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FAQs

Who is Utermöhlen?

Founded in 1880, Royal Utermöhlen is a long-standing Dutch manufacturer of wound care and related products. They are the original marketer and manufacturer of the dimethyl ether cryosurgical product archetype invented by Dutch general practitioner Dr. Willem Swart, which they introduced in Europe in the late 1980’s, and the US in 1991. These products are commonly referred to today as cryosurgical “H” type products.

Why is Gebauer Company involved with Utermöhlen and the Cryo Professional product?

Like Utermöhlen, Gebauer Company is a 120-year-old family-owned medical device company. The two companies have similar high standards and objectives and have identified a variety of business synergies resulting in this distribution arrangement.

How is Cryo Professional different than the original product introduced to the US in 1991?

Other than the brand name under which it is sold, Cyro Professional is the same trusted Dimethyl Ether (DME)-based formula and applicator used by US practitioners since 1991.

How are “H” type aerosol cryosurgical systems different than “V” type systems?

Cryo Professional and other “H” type products reach a sub-lethal freeze temperature of -55°C delivered by applicators and are FDA cleared for treatment of nine indications. Cryosurgical “V” type products typically utilize cone applicators and reach a freeze temperature of -70°C, enabling them to treat several additional less common indications.

Why use Cryo Professional instead of liquid nitrogen?

Unlike liquid nitrogen, which requires frequent refilling of dispensers and bulk storage of cryogen, Cryo Professional is provided in a convenient aerosol format which requires no additional equipment. It is ready to use whenever the need arises, making it an ideal choice for general practitioners such as family and pediatric practices, podiatry, and others for treatment of warts and other common lesions.

What is the shelf life of Cryo Professional?

Cryo Professional has a shelf life of 3 years from date of manufacture. See canister and kit labeling for expiry.

Is Cryo Professional flammable?

Yes, Cryo Professional contains dimethyl ether, propane, butane, isobutane and, like isopropyl alcohol and other common substances used in clinics and similar facilities, is flammable.

What are the storage requirements for Cryo Professional?

Cryo Professional should be stored at normal room temperature up to 77°F and may be kept ready to use on a countertop. See Instructions for Use and product SDS for additional information. The product should be stored in a cool and dry place at a maximum of 25°C. It should not be stored in direct sunlight.

Does Cryo Professional require HAZMAT shipping? 

If Cryo Professional is purchased from a major distributor and delivered by the distributor’s fleet truck, there will be no hazardous shipping fee. However, if your shipment is made via an alternative carrier such as UPS, USPS, or FedEx, HAZMAT shipping fees may apply. Keep in mind that such fees are applied per shipment, no matter how many units are purchased, and savings may result by purchasing in larger quantities.

How many treatments will each Cryo Professional kit provide?

Each Cryo Professional kit includes two canisters of liquid cryogen. Depending on the applicator used, this should be sufficient to administer approximately fifty treatments. Keep in mind that the smaller 2mm applicator will require slightly less cryogen than the larger 5mm applicator, and that there will be some variation between individual clinicians.

Are demonstration or sample kits available?

Contact your Gebauer sales representative to discuss samples or to arrange for a demonstration. Please note that sample quantities are limited. Keep in mind that since Cryo Professional is used for a variety of reimbursable procedures, a kit typically pays for itself within 3-4 uses.

Can I order extra applicators or canisters of cryogen separately?

No, Cryo Professional is supplied only in kit form with an appropriate supply of applicators in each.

What types of lesions can be treated with Cryo Professional?

Cryo Professional is FDA cleared for the treatment of Verruca vulgaris (common wart), Verruca plana (flat wart), Verruca plantaris (plantar wart), Condyloma (genital warts), Lentigo (age spots), Keratoses (sun spots), Achrochordon (skin tags), Molluscum Contagiosum (water warts). See Instructions for Use to review specific indications and treatment guidelines.

Is Cryo Professional effective on cancerous lesions?

No, the Cryo Professional system is for use only on indicated benign lesions. Refer to the Instructions for Use for more information.

What is the procedure and how long should a frozen applicator be applied when treating a lesion?

Please read the Instructions for Use booklet thoroughly before handling or using the Cryo Professional product.

Can applicators be reused?

Applicators are designed to be single-use disposable and not to be used on more than one patient. An applicator may be used on more than one treatment site of a single patient but should not be used on different types of lesions on the same patient or be re-saturated. If the applicator is no longer sufficiently cold, a new applicator should be used.

Can applicators be frozen more than once?

A 2mm applicator will remain saturated and cold for approximately 90 seconds, while a 5mm applicator will last around 120 seconds. Additional treatments may be administered within these cycles. It is not recommended that applicators be saturated again and refrozen for a second use. If the applicator is no longer sufficiently cold, a new applicator should be used for additional treatments.

Can Cryo Professional be used during pregnancy or breastfeeding?

The safety of Cryo Professional applied to pregnant or breastfeeding patients has not been determined.

Can Cryo Professional be used on small children?

The safety of Cryo Professional in use with pediatric patients has not been established. Cryo Professional should not be used on patients under the age of 4 years without the consultation of a pediatrician.

Cryo Professional

Featured Download | Cryo Professional Overview Document

Cryosurgery Application Times, Average Payment, and Reimbursement Rates

TIMELINE

Utermöhlen Cryo Professional Portable Cryosurgical System

Both Utermöhlen and Gebauer Company are family-owned medical device companies with more than 120 years of expertise in product development and distribution.

Learn more about the history of the Cryo Professional portable cryosurgical system, previously introduced to the market as Histofreezer®.

Chronological Overview of Histofreezer®Ownership and Manufacturing

Late 1980’s

  • Histofreezer® was invented by Dutch general practitioner Dr. Willem Swart. This patent (US patent 4,865,028) covered an aerosol canister with Dimethyl Ether and ‘Fluffy’ cotton wool applicators.
  • Utermöhlen obtained the exclusive rights to this “Swart” patent and started manufacturing & marketing the Histofreezer®. Initially in several European countries and starting in 1991 in the USA through its distributor STC Technologies (to become OraSure Technologies later).
1980’s

1993 Foam Applicator

  • While looking for increased performance a new patent was applied for by Utermöhlen introducing the current foam applicator (US patent 5,738,682 – K. Jensma) to replace the old ‘fluffy’ cotton wool applicator. This turned out to be a good step forward and led to increased sales in many countries, including the USA.
1993

1998 OraSure

  • OraSure Technologies acquired the rights to the patents, trademark, and business from Utermöhlen.
  • Under a manufacturing agreement, Utermöhlen continued to manufacture Histofreezer® for OraSure until 2015.
1998

2015 Patent Expiry

  • Around this time the relevant patents owned by OraSure expired.
2015

2016 Cryo Professional

  • As Utermöhlen was now free of obligations towards OraSure, Utermöhlen started manufacturing the same product in 2016 under the Cryo Professional brand and has achieved a dominant position in many territories.
2016

2018 Lawsuit

  • OraSure contested Utermöhlen’s right to market Cryo Professional (claiming know-how ownership). Utermöhlen successfully defended the case.
2018

2021 Brand Acquired

  • The Histofreezer® brand was acquired from OraSure by CryoConcepts LP.
2021