TheraNova and UCSF Surgical Innovations: Partnership with a Brain

“Innovation” in today’s challenging and evolving medtech industry doesn’t just apply to product development—it also means thinking in creative new ways to speed devices to market, increase efficiency and build sustainable businesses. Two organizations that are focused on this more expansive definition of innovation, San Francisco-based TheraNova LLC and UCSF Surgical Innovations, have forged a partnership to not only push forward their own in-house inventions that address serious unmet clinical needs, but also to co-develop new device technologies. They are starting by tackling one of the surgical community’s most challenging realms, brain cancer.

Last month, TheraNova and UCSF Surgical Innovations, an incubator-accelerator for medical technology innovations developed out of the University of California, San Francisco (UCSF), announced a partnership that establishes access to expertise at both sites, enabling supported technologies to benefit from UCSF's expertise in clinical trials and academic grants, and TheraNova's certified manufacturing facilities, product development expertise and fundraising experience.

TheraNova, founded in 2003 and headed by Daniel Burnett, MD, has created and spun out 14 companies to date and raised more than $280 million in venture financing. Located blocks from UCSF's campus, the incubator is committed to developing innovative solutions addressing large unmet needs and bringing them to market with in-house capabilities including R&D, clinical, regulatory, quality, intellectual property and business development. Its spin-outs include Potrero Medical, which has developed a smart sensor-based urinary catheter to accurately monitor patients' vital signs in real-time. The company, founded in 2011, closed a $26.6 million Series C financing earlier this month, led by China-focused healthcare investment firm GT Healthcare Capital Partners and Silicon Valley-based Sonder Capital. Other TheraNova companies, several of which focus on smart sensor technology and are currently seeking funding, include Sequana Medical, EMKinetics, Velomedix, Baronova, Respirix, Esculon, Piccolo Medical, Gravitas Medical, and Channel Medsystems. Backers of these start-ups include Boston Scientific Corp., Allergan Inc., Highland Capital, Onset Ventures, Sante Ventures, Scientific Health Development, Oakwood, Easton Capital, Third Point Ventures, and WS Investment Co., along with SBIR grant funding. Its crop of stealth-mode start-ups currently being incubated include Perikinetics (intraperitoneal artificial pancreas for type 1 diabetes), Mimetix (wearable biomechanical stimulation technology to prevent osteoporosis), Easter (technology for improved egg retrieval in in vitro fertilization), and Handl Medical (wearable neuromodulation technology for migraine). “One of our MOs is to pick the areas that aren’t sexy but have a lot of clinical utility,” says Burnett, in a recent interview with MedTech Strategist’s Community Blog.

This isn’t the first time that the two organizations, located just blocks from each other, have collaborated. Burnett has spent the past six years advising projects at UCSF as Industry Director of the UC Berkeley-UCSF Master of Translational Medicine (MTM) program, which provides students with a background on medical device commercialization strategies and opportunities. Also, he recently joined UCSF as an entrepreneur-in-residence with UC life sciences accelerator QB3, and as adjunct faculty in the Bioengineering Department. “Our job is taking ideas all the way through the ideation stage through commercialization,” says Burnett. “There is a lot of potential synergy here between our two programs,” he continues.

The Community Blog also spoke with Shuvo Roy, PhD, a UCSF Professor of Bioengineering & Therapeutic Sciences and Surgery who is the engineering lead at UCSF Surgical Innovations and, working with Burnett, is also a Director of the UC Berkeley-UCSF MTM program. “Together we decided to formalize a partnership that would let us streamline ideas between UCSF’s academic and TheraNova’s commercial pathways, and share resources,” says Roy.

UCSF Surgical Innovations is a five-year-old, highly collaborative initiative of the UCSF Department of Surgery in partnership with the Department of Bioengineering & Therapeutic Sciences to identify, mentor, and facilitate the translation of novel medical technologies developed by problem-solving-focused surgeons into transformative new devices and treatments to improve human health (with an original focus on pediatric devices). To date, the program has advanced eight novel devices, including an artificial kidney technology (Roy’s project), a magnet-based sleep apnea device and an intestinal anastomosis device, into preclinical and clinical trials. It has attracted over $30 million in grants and seed-stage investments.

The first technology that TheraNova and UCSF Surgical Innovations will be co-developing, along with inventor Mitchel Berger, MD, Chair of Neurological Surgery and Director of the Brain Tumor Research Center at UCSF, is a low-cost, handheld cortical stimulator device, called the Berger Brain Mapper, for use in optimizing brain tumor resections. Each year in the US, approximately 75,000-80,000 new brain tumor cases are diagnosed; about 75% of all malignant brain tumors are gliomas. Gliomas begin in the gluey supportive cells (glial cells) that surround nerve cells and help them function. When this type of cancer is resectable, the primary goal is to remove as much of the tumor as possible without affecting important brain function. Technologies such as intraoperative MRI/CT, ultrasound, endoscopy, intraoperative molecular diagnostics, laser ablation, navigation, and cortical stimulation mapping are used to assist the surgeon in removing the tumor while avoiding damaging functional tissue. Cortical stimulation is considered standard for operations involving gliomas to help identify critical areas of a patient's brain and reduce loss of motor function and overall morbidity. However, in less developed countries where expensive assistive technologies aren’t available, there is a need for a low-cost cortical stimulator that can assist the surgeon in removing cancerous brain tissue with minimal damage to healthy tissue.

Berger has an extensive background in this area, as his main clinical interests are the treatment of brain tumors in adults and children and of epilepsy related to brain tumors. He has extensive expertise in intraoperative mapping of the brain to identify the sites of motor, sensory, and language function and thereby avoid their involvement or injury during surgery.

The development-stage Berger Brain Mapper is being designed as an easy-to-use, low-cost alternative to generators on the market that can cost $12-$15,000. It will be similar in size, shape, and weight to a Sonicare toothbrush. It features a pliable electrode tip, controls to adjust pulse parameters and initiate stimulation, displays for functional feedback, an internal rechargeable battery, and a disposable probe tip that is integrated with a sterile bag. TheraNova and UCSF Surgical Innovations are currently seeking funding to help support testing and clinical trials of the device toward FDA 510(k) and CE mark clearance by year-end 2019. In addition to the cortical stimulator, Burnett and Roy say that the two organizations are exploring other potential target areas for collaboration.

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