Recent news items from Neotherix are listed below. See the Archived News page for older articles.

Neotherix is delighted to announce the grant of US patent 10,687,790 ("Sampling Device") which covers the critical technology for the RegeniTherix™ device.

RegeniTherix is a theranostic system consisting of a bioresorbable electrospun polymer 'scaffold' to encourage growth of the patient's own cells into the wound space to begin repair, and a thermo-switchable hydrogel to enable the collection and sampling of biomarkers produced by these reparative cells. RegeniTherix can be applied to a variety of chronic and non-healing wounds such as diabetic foot ulcers to monitor the physiological status of associated soft tissue and any underlying events or pathologies that may present a barrier to healing. The scaffold further functions to facilitate the healing of these tissues once such barriers have been identified and managed.

RegeniTherix received Bionow's Project of the Year award in 2015 (Bionow). The granting of this patent is a major step towards the commercialisation of this innovative device.

We would like to thank Dr Peter Iddon and Dr Lorenzo Pio Serino for all their hard work and effort in developing RegeniTherix and Innovate UK and the National Institute for Health Research for funding.

We are pleased to welcome Ramisha Rehman to Neotherix who has joined as Translational Projects Manager. Ramisha joins us from the University of Leeds where she was a Curriculum Development Officer for the National MedTech Skills Academy project having previously completed a PhD in Medical and Healthcare Technologies at the University of Bradford.

Ramisha will be responsible for managing Neotherix' participation in the NIHR-funded Seton-Scaffold project ("Transforming treatment of fistula-in-ano: a novel bioresorbable Seton-Scaffold"). She will also play a key role in the progression of Neotherix' other translational projects (EktoTherix, RegeniTherix and PhotoTherix) with a view to engaging with partners for the next steps in the commercialisation of these product opportunities.

After more than 11 years, Dr Peter Iddon has decided that this is the right time to plan his next move and he has now stepped down from his Development Manager position. He will switch to a consultancy role with Neotherix as we transition to a new business model. I'd like to record my thanks to Peter for his significant contribution to the establishment and growth of Neotherix and look forward to working with him under these new arrangements.

Ramisha will take on responsibility for a number of activities previously managed by Peter.

Researchers at UEA have published a paper in Bioconjugate Chemistry on the rapid immobilisation of protein on polyester microcarriers using click chemistry in physiological conditions and without the use of coupling reagents. A one-step copper-free click chemistry reaction was able to functionalise monodisperse polyester microcarriers with protein at high efficiency in 10 minutes. This approach is readily adaptable to a wide range of active biological factors and polyester polymers. In this case, our clinical target is the repair of damaged tendons.

Authors include Dr Aram Saeed and members of his research group Grace Walden (whose PhD studies are supported by an EPSRC iCASE grant with Neotherix) and Xin Liao. Professor Mike Raxworthy is the industrial supervisor and Grace's other supervisors Dr Graham Riley (UEA) and Professor Simon Donell (Norwich Medical School) are also authors on the paper.

The article is available via the publisher's website: G. Walden et al, Synthesis and fabrication of surface-active microparticles using a membrane emulsion technique and conjugation of model protein via strain-promoted azide-alkyne click chemistry in physiological conditions, Bioconjugate Chemistry (2019), DOI: 10.1021/acs.bioconjchem.8b00868 .

Neotherix CEO Professor Mike Raxworthy was recently interviewed by RegMedNet on developing an electrospun scaffold for tissue regeneration. He also talks about Regener8 - part of the Medical Technologies IKC community of academics, clinicians and industry collaborators.

The interview, "Developing a regenerative material in an evolving industry", can be viewed on the Medical Technologies IKC website .

Neotherix CEO Professor Mike Raxworthy will be speaking at Breakthroughs in Healthcare Technologies on Thursday 8 November. The conference is organised by the London Interdisciplinary Biosciences Consortium Doctoral Training Programme (LIDo-DTP), in conjunction with the UCL-Birkbeck MRC DTP, and will be held at The Hatton in Farringdon, London.

The conference will provide early career researchers the opportunity to share their own research and to hear from prominent speakers in industry and academia. The conference themes are biophysics and soft matter physics, biomaterials and tissue engineering, clinical technologies, and medical imaging, with emphasis on the translational potential within industry and the UK health sector.

Mike's keynote presentation, "Electrospun Bioresorbable Tissue Repair Scaffolds: from Laboratory to Clinic," will describe innovation in the MedTech sector and how that is critical to translation of research into the marketplace, and provide a summary of Neotherix' technology and current product development portfolio.

For more information on the conference see the event web page .

In June a paper written by Professor Mike Raxworthy, Neotherix CEO and RAEng Visiting Professor at the University of Leeds, was published on IEEE Xplore under the proceedings of the 2018 3rd South African Biomedical Engineering Conference (SABEC 2018). "Introducing and embedding innovation practices in a UK medical engineering degree course," was presented at SABEC 2018 in April 2018. The paper describes the work undertaken at the University of Leeds, UK under the RAEng Visiting Professors scheme from 2015-2017 to introduce training in innovation practices and translation to a group of medical engineering students. The new module, MedTech BEST (Business and Entrepreneurial Skills Training), was developed to focus on the needs of the medical technology industry sector and piloted at the University of Leeds in 2016/2017.

The paper has been published on IEEE Xplore: M. J. Raxworthy, "Introducing and embedding innovation practices in a UK medical engineering degree course," 2018 3rd Biennial South African Biomedical Engineering Conference (SAIBMEC), Stellenbosch, South Africa, 2018, pp. 1-4. DOI: 10.1109/SAIBMEC.2018.8363182 . Alternatively, you can download a PDF of the accepted version here.

