Dignitana

What Dignitana does

Dignitana AB (publ) is a Swedish medical technology company that develops, manufactures, and markets the DigniCap Scalp Cooling System, an FDA-cleared Class IIa medical device designed to minimize chemotherapy-induced alopecia in cancer patients with solid tumors. The core technology combines a thermoelectric cooling unit with a flexible silicone-based Cooling Wrap and neoprene Thermal Cap; temperature-regulated coolant (branded DeltaCool) circulates through a labyrinth channel pattern in the wrap, with dual fluid sensors and a backup sensor maintaining consistent scalp temperature. DigniCap received FDA De Novo clearance in December 2015 for breast cancer patients, expanded FDA clearance in 2017 for all solid tumor indications, and FDA clearance for the next-generation DigniCap Delta system in June 2019.

Dignitana generates revenue through a hybrid model: capital equipment (DigniCap Delta and legacy C3 systems) sold or leased directly to hospitals and cancer centers, recurring single-patient-use consumables (Cooling Wraps, Thermal Caps, DeltaCards prepaid treatment credits), per-treatment billing through the myDigniCap.com portal, and US insurance reimbursement under CPT Category I codes as a third-party out-of-network provider. Clinical evidence underpinning the system includes a JAMA-published pivotal trial showing 66.3% hair preservation in breast cancer patients and additional peer-reviewed studies across anthracycline regimens and broader solid-tumor populations. The company is publicly traded on Nasdaq First North Growth Market, with headquarters in Lund, Sweden, a US operations center in Dallas, Texas, and an Italian subsidiary in Milan; distribution extends across roughly 20+ countries through direct enterprise sales and a global network of exclusive and non-exclusive distributors.

Name

Dignitana

Legal name

Dignitana AB (publ)

Website

https://dignicap.com

Company type

Public

Founded year

1990

Operating status

Operating

Headcount range

11–50 employees

Short description

Dignitana AB is a Swedish medical technology company that markets the FDA-cleared DigniCap Scalp Cooling System to hospitals and cancer centers, reducing chemotherapy-induced hair loss in solid tumor patients via a thermoelectric cap with single-patient-use consumables.

Ownership category

akta.pro rank

Product category

Medical Devices — Oncology Supportive Care

NAICS

Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Wound Care & Ulcer Management (HLAKACAN)

akta.pro secondary industry

Treatments & Scalp Care (Serums, Oils, Anti-dandruff, Growth) (CRABABAE)

Keywords

• Scalp cooling device
• Medical device manufacturing
• Chemotherapy alopecia treatment
• Oncology supportive care
• Thermoelectric cooling system

Headquarters

HQ city

Dallas

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Supply Chain

Revenue model

1. Device Sales and Leasing: Dignitana sells or leases DigniCap Delta cooling units to hospitals and cancer treatment centers. The company deploys its equipment at contracted healthcare facilities where scalp cooling services are provided to patients.
2. Single-Patient-Use Consumables: Patients purchase single-patient-use consumable components — Cooling Wraps and Thermal Caps — for their treatment series. The DigniCap Delta Kit (single-patient-use components) cannot be returned once received. Treatment Cards (DeltaCards) are prepaid credits for treatment sessions and can be returned for a refund within 6 months of purchase, subject to a $60 restocking fee.
3. Per-Treatment Billing: Patients pay per treatment session either through the myDigniCap.com online portal or at the treatment facility. Payment and consent must be provided prior to each treatment session.
4. Insurance Reimbursement: Scalp cooling services are billed under CPT Category I codes through Dignitana's insurance-based billing model throughout the United States. As a third-party out-of-network provider, Dignitana does not have direct agreements with insurance companies — reimbursement depends on individual plan coverage. Success with reimbursement varies by plan, coverage, and location.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

Dignitana designs, manufactures, and distributes the DigniCap Scalp Cooling System, an FDA-cleared Class IIa medical device that uses thermoelectric cooling and a flexible silicone Cooling Wrap with circulating DeltaCool coolant to reduce chemotherapy-induced hair loss in cancer patients with solid tumors. The company sells or leases the DigniCap Delta device to hospitals and cancer centers and supplies single-patient-use consumables (Cooling Wrap, Thermal Cap, DeltaKit, DeltaCard treatment credits) on a recurring per-treatment basis.

