Regenerative Medicine in Sweden

NovaHep is a Gothenburg-based Swedish regenerative medicine company with a unique technology for developing a broad range of biocompatible tissues and organs. The company is addressing the major shortcomings and drawbacks associated with organ transplantation of today, such as a lack of suitable organs available, the adverse side-effects of immunosuppressive drugs, and the oftentimes need for repeated surgery. Their objectives are to provide for improved quality of life for patients worldwide, and cost-effective care for hospitals, healthcare-providers and society. NovaHep's products in development rely on patient-individualization of donated organs and tissues by applying advanced, proprietary stem cell technology. NovaHep continues to progress with its preparations for an upcoming Scandinavian clinical trial related to its personalized tissue-engineered vein with competent valves, targeting the disease chronic venous insufficiency (CVI).

NovaHep is currently generating preclinical documentation to apply to the competent authorities for permission to perform a Phase I/II clinical study in Norway to cure patients with CVI using personalized tissue-engineered veins (P-TEV). The study will be performed in close collaboration with vascular surgeons at Oslo University hospital (OUH). Ethical permit from the Norwegian regional ethical committee (REK) has been obtained. The committee has concluded that the potential benefit for the patients is significant while the risks associated with the trial are small. NovaHep is planning to develop P-TEV as an advanced therapy medicinal product (ATMP) following the EUs applicable laws and regulations. The required clinical trials will be well supported by the regulatory authorities in the respective countries and the data obtained in the different clinical trials will be used to apply for marketing authorization at the European medicines agency (EMA).

The way NovaHep performs clinical development as a company is in clear contrast to the academically driven surgeries at the Karolinska Institute in Stockholm performed by the scandal surgeon Paolo Macchiarini, as well as at Sahlgrenska University hospital in Gothenburg by Professors Suchitra Sumitran Holgersson and Mikael Olausson that have been the subject of sharp criticism in Sweden. The sole model for NovaHep is to apply per all standard procedures, using all documentation needed to start a traditional Phase I/II trial, in the same way as other small and big companies in this space do.

One of the founders and current minority owners of NovaHep, Prof. Suchitra Holgersson is under investigation for potential scientific misconduct. These allegations regarding image duplications strictly concern her academic publications produced at Gothenburg University. NovaHep is an independent company and all data that is used for clinical applications is generated at NovaHep by own personnel. NovaHep's work is independent from the academic research or the clinical work performed by Professors Michael Olausson and Suchitra Sumitran Holgersson and neither of the two has any influence on the company or on the way the company is planning its clinical development or future products. That is, neither of the two are engaged in NovaHep's management, in the Board of Directors, nor in any of the company┬┤s advisory boards.

Nevertheless, some newspapers either have misunderstood the situation completely or are trying to create a selling story by mixing up the facts between the academic and the industrial world. In fact, NovaHep was not even involved in the surgeries performed at Sahlgrenska University Hospital but licensed the technology at a later timepoint.

Finally, NovaHep is collaborating with several clinicians on the P-TEV project, as well as with both Swedish governmental research organizations and teams on EU-level. The company has also recently received financing both from the Swedish government and from the EU. All this should be seen in the light that the company is very transparent with the fact that one of its founders currently is under investigation. It is understood that this investigation is only concerning the generation of academic data.

This shows once again that diligence and careful examination of facts is needed, when trying to form an educated opinion. Fortunately for the patients, the company and many collaborators are fully committed to bring this technology to a clinical reality for patients with uncured cardiovascular disease. We will continue to follow the developments in the NovaHep case to better understand the situation concerning regenerative medicine in Sweden. To us, it is of outmost importance that novel technologies with the capacity to help patients with hitherto uncured diseases will not be hindered by a skewed debate.