colombia: INVIMA grants automatic approval for Class I and IIa devices. It is the fastest and least costly entry point in the region, ahead of Peru.
  3. Peru: DIGEMID, 90 business days for Class II.
  4. Mexico and Brazil, through partners: COFEPRIS in 3 to 6 months —Chile is not among the jurisdictions eligible for the abbreviated pathway— and ANVISA in 6 to 12 months with MDSAP.
  5. United States and Europe: 510(k) Class II, with the United Kingdom as the entry point to the European Union.

All five regional markets require a local legal representative: this is a per-country entry cost. Timing and extension to other solid tumors remain hypotheses subject to results and regulatory requirements.

Trust does not require accepting every project hypothesis. It depends on clearly distinguishing what has been built, what has been observed, what remains pending, and what each party is prepared to verify before committing resources, reputation, or clinical access.

Main sources
  1. 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.
  2. IARC. Global incidence of lip, oral cavity and pharyngeal cancers by subsite in 2022; GLOBOCAN 2022 data for laryngeal cancer.
  3. American Head and Neck Society. AHNS 12th International Conference on Head and Neck Cancer, Boston, July 18–22, 2026. Sociedad Latinoamericana de Patología, SLAP 2025 Congress.
  4. Library of the National Congress of Chile. Law No. 21,719, effective December 1, 2026.
  5. Instituto de Salud Pública de Chile: medical-device regulation in force since March 2026, with a 36-month transition period for clinical software.
  6. FALP institutional letter, Start-Up Chile Ignite award, pilot documents, and EXStar inventory consolidated in August 2026: internal supporting materials available for verification subject to authorization.
  7. SPHERA evaluation dossier, Altitud 100K SpA, August 26, 2026 (Spanish and English editions, 13 pages).

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.

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