In July Professor Mike Raxworthy was invited to speak at the UK-China Workshop for Regenerative Dentistry - from Tooth Development to Regeneration, a three day event jointly organised by the University of Leeds, UK and Sichuan University, China. Funded by the Newton Fund, the British Council, and National Natural and Science Foundation of China (NSFC), the international workshop brought together early career researchers (ECRs) from the UK and China in Leeds to disseminate research findings and enhance their professional development. Focussing on tooth development and tissue engineering research, the event included keynote lectures, oral presentations from ECRs, mentoring sessions, networking sessions, and invited talks from industry.

Mike's presentation, "Tissue Repair Scaffolds - From Test Rig to Clinic," described Neotherix' technologies and product development portfolio, focussing on the development of the PhotoTherix scaffold technology for soft tissue repair in dental and wound applications and how we have demonstrated that electrospinning is an effective technique for the manufacture of clinically-effective tissue repair scaffolds.

We are delighted to announce that Neotherix has been short-listed in the final round of the 2018 OBN (Oxfordshire Bioscience Network) Awards for our involvement in the NIHR-funded collaborative project "Transforming treatment of fistula-in-ano (FIA): a novel bioresorbable seton scaffold device" (see our previous news item regarding this project). OBN is a membership organisation supporting and bringing together the UK's innovative life sciences companies, corporate partners and investors.

Neotherix is one of four finalists in the Best Innovative Medtech Company category, which will be awarded on the basis of innovativeness and potential impact of the technology. The winners of this and other awards for 2018 will be announced at the awards evening taking place on Thursday 11 October at The Examinations Schools in Oxford.

Dr John Harris, CEO of OBN (UK) said: "We received the highest number of qualifying entries for the OBN Awards this year, up a staggering 40% on last year's total. The standard of entries across all categories was extremely high and we are encouraged about the level of exciting new innovation and positive growth we are seeing in UK Life Sciences. We look forward to celebrating with all our finalists on 11 October at the Examination Schools in Oxford."

For more information please visit the OBN Awards website .

Two blogs written by Neotherix Development Manager Dr Peter Iddon and University of Bradford Lecturer in Biomedical Engineering Dr Farshid Sefat have been published on the Translate Medical Technologies website. They describe the outcomes of Peter's secondment to the University of Bradford earlier this year, which was supported by funding from Translate - a partnership of universities in the Leeds City Region with world-class capabilities in the development of new medical technologies.

Peter spent three months at the start of 2018 working part-time at the University of Bradford with Dr Farshid Sefat along with Dr Pete Twigg (Reader in Medical Engineering). The successful collaboration allowed us to develop proof-of-principle for an exciting new electrospun scaffold technology incorporating an additive developed at the University of Bradford. This work leveraged both the skills and facilities available at Bradford and Peter's experience of electrospinning to demonstrate the potential of the approach and generate data to support an application for substantial funding.

It also allowed one of our scientists to directly take advantage of the facilities available at a leading research-focussed university, and so to more effectively contribute to an existing but separate collaborative project between Neotherix and the University of Bradford. The completion of that work removed a potential barrier to project completion, enabling a key technology development programme to progress.

Read Farshid's blog post and Peter's blog post on the Translate website.

We are pleased to congratulate Amy Smith for winning the best poster prize at the annual University of Leeds School of Dentistry Research Day, held on 11 July 2018. Her poster "Light-Activated Antimicrobial Biomaterials" describes work undertaken as part of her doctoral project to demonstrate proof-of-concept for dental applications of PhotoTherix™, an electrospun antimicrobial-releasing tissue repair scaffold.

Amy's CASE PhD project ("Tissue repair capacity of a Prototype Antimicrobial-Releasing Scaffold") is supervised by Dr Giuseppe Tronci and Dr Simon Wood from the School of Design and School of Dentistry respectively at the University of Leeds, and Professor Mike Raxworthy from Neotherix. Amy is a member of the Centre for Doctoral Training in Tissue Engineering and Regenerative Medicine - Innovation in Medical and Biological Engineering at the University of Leeds.

Dr Peter Iddon, Development Manager at Neotherix, will be presenting at the Medical Technologies IKC and Regener8 Annual Conference 2018. This conference will take place on Friday 29 June 2017 in Leeds and is focussed on best practice in translating regenerative devices.

Peter will be co-presenting "Evaluation of the novel PhotoTherix™ scaffold system for treating infected skin wounds: an update" with Richard Baker, Research Assistant at the Centre for Skin Sciences at the University of Bradford. The presentation will describe work carried out to evaluate the interaction of PhotoTherix antimicrobial-releasing scaffold with human and bacterial cells relevant to skin wounds.

The project is funded by the Medical Technologies Innovation and Knowledge Centre (IKC), and aims to generate proof-of-concept data for the repositioning of the PhotoTherix technology for skin wound applications in addition to those already explored for oral surgery and periodontology. The Centre for Skin Sciences, University of Bradford leads the project consortium with Professor Des Tobin as Principal Investigator and Neotherix as the industrial partner. The consortium was supported by the WoundTec Health Technology Co-operative as clinical partner with commercial support provided by Medilink Yorkshire & Humber.

Please see the conference web page for more information.

A paper written by Neotherix authors Prof Mike Raxworthy, Dr Lorenzo Pio Serino and Dr Peter Iddon has been published on IEEE Xplore under the proceedings of the 2018 3rd South African Biomedical Engineering Conference (SABEC 2018).

