A Point-of-Care Biomarker Diagnostic Platform…

Infectious Diseases, Human Ophthalmology & More

A Dry Eye & Biomarker Diagnostic Platform

Summary of the Diagnostic Technology Platform

The LacriPen

LacriSciences, LLC is a pre-clinical Delaware corporation based in Baltimore, MD. LacripenThe Company has developed a novel hand held device (the LacriPen, Figure 1) utilizing proprietary Surface Plasmon Resonance (SPR) technology that can perform a wide range of diagnostic functions, including rapid point-of-care quantitative measurement of analytes in various bodily fluids within seconds. The device can be used in vivo with bodily fluids such as urine, saliva, mucus, vaginal fluid, serum, etc., plus in vitro measurements such as the quantitative determination of biomarkers in tear film for Eyecare.

Disposable, single use sensor cap

The LacriPen utilizes a low-cost single use disposable plastic sensor cap (Figure 2) which is made specific for virtually any target substance whose chemical constituents are being identified and measured (an analyte) through the attachment of analyte-specific antibodies or genetic markers to the small (1×3 mm) inexpensive gold surface of the cap, i.e., the sensing surface. The biochemistries for attaching biofilms to the gold-coated sensor cap have been designed in such a way that not only can many different antibodies and genetic markers be used with the pen, but these bio-sensing films can be reproducibly deposited in a high-throughput manner using an in-house robotic bioprinter.

The LacriPen is approximately six inches long, lightweight (approx. 25 g), battery-powered and features blue tooth capability to transmit “results” data from the Pen. Its generic software allows compatibility with external electronic medical record systems. The lithium-ion rechargeable battery is capable of continuous use for 8+ hours and is simply recharged by placing it in a holder (like a toothbrush) for a few hours. The Pen has an onboard Cortex-M4 microprocessor which enables rapid signal processing and for its onboard proprietary algorithms to determine the concentration level of an analyte — typically within one second. The ability to readily amend the onboard firmware and software allows the LacriPen to be quickly updated to add new analyte tests (with corresponding sensor caps). The simplicity of the Pen, coupled with user-friendly audible and visual outputs, enables rapid testing of either patient samples or patients themselves by either a technician or physician, requiring only simple basic training on techniques for use.

Point-of-Care Diagnostic Applications

The design of the LacriPen, its associated software and the single-use sensor with specific printable biofilms has positioned the Pen as a true platform technology that can be readily adapted to test a variety of both in vivo and in vitro human or animal fluids for the presence of any biomarker, and particularly analytes associated with viral, bacterial or fungal pathologies. Moreover, the use of the platform to quantitate a new target biomarker can be rapid, where only the software and sensor biofilm need to modified / tailored to the new biomarker. As a platform technology, the LacriPen is ideally positioned to diagnose and quantitate both current and emerging diseases.

Corporate Structure

LacriSciences owns the SPR Technology Intellectual Property Portfolio (see IP Section) and is the majority owner of LacriSciences Vision, Inc., the EyeCare/ophthalmology subsidiary, a Delaware corporation that has a License Agreement to the SPR Technology in the Field of Human Ophthalmology. LacriSciences is currently in the process of establishing a second market-based subsidiary in the Field of Infectious Diseases, which would include Respiratory Viruses (like COVID-19 and Respiratory Syncytial Virus), Sexually-Transmitted and other infectious diseases. LacriSciences has also identified additional future verticals for the SPR Technology in the Fields of Women’s Health, Veterinary Medicine and Food Safety Testing. Alternatively, LacriSciences and its vertical subsidiaries could be acquired, with certain market-based verticals possibly remaining standalone companies.

LacriSciences Vision, Inc.

In 2020 LSHC formed LacriSciences Vision Inc. (LSV) to commercialize its SPR Diagnostic Technology in the Field of Human Ophthalmology. LSV initially focused on the two biomarkers commonly associated with Dry Eye Disease, Osmolarity (measuring the salt content of tears) and Matrix Metalloproteinase-9 or MMP-9 (a primary biomarker for inflammation). Following regulatory delays relating to COVID and a de-emphasis in Dry Eye by LSV’s strategic partner, together with some advances in producing biofilm-based analytes, LSV is currently working on a broader spectrum of EyeCare-related analytes, including allergy biomarkers (histamines, tryptase, IgG and IgE), bacterial and viral conjunctivitis (Pink Eye and Adenovirus), Inflammation (cytokines), MRSA and Herpes. Reimbursement rates exist for many of these Eyecare tests.

To the best of LSV’s knowledge there are no current competing ocular diagnostic testing technologies that offer quantitative rapid point-of-care testing for a broad range of ophthalmic diseases and conditions, LSV is currently seeking funding to complete its clinical study requirements for Osmolarity and MMP-9.

COVID/Infectious Diseases

LacriSciences is currently in active discussions for its SPR testing technology with participants in the COVID and Infectious Disease markets, that are seeking an alternative rapid point-of-care quantitative testing technology to replace PCR, QPCR and RT-QPCR. LacriSciences’ SPR technology appears to be an excellent candidate, providing a rapid (results in seconds) point-of-care test that also provides highly accurate quantitative results. LacriSciences is evaluating the use of its antibody linker technology to deposit a COVID-based biofilm on its single-use sensor caps to quantitate COVID antibodies for determining the feasibility of a rapid COVID or Infectious Disease test. If successful, a second vertical will be formed to develop a version of the LacriPen for testing in the field of Infectious Diseases.

Capital Requirements

LSV has funded its technology development to date with ~$8M from various investors. Depending on development scope, target market and investor preferences, LacriSciences can develop a customized budget and deliverables ranging in cost from $1.0-4.5M and five to 14 months. Additional details regarding budget options are available upon request.

LacriSciences IP Portfolio

LSHC’s patent portfolio is summarized in the table below. Including foreign filings, LSHC has 13 Patents issued and allowed (7 in the US), with another 19 pending. In addition, LSHC has an additional twenty matters protected as Trade Secrets and owns trademarks on the names LacriPen and VersaPen.