Contura – Hydrogels for life

OUR HISTORY

Since 2000, we have been developing and delivering innovative and high-quality medical products.

Using our patented hydrogel technology, and from our state-of-the-art manufacturing facility in Denmark, we have developed hydrogel products which make a meaningful difference to the lives of patients across the world. Our hydrogels are currently marketed for urinary incontinence, facial contouring and reconstruction.

In addition to our patented technology, we work with international pharmaceutical and medical device manufacturers which enables us to offer comprehensive treatment options.

By working with the scientific community and using our extensive expertise, we seek out new areas where our unique hydrogel technology offers significant advantages over existing technologies.

Current development programs include the application of our unique hydrogel technology for the treatment of osteoarthritis in the knee of man, inspired by promising results we achieved in the treatment of lameness in horses and osteoarthritis in companion animals. Additionally, we are looking into the efficacy of our technology in the treatment of faecal incontinence.

OUR HISTORY

Since 2000, we have been developing and delivering innovative and high-quality products.

Using our patented hydrogel technology, and from our state-of-the-art manufacturing facility in Denmark, we have developed hydrogel products which continue to make a meaningful difference to the lives of patients across the world. Our hydrogels are currently marketed for facial contouring and reconstruction, urinary incontinence and vesicoureteral reflux.

In addition to our patented technology, we work with international pharmaceutical manufacturers which enables us to offer comprehensive treatment options.

By working with the scientific community and using our extensive expertise, we continue to seek out new areas where our unique hydrogel platform can not only offer significant advantages over existing technologies but also provide viable business opportunities.

OUR MILESTONES

2020

Approval of Bulkamid in the United States for the treatment of stress urinary incontinence due to intrinsic sphincter deficiency in adult women who have SUI or stress predominant mixed incontinence.

2019

Approval of Arthramid Vet in New Zealand as a novel drug for the treatment of lameness in horses.

Commencement of a multi-centre, randomized, controlled clinical study of Arthrosamid for knee osteoarthritis.

Commencement of a prospective, open-label clinical investigation of Arthrosamid in knee osteoarthritis.

Publication of “Voice your Choice”, a study of women’s choice of surgery for primary stress urinary incontinence.

Distribution agreement with Mylan for Regurin XL extended for a further three years through mid-2022.

Publication in Clinical Orthopedics Advanced Research Journal, of the safety results for Arthrosamid for the treatment of knee osteoarthritis symptoms in a retrospective case series.

Publication in Research and Reports in Urology on particulate versus non-particulate bulking agents in the treatment of stress urinary incontinence.

2018

Acquisition of the Company’s freehold manufacturing facility in Denmark.

Acquisition of Antematter IP Limited, the holder of worldwide rights to all veterinary uses of the Company’s hydrogel technology.

Cessation of distribution of Mitem in Germany and Austria.

Change of notified body from Presafe, Denmark to Tüv Süd, Germany in preparation for the introduction of the new Medical Device Regulations (MDR) in mid-2020.

Publication of the results of an observational proof-of-concept cohort study of Arthrosamid in the Journal of Clinical and Experimental Rheumatology.

2017

Prospective observational multicentre trial evaluating Bulkamid as a primary procedure for stress urinary incontinence (SUI) commenced in UK.

Contura’s manufacturing facility granted EU GMP certificate.

Premarket approval application for Bulkamid submitted to the US Food and Drug Administration (FDA).

Worldwide rights to Mitem sold with distribution rights for Germany & Austria retained.

2015

2 year follow-up of Arthramid Vet clinical study reports with impressive results.

Arthramid Vet licensed to Antematter Ltd. for sale in the veterinary market.

Randomised clinical trial of Bulkamid versus Tension-free Vaginal Tape (TVT) for 1^st line surgical treatment of stress urinary incontinence (SUI) commences in Finland.

Distribution rights licensed by the company for Cystistat in Germany and France for the symptomatic treatment of bladder conditions such as interstitial cystitis.

2014

Following impressive results in the clinical study of Arthramid Vet, development of Arthrosamid commences for the treatment of osteoarthritis in the knees of humans.

2013

Worldwide distribution rights for Bulkamid taken back from Ethicon and direct sale by the company commences.

North American randomised controlled trial of Bulkamid successfully completed.