"Electrospun Bioresorbable Tissue Repair Scaffolds - from Laboratory to Clinic", was presented at SABEC 2018 on 4 April 2018 (see previous news item). The paper describes the development of regenerative tissue scaffolds providing 3D structure for cells involved in the repair of soft tissue injuries. It focuses on the translation of EktoTherix™ Tissue Repair Scaffold from early stage laboratory work through manufacturing process development and clinical investigation, and also includes work carried out to develop other electrospun tissue repair scaffolds such as PhotoTherix™ antimicrobial-releasing scaffold.

The paper has been published on IEEE Xplore: M. J. Raxworthy, L. P. Serino and P. D. Iddon, "Electrospun bioresorbable tissue repair scaffolds: From laboratory to clinic," 2018 3rd Biennial South African Biomedical Engineering Conference (SAIBMEC), Stellenbosch, South Africa, 2018, pp. 1-4. DOI: 10.1109/SAIBMEC.2018.8363177 . Alternatively, you can download a PDF of the accepted version here.

Amy Smith, Neotherix PhD CASE student at the University of Leeds, has been awarded a MeDe Early Career Researcher secondment to the University of Sheffield. This four week placement is expected to allow the exploration of the suitability of an in vitro oral mucosal model to study the performance of PhotoTherix electrospun antimicrobial-releasing tissue repair scaffolds.

The University of Leeds and Neotherix have a track record of collaboration and co-development of this product concept over a number of years and this secondment will provide preclinical data on scaffold prototypes in a 3D tissue model.

Dr Helen Colley and Dr Craig Murdoch at the University of Sheffield have developed an in vitro co-culture oral mucosal model which can also incorporate oral bacterial strains. Use of this model will allow screening of prototypes without the need to use animal models.

Amy's project ("Tissue repair capacity of a Prototype Antimicrobial-Releasing Scaffold") is supervised by Dr Giuseppe Tronci and Dr Simon Wood from the School of Design and School of Dentistry respectively at the University of Leeds and Professor Mike Raxworthy from Neotherix.

Mike Raxworthy's abstract "Electrospun Bioresorbable Tissue Repair Scaffolds - from Laboratory to Clinic" has been accepted by SABEC and will be presented at the meeting on 4 April 2018. A paper has been prepared and this has also been accepted for publication.

SABEC 2018 takes place on 4 - 6 April close to Stellenbosch University, South Africa. The meeting seeks to "facilitate collaboration between universities, science councils and industry". They note that "there remains a huge potential for innovation and human capacity building in this field in South Africa and abroad". Mike's presentation describing work performed for EktoTherix™ and PhotoTherix™ will be in the Nano or Micro Technology session.

For more information please see the SABEC web site .

Neotherix is pleased to announce that we have been short-listed in the Medilink Northern Powerhouse Healthcare Business Awards 2018, taking place at the Lowry Hotel in Manchester on Wednesday 7 March 2018. These awards now recognise achievements across the whole of the Northern Powerhouse region.

Neotherix is one of six finalists in the Partnership with Academia Award category, which is for those healthcare businesses and organisations which develop partnerships with academia that have a major impact. Criteria for the award include demonstrating that the academic partnerships have improved performance and benefited patient care.

Neotherix has been cited for our work in partnership with the Universities of Leeds and Bradford on bioresorbable tissue scaffolds able to augment their function with an on-demand antimicrobial effect.

For more information please see the Medilink Northern Powerhouse Healthcare Business Awards web page .

Neotherix is delighted to announce the award of major funding from the National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme. We are working as part of a consortium led by the University Hospitals Birmingham NHS Foundation Trust (UHB) on "Transforming treatment of fistula-in-ano: a novel bioresorbable seton scaffold device", a three year project also involving the NIHR MedTech Cooperative based in Birmingham and Keighleycolo Ltd. This interdisciplinary team will work with patients and clinicians to finalise the design of a novel seton device (a cord left in an anal fistula to keep it open and allow it to drain, thereby aiding healing).

Fistula-in-ano (FIA) is a condition in which sufferers experience daily discomfort and smelly discharge from an abnormal tunnel connecting their lower bowel (back passage) to the skin next to the anus. Notoriously difficult to treat, the condition typically requires multiple operations under general anaesthetic which carries a risk of permanent anal incontinence. Failure rates are high, meaning some patients must live with FIA symptoms for the rest of their lives.

The project team aims to transform FIA treatment by combining current management techniques with the latest therapeutic materials technology. The new project is complimentary to Neotherix' existing interests in the use of regenerative scaffold devices for soft tissue repair, and will address a significant unmet clinical need for this intrusive and embarrassing condition that affects around 12,000 new patients every year in the UK by creating a simple, cheap, safe and effective treatment which preserves continence, and avoids multiple sequential surgical procedures.

The report for the Leeds City Region's Science and Innovation Audit (SIA) was published at the end of September. This SIA - awarded by the Department of Business, Energy and Industrial Strategy (BEIS) to a University of Leeds-led consortium - focuses on the Leeds City Region's strengths in Medical Technology and identifies investment opportunities.

Neotherix participated in the audit (see previous news items here and here), and is mentioned several times in the report as an example of the type of micro-SME engaged in developing emerging technology into new products for the medical technology sector.

Of the 2,683 medical technology companies located in the region, only 3% have more than 250 employees. The rest comprise SMEs, with 42% of those having less than 5 employees. The participation of SMEs such as Neotherix is therefore essential in identifying solutions to the obstacles that can prevent such companies taking advantage of the emerging global health market.

