BREAKING NEWS: We are pleased to announce FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. To the hundreds of women and dedicated investigators who participated in this important clinical work that brought us to where we are today, THANK YOU! We wouldn’t be here without your support. 

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See what matters most. Illuminate breast cancer in real-time.

Hechler brings more than 15 years of focused life-sciences experience in M&A, strategy, and
operations

Newton, Mass., Sept. 16, 2020 – Lumicell, Inc., a leader in image-guided cancer surgery, today announced the addition of Howard Hechler as Senior Vice President of Strategy & Business Development. In this new role, Mr. Hechler will leverage his depth of transactional and operational experience across a range of life sciences technologies to optimize and execute Lumicell’s corporate strategy.

“Lumicell welcomes Howard Hechler as a key member of our leadership team in this highly visible role,” said Kevin Hershberger, CEO, Lumicell. “He joins at an important time for the company as we progress closer to an FDA market application for our first indication in breast cancer. Given the broad applicability of Lumicell’s drug and imaging technology across a range of cancers, we are excited for Howard to lead our corporate development activities.”

The Lumicell system for fluorescence guided surgery (FGS) was developed to enable real-time in vivo visualization and removal of residual cancer during primary surgeries – with the goal of reducing the risk of repeat surgeries and local cancer recurrence. Lumicell’s recent Feasibility Phase C trial (234 patients at 16 sites) demonstrated that, by using the intraoperative molecular imaging system, additional residual disease was identified and removed, for both invasive cancers and ductal carcinoma in situ (DCIS), in 11% of patients.

Mr. Hechler brings more than fifteen years of experience in medical devices, diagnostics, pharmaceuticals, and drug-device combination products, leading cross-functional teams to develop business cases and C-suite strategic plans. Most recently, Mr. Hechler worked at Locust Walk, a boutique life sciences investment bank, where he supported the firm’s growth and extended its medical technology practice reach. Prior to Locust Walk, Mr. Hechler was Chief Business Officer at PolarityTE, where he steered business development, marketing, sales, and market access/reimbursement strategies. Much of his career was spent at Medtronic, where he ran Business Development and Strategy for the company’s $2B Surgical Technologies division. His career began as an Associate Practice Executive for Campbell Alliance’s M&A group, advising small, medium, and large pharma and biopharma companies on a range of deals. He has also worked at XL TechGroup, Mallinckrodt Pharmaceuticals, and founded his own life-sciences consulting firm, Obliquity Consulting.

“At various points throughout my career, I have focused on interventional oncology and breast cancer in particular. It’s an area I am passionate about, and so I am very pleased to join Lumicell, a company I’ve long followed and admired,” said Mr. Hechler. “Lumicell is leading the way in image-guided cancer surgery and I’m eager to pair my specific experience in this space with my expertise in strategy and business development to advance Lumicell’s groundbreaking surgical technology.”

Mr. Hechler graduated cum laude with a Bachelor of Arts degree from Harvard University. Following his undergraduate studies, he went on to earn Master of Business Administration and Juris Doctorate degrees from the University of Virginia.

About Lumicell, Inc.

Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s Lumicell System has unprecedented ability to see and guide removal of cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the Lumicell System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit www.lumicell.com

What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™, an optical imaging agent, and Lumicell™ DVS, a fluorescence imaging device. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

Indications for Use (Test)

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

IMPORTANT SAFETY INFORMATION FOR LUMICELL™ DVS and LUMISIGHT™

LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG).

Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.

LUMISIGHT™ (pegulicianine) Important Safety Information

What is LUMISIGHT (pegulicianine)?

LUMISIGHT (pegulicianine) is an optical fluorescence imaging agent used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.

Important Safety Information

  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT.

What are the most common side effects of LUMISIGHT?

The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.

Lumicell™ Direct Visualization System (DVS) Important Safety Information

What is the Lumicell™ DVS?

The Lumicell™ Direct Visualization System (DVS) is for use in patients with breast cancer to help detect cancerous tissue within the lumpectomy cavity after the removal of the primary specimen during surgery. The Lumicell DVS is used with LUMISIGHT™ (pegulicianine), an imaging agent to visualize the lumpectomy cavity.

Important Safety Information

  • Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.
  • Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage.
  • Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
  • Eye discomfort: Your healthcare provider should avoid direct eye exposure to handheld light probe as it may cause pain.

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.  For complete product information visit www.LumiSystem.com