Prima Donna

Introducing Project Prima Donna: the first-ever treatment designed to regenerate lost enamel to keep you smiling for a lifetime. Enamel erosion is an irreversible, age-related condition that no one is immune from, leading to tooth sensitivity, cavities, and more severe health complications. Current solutions, such as fluoride rinses, crowns, or veneers, merely mask the problem without addressing the root cause.

Spearheaded by renowned stem cell researchers and dentists Dr. Hannele Ruohola-Baker, Dr. Julie Mathieu, and Dr. Jonathan An, this project utilizes breakthroughs in induced pluripotent stem cell (iPSC) technology to develop enamel-regenerating organoids. These organoids have shown promising results in the lab and are now ready for testing in a relevant animal model. This is an important step towards developing a drug that can move us beyond mere symptom management, to restore our natural ability to produce enamel.

The global economic burden of poor oral health was estimated to be $544 billion in 2015, and oral health is the most prevalent non-transmissible disease worldwide. If successful, this treatment stands to significantly reduce the global burden of dental diseases and healthcare costs. Join us on our journey to revolutionize oral health and to create a future where aging never dims your brilliant smile.

Enamel is like the prima donna of our body - brilliantly shining, the center of attention, but also quite temperamental. It's the toughest material in our body, acting as a shield for our teeth against damage, guarding the softer, sensitive layer underneath called dentin. Despite our best efforts with brushing and a healthy diet, enamel wears down as we get older. This wear can lead to sensitive and yellowing teeth, cavities, and even more severe systemic issues like heart disease and respiratory infections. Unfortunately, once enamel is gone, it's gone for good, as it cannot regrow. Studies show that poor oral health, including tooth discoloration, can significantly impact mental well-being and quality of life. Over 90% of people around the globe face enamel loss during their lives, with no hope of seeing their prima donna ever again.

Current methods of combatting enamel loss in the dental health industry vary based on how severe the erosion is:

• In mild cases, dentists may provide fluoride or a remineralizing treatment to strengthen the remaining enamel.
• Advanced cases of enamel erosion can be addressed by tooth bonding, the application of a tooth-colored material known as resin to stained or damaged teeth to cover up discolorations and protect teeth. Alternatively, the teeth lacking enamel can be covered with veneers or dental crowns.
• Severe cases of erosion result in tooth loss, and require dental implants or dentures to replace the entire tooth or row of teeth

While there are existing methods to repair enamel, they require continued application and fail to address the cause of enamel loss. Plus, the understudy can never beat the original when it comes to bite, comfort, and overall oral health. Thus, there is an unmet need for a method of treatment that regenerates lost enamel around teeth and prevents further enamel loss in aging humans, so they can keep smiling for a lifetime.

Project Prima Donna focuses on the widespread problem of enamel erosion. The team has already developed a novel co-culture protocol in the lab for growing cells into organoids that produce enamel. In addition, initial animal studies using mice have shown that these organoids produce enamel when placed inside the kidney capsule - a key first experiment to first see whether these cells would survive.

After these early successful steps, the team is now ready to test the organoids in a more relevant animal model, by placing these organoids within the teeth of animals who will have their enamel eroded. In this way, it will be determined whether it's possible to grow enamel in the tooth, in the exact location where it's needed. Upon successful completion of these studies, the team will use the data to identify key pathways that can be targeted by a drug, and will then work on developing novel chemistry to be used as a therapy, that can ideally be applied as a gel, foam, or rinse.

For now, our primary focus is on harnessing the power of stem cells to confirm whether they can indeed facilitate the formation and regeneration of tooth enamel, a concept that has remained largely theoretical until recently, due to the groundbreaking discoveries of our group.

This direct treatment contrasts with currently available methods that only protect the remaining enamel. There is no existing regenerative solution for enamel erosion, giving Project Prima Donna a unique advantage. This approach could improve dental health outcomes and cut long-term healthcare costs. The project will explore options for use both at home and by professionals, offering a significant upgrade from temporary fixes. The global market for dental consumables purchased by dentists for their offices was valued at USD 27.4 billion in 2021, with restorative and preventative materials and treatments, including professionally applied whiteners, fluoride rinses, implants, and veneers comprising more than 50% of the market revenue. With the increased longevity of the population and continued education on the necessity of proper oral hygiene, this market will only continue to grow.

Patent strategy

The IP space surrounding enamel regeneration has little prior art and few competitors.

Current patents

In vitro models for enamel production

• Patent filed for ameloblast culture protocol in the US
• Patent filed for odontoblast culture protocol in the US Both patents are required for a cell culture model that produces enamel in vitro.

Patentable opportunities

• Development of novel chemical matter for enamel regeneration
• Formulations in combination with novel chemical
• Options to explore alternative uses for enamel production for medical and non-medical purposes based on its physiochemical properties: Biomaterials & Engineering

Little competition in this space makes this a compelling, novel opportunity.

Project Plan

The team is in a unique position to match any funds that have been raised on Catalyst, up to $200,000. The total project plan is USD $474,204 and the team needs your help! They are prepared to match funds up to USD $200,000; $100,000 will be matched per milestone.

The project is broken down into 2 fundraising moments:

1. Milestone 1: $253,541 needed → $100,000 match → therefore $153,541 needed to be raised on Catalyst for in vitro experiments
2. Milestone 2: $220,664 needed → $100,000 match → therefore $120,663 needed from a follow-on IPT crowdsale for in vivo experiments

Therefore, only ~$200k is needed from supporters to fund ~$400k worth of work.

Project Timeline and Costs

For the full funding application navigate to project documents.