The report identifies key propositions to address reported difficulties in getting new medical devices evaluated in the NHS; the shortage of multidisciplinary graduate engineers; the lack of collaborative MedTech technology and innovation parks; and the need for wider business and innovation support to help companies navigate a complex and highly regulated sector.

The report concludes that government, industry and the NHS need to invest £200-250 million in the Leeds City Region's medical technology sector over the next five years, to enable it to exploit opportunities in the global health market and grow UK MedTech economic output by at least an additional £10bn per year by 2025.

See the IKC-Regener8 news article for more information. The report, which will be officially launched in Leeds on Wednesday 1 November, can be downloaded from the Leeds City Region MedTech web site .

Neotherix CEO Mike Raxworthy will be one of the plenary lecturers at the forthcoming Recent Appointees in Polymer Science (RAPS) meeting at the University of East Anglia. The meeting takes place from 6 - 8 September and Professor Raxworthy is speaking on "From Test Rig to Clinic - Lessons from Falling Over" on the afternoon of Thursday 7 September.

This talk seeks to draw lessons viewed from Mike's position as a biologist supported by the Royal Academy of Engineering seeking to commercialise an innovation in polymer science! It will cover a journey from post-doctoral work though to large company scientific and departmental management and eventually to the start-up/SME world. This will include lessons and observations on how scientists are regarded by marketers and how Mike now, as a CEO, regards scientists. Mike will also discuss what he's learnt about collaboration, innovation, regulations and translation and will use case studies from Neotherix, Regener8 and his role as a Visiting Professor at the University of Leeds to illustrate.

Please see the RAPS meetings page for more details.

Richard Baker, Research Assistant at the Centre for Skin Sciences, University of Bradford, will be presenting a poster titled "Evaluation of the novel PhotoTherix™ scaffold system for treating infected wounds". The poster provides an update on progress made in the project of the same name, describing the interaction of PhotoTherix with human and bacterial cells relevant to skin wounds.

The project is funded by the Medical Technologies Innovation and Knowledge Centre (IKC), and aims to generate proof-of-concept data for the repositioning of the PhotoTherix technology for skin wound applications. The Centre for Skin Sciences, University of Bradford leads the project consortium with Neotherix as the industrial partner. The consortium is further supported by the WoundTec Health Technology Co-operative as clinical partner with commercial support provided by Medilink Yorkshire & Humber.

Please see our previous news article on the PhotoTherix project for more details of the project.

Dr Lorenzo Pio Serino, Biomaterials Scientist at Neotherix, will be presenting at the Medical Technologies IKC and Regener8 Annual Conference 2017. This joint conference will take place on Friday 23 June 2017 in Leeds and is focussed on best practice in translating regenerative devices.

Lorenzo Pio will be co-presenting "Tissue repair capacity of a prototype antimicrobial-releasing scaffold: dental applications" with Dr Giuseppe Tronci, Lecturer in Healthcare Materials at the University of Leeds. In addition to summarising work undertaken to demonstrate proof-of-concept for dental applications for our PhotoTherix™ tissue scaffold technology, the presentation will describe recent work evaluating the interaction of relevant human and bacterial cells with photosensitiser-loaded scaffolds.

Please see the conference web page for more information.

Dr Peter Iddon will give a talk at the forthcoming UK Society for Biomaterials meeting at Loughborough University. "Electrospun bioresorbable tissue repair scaffolds: travelling the pathway from laboratory to clinic" will form part of the session on 3D materials on Day 2 (Wednesday 21 June). Peter will cover the concepts underlying the electrospinning process and the particular applications to which Neotherix have deployed this. These include clinical use for acute wound repair (EktoTherix™), delivery of antimicrobial activity to infected wound sites (PhotoTherix™) and in vitro use for tissue and disease modelling. The full programme can be viewed on the event's web page .

The full Sector Panel has now been announced for the panel discussion taking place at the The Future of Med Tech in the Leeds City Region: Translate in Action event in Leeds on Tuesday 25 April 2017. SMEs are a vital component of the MedTech sector and, as announced in our previous news item, we are very pleased that Neotherix has been invited to give the views from this part of the industry mix.

See the event's web page for more information.

Neotherix' Development Manager, Dr Peter Iddon has been invited to sit on the panel for a discussion on current and future opportunities for economic growth in the Medical Technology sector in the Leeds City Region. The panel discussion will take place at The Future of Med Tech in the Leeds City Region: Translate in Action, a one day event taking place on Tuesday 25 April 2017 and organised by Translate, a partnership of universities in the Leeds City Region with world-class capabilities in the development of new medical technologies.

Neotherix' participation in the panel will ensure that the perspectives of micro-SMEs are included in the debate, which is essential in bringing a balanced view to the development of a vision for the role of the Medical Technology sector in the Leeds City Region.

See the event's web page for more information.

Neotherix' Development Manager, Dr Peter Iddon has been interviewed as part of the Leeds City Region's Science and Innovation Audit (SIA). This SIA - awarded by BEIS to a University of Leeds-led consortium - focuses on the UK's strengths in Medical Technology. The Leeds City Region - in which Neotherix is located - has a "world-leading concentration of excellence in research and innovation in medical technology" according to Professor John Fisher who is leading the SIA.

Commenting on Neotherix' participation in the SIA, Peter said "we welcome the recognition of the region's contribution to medical technology innovation, and look forward to the SIA providing evidence of this sector's existing strengths and how these can be built upon to enable its full potential to be reached. We're pleased to have an input into this process".

