MEMS, Microfluidics and Microsystems Executive Review: Stem cells and microfluidics

Aldagen, a venture funded startup with a set of technologies to identify and isolate stem and progenitor cells, has recently announced a partnership with IMT to develop a microfluidic device for clinical cell sorting. We recently spoke with the President and COO of the company, Ed Field, and discussed Aldagen’s business model, marketing and regulatory approval efforts as well as its ongoing round of financing.

MEMS Investor Journal: In a nutshell, what do your products do and how do they help the biomedical industry?

Ed Field: The company’s proprietary products identify and isolate potent, highly effective adult stem and progenitor cells which can be quickly administered to regenerate or repair tissue.

MEMS Investor Journal: Where did the original technology come from?

Ed Field: The original technology was licensed from both Johns Hopkins and Duke University.

MEMS Investor Journal: What is your current business model?

Ed Field: The current business model is to sell our clinical use product, ALDESORT®, to existing cell processing labs for therapeutic applications. We will begin selling this product once we have obtained a PMA (Pre Market Approval) from the FDA for a specific therapeutic application.

ALDESORT is a set of proprietary reagents that can be used with currently available cell sorting systems to isolate a highly potent population of stem and progenitor cells from human bone marrow, peripheral blood and cord blood for clinical use.

Aldagen is collaborating with IMT to develop the ALDESORTER. Unlike currently available cell sorters that are large, complex research instruments, the ALDESORTER is specifically designed to address the needs of clinical cell sorting including: ultra-high speed sorting, completely sealed fluidic path for disposability and sterility, compact size, and ease-of use. When completed, the ALDESORTER will be desk-top size and have the ability to sort therapeutic stem cell doses in one to three hours. This system will be used with Aldagen’s ALDESORT product and is designed to isolate unique stem cell populations for the treatment of chronic heart failure, peripheral vascular disease, leukemias, genetic enzyme deficiencies and other diseases.

MEMS Investor Journal: You currently have your device being used in over 100 research labs throughout the world. What kind of feedback have you been getting from the users? Could you comment on both positive and negative outstanding issues?

Ed Field: Our RUO (Research Use Only) product, ALDEFLUOR is currently being sold and has been used in over a 100 research labs. The feedback has been positive on the technology. Sales of ALDEFLUOR are growing rapidly and there have been a number of scientific papers written by users of the product.

MEMS Investor Journal: Do you plan to change your business model in the future as your customer base matures?

Ed Field: The development of the ALDESORTER will change our business model to one where we will sell the ALDESORTER and a set of disposables to cell processing labs to allow them to isolate the unique population of stem and progenitor cells for specific therapeutic applications.

MEMS Investor Journal: Your products are currently in clinical trials. Could you comment on the overall FDA approval process for your class of devices? Where are you now in the process cycle?

Ed Field: ALDESORT is currently being tested in three clinical studies for ischemic heart failure, critical limb ischemia and cord blood transplantation. We will ultimately seek a PMA from the FDA basis on the clinical data generated in these clinical studies. We are currently in Phase I/II trials with ALDESORT.

MEMS Investor Journal: You’ve recently announced your collaboration with IMT on microfluidic cell sorting devices. How are you currently fabricating your devices and why did you decide to partner with IMT?

Ed Field: We are in the prototype development phase of the process. IMT has contracted with a third party contract manufacturer who is building the prototypes. IMT is fabricating the MEMS chips. We chose IMT as a partner because they are currently the world’s leading contract manufacturer for MEMS and had already made many significant advances in the development of their Rare Cell Purification System. Our initial discussions were very productive and we felt comfortable with the people at IMT that we interacted with.

MEMS Investor Journal: Why did you choose a microfluidic approach?

Ed Field: It appeared to be the best available solution to increase the speed of cell sorting as well as provide an avenue for a cost effective, disposable sterile fluid path that could be used on a per patient basis.

MEMS Investor Journal: As a venture funded company are you currently looking for additional funding?

Ed Field: We are currently in the process of closing our Series C round of financing. We are seeking to raise $12 million. We have commitments from our existing investors and a term sheet from a new lead investor.

MEMS Investor Journal: What advice would you have for other startups working on biomedical MEMS applications?

Ed Field: Understand the requirements of the market and users and be sure there are specific applications where the technology can be used. Don’t develop the technology first and then look for an application. Also, understand the regulatory path well.

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Mr. Field joined ALDAGEN in October, 2004. Mr. Field has over 15 years experience in the biotechnology industry as an executive with direct responsibility for fund raising, corporate partner, product commercialization and development. Prior to joining Aldagen, he was the President/CEO of two biotechnology companies (Molecumetics and Inologic) where he was responsible for raising nearly $100 million in equity and corporate partnering funding. Mr. Field has also evaluated early-stage life science investments for a corporate venture arm that had nearly $300 million in committed capital and was a consultant to pharmaceutical and chemical companies in the areas of strategic planning and competition and market analysis. Mr. Field received a Masters in Business Administration from the University of Virginia’s Darden School of Business Administration and a BS in Economics from Duke University.