May 2023
Vol 9 | Issue 603

Q&A with Kevin Hershberger of Lumicell, Inc.

President & CEO

Principal Series:

Lumicell is focused on innovative fluorescence-guided technologies for cancer surgery to improve outcomes – starting with breast cancer. The company’s Lumicell Direct Visualization System (DVS) is intended to guide the removal of residual cancer during surgery in real time. The platform technology consists of an optical imaging agent, a handheld imaging probe, and patient-calibrated cancer detection software that work together to find, view and guide the resection of residual cancer. Lumicell has treated over 700 patients in the breast cancer trials and has submitted its New Drug Application (NDA) for the LUMISIGHT Optical Imaging Agent and Premarket Approval (PMA) application for Lumicell DVS to the U.S. FDA. The company is expecting approval and commercial launch in Q4 2023\Q1 2024.

Major Company Update


The company has a new press release  issued last week to announce the clinical data publication in NEJM Evidence and the presentation of the data at the American Society of Breast Surgeons (ASBrS) meeting by Dr. Barbara Smith, Director of the Breast Program at Massachusetts General Hospital, Professor of Surgery at Harvard Medical School, and the lead investigator in our trial.

Lumicell DVS Pivotal Trial Results Published in NEJM and Presented at ASBRS

Join us for a private Family Office Insights Luminary featuring Kevin Hershberger, President & CEO of Lumicell, a medical device company aiming to improve cancer surgery outcomes, first targeting breast cancer. The Lumicell team, in close collaboration with leading breast surgeons, has developed the Lumicell™ Direct Visualization System to assist surgeons in the detection and removal of residual cancerous tissue within the breast cavity, in real time, during breast conserving surgery.

May 11th, 2023 at 2:15pm-3:15pm EST
RSVP & Confirmation Required
Investors Only Please!

Family Office Insights is a voluntary, “opt-in” collaborative peer-to-peer community of single family offices, qualified investors and institutional investors. Join the community here

What are the primary considerations in breast cancer surgery and how is Lumicell addressing these?

The entire surgical treatment protocol is designed around complete removal of cancerous tumor. Incomplete tumor resection has been shown to double the risk of recurrence. However, the current standard of care has well known, clinically proven limitations including – roughly 30% of all patients need to have a second surgery to ensure clean margins, and 19% of the time residual cancerous tissue is missed. The Lumicell DVS is the first and only solution designed to assist the surgeon in real time, intracavity identification and removal of cancerous tissue that would otherwise require a second surgery to remove or would be completely missed and potentially lead to recurrence.

How does the Lumicell Direct Visualization System differentiate itself versus competitive solutions?

1) The agent mode of action –LUMISIGHT, the optical imaging agent is activated by the body’s host immune response to cancer. Unlike many other imaging agents that target certain receptors and are by nature limited to cancers with those receptors, LUMISIGHT is truly pan-cancerous because the body’s host immune response to solid tumor cancers is universal.

2) Intra-Cavity Imaging – The Lumicell DVS is the only technology that looks directly inside the surgical cavity – where it matters.

3) Fits seamlessly into the surgical workflow – The Lumicell solution fits into the current workflow. The imaging agent is administered 2 hours before surgery in a simple 3-minute IV push and the imaging and removing residual cancer takes less than 10 minutes after primary tumor removal.

How should an investor think about the company’s exit strategy?

Lumicell is building the company to fill this critical need in breast cancer surgery. The company is planning to achieve greater than $300M in annual revenue by year five. In the Med-tech industry exit discussions, either IPO or M&A, typically center around 4-6 quarters of strong sequential growth. In this breast cancer space, there are multiple large medical device companies that are likely M&A partners with which Lumicell continues to have regular discussions.

Kevin Hershberger of Lumicell, Inc.

Kevin Hershberger brings over 25 years of global leadership experience to Lumicell where he leads a team dedicated to improving cancer surgical outcomes. He joined Lumicell as Chief Financial Officer in 2018 and was appointed President and CEO in 2020. Prior to joining Lumicell Kevin served as Chief Financial Officer of ReWalk Robotics, a medical device company focused on robotic exoskeleton technology for individuals living with spinal cord injuries. Previously, he served in a variety of leadership positions with NxStage Medical and Boston Scientific.

Contact Kevin: