Biocompatibles International plc is pleased to announce that The International Neuroscience Institute (INI), Hannover today held a press conference which covered the following:

- Milestone in Medical Treatment
- First ever Treatment of Stroke Patient with Stem Cell Therapy Product
- International Neuroscience Institute Hannover developed novel neurosurgical Technique for the Transplantation of Stem Cells to the Brain

The International Neuroscience Institute (INI), Hannover is pleased to announce that the first patient has been treated in the first ever clinical trial for the treatment of stroke with a stem cell product.

On October 15th a 49 year old male was admitted to a community hospital and diagnosed with a haemorrhagic stroke. The patient was stabilised and provided informed consent for the treatment of surgery to relieve the pressure on the brain combined with stem cell therapy. The patient was under the care of Professor Thomas Brinker from the INI. The surgical procedure was successfully conducted at INI by Priv. Doz. Dr. Amir Samii.

The patient was treated as part of a twenty patient clinical trial approved by the Paul Erlich Institute, the regulatory institute of the Ministry of Health, and approved by the ethics committee.

The patient made a good recovery from the surgery and there are clear signs of improvement from his condition prior to surgery. He has now been discharged from hospital. Professor Brinker commented: "We see a path of recovery as good as this only in the minority of patients, so it is an encouraging start. It is most important that we found definitively no side effects from the treatment."

Stroke is one of the leading causes of death in the elderly population in the developed world. The incidence rate has been reported as 145 per 100,000. Hemorrhagic stroke is responsible for ~15 to 20% of all stroke and it is the least treatable form of stroke. It is associated with the highest morbidity and mortality rate of all stroke with only 44% of affected patients surviving the first 30 days. Only 20% of these survivors regain functional independence. The cascade of events starts with the sudden rupture of a blood vessel in the brain, causing haemorrhage and pressure inside the skull. Surgery may be used to relieve the pressure; but the haemorrhage causes a longer-term process of programmed cell death, or apoptosis, and it is this that causes the lasting neurological damage.

The CellBeads™ are delivered directly to the injury site during the surgery. They are programmed to deliver CM1, a proprietary version of a naturally occurring protein, GLP-1, which has been shown to have powerful anti-apoptotic effects. The delivery mechanism is a cluster of human adult mesenchymal stem cells obtained from a healthy donor and encapsulated in alginate beads. The cells are genetically engineered to produce the protein, which is delivered continuously, directly to the injury site. The alginate beads protect the stem cells from the body's immune system, which would otherwise destroy the foreign cells. CellBeads™ are transplanted within a retrievable mesh device and are removed completely after a treatment period of 14 days. Retrieval of the implant prevents possible long-term side effects from the transplanted cells.

Twenty patients will be treated in this Phase I/II trial. The trial's primary end-point is safety; and data will be gathered on a number of indicators of efficacy. If successful, a larger, international trial will be designed with a view to securing a product licence in the 2012-15 time-frame.

This is the first trial authorised by regulators and hospital ethics committees for the treatment of stroke with a stem cell therapy product1.

This programme has been supported by grants from the German government, from the State of Bavaria, and from the International Neurobionics Foundation; and is sponsored by CellMed AG, the manufacturers of the CellBeads™ product used in the treatment.

Professor Madjid Samii, Founder and President of the INI, commented "I am very proud of INI's involvement with this exciting programme. Stem cell science rightly attracts a lot of public interest but we have to show that treatments are safe, effective and reproducible; and that process is now well under way.

1 Stem cell therapy using the patients' own cells has been described, but by definition this treatment is not a product; and there are no published clinical papers describing the results of any trial.

Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products, operating through three businesses. The International Division conducts the marketing of Biocompatibles' approved products - Biocompatibles' Drug-Eluting Bead products which are used in the treatment of primary and secondary liver cancers and BrachySciences' radiation-delivering seeds which are used in the treatment of prostate cancer.

The Drug Delivery Division and CellMed are engaged in new product development and licensing. The Drug Delivery Division is developing new products for oncology and other indications, based on the company's core drug delivery technologies. CellMed is developing a Bead product for cosmetic dermatology and a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology.

Our strategic partners include Angiodynamics Inc, Medtronic Inc, Merz AG and Terumo Corporation.

Biocompatibles International plc