A Successful Model for Accelerating Medical Innovation

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<p>Nano-scale surface features for vascular stents</p>

Nano-scale surface features for vascular stents

The Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California was established in 1998 as a non-profit organization to bridge the gap between biomedical invention and the creation of commercially successful medical devices that save and improve people’s lives. It was established at USC to take advantage of the $700 million in annual research expenditures and the excellent graduate programs in innovative health, science, engineering, and entrepreneurship.

Providing the missing link

Brilliant research and innovation is found in many universities and research centers worldwide. Too often missing are the skills and resources to commercialize these inventions.

Since its inception nearly 20 years ago, AMI-USC provides what is missing using a Pull Model for commercialization. The Pull Model is designed to accelerate medical innovation. The main phases of this model are delineated below.

1. Needs Analysis. This phase answers the question “Does the biomedical invention satisfy commercial and clinical needs in the marketplace?”

2. Commercial Viability. In this phase, the question that is posed and answered is “Can commercially successful product assets be developed from the biomedical invention?”

3. Product Performance. This phase answers the all-important question “Will the resulting product successfully meet user requirements?”

Professional team

To facilitate the commercialization process, AMI-USC has assembled a talented team of experienced professionals that includes engineers, scientists, patent attorneys, regulatory and business experts. Six members of its team have been elected as Fellows of AIMBE (American Institute for Medical and Biological Engineering), a non-profit organization headquartered in Washington, DC that represents the top 2% of medical and biological engineers.

Successful implementations

The true test of an organization that seeks to commercialize inventions is the successful spin-out of companies that can bring them to market. To date, AMI-USC has launched three successful companies.

  • Pulse Biosciences, Inc. offers technology and products that employ nanosecond electric pulses to treat skin lesions and internal tumors. The technology originated in the labs of Professor Martin Gundersen within the Department of Electrical Engineering at the University of Southern California and the Frank Reidy Research Center for Bioelectrics at Old Dominion University. Pulse Biosciences’ IPO was in May 2016 and is listed on the NASDAQ as PLSE.
  • Varocto, Inc. uses Optical Coherence Tomography (OCT) to provide angiographic images of the human retina. This imaging technology is particularly useful for the clinical diagnosis of Diabetic Retinopathy (DR) and Age-related Macular Degeneration (AMD). This technology is noninvasive, rapid, and provides many significant advantages over other methods of retinal angiography. The technology was developed by AMI-USC in partnership with Professor Scott Fraser of the Translational Imaging Center at USC and financed through a private equity investment.
  • Proa Medical, Inc. is a women’s health medical device company from AMI-USC that raised private capital from investors in several countries. Proa commercially launched its first product, a patented surgical retractor for postpartum visualization and repairs of the birth canal and perineum, which received overwhelmingly favorable feedback from physicians.

Projects in the pipeline

In addition to its successful spin-outs, AMI-USC continues to work with transformational researchers from the USC Medical and Dental Schools, the Viterbi School of Engineering, Lloyd Grief Center for Entrepreneurial Studies, Stevens Center for Innovation, Dornsife College of Letters, Arts and Sciences, and the Marshall School of Business to help them commercialize their inventions.

Some projects in the pipeline include:

  1. Adhesives for Fragile and Sensitive Skin is a thermally-triggered reversible adhesive that can be used on dressings, bandages, wound closure systems, and dermal drug delivery systems. The adhesive firmly adheres to skin at body temperature (30-38°C), decreasing the temperature inactivates the adhesive (15°C). The initial focus is on bandages and dressings for the geriatric and pediatric markets. Patents have been issued and are pending. This is a collaboration program with Professor Mark Thompson within the Department of Chemistry at the University of Southern California.
  2. Biofilm Disruption uses nanotechnology for effective disruption of bacterial colonies in skin wounds to reduce inflammation and promote healing.
  3. PhaseSpec, Inc. provides hyperspectral imaging for dermatology and other medical imaging applications.
  4. Biothelium, Inc. Pro-Healing Coatings for Vascular Applications incorporates a nano-engineered coating on the stent surface (as shown in the photo above), which reduces restenosis and thrombosis via improvements in the endothelium to smooth the muscle cell regeneration ratio by promoting endothelial cell proliferation while inhibiting smooth muscle proliferation.
  5. Mesencyte is a platform of regenerative cell therapy for autoimmune diseases, such as Lupus and Type 1 Diabetes, and dental tissue regeneration. The technology is based on research done in the USC School of Dentistry with clinical data collected from over 200 patients.
  6. Osteocyte provides a custom regenerative solution for bone repair and regeneration.
  7. Neuroimaging involving Optical Coherence Tomography (OCT) systems for early detection of Alzheimer’s Disease.
  8. Thermal Imaging & Ablation uses non-surgical microwave technology to monitor and destroy internal tumors.
  9. DermaPort is a Biocompatible implanted port for safe, easy, and long-term percutaneous access to the body.
  10. Glucose Monitor is a non-invasive diagnostic tool for blood glucose monitoring.
  11. Microbiome Dx is a gut microbiome based prognostic tool for chemo- or radiation-therapy induced GI toxicity.
  12. Sound Sciences offers audio diagnostics and mitigation specifically designed for the sound-sensitive community.

Bright future

With all the crazy things going on in the world, it is gratifying to know that there are brilliant inventions being developed at universities that will improve and save lives. What’s even more encouraging is that there are organizations such as AMI-USC that help inventors commercialize these by accelerating their introduction into the marketplace so we will be able to benefit from them. I am happy to do my part, however small, to get the word out and let the marketplace know about them.

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