Medical Device Licensing Opportunities

Tufts possesses distinctive capabilities in medical device development. Therapeutic areas include diagnostic imaging, ophthalmology, and medical device coatings. TTIC has been receiving an increasing number of medical device disclosures and has a proven record of medical device start-up creation. Below are select medical device innovations available for licensing.

  • INFORCE™ Biopsy: One-Step Method for Incision and Forceps Biopsy Procedure During Endoscopy

    Sector

    Gastrointestinal endoscopy biopsy

    Development Phase

    Preclinical

    Description

    Physicians at Tufts Medical Center have invented a device that allows incision and forceps biopsy to be performed as a one-step procedure with a single instrument rather than with two distinct catheters.

    Problem

    Subepithelial lesions are a common finding during upper endoscopy (EGD). Of the more than 2.8 million EGDs performed in the United States annually, there is an estimated 3.5% incidence of subepithelial tumors, with a total of 98,000 patients who require evaluation. Tissue sampling of the subepithelial lesion is essential to establish the diagnosis, which may include GI stromal tumors, malignant lymphomas, carcinoid tumors, gastric cancer, and benign tumors such as leiomyomas, aberrant pancreas, and lipomas. Current tools for biopsy of upper GI subepithelial lesions are awkward and offer poor diagnostic yield (17-65%).

    Current Technology

    The 98,000 patients requiring evaluation are currently managed with serial EGD surveillance and endoscopic ultrasound with fine-needle aspiration. EUS-FNA has an average diagnostic yield of 45%, with the procedural limitations that it requires an on-site cytopathologist and is appropriate for lesions of larger than 20 mm. Another technique is endoscopic ultrasound (EUS) with single-incision needle-knife (SINK) biopsy, which can be performed on lesions smaller than 20 mm and has a low risk of complications. After EUS examination of the subepithelial lesion, a 6 to 10 mm linear incision is made with a needle-knife sphincterotome, followed by introduction of large-capacity biopsy forceps for obtaining tissue specimens and closing the incision with endoclips. Although the SINK technique has a 92% diagnostic yield, it involves the use of two distinct catheters and occlusion clip placement, and it is expensive.

    Solution

    Tufts Medical Center physicians have invented a device that allows incision and forceps biopsy to be performed as a one-step procedure with a single instrument rather than with two distinct catheters. The invention is inserted through the endoscope working channel as a standard biopsy forceps. The unique design features of Tufts Medical Center’s INFORCE™ biopsy device mitigate the risk of perforation with a blunted forceps edge, which improves the margin of safety of performing subepithelial biopsy in comparison with available tools.

    INFORCE™ Biopsy Device for Performing Incision Biopsy

    Some operators may avoid performing SINK biopsy because of reluctance to using a needle-knife sphinctertome. Tufts Medical Center’s INFORCE™ biopsy device has several innovative features that address the particular operator requirements of the SINK technique and that supplement “hot biopsy forceps” designs on the market. The INFORCE™ biopsy solution would require modest incremental demands to translate into a commercial product.

    Fig 1Fig 2

    Lead Investigator(s)

    Moises Guelrud and Keo Thormika, Department of Medicine, Gastroenterology, Tufts Medical Center, Boston, Massachusetts

    Contact

    Nancy Wetherbee
    NWetherbee@tuftsmedicalcenter.org
    617 636 6182

  • Software for Detection of Vulnerable Plaques During Angioscopy

    Sector

    Angioscopy

    Description

    Researchers at Lahey Clinic Foundation developed a new angioscopy-based method for the detection of lipid cores underneath thin fibrotic caps and thin-cap fibroatheromas in patients evaluated for risk of having vulnerable atherosclerotic plaques, thrombosis, and acute coronary syndrome.

    Routine angioscopy is minimally invasive and widely used for the analysis of large arterial vessels. This inexpensive and informative method allows direct visualization of the inner surface of the arteries but does not offer quantitative analysis of the risks associated with atherosclerotic abnormalities.

    Software developed by the inventors allows for highly sensitive and specific detection of vulnerable plaques and plaques at risk of disruption during routine angioscopic procedures. The new computer algorithm allows specific detection of several conditions associated with atherosclerotic plaque formation and quantitative analysis of the risk associated with these conditions. This information provides considerable advantages over existing systems and will significantly improve the process of designing optimal treatment strategies and improve patient outcomes.

