Clinica's MedTech Ventures: Kerecis

Specialty area(s): Fish skin-based biologic matrix for medical use
Based in: Isafjordur, Iceland
Founded in: 2009
No. of employees: 20
Total investment received to date: $5m
Investors: NSA ventures, Omega3, Capital, 1924, Sk�gur, Klofningur, Hradfrystihusud-Gunnvor

The health benefits of omega-3 fatty acids, which are found naturally in oily fish, have been widely extolled to the public. In particular, the anti-inflammatory properties of these essential fatty acids are believed to help ward off myriad illnesses ranging from heart disease to arthritis, among other things.
Icelandic company Kerecis is now adding chronic wound care to this list, having developed an acellular biological matrix made from the skin of cod.
“Chronic wounds like diabetic ulcers are very common; in the US, there are 100,000 amputations every year resulting from [hard-to treat] chronic wounds,” said CEO Gudmundur Fertram Sigurjonsson. The MariGen Omega3 Wound product, which has all the cells removed from the raw fish skin before it is processed into a medical-grade matrix, is designed so that it can be cut into the desired shape to fit the wound. The product then acts as a scaffold for the body’s own cells to proliferate and grow into healthy tissue. Over time, the scaffold is resorbed into the body.
According to the firm, preclinical studies have shown that “cells proliferate faster in MariGen than in competing porcine-derived scaffolds.” The company has also conducted a randomized controlled trial to assess the performance of the product on 140 acute wounds; patients treated with MariGen showed accelerated wound closure, Mr Sigurjonsson told Clinica.
The CEO said that MariGen Wound will be priced similarly to other available chronic wound products, “but it will have the added benefit of having naturally-occurring omega-3 fatty acids.” Also, that fact that MariGen is derived from fish – rather than pig (which is common among rival scaffolds of this kind) – eliminates any potential religious or cultural constraints, so it can used on Muslim and Jewish patients, for example.
MariGen Wound was both CE-marked and US FDA-cleared in 2013 and it is now being commercialized in Iceland, as well as distributed in the UK and Middle East by Medline. Kerecis is looking to establish partnerships in other markets, primarily in the US. “The biologic products segment is particularly large in the US and products [such as MariGen] are used in all sort of applications,” said Mr Sigurjonsson.
Indeed, Kerecis is not just pursuing the wound care market, but is developing MariGen for other indications.
The second most advanced product in its portfolio is the MariGen Omega3 Dura, for the reconstruction of the dura mater. The dura mater is the leather-like membrane covering and protecting the brain and spinal cord. Kerecis’s dura substitute is designed to be sutured to close up any dura openings resulting from brain surgery, or to repair the membrane damaged through head injury or cancer ingrowth.
MariGen Dura is currently in clinical trials and the company hopes to have it on the market in early 2015. According to Mr Sigurjonsson, MariGen Dura has been designed to be “thicker and easier to handle” than any of the competing products. “You can easily reposition the material without rupturing it,” he said. 
Following the dura mater product, Kerecis is also developing its technology for use in hernia repair and breast reconstruction. Mr Sigurjonsson believes the market for these two products, MariGen Hernia and MariGen Pectus, is evident: “The number of hernia repair procedures is going up because of the rise in obesity, while the number of breast reconstruction surgeries is increasing because more women are electing to have breast reconstruction, rather than implants, as surgical techniques and products improve.” The CEO envisages the hernia repair and breast reconstruction products to come out later in 2015/early 2016. These products will take more time to reach the market as they call for more extensive trials, due to them being more demanding in terms of mechanical strength properties.
The company is well-financed to see it through these various projects. It raised $2m in February, the third tranche of a series A financing round. These funds will support the firm right through to the market launch of MariGen Pectus and MariGen hernia.

Cod’s the common catch

Kerecis’s patent for its MariGen technology platform covers the manufacture of biologic matrices based on all fish skin, not just cod. However, the company chose to use cod because it is the most fished species and it is not seasonal, being available all year round, says CEO Gudmundur Fertram Sigurjonsson.

Gudmundur Fertram Sigurjonsson, CEO, president and chairman.
Tel: [phone]. Email: [email protected]
Kerecis. Eyrargata 2, 400 Isafjordur, Iceland.
www.kerecis.com