Prospective controlled clinical study of Arthramid Vet successfully completed.

2011

Clinical development of Arthramid Vet commenced for the treatment of osteoarthritis in horses.

2010

Worldwide rights acquired for Mitem, a mitomycin product for the treatment of bladder cancer.

2009

Distribution rights licensed by the company for Regurin XL in the UK indicated for the treatment of overactive bladder.

2008

Bulkamid granted ‘Investigational Device Exemption’ by the US Food and Drug Administration (FDA) allowing it to be used in a North American randomised controlled trial.

North American randomised controlled comparative study of Aquamid and Restylane successfully completed.

2007

Contura signs agreement with Johnson & Johnson granting Ethicon, its women’s health subsidiary, exclusive worldwide distribution rights for Bulkamid.

2006

Aquamid granted ‘Investigational Device Exemption’ by the US Food and Drug Administration (FDA) allowing it to be used in a North American randomised controlled trial.

Contura obtains ISO 13485 certificate.

2004

Aquamid Reconstruction granted CE-mark for larger volume corrections, rhinoplasty and lipoatrophy.

2003

Bulkamid granted CE-mark for use in the treatment of female urinary incontinence.

2001

Aquamid granted CE-mark for use in facial augmentation.

2000

Contura established.

OUR TECHNOLOGY

Our technology is based upon patented hydrogels, comprising 97.5% water and 2.5% cross-linked polyacrylamide. Once injected, these homogenous, biocompatible, viscoelastic, synthetic biomaterials maintain their volume by continually exchanging water with the surrounding host tissues. They are permeable to salts and organic molecules, allowing cells to integrate through the gel after injection.

Our hydrogels do not contain micro particles. They provide an inert template or scaffold for host cells and unlike many gels, they are non-degradable, e.g. they are not broken down or metabolised by the body. As such, they do not rely upon a reaction from host tissue to generate their desired effect and they do not suffer from the inherent issues of particulate-based gels, namely unpredictable effect and particle migration.

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OUR FACILITY

Our hydrogel products are developed and produced in our state-of-the-art manufacturing facility in Denmark.

Our manufacturing is carried out using proprietary automated processes. Our aim is to produce the highest quality products for our customers.

The Company has the following certifications:

GMP authorisation by the Danish Medicines Agency
EC Certificate, in accordance with the European Medical Devices Directive 93/42/EEC Annex II
ISO 13485 Medical Device Quality Systems
Canadian CMDCAS SOR/98-282 as Canadian Medical Devices Conformity Assessment System
Korea GMP Certificate

Our hydrogel products are developed and produced in our state-of-the-art manufacturing facility in Denmark.

Our manufacturing is carried out using proprietary automated processes. Our aim is to produce the highest quality products for our customers.

The Company has the following certifications:

GMP authorisation by the Danish Medicines Agency

EC Certificate, in accordance with the European Medical Devices Directive 93/42/EEC Annex II

ISO 13485 Medical Device Quality Systems

Canadian CMDCAS SOR/98-282 as Canadian Medical Devices Conformity Assessment System

Our facility is subject to regular audit by, among others, our Notified Body and Danish Medicines Agency to ensure that we continue to meet the highest quality standards at all times.

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CONTURA PRODUCTS

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All Contura’s hydrogel products use a patented formula consisting of 97.5% water and 2.5% cross-linked polyacrylamide

Aquamid is a non-absorbable hydrogel that is used to rejuvenate and contour the face

Aquamid Reconstruction is a non-absorbable hydrogel for soft tissue augmentation

Bulkamid is a homogenous hydrophilic hydrogel used in the treatment of female stress urinary incontinence

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Aquamid is a non-absorbable hydrogel that is used to rejuvenate and contour the face

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Aquamid Reconstruction is a non-absorbable hydrogel for soft tissue augmentation

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Bulkamid is a homogenous hydrophilic hydrogel used in the treatment of female stress urinary incontinence

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PRODUCTS WE DISTRIBUTE

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Regurin XL is indicated to help control the symptoms of an overactive bladder

Cystistat is a sterile sodium hyaluronate solution for temporary replacement of the glycosaminoglycan layer in the bladder helping to protect it against natural irritants, treating interstitial Cystitis

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