Editor: What To Know
- Prior to joining Lumicell, she spent over 17 years at Boston Scientific in roles of increasing responsibility, most recently serving as director of global digital marketing, which will be invaluable to the future launch of the Lumicell DVS given the increase in digital today.
- Results of a feasibility study of 234 patients at 16 sites were published recently in JAMA Surgery, and findings from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial of 406 patients at 14 sites are pending peer-review.
- Drug Administration, which granted Breakthrough Device and Fast Track designations to the Lumicell DVS in recognition of the potential to fill an unmet need in the marketplace.
Lumicell, Inc. is a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery. Today they announced they are building a commercial team to prepare for the market launch of the Lumicell Direct Visualization System (DVS), which includes its novel optical imaging agent LUMISIGHT, upon FDA approval.
The company appointed industry veterans Brent Palmisano as chief commercial officer and Lauren Cohen as vice president of marketing and communications.
“Brent and Lauren’s experience in launching women’s health and medical device technologies will be instrumental as we focus on bringing our innovative Lumicell DVS to market,” said Kevin Hershberger, president and chief executive officer of Lumicell. “Lumicell is at an incredible inflection point. Robust data from clinical trials enrolling more than 700 breast cancer patients have shown our Lumicell DVS has the potential to improve care, and we’re excited to build a world class commercial organization to bring this technology to surgeons and patients.”
Palmisano brings more than 20 years of experience to Lumicell and has a demonstrated track record in building and leading medical device commercial organizations. Most recently he served as senior vice president of global commercial operations for Dysis Medical, a company focused on the cervical cancer market. Previously, he spent 15 years at Boston Scientific in a variety of sales and marketing leadership roles and oversaw the commercial development of more than 25 devices.
Cohen has more than 25 years of experience managing global integrated marketing and communications across new product launches, expanded indications and commercialization at industry-leading and start-up medical device organizations. Prior to joining Lumicell, she spent over 17 years at Boston Scientific in roles of increasing responsibility, most recently serving as director of global digital marketing, which will be invaluable to the future launch of the Lumicell DVS given the increase in digital today. Earlier in her career, she held marketing positions at Endius, Odin Medical Technologies and ESC/Sharplan Lasers.
About the Lumicell Direct Visualization System
The investigational Lumicell Direct Visualization System (DVS) is a novel solution designed to enable real-time assessment of the breast cavity, illuminating cancerous tissue that may have otherwise been left behind during the initial lumpectomy procedure. The Lumicell DVS features the proprietary LUMISIGHT investigational optical imaging agent, hand-held imaging probe and patient calibrated software.
The safety and efficacy of the Lumicell DVS in detecting residual cancer missed by standard of care surgical procedures has been evaluated in two studies: Results of a feasibility study of 234 patients at 16 sites were published recently in JAMA Surgery, and findings from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial of 406 patients at 14 sites are pending peer-review. Data from the INSITE study will be used to support the company’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration, which granted Breakthrough Device and Fast Track designations to the Lumicell DVS in recognition of the potential to fill an unmet need in the marketplace.
The Lumicell DVS is a new combination product, and its components, including the new drug LUMISIGHT, are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.
