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Innovation & Technologie Angebot

Non invasive personalized vision correction with light

Country of Origin: Italy
Reference Number: TOIT20190307002
Publication Date: 7 March 2019

Summary

Italian medtech company focused on development of innovative medical devices for eye care, which has developed a theranostic medical device able to correct visual disability caused by keratoconus with non-invasive reshaping of the cornea through real time estimation of treatment efficacy, is looking for partners in India, China, USA, Canada and Brazil,  able to sell and distribute the product under commercial agreement with technical assistance, or financial agreement.

Description

The co-founders and shareholders of the Italian company hold both medical and technological expertise. The team is supported by a FDA (Food and Drug Administration) approved factory of medical devices for eye care and advisors with expertise in corneal surgery, management and innovation technology for eye care.
Its mission is to meet the medical needs of eye doctors through inventive scientific and technological solutions.
Keratoconus is a progressive, ectatic, corneal disease, characterized by stromal thinning and weakening that leads to corneal distortion; it is the primary cause of corneal transplantation worldwide. In recent years, riboflavin/UV-A corneal cross-linking has been shown to be a valid treatment for halting disease progression. The gold standard surgical protocol (i.e., the Dresden protocol) has enough evidence to be often effective for the management of progressive keratoconus, though severe safety concerns have been raised by several clinical studies. For this reason, novel intervention protocols have been developed. These, however, show high variability of clinical outcomes, related to the unknown rate of penetration of riboflavin into the corneal tissue and to its effective photodegradation by UV-A light irradiation. State-of-the-art technologies are therefore unable to assist the surgeon on how to best tailor the treatment.
The medical device developed by the company is the first theranostic medical device in eye care opening a new frontier in the personalized treatment of keratoconus. Theranostics is a combination of therapy and diagnostics; it is considered the pathway to what has been termed personalized and precision medicine, which makes use of real-time non-invasive molecular analysis to achieve optimal treatment outcomes in the management of disease. The device is the only able to give access to the non-invasive measurement of intracorneal riboflavin and its photodegradation during treatment; it assists the surgeon on how to best tailor the procedure to each patient’s eye in order to reduce the occurrence of treatment failure and the risk of human error without increasing current treatment costs.
The main features of this medical device include the non-invasive detection of riboflavin in the corneal tissue and the measurement of the concentration of such chromophore in the cornea. The inventive technology of the instrument is based on registration of the corneal tissue images by means of a RGB (Red Green Blue) camera during treatment. The images are processed and analysed by a proprietary algorithm that, by measuring the fluorescence emitted from the intracorneal riboflavin when illuminated by UV-A light, calculates in real time the concentration of riboflavin with a sensitivity of 5x10-6 g/cm3. The device enables surgeons, through computerized image analysis, to estimate treatment efficacy in real time, thus achieving significant corneal stiffening on a personal basis via optimized UV-A light irradiation on tissue. The theranostic technology developed presents an enormous potential for the future. The product is ready to be implemented with:
- artificial intelligence capable of enhancing the product’s performance by learning from data;
- cloud computing platform for remote data collection and analysis in order to maximize product’s performance across intelligent IoT (Internet-of-Things) network;
- refractive module for inducing a predictive reshaping of the anterior cornea without incisions in order to correct for low grade myopia and presbyopia.
The company is interested to sign commercial agreement with technical assistance (to find partners interested in selling and distributing the product in extra-EU territories, including, but not limited, to India, China, USA, Canada, and Brazil) or financial agreement (to find equity investors, including venture capital firms, interested to accelerate the firm’s business plan).

Advantages and Innovations

The medical device performs image-guided photodynamic therapy of corneal disorders; it provides real time measures of treatment efficacy and assists the operator to perform personalized surgery. Thanks to proprietary patented technology, corneal reshaping is realized without incisions; this in turn provides the option to repeat treatment for improving vision caused by progressive ocular disorders, such as keratoconus. Their expertise in the field and their IP strategy are the main barriers to our competitors.

Stage Of Development

Available for demonstration

Stage Of Development Comment

The medical technology (hardware and software) has been successfully demonstrated in a pre-clinical environment using human eye bank donor corneal tissues. The experimental results, which have been published in two major scientific journals, have shown that the device is reliable in determining the intracorneal concentration of riboflavin and the stiffening effect of corneal cross-linking on the human cornea. The product is going to be engineered for passing tests for CE approval by Q1-2020; it requires improvements in ergonomics, interface and connectivity; further industrialization work is needed to enable scaling up the manufacturing while reducing the cost per unit. The Technology Readiness Level (TRL) has therefore approached 6.

Requested partner

For commercial agreement with technical assistance, the ideal partner should be already active in the health sector, preferably with knowledge of the ophthalmic market sector. The desired outcome would be to expand the business to emerging markets and provide technical assistance to customers through international partnership.
For financial Agreement, the firm is looking for equity investors, which may be interested to accelerate the firm’s business plan. The equity investor would enter into a creative medtech firm hosting serial inventors whose vital scope is to improve prevention and treatment of eye disorders on a personal basis.

Dissemination Countries

Brazil, China, India, USA

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