Stempeutics Research, part of Manipal Education & Medical has now commenced the development of an innovative point-of-care, fully automated stem cell isolation device ‘Stempeutron’ which is a boon for plastic and cosmetic surgeons. The device first time being developed in India, can be used for breast reconstruction/cosmetic breast augmentation, facial restructuring, deformity correction, scar and wrinkle reduction.

The device which has proved its engineering functionality and commercial viability will now need a strategic partner for which Stempeutics is gearing up to initiate dialogue with global medical device majors like GE, Siemens, Phillips and J&J, BN Manohar, CEO, Stempeutics Research told Pharmabiz.

Stempeutron is positioned to be an easy to use and affordable device which would deliver a cellular product within 2 hours. The viability and composition of the SVF processed by Stempeutron is likely to be far superior to that from existing devices. The device will be ready for marketing in early 2014. “We have applied for a provisional patent in India and would get into other markets via the PCT route,” he added.

It was over  a year-ago that Stempeutics commenced the development of the  innovative stem cell medical device Stempeutron in technical collaboration with Vignani, a engineering services company in Bangalore. The automated medical device which is for isolation of stromal vascular fraction (SVF) cells from human adipose tissue lipo aspirate is the first such device to be developed indigenously, that will comply with international regulatory standards, and will be based on an entirely novel process and technology as compared to the existing devices.

SVF cells is known to have therapeutic efficacy in a number of disease conditions, particularly in soft tissue repair in plastic and reconstructive surgery, stated the Stempeutics CEO.

Mid to large-sized hospitals and clinics in India that routinely perform such procedures would be the main market for the proposed SVF isolation device.

The global market for cosmetic surgery services were $31.7 billion in 2008, a figure that is expected to reach $40.1 billion in 2013, with a compound annual growth rate (CAGR) of 5.2 per cent. According to the International Society of Plastic Surgeons survey, India ranks 4th in the number of cosmetic surgical procedures(850,000) performed per year compared to the No.1 Ranking country  (US = 3,100,000). India also ranks 4th in the number of breast augmentation surgeries performed annually which is a market valued at US$ 600 million market.

The manual procedure for obtaining SVF in healthcare facilities poses major obstacles such as requirement of highly expensive Good Manufacturing Practices (GMP) -compliant infrastructure for tissue processing and skilled technical personnel, which would be circumvented by an automated closed aseptic point-of-care system like Stempeutron.

The innovation in Stempeutron lies in the isolation, purification and concentration of clinical grade SVF cells without centrifugation. This is achieved by separation of the fatty and aqueous fractions of enzymatically digested fat tissue in a uniquely designed mechanized tissue processing unit, followed by concentration of the stem and progenitor cells by a novel filtration unit, he explained.

While the medical device market is projected to grow to $4.5 billion in 2012 with a CAGR of 15 per cent, indigenously developed technologies will address this short coming.

According to Kumar Ramachandran, CEO, Vignani Technologies, “SVF based cell therapies are poised to enter the clinic, and this has encouraged the development of automated systems for SVF isolation at the point of care. The device will meet compliance for CE/UL mark and will be manufactured with ISO 13485 certification to meet regulatory standards in the US. With these quality and regulatory requirements, Stempeutron can be marketed in SE Asia and eventually into Europe and the US.”