Neotherix are pleased to announce that the First in Man clinical investigation of EktoTherix™ Tissue Repair Scaffold has recruited twelve participants. Recruitment is now closed and the clinical data collected from all participants are undergoing 100% source data verification prior to statistical analysis.

This initial safety study has assessed EktoTherix for the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. Study outcomes following the application of EktoTherix Tissue Repair Scaffold to these excisional wounds were recorded. The scaffold is expected to promote repair of the wound by the patients' own cells, enhancing healing and improving quality of repair. EktoTherix is designed to be completely resorbed by the body during the healing process so there is no need for removal when the wound has healed.

The primary objective of this current study was to assess the safety of EktoTherix in humans with a secondary objective to evaluate its clinical performance. Our hypothesis is that use of EktoTherix will increase incidence of complete and problem-free healing and result in an overall better cosmetic result (cosmesis) of the healed wound.

For more information on the study see the EktoTherix study record on ClinicalTrials.gov .

A consortium led by the Centre for Skin Sciences, University of Bradford with Neotherix as the industrial partner has won a Proof of Concept grant to evaluate PhotoTherix™ as a skin wound regenerative scaffold. The £119k grant from the Medical Technologies Innovation and Knowledge Centre (IKC), will allow the project team to continue the work on photodynamic therapy (PDT) delivered by Neotherix' PhotoTherix™ tissue scaffold technology.

The project, led by Professor Des Tobin from the University of Bradford, started work in January and aims to develop an enhanced bioresorbable scaffold functionalised with a photo-sensitising agent to provide a 3D substratum for wound healing whilst delivering broad spectrum antimicrobial activity via PDT. Testing will include activity of PhotoTherix prototypes against common wound pathogens when activated by light. The project will benefit from the collaboration with the clinical partner WoundTec Health Technology Co-operative and will also receive commercial support from Medilink Yorkshire & Humber. It will also complement existing projects to develop the technology for dental applications in collaboration with the University of Leeds.

Link to the Medical Technologies IKC and to our PhotoTherix™ development partners the Centre for Skin Sciences , WoundTec HTC and Medilink Yorkshire & Humber .

Neotherix will be exhibiting at Venturefest Yorkshire 2016, a one day exhibition of Yorkshire's most inspiring science, technology and knowledge companies, on 16 November 2016 at York Racecourse. The event is designed to nurture business growth in the region by showcasing entrepreneurs to potential investors and helping innovators develop their ideas.

Mike Raxworthy (Neotherix' CEO) will be chairing the Bioscience session at 15:00 in the afternoon. The session is a showcase of Yorkshire life sciences and includes several excellent speakers who will deliver presentations covering robotic surgery, stem cells, smart orthopaedics and next generation therapeutics.

Please come and visit us at stand B11 in the Bio-Synergy Zone on the second floor.

See the Venturefest Yorkshire website for more information, including more details of the seminar programme.

A collaboration involving UEA, Neotherix and the University of Leeds has published a review on "A Clinical, Biological, and Biomaterials Perspective into Tendon Injuries and Regeneration". The review by Walden et al (Tissue Engineering Part B: Reviews. September 2016, ahead of print. doi:10.1089/ten.teb.2016.0181) can be found at online.liebertpub.com/doi/abs/10.1089/ten.TEB.2016.0181 . The review considers the means of stimulating the body's own repair system to produce de novo tissue through the use of cells, proteins, and genes delivered by a biomaterial scaffold.

We are pleased to announce that Neotherix has been selected to give a company pitch at the annual BioCap conference on Thursday 29 September 2016 at the Alderley Park Conference Centre in Cheshire. Now in its fifth year, the specialist life science and investment conference will bring together investors, life science companies seeking finance, and those with a track record of raising finance.

Dr Mike Raxworthy, the company's founder and CEO, will be presenting on Neotherix to an invited audience of investors. Mike's presentation will cover all Neotherix' current regenerative tissue scaffold projects before concluding with a closer look at recent clinical and manufacturing progress made with EktoTherix™.

Please see the BioCap conference web page for more information.

Mike Raxworthy has been invited to organise and chair the Bioscience seminar session at Venturefest Yorkshire 2016. Bioscience will be one of the seminars taking place within the Bio-Synergy zone at the event. The seminar programme is currently being finalised and the speaker line-up will be announced soon.

Venturefest Yorkshire "is a one day festival with a clear remit to nurture business growth in the region - by helping innovators develop their ideas and helping entrepreneurs get investment". It takes place at York Racecourse on 16 November 2016. Full details are on the Venturefest Yorkshire website .

Researchers at UEA have had a paper published in the European Polymer Journal on the use of polymers made by a novel synthetic route to complex with DNA (polyplexation). Star-shaped PDMAEA polymers were found to perform better in polyplexation than linear polymer variants and to be equally non-cytotoxic at low (10kDa) molar mass. The findings indicate that star-shaped PDMAEA polymers may be effective as non-viral gene delivery vectors.

Authors include Dr Aram Saeed and members of his research group (Xin Liao, Noelia Falcon and Grace Walden - whose PhD studies are supported by an EPSRC ICASE grant for which Mike Raxworthy is the industrial supervisor. Grace's other supervisors Simon Donell and Graham Riley are also authors on the paper.

The article in press is X. Liao et al, A direct comparison of linear and star-shaped poly(dimethylaminoethyl acrylate) polymers for polyplexation with DNA and cytotoxicity in cultured cell lines; Eur Polym J (2016) .

Neotherix are pleased to announce the addition of a third site to the First in Man clinical investigation of EktoTherix™ Tissue Repair Scaffold. James Cook University Hospital (South Tees Hospitals NHS Foundation Trust) commenced participation on 25 July, and the clinical team there have already recruited one additional patient to the study.

