Announced transaction

Acquiring CATS Tonometer, LLC.

EarlySignal has entered into a definitive Membership Interest Purchase Agreement to acquire one hundred percent of the membership interests of CATS Tonometer, LLC, an Arizona limited liability company based in Tucson. On closing, CATS would become a wholly owned operating subsidiary and would continue its existing ophthalmic device business.

 

The business

A prism that measures the pressure inside the eye.

Intraocular pressure is the number an eye doctor relies on most when detecting and managing glaucoma. It has been measured the same way for sixty years, using a flat applanation prism mounted on a Goldmann tonometer.

CATS makes a patented replacement for that prism. According to CATS, its dual-curved applanation surface is designed to reduce measurement error caused by properties of the cornea — thickness, curvature, hysteresis and tear-film adhesion — and a rolled outer edge is intended to limit tear-film effects. CATS states that the prism is designed to be adopted with no change to a clinician’s technique, clinic workflow, patient throughput or instruments, because it fits existing Goldmann- and Perkins-type tonometers in place of the legacy prism.

CATS states that the prism has been cleared by the FDA for marketing in the United States in both reusable and single-use sterile disposable versions, and that it maintains issued United States utility and design patents together with foreign patents and design registrations in Australia, Canada, the European Union, India, Japan, Korea and Mexico, with further applications pending.

Source of these statements

The descriptions above, including any statements about performance, clearances and intellectual property, are the statements of CATS Tonometer, LLC and of the authors of the publications it references. They are not statements of EarlySignal Diagnostics, and EarlySignal has not independently verified them. Product details, configurations and pricing are set by CATS and may change at any time —see catsiop.com.

Product line

Four configurations, sold through ophthalmic distributors and direct.

Product Description  
CATS-R Reusable prism with the modified dual-curved applanation surface  
CATS-L Traditional flat-surface Goldmann-style prism  
CATS-D Sterile single-use disposable modified prism with a proprietary snap-fit attachment, boxed in hundreds  
Diagnostic set One CATS-R and one CATS-L supplied together  

Rationale

Why a device company sits alongside a genomics programme.

These are our management’s expectations for the transaction. They are forward-looking and may not be borne out.

An operating business

Existing products, customers, distribution relationships, manufacturing arrangements and intellectual property, rather than a plan for them.

Revenue potential in the near term

A commercial business with revenue, set against a pre-revenue development programme. We make no claim about the scale or profitability of that revenue.

Experience in a regulated environment

Day-to-day practice with FDA quality systems, labelling, complaint handling and adverse event reporting — the same disciplines our own product candidate will eventually be judged by.

A broader base

Two diagnostics businesses under one roof: one in ophthalmology today, one in oncology in development.

Status and disclosure

Where the transaction stands.

Structure

Purchase of 100% of the membership interests of CATS

On closing

CATS becomes a wholly owned operating subsidiary

Operations

The CATS business continues as it is today

Our focus

The MCED programme remains our principal business

Closing

Subject to customary conditions; not yet completed

The sellers of CATS are an entity and an individual affiliated with officers and directors of EarlySignal. Dr. Sean McCafferty, our President and Chief Executive Officer, is the founder and chief executive of CATS. Dr. Demetri Panayi, one of our directors, holds a minority interest in CATS. The transaction is accordingly a related-party transaction that was not negotiated at arm’s length, was not reviewed by any independent director or committee, and is not supported by an independent valuation, appraisal or fairness opinion. There can be no assurance that it will be completed.

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