April 2022 Ravata Newsletter

Introduction

Thank you for reading Ravata’s monthly newsletter where we aim to keep our friends, customers, collaborators, and future partners informed of Ravata’s news.  In this issue, we will cover why Ravata is commercializing in animal applications prior to human IVF success.

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BREAKING NEWS!

Ravata Solutions has received a “Notice of Allowance” from the US Patent and Trademark Office for its platform’s application of “Microelectrode Techniques for Electroporation” which includes approaches for viability selection. This protects Ravata’s consumables and the interaction with our hardware upon which further work has been developed for commercial embryo applications.

What’s next?

Today, Ravata answers some commonly asked questions.

1. What steps will take you to the Human Market?

Ravata intends to follow the commercial and regulatory milestones listed below:

  • Launch a commercial system for Animal IVF

  • Define Indication for use with FDA regarding Human IVF

  • Complete Pre-Clinical Studies 

  • Submit IRB for Clinical Trials 

  • Submit FDA 510(k)

  • Achieve Regulatory Compliance 

  • Launch a commercial system for Human IVF

2. What does pre-medical device revenue look like? 

In 2021 the Mouse and Bovine IVF market was worth a combined $470 million and is expected to grow due to the desire to increase yields and sustainability through genetics management. The annual TAM from this market is approximately $40M driven largely by improving pregnancy success rates. Increased relevance of precision medicines for human therapeutics, sustainable food production, and more resilient livestock herds will contribute to the continued use of IVF for animal husbandry in mice and cattle. 

Innovation Adoption Curve: Ravata is currently in the Early Adopters phase of the Innovation Adoption Curve, which means we are publicly accepted as innovators and are in the process of carefully fine-tuning any new ideas to fit the company.

3. What are the pertinent regulations?

Currently, the FDA regulates animal feed, pesticide and drug use, grooming aids, and drug use; none of these are relevant to Ravata’s Animal IVF revenue potential. The USDA focuses on the preservation of animal welfare but has few specifics regarding animal reproduction processes. Finally, the system is classified as scientific equipment under FCC rules 47 CFR Part 18 so Ravata’s bio-chip technology is not subject to stringent emissions regulations. This allows a wide range of animal research trials to be conducted with little to no regulatory barriers. 

4. What value do animal IVF applications provide and is it a distraction?

Bringing a novel diagnostic directly to humans through the FDA is notoriously expensive and slow. This is due to a requirement to prove efficacy and safety in identifying specific diagnostic measurements and their relationship to medical conditions. The clinical trial requirements for IVF diagnostic will rely on an assessment of pregnancy outcomes which will result in each cohort requiring over 9 months of study with a limited quantity of suitable study participants. 

By working with animal embryos Ravata will have access to over 7.5 million embryos annually through our customers which will provide an enormous experimental base of measurements for pregnancy outcomes. The high volume of information collected from animal embryo testing generates invaluable sensor and AI training data. Additionally, the magnitude of the research gives opportunities for metabolic discovery, which can aid scientists in the development of treatments for metabolic disorders. It is Ravata’s ultimate goal to create a bio-chip of excellent quality that can eventually be used in human clinics and produce long-term revenue through licenses and patents.

We Need help!

We are surveying the assisted reproduction landscape to identify the needs of embryologists, lab techs, and directors nationwide regardless of the mammalian species they work with.

Please help us gain traction in this endeavor by forwarding our survey to anyone you believe fits the demographic. Survey results will be shared with respondents and via newsletter!

Regards,

Ravata Team