The addition of James Cook University Hospital supports the work of the two original sites, York Hospital and Scarborough Hospital (both York Teaching Hospital NHS Foundation Trust), and is expected to significantly enhance the rate of patient recruitment to the study.

As reported previously, this initial safety study assesses EktoTherix for the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. Study outcomes following the application of EktoTherix Tissue Repair Scaffold to wounds resulting from these surgical excisions are recorded. The scaffold is expected to promote repair of the wound by the patients' own cells, enhancing healing and improving quality of repair. The tissue scaffold is designed to be completely resorbed by the body during the healing process so that there is no need for removal when the wound has healed.

Although the primary objective is to assess the safety of EktoTherix in humans, a secondary objective is to evaluate its clinical performance. The ability of EktoTherix to increase incidence of complete healing and result in an overall better cosmetic result (cosmesis) of the healed wound will be monitored.

For more information on the study see the EktoTherix study record on ClinicalTrials.gov .

We are delighted to announce that Neotherix has achieved the milestone of ISO 13485 certification - the standard specifying comprehensive requirements for quality management systems used by medical device manufacturers and distributors.

We are certified to both ISO 13485:2003 and EN ISO 13485:2012 for the "design and manufacture of sterile bioresorbable wound repair products." The award of this certification (by the Notified Body SGS) demonstrates Neotherix' commitment to high standards of quality. SGS is accredited by UKAS to assess whether manufacturers and their medical devices meet the requirements set out in European legislation.

Commenting on the accomplishment, CEO Prof. Mike Raxworthy said "Neotherix Ltd is committed to the highest level of quality in all our operations, including the development, manufacture, sale and support of our products and services. Our overall objective is to provide high quality medical technology and regenerative medicine products and services that satisfy customer needs. Attaining the high standards demanded by ISO 13485 certification is a very significant milestone in our path towards eventually gaining a CE marking for our lead product EktoTherix™, and I'm very proud of this achievement."

Independent verification of our certification status can be found online through SGS's Certified Client Directory .

We are pleased to announce that Neotherix is one of 30 local small businesses and entrepreneurs chosen to join the recently launched Hiscox Business Club, operating within Hiscox' new landmark office in York. The Club is an initiative of Hiscox in collaboration with York St John University, Make it York and the York, North Yorkshire & East Riding Local Enterprise Partnership. Membership benefits extend beyond the use of state-of-the-art office facilities and meeting/video-conferencing rooms and provides the opportunity to work with other small companies in York, bringing our experience, connections and insights into innovation and technology translation. We are looking forward to taking part in events, networking and insight sessions - and the roof garden (with spectacular views of York Minster) would be a fantastic venue for the launch of EktoTherix™!

See the Hiscox Business Club page for more information on the club and the Hiscox blog for more information on its members,

Neotherix projects and other activities were covered in a recent Super North Life Sciences supplement for The Times, published on 23 February 2016. The Bionow awards for 2015 included the RegeniTherix™ Wound Theranostic System as the winner of the Project of the Year Award (for which Neotherix is a member of a consortium led by NPL and including SensaPharm, Complement Genomics and Leeds Teaching Hospitals). The potential of this product to improve the treatment of chronic wounds was noted and was that of Neotherix' lead product EktoTherix™ - currently undergoing clinical investigation - for the repair of acute (surgical) wounds. Neotherix CEO Mike Raxworthy's contribution to the Super North Forum on the strength of the life sciences sector in the North of England was also recognised.

Please see the attached Super North supplement (copyright ©2016 Super North).

Neotherix CEO, Mike Raxworthy has recently been appointed as a Royal Academy of Engineering (RAEng) Visiting Professor in Medical Technology Innovation and Translation at the University of Leeds.

As Visiting Professor, Mike will work closely with academic colleagues to embed innovation into undergraduate teaching in Medical Engineering. Students in this area of study currently have little exposure to innovation which is inconsistent with the idea that the UK economy requires innovation-competent engineers and scientists to develop ground-breaking medical technology products. This Visiting Professorship will also enhance student understanding of the steps required to translate an idea from concept to marketed product and, in so doing, improve the employability skills of engineering graduates.

In addition, Mike's extensive network will allow the University of Leeds to strengthen external partnerships with the medical device/medical technology industry and to broaden both the group of industry contacts and the number and type of activities that the students participate in. Mike will co-ordinate a programme in which industry experts deliver face-to-face teaching and offer inspiration through their knowledge and experience, allowing the development of an exciting innovation and translation curriculum.

The RAEng Visiting Professorship recognises the value that companies such as Neotherix bring to the innovation and translation processes and seeks to use some of this experience and know-how to benefit undergraduate and postgraduate learning in medical technology. Mike will combine this with his role as Operations Director of Regener8 which will continue to run alongside his Neotherix responsibilities.

The award will also allow Mike to extend his study of the work of regenerative medicine/medical technology translation centres to look at both European and developing world centres.

Please see the RAEng web pages introducing the Visiting Professors initiative and listing current Visiting Professorship awardees for more information.

Neotherix CEO, Dr Mike Raxworthy has been appointed an External Examiner by Swansea University. He will attend the viva and examine a PhD thesis on "Products of Antimicrobial Nanofibrous Non-Wovens using the Electrospinning Technique."

Link to the University of Swansea's Nanotechnology page .