Product overview

Dignitana develops and markets The DigniCap Scalp Cooling System, a patented medical device that minimizes chemotherapy-induced hair loss. The product line includes two device models: DigniCap C3 (earlier generation) and DigniCap Delta (next generation with improved flexible wrap and thermal cap system). Both consist of a cooling unit connected to a form-fitting cap that circulates temperature-regulated coolant. The system is FDA cleared for patients with solid tumors and CE certified as Class IIa. Single-patient use components include the Cooling Wrap, Thermal Cap (Delta), and DeltaCool coolant. Consumable Treatment Cards (DeltaCards) enable pre-paid treatment sessions.

Differentiator

Problem solved

Functional benefit

Brands

• DigniCap Delta: The next generation DigniCap Scalp Cooling System with thermoelectric cooling, form-fitting cap system, and device portability with battery for optimal throughput.
• DeltaCool

Products and services

• DigniCap Delta Scalp Cooling System Current-generation FDA-cleared scalp cooling medical device consisting of a thermoelectric cooling unit with integrated touchscreen computerized control, connected to a flexible Cooling Wrap and Thermal Cap. Uses circulating DeltaCool temperature-regulated coolant to minimize chemotherapy-induced hair loss in cancer patients with solid tumors. Includes battery capability for device portability and quick-connect hose mechanism.
• DigniCap C3 Scalp Cooling System Earlier generation DigniCap model offering scalp cooling for chemotherapy patients with technical specifications available for clinical reference.
• DeltaKit (Single-Patient-Use Components) Single-patient-use consumable kit including Cooling Wrap and Thermal Cap for the DigniCap Delta system. Non-returnable per FDA medical device regulations.
• DeltaCool Coolant Temperature-regulated coolant that circulates through the DigniCap Delta cooling system from the device via hose to the Cooling Wrap, providing precise scalp temperature control.
• DeltaCard (Treatment Cards) Prepaid treatment cards redeemable for DigniCap Delta sessions, valid for up to 6 months from purchase. Unused cards may be returned for refund within 6 months subject to a $60 per-shipment restocking fee.

Quantifiable outcome

• 66.3% of breast cancer patients prevented from significant hair loss in pivotal trial vs. 100% hair loss in control group
• +4 more outcomes

Named customers10 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature6 records

Partnerships

15 partnerships are on record, tiered core and minor.

