Led · Series A · Jun 2020

CereVasc is a clinical-stage medical device company based in Massachusetts developing the eShunt System, an investigational, patented endovascularly implantable cerebrospinal fluid shunt and delivery components. The eShunt employs a percutaneous transvenous-transdural approach intended to enable a minimally invasive treatment for communicating hydrocephalus. The company is currently conducting the STRIDE pivotal trial, a prospective, multi-center, randomized, controlled study comparing the eShunt System to the standard ventriculo-peritoneal (VP) shunt to evaluate safety and effectiveness. Data from STRIDE are intended to support a future FDA Premarket Approval (PMA) submission. CereVasc describes the eShunt as investigational and not yet approved for commercial sale. The company plans to use recent Series C proceeds to complete the pivotal trial, advance regulatory work, scale operations, and prepare for U.S. commercialization.

Led · Equity · Jul 2017

Dune Medical Devices develops RF spectroscopy-based tissue characterization technology, commercialized as the MarginProbe System for breast cancer lumpectomy. MarginProbe is FDA-approved and has been studied in three large randomized controlled trials and multiple peer-reviewed publications covering over 2,500 women, showing reductions in re-excision rates up to 79%. Data cited in the company materials note that without effective margin assessment 20–30% of women who undergo lumpectomy will face an additional surgical procedure, highlighting the potential quality, outcomes, and cost impact of the technology. Dune is exploring applications of its RF spectroscopy platform in other disease sites and cancers and is developing an RF spectroscopy-based biopsy system. In August 2016 the company received a €3 million EU Horizon 2020 award to support continued development of that biopsy system. The company is based in Alpharetta, Georgia and Caesarea, Israel, and recently completed a financing to support near-term strategic initiatives including coding and payment efforts for MarginProbe. Dune Medical builds medical devices that use radio‑frequency spectroscopy to characterize soft tissue in real time. Its commercial product, the MarginProbe, was cleared by the FDA in 2013 and is used by surgeons after lumpectomy to detect cancer at margins. The company has completed the design of a new biopsy device that applies the same tissue‑characterization technology along the tip of a biopsy needle. Dune says the device will provide radiologists and surgeons immediate graphic characterizations of tissue abnormalities just before samples are taken, potentially reducing repeat biopsies and time to diagnosis. The company’s U.S. operations are based in Paoli, Pennsylvania. Dune plans to commercialize the biopsy system in Europe first using the new grant and eventually seek a U.S. regulatory pathway. Dune Medical Devices is a Westborough, MA–based provider of a medical device for real-time breast cancer detection. Its first product, the MarginProbe System, enables real-time detection of cancer at the surface of excised tissue specimens during breast cancer surgery. The company is led by CEO Dr. Dan Hashimshony. Dune completed the first closing of a two-stage $21M equity financing, securing $14M in the initial tranche with a $7M second tranche planned by October 2014. Backers on the round included the Kraft Group and Canepa Advanced Healthcare Fund, among others. The company intends to use the funds to expand sales and marketing efforts for the MarginProbe System.