We are proud to announce that RegeniTherix - a system for the point of care testing and treatment of chronic, non-healing wounds such as diabetic foot ulcers and venous leg ulcers - won the Project of the Year category at yesterday's Bionow Awards.

The RegeniTherix consortium is National Physical Laboratory (project leader), Neotherix, Leeds Teaching Hospitals NHS Trust, SensaPharm and Complement Genomics. The project is funded by the National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme.

See the Bionow announcement for details of the award winners.

For more information on the RegeniTherix project and Bionow awards please see our previous news article.

RegeniTherix - a system for the point of care testing and treatment of chronic, non-healing wounds such as diabetic foot ulcers and venous leg ulcers - has been shortlisted in the Project of the Year category in the Bionow Awards, which recognise the very best life sciences companies and innovations in the north of England.

The RegeniTherix system consists of a bioresorbable 'scaffold' to encourage growth of the patient's own cells into the wound space to begin repair and a hydrogel to enable the collection and sampling of biomarkers produced by these new cells. The biomarkers are measured using a hand-held reader device and provide clinicians with information on the healing or non-healing status of the wound. Knowing whether certain barriers to healing are present, such as excessive inflammation, high levels of degradative enzymes, poor tissue perfusion or infection, allows clinicians to select the most appropriate wound treatments for different patient groups. In this way, RegeniTherix is both a therapeutic - promoting chronic wound healing - and a diagnostic device ("theranostic").

The RegeniTherix system has been developed by a consortium led by the National Physical Laboratory (NPL) and involving York-based Neotherix, Leeds Teaching Hospitals NHS Trust and the Durham-based companies SensaPharm and Complement Genomics. The project is funded by the National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme.

The cost of wounds to the NHS has been estimated to be more than £3 billion per year and to consume around 3% of the NHS's entire budget. NICE estimates that the cost of a wound to the NHS is £4,750 per patient and a range of £4,850-£7,500 per patient has been estimated for Europe as a whole. With an ageing population and the rising incidence of chronic diseases - both of which increase the incidence of chronic wounds - controlling and reducing the amount spent on treating wounds is of vital importance. A saving of 5% (achieved through improved healing, earlier patient discharge and fewer "wasted" dressings) will take around £200m pa off the NHS's budget and this is the initial target for RegeniTherix.

The Bionow Project of the Year Award criteria include the need to demonstrate the use of innovative approaches to develop biomedical products and will be awarded on the basis of the quality of the project and the degree of innovation. The winners of this and other awards for 2015 will be announced at the Bionow Annual Awards Dinner taking place on Thursday 26 November at the Mere Golf Resort and Spa, Cheshire at which the RegeniTherix consortium will be represented by Dr Mike Raxworthy from Neotherix.

For more information please see the Bionow Annual Awards Dinner web page .

Neotherix CEO Dr Mike Raxworthy will be speaking at the World Conference on Regenerative Medicine 2015, to be held in Leipzig, Germany on 21-23 October. The interdisciplinary conference, which is typically attended by around 1,000 delegates, covers a broad range of regenerative medicine topics including biomaterials and tissue interaction, cell therapies, models of regeneration, tissue engineering and regulatory affairs.

Mike's presentation will be given during the Muscle, Skin, and Soft Tissue Regeneration session on Day 3 of the conference, 23 October, and will focus on the translation of our EktoTherix™ tissue repair scaffold "from test rig to clinic". The presentation will describe the pathway travelled and the learning gained by Neotherix during the development of EktoTherix. The product is currently being evaluated in a First in Man clinical safety study which is, to the best of our knowledge, the first full clinical investigation of a bioresorbable electrospun scaffold.

For more information, please see the World Conference on Regenerative Medicine web page .

We are delighted to announce that Neotherix has been selected to give a company pitch at the annual BioCap conference on Wednesday 30 September 2015 at the Alderley Park Conference Centre in Cheshire. Now in its fourth year, the conference will bring together investors, life science companies seeking finance, and those with a track record of raising finance. BioCap is reported to be the only life science and investment conference in the North of England.

Dr Mike Raxworthy, the company's founder and CEO, will be presenting on Neotherix to an invited audience of investors. Mike's presentation will focus mainly on EktoTherix™ regenerative tissue scaffold for acute wound repair but will also cover wider opportunities arising from EktoTherix and from pipeline projects.

Please see the BioCap conference web page for more information.

Dr Peter Iddon, Development Manager at Neotherix, will be presenting at the Regener8 Annual Conference 2015, which is one track of the MEIbioeng15 Conference taking place at the University of Leeds on Monday 7 and Tuesday 8 September 2015. Peter's presentation, Translation of EktoTherix™, a synthetic acellular scaffold for wound regeneration: learning by doing, will take place during The Delivery of Regenerative Medicine track on the second day. It will focus on the learning gained from assembling the evidence required in order to take our lead scaffold technology, EktoTherix™, to its first evaluation in a clinical investigation.

Please see the Regener8 Annual Conference web page and MEIbioeng15 web site for more information.

Neotherix is pleased to announce the start of a new collaboration with the School of Dentistry, University of Leeds. This continues our work on photodynamic therapy delivered by our PhotoTherix™ tissue scaffold technology. Research work will be conducted by Malaysian PhD student Rina Haryani bt. Osman Basah and supervised by Dr Simon Wood and Professor Xuebin Yang from the School of Dentistry and Dr Mike Raxworthy from Neotherix. We welcome Rina to the UK and to the project!

Link to the School of Dentistry at the University of Leeds .

