A Medical Device Daily

Medical Device Innovations (MDi; Chester, UK), an intellectual property development company focused on medical devices, reported completing a Series A financing round, raising £2.9 million.

The round was led by existing seed investor Avlar Bioventures (Madingley, UK), alongside new monies from a fund managed by YFM Private Equity (Leeds/Manchester, UK). MDi received £500,000 seed financing in 2002, also led by Avlar.

MDi acquires the intellectual property relating to a new medical device and develops the device to proof-of-concept stage. The company said: "Adding value in the transition between the inventor and the medical device companies, MDi progresses inventions which might not normally be broad-based enough to form the basis of a company or are at too early a stage to out license to established medical device companies."

Once a device has been advanced to proof-of-principle stage, it is then either licensed or sold to a major device company or grouped with synergistic projects as the basis for a spin-out company, MDi said.

MDi reports currently having six companies in its portfolio, with the applications under development including radiology, cancer treatment, orthopedic/plastic surgery and emergency medicine.

MDi CEO David Cottier said, "As the first company in Europe set up purely to source and develop innovative new medical technologies, we are encouraged and excited to have successfully completed this round of financing. It provides further endorsement of the MDi business and recognition of the significant opportunities in interventional medical devices."

MDi said it will use the new funds to accelerate the development of current projects and develop new ones.

Doug Stellman of YFM Private Equity said, "Medical technology varies from the very sophisticated to the quite simple but clever idea. The major medical equipment suppliers are investing heavily in improving patient care but it is often the medical professionals closest to delivery that have the best ideas. This is why we see the strong commercial potential in the MDi approach to bringing these ideas forward, and they have the medical device industry expertise to spot the likely winners."

Genzyme wins Thyrogen market OK

Genzyme (Cambridge) reported that the European Commission has approved its marketing application for a therapeutic indication for Thyrogen (thyrotropin alfa for injection) when used in combination with radioiodine. The new label permits the product's use in the EU for the ablation of remnant thyroid tissue, a procedure patients commonly undergo when treated for thyroid cancer.

About 35,000 ablation procedures are performed annually in the U.S. and Europe combined, and Genzyme estimates that Thyrogen has the potential to be used by up to 80% of these patients. Genzyme also is seeking to add the ablation indication to the product's U.S. label and expects regulatory action on its submission in the second half of this year.

Thyrogen is a recombinant form of TSH administered by injection, allowing patients to continue taking hormone supplements and avoid the symptoms associated with thyroid hormone withdrawal.

The new indication on the European label allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer: surgical removal of the cancerous thyroid followed by remnant ablation, designed to destroy remaining thyroid tissue that may not have been removed during surgery, including any cancerous cells in the thyroid bed. This may help reduce the risk of disease recurrence and facilitate follow-up monitoring.

In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be elevated. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, ranging from fatigue to depression.

Results from a clinical study presented last June at the annual meeting of the Endocrine Society suggest, Genzyme said, that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side-effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.

"We believe that the use of Thyrogen in remnant ablation procedures can provide clear benefit for patients," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This approval represents significant progress in our program to increase the potential clinical applications for Thyrogen."

Genzyme established a commercial oncology franchise last year to address cancer care from diagnosis to therapeutics to follow-up monitoring. Thyrogen is an adjunct to thyroid cancer management by leading to earlier detection of recurrence, which in turn may prevent deaths from this treatable disease.

Thyrogen is currently approved in about 40 countries. It was first approved in the U.S. in 1998 as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging.

Genzyme's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing.

Schlossberg Medical adds BSD system

BSD Medical (Salt Lake City) reported that it has sold a new BSD-2000/3D system to the Schlossberg Clinic (Oberstaufen, Germany), operating as a member of the Munich Comprehensive Cancer Center and under a clinical cooperation contract with the LMU Munich University Medical School (Klinikum Grosshadern, Germany), a prominent clinical cancer research facility.

The Schlossberg Clinic is preparing for the grand opening on April 15-16, when physicians will present the state of the art of hyperthermic therapy. The hyperthermia facility at the Schlossberg Clinic will be the seventh BSD 2000-based deep regional hyperthermia treatment facility in the state of Bavaria. The Schlossberg Clinic will treat patients both in combination with chemotherapy and with radiation.

According to BSD Medical, treating GYN cancer with BSD systems has been of interest since the conclusion of a Phase-III European trial that showed a nearly doubled rate of survival for advanced cervical cancer patients treated with the BSD-2000 in combination with radiation therapy, as compared to those who received radiation alone. The BSD-2000/3D at the Schlossberg Clinic is being received as a pilot installation, with the potential for further use of BSD systems at other centers owned by the Humaine Kliniken Group.

BSD developers microwave and radio frequency (RF) systems for thermal medicine applicable to the treatment of cancer, benign diseases and other medical conditions. Its systems are used to superheat and kill cancer cells and to boost the effectiveness of radiation and chemotherapy. The BSD-2000/3D employs an annular phased array of 24 RF antennae placed around the patient to focus RF energy steered in 3-D.