COMPANY FOCUS Clinica // March 2010

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Cytori Therapeutics specialises in pro-viding “affordable, real-time access” to clinical-grade, adipose-derived

stem and regenerative cells (ADRCs). These cells, which occur naturally, promote heal-ing of scarred or injured tissue and Cytori currently uses them in procedures for breast reconstruction and breast augmentation. However, the San Diego, California firm believes that ADRCs can be used for a potentially unlimited number of medical conditions.

Cytori’s lead product is the Celution system, which enriches fat grafts, used to mend a wound or sculpt a part of the body, with the patient’s own ADRCs. This process is intended to take place primarily at the patient’s bedside after the ADRCs have been sourced, so that the cells can be taken from the patient and added to the graft during the actual grafting procedure. Alternatively, they can be preserved for future use.

According to Mr Daniels, this method of grafting provides “a more stable and predictable result compared with other existing methods of using fat tissue to regenerate wounds”.

The most traditional procedure used in fat grafting is the Coleman method of centrifuging fat cells, pioneered by liposuction and reconstructive surgery specialist Sydney Coleman. However, Mr Daniels said that this method can vary from surgeon to surgeon, so fat transfers have been proven to produce “unpredictable” grafts that could deteriorate over time and fail to perform to optimum effect. He also said that this procedure could take well over three hours for larger fat graft volumes.

Mr Daniels said the Celution procedure could “turbo-charge traditional grafting techniques”, by enriching the graft with naturally occurring adipose-derived stem and regenerative cells. In addition, Celution could decrease the amount of time it takes

to complete one large-volume fat grafting procedure. The Celution system can produce a better-quality graft in around 120 minutes.

Key marketsMr Daniels said that the cosmetic and reconstructive surgery (CRS) market is worth more than $3bn and provides Cytori with a low-risk, near-term private pay opportunity. There are 690,000 breast augmentation cases and 730,000 breast reconstruction procedures conducted globally each year. Cytori itself has treated more than 1,000 patients in the CRS market, with an EU post-marketing study (RESTORE-2) complete and awaiting final data analysis. The US regulatory path for CRS indications is underway.

The breast reconstruction market is particularly attractive for Cytori, as there are limited reconstructive options to address tissue defects and asymmetry

Cytori eyes billion-dollar regen medicine space with grafting Celution

Adipose tissue specialist Cytori Therapeutics believes that regenerative medicine holds the potential to transform the field of medicine in the same way that computers changed communication. Joseph Harvey spoke to Eric Daniels, the director of Cytori’s European and Middle Eastern operations, and found out how the company aims to build a market-leading franchise in this potentially revolutionary field

Eric Daniels

Clinica // March 2010 COMPANY FOCUS

www.clinica.co.uk © Informa UK Ltd 2010 39

which result from mastectomy or lumpectomy. Mr Daniels said that breast implants do not adequately address these defects as they cannot be fitted to the exact size of the wound. Transplantation of autologous fat tissue is a more efficient solution as it has the capability to be applied to wounds of any shape or size.

In the area of reconstructive surgery, Cytori is sponsoring a European clinical study for patients requiring breast reconstruction after lumpectomy for breast cancer.

The company is also exploring the cardiac market, which represents a higher risk and a longer time to market compared with the CRS sector, but is potentially more lucrative.

Mr Daniels said that, in order to exploit the full potential of these markets, the company has deployed a razor/razorblade sales model, generating around $100,000 for the sale of each Celution system and approximately $2,500 for the disposable instruments.

Cytori’s ambition is to have a Celution system “in every major hospital and in thousands of specialty medical clinics around the world”.

On the assumption that Cytori’s installed base would grow to 100 systems being operated three times per week, the company believes that it could generate around $375,000 per device each year, earning revenue of around $38m for every 100 devices.

However, reconstruction procedures using the Celution system are not reimbursed (cosmetic cases remain private, fee-for-service operations). “The key to Cytori’s success would be gaining

reimbursement for reconstruction procedures using Celution. It’s hard to say when this would be granted,” said Mr Daniels.

Competition?Mr Daniels said that competition to the Celution system remained the more conventional fat grafting procedures. These techniques are cheaper for the patient but potentially less reliable.

He did highlight one company that is developing a similar platform to Cytori – Tissue Genesis specialises in advanced tissue engineering and cell therapy, using adipose-derived regenerative cells to coat implants, repair damaged tissue and treat a range of diseases and medical needs. However, the Hawaii-based firm has yet to receive any regulatory approval for its technology under any international; medical directives.

Looking to the futureThe company’s key upcoming milestones include: to report results in European chronic heart disease and heart attack feasibility studies; to report results from ongoing investigator-initiated studies and trials; to report results of a completed European breast reconstruction study; to grow sales in cosmetic and reconstructive markets in the EU and Asia Pacific markets; and to grow product sales worldwide.

Mr Daniels said that in the long term, the company was aiming to improve its technology by shortening its procedure time and by allowing the processing of different volumes of cell-enriched solutions.

Cytori is also hoping to build a fat grafting franchise in the CRS market,

whereby it offers a full suite of autologous fat grafting products. The company’s second product, the PureGraft autologous fat graft system, received FDA clearance in January 2010 and is set to be CE marked in the first half of the year. PureGraft is a non-cell-enriched graft targeted towards the existing US autologous fat graft market, which sees around 46,000 procedures annually.

One difference between PureGraft and Celution is its price – PureGraft is a cheaper option, thus opening out Cytori’s technology to a broader market. The other difference is in performance, as PureGraft does not allow for fat grafts to be enriched with cells. Mr Daniels said that the price and performance difference between the two products would ensure that any cannibalisation of revenue would be slight.

The company is also exploring the use of its technology to treat chronic heart disease and acute heart attacks, while investigators,academics and hospitals around the world are performing their own independent studies using the Celution system for liver insufficiency, stress urinary incontinence, renal failure, peripheral artery disease, radionecrosis of the mandible, burns and vocal chord paralysis.

Cytori also has backing from some of the major players in the medtech arena. Olympus owns 4.013 million shares in Cytori, therefore giving it a 10% ownership, while the firm has GE Healthcare as its EU and US sales partner. Both connections are aimed at helping to increase the visibility of Cytori as a brand name within the fat grafting market.

Celution: high-quality fat grafting in 120 minutes

History of CytoriIn 2000, plastic surgeon Marc Hedrick co-founded a company specialising in stem cell research called StemSource. This company developed Dr Hedrick’s work in the field of tissue engineering and, specifically, tissue regeneration using a patient’s own cells.

Three years later, the company merged with MacroPore Biosurgery, a firm specialising in resorbable technology in the orthopaedic surgical implant field and also a seed investor of StemSource. Subsequently, the screws and plates business of MacroPore was sold off to focus on the regenerative medicine market. In 2004, the remaining business was renamed Cytori.

MacroPore’s CEO and co-founder of Cytori Chris Calhoun retains his position as the firm’s CEO and director of the board.

It was at the time of the merger between StemSource and MacroPore that the “lab-in-a-box” idea began, and the result was the Celution system. Mr Daniels told Clinica that the firm realised it had to improve on the everyday restrictions that arose in a laboratory to gain commercial success. He explained that Cytori aimed to produce an instrument that could cut cost and workflow, and take up less space in the laboratory.

After a total of six years of product development and $200m of investment, Cytori CE marked Celution in 2008 and is now making plans for studies in the US.