Rhenium-SCT® Receives Positive Assessment from German Society of Nuclear Medicine (DGN)

Announcement Date: July 13, 2017

Garching n. Munich, Germany, (July 13, 2017) – OncoBeta GmbH®, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies, is pleased to announce that the Rhenium-SCT® Received a Positive Assessment the from German Society of Nuclear Medicine (DGN e.V.) pertaining to their treatment of Non-Melanoma Skin Cancers with the Rhenium-SCT® Therapy. The radiation committee came to a unanimous conclusion that Re-188-SCT can be considered an accepted medicine [Heilkunde] in accordance with the German Radiation Protection Ordinance

Excerpt from the official announcement:

German Society of Nuclear Medicine (DGN e.V.)

13 July 2017

Enforcement of the German Radiation Protection Ordinance “Use of a rhenium-188 paste for the epidermal treatment of skin cancer lesions and tumours”

Thank for your query as to whether Re-188-SCT can be classified for the outpatient treatment of Basalioma and spinalioma as a new therapeutic option in medicine as per section 80 StrlSchV [German Radiation Protection Ordinance].

We have come to the conclusion in this regard that Re-188-SCT can be considered an accepted medicine [Heilkunde] in accordance with section 80 StrlSchV [German Radiation Protection Ordinance].

Justification

The procedure includes covering the area of skin to be treated with a film to which a paste containing Re-188 is then applied using a special application device. The paste quickly hardens, thereby giving it a stable form. After the irradiation time has passed, the film and the hardened paste are peeled away. At no time during the correct application does the patient come into direct contact with open radioactive substances. The irradiation time is determined by the size of the area requiring treatment and the depth of the tumour. The values in the values provided by the manufacturer should be referred to for this purpose.

The procedure, including the application devices and the Re-188 paste, are CE-certified. The effectiveness of the procedure in the treatment of basalioma and spinalioma has been proven in multiple publications (e.g. Sedda et al., Clin Exp Dermatol33,745-749). The procedure offers special benefits in the case of anatomically difficult structures (e.g. eye comer fold, auricle).

End of excerpt.

“This assessment is a mile stone for the treatment of Non-Melanoma Skin Cancer in Germany,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta GmbH. “This shows again that the Rhenium-SCT® is a safe and simple new form of Brachytherapy that should be made more accessible to physicians and patients.”

The Rhenium-SCT® is available for use in all countries of the European union.

About the Rhenium-SCT® (Skin Cancer Therapy)

The Rhenium-SCT® is a non-invasive, painless therapy generally providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat. The Rhenium-SCT® utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). Due to the specially designed devices and accessories the Rhenium-SCT® compound never comes in direct contact with the patients’ skin and the application is safe and simple for the applying physician. Most cases of non-melanoma skin cancers (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT® with a single application, applied in one single session. Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.

About OncoBeta® GmbH

OncoBeta® GmbH with its headquarters located at the Garching Technology and Founders Center GATE near Munich, is a privately held medical device company, specializing in the development and commercialization of state-of-the-art, innovative therapies utilizing epidermal radioisotope applications. Since its foundation, OncoBeta® GmbH has concentrated its efforts on the development, regulatory approval(s) and commercialization of the epidermal radioisotope therapy Rhenium-SCT® (Skin Cancer Therapy), targeting non-melanoma skin cancers. Since then, OncoBeta® has successfully perfected the customized application and device management system in conformity with all health, safety, and environmental protection regulatory standards. OncoBeta® GmbH is European CE certified and has filed for regulatory approval in several other countries outside the EU.

Furthermore, having the patient in focus, OncoBeta® is enthusiastically working with medical, scientific and industrial partners as well as local and national authorities to make this personalized, painless and non-invasive therapy accessible to patients all over the world. The Rhenium-SCT® significantly improves outcomes and the quality of life of non-melanoma skin cancer patients.

Find out more about the Rhenium-SCT® at www.oncobeta.com

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