    The sensitivity and specificity of the new colorimetric method of detection of atherosclerotic plaques is similar or better than that of other, often more expensive and less available techniques. The present system works in visible light, which simplifies  image analysis by the cardiologists performing the angioscopy.

    The potential market for the technology is very large and may include hospitals in metropolitan areas and small rural or suburban health care centers where angioscopy continues to be a method of choice for cardiologists.  One of the advantages of the technology is its compatibility with numerous commercially available angioscopic systems and fiber-optic catheters.

    Lead Investigator(s)

    Sergio Waxman and Fumiyuki Ishibashi, Lahey Clinic Medical Center, Burlington, Massachusetts

    Key Publication

    Inami, S. et al. Circ J. (2008) 72: 399-403

    Milestones

    US patent 8,774,905 issued 07/08/2014

    Contact

    John Cosmopoulos

  • Silk-Based Food Sensors

    Sector

    Wireless sensors

    Development Phase

    Proof of concept demonstrations testing sensors on bananas, eggs, apples, cheese, and milk

    Description

    Tufts investigators published a method to make wireless passive antennas on silk substrates across multiple regions of the electromagnetic spectrum.  Silk flexible sensors are created by embedding gold antennae in a purified silk film that can be easily applied to curved objects and adhere conformally.

    The devices were tested for function by monitoring their resonant responses continuously during the spoilage process to assess potential to monitor changes in food quality.  Proof-of-principle demonstrations were performed by monitoring fruit ripening with an RFID-like silk sensor transferred onto fruit skin, and spoilage of dairy products through surface contact or immersion.

    Pure-protein silk film substrates can be used as inexpensive, edible, and eco-friendly sensing platforms that safely interface with consumable goods and provide in situ monitoring of food quality.

    Lead Investigator(s)

    Fiorenzo Omenetto, David Kaplan and Hu Tao, Department of Biomedical Engineering, Tufts University

    Key Publication

    Tao, H. et al. Adv Mater (2012). 24: 1067–1072

    Milestones

    US Patent Application 13/641,000

    Contact

    Martin Son

  • Dynamic Silk Coatings for Implantable Devices

    Sector

    Medical device coatings

    Development Phase

    Proof of concept demonstrations

    Description

    Silks are fibrous proteins with remarkable mechanical properties produced in fiber form by silkworms and spiders. Regenerated silk solutions have been used to form a variety of biomaterials for medical applications, such as gels, sponges, and films.

    Silk fibroin is biocompatible, sterilizable, and available in a variety of formats. Long-standing FDA regulatory approval of silk sutures, its abundance as raw fiber material, and its controlled proteolytic degradability in vitro and in vivo establish silk fibroin as an important biomaterial.

    Recent studies demonstrate that silk coatings improve the mechanics and biocompatibility of implantable devices. Silk coatings can be applied before implantation, as a means of providing mechanical strength to a flexible device, or formed renewably in situ on conducting surfaces post-implantation. These coatings can be loaded with bioactive agents to promote tissue growth and control inflammation at the site of implantation.

    Lead Investigator(s)

    Fiorenzo Omenetto, David Kaplan, Department of Biomedical Engineering, Tufts University

    Key Publication

    Serban M.A. et al. J Biomed Mater Res Part A (2011), 98:567–575

    Milestones

    Dynamic Silk Coatings for Implantable Devices: US Patent Application 14/112,078

    Contact

    Martin Son

  • Adaptor for Standard Fundus and Fluorescein Angiography

    Sector

    Ophthalmic and optical devices

    Development Phase

    Working prototype

    Description

    A digital single lens reflex adaptor for fluorescein angiography imaging that can be attached to any digital camera and provide an inexpensive alternative for imaging both the anterior and posterior segments of the eye.  The adaptor has the potential to drastically cut the total cost of ophthalmic diagnostic imaging. This innovative adaptor could revolutionize the digital imaging of the eye in animals and humans.

     

    Lead Investigator(s)

    Chris Pirie, Cummings School of Veterinary Medicine, Tufts University

    Key Publication

    Pirie, C. et al. J Visual Comm Med (2011), 34:146–155

    Milestones

    US Patent 8,926,094 issued 01/06/2015

    Contact

    Larry Steranka