• Boa TechnologycoreTechnology or Integration · 13 December 2016Dignitana partnered with Boa Technology to develop the world's first precision-fit scalp cooling cap. Boa Technology is known for its dial-based closure systems originally developed for snowboard boots, which were adapted to provide a precision fit for the DigniCap cooling cap.
• Susan G. KomencoreGTM or Marketing PartnerDignitana is a proud supporter of Susan G. Komen and their mission to save lives by meeting the most critical needs in communities and investing in breakthrough research to prevent and cure breast cancer.
• HairToStaycoreGTM or Marketing PartnerHairToStay is the first and only national nonprofit organization dedicated to helping cancer patients afford scalp cooling. Dignitana partners with HairToStay to provide financial assistance to qualifying patients.
• Cold Capital FundminorGTM or Marketing PartnerCold Capital Fund provides financial assistance to chemotherapy patients in Washington DC, Maryland, and Virginia who are trying to prevent hair loss through scalp cooling.
• Hope for Hair FoundationminorGTM or Marketing PartnerHope for Hair Foundation provides support to cancer patients in North Carolina through financial aid for DigniCap treatment and by educating patients about products that help ensure successful hair retention.
• Cap and ConquerminorGTM or Marketing PartnerCap and Conquer is a 501(c)(3) nonprofit that raises funds for cancer patients in Southeast Michigan who choose to use scalp cooling technology to reduce hair loss during chemotherapy.
• Aurora BioScience Pty LtdcoreChannel Partner/ Reseller/ DistributorAurora BioScience is the exclusive distributor of DigniCap Delta in Australia and New Zealand, providing local sales, support, and distribution for the DigniCap scalp cooling system in the ANZ region.
• Konica MinoltacoreChannel Partner/ Reseller/ DistributorKonica Minolta distributes DigniCap in Japan, providing local market access and distribution for the scalp cooling system in the Japanese market.
• OncoMedical AGcoreChannel Partner/ Reseller/ DistributorOncoMedical AG is the distributor of DigniCap in Switzerland and Liechtenstein, handling local sales and distribution of the scalp cooling system.
• Science International CorporationcoreChannel Partner/ Reseller/ DistributorScience International Corporation distributes DigniCap in Hong Kong and Macau, providing local market access for the scalp cooling system.
• Tesla Medical SolutionscoreChannel Partner/ Reseller/ DistributorTesla Medical Solutions distributes DigniCap across the Middle East and North Africa, covering Armenia, Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yemen.
• Celeritas TradingcoreChannel Partner/ Reseller/ DistributorCeleritas Trading is the distributor of DigniCap in Mexico, providing local sales and distribution through its DigniCap Mexico directory.
• BoosstminorChannel Partner/ Reseller/ DistributorBoosst distributes DigniCap in Ecuador and Peru, providing local market access for the scalp cooling system.
• Chronos Trade MedicalminorChannel Partner/ Reseller/ DistributorChronos Trade Medical distributes DigniCap in Romania.
• DignilifeminorChannel Partner/ Reseller/ DistributorDignilife distributes DigniCap in Chile, providing local sales and distribution for the scalp cooling system.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Medline Industries: Medline is a major medical supplies manufacturer and distributor that supplies hospitals and oncology centers with a broad portfolio including supportive care products. While not a direct scalp cooling competitor, it could leverage its scale and hospital relationships to enter or distribute competing solutions in the supportive oncology care space.
• Smith & Nephew: Smith & Nephew is a major medical device company with established oncology and wound care franchises. While not directly competing in scalp cooling, its scale in medical devices and hospital sales channels makes it a potential acquirer or adjacent entrant into the oncology supportive care device category.
• Amgen (Neulasta / supportive care portfolio): Amgen operates in the oncology supportive care space through products like Neulasta (for chemotherapy-induced neutropenia). It represents a broader incumbent addressing adjacent chemotherapy side effects and could expand into alopecia prevention through internal development or acquisition.

Direct peers

• Penguin Cold Caps: Penguin Cold Caps offers a non-electric, gel-based manual scalp cooling system used by chemotherapy patients. While operating via a different delivery mechanism than DigniCap's thermoelectric approach, it directly competes for the same patient population seeking to prevent chemotherapy-induced hair loss.
• Arctic Cold Caps: Arctic Cold Caps provides manual gel-based cold cap systems for chemotherapy patients, primarily operating in the US market. It competes with DigniCap on the same hair-preservation use case but through a lower-cost, patient-managed approach without the controlled cooling technology of DigniCap Delta.
• Paxman Scalp Cooling: Paxman Scalp Cooling is the most direct competitor to Dignitana, also manufacturing and selling thermoelectric scalp cooling systems to oncology centers globally. Both companies target the same clinical use case — preventing chemotherapy-induced alopecia — with similar per-treatment consumables revenue models and competing published clinical evidence.

Emerging players

• Elasto-Gel (North American Healthcare): Elasto-Gel manufactures gel-based therapeutic products including cold therapy wraps used in medical settings. It serves adjacent cold therapy applications and could expand into chemotherapy scalp cooling given its existing manufacturing capability in gel-based cooling products.
• Capelli Medical: Capelli Medical develops scalp cooling devices targeting the same oncology supportive care market as DigniCap. As a more recent entrant, it represents an emerging competitive threat with similar product positioning around chemotherapy-induced hair loss prevention.
• Hilotherm: Hilotherm manufactures controlled cooling therapy devices used for post-surgical and chemotherapy-related applications. While focused on broader therapeutic cooling rather than scalp cooling specifically, it operates in the same medical device cooling category and represents an adjacent competitive threat.

Others

• Boa Technology: Boa Technology is a precision-fit closure technology provider that partnered with Dignitana in 2016 to develop the precision-fit scalp cooling cap. As a technology supplier with existing adjacency to medical device applications, it represents an enabling partner rather than competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/dignicap
• Facebookfacebook.com/dignicap
• Instagraminstagram.com/DigniCap
• Xx.com/dignicap

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries2 records

Funding overview

Funding rounds1 record

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Dignitana