On Target Laboratories Granted New Technology Add-On Payment (NTAP) for CYTALUX® (pafolacianine) injection in Ovarian and Lung Cancer Indications

West Lafayette, Ind. (Aug. 10, 2023) — On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for CYTALUX for use in ovarian and lung cancer. CYTALUX is the only FDA-approved targeted intraoperative molecular imaging agent that illuminates ovarian and lung cancer in real time, enabling the detection of more cancer for resection.  Under NTAP, CMS will provide hospitals with additional payment of up to 65 percent of the average cost of CYTALUX, with a maximum payment of $2,762.50.

CYTALUX was granted one of only eight new approvals for NTAP payments this year.  To qualify for NTAP, On Target Laboratories demonstrated CYTALUX represents a substantial clinical improvement for patients over existing technology because it can help surgeons detect lung and ovarian cancer that is currently undetectable during surgery.

“We are thrilled CYTALUX has been granted NTAP for both lung and ovarian cancer indications,” said Ben Lundgren, Chief Executive Officer of On Target Laboratories. “This approval reinforces the clinical benefits of CYTALUX and will make our technology accessible to more patients.”

NTAP, which is part of the CMS Inpatient Prospective Payment System (IPPS), was set up to support the adoption of cutting-edge technologies that have demonstrated substantial clinical improvement and ensure early availability to Medicare patients. This incremental payment seeks to mitigate financial disincentives for use on Medicare patients by providing hospitals with an add-on payment to help offset the technology’s cost.

To facilitate administration of the NTAP approval, CYTALUX was granted ICD-10-PCS procedure codes in June 2023 for use by health care professionals, health care organizations, and insurance providers to better support data collection, payment, and electronic health records.  CYTALUX was also recently assigned a unique Level II HCPCS code by CMS to support hospital claims submission.

The approval is effective October 1, 2023.

About On Target Laboratories, Inc.

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, is comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX, the Company’s first product, received FDA approval of a New Drug Application for ovarian cancer in November 2021 and a supplemental New Drug Application for lung cancer in December 2022. CYTALUX targets the folate receptors commonly found on many cancers, binds to the cancerous tissue, and illuminates under near-infrared light. A single dose of the agent is administered via intravenous infusion prior to surgery and assists surgeons in visually identifying additional cancerous tissue to be removed during the operation. For more information visit www.ontargetlabs.com and www.cytalux.com.