Stempeutron™ is a point-of-care, closed system, automated medical device for the isolation of SVF cells from human adipose tissue for the broad field of regenerative medicine. Stempeutron™ is the first product to use novel robotic and filtration technology to isolate clinical grade stem cells from adipose tissue. It is now established that SVF derived from fat tissue is a rich source of mesenchymal stem cells and endothelial progenitor cells, as well as other tissue-building cells such as vascular smooth muscle cells, pericytes, pre-adipocytes and fibroblasts. SVF therefore has broad clinical utility in cell therapy and regenerative medicine for repair of diseased organs as well as in plastic and reconstructive surgery. Isolation of SVF typically requires fat to be harvested by liposuction, washed, enzymatically digested and centrifuged to recover the cells. Manual processing has been in practice for some time, but requires skilled technicians, expensive infrastructure and laboratory with GMP and GCP compliance, which are not available at most healthcare units. Isolation in a certified external laboratory entails storage, handling and transportation of fat tissue and cells from and to the clinic, and multiple patient visits. Stempeutron™ is specifically designed to help overcome most, if not all, of the shortcomings of the status quo. The proof of concept for the Alpha device has been established. The Beta device is currently under development. Stempeutics holds 5 usage patent applications and 4 design patents relating to Stempeutron™. Stempeutics is seeking collaborative partnerships to complete the development of the Beta device with a view to subsequent divestment of the Stempeutron™ asset.

Product/Technology Overview and Rationale

Stempeutron™ is a medical device intended for automated isolation of SVF cells from the patient's own fat tissue at the point-of-care, with minimal manipulation and human intervention. The device will comprise of a hermetically sealed enclosure housing the mechanical and electronic components, within which the tissue processing will be carried out using sterile single-use disposables. Stempeutron™ is designed to operate through a proprietary process and technology developed by Stempeutics. A key innovation in Stempeutron™ is the concentration of clinical grade SVF cells without the use of a centrifuge, which is the conventional process for recovering the cells. This is achieved by using a proprietary filtration system. By eliminating centrifugation, the isolation becomes gentle, and the cost and footprint of the device is reduced. Stempeutron™ is under development as a fully automatic, embedded controlled, robotics technology based device. It is under development as a trolley mounted device, with a TFT display for the user interface. It will be enabled with tightly interlocked sensor based controls for safe and sequence based operations. The device will have inbuilt remote monitoring enablers which when put on ethernet backbone will facilitate monitoring and control from a central server.

StempeutronTM Development Status


Applications for SVF

 

SVF has significant potential in plastic and reconstructive surgery applications such as soft tissue augmentation for post mastectomy breast reconstruction/cosmetic breast augmentation, facial restructuring, deformity correction, scar and wrinkle reduction etc. The global market for cosmetic surgery services is estimated at $40Bn in 2014.

 

Significant potential for autologous use in regenerative cell therapies – such as cardiovascular disease, liver insufficiency, peripheral artery disease, renal failure and wound healing.

 

In addition to hospitals and clinics, the device will be beneficial for companies interested in the banking of adipose tissue derived stem cells.

 

SVF based therapeutics is also gaining importance in veterinary applications, particularly for equine bone and cartilage regeneration, and may be suitable for use in other domestic animals as well