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Lumina Life Sciences: The Challenges of Raising Capital to take to Market a Promising Technology Innovation

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biotechnology management case

Magda Choruzy1, Andrew Maxwell1, Michael Alvarez2
1University of Toronto; 2Stanford University

Summary and key issues/decisions: Lumina Life Sciencesis an early stage company that has developed a combination drug-device technology for neurosurgery that improves surgical efficacy and efficiency. Dr. Arjen Bogaards, president of Lumina Life Sciences, has developed a patented technology that uses the fluorescent properties of certain drugs to emphasize the presence of tumor tissues. He has developed an imaging technology that then enables neurosurgeons to remove tumor cells more rapidly and with greater accuracy during the restriction process. At this point the venture needs additional funding in order to proceed, but from an investor standpoint the viability of the company is not clear. Significant concerns remain surrounding the company’s ability to secure FDA approval on both the proprietary drugs and imaging technology, prove the efficacy of the solution, and resolve patent issues with the University Health Network (UHN) where the technology was developed. UHN will not agree to conclude an ongoing business relationship unless they can see a business plan that shows that successful market entry as likely. Such a demonstration will be challenging since the market for the solution is small, and it is unclear who benefits or will pay for the deployment of the innovative technology.

Companies/institutions: Lumina Life Sciences, University Health Network in Toronto, Canada

Technology: The Lumina technology is a novel imaging technology to aid surgeons in the removal of brain tumors using a fluorescent targeting drug to identify tumor cells. A targeting dye, TumorTarget®, localizes in the Glioblastoma multiforme (the most aggressive type of primary brain tumor) and causes the tumor to fluoresce. The SurdiGuide® platform, an imaging technology that comprises a visualization software platform and associated hardware technology, then enables the surgeon to visualize the effectiveness of tumor removal in real time during the surgery. This improves the efficiency of the procedure and is thought to improve surgical outcomes.

Stage of development at time of issue/decision: The SurdiGuide® platform has been approved by Health Canada and the FDA for use in human clinical trials. TumorTarget® has been proven, through clinical studies, to provide enhanced fluorescence guided imaging in the brain. The next step is to conduct clinical trials on the drug-device combination, in order to obtain FDA, before the product can be marketed.

Indication/therapeutic use: The Lumina technology has been developed to assist neurosurgeons in ensuring that they can more quickly remove all of the tumor cells in a brain tumor. The increased speed of the procedure will reduce the likelihood of complications, while the increased likelihood of removing all of the tumor cells, increases the long-term patient outcome (although the long term prognosis remains poor).

Geography: US, Canada

Keywords: brain tumor, drug-device, approvals, reimbursement, alternate business models, institutional IP policy, critical venture factors

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