Live Births from Vitrified and Replanted Whole Ovaries in Large Mammals

Simple summary

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CryoDAO’s purpose is to finance academic, research, and commercial projects in cryopreservation, including whole-organism biostasis. A project was submitted to CryoDAO, and our due diligence and an external scientific review had a positive outcome.

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The expected outcome of the project is to achieve the world’s first live births from vitrified and replanted whole ovaries in large animals (sheep).

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This will demonstrate, for the first time in history, that it is viable to recover complex organs from large mammals from ice-free storage at extremely low temperatures back into a state of full viability and functionality. The live births leave no doubts about the project results. This also has the potential to become the first human vascularized organ to get FDA approval for cryogenic vitrification, which in turn can help accelerate FDA paths for vital organs and beyond.

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Approval of this governance proposal enables CryoDAO to be forever part of this unprecedented achievement in scientific history, by being the sole funder/enabler of the live births.

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WG dealflow and team members have conducted a review and due diligence, and propose the project below to be funded by CryoDAO.

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Project description

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Gaia Life is a biotechnology company with a vision to preserve fertility, natural hormone balance and overall health and longevity in women by “stopping biological time” for human ovaries with cryopreservation, enabling later replantation to restore and extend hormone and/or fertility function.

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Gaia’s founding team has previously received millions in research funding from the Department of Defense and National Institutes of Health, including the National Cancer Institute and National Institute of Child Health and Human Development to support the R&D included in this project. It is proposed that CryoDAO add to the current funding in a way where it creates a significant multiplier effect, enabling a faster route to FDA approval, and thus to the patient.

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The NIH funding covers surgical recovery of entire sheep ovaries, vitrification, rewarming, and re-transplantation, followed by post-transplant evaluations.

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CryoDAO funding would further enable fertility trials, pregnancies and live births.

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Technology

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Gaia’s proprietary methods capitalize on the following technological and scientific breakthroughs their team contributed to:

1.  Nanowarming. Scalable and biocompatible nanowarming technology using radiofrequency excited iron oxide nanoparticles (IONPs) to uniformly warm large vitrified volumes (up to 80 mL) at >100°C/min, an order of magnitude faster than conventional warming and avoid both (i) ice crystallization and (ii) fracturing, while (iii) decreasing the total concentration of toxic cryoprotectants needed.
2.  Isochoric (constant volume, changing pressure) preservation. In an isochoric system, volumetric expansion that normally results from ice formation in a chilled solution is prevented by using a simple pressure-resistant constant volume chamber. This innovation enables: (i) better viability and function at lower concentrations of CPAs, (ii) higher temperature storage that still enables indefinite preservation, and (iii) minimal injury associated with freezing, cryoprotectant or osmotic toxicity, or fracturing.
3.  A proprietary automated ovary perfusion device.
4.  A proprietary whole-ovary vitrification solution.

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Team

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The founders have strong previous track records in developing, commercializing, and bringing, through FDA and via exit/IPO, lifesaving technology and logistical infrastructure for organ preservation and cancer treatment to patients.

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The Gaia Life Team is led by President/CEO/Cofounder, Dr. Bradley Weegman, who has over 15 years of experience in developing organ preservation technologies including with his previous company, as a co-founder and Chief Operating Officer. Dr. Weegman is leading the broader scientific and commercialization efforts for reproductive organ preservation technologies and oncofertility, including 3 independent research projects in this area with active and ongoing funding from the NIH and previous funding also from the DOD. Dr. Ting, is our Chief Science Officer and co-founder of Gaia Life, who has over 15 years of experience with cryopreservation and over 20 years of experience with reproductive biology and their applications to fertility preservation for young cancer patients. She has led another NIH Phase II project as the Principal Investigator on whole ovary cryopreservation and replantation in large animal models (sheep and porcine) and developed a small organ perfusion system for perfusion whole ovaries with her previous company. Dr. Sebastian Eriksson Giwa, Cofounder and Chairman of Gaia Life, is a Harvard MBA and Baker Scholar with significant biotech, medtech and business experience including successfully raising multi-million-dollar funding from leading VC and industry investors.

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Scientific Review Results

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Reviewer 1
Scientific Merit 4/5
Feasibility, Impact, Budget 4/5
Team 5/5
Overall 4.5

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Reviewer 2
Scientific Merit 5/5
Feasibility, Impact, Budget 5/5
Team 4/5
Overall 4.5

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Please consult the project proposal for a detailed implementation timeline.
https://drive.google.com/file/d/1iwD1fuKYvg1kBHTnrg7me7CziWK53Li-

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