Dr Mike Raxworthy, Dr Lorenzo Pio Serino and Dr Peter Iddon are co-authors of a paper just published online in Biofabrication. The paper, "A three dimensional model of primary bovine endometrium using an electrospun scaffold", describes collaborative work carried out by Dr Siân MacKintosh of Swansea University using Neotherix electrospun scaffold technology to create a functional 3D model of bovine endometrium. Stromal and epithelial cells were grown on the Neotherix scaffold, resulting in a layered arrangement similar to native endometrium. Analysis confirmed the appropriate expression of key biomarkers for this tissue type.

This 3D model could be used for the study of the pathophysiology of this commercially important tissue. In cattle the endometrium plays key roles in reproduction, and diseases affecting this tissue are a large burden to the farming industry. For example, according to senior author Professor Martin Sheldon , infection of the uterus following calving is estimated to cost the EU farming industry €1.4bn annually due to the cost of treatment, infertility and reduced milk yields.

This approach could be used to create other species-specific 3D models of important tissue types, including human tissue, and these results are further evidence of the versatility of electrospun scaffolds in the construction of in vitro disease and tissue models.

For more detail please see the published paper MacKintosh, SB, Serino, LP, Iddon, PD, Brown, R, Conlan, RS, Wright, CJ, Maffeis, TGG, Raxworthy, MJ, and Sheldon, IM, Biofabrication 2015, 7:025010 . A pre-print version is also available here .

Neotherix are pleased to announce a major milestone in the development of EktoTherix™ Tissue Repair Scaffold: a First in Man clinical investigation is currently open for recruitment and the first patients have been recruited. This initial safety study will assess EktoTherix in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers. Up to fifteen patients will be recruited across two sites in the York Teaching Hospital NHS Foundation Trust: The York Hospital and Scarborough Hospital.

The Investigation will assess outcomes following the application of EktoTherix Tissue Repair Scaffold to wounds resulting from these surgical excisions. The scaffold is expected to help the patients' own cells repair the wound, enhancing healing and improving quality of repair. The tissue scaffold is designed to be completely absorbed by the body during the healing process so that there is no need to remove it when the wound is healed.

Although the primary objective is to assess the safety of EktoTherix in humans, a secondary objective is to evaluate its clinical performance. Our hypothesis is that use of EktoTherix will increase incidence of complete healing and result in an overall better cosmetic result (cosmesis) of the healed wound.

For more information on the study see the EktoTherix study record on ClinicalTrials.gov .

Dr Peter Iddon, Development Manager at Neotherix, will be presenting at Regener8/Science City York Technology Digests - Regenerative Scaffolds, to be held at the Department of Biology at the University of York on Wednesday 13 May 2015. Peter's presentation, Synthetic Bioresorbable Scaffolds: From Test Rig to Clinic will focus on the pathway our lead scaffold technology, EktoTherix™, has taken from its early development stages to its first evaluation in a clinical investigation.

Please see the event web page for more information.

Neotherix CEO Dr Mike Raxworthy will be presenting a poster titled "An Antimicrobial-Releasing Tissue Scaffold for the Repair of Oral Surgical Sites and Prevention of Graft Loss due to Infection" at the 2015 BioSynergy Conference, to be held on Tuesday 21 April at the National Agri-Food Innovation Campus in York. The one day event, on "Overcoming Barriers", will be co-hosted by Bionow and Science City York, and will focus on helping the life sciences community connect with potential partners.

Please see the BioSynergy event page for more information.

Dr Mike Raxworthy will be presenting at the launch event for the interactive exhibition Super Cells, to be held at the Centre for Life in Newcastle on Thursday 5 March 2015. Mike's presentation will consider 'The Power of Cells' from an industry point of view. Other talks will cover the clinical perspective (from Prof Jim Shaw, Newcastle University) and that of the Cell Therapy Catapult (from CEO Keith Thompson).

The Super Cells exhibition is being held at the Centre for Life from 28 February to 19 April 2015. It explores what stem cells are, how they live and their potential uses in medicine.

To enquire about attending the launch event please email supercells@ct.catapult.org.uk. Booking is not required to attend the Super Cells exhibition itself.

Please see the Super Cells web page for more information.

Mike Raxworthy visited the University of East Anglia on 9 February to meet with academic supervisors Dr Aram Saeed and Dr Graham Riley, clinical supervisor Professor Simon Donell and the PhD student working on the project, Grace Walden. Plans for the development of a bioresorbable microparticulate approach to tendon repair were reviewed and approved. Neotherix is the industry sponsor for this iCASE project (see news item of 04/06/14) with Dr Raxworthy the industrial supervisor.

Dr Lorenzo Pio Serino, Biomaterials Scientist at Neotherix, is a co-author of a paper just published in Materials Science and Engineering C (Materials for Biological Applications). The paper, "Formulations for modulation of protein release from large-size PLGA microparticles for tissue engineering" describes collaborative work carried out by Lorenzo Pio while seconded by Neotherix to the University of Nottingham to learn about PLGA hydrogel technology.

The paper describes a new approach to modifying the rate of protein release from poly(DL-lactic acid-co-glycolic acid) (PLGA) microparticles. Blending the PLGA with triblock copolymers of PLGA and poly(ethylene glycol) (PEG) allowed the rate of release of a model protein, lysozyme, to be 'pre-programmed' or pre-selected. This approach could be used to create microparticle-based tissue engineering constructs with pre-programmed release properties. Neotherix are now applying some of the broad concepts explored during this secondment to their i4i-funded RegeniTherix project.

Please see Qodratnama, R, Serino, LP, Cox, HC, Qutachi, O and White, LJ Materials Science and Engineering C 2015, 47:230-236 for more information.