Periodic Reporting for period 1 - Embryospin (Increasing IVF success rate through the first magnetic resonance system for embryonic quantitative analysis at the cell scale)
Reporting period: 2018-12-01 to 2019-05-31
In Vitro Fertilization (IVF) is one of the most common Assisted Reproductive Technologies (ART). A proper selection of the embryo to be transferred represents a crucial part of IVF procedures. Indeed, the choice of the healthiest and most lively embryo for the transfer is essential to reach a high percentage of pregnancy rates. Such a delicate procedure is nowadays performed by optical morphological analysis, which is a microscopy based qualitative observation of embryo’s morphological markers. The lack of quantitative markers causes a disappointing percentage of successful IVF cycles of about 33%, which leads to important issues like undesirable multiple pregnancies, the emotional stress of repeating IVF treatments and increased costs for both patients and national health systems. Annaida Technologies is developing Embryospin, which is the first Nuclear Magnetic Resonance (NMR) device able to perform NMR analysis at embryo scale. It allows a non-invasive quantitative analysis of the embryos to be implanted, thus making the embryo selection more reliable and increasing the success rate of first embryos’ implantations in IVF.
The unprecedented sensitivity of Embryospin makes it also extremely useful for research labs and universities, enabling new potential discoveries and applications.
The Phase 1 Project objectives are:
Technical Feasibility:
• Goal 1: Definition of the final features of the NMR device;
• Goal 2: Description of the laboratory tests performed on the Measuring Unit, prototypes, casing and probe insert. Definition of a set of markers to ensure the highest accuracy and effectiveness during the analysis;
• Goal 3: Definition of the measuring protocol;
• Goal 4: Certification of materials biocompatibility;
Business Feasibility:
• Goal 1: Validation of the expected benefits, of the pricing, and the distribution network;
• Goal 2: Market Analysis: estimation of the potential demand and understanding of the entry barriers;
• Goal 3: Financial projections.
The unprecedented sensitivity of Embryospin makes it also extremely useful for research labs and universities, enabling new potential discoveries and applications.
The Phase 1 Project objectives are:
Technical Feasibility:
• Goal 1: Definition of the final features of the NMR device;
• Goal 2: Description of the laboratory tests performed on the Measuring Unit, prototypes, casing and probe insert. Definition of a set of markers to ensure the highest accuracy and effectiveness during the analysis;
• Goal 3: Definition of the measuring protocol;
• Goal 4: Certification of materials biocompatibility;
Business Feasibility:
• Goal 1: Validation of the expected benefits, of the pricing, and the distribution network;
• Goal 2: Market Analysis: estimation of the potential demand and understanding of the entry barriers;
• Goal 3: Financial projections.
Technical Feasibility:
• Goal 1 - Definition of the final features of the NMR device:
During the phase 1 project, the proposed technology has been validated by means of interactions with key stakeholders. As a result, the final attributes and specifications for the main blocks that compose the Embryospin solution have been defined;
• Goal 2 - Description of the laboratory tests performed on the Measuring Unit, prototypes, casing and probe insert. Definition of a set of markers to ensure the highest accuracy and effectiveness during the analysis:
Several tests have been conducted to evaluate the performance of the Embryospin solution, with particular reference to embryo’s metabolism.
• Goal 3 - Definition of the measuring protocol:
During the phase 1 project, there were several interactions with embryologists from IVF clinics, which represent Annaida’s potential key customers, in order to define a measuring protocol, which is in line with their best practices related to embryo manipulation.
• Goal 4 - Certification of materials biocompatibility:
Tests to certify the safety of materials have been successfully conducted using standard Mouse Embryo Assays
Business Feasibility:
• Goal 1 - Validation of the expected benefits, of the pricing, and the distribution network:
The Embryospin’s business model have been validated by means of interactions with key stakeholders. As a result, the Embryospin’s value proposition and Annaida’s value chain have been defined.
• Goal 2 - Market Analysis: estimation of the potential demand and understanding of the entry barriers:
A market analysis has been performed, estimating the Embryospin addressable and obtainable market. By means of interactions with prospected customers, the main entry barriers have been identified, finding the associated counteractions.
