Leartiker cleanroom used through our partnership

Advancing therapies goes beyond developing the treatment.

OUR PARTNERS

Leartiker, member of Basque Research & Technology AllianceClínica Universidad de Navarra

WITH THE SUPPORT OF

THE NEED WE ADDRESS

Advanced therapies.
Practical handling challenges.

We help laboratories and clinical teams preserve, handle and deliver high-value biological products. Our development approach focuses on three priorities.

01

Protect the product

Design for closed handling, with contamination risk and sample integrity in mind.

02

Preserve the dose

Address sample loss and recovery when working with small, high-value volumes.

03

Simplify the workflow

Connect steps and reduce unnecessary transfers between devices.

DESIGN & DEVELOPMENT

From clinical needs
to device design.

We translate handling challenges into device concepts, working with our clinical and engineering partners to develop practical solutions for advanced therapies.

Development supported by specialist facilities

Through our partnership with Leartiker, we have access to a 65 m² ISO Class 7 cleanroom with thermoplastic and liquid silicone rubber (LSR) injection moulding capabilities, supported by Leartiker’s ISO 13485-certified quality management system.

Clinical insightEngineering designManufacturing in mind
CryoKeep product rendering on a pale blue watercolour background

CRYOKEEP

In development · Preclinical evaluation underway.

From cryopreservation
to patient delivery.
All in one closed system.

CryoKeep is a single-use device designed to integrate the cryopreservation, transport and administration of human cells for advanced therapies.

Designed for 1–5 mL volumes.

IP-protected
technology

ONE INTEGRATED SYSTEM

Designed around the cell therapy journey

Illustrated workflow: Load, Seal, Cryopreserve, Dispense
01

Load

Designed to receive the cellular product in volumes from 1 to 5 mL.

02

Seal

Designed to close the system after loading.

03

Cryopreserve

Designed for cryogenic preservation of the cellular product.

04

Dispense

Designed for delivery from the same device.

The device is also designed to keep the cellular product in the same system during transport.

WHY CRYOKEEP

Every small volume matters

Designed to protect valuable cellular products and simplify their journey to the patient.

Photograph of the CryoKeep prototype held in blue-gloved hands
CryoKeep prototype · Original photograph

A closed pathway

Designed to minimise contamination risk by integrating cryopreservation, transport and administration within one closed system.

Focus on dose recovery

Designed to minimise sample loss and support volume recovery during administration.

Continuity through the workflow

Keeping the cellular product in the same device is intended to simplify handling and support traceability.

Cell viability in mind

Preserving cell viability through handling and administration is a core design objective.

DEVELOPMENT PROGRESS

Moving towards the first clinical batch.

Last updated:

Completed

Prototypes developed

CryoKeep prototypes have been developed.

In progress

Preclinical evaluation

Preclinical evaluation is underway.

In progress

Final design

We are finalising the design in preparation for manufacturing the first clinical batch.

OUR DEVELOPMENT VISION
LTK Cryosolutions watercolour symbol
High-value biological products
PreparePreserveDeliver

Connected by design.

OUR VISION

Engineering the journey
of advanced therapies.

At LTK CRYOsolutions, we are developing complementary tools for cell therapy handling, with a shared focus on connecting preservation, handling and delivery.

FIRST PRODUCT IN DEVELOPMENT

CryoKeep

A single device designed to connect cryopreservation, transport and administration.

PLANNED EXPANSION

Storage & handling

Complementary containers, boxes and racks, alongside future device variants.

LONGER-TERM DIRECTIONS

Connected workflows

Potential solutions for filling, aliquoting and freezing or thawing operations.

EXPLORING COMPLEMENTARY SOLUTIONS

Thinking beyond the device.

Packaging, storage and handling concepts that build on the CryoKeep workflow.

CryoKeep multipack packaging concept
Multipack packaging · Concept
CryoKeep two-tier cryogenic storage box concept containing eight devices
Cryogenic storage box · Concept
Rack with CryoKeep storage boxes, concept rendering
Storage rack · Concept
Edilberto Ojeda, CEO of LTK Cryosolutions

LEADERSHIP

Edilberto Ojeda

CEO · PhD, MBA

Edilberto combines a PhD in Biomedicine with an MBA and experience in medical device development, technology transfer and business development.

His background spans gene delivery research, microfluidics and the development of biomedical technologies in academic and industry settings. At LTK Cryosolutions, he leads the company’s development, working with Leartiker and Clínica Universidad de Navarra to advance CryoKeep.

SCIENTIFIC & MEDICAL ADVISORS

Expertise connecting science and clinical practice.

Dr. Enrique J. Andreu Oltra

Scientific Advisor

Dr. Enrique J. Andreu Oltra

Clínica Universidad de Navarra

Technical and Quality Assurance Director of the Cell Therapy GMP Laboratory at Clínica Universidad de Navarra. His expertise spans stem cell biology, advanced therapies and the manufacture of therapeutic cell products under EU GMP standards.

GMP manufacturing · Cell therapy quality

View CUN profile ↗
Dr. Felipe Prósper Cardoso

Medical Advisor

Dr. Felipe Prósper Cardoso

Clínica Universidad de Navarra

Director of Cell Therapy and Co-director of Hematology and Hemotherapy at Clínica Universidad de Navarra. A clinician and translational researcher, he has led more than 30 clinical trials as principal investigator, connecting cell therapy research with clinical practice.

Clinical translation · Hematology

View CUN profile ↗

LET’S TALK

Let’s advance
biologics handling.

Interested in our technology, a development collaboration or investing in LTK Cryosolutions? We would welcome a conversation.

For clinical teams, researchers, industry partners and investors.

[email protected]