Dear , 

Regenerative biomaterials offer orthopaedic surgeons an alternative to the functional ‘heavy metal’ joint replacement technologies and corrective surgical interventions, allowing orthopaedic tissue to be supplemented and restored rather than simply excised or replaced with a prosthetic.

Orthox is a medical device company founded in 2008 to exploit FibroFix, a novel silk-based biomaterial platform, for the repair of injuries to cartilage and bone. FibroFix combines exceptional strength and resilience with a porous architecture and chemical structure similar to Fibronectin, an essential component of human cartilage. Orthox believes these properties will allow FibroFix™ to act as both an immediate functional replacement for damaged cartilage, and a long term regenerative repair solution.

The Technology

Silk has a long and highly successful history as an implantable medical material used principally in surgical suture threads. Orthox’s FibroFix™ technology is based on silk Fibroin, a long chain, structural protein which provides silk fibres with their great strength and resilience. Fibroin is also very similar to the human protein Fibronectin, an essential constituent of orthopaedic tissues and known to play an important role in cartilage regeneration.

Orthox extract Fibroin from commercial silk fibres, and form it into highly porous Fibroin hydrogels, capable of acting as scaffolds for regenerating tissue to grow through. The processing technology used to create these hydrogel ‘tissue scaffolds’ makes them exceptionally smooth, tough, and resilient – all of which are essential characteristics of cartilage.

By manufacturing the porous body and smooth surface in a single process step, and fusing the Fibroin fibres into the porous Fibroin hydrogel, an integrated composite structure is formed, using only a single type of molecule. This minimises the risk of delamination of one component from the others under the exceptional loads and millions of cycles experienced by articulating joints.

The Market

There are around 46 million people in the US and EU suffering from knee osteoarthritis, for which the only current long-term treatment is total knee replacement (TKR).  TKR is the highest grossing implant in the US, with the total global market estimated to be worth $12bn.  This market is set to grow by 500% by 2030.  Orthox’s two most developed products aim to address this huge market opportunity

FibroFix™ Meniscus:

• Replaces damaged meniscal tissue
• Mechanical replacement and regenerative repair

FibroFix™ Cartilage:

• Resurfacing large & osteoarthritic cartilage defects
• Major pain relief and restoration of patient mobility

Cadaver and in vivo trials have been successful, demonstrating impressive clinical and surgical results.  Commercial modelling also indicates that delivery of these products can be achieved at highly competitive price-points compared to alternative remedies.    

 The Model

With regulatory pathways likely to require the Pre-Market Approval (PMA) route for access to the US, Orthox will focus on European markets to develop the business case for FibroFix™ products. The commercial operation will generate an extensive clinical database and compelling health economics dossier together with key opinion leader contacts, all of which can be translated into a US model. This platform, in conjunction with direct experience with an EU regulatory body, will establish the sustainable business case required to underpin business to business discussions with potential multi-national acquirers / partners.

Initially, once CE mark has been granted for a FibroFix™ product, Orthox will establish a small, direct sales team focused on the major metropolitan areas. The immediate goal will be the generation of clinical studies to be presented at surgical symposia, whilst also driving revenue growth.

IP

Orthox has three international patent families, exclusive licences to a further three patent families, and granted patents across multiple territories in five of these six families. In addition there is significant proprietary know-how in the manufacture of Orthox’s silk Fibroin implants, which is retained within the Company through an entirely in-house manufacturing process. 

The Team

Dr. Nick Skaer CEO and CSO, has over 20 years' experience in life science and materials research, and 10 years as a medtech CEO, raising over £11m. He founded Orthox with Prof. Oliver Kessler in 2008 and has led the scientific and commercial development of the business since then. Between 1992 and 2003 he studied Molecular Biology at the Universities of Oxford, Cambridge and Strasbourg (France), where he obtained his PhD.

James Mallinson, Non-Executive Chairman, has over 20 years’ experience in venture capital. He has made investments in, and been closely involved with, the development of many technology companies.  He has been Portfolio Director of Oxford Spin-out Equity Management (OSEM) since its inception in 2008.  He is an Engineering Science graduate from the University of Oxford, and gained his MBA from Cranfield University in 1990.

Prof. Oliver Kessler, Medical Director & Chief Medical Officer, is a practising knee surgeon based in Zurich with a strong track record of biomaterials research and a focus on meniscal and cartilage repair systems and joint kinematics. He spent 6 years at Stryker Orthopaedics as Director of Orthobiologics supervising major meniscal and cartilage tissue engineering programmes. He has extensive contacts within both the orthopaedic industry and the surgical community. 

Sarah Nurse, ACA Operations Director, is an experienced Operations and Finance Director with the skills to create and manage a corporate services function. She has over 20 years' experience incorporating start-ups and growing SME companies; ensuring full financial and management accounting control, and managing human resource, information technology and quality assurance functions in both the public and private sectors.

Dr. Robert Walker, Chief Technical Officer, has a PhD in Biochemistry from the University of Sheffield and acquired ISO13485 and GMP manufacturing experience with BD Biosciences. Here, he worked in a small team developing new products for BD's medical cell culture range, taking them from concept through production feasibility to manufacturing scale up.

The Investment Case

There is general recognition that the developed world is experiencing an “epidemic of joint disease” and Orthox’ disruptive technology could prove to be the basis of a novel therapeutic treatment in this huge and rapidly growing area.  In addition, the underlying technology has applications in areas well beyond orthopaedics – a true platform technology.
The management team is strong, with good clinical and commercial links and the investor base appears well structured and with relevant market access to support future growth.
However, this is an early-stage company seeking to operate in a highly regulated and competitive market place, where the risks can be significant.
Parkwalk Fund VI, the Parkwalk Opportunities EIS Fund and the Parkwalk-managed University of Oxford Isis fund invested alongside existing investors.

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