• Goal 3 - Financial projections:
Multi-annual economic and financial projections have been outlined, in order to derive economic indicators that can support the investment decision.
• Goal 1 - Definition of the final features of the NMR device:
During the phase 1 project, the proposed technology has been validated by means of interactions with key stakeholders. As a result, the final attributes and specifications for the main blocks that compose the Embryospin solution have been defined;
• Goal 2 - Description of the laboratory tests performed on the Measuring Unit, prototypes, casing and probe insert. Definition of a set of markers to ensure the highest accuracy and effectiveness during the analysis:
Several tests have been conducted to evaluate the performance of the Embryospin solution, with particular reference to embryo’s metabolism.
• Goal 3 - Definition of the measuring protocol:
During the phase 1 project, there were several interactions with embryologists from IVF clinics, which represent Annaida’s potential key customers, in order to define a measuring protocol, which is in line with their best practices related to embryo manipulation.
• Goal 4 - Certification of materials biocompatibility:
Tests to certify the safety of materials have been successfully conducted using standard Mouse Embryo Assays
Business Feasibility:
• Goal 1 - Validation of the expected benefits, of the pricing, and the distribution network:
The Embryospin’s business model have been validated by means of interactions with key stakeholders. As a result, the Embryospin’s value proposition and Annaida’s value chain have been defined.
• Goal 2 - Market Analysis: estimation of the potential demand and understanding of the entry barriers:
A market analysis has been performed, estimating the Embryospin addressable and obtainable market. By means of interactions with prospected customers, the main entry barriers have been identified, finding the associated counteractions.
• Goal 3 - Financial projections:
Multi-annual economic and financial projections have been outlined, in order to derive economic indicators that can support the investment decision.
With Embryospin, embryos are analysed using a disposable probe at day-3 or day-5, prior to implantation, and the results are immediately available, which is in line with the standard workflow of an IVF clinic. The Embryospin solution offers IVF clinics the following unique selling points:
• Unprecedented sensitivity: exploiting micro-NMR potential, Embryospin allows quantitative analysis of embryo metabolites such as glucose and lactate, creating new markers for embryo selection and improving IVF success rate;
• Safe embryo analysis: NMR analysis offered by Embryospin is a completely non-invasive and safe technique;
• Ease of use: the Embryospin device is very user friendly and can be operated with minimal training. The results of analysis are instantly displayed on the connected computer, allowing fast selection processes
Socio-economic impact and societal implications of the project include:
• To patients and NHSs: A significantly increased success rate at first IVF cycle, which leads to huge savings for patients and NHSs
• To patients: Increased pregnancy rate after a single IVF cycle, which is poised to have a huge societal impact, by considerably decreasing the time-to-pregnancy, avoiding the emotional stress related to a failed attempt, and the physical stress due to undergoing several treatment cycles.
• To IVF clinics: Increased reputation for IVF clinics, which will be able to offer their patients a more effective treatment with a significantly higher success rate at first cycle. During our interactions with IVF clinics, it has emerged that an increased success rate can attract a wider customer base, which is extremely important in a highly competitive market as the ART
• Unprecedented sensitivity: exploiting micro-NMR potential, Embryospin allows quantitative analysis of embryo metabolites such as glucose and lactate, creating new markers for embryo selection and improving IVF success rate;
• Safe embryo analysis: NMR analysis offered by Embryospin is a completely non-invasive and safe technique;
• Ease of use: the Embryospin device is very user friendly and can be operated with minimal training. The results of analysis are instantly displayed on the connected computer, allowing fast selection processes
Socio-economic impact and societal implications of the project include:
• To patients and NHSs: A significantly increased success rate at first IVF cycle, which leads to huge savings for patients and NHSs
• To patients: Increased pregnancy rate after a single IVF cycle, which is poised to have a huge societal impact, by considerably decreasing the time-to-pregnancy, avoiding the emotional stress related to a failed attempt, and the physical stress due to undergoing several treatment cycles.
• To IVF clinics: Increased reputation for IVF clinics, which will be able to offer their patients a more effective treatment with a significantly higher success rate at first cycle. During our interactions with IVF clinics, it has emerged that an increased success rate can attract a wider customer base, which is extremely important in a